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WO2015008194A1 - Structure vitréo-rétinienne géodésique - Google Patents

Structure vitréo-rétinienne géodésique Download PDF

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Publication number
WO2015008194A1
WO2015008194A1 PCT/IB2014/062969 IB2014062969W WO2015008194A1 WO 2015008194 A1 WO2015008194 A1 WO 2015008194A1 IB 2014062969 W IB2014062969 W IB 2014062969W WO 2015008194 A1 WO2015008194 A1 WO 2015008194A1
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WO
WIPO (PCT)
Prior art keywords
tamponade
vitreous
tensile
static
vitreo
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IB2014/062969
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English (en)
Inventor
Salvatore CRUGLIANO
Antonio DI ZAZZO
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Individual
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Individual
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Publication of WO2015008194A1 publication Critical patent/WO2015008194A1/fr
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/00727—Apparatus for retinal reattachment

Definitions

  • the present invention refers to the field of medical devices. More in detail the present invention refers to a tamponade vitreous substitute to be applied in a vitreous chamber, following a pars plana vitrectomy, in order to restore the physiological functioning of the retina. State of the art
  • vitreo-retinal ocular surgery makes use of two main methods: first, ab externo or episcleral surgery, which has several problems.
  • vitreo- retinal pathologies provides for an ab interno approach and takes the name of pars plana vitrectomy.
  • This technique consists of the surgical removal of the vitreous body, which is a gelatinous, transparent and colorless substance present inside the eyeball.
  • This operation has a variable duration, according to the particular pathology that requires it, the overall condition of the patient and the practiced surgical techniques, which range from circa 30-40 minutes in the "simple" vitrectomies to many hours in the more complex cases.
  • a further technique associated with the pars plana vitrectomy is the injection of silicone oil, applied in the cases in which it is necessary to support the reattached retina with silicone oil, which is an inert substance more effective than air or gas in supporting the retina, since it is not reabsorbable and is more enduring.
  • standard vitrectomy which uses 20 Gauge technique
  • transconjunctival vitrectomy with 23 Gauge technique transconjunctival vitrectomy with 25 Gauge technique.
  • the 23 Gauge technique which can be defined as a "mini-invasive" technique, is the currently preferred technique since it allows the use of instruments with slightly larger diameter in comparison with those used with the 25 Gauge technique, it ensures a lower flexibility of the instruments themselves and allows sucking a greater quantity of vitreous.
  • vitrectomy today remains one of the most advanced micro-surgery techniques, which allows finding an effective solution to many otherwise unsolvable conditions. Indeed, currently there is no alternative to the surgical operation of vitrectomy.
  • the object of the present invention is to provide means that allow considerably increasing the possibilities of success of vitrectomy via pars plana, reducing to a minimum - if not completely eliminating - the probability of incurring the aforesaid complications and consequent alterations.
  • the present industrial invention patent application described in detail hereinbelow, proposes a new structure adapted to restore the physiological activity of a damaged or dysfunctional retina after having removed the vitreous from the eye interior. All this occurs with the current techniques employed for vitrectomy and preferably with the 23 Gauge technique.
  • the vitreous tamponade means are homogenous fluids that can be reabsorbed over a variable time, or they are not reabsorbable. They can have different density as a function of the surgical requirements and are injected by means of suitable apparatuses and dedicated injectors in a vitreous chamber in order to fill the latter during the terminal steps of the ab interno vitreo-retinal surgery or pars plana vitrectomy.
  • Said tamponade means already known, aim to mimic the vitreous biomechanical physiology and to maintain the retina in situ.
  • Object of the present invention is to provide an atoxic biocompatible tamponade vitreous substitute that respects the normal physiology of the intraocular structures and ensures a decidedly more enduring maintenance of the surgery results, with respect to that encountered with the use of the known tamponade systems.
  • the present industrial invention patent application describes a new tamponade vitreous substitute adapted to maintain and/or restore the physiological functioning of the retina as well as the correct positioning thereof. More in detail the present invention describes a vitreous substitute to be implanted in the vitreous chamber during the pars plana vitrectomy, preferably with the aid of surgical instrumentation of 23 gauge type.
  • the present tamponade vitreous substitute is represented by a tensile- static structure adaptable to the inner surface of the retina, in which all the load-bearing elements are in direct continuity with each other, at the points where said structure is in contact with the retina, in a manner so as to be atraumatic for the latter.
  • the present vitreous tamponade is represented by a tensile-static structure having the form of a spherical cap, preferably incomplete, whose surface is shaped like that of a geodesic dome or like that of the fullerene molecular structures and in particular of the fullerene structures of buckyball type, i.e. spheroid or ellipsoid fullerenes.
  • Said structure when applied during the surgical operation, comes to be extended from the ora serrata, front limit of the neurosensory retina, well-known to those skilled in the art, up to approximately the front limits of the rear pole, more specifically intended along a curved line running slightly outside the temporal retinal arterial arcades and respectively passing through the points preferably situated at two papillary diameters from the optic papilla, above and beneath it along the vertical axis thereof, at two papillary diameters medially and at five papillary diameters laterally with respect to the aforesaid margin, according to the horizontal axis of the optic papilla or head of the optical nerve.
  • Said front and rear limits of the present tamponade structure are examples of a possible spatial configuration thereof, and can both vary considerably as a function of surgery requirements, given that said structure is highly personalizable.
  • the geodesic tensile- static structure is initially inserted in folded conformation, like an umbrella, inside a suitable plunger injector adapted for the implantation of said structure in its seat of use. Once inserted inside the eyeball, the geodesic structure will be unfolded, assuming the desired configuration.
  • the conformational change and adaptation of the present structure are consequences of the type of biocompatible material used for obtaining the tamponade vitreous substitute in question, and in particular are the result of the structural "memory" of said material.
  • the geodesic tensile- static structure under examination is in principle obtained in a manner such to spatially conform and configure its constituent material, in a manner such that it is adaptable and similar to the conformation of the ocular retina that must undergo surgical operation.
  • Said material preformed like a geodesic dome, has chemical-physical properties such to allow its folding up and insertion inside a specific plunger injector.
  • the material Once injected in specific points inside the eyeball, the material will be unfolded and will reassume its initial spatial configuration, "remembering" its original spherical cap shape with geodesic surfaces, hence it will be correctly extended over the dysfunctional retina.
  • the result of such application is that of re-establishing the physiological biomechanical characteristics of the vitreous chamber.
  • An important parameter of the present tensile-static structure is defined here as the frequency V, or chord factor, which represents the number of polygons identifiable on the implanted dome, defining this as the degree of complexity.
  • Said dome is indeed composed of a plurality of segments, of specific material, suitably combined in a manner such to define a tensile- static structure with spherical cap, preferably incomplete, having the surfaces with a plurality of holes with polygonal shape, preferably triangular and/or pentagonal and/or hexagonal and/or octagonal.
  • V represents the number of said polygons, preferably triangles, defined by segments of biocompatible material extended on the retinal surface and defining the present geodesic structure.
  • the material used for obtaining the vitreous tamponade is a foldable biocompatible material, provided with "structural memory" and personalizable.
  • the material employed for obtaining the object of the present invention are hydrocolloids, more in detail hydrogels, i.e. colloids formed by polymer chains of molecules dispersed in the water, whose content of the aqueous medium can exceed 99%.
  • the hydrogels used for obtaining the object of the described invention are generally but not necessarily synthetic materials, which show the aforesaid properties and are usually silicone-based and/or polyacrylamide-based.
  • FIGURE 1 shows a perspective view of the tensile-static tamponade 1 to be implanted as vitreous substitute inside the vitreous chamber and object of the present industrial invention patent application.
  • the figure in question intends to emphasize the particular shape of said tamponade 1, i.e. of its geodesic dome shape.
  • the figure indicates the convex surface 2, adapted to contact the dysfunctional retina, and the concave surface 2' .
  • a plurality of holes 3 can be identified, with triangular shape, defined by filaments 4 and overall generating a geodesic dome with a specific frequency V. Said frequency indicates the number of triangles present for each triangular face of the polyhedron defining the dome in question.
  • FIGURE 2 shows a perspective view of the tamponade 1 in which the presence of the central hole 5 can be observed in the dome structure.
  • Said hole 5 is adapted to preserve the rear pole of the retina from possible compressions exerted on the same tamponade 1.
  • FIGURE 3 shows a front view of a particular embodiment of the present tensile- static tamponade 1.
  • the figure in question intends to emphasize that said tamponade has a structural conformation similar to that of the fullerene allotropic structures of buckyball type.
  • FIGURE 4 shows a perspective view of tensile-static tamponades 1 having different frequency V.
  • Object of the figure under examination is to emphasize the versatility and the personalizable character of the present tensile-static tamponade 1.
  • the latter as repeated multiple times in the course of the present description, is obtained with predefined quantities of material and is designed with a specific frequency V and with a predetermined radius of curvature in accordance with the type of conformation and/or ocular anomaly encountered.
  • FIGURE 5 shows an exemplifying representation of the plant of the present tensile-static tamponade 1 inside the vitreous chamber in order to correct the alterations due to the dysfunctional retina.
  • figure 4 (a) shows a geodesic tensile-static tamponade 1 as illustrated in the preceding figures
  • figure 4 (b) shows a transverse section of the human eye 20 in which the retina 10 is shown
  • figure 4 (c) shows the tamponade 1 of figure 4 (a) inserted within an injector (30)
  • figure 4 (d) shows a transverse section of the human eye in which said tamponade 1 has been implanted in order to contact the retina 10 and maintain it in situ, thus accomplishing in every respect the same function of the vitreous humor removed following a pars plana vitrectomy.
  • the geodesic tensile-static structure indicated hereinbelow as a tensile-static tamponade 1, subject of the present industrial invention patent application, comprises a plurality of segments 4 of the biocompatible material selected for the obtainment thereof, suitably combined in a manner such to obtain a tensile-static tamponade 1 which has, macroscopically, the form of a spherical cap with geodesic surfaces. More in detail, said tamponade 1 has its convex surface 2, as well as its concave surface 2', having a plurality of holes 3 defined by a polygonal shape.
  • said holes 3 have a triangular shape, as in the well-known architectural geodesic domes, or a pentagonal and hexagonal shape as can be encountered in the micro-structural arrangement of the spheroid and ellipsoid fullerene allotropes, termed "buckyball".
  • buckyball a plurality of holes 3 can therefore be identified that are spatially configured and consist of a number such to generate a tensile-static tamponade 1 shaped as a geodesic dome; when such dome is implanted on the dysfunctional retina 10, it does not result traumatic for the same, i.e. it is smoothed in the points where said tamponade 1 contacts the retina 10.
  • the segments 4 of the material used are combined for such purpose, generating a structure without interruption.
  • the implant of a structure with geodesic shape inside the vitreous chamber ensures a stable and durable localization of the retina in situ.
  • Said geodesic shape represents the element characterizing the object of the invention, allowing the attainment of the object of the invention, i.e. to provide a tamponade vitreous substitute, to be implanted during the pars plana vitrectomy, which allows obtaining the maintenance of the results reached following the surgical treatment.
  • the present tamponade 1 has a structure in which the "deformation resistance" of the preferably triangular meshes accompanies the efficiency of the spherical form, thus obtaining a decidedly stable and self -bearing structure.
  • Such structure in fact has a high load capacity, even if a relatively small amount of material is employed for obtaining it.
  • an important parameter of the present tensile- static tamponade 1, which determines the efficiency thereof, is the frequency V which represents the number of polygons identifiable inside the structure defining said tamponade 1.
  • the shape of said polygons is triangular, and V represents the number of triangles present in each triangular face of the tamponade 1 with polyhedral geometry.
  • V represents the number of triangles present in each triangular face of the tamponade 1 with polyhedral geometry.
  • the triangular faces of a polyhedron with twenty faces i.e. an icosahedron
  • the polyhedral faces are subdivided into nine smaller triangles and are formed by three different side lengths.
  • Geodesic structures are well-known, above all in the architectural field, and for such purpose it should be specified that the present invention intends to describe and claim not a self-standing geodesic structure, but rather the application of a geodesic structure as tamponade vitreous substitute, i.e.
  • the materials in question are the hydrocolloids and in particular the hydrogels comprising polymers, derived from methyl and ethyl methacrylates, and/or from hydroxylated methyl and ethyl methacrylates such as polyhydroxyethylmethacrylate (PHEMA), in hydrophobic and hydrophilic variants and combinations thereof.
  • said materials are the hydrogels comprising PHEMA in combination with PMMA.
  • hydrogels comprising silicone polymers in hydrophobic and hydrophilic forms thereof.
  • a usable material that was used for obtaining the tamponade 1 is represented by the combination: silicone/silicone hydrogel. Said materials are adapted for obtaining the object of the invention not only since they are atoxic biocompatible materials in their seat of use, but also for the fact that they are provided with "structural memory”.
  • Said materials in order to be implanted in a vitreous chamber in geodesic dome form must necessarily and intuitively be initially in folded conformation, in a manner so as to generate a folded structure like an umbrella that can be received inside a plunger injector, from which said structure, i.e. the tamponade 1, is made to exit outward following the injection in a vitreous chamber.
  • the tamponade 1 Once injected in specific points of said chamber, the tamponade 1 is unfolded, assuming its geodesic spatial conformation and configuration, thus completing its function of contacting and maintaining in situ the dysfunctional retina.
  • the tamponade 1, therefore, before being inserted within the injector, is made in a manner so as to spatially constitute the desired geodesic structure.
  • the material(s) used for obtaining the tamponade 1 is such to memorize its initial structural configuration and conformation, so that even following its folding up and insertion within the injector, it is able to reassume its initial conformation, i.e. the geodesic shape, when subsequently injected and unfolded in a vitreous chamber. These characteristics also allow obtaining personalized tensile- static tamponades 1. More in detail, the present tensile- static tamponades 1 can be obtained by meeting specific needs corresponding to determinate ocular anomalies and/or pathologies causing dysfunctions of the retina. Thus, said tamponades 1 are made with specific quantities of biocompatible material provided with "structural memory", obtaining geodesic dome structures having a predefined radius of curvature and a frequency V.
  • the present tensile- static tamponade 1 is designed and obtained in order to give rise to an arrangement of segments 4 combined so as to obtain a geodesic dome.
  • the latter is preferably but not exclusively provided with a hole 5 at the pole of said dome, with shape defined by any polygonal shape or closed curve, and typically with elliptical shape.
  • said tensile-static tamponade 1 comes to be extended, when injected in a vitreous chamber, from the ora serrate, front limit of the neurosensory retina, up to the front limits of the rear pole, more specifically being intended along a curved line running slightly outside the temporal and nasal retinal arterial arcades and respectively passing through the points situated at two papillary diameters from the optic papilla, above and beneath it along the vertical axis thereof, at two papillary diameters medially and at five papillary diameters laterally with respect to the aforesaid margin, according to the horizontal axis of the papilla or head of the optical nerve.
  • the spatial conformation and configuration of the tamponade 1 thus extended in a vitreous chamber indeed corresponds with a geodesic dome having a hole 5 with elliptical shape.
  • said hole 5 can have a circular or elliptical shape or a specific polygonal shape, or even be entirely absent. The latter condition is verified, for example, when the retina is substantially damaged.
  • the tamponade 1 has the hole 5, in order to prevent compressions exerted by the same tamponade 1 on the rear pole of the retina.
  • the size of the segments 4 forming the tamponade 1 can vary in accordance with the type of anomaly encountered. Typically said segments have a transverse section with a diameter that varies from 0.3 mm to 0.4 mm and preferably is 0.38 mm.
  • the tensile-static tamponade 1 comprises segments 4 having different sections inside the same dome structure. All of the above in order to meet specific needs corresponding to the type of dysfunction and/or anomaly encountered.
  • the present tensile- static tamponade 1 is obtained with known methods. More in detail, production methods of the tamponade 1 - starting from the raw material found on the market, obtained via polymerization, photopolymerization, polyaddition, or polycondensation - can by way of non-limiting example provide for techniques that use molds, such as: compression molding, injection molding, transfer molding and thermoforming. Alternatively, methods can be applied that use a low temperature production type, such as: polymerization in low- temperature mold - cast molding - and cryolathing which provides for the molding starting from a block of preformed polymer, modeling it according to the required geometry, by removal of material at low temperature.

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Absorbent Articles And Supports Therefor (AREA)
  • Prostheses (AREA)
  • Revetment (AREA)

Abstract

L'invention concerne un tamponnement (1) oculaire vitréo-rétinien statique en traction, atraumatique et personnalisable, destiné à être implanté en tant que substitut vitreux dans une chambre vitreuse consécutivement à une vitrectomie de la pars plana, le tamponnement étant caractérisé en ce qu'il présente une forme du type dôme géodésique. Ledit tamponnement (1) comprend une pluralité de segments (4) faits d'une matière biocompatible, qui sont combinés de manière appropriée en continuité directe afin de produire un dôme géodésique statique en traction, qui présente une surface convexe (2) et une surface concave (2') complètement lissées, lesdites surfaces comportant une pluralité de trous (3) de forme polygonale, ladite forme étant définie par lesdits segments (4). Ledit tamponnement (1) maintient la rétine (10) in situ, ladite surface convexe (2) se prolongeant, dans une chambre vitreuse, sur ladite rétine (10).
PCT/IB2014/062969 2013-07-19 2014-07-09 Structure vitréo-rétinienne géodésique Ceased WO2015008194A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITRM2013A000427 2013-07-19
IT000427A ITRM20130427A1 (it) 2013-07-19 2013-07-19 Struttura geodetica vitreoretinica.

Publications (1)

Publication Number Publication Date
WO2015008194A1 true WO2015008194A1 (fr) 2015-01-22

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PCT/IB2014/062969 Ceased WO2015008194A1 (fr) 2013-07-19 2014-07-09 Structure vitréo-rétinienne géodésique

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IT (1) ITRM20130427A1 (fr)
WO (1) WO2015008194A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107874871A (zh) * 2016-09-29 2018-04-06 上海市同济医院 植入式视网膜支架

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090156881A1 (en) * 2007-10-15 2009-06-18 Stokes John P Convergent well irradiating plaque for choroidal melanoma
US20130046382A1 (en) * 2010-02-22 2013-02-21 Rudy A. Mazzocchi Minimally-invasive method and apparatus for restructuring the retina

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090156881A1 (en) * 2007-10-15 2009-06-18 Stokes John P Convergent well irradiating plaque for choroidal melanoma
US20130046382A1 (en) * 2010-02-22 2013-02-21 Rudy A. Mazzocchi Minimally-invasive method and apparatus for restructuring the retina

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107874871A (zh) * 2016-09-29 2018-04-06 上海市同济医院 植入式视网膜支架

Also Published As

Publication number Publication date
ITRM20130427A1 (it) 2015-01-20

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