Pupil dilator device

Abstract

Pupil dilator device consisting of a ring-shaped element (100), delimiting an internal circular surface divided into three distinct circular sectors (200) having the respective circumferential arcs connected to the internal edge of said ring-shaped elements (100), wherein each extreme portion of said circular sectors (200) ends with a hooked portion (220) obtained coplanar to said circular sector (200), wherein near each of said hooked portions (220) there is a hooking hole (230) adapted to be engaged by a surgical instrument, wherein lateral to each of the two spokes of each circular sector (200) there is a left hooked portion (240) and a right hooked portion (245) and wherein at least three equidistant fins (300) are present on said ring-shaped element (100) in a coplanar and peripheral manner.

Description

[0001] “Pupil dilator device”

[0002] Description

[0003] Technical Field

[0004] The present patent application for invention generally relates to the field of medical devices and more specifically to the field of surgical instruments.

[0005] The invention is applicable to any field where such a device can be advantageously used, but preferably this relates to the field of ophthalmic surgery.

[0006] Background art

[0007] In ophthalmic surgery, the need to dilate the iris membrane allows to easily visualize the structures behind the iris. Methods associated with limitations resulting from poorly dilatable pupils can lead to significant complications such as capsular ruptures, iris trauma, dislocation of the nucleus or IOL in the vitreous cavity, corneal edema and retinal detachment.

[0008] To obtain adequate pupil dilation for surgery to be performed, the surgeon can use various techniques such as iris stretching, multiple sphincterotomies or mechanical dilation of the iris membrane by means of specific devices.

[0009] Although they are more expensive, in terms of money and time, devices for the mechanical dilation of the iris membrane are the best solution among those mentioned. In particular, pupil dilator rings have rapidly become the first choice when it comes to inducing mechanical pupil dilation, as they minimize damage to the iris sphincter, inducing circumferential expansion on a physiological level, while protecting the pupillary margin and avoiding the typical drawbacks of the previous methods.

[0010] Currently, a device widely used by ophthalmic surgeons is the Malyugin ring, introduced in 2007. This device consists of a temporary prosthesis, consisting of a square-shaped 4-0 prolene thread with four circular coils, capable of expanding the iris at equidistant points. It is a unique piece with coils at each corner of the ring, which allow for a balanced stretching and gentle expansion of the iris diaphragm. The ring is inserted through a 2.2 mm incision. The pupil dilator is positioned centrally and gently pushed at each corner with the help of a special hook to trap the iris in the four coils. Once inserted, the ring widens the pupil aperture to 6.25 or 7 mm, depending on the version of the ring used.

[0011] Another valid device is represented by the XpandNT Iris Speculum, which to date appears to be the most technically advanced pupil expansion ring available on the market. XpandNT is a tool to assist in the management of small pupils, in IFIS and in interoperative pupil miosis. Forged from a Nitinol-shape memory alloy, the low-profile XpandNT does not pinch the iris like most devices, gently constrains the pupillary margin and allows for a more natural mechanical opening. Thanks to its unique design, it is inserted through a 2.4 mm incision, creating a nearly circular dilation of 6.75 mm, creating a stable device that is easier to manipulate and providing clear access to all ophthalmic instrumentation.

[0012] Both said devices are quite valid and able to create a pupil dilation area close to 7 mm and therefore able to create easy access for instrumentation. However, both devices have a drawback that prevents them from being chosen as the devices of choice in the art by all surgeons. Basically, this drawback consists of a certain difficulty encountered by operators in managing the hooking of these rings to the edge of the iris diaphragm. This feature actually forms a major limitation to the aforementioned devices, which can only be overcome with great skill and experience on the part of the surgeons themselves.

[0013] In light of the above, it is clear and evident that the background art has undisputed technical problems and that, therefore, there is a strong need to resolve them.

[0014] Therefore, an object of the present invention is in general to make a device capable of maintaining all those features of minimum encumbrance already present in the prior art unchanged, but on the other hand mainly to make a product that is easily manageable by the surgeon, with regard to the ease of hooking to the edge of the iris membrane and therefore of spreading the pupil.

[0015] Therefore, an unavoidable need still exists to advance the state of the art by making a pupil dilator device designed to resolve or at least minimize the above problems, as will be clear from the detailed description of one of its exemplary and non-limiting embodiments, illustrated below.

[0016] Summary of the Invention

[0017] With the present patent application for an industrial invention, it is intended to describe and claim a new and alternative solution to the solutions known so far and in particular the aim is to overcome one or more of the drawbacks or problems referred to above and / or to satisfy one or more needs perceived in the art and in particular deduced from what has been reported above.

[0018] Therefore, the specific object of the present invention is to make an innovative pupil dilator device intended to be housed in the posterior segment of the eye, by insertion into the patient's pupil orifice.

[0019] Said pupil dilator device basically consists of a ring-shaped element delimiting an internal circular surface, which is divided into three distinct circular sectors, originating from the internal edge of said ring-shaped element. The extreme portion of each circular sector ends with a hooked portion adapted to be constrained to the patient's corneal surface.

[0020] Laterally to each of the two spokes of each circular sector there are hooked portions, suitable for engaging the pupillary margin of the patient's iris membrane and therefore inducing it to open, during the lifting and spreading step of the aforementioned circular sectors.

[0021] Therefore, the present invention achieves its main objects, consisting of greater effectiveness or convenience of application / use, by making an invention whose main object is to be able to be easily used by most specialists in the field, even if they have little practice and manual skills.

[0022] Therefore, there is still an essential need to advance the state of the art, making devices provided with a high degree of functionalization and at the same time free from difficulties arising from their use and installation.

[0023] For this purpose, to facilitate the entry of said device into the posterior segment of the eye through the pupillary orifice, at least three equidistant fins are obtained, peripherally and coplanar to said ring-shaped element, adapted in shape and size to form a valid instrument to engage the pupillary margin and create a valid support point and facilitate the insertion of said pupil dilator device into the posterior segment of the eye.

[0024] Another particularly favorable feature, for the purposes of the present invention, consists of the fact that near said hooked portion there is a hooking hole, adapted to be easily engaged by any suitable surgical instrument, capable of lifting and spreading said circular sectors.

[0025] A further technical feature, which differentiates the pupil dilator device which is the subject of the present invention from those present in the known art, is that the particular inventive conformation makes said inventive device easily usable even by the most inexperienced health workers, since the gradual simple lifting and spreading of said circular sectors is able to first engage the pupillary margin, easily by means of the aforementioned suitable hooked portions and then widen said iris membrane by spreading said circular sectors.

[0026] Therefore, these solutions according to the present invention constitute an optimal compromise, since the creation of said inventive device has the result of being able to correct or at least minimize all those problems identified in the prior art.

[0027] A further objective is to propose an inventive pupil dilator device, which can be manufactured on an industrial scale, whose components are of a standard type, perfectly available on the market and whose production is fully sustainable from an economic and environmental point of view.

[0028] Obviously, the entire device, in order to achieve its advantages, must be made by selecting constituent materials provided with a high degree of deformability and elasticity, or having features of foldability and softness, capable of allowing the adaptation of the device to the dimensions required in the operating field. Therefore, as regards the constituent materials, these can be chosen by the person skilled in the art, in order to satisfy the technical features just mentioned, from among those that are usually used for the creation of intraocular lenses. As instead regards the dimensions of said inventive pupil dilator device, it should be noted that these are purely indicative and not limiting of the invention. However, the dimensions of said inventive device can be expressed and overall summarized, as regards the width of the diameter of the ring-shaped element, in a range between 10 mm and 6 mm and more preferably equal to 8 mm.

[0029] The most important advantages obtained have already been illustrated in detail, while the other advantages will result from the detailed description of an exemplary and non-limiting embodiment thereof, illustrated in the following detailed description of one or more specific embodiments, protected by the various dependent claims.

[0030] The previous advantages, as well as other advantages and features of the present invention, will be illustrated by referring to the attached figures, which are to be considered purely illustrative and not limiting or binding for the purposes of the present patent application, in which:

[0031] - FIGURE l is a plan view of the pupil dilator device according to the present invention;

[0032] - FIGURE 2 is a plan view of a detail of the inventive device;

[0033] - FIGURE 3 is a plan view of a further embodiment of the inventive device;

[0034] - FIGURE 4 is a plan view of the device with the circular sectors spread apart;

[0035] - FIGURE 5 is a plan view of the inventive device closed and housed under the iris membrane;

[0036] - FIGURE 6 is a sectional view of the device in the configuration shown in Fig. 5;

[0037] - FIGURE 7 is a plan view of the inventive device with the circular sectors spread apart and housed under the iris membrane;

[0038] - FIGURE 8 is a sectional view of the device in the configuration shown in Fig. 7.

[0039] Please note that the attached drawings are merely for illustrative purposes and are not to scale. In particular, the ratios between empty and full spaces of the illustrated lenses can vary and the hooking holes 230 can be made either based on the hooked portions 220 or near the head thereof, to facilitate gripping the device.

[0040] Detailed Description of the Invention

[0041] Referring to Figs. 1-2, these show a pupil dilator device comprising a ring-shaped element 100, delimiting an internal circular surface and resulting divided into three distinct circular sectors 200 and in which the respective circumferential arcs are connected to the internal edge of said ring-shaped element 100.

[0042] With reference to FIGs. 5-6, said inventive device is suitable for its conformation and size to be inserted into the pupil orifice and housed in the posterior segment of the eye in contact with the iris membrane 400.

[0043] The extreme portion of said circular sectors 200 ends with a hooked portion 220 obtained coplanar to said circular sector. Near said hooked portion 220 there is a hooking hole 230, adapted to be easily engaged by any suitable surgical instrument, capable of lifting said hooked portions 220 one at a time and then spreading said circular sectors 200, as shown in Figs. 7-8, until said hooked portions 220 come into contact with the patient's corneal surface.

[0044] Laterally to each of the two spokes of each circular sector 200 there is a left hooked portion 240 and a right hooked portion 245, suitable in shape and position to engage the pupillary margin of the iris membrane 400 during the lifting step of said hooked portions 220 of the patient and therefore to induce the opening of the iris membrane 400 through spreading said circular sectors 200.

[0045] As shown in FIGs. 1 and 3, the conformation of said hooked portions is such that in the closed configuration said left hooked portion 240 fits in a planar manner into the respective right hooked portion 245 of the adjacent circular sector 200 and that said right hooked portion 245 fits in a planar manner into the respective left hooked portion 240 of the other adjacent circular sector 200, so as to create a planar conformation in the closed condition of the device. It must be considered that said planar conformation represents an essential condition so that said inventive pupil dilator device can be easily fitted into the patient's pupil orifice and without any obstacle.

[0046] A further aspect, on the margin of all the technical solutions described so far, but of particular relevance in the creation of the invention, consists of the fact that peripherally and coplanar to said ring-shaped element 100 (see Figs. 1-2) there are at least three fins 300 that are equidistant and suitable in shape and size to constitute a valid instrument for engaging and creating a valid support point on the pupillary margin of the iris membrane 400 and facilitating the insertion of said pupil dilator device into the posterior segment of the eye.

[0047] In the illustrated example, the surface of the circular sectors 200 is continuous, however, in a particularly preferred embodiment of the present invention and shown in Figs. 3-8, the inventors of the present patent have developed an inventive device, in which at least a foramen 250 is obtained on each circular sector 200. The aforementioned feature is actually fundamental, as it is adapted to impart features of elasticity and deformability to said circular sectors 200, perfectly calibrated to the type of material and thickness used in the inventive creation.

[0048] Therefore, these solutions according to the present invention constitute an optimal compromise, since the creation of said inventive device has the result of being able to correct or at least minimize all those problems identified in the prior art relating to the technical difficulty in applying the device.

[0049] Therefore, the specific object of the present invention is to have made a pupil dilator device which is provided with a high degree of functionality and easy to use, even by those healthcare professionals who are less experienced or in any case have little manual skill in the art.

[0050] Therefore, with the present finding it is intended to propose a new and alternative solution to the solutions known so far and in particular the aim is to overcome one or more of the drawbacks or problems referred to above and / or to satisfy one or more needs perceived in the art and in particular deduced from what has been reported above.

[0051] For this purpose, it will be immediately obvious that countless variations and modifications can be made to what has been described, for example related to shape, dimensions, arrangements and parts with equivalent functionality, and all this without departing from its scope of protection, as defined by the following dependent claims.

Claims

Claims1. Pupil dilator device characterized in that it comprises a ring-shaped element (100), delimiting an internal circular surface divided into three distinct circular sectors (200) having the respective circumferential arcs connected to the internal edge of said ringshaped elements (100), from the fact that each extreme portion of said circular sectors (200) ends with a hooked portion (220) obtained coplanar to said circular sector (200), from the fact that near each of said hooked portions (220) there is a hooking hole (230), from the fact that lateral to each of the two spokes of each circular sector (200) there is a left hooked portion (240) and a right hooked portion (245) and from the fact that coplanar and peripheral manner at least three equidistant fins (300) are present on said ring-shaped element (100).

2. Pupil dilator device according to claim 1, characterized in that at least a foramen (250) is obtained on each circular sector (200).

3. Pupil dilator device according to any of the preceding claims, characterized in that the conformation and positioning of said hooking hole (230) is suitable to be engaged by any surgical instrument capable of lifting said hooked portion (220) and then spread said circular sector (200).

4. Pupil dilator device according to any of the preceding claims, characterized in that the conformation and positioning of said left hooked portion (240) and said right hooked portion (245) are suitable for engaging the pupillary margin of the iris membrane (400).

5. Pupil dilator device according to any of the preceding claims, characterized in that the conformation and positioning of said hooked portions (220) are suitable for being connected to the patient’s corneal surface.

6. Pupil dilator device according to any one of the preceding claims, characterized in that the conformation of said hooked portions is such that in a closed configuration said left hooked portion (240) fits into the respective right hooked portion (245) of the circular sector (200) adjacent and that said right hooked portion (245) fits into the respective left hooked portion (240) of the other adjacent circular sector (200).

7. Pupil dilator device according to any of the preceding claims, characterized in that said closed conformation is a planar conformation.

8. Pupil dilator device according to any of the preceding claims, characterized in that the width of the diameter of the ring-shaped element (100) is included in a range between 10 mm and 6 mm and more preferably equal to 8 mm.

Images