阅读说明：本技术 用于晶状体囊的修复和张紧的设备 (Device for repair and tensioning of the lens capsule ) 是由 扬尼斯·帕里卡里斯 欧纽尔凯·沙欣 于 2018-03-01 设计创作，主要内容包括：在本文中提供了用于在白内障手术之后修复天然晶状体囊的设备。该设备使用基本上环形的刚性和柔性组件来接触白内障手术之后的囊的后表面和前表面以修复囊形状。还提供了用于在白内障手术之后使囊张紧的设备。弹性环状主体成形为以夹状构造固定撕囊的边缘。备选地,与囊修复设备的刚性和柔性组件类似,弹性环状主体形成为具有从主体垂下的下组件和从下组件延伸的柔性环形主体。(Provided herein are devices for repairing a natural lens capsule after cataract surgery. The device uses substantially annular rigid and flexible components to contact the posterior and anterior surfaces of the capsule after cataract surgery to restore the capsule shape. An apparatus for tensioning the balloon after cataract surgery is also provided. The resilient annular body is shaped to secure the edge of the capsulorhexis in a clip-like configuration. Alternatively, the resilient annular body is formed with a lower member depending from the body and a flexible annular body extending from the lower member, similar to the rigid and flexible members of the balloon repair device.)

1. An apparatus for repairing a natural lens capsule of an eye after cataract surgery, the apparatus comprising:

a rigid ring assembly, the rigid ring assembly comprising:

a distal end in contact with an anterior surface of the balloon; and

a proximal end disposed proximate to a ligamentum wegener in the eye; an annular flexible assembly substantially concentric with the rigid assembly and flexibly mounted against an inner surface of the bladder, the annular flexible assembly comprising:

a proximal end formed on an outer surface of the proximal end of the rigid component; and

a distal end extending away from the rigid component; and

a groove disposed on an inner surface of the rigid component, the groove configured to receive a haptic on an intraocular lens.

2. The apparatus of claim 1, further comprising a protrusion formed from a top of the distal end of the rigid component.

3. The apparatus of claim 2, wherein the protrusion comprises a plurality of markers disposed on a top surface thereof, the plurality of markers configured to guide toric lens alignment.

4. The apparatus of claim 2, wherein the protrusion has a width of about 0.1mm to about 1 mm.

5. The apparatus of claim 1, wherein the proximal end of the rigid component has a thickness of about 0.2mm to about 1mm and the distal end of the rigid component has a thickness of about 0.1mm to about 0.5 mm.

6. The apparatus of claim 1, wherein the annular rigid component comprises silicon, acrylic, hydrogel, or a combination thereof.

7. The apparatus of claim 1, wherein the annular rigid component is substantially perpendicular to the anterior surface of the natural lens capsule.

8. The apparatus of claim 1, wherein the annular flexible member is configured to bend away from the rigid member when the ciliary muscle is relaxed and the zonules are in tension, and to bend toward the rigid member when the ciliary muscle is contracted and the zonules are relaxed.

9. The apparatus of claim 1, wherein the annular flexible assembly further comprises a plurality of gaps disposed about a circumference thereof.

10. The apparatus of claim 9, wherein the gaps each have a width of about 0.1mm to about 5 mm.

11. The apparatus of claim 1, wherein the annular flexible member has a thickness of about 0.05mm to about 0.75 mm.

12. The apparatus of claim 1, wherein the annular flexible member comprises silicon, acrylic, hydrogel, or a combination thereof.

13. The apparatus of claim 1, wherein the annular rigid component and the annular flexible component form an angle of about 2 degrees to about 90 degrees when mounted inside the natural lens capsule.

14. An apparatus for flexibly restoring tension to a natural lens capsule after cataract surgery, the apparatus comprising:

an annular rigid assembly, the annular rigid assembly comprising:

a distal end disposed in supporting relation to an anterior surface of the lens capsule; and

a proximal end disposed in supporting relation to a posterior surface of the capsule and disposed proximate to a ligamentum wegener of the eye; and

a protrusion formed from a top of the distal end of the rigid component; an annular flexible component substantially concentric with the rigid component and flexibly mounted against the inner surface of the capsule, the annular flexible component configured to bend away from the rigid component when the ciliary muscle is relaxed and the zonules are in tension and to bend toward the rigid component when the ciliary muscle is contracted and the zonules are relaxed, the flexible component comprising:

a proximal end formed on an outer surface of the proximal end of the rigid component; and

a distal end extending away from the rigid component; and

a groove disposed on an inner surface of the rigid component, the groove configured to receive a haptic on an intraocular lens.

15. The apparatus of claim 14, further comprising a plurality of markers disposed on a top surface of the protrusion, the plurality of markers configured to guide toric lens alignment.

16. The apparatus of claim 14, further comprising disposing a plurality of gaps around a circumference of the annular flexible member, the plurality of gaps configured to increase flexibility of the annular flexible member.

17. The apparatus of claim 16, wherein the gaps each have a width of about 0.1mm to about 5 mm.

18. The apparatus of claim 14, wherein the protrusion has a width of about 0.1mm to about 1 mm.

19. The apparatus of claim 14, wherein the proximal end of the rigid component has a thickness of about 0.2mm to about 1mm and the distal end of the rigid component has a thickness of about 0.1mm to about 0.5 mm.

20. The apparatus of claim 14, wherein the annular rigid component comprises silicon, acrylic, hydrogel, or a combination thereof.

21. The apparatus of claim 14, wherein the annular rigid component is substantially perpendicular to the anterior surface of the natural lens capsule.

22. The apparatus of claim 14, wherein the annular rigid component and the annular flexible component form an angle of about 0 degrees to about 90 degrees when disposed inside the natural lens capsule.

23. A system for flexibly restoring tension to a natural lens capsule after cataract surgery, the system comprising:

the apparatus of claim 14; and

a resilient annular body having an opening formed therein in a clip-like configuration around an outer perimeter of the annular body.

24. The system of claim 23, wherein the resilient annular body comprises an upper portion having a tongue depending from a lower surface of the upper portion and a lower portion having a groove disposed about an upper surface of the lower portion, the groove configured to receive the tongue within the groove.

25. The system of claim 23, wherein the elastic toroidal body has an inner diameter of about 5 to 8mm and an outer diameter of about 6mm to about 10 mm.

26. The apparatus of claim 23, wherein the elastic ring-shaped body comprises a material having elastic properties substantially similar to the elastic properties at an anterior peripheral region of a capsule in a young human eye.

27. An apparatus for tensioning a capsule of an eye after cataract surgery, the apparatus comprising:

a resilient annular body having upper and lower portions of a clip-like configuration formed by surrounding an outer perimeter length of the annular body to an opening in the annular body.

28. The apparatus of claim 27, wherein the upper portion includes a tongue depending from a lower surface of the upper portion, and the lower portion has a groove disposed about an upper surface of the lower portion, the groove configured to receive the tongue therein.

29. The apparatus of claim 27, wherein the resilient annular body has an inner diameter of about 5 to 8mm and an outer diameter of about 6mm to about 10 mm.

30. The apparatus of claim 27, wherein the elastic ring-shaped body comprises a material having elastic properties substantially similar to the elastic properties at an anterior peripheral region of a capsule in a young human eye.

31. A tensioning device for a natural capsule of an eye following cataract surgery, the tensioning device comprising:

a resilient annular body, the resilient annular body comprising:

an upper assembly having an upper body portion and a lower body portion separated in a clip-like configuration by an opening formed therein around an inner perimeter thereof, and

a lower assembly formed to hang down from a lower surface of the lower body portion at an upper end; and

a flexible annular body substantially concentric with and extending outwardly from a lower end of the lower assembly.

32. The tensioning device of claim 31, the lower assembly further comprising a groove disposed about an inner surface thereof, the groove configured to receive a haptic on an intraocular lens.

33. The tensioning device of claim 31, wherein the upper body portion includes a tongue depending from a lower surface of the upper body portion, and the lower portion has a groove disposed about an upper surface of the lower portion, the groove configured to receive the tongue therein.

34. The tensioning device of claim 31, wherein the flexible ring body comprises a continuous surface.

35. The tensioning device of claim 31, wherein the flexible annular body includes a plurality of gaps circumferentially disposed thereon.

36. The tensioning device of claim 35, wherein the plurality of gaps each have a width of about 0.1mm to about 5 mm.

37. The tensioning device of claim 31, wherein the elastic ring body has an inner diameter of about 5 to 8mm and an outer diameter of about 6mm to about 10 mm.

38. The tensioning device of claim 31, wherein the elastic ring-shaped body comprises a material having elastic properties substantially similar to the elastic properties at the anterior peripheral region of the balloon in a young human eye.

39. The tensioning device of claim 31, wherein the lower assembly of the resilient annular body has a thickness of about 0.2mm to about 1mm at an upper end and a thickness of about 0.1mm to about 0.5mm at a lower end.

40. The tensioning device of claim 31, wherein the flexible ring body has a thickness of about 0.05mm to about 0.75 mm.

41. The tensioning device of claim 31, wherein the flexible ring body comprises silicon, acrylic, hydrogel, or a combination thereof.

Technical Field

The present invention relates to the field of ophthalmology and surgical devices for performing surgery on an eye. More particularly, the present invention relates to such devices for the functional and anatomical repair (reconstruction) of the human lens capsule and for the precise placement of intraocular lenses (intraocular lenses) for any procedure requiring replacement and alignment of the lens.

Description of the Related Art

Intraocular lenses are plastic lenses having substantially the same optical power as the natural lens intended to be replaced. Typically, during cataract surgery, the ophthalmic surgeon removes the cataract-damaged natural lens and replaces it with an artificial intraocular lens. There are generally three types of intraocular lenses, including refractive lenses, diffractive lenses, and refractive-diffractive lenses. Refractive lenses concentrate light towards a focal point on the optical axis by refraction, while diffractive lenses produce a diffraction pattern that forms a focal point on the optical axis of each diffraction order. Refractive-diffractive lenses combine two types of features. However, these purely refractive bifocal or multifocal lenses have some significant disadvantages. First, their effectiveness depends largely on the size and centration (centration) of the pupil. Second, the resulting contrast is reduced because they have multiple focal points. Especially in distance vision, this may cause the formation of halos and the reduction in luminance (see, for example, U.S. patent No. 8,636,796B 2).

Furthermore, posterior capsule opacification (PCO or after cataract (after cataract)) remains a common problem after cataract surgery to implant intraocular lenses. Posterior capsular opacification is generally caused by the transition from intracapsular cataract extraction (ICCE) to extracapsular cataract extraction (ECCE), where the posterior lens capsule remains intact during surgery. Patients with posterior capsular opacification suffer from reduced visual acuity, impaired contrast sensitivity and blindness to glare. Clinically, members of posterior capsular opacification are identified as regenerative members and fibrotic members, and regenerative posterior capsular opacification members are much more common than fibrotic members.

Regenerative posterior capsular opacification is caused by residual Lens Epithelial Cells (LECs), so-called E-cells, from the equator of the lens, which migrate into the space between the posterior capsule and the intraocular lens and proliferate and form a layer of lens material and Elschnig pearls (Elschnig pearls). In contrast, post-fibrotic capsular opacification is caused by LECs from the anterior capsule that undergo transformation into myofibroblasts and enter the posterior capsule, whitening and wrinkling the capsule. This can lead to decentration of the intraocular lens and hinder imaging of the peripheral retina. Findl et al (J CataractRefract Surg 2003; 29(1):106-11) disclose that two members of posterior capsule opacification cause a decrease in visual function when they affect the central region around the visual axis. YAG or Nd lasers used in YAG laser capsulotomy (capsulotomy) are most commonly used to treat posterior capsule opacification. However, as disclosed in Georgalas et al (the Clin Risk Manag.2009; 5: 133-.

European patent No. 507292B 1 describes the need for a "restraining device" for keeping the capsular bag shape substantially circular after cataract extraction and restraining problems such as deteriorated epithelial cell invasion into the posterior capsular bag, and further relates to a restraining device in which the intraocular lens can be kept in good condition by forming a groove in the inner periphery of the intraocular lens. He describes a stable circular shape of the device that effectively inhibits balloon collapse without involving the actual diameter of the outer portion of the ring.

U.S. publication No. 2006/0047339 a1 describes a device that interfaces with the natural lens capsule so that the lens capsule can be maintained in a configuration that avoids postoperative changes detrimental to vision. An adjustable single optical system or a dual optical system is provided. Emphasizes the role of "postoperative shrinkage" of the empty capsule in lens displacement leading to optical changes and to induced astigmatism. Therefore, there is a need to provide devices or apparatus and operations to maintain the form of the lens capsule and maintain the diameter (capsulotomy opening for the device).

International application No. WO2007044604 a1 describes the establishment of a preoperative anatomical relationship by preoperatively measuring the "spatial relationship of structures within the eye, such as the distance from the corneal surface to the posterior surface of the lens capsule and from the cornea or the posterior surface of the lens capsule to the retina", for example, by using ultrasound, partial coherence measurement, optical coherence tomography or laser measurement techniques, or by any other means known in the art. A surgical procedure such as an intraocular lens implantation is performed and spacing means are provided to restore those pre-measured spatial relationships or predetermined new spacing. The spacing means may comprise, for example, a spacer, a ring, an inflatable structure, or a thick or multiple lens. These tools help maintain the normal depth of the patient's anterior and posterior capsule and prevent anterior movement of the vitreous and retinal detachment that may occur as a result of such movement.

Goldberg (Clin Ophthalmol.2011; 5:1-7) claims a crossed zonule (zonule) to provide a scaffold for the posterior lens and to stabilize its shape. In this model, the anterior vitreal zonules are inserted in the wisger's ligament, and the PIZ-LE zonules anchor the lens equator to the posterior insertion zone. The crossed zonules and the wiggle ligament maintain the lens positioning while the anterior and posterior zonules provide reciprocal accommodation (accommodation) and disorganization (disaccordination). The wiggle ligament, which represents the mid-peripheral region of the posterior capsule, is the most important region for stabilizing the position of the lens during accommodation.

U.S. publication No. 2010/0204790 a1 describes an intraocular lens device having an annular fixation platform that can form a "box" … … into which an intraocular lens of the present invention can be attached and concludes that the discovery of the present invention makes possible a surgical method for insertion and subsequent removal and replacement of an intraocular lens with reduced risk of damaging the eye or losing vision.

Based on Market Scope reports (Market Scope reports) (2015 Global Intraocular Lens Market general Report on the Global Intraocular Lens Market, 2015 6 months), the high-end Intraocular Lens Market will reach 9.3% of Global quantities and 34% of the Global Intraocular Lens Market total revenue. Multifocal and toric IOLs will dominate the high-end intraocular lens market with almost 90% market share. Toric and multifocal surfaces are very sensitive to precise coaxiality and capsular positioning.

Several patents and publications, including U.S. patent No. 9,339,375B 2, US4710194, US publication No. 2005/0085,907, US publication No. 2005/0209692, US publication No. 2010/0204790, US publication No. 2010/0228344, US publication No. 2011/0082543, and european application No. 037,390 a2, disclose various intracapsular rings for different purposes. However, these work describe a standard size or multiple size ring that does not have any adjustability for adjustment. These devices typically include a ring and an optical system that is adapted to the ring. Some devices include deformable rings that change the shape of the central optic portion under ciliary pressure and mimic the accommodation mechanism.

Due to the complexity of zonule traction in multifocal and toric intraocular lenses that have existed in the market and are expected to improve rapidly in the near future, no previous work in the art has considered today's theory of accommodation and the maintenance of continuous changes in capsular shape. Accordingly, there is a recognized need in the art for devices and methods for repairing a balloon. In particular, the prior art has drawbacks in terms of the equipment that achieves precise placement and alignment of the intraocular lens post-operatively. The present invention fulfills this long-standing need and desire in the art.

Background

Summary of The Invention

The present invention relates to a device for repairing the natural lens capsule of the eye after cataract surgery. The apparatus includes an annular rigid assembly. The rigid component includes a distal end in contact with the anterior surface of the capsule and a proximal end disposed on the posterior surface of the capsule and in close proximity to the ligamentum weger's ligament in the eye. An annular flexible member substantially concentric with the rigid member is flexibly mounted against the inner surface of the bladder. The annular flexible member includes a proximal end formed on an outer surface of the proximal end of the rigid member, and a distal end extending away from the rigid member. Grooves are provided on the inner surface of the rigid component, the grooves being configured to receive haptics (haptics) on the intraocular lens. The present invention relates to an associated apparatus that further includes a protrusion formed from a top of the distal end of the rigid assembly.

The invention also relates to a device for flexibly restoring tension to the natural lens capsule after cataract surgery. The apparatus includes an annular rigid component including a distal end disposed in supporting relation to an anterior surface of the lens capsule, a proximal end disposed in supporting relation to a posterior surface of the lens capsule and disposed proximate to the ligamentum wegener of the eye, and a protrusion formed from a top of the distal end of the rigid component. An annular flexible member substantially concentric with the rigid member is flexibly mounted against the inner surface of the bladder. The flexible member is configured to bend away from the rigid member when the ciliary muscle is relaxed and the zonules are in tension, and to bend toward the rigid member when the ciliary muscle is contracted and the zonules are relaxed. The annular flexible member includes a proximal end formed on an outer surface of the proximal end of the rigid member, and a distal end extending away from the rigid member. Grooves are provided on the inner surface of the rigid component, the grooves configured to receive haptics on the intraocular lens. The present invention relates to an associated apparatus that further includes a plurality of markers disposed on the top surface of the protrusion configured to guide alignment of the toric lens. The present invention is directed to another related apparatus that further includes a plurality of gaps disposed about a circumference of the annular flexible member configured to increase flexibility of the annular flexible member.

The invention also relates to a system for flexibly restoring tension to the natural lens capsule after cataract surgery. The system includes a device for flexibly restoring tension to a natural lens capsule as described herein, and an elastic annular ring body having an opening formed therein in a clip-like configuration around an inner perimeter of the annular ring body.

The present invention is still directed to an apparatus for tensioning the capsule of the eye after cataract surgery. The apparatus includes a resilient annular body having upper and lower portions of a clip-like configuration formed by surrounding an outer perimeter length of the annular body to an opening in the annular body.

The present invention still relates to a tensioning device for the natural capsule of the eye after cataract surgery. The tensioning device includes a resilient annular body and a flexible annular body substantially concentric with and extending outwardly from a lower end of the lower assembly. The resilient annular body includes an upper assembly having an upper body portion and a lower body portion separated in a clip-like configuration by an opening formed therein about an inner perimeter thereof, and a lower assembly formed to depend from a lower surface of the lower body portion at an upper end. The present invention relates to a related tensioning device wherein the lower assembly of the resilient annular body further comprises a groove disposed about its inner surface, the groove configured to receive a haptic on an intraocular lens.

Other and further aspects, features and advantages of the present invention will be apparent from the following description of the currently preferred embodiments of the invention. These embodiments are given for the purpose of disclosure.