Bag tension ring assembly and using method thereof

Abstract

The invention discloses a capsular bag tension ring assembly which comprises a capsular bag tension ring, a suture line and a suture needle, one end of the suture line is connected with the capsular bag tension ring, and the other end of the suture line is connected with the tail of the suture needle. The invention further discloses a using method of the capsular bag tension ring assembly, and the using method comprises the following steps that S1, the capsular bag tension ring is stored in a releaser needle tube, and the suture line and the suture needle are located outside the needle tube; s2, one end of a suture is fixed to the capsular bag tension ring, then the suture and the capsular bag tension ring are implanted into the lens capsular bag together, and the suture is adjusted to be located in the center of the dislocation capsular bag; and S3, inserting a needle from the main incision, penetrating through the anterior chamber and passing through the rear part of the iris, withdrawing the needle from the edge of the keratosclera, fixing the capsular bag tension ring by using a suture technology after withdrawing the needle, and keeping the lens capsular bag, the capsular bag tension ring and a suture in the center and constant, so that the artificial lens is safely implanted and the dislocation condition is corrected. The invention is mainly used for maintaining the stability of the lens capsular bag in the moderate and severe lens imperfect dislocation operation.

Description

Technical Field

[0001] The present invention relates to the technical field of ophthalmic appliances, and in particular to a capsular bag tension ring assembly and a use method thereof. Background Art

[0002] The lens is an important component of the eye's refractive system and the only structure that can adjust the refractive power. Under normal circumstances, the lens is connected to the ciliary body through the lens suspensory ligament, keeping its anterior-posterior axis aligned with the visual axis. Due to hereditary autosomal dominant genetic diseases (Marfan syndrome, Weill-Marchesani syndrome, etc.), trauma or multiple systemic diseases, the lens suspensory ligament may be partially or completely loose or broken, causing the lens to deviate from its anatomical position. This condition is called subluxation of the lens. According to the proportion of the exposed part of the lens to the entire pupil area after mydriasis, the degree of subluxation of the lens can be divided into three levels: mild (0-25%), moderate (25%-50%), and severe (more than 50%). Moderate and severe subluxation of the lens can manifest as progressive blurred vision, monocular diplopia, and even secondary angle-closure glaucoma, leading to a poor prognosis. Therefore, effective intervention is very urgent. In this case, preserving the posterior capsule is the key to preventing complications such as glaucoma, IOL dislocation, and vitreoretinopathy.

[0003] At present, intraocular lens (IOL) suspension, various new capsular bag auxiliary devices, scleral suture fixation of the capsular bag, and implantable capsular hook are commonly used in clinical practice, as follows:

[0004] IOL suspension: This method does not retain the capsular bag, and there are serious tilt, eccentricity, and dislocation of the IOL. The operation is cumbersome, the surgical trauma is large, and many incisions are required. The damage and disturbance to the intraocular tissues can easily cause symptoms such as intraocular hemorrhage, vitreous traction, and even retinal detachment. The sutures that fix the IOL often rub against the eyeball and cause pain, or break due to excessive friction, which can cause IOL dislocation. In addition, there may be a risk of severe inflammatory reaction, corneal endothelial decompensation, and secondary glaucoma after surgery.

[0005] New capsular auxiliary devices, such as modified capsular tension ring (mCTR) or capsular tension band (CTS), are currently unavailable in China due to expiration of the registration certificate. In addition, mCTR is fixed to the sclera with 10-0 polypropylene sutures. Long-term follow-up observations have found that due to the thin sutures that are easily degraded, there is a risk of displacement or posterior dislocation of the mCTR-IOL complex.

[0006] Implantable capsular hook: 5-0, 6-0 or 7-0 polypropylene sutures are fully thermoformed during surgery to make an implantable capsular hook to fix the capsular bag. However, if the traction angle is not ideal or the thermoforming is insufficient, especially for inexperienced surgeons, the hook may fall off. In addition, the capsular hook generates excessive tension at the contact point of the capsulorhexis, which increases the risk of anterior capsule tear. The temporary production of the hook during surgery requires superb surgical skills and may prolong the operation time. The capsular hook only fixes part of the anterior capsule and provides point-to-point support. It has no supporting effect on the equatorial part and posterior capsule of the capsular bag. Especially when the zonular ligament of the lens is ruptured or the relaxation range is large, the posterior capsule is more likely to flow into the anterior chamber, resulting in anterior chamber instability.

[0007] At present, Chinese patent application publication number CN115957072A discloses a lens capsular bag retractor with prefabricated sutures, which includes a needle, a suture and a capsular bag retractor complex; the capsular bag retractor complex has a tension segment and a plurality of retractors, the tension segment is arc-shaped and has an adjustment hole at the end, the retractor is L-shaped and has a first end and a second end, the first ends of the plurality of retractors are connected to the tension segment, and the second ends of two adjacent retractors are combined and connected to one end of the suture; the other end of the suture is connected to the needle; the retractor can be implanted into the eye through a smaller corneal incision, and can be conveniently fixed on the scleral wall in any orientation to avoid discomfort caused by friction between the suture and the intraocular tissue and fall off, and can stably support the lens capsular bag. There is also a Chinese patent application publication number CN110464540A that discloses an ophthalmic lens subluxation suture-free capsular bag tensioner, which includes a head, a body and a tail that are integrally formed and arranged in sequence, one end of the head has at least one reverse tooth, the other end of the head is connected to the body, the body is an arc-shaped structure, one end of the body is connected to the head and the other end is connected to the tail, and the tail is a ring-shaped hook structure. The present invention is used to maintain the stability of the lens capsular bag during ophthalmic lens subluxation surgery. The edge of the head has several reverse teeth, which can fix the present invention after entering the sclera layer. The body is an arc-shaped structure that fits the edge of the capsular bag, and the tail is a ring-shaped hook structure. During the operation, the tail hook can be implanted into the capsular bag with the help of an artificial lens adjustment hook. The patent can be fixed between the sclera layers through the reverse teeth of the head, avoiding additional suture fixation.

[0008] However, the above patent is not applicable to the case of moderate to severe lens subluxation. Currently, there is no capsular bag tension ring assembly applicable to the case of moderate to severe lens subluxation. Summary of the invention

[0009] The purpose of the present invention is to address the above-mentioned deficiencies and defects of the prior art and to provide a capsular tension ring assembly and a method of using the same, which is mainly used to maintain the stability of the lens capsular bag during surgery for moderate to severe lens subluxation, retain the patient's lens capsular bag, and maximize the retention and reshaping of the capsular suspensory ligament septum to solve the above-mentioned problems.

[0010] The technical problem solved by the present invention can be achieved by adopting the following technical solutions:

[0011] A bladder tension ring assembly comprises a bladder tension ring, a suture and a suture needle, wherein one end of the suture is connected to the bladder tension ring, and the other end of the suture is connected to the tail of the suture needle.

[0012] In a preferred embodiment of the present invention, the suture is a 9-0 double-strand polypropylene suture or an 8-0 double-strand polypropylene suture.

[0013] In a preferred embodiment of the present invention, when the suture is a 9-0 double-strand polypropylene suture, the suture needle comprises an arc-shaped suture needle with an arc length of 15 mm.

[0014] In a preferred embodiment of the present invention, when the suture is an 8-0 double-stranded polypropylene suture, the suture needle comprises an arc-shaped suture needle with an arc length of 6.5 mm.

[0015] In a preferred embodiment of the present invention, the length of the 9-0 double-strand polypropylene suture is 20 cm, and the length of the 8-0 double-strand polypropylene suture is 45 cm.

[0016] In a preferred embodiment of the present invention, the bladder bag tension ring comprises a standard bladder bag tension ring, and the standard bladder bag tension ring comprises a tension ring with a C-shaped structure, and positioning holes are respectively provided at both ends of the tension ring.

[0017] In a preferred embodiment of the present invention, the bladder tension ring is a pre-installed bladder tension ring or a non-pre-installed bladder tension ring.

[0018] A method for using the bladder tension ring assembly as described in any of the above technical solutions comprises the following steps:

[0019] S1: The bladder tension ring is stored in the releaser needle tube, and the suture thread and suture needle are located outside the needle tube;

[0020] S2: Then, one end of the suture is fixed to the capsular bag tension ring and then implanted into the lens capsular bag together, and the suture is adjusted so that the suture is located in the center of the dislocated capsular bag;

[0021] S3: The needle is inserted from the main incision, through the anterior chamber and behind the iris, and then removed at the edge of the cornea and sclera. After the needle is removed, the capsular tension ring is fixed using suturing technology to keep the lens capsular bag, capsular tension ring, and sutures centered and constant, thereby safely implanting the intraocular lens and correcting dislocation.

[0022] In a preferred embodiment of the present invention, in step S3, removing the needle at the edge of the corneosclera includes removing the needle at a distance of 2.0 mm from the edge of the corneosclera.

[0023] In a preferred embodiment of the present invention, the use of suturing technology to fix the capsular bag tension ring after the needle is removed includes using a knotless "Z" type scleral interlayer suturing technology to fix the capsular bag tension ring after the needle is removed.

[0024] Due to the adoption of the above technical solution, the capsular bag tension ring assembly of the present invention is mainly used to maintain the stability of the lens capsular bag during moderate to severe lens subluxation surgery, fully utilizing the capsular bag tension ring currently available in China while retaining the patient's lens capsular bag, maximally retaining and reshaping the capsular bag suspensory ligament septum, and the method of using the capsular bag tension ring assembly of the present invention does not rely on complex equipment, does not require additional production of T-shaped capsular bag retractors during surgery, reduces the operator's operating skills requirements, and shortens the operation time. The present invention can improve the patient's best corrected visual acuity, reduce the risk of abnormal inflammation, low intraocular pressure, suture exposure, capsular bag rupture, and vitreoretinal related complications, and reduce the occurrence of postoperative IOL tilt or eccentricity. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0026] Figure 1 It is a schematic structural diagram of a bladder tension ring assembly according to an embodiment of the present invention.

[0027] Figure 2 This is one of the schematic diagrams of the use method of an embodiment of the present invention (the suture is wrapped around one end of the bladder tension ring).

[0028] Figure 3 This is the second schematic diagram of the use method of an embodiment of the present invention (the suture cerclage is fixed to one end of the capsular tension ring).

[0029] Figure 4 This is the third schematic diagram of the use method of an embodiment of the present invention (the bag tension ring is stored in the releaser needle tube).

[0030] Figure 5 This is the fourth schematic diagram of the method of use of an embodiment of the present invention (implanting the capsular bag tension ring into the lens capsular bag).

[0031] Figure 6 This is the fifth schematic diagram of the method of use of an embodiment of the present invention (adjusting the suture knot to be located in the center of the dislocated sac).

[0032] Figure 7 This is the sixth schematic diagram of the method of use of an embodiment of the present invention (adjusting the tension of the suture to center the pouch and suturing to fix it).

[0033] Reference numerals: lens bag 1; main incision 2; iris 3; corneoscleral edge 4; releaser needle 10; bag tension ring 100; tension ring 110; two ends 110a, 110b; positioning hole 111; suture 200; suture needle 300. DETAILED DESCRIPTION

[0034] The preferred embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although the preferred embodiments of the present invention are shown in the accompanying drawings, it should be understood that the present invention can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided to make the present invention more thorough and complete, and to fully convey the scope of the present invention to those skilled in the art.

[0035] The terms used in the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The singular forms "a", "the" and "the" used in the present invention and the appended claims are also intended to include plural forms unless the context clearly indicates other meanings. It should also be understood that the term "and / or" used herein refers to and includes any or all possible combinations of one or more associated listed items.

[0036] It should be understood that although the terms "first", "second", "third", etc. may be used to describe various information in the present invention, such information should not be limited to these terms. These terms are only used to distinguish the same type of information from each other. For example, without departing from the scope of the present invention, the first information may also be referred to as the second information, and similarly, the second information may also be referred to as the first information. Thus, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, the meaning of "multiple" is two or more, unless otherwise clearly and specifically defined.

[0037] See also Figure 1The bladder tension ring assembly shown includes a bladder tension ring 100 , a suture 200 and a suture needle 300 , one end of the suture 200 is connected to the bladder tension ring 100 , and the other end of the suture 200 is connected to the tail of the suture needle 300 .

[0038] In this embodiment, one end of the suture 200 is connected to one end of the capsular tension ring 100. Of course, one end of the suture 200 can also be connected to the middle of the capsular tension ring 100. It is sufficient to fix the capsular tension ring 100 and one end of the suture 200 outside the eye. The position of the suture 200 can be adjusted according to the dislocation after entering the eye. The ultimate goal is to fix the position of the suture 200 in the eye at the most significant place where the lens is subluxated. The suture 200 is a 9-0 double-strand polypropylene suture or an 8-0 double-strand polypropylene suture. Compared with the most commonly used 10-0 polypropylene suture, the diameter and cross-sectional area of ​​the 9-0 double-strand polypropylene suture or the 8-0 double-strand polypropylene suture are increased, the tensile strength is high, and the fracture resistance is better in theory. Some foreign scholars also use 7-0 polytetrafluoroethylene (Gore-Tex CV8) suture fixation, which is more stable in physical and chemical properties than polypropylene sutures, and is resistant to high temperatures and corrosion. However, it is currently a non-indication choice in ophthalmology). When the suture 200 is an 8-0 double-strand polypropylene suture, the suture needle 300 includes an arc-shaped suture needle with an arc length of 6.5 mm, and the length of the 8-0 double-strand polypropylene suture is 45 cm; when the suture 200 is a 9-0 double-strand polypropylene suture, the suture needle 300 includes an arc-shaped suture needle with an arc length of 15 mm, and the length of the 9-0 double-strand polypropylene suture is 20 cm.

[0039] The bladder tension ring 100 includes a standard bladder tension ring, which includes a tension ring 110 with a C-shaped structure, and positioning holes 111 are respectively provided at both ends 110a and 110b of the tension ring 110. The bladder tension ring 100 in this embodiment is a pre-installed bladder tension ring, which is more convenient to operate. Of course, the bladder tension ring 100 can also be a non-pre-installed bladder tension ring.

[0040] The capsular bag tension ring assembly of the present invention is mainly used to maintain the stability of the lens capsular bag during surgery for moderate to severe lens subluxation. It fully utilizes the capsular bag tension rings currently available in China, while retaining the patient's lens capsular bag and maximally retaining and reshaping the capsular bag suspensory ligament septum.

[0041] Combination Figures 1 to 7 As shown, a method for using a bladder tension ring assembly comprises the following steps:

[0042] S1: The bag tension ring 100 is stored in the releaser needle tube 10, and the suture 200 and the suture needle 300 are located outside the needle tube 10;

[0043] S2: Then, one end of the suture 200 is fixed to the capsular bag tension ring 100 and then implanted into the lens capsular bag 1 together, and the suture 200 is adjusted so that it is located in the center of the dislocated capsular bag;

[0044] S3: Insert the needle from the main incision 2, pass through the anterior chamber and behind the iris 3, and remove the needle at the edge of the cornea and sclera 4. After removing the needle, use the suturing technique to fix the capsular bag tension ring 100, so that the lens capsular bag 1, the capsular bag tension ring 100, and the suture 200 remain centered and constant, thereby safely implanting the intraocular lens and correcting the dislocation. In this step, it is preferred to adjust the suture to be located at the central position of the weak point of the lens suspensory ligament, and remove the needle 2.0 mm away from the cornea and sclera. After removing the needle, preferably, use the knotless "Z" type scleral interlayer suturing technique to fix the capsular bag tension ring 100. The knotless "Z" type scleral interlayer suturing technique does not require the production of a scleral flap. The suture 200 travels back and forth between the scleral layers to avoid the suture causing the IOL capsular bag complex to dislocate due to cutting the sclera. In addition, there are no line nodes, which reduces ocular surface damage and reduces the chance of endophthalmitis. Additionally, other methods of scleral suture fixation, such as a classic scleral flap, a reverse scleral flap, a scleral groove, or rotating the knot into the eye, may also be used to secure the capsular tension ring 100.

[0045] The method for using the capsular bag tension ring assembly of the present invention does not rely on complex equipment, does not require additional production of a T-shaped capsular bag retractor during surgery, reduces the requirements on the operator's operating skills, and shortens the operation time.

[0046] The present invention can improve the patient's best corrected visual acuity, reduce the risk of abnormal inflammation, hypotony, suture exposure, capsular bag rupture, and vitreoretinal complications, and reduce the occurrence of postoperative IOL tilt or decentration.

[0047] Unless otherwise specifically stated, the relative arrangement, numerical expressions and numerical values ​​of the parts and steps set forth in these embodiments do not limit the scope of the present application. At the same time, it should be understood that, for ease of description, the sizes of the various parts shown in the accompanying drawings are not drawn according to the actual proportional relationship. The technology, method and equipment known to those of ordinary skill in the relevant field may not be discussed in detail, but in appropriate cases, the technology, method and equipment should be considered as a part of the authorization specification. In all examples shown and discussed here, any specific value should be interpreted as being merely exemplary, rather than as a limitation. Therefore, other examples of exemplary embodiments may have different values. It should be noted that similar reference numerals and letters represent similar items in the following drawings, so that once a certain item is defined in an accompanying drawing, it does not need to be further discussed in subsequent drawings.

[0048] In the description of the present application, it should be understood that the directions or positional relationships indicated by directional words such as "front, back, up, down, left, right", "lateral, vertical, perpendicular, horizontal" and "top, bottom" are usually based on the directions or positional relationships shown in the drawings, and are only for the convenience of describing the present application and simplifying the description. Unless otherwise specified, these directional words do not indicate or imply that the device or element referred to must have a specific direction or be constructed and operated in a specific direction, and therefore cannot be understood as limiting the scope of protection of the present application; the directional words "inside and outside" refer to the inside and outside relative to the contours of each component itself.

[0049] For ease of description, spatially relative terms such as "above", "above", "on the upper surface of", "above", etc. may be used here to describe the spatial positional relationship between a device or feature and other devices or features as shown in the figure. It should be understood that spatially relative terms are intended to include different orientations of the device in use or operation in addition to the orientation described in the figure. For example, if the device in the accompanying drawings is inverted, the device described as "above other devices or structures" or "above other devices or structures" will be positioned as "below other devices or structures" or "below other devices or structures". Thus, the exemplary term "above" can include both "above" and "below". The device can also be positioned in other different ways (rotated 90 degrees or in other orientations), and the spatially relative descriptions used here are interpreted accordingly.

[0050] The above shows and describes the basic principles and main features of the present invention and the advantages of the present invention. It should be understood by those skilled in the art that the present invention is not limited to the above embodiments. The above embodiments and descriptions are only for explaining the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention may have various changes and improvements, which fall within the scope of the present invention to be protected. The scope of protection of the present invention is defined by the attached claims and their equivalents.

Claims

1. A bladder tension ring assembly, characterized in that: It comprises a bladder tension ring, a suture and a suture needle, one end of the suture is connected to the bladder tension ring, and the other end of the suture is connected to the tail of the suture needle.

2. A bladder tension ring assembly according to claim 1, characterized in that: The suture is a 9-0 double-strand polypropylene suture or an 8-0 double-strand polypropylene suture.

3. A bladder tension ring assembly according to claim 2, characterized in that: When the suture is a 9-0 double-stranded polypropylene suture, the suture needle comprises an arc-shaped suture needle with an arc length of 15 mm.

4. A bladder tension ring assembly according to claim 2, characterized in that: When the suture is 8-0 double-stranded polypropylene suture, the suture needle comprises an arc-shaped suture needle with an arc length of 6.5 mm.

5. The bladder tension ring assembly according to claim 2, characterized in that: The length of the 9-0 double-strand polypropylene suture is 20 cm, and the length of the 8-0 double-strand polypropylene suture is 45 cm.

6. The bladder tension ring assembly according to claim 1, characterized in that: The bladder bag tension ring includes a standard bladder bag tension ring, and the standard bladder bag tension ring includes a tension ring with a C-shaped structure. Positioning holes are respectively provided at both ends of the tension ring.

7. The bladder tension ring assembly according to claim 1, characterized in that: The bladder bag tension ring is a preinstalled bladder bag tension ring or a non-preinstalled bladder bag tension ring.

8. A method for using the bladder tension ring assembly according to any one of claims 1 to 7, characterized in that: The steps include: S1: The bladder tension ring is stored in the releaser needle tube, and the suture thread and suture needle are located outside the needle tube; S2: Then, one end of the suture is fixed to the capsular bag tension ring and then implanted into the lens capsular bag together, and the suture is adjusted so that the suture is located in the center of the dislocated capsular bag; S3: The needle is inserted from the main incision, through the anterior chamber and behind the iris, and then removed at the edge of the cornea and sclera. After the needle is removed, the capsular tension ring is fixed using suturing technology to keep the lens capsular bag, capsular tension ring, and sutures centered and constant, thereby safely implanting the intraocular lens and correcting dislocation.

9. A method for using a bladder tension ring assembly according to claim 8, characterized in that: In the step S3, removing the needle at the edge of the cornea and sclera includes removing the needle at a distance of 2.0 mm from the edge of the cornea and sclera.

10. The method for using the bladder tension ring assembly according to claim 8, characterized in that: After the needle is removed, the capsular tension ring is fixed using a suture technique, including a knotless "Z" type scleral interlayer suture technique to fix the capsular tension ring after the needle is removed.

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