Intraocular lens capsular injector and intraocular lens capsular injection assembly

Abstract

Intraocular lens capsular injector and intraocular lens capsular injection assembly. The intraocular lens capsular injector includes: an injector head, the injector head includes a first hollow tube body, and the tube inside the first hollow tube body is a first tube; an injector grip, including a second hollow tube body, and the tube inside the second hollow tube body is a second tube; an injector handle, including a handle rod and an injection core connected together; the injector head and the injector grip are connected, the rear end of the first hollow tube body is connected to the front end of the second hollow tube body, and the second tube communicates with the first tube; the handle rod is located inside the second tube, and the handle rod can slide inside the second tube; the injection core is located inside the second tube, and the injection core can move inside the second tube and the first tube. The intraocular lens capsular injector is used for the implantation of an intraocular lens capsule.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to an intraocular lens capsular injector and an intraocular lens capsular injection assembly. Background Art

[0002] The lens consists of a lens capsule, lens epithelium, lens fibers, and zonular fibers. The zonular fibers connecting the lens capsule and the lens, together with the iris, form the lens-iris diaphragm system, which divides the eyeball into anterior and posterior segments. The anterior and posterior segment structures play important roles in the anatomy and physiology of the eyeball.

[0003] Ophthalmic lens diseases clinically include: Marfan syndrome, traumatic lens subluxation and total dislocation, iatrogenic lens capsule rupture and zonular fiber injury, etc.

[0004] These ophthalmic lens diseases can cause defects or even absence of the lens capsule and zonular fibers. Once the capsule is defective, it is easy to cause problems such as the inability to fix the intraocular lens during surgery or the displacement of the intraocular lens after surgery. And the absence of the capsule will lead to the inability to implant an intraocular lens using the traditional in-lens-capsule fixation method. Summary of the Invention

[0005] The problem solved by the present invention is to provide an intraocular lens capsule to solve the problem of the inability to implant an intraocular lens caused by the absence of the capsule.

[0006] To solve the above problem, the present invention provides an intraocular lens capsule, including: a capsule main body, the capsule main body being a flexible and foldable bag body with a capsule opening; a capsule support and fixation structure, the capsule support and fixation structure including a first shape memory alloy body and a second shape memory alloy body; the first shape memory alloy body and the second shape memory alloy body penetrate through the capsule main body; in the implanted state of the intraocular lens capsule, the first shape memory alloy body and the second shape memory alloy body enclose an annular structure, and the annular structure is located inside the capsule main body to be used for stretching and expanding the capsule main body, so that the capsule main body can load an intraocular lens; in the injection state of the intraocular lens capsule, the first shape memory alloy body and the second shape memory alloy body are straightened into a linear structure, and the capsule main body is wound around the linear structure.

[0007] Optionally, the capsule main body is integrally in a flattened spherical shape with the capsule opening.

[0008] Optionally, the capsule support and fixation structure further includes a first fixing wing and a second fixing wing, the first fixing wing is connected to the first ends of the first shape memory alloy body and the second shape memory alloy body, and the second fixing wing is connected to the second ends of the first shape memory alloy body and the second shape memory alloy body.

[0009] Optionally, the intraocular lens capsular bag further includes a first fixing rod and a second fixing rod. The first fixing rod is used to fix the first fixing wing to the eye, and the second fixing rod is used to fix the second fixing wing to the eye.

[0010] Optionally, the first fixing wing has a first through hole. The length of the first fixing rod is greater than the length of the first through hole. The first fixing rod passes through the first through hole and both ends protrude from the first through hole. Both ends of the first fixing rod are used to be fixed on the scleral surface or between the scleral layers of the eye. The second fixing wing has a second through hole. The length of the second fixing rod is greater than the length of the second through hole. The second fixing rod passes through the second through hole and both ends protrude from the second through hole. Both ends of the second fixing rod are used to be fixed on the scleral surface or between the scleral layers of the eye.

[0011] Optionally, the second fixing wing is further connected with a guiding tail rod; or, the second fixing wing is further connected with a guiding tail tube.

[0012] Optionally, the lengths of the first fixing wing and the second fixing wing are half of the lengths of the first fixing rod and the second fixing rod.

[0013] Optionally, the materials of the first fixing wing, the second fixing wing, the first fixing rod, the second fixing rod and the guiding tail rod are PMMA.

[0014] Optionally, the materials of the first shape memory alloy body and the second shape memory alloy body are titanium shape memory alloy.

[0015] Optionally, the material of the capsular bag body is acrylate.

[0016] The advantages of the intraocular lens capsular bag of the present invention include:

[0017] 1. It can be used for the implantation of an intraocular lens to solve the problem of inability to implant an intraocular lens caused by the lack of the capsular membrane.

[0018] 2. Its structure enables it to be used for loading various different types of intraocular lenses. Since the intraocular lens capsular bag (capsular bag body) itself has a regular structure, the capsular bag body is a flat spherical structure with a capsular bag opening, and the capsular bag body is flexible. Therefore, it can ensure the correct position of the intraocular lens after surgery and can ensure the correct position of the intraocular lens after surgery.

[0019] 3. Due to its structural characteristics, it has different states, and thus its implantation method is unique, enabling minimally invasive implantation. Only two small incisions (such as 3 mm) need to be made on the scleral surface, with little damage. At the same time, suture stitching is avoided, making it convenient to use.

[0020] To solve the above problems, the present invention also provides an intraocular lens capsular injector, comprising: an injector head, the injector head includes a first hollow tube body, and the pipeline inside the first hollow tube body is a first pipeline; an injector grip, the injector grip includes a second hollow tube body, and the pipeline inside the second hollow tube body is a second pipeline; an injector handle, the injector handle includes a handle rod and an injection core connected together; the injector head and the injector grip are connected, the rear end of the first hollow tube body is connected to the front end of the second hollow tube body, and the second pipeline is communicated with the first pipeline; the handle rod is located inside the second pipeline, and the handle rod can slide inside the second pipeline; the injection core is located inside the second pipeline, and the injection core can move inside the second pipeline and the first pipeline.

[0021] Optionally, the injection core is a solid rod, or the injection core is an open tube, or the injection core is a semi-solid rod with a nozzle at the end.

[0022] Optionally, the injector head further includes a guiding groove, and the guiding groove is connected to the rear end of the first hollow tube body; when the injector head and the injector grip are connected, the guiding groove is inserted into the second pipeline.

[0023] Optionally, the guiding groove is a groove body with a semi-circular tubular structure.

[0024] Optionally, the side surface of the guiding groove has a pair of connecting wings; the pipe wall of the second hollow tube body has a connecting groove opened from the end face inwards; when the injector head and the injector grip are connected, the connecting wings are inserted into the connecting groove.

[0025] Optionally, the inner diameter of the second pipeline is equal to the outer diameter of the first hollow tube body, and when the injector head and the injector grip are connected, the end face of the second hollow tube body and the connecting wings form an annular stepped surface.

[0026] Optionally, the injector grip further includes a pair of gripping wings, and the gripping wings are symmetrically located on the outer side wall of the second hollow tube body.

[0027] Optionally, the injector handle further includes a tail plate, and the tail plate is connected to the rear end face of the handle rod.

[0028] The advantages of the intraocular lens capsular injector of the present invention include:

[0029] 1. Adopting a split design, it can place the implanted intraocular lens capsule and conveniently realize the implantation of the corresponding intraocular lens capsule.

[0030] 2. It can be used to implant the corresponding intraocular lens capsule bag through a small incision (such as 3 mm). The small incision only needs to be able to pass the head of the injector, with a small wound and low risk;

[0031] 3. The components of each part are compact in structure, convenient to use, and low in manufacturing cost.

[0032] To solve the above problems, the present invention also provides an intraocular lens capsule bag injector assembly, including the intraocular lens capsule bag injector as described above, and further including a guide. The guide includes a holding portion and a guide tube, and the guide tube is connected to the lower side of the holding portion. The intraocular lens capsule bag injector assembly further facilitates the implantation process of the intraocular lens capsule bag. Description of the Drawings

[0033] Figure 1 It is a schematic diagram of the intraocular lens capsule bag provided by the embodiment of the present invention in the implanted state;

[0034] Figure 2 It is Figure 1 A schematic diagram of the intraocular lens capsule bag shown after omitting the capsule bag body;

[0035] Figure 3 It is Figure 1 A schematic diagram of the intraocular lens capsule bag shown in the first transition state;

[0036] Figure 4 It is Figure 3 A schematic diagram of the intraocular lens capsule bag shown after omitting the capsule bag body;

[0037] Figure 5 It is Figure 1 A schematic diagram of the intraocular lens capsule bag shown in the second transition state;

[0038] Figure 6 It is Figure 1 A schematic diagram of the intraocular lens capsule bag shown in the injection state;

[0039] Figure 7 It is Figure 1 A schematic diagram of the side of the capsule bag body of the intraocular lens capsule bag shown;

[0040] Figure 8 It is Figure 1 An enlarged schematic diagram of the first fixing wing in the intraocular lens capsule bag shown;

[0041] Figure 9 It is a schematic diagram after the first fixing rod and Figure 8 the first fixing wing shown cooperate;

[0042] Figure 10 It is a schematic diagram of the injector head of the intraocular lens capsule bag injector provided by the embodiment of the present invention;

[0043] Figure 11 It is a schematic diagram showing the connection between the injector grip part and the injector handle in the intraocular lens capsular injector provided by the embodiment of the present invention;

[0044] Figure 12 It is a schematic diagram of the injector handle of the intraocular lens capsular injector provided by the embodiment of the present invention;

[0045] Figure 13 is Figure 11 It is an enlarged schematic diagram of the front-end part structure of the shown injector grip part;

[0046] Figure 14 It is a schematic diagram of the assembled intraocular lens capsular injector provided by the embodiment of the present invention;

[0047] Figure 15 It is a schematic diagram of the guide in the intraocular lens capsular injector assembly;

[0048] Figure 16 It is a schematic diagram of the intermediate state of the intraocular lens capsular injector and the intraocular lens capsule during the implantation of the intraocular lens capsule. Detailed implementation manners

[0049] For the defects or absences of the lens capsule and zonular fibers, the current clinical solution is to adopt the method of suspending the intraocular lens with sutures. The disadvantages of this method include:

[0050] (1) Not all types of intraocular lenses can be sutured and suspended;

[0051] (2) Since the intraocular lens is sutured and fixed manually in the intraocular lens suture suspension, it is very difficult to achieve a completely balanced tension for each intraocular lens loop. Therefore, the intraocular lens often deviates during or after the operation, affecting the postoperative vision of the patient;

[0052] (3) Adopting the suture fixation method, in the long term (it is pointed out in the literature that it is more than 10 years), suture degradation may occur, resulting in the displacement or posterior dislocation of the intraocular lens, and a second operation is required.

[0053] For the situation of partial defect of the lens capsule or partial rupture of the zonular fibers, some other current clinical solutions are to adopt the method of implanting a capsular tension ring. This method has the following disadvantages:

[0054] (1) This method cannot be used for patients with complete absence of the capsule;

[0055] (2) Implanting a capsular tension ring still needs to be fixed by the natural lens zonular fibers. However, for patients with poor development of their own zonular fibers such as Marfan syndrome, there is still a risk of intraocular lens displacement in the long term;

[0056] (3) If an improved suture - type capsular tension ring is implanted, due to unbalanced suture forces, the intraocular lens is prone to displacement after surgery, affecting the visual quality of the patient. Moreover, when using the suture - fixation method, there is a risk of displacement of the intraocular lens - tension ring complex caused by long - term suture degradation.

[0057] The inventor analyzed that if there are defects or absences in the lens capsule and zonular fibers, it is considered to implant an intraocular lens capsule. However, currently in clinical practice, there are no reports on intraocular lens capsule products.

[0058] The inventor of the present invention proposes an intraocular lens capsule that can be minimally invasively implanted (e.g., 3 mm) through a scleral incision without sutures. The implantation process of this intraocular lens capsule can be used in conjunction with a special injector. Therefore, the present invention also provides an injector specifically for implanting the intraocular lens capsule.

[0059] For a clearer illustration, the present invention will be described in detail below with reference to the accompanying drawings.

[0060] An embodiment of the present invention provides an intraocular lens capsule. Please refer to Figures 1 to 9 .

[0061] As Figure 1 , the intraocular lens capsule provided in this embodiment includes a capsule body 110 and a capsule support and fixation structure (not fully labeled).

[0062] The capsule body 110 is a flexible and foldable bag body with a capsule opening 111.

[0063] The capsule support and fixation structure includes a first shape - memory alloy body 121 and a second shape - memory alloy body 122. The first shape - memory alloy body 121 and the second shape - memory alloy body 122 penetrate through the capsule body 110. Figure 1 And Figure 3 Both show that the first shape - memory alloy body 121 and the second shape - memory alloy body 122 penetrate through the capsule body 110.

[0064] Figure 1 What is shown is the structure of the intraocular lens capsule in the implanted state. The capsule body 110 is in a natural unfolded state and can be used to implant the corresponding intraocular lens.

[0065] The first shape - memory alloy body 121 and the second shape - memory alloy body 122 located inside the capsule body 110 enclose an annular structure (the annular structure is not separately labeled, refer to Figure 2 the corresponding content). The annular structure is located inside the capsule body 110 to expand and unfold the capsule body 110, so that the capsule body 110 can load the intraocular lens.

[0066] Among them, Figure 2 is Figure 1In the figure, the structure after omitting the display of the capsular bag body 110 is shown, that is, the structure of the capsular bag support and fixation framework alone, and it is the structural form of the capsular bag support and fixation framework in the implanted state (or when it is initially fabricated). From Figure 2 It can be seen that the first shape memory alloy body 121 and the second shape memory alloy body 122 enclose a circular structure as described above. The diameter of the circular structure is about 10 mm, and the circular structure serves to support the capsular bag body 110. Figure 2 It can also be seen in the figure that in addition to enclosing the circular structure in the middle, both ends of the first shape memory alloy body 121 still have a straight rod structure (not labeled) respectively, and both ends of the second shape memory alloy body 122 still have a straight rod structure (not labeled) respectively. These straight rod structures can be set to be relatively short, such as 1 - 2 mm, etc.

[0067] The existence of the above - mentioned straight rod structures makes the cooperation between the first shape memory alloy body 121 and the second shape memory alloy body 122 and the capsular bag body 110, as well as the cooperation between the first shape memory alloy body 121 and the second shape memory alloy body 122 and the subsequent fixing wings, easier. However, in other embodiments, the above - mentioned straight rod structures may not be required.

[0068] The first shape memory alloy body 121 and the second shape memory alloy body 122 are made of shape memory metal alloy materials. When the external force is removed, the state is as Figure 2 shown.

[0069] Figure 6 What is shown is that in the injection state of the intraocular lens capsular bag, the first shape memory alloy body 121 and the second shape memory alloy body 122 are straightened into a linear structure, and the capsular bag body 110 is wound around the linear structure.

[0070] Figure 1 This is both the form (state) in the implanted state and the form of the initially fabricated intraocular lens capsular bag. Therefore, after the intraocular lens capsular bag is fabricated, in order to achieve the subsequent implantation process, it is necessary to first adjust the intraocular lens capsular bag from the Figure 1 shown form to the Figure 6 shown form. Therefore, the corresponding process of Figures 1 to 6 needs to be referred to.

[0071] Among them, Figure 3 and Figure 5shows the first transitional state and the second transitional state of the intraocular lens capsule. As described above, this is because the intraocular lens capsule provided in this embodiment includes two states. One is the deployed state after implantation, that is, the implanted state; the other is the injection state (at this time, the first shape memory alloy body 121 and the second shape memory alloy body 122 are straightened, and the capsule body 110 is folded and wound around the first shape memory alloy body 121 and the second shape memory alloy body 122 in a scroll shape). In order to switch between the two states, corresponding intermediate transitional states are also required. Figure 3 For the first transitional state, that is, before the implanted state, the first shape memory alloy body 121 and the second shape memory alloy body 122 are straightened, but the capsule body 110 is not folded. Therefore, the capsule body 110 is not wound around the first shape memory alloy body 121 and the second shape memory alloy body 122 either. Figure 5 For the second transitional state, which is also before the implanted state, the capsule body 110 is only a schematic of a folded shape in half, and the capsule body 110 is also not wound around the first shape memory alloy body 121 and the second shape memory alloy body 122. Additionally, Figure 4 is Figure 3 the structure after removing the capsule body 110 in the first transitional state shown. At this time, the first shape memory alloy body 121 and the second shape memory alloy body 122 are in a linear structure.

[0072] Please refer to Figure 7 , which shows the side view structure of the capsule body 110. The capsule body 110 is an overall oblate spherical bag body with a capsule opening 111. When viewed from the side, it is an oblate spherical structure with two faces. One of the two faces corresponds to Figure 1 the front shown in Figure 1 (it has a capsule opening 111 with a circle of about 5.5 mm in diameter at its center, and the capsule opening 111 serves as the implantation hole for the intraocular lens). The other face of the two faces is the back, that is, the inner bottom back corresponding to the inside of the opening 111 in

[0073] In this embodiment, the capsule body 110 is a foldable capsule bag body, specifically a flexible foldable bag body. Among them, the material of the capsule body 110 can be acrylate to ensure the corresponding flexibility. The material of the capsule body 110 can be hydrophilic acrylic or hydrophobic acrylic.

[0074] In other embodiments, the capsule body 110 may also be other polymer materials, as long as it can be implanted into the eye, is transparent and stable without deformation.

[0075] Please refer to Figures 1 to 6, in this embodiment, the capsular support and fixation structure further includes a first fixing wing 123 and a second fixing wing 124. The first fixing wing 123 is connected to the first ends (not labeled) of the first shape memory alloy body 121 and the second shape memory alloy body 122, and the second fixing wing 124 is connected to the second ends (not labeled) of the first shape memory alloy body 121 and the second shape memory alloy body 122. Moreover, each fixing wing is connected to the end of the straight rod structure of each shape memory alloy body (when there is no straight rod structure, Figure 1 and Figure 2 the fixing wing is directly connected to the annular structure).

[0076] In this embodiment, Figure 8 shows an enlarged structure of the first fixing wing 123. The hollow pipe of the first fixing wing 123 is the first through hole 1230. That is to say, the first fixing wing 123 has the first through hole 1230.

[0077] As Figure 9 , Figure 9 associated with Figure 8 , it further shows that the intraocular lens capsule of this embodiment further includes a first fixing rod 140 and a second fixing rod (the second fixing rod is not shown and can refer to the first fixing rod 140). The first fixing rod 140 is used to fix the first fixing wing 123 on the eye, and the second fixing rod is used to fix the second fixing wing 124 on the eye.

[0078] In this embodiment, the length of the first fixing rod 140 is greater than the length of the first through hole. The first fixing rod 140 passes through the first through hole and both ends protrude from the first through hole; both ends of the first fixing rod 140 are used to be fixed on the scleral surface or between the scleral layers of the eye.

[0079] It should be noted that although not shown in the figure, in this embodiment, the second fixing wing 124 also has a second through hole. The length of the second fixing rod is also greater than the length of the second through hole. The second fixing rod passes through the second through hole and both ends protrude from the second through hole; both ends of the second fixing rod are used to be fixed on the scleral surface or between the scleral layers of the eye. That is to say, the first fixing wing 123 can be in the shape of a hollow cylinder, and the second fixing wing 124 can also be in the shape of a hollow cylinder.

[0080] As can be seen from the above, the shapes of the two fixing wings in this embodiment can be the same. For example, the fixing wing can specifically be a cylindrical hollow column with a circular hollow pipe with a diameter of 1 mm.

[0081] As can be seen from the above, the first fixing rod 140 and the second fixing rod in this embodiment can both be cylindrical small rods with conical shapes on both sides, Figure 9The first fixing rod 140 shown in the figure may have a diameter of 0.9 mm and a length (total length) of 4 mm. The fixing rod is designed as a conical cylindrical rod to facilitate passing through the hollow pipe in the center of the fixing wing and fixing it on the scleral surface or between the scleral layers. Figure 9 It is shown in the figure that the first fixing rod 140 passes through the first through hole 1230 of the first fixing wing 123 (as Figure 8 ), and both ends of the first fixing rod 140 are used to fix at the corresponding positions on the eye (correspondingly, both ends of the second fixing rod are also used to fix at the corresponding positions on the eye). At this time, the fixing rod can be fixed at the corresponding part of the eye like a nail, so that the whole intraocular lens capsule can be fixed on the eye without suture, avoiding suture stitching, and thus seamless fixation can be achieved.

[0082] In other embodiments, the tip of the fixing rod can be set to be relatively blunt (not Figure 9 the spiked shape in the figure).

[0083] In this embodiment, furthermore, the lengths of the first fixing wing 123 and the second fixing wing 124 can be half of the lengths of the first fixing rod 140 and the second fixing rod.

[0084] In other embodiments, the lengths of the first fixing wing 123 and the second fixing wing 124 can both be 2 mm, the outer diameters of the cylindrical shapes of the first fixing wing 123 and the second fixing wing 124 can both be 2 mm, and the inner diameters can be 1 mm (it should be noted that the ratio in the figures here is slightly different from the listed data. This also indicates that in other embodiments, these dimensions can be adjusted).

[0085] In this embodiment, the side of the first fixing wing 123 is connected to the first ends of the first shape memory alloy body 121 and the second shape memory alloy body 122, and the side of the second fixing wing 124 is connected to the second ends of the first shape memory alloy body 121 and the second shape memory alloy body 122.

[0086] It should be noted that in other embodiments, the combination of the fixing wing and the fixing rod (rod) can also be Figure 9 other shapes than this, for example, it can be cylindrical, obtuse square, and further preferably can be an ergonomic shape conforming to the outer ring shape of the eyeball, a shape similar to an Australian boomerang.

[0087] It should be noted that in other embodiments, the shapes of the first fixed wing and the second fixed wing can be deformed accordingly. For example, the two fixed wings can be in the shape of an arrow with a fold (in this case, the corresponding fixed rod is not required), or the fixed wing has a structure with an elastic ejection device (in this case, the corresponding fixed rod is not required), the fixed wing is in the shape of an inflatable sphere (in this case, the corresponding fixed rod is not required), and the fixed wing has a hollow spiral fixing cap, such as a square, a hexagon, or a threaded button shape (in this case, the corresponding fixed rod is not required). Generally speaking, the connection method between the fixed wing and the fixed rod can be integrally formed, reversely folded and fixed, or the end is enlarged and fixed, etc., and the fixed rod can be omitted.

[0088] Please refer to Figures 1 to 6 , in this embodiment, the second fixed wing 124 is further connected with a guiding tail rod 125.

[0089] It should be noted that in other embodiments, the second fixed wing can also be connected with a guiding tail tube. The designs of the guiding tail rod and the guiding tail tube are related to the pusher core of the subsequent injector. Please refer to the subsequent content of this specification.

[0090] In this embodiment, the opposite side of the second fixed wing 124 is connected to the guiding tail rod 125. The diameter of the guiding tail rod 125 can be 1 mm, and the length can be 2 - 20 mm.

[0091] In this embodiment, the materials of the first fixed wing 123, the second fixed wing 124, the first fixed rod 140, the second fixed rod, and the guiding tail rod 125 can be PMMA. That is, in this embodiment, the fixed wings on both sides and the guiding tail rod 125 made of PMMA material are selected. At the same time, correspondingly, the fixed rod is made of PMMA material. The use of PMMA material for medical devices has been relatively mature.

[0092] This embodiment is an intraocular lens capsular bag made using the shape memory alloy principle. Shape memory alloys generally refer to shape memory alloys (SMA).

[0093] This embodiment can use shape memory alloy materials and other materials to make Figure 1 the intraocular lens capsular bag as shown. After that, the entire capsular bag support and fixation structure can be straightened first, and then the flexible capsular bag body 110 can be wound around the folded capsular bag support and fixation structure;

[0094] Since the capsular bag body 110 itself is made of a polymer film, it has a certain film adhesion effect, especially the film made of acrylate material. After winding it around the capsular bag support and fixation structure, the overall intraocular lens capsular bag can be maintained Figure 6 in the state as shown; or, in other cases, in order to ensure that the capsular bag body 110 is maintained Figure 6If the shown state is not released, a small amount of viscoelastic agent can be used to stick the bag body 110, and then these viscoelastic agents can be aspirated in the eye during subsequent surgeries;

[0095] After that, after the intraocular lens bag is sent to the corresponding position in the eye, by bypassing the corresponding bag body 110, the bag support and fixation structure can slowly and naturally unfold due to the "memory" function of the first shape memory alloy body 121 and the second shape memory alloy body 122. This process can be assisted by a certain external force to slowly restore the intraocular lens bag back to Figure 1 the shown shape (this process is carried out step by step, and the middle part of the bag support and fixation structure can retract into the bag body 110). From Figure 1 the shown state, the bag body 110 unfolds, and the parts of the first shape memory alloy body 121 and the second shape memory alloy body 122 located inside the bag body 110 are restored to an annular structure (as Figure 2 shown), and the annular structure keeps the bag body 110 in a stretched and unfolded state, so that the bag body 110 can be used for the implantation of various existing intraocular lenses in the future.

[0096] In this embodiment, the materials of the first shape memory alloy body 121 and the second shape memory alloy body 122 can specifically be titanium shape memory alloy, that is, they can adopt titanium alloy memory materials.

[0097] It should be noted that on the basis of the first shape memory alloy body 121 and the second shape memory alloy body 122 penetrating the bag body 110, when the first shape memory alloy body 121 and the second shape memory alloy body 122 are pulled into a straight line shape, the plane where these two straight line shapes are located is parallel to the bag opening 111, that is, the first shape memory alloy body 121 and the second shape memory alloy body 122 penetrate the bag body 110 along the direction parallel to the plane where the bag opening 111 is located.

[0098] It should be noted that the ring (ring structure) formed by the first shape memory alloy body 121 and the second shape memory alloy body 122 has corresponding through holes (not shown) passing through the part of the capsule main body 110. However, these through holes are holes with fixed sizes, that is, the holes through which the first shape memory alloy body 121 and the second shape memory alloy body 122 pass through the capsule main body 110. The relative positions of the through holes and the first shape memory alloy body 121 and the second shape memory alloy body 122 are not fixed. Thus, it is ensured that the first shape memory alloy body 121 and the second shape memory alloy body 122 can move back and forth a certain distance through these through holes, and further, the first shape memory alloy body 121 and the second shape memory alloy body 122 can undergo structural changes to achieve different states. For example, in the implanted state, the turning parts (the turning parts are the connection positions of the aforementioned straight rod structure and the ring structure) of the first shape memory alloy body 121 and the second shape memory alloy body 122 are exactly located within the through holes to be used for positioning the position of the capsule main body 110 after the ring structure is restored, so as to make the capsule main body 110 in the correct position. Correspondingly, when the first shape memory alloy body 121 and the second shape memory alloy body 122 are straightened into a straight line state, more parts of them are exposed outside the through holes.

[0099] The intraocular lens capsule provided by the embodiment of the present invention can be used to replace the natural lens capsule to restore the anatomical structure of the lens-iris diaphragm and solve the problem of inability to implant an intraocular lens caused by the lack of the capsule membrane.

[0100] The intraocular lens capsule provided by the embodiment of the present invention can be used to load various different types of intraocular lenses and can assist in implanting posterior chamber intraocular lenses of all current design types. Moreover, by using the intraocular lens capsule provided by the embodiment of the present invention, since the intraocular lens capsule (capsule main body 110) itself has a regular structure, the capsule main body 110 has a regular open oblate spherical structure, and the capsule main body 110 is flexible, thus, it can ensure that the intraocular lens is in the correct position after the operation.

[0101] The intraocular lens capsule provided by the embodiment of the present invention has different states due to its structural characteristics, and further leads to a unique implantation method (please continue to refer to the subsequent content of the specification), so that minimally invasive surgery can be achieved. Only 2 small incisions (such as 3 mm) are made on the scleral surface, with little damage; at the same time, suture stitching is avoided, and it is convenient to use.

[0102] All kinds of materials used in the embodiment of the present invention are well compatible with the human body, have no rejection, and have high safety. The corresponding production materials are all existing mature materials, which have been clinically applied for a long time and can be used for life without replacement.

[0103] The embodiment of the present invention also provides an intraocular lens capsule injector.

[0104] Please refer to Figures 10 to 14, the intraocular lens capsular injector includes:

[0105] An injector head (not labeled), such as Figure 10 , the injector head includes a first hollow tube body 211, and the tube inside the first hollow tube body 211 is the first tube (not labeled);

[0106] An injector grip (not labeled), such as Figure 11 , the injector grip includes a second hollow tube body 221, and the tube inside the second hollow tube body 221 is the second tube (not labeled);

[0107] An injector handle (not labeled), such as Figure 11 and Figure 12 , the injector handle includes a handle rod 231 and an injection core 232 connected together;

[0108] The injector head and the injector grip are connected, such as Figure 14 , the rear end of the first hollow tube body 211 is connected to the front end of the second hollow tube body 221, and the second tube communicates with the first tube;

[0109] The handle rod 231 is located inside the second tube, and the handle rod 231 can slide inside the second tube;

[0110] The injection core 232 is located inside the second tube, and the injection core 232 can move inside the second tube and the first tube.

[0111] Figure 14 What is shown is a schematic diagram of the assembled intraocular lens capsular injector. It can be seen that the injector head is located at the frontmost end, the injector grip is located in the middle, the injector handle is located at the rearmost end, and a part of the injector handle extends into the injector grip (in this embodiment, the front and rear are defined as follows: the position closer to the human eye during the surgical process is the front, and the position farther from the human eye during the surgical process is the rear).

[0112] Figure 12 It further shows that the handle rod 231 and the injection core 232 are usually connected front and rear, and the injection core 232 extends forward along the front end face of the handle rod 231.

[0113] In this embodiment, the injection core 232 is an open tube body. Correspondingly, at this time, the second fixing wing 124 of the foregoing embodiment is connected to the guiding tail rod 125. In this way, the injection core 232 can cooperate with the guiding tail rod 125. By inserting the guiding tail rod 125 into the injection core 232 (open tube body), the intraocular lens capsular injector can be better used to inject the intraocular lens capsule.

[0114] In other embodiments, the injection core can also be a solid rod, or the injection core can be a semi-solid rod with a nozzle at its end. Specifically, when the second fixing wing of the foregoing embodiment is connected with a guiding tail tube, the injection core can be a solid rod; when the second fixing wing of the foregoing embodiment is connected with a guiding tail rod, the injection core can also be a semi-solid rod with a nozzle.

[0115] Please return for reference Figure 10 , the injector head further includes a guiding groove 212, and the guiding groove 212 is connected to the rear end of the first hollow tube 211. When the injector head and the injector grip are connected, the guiding groove 212 is inserted into the second pipe.

[0116] Please return for reference Figure 10 , in this embodiment, a pair of connecting wings 213 are provided on the side surface of the guiding groove 212. The pipe wall of the second hollow tube 221 has a connecting groove 223 opened from the end face inward (refer to Figure 13 ). When the injector head and the injector grip are connected, the connecting wings 213 are inserted into the connecting groove 223.

[0117] It should be noted that in this embodiment, the guiding groove 212 is a groove body, but the connecting groove 223 is a groove space.

[0118] Figure 13 Shows Figure 11 In the structure shown, a schematic enlarged view of the front-end part structure of the second hollow tube 221.

[0119] It should be noted that, Figure 13 Shows that the connecting groove 223 does not penetrate through the entire pipe wall of the second hollow tube 221 in this embodiment. However, in other embodiments of the present invention, the connecting groove can penetrate through the pipe wall of the second hollow tube from the inside to the outside.

[0120] In this embodiment, the inner diameter of the second pipe is equal to the outer diameter of the first hollow tube 211 (obviously, the outer diameter of the second hollow tube 221 is greater than the outer diameter of the first hollow tube 211). When the injector head and the injector grip are connected, the end face (front end face) of the second hollow tube 221 and the connecting wings 213 form an annular stepped surface. The annular stepped surface is a position that can prevent the injector grip from entering the corresponding surgical wound.

[0121] It should be noted that by making full use of the above-mentioned circular stepped surface, it is possible to prevent the disconnection between the head of the injector and the grip part of the injector during use. Specifically, since the circular stepped surface is formed by inserting the connecting wing 213 into the connecting groove 223, if glue is applied to the circular stepped surface or some fixing rings are put on (the fixing rings can be hung on the following gripping wings 222 through other structures), it can better prevent the connecting wing 213 from disengaging from the connecting groove 223 during use, that is, prevent the disconnection between the head of the injector and the grip part of the injector. When it is necessary to separate the head of the injector and the grip part of the injector, the corresponding anti-disconnection effect can be released by removing the glue or the fixing rings.

[0122] In this embodiment, the grip part of the injector further includes a pair of gripping wings 222, and the gripping wings 222 are symmetrically arranged on the outer side wall of the second hollow tube body 221.

[0123] In this embodiment, the injector handle further includes a tail plate 233, and the tail plate 233 is connected to the rear end face of the handle rod 231. The tail plate 233 increases the area of the tail of the injector handle, making the injector more comfortable to use.

[0124] In this embodiment, the head of the injector specifically may include a first hollow tube body 211 with a diameter of 2 mm (a hollow cylinder, and the inside is the first pipeline), and the length of the first hollow tube body 211 may be 20 mm. The first pipeline may also be referred to as a guiding pipeline.

[0125] In this embodiment, the first hollow tube body 211 is connected with a guiding groove 212, and the groove body of the guiding groove 212 may be connected to and integrally formed with the first hollow tube body 211.

[0126] In this embodiment, the guiding groove 212 is a groove body with a semi-cylindrical tubular structure. That is, the guiding groove 212 may specifically be a semi-cylindrical tubular structure (semi-hollow cylinder) with the side bottom facing upwards, as Figure 10 shown, the guiding groove 212 can place the artificial lens capsule (refer to the corresponding content of the foregoing embodiment). In Figure 10 only the guiding tail rod 125 of the artificial lens capsule is shown, and the other parts of the artificial lens capsule have been placed in the first pipeline of the first hollow tube body 211 in an implanted state.

[0127] The length of the guiding groove 212 may be 20 mm. The length of the guiding groove 212 may be approximately equal to the length when the first shape memory alloy body 121 and the second shape memory alloy body 122 of the artificial lens capsule are in a straight line, or may be slightly less than the length when the first shape memory alloy body 121 and the second shape memory alloy body 122 are in a straight line. The radius of the guiding groove 212 may be 1 mm (that is, the diameter is also 2 mm).

[0128] The length of the first pipeline, that is, the length of the first hollow tube body 211, can be equal to the length when the first shape memory alloy body 121 and the second shape memory alloy body 122 are in a straight line, or slightly greater than the length when the first shape memory alloy body 121 and the second shape memory alloy body 122 are in a straight line.

[0129] In this embodiment, the two sides of the guiding groove 212 are symmetrically connected to a pair of connecting wings 213. The connecting wings 213 can be in a cuboid structure, with a length of 15 mm, a width of 10 mm, and a thickness of 2 mm (it should be noted that the corresponding dimensional ratios are not shown in the figure).

[0130] The materials of the various parts of the intraocular lens capsular injector provided in this embodiment can be selected as medical PVC materials that are resistant to high temperature and high pressure.

[0131] The intraocular lens capsular injector provided by the embodiment of the present invention adopts a split design, can place the intraocular lens capsule in an implanted state, and realizes the implantation of the corresponding intraocular lens capsule.

[0132] For the intraocular lens capsular injector provided by the embodiment of the present invention, due to the split design, the head of the injector can be designed to be smaller, so it can be used to implant the corresponding intraocular lens capsule through a small incision (such as 3 mm). The small incision only needs to be able to pass through the head of the injector, with a small wound and low risk.

[0133] The intraocular lens capsular injector provided by the embodiment of the present invention has a compact structure for each part, is convenient to use, and has a low manufacturing cost.

[0134] The overall structure of the intraocular lens capsular injector provided by the embodiment of the present invention can adopt PVC materials. The materials are mature, can be sterilized by high temperature and high pressure, and are convenient for production.

[0135] For the intraocular lens capsular injector provided by the embodiment of the present invention, its injection power structure (injector handle) can also be integrally formed, with smooth implantation and convenient pushing.

[0136] For the intraocular lens capsular injector provided by the embodiment of the present invention, a hollow injection tube is designed (the injector grip and the injector head are in communication, and the injector head can completely incorporate the guiding tail rod 125 on the intraocular lens capsule body, or the guiding tail rod 125 can be exposed in the guiding groove 212 first). When pushing later, it is stable and convenient.

[0137] The intraocular lens capsular injector provided by the embodiment of the present invention has an integrated injector head, that is, a first hollow tube body 211 and a guiding groove 212 (receptor groove) with an integrated structure. The main body length of the injector head can be greater than 15 mm (that is, the length of the first hollow tube body 211 is greater than 15 mm), which is convenient for the whole to penetrate the eyeball.

[0138] An embodiment of the present invention further provides an intraocular lens capsular bag injection assembly.

[0139] Please refer to Figure 15 , the injection assembly includes the intraocular lens capsular bag injector provided in the foregoing embodiment, and further includes a guide (not labeled).

[0140] The guide includes a holding portion 311 and a guide tube 312. The guide tube 312 is connected to the lower side of the holding portion 311. Among them, the orifice of the guide tube 312 is an inclined orifice, and this inclined orifice helps to realize the functional role of the guide.

[0141] The holding portion 311 of the guide can be a cuboid structure, its length can be 5 mm, its width can be 5 mm, and its height can be 10 mm. There is a hollow pipe cylindrical structure with an inclined surface near the bottom surface on one side of the holding portion 311, that is, the guide tube 312. The pipe diameter of the guide tube 312 can be 2.5 mm, so that the injector head with a diameter of 2 mm (refer to the corresponding content of the foregoing embodiment) can be sleeved. The appearance of the guide tube 312 can be 3 mm, and its length can be 10 mm.

[0142] The material of each part structure of the guide provided in this embodiment can also be selected as a medical PVC material that is resistant to high temperature and high pressure.

[0143] In summary, the intraocular lens capsular bag injection assembly provided in this embodiment, in addition to having an intraocular lens capsular bag injector, also has a guide, and the guide can make the actual surgical operation simpler and more convenient. Please refer to the subsequent content of this specification.

[0144] In summary, the present invention provides an intraocular lens capsular bag and an intraocular lens capsular bag injector, and further provides an intraocular lens capsular bag injection assembly including the intraocular lens capsular bag injector and the guide together.

[0145] Please refer to in combination Figures 1 to 16 , using the intraocular lens capsular bag injection assembly of the present invention (including the intraocular lens capsular bag injector and the guide), the implantation of the intraocular lens capsular bag of the present invention can be realized, and the process can be as follows:

[0146] Make a conjunctival incision at the 10:00 and 4:00 positions of the cornea of the eye, and a rectangular scleral flap of 3 mm×4 mm can be made. The thickness of the flap is about 1 / 2 - 1 / 3 mm:

[0147] Use a 3 mm scleral puncture knife to make a transparent corneal assistant incision, and inject viscoelastic agent into the anterior chamber to support the anterior chamber with the viscoelastic agent;

[0148] Use a 3-mm scleral puncture knife to puncture the sclera under the scleral flap or 1-2 mm posterior to the corneal limbus on the scleral surface in the iris orientation to form two corresponding scleral implantation ports with a length of 3 mm;

[0149] Take out the intraocular lens capsule bag (after taking out, it is in a state of being pushed, as Figure 6 shown), place it in the guiding groove 212 of the intraocular lens capsule bag injector, and push the whole intraocular lens capsule bag into the first hollow tube 211 along the guiding groove 212 in advance, and only the guiding tail rod 125 at the rear end can be left, as Figure 10 shown;

[0150] Align the hollow injection tube (i.e., the injection core 232) of the injector handle with the guiding tail rod 125 and insert it. Connect the injector head with the injector grip and the injector handle. Fix it by embedding the connecting wing 213 of the injector head into the connecting groove 223 of the injector grip to form a state where injection can be performed, as Figure 14 ;

[0151] Hold the intraocular lens capsule bag injector with the right hand facing up, insert the injector head from the scleral implantation port at the 10:00 position, and insert the guide of the intraocular lens capsule bag injection assembly into the scleral implantation port at the 4:00 position (as Figure 15 ). Guide the injector head to penetrate the scleral surface from the scleral implantation port at the 4:00 position through the guide in the intraocular pupil area. Gently push the injector handle to push out the first fixing wing 123 of the intraocular lens capsule bag from the injector head. The state at this time is as Figure 16 shown (the eye is not shown), Figure 16 It also shows that a part of the first shape memory alloy body 121, the second shape memory alloy body 122 and the capsule bag main body 110 has also been pushed out from the injector head;

[0152] It can be in the state as Figure 16 shown (or it can be in the state at a previous time, that is, when only the first fixing wing 123 is pushed out). Hold the first fixing rod 140 with the left hand using a microscopic non-toothed forceps and pass it through the first through hole 1230 of the first fixing wing 123 (refer to the corresponding content above), and make the first fixing wing 123 located at the midpoint of the first fixing rod 140. The first fixing rod 140 and the first fixing wing 123 are both outside the scleral surface;

[0153] Then, while retracting the whole injector, push the injector handle to implant the intraocular lens capsule bag into the eye;

[0154] Withdraw the injector head from the scleral implantation port at the 10:00 position, leaving the second fixing wing 124 and the guiding tail rod 125 outside the sclera. At this time, the left hand can hold a microsurgical non-toothed forceps to clamp a second fixing rod (not shown) through the second through hole (hollow tube) of the second fixing wing 124, and make the second fixing wing 124 located at the midpoint of the second fixing rod. The second fixing rod and the second fixing wing 124 are together located at another position outside the scleral surface;

[0155] Use microsurgical intraocular forceps to lift the folded capsular bag body 110 from the limbal auxiliary incision, so that the shape memory metal restores the annular structure (that is, the first shape memory alloy body 121 and the second shape memory alloy body 122 restore the annular structure), and support the entire capsular bag body 110 to unfold. As the shape memory metal restores the annular structure, both fixing wings will slowly approach the sclera (especially the second fixing wing 124 approaching the sclera). When the final annular structure is formed, the second fixing wing 124 is clamped to the outer surface of the sclera by the second fixing rod assembly to achieve the corresponding fixing effect;

[0156] After that, it is possible to check whether the position of the intraocular lens capsular bag is in place. If it is not in place, continue to adjust. When it is confirmed to be in place, the guiding tail rod 125 can be cut off with a microsurgical scissors close to the outside of the second fixing wing 124;

[0157] Reset the scleral flap, suture the scleral flap or suture the scleral puncture port to prevent eye leakage, close the conjunctival incision. After that, almost any type of existing posterior chamber intraocular lens can be implanted through the limbal incision in the normal intraocular lens implantation method. The intraocular lens is placed through the opening 111 on the front surface of the capsular bag body 110. The intraocular lens can be fixed in the eye by the intraocular lens capsular bag of this embodiment. After that, an ia head (automatic aspiration needle) or a manual aspiration head can be used to aspirate the viscoelastic agent in the eye (if the corresponding viscoelastic agent is used in the capsular bag body 110, it can be aspirated together at this time);

[0158] After that, the incision can be hydrated to complete the surgery.

[0159] It should be noted that in other surgical methods, the above scleral flap may not be made, and only a scleral incision needs to be made instead of the above scleral flap.

[0160] The intraocular lens capsular bag provided by the present invention can be provided in sets and can have 8 - 11 different specifications to meet the needs of adults and children. Correspondingly, the intraocular lens capsular bag injector can also have 8 - 11 different specifications, and the intraocular lens capsular bag injection assembly can also have 8 - 11 different specifications accordingly.

[0161] Although the present invention is disclosed as above, the present invention is not limited thereto. Any person skilled in the art can make various changes and modifications without departing from the spirit and scope of the present invention. Therefore, the protection scope of the present invention should be subject to the scope defined by the claims.

Claims

1. An intraocular lens capsular injector, characterized in that, Comprising: A syringe head, the syringe head comprising a first hollow tube body, and the tube inside the first hollow tube body being a first tube; A syringe grip, the syringe grip comprising a second hollow tube body, and the tube inside the second hollow tube body being a second tube; A syringe handle, the syringe handle comprising a shank and a plunger core connected together; The syringe head and the syringe grip are connected, the rear end of the first hollow tube body is connected to the front end of the second hollow tube body, and the second tube communicates with the first tube; The shank is located inside the second tube, and the shank can slide inside the second tube; The plunger core is located inside the second tube, and the plunger core can move inside the second tube and the first tube; The syringe head further comprises a guiding groove, the guiding groove being connected to the rear end of the first hollow tube body; when the syringe head and the syringe grip are connected, the guiding groove is inserted into the second tube; The side surface of the guiding groove has a pair of connecting wings; The tube wall of the second hollow tube body has a connecting groove opened from the end face inwards; When the syringe head and the syringe grip are connected, the connecting wings are inserted into the connecting groove; The guiding groove is used for placing an intraocular lens capsule bag; the intraocular lens capsule bag comprises a capsule bag body and a capsule bag support and fixation framework; the capsule bag support and fixation framework comprises a first shape memory alloy body and a second shape memory alloy body; in the injection state of the intraocular lens capsule bag, the first shape memory alloy body and the second shape memory alloy body are straightened into a linear structure, and the capsule bag body is wound around the linear structure; the capsule bag support and fixation framework further comprises a first fixing wing and a second fixing wing, and the second fixing wing is further connected with a guiding tail rod.

2. The intraocular lens capsular injector according to claim 1, wherein, The plunger core is a solid rod, or the plunger core is an open tube, or the plunger core is a semi-solid rod with a tube orifice at the end.

3. The intraocular lens capsular injector according to claim 1 or 2, characterized in that, The guiding groove is a groove body in a semi-circular tubular structure.

4. The intraocular lens capsular injector according to claim 1 or 2, characterized in that, The inner diameter of the second tube is equal to the outer diameter of the first hollow tube body, and when the syringe head and the syringe grip are connected, the end face of the second hollow tube body and the connecting wings form an annular stepped surface.

5. The intraocular lens capsular injector according to claim 1, wherein, The syringe grip further comprises a pair of gripping wings, and the gripping wings are symmetrically arranged on the outer side wall of the second hollow tube body.

6. The intraocular lens capsular injector according to claim 1, wherein, The syringe handle further comprises a tail plate, and the tail plate is connected to the rear end face of the shank.

7. An intraocular lens capsular injection assembly, characterized in that, Comprising the intraocular lens capsule bag injector according to any one of claims 1 to 6, further comprising a guide, the guide comprising a gripping part and a guiding tube, and the guiding tube being connected to the lower side of the side face of the gripping part.

8. The intraocular lens capsular injection assembly according to claim 7, wherein, The orifice of the guiding tube is an inclined orifice.

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