EP2004093A1 - Élément de soutien en vue de la compensation des déformations de la cornée de l'oeil - Google Patents

Élément de soutien en vue de la compensation des déformations de la cornée de l'oeil

Info

Publication number
EP2004093A1
EP2004093A1 EP07727535A EP07727535A EP2004093A1 EP 2004093 A1 EP2004093 A1 EP 2004093A1 EP 07727535 A EP07727535 A EP 07727535A EP 07727535 A EP07727535 A EP 07727535A EP 2004093 A1 EP2004093 A1 EP 2004093A1
Authority
EP
European Patent Office
Prior art keywords
element according
support element
flattening
cornea
support
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.)
Withdrawn
Application number
EP07727535A
Other languages
German (de)
English (en)
Inventor
Mark Tomalla
Gebhard Tomalla
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
TOMALLA, JUTTA
Original Assignee
Acritec AG
Tomalla Jutta
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Acritec AG, Tomalla Jutta filed Critical Acritec AG
Publication of EP2004093A1 publication Critical patent/EP2004093A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/147Implants to be inserted in the stroma for refractive correction, e.g. ring-like implants

Definitions

  • the invention relates to a support element for compensating deformations of the cornea of an eye, which has a transverse slotted annular support body.
  • Such support elements here also referred to as support rings, are inserted into a channel which is introduced into the cornea of a human or animal eye and generally runs parallel to its contour in order to eliminate local, sight-limiting bulges of the cornea.
  • Such bulges are also referred to in the jargon as “keratoconus.” They result from a progressive thinning and subsequent conical deformation of the cornea of the eye.
  • the corneal deformations arched outwards in keratoconus patients can be compensated by the formation of raised bulges, ie towards the interior of the eye. These bulges are generated by the introduction of displacement bodies, so-called “Intacs", in the proximal, ie pointing to the body, half of the cornea as possible outside of the visual field or in its edge zone.
  • the known Intacs used as support elements are usually formed annularly with a round or hexagonal cross-section and produce after implantation in the cornea a torus. Due to the formation of beads, transversal tensile forces are generated in the cornea. These can be adjusted by an appropriate design of the socket element itself and the channel so that the diseased corneal tubercle (keratoconus) is compensated in accordance with the normal corneal vaulting.
  • the known support elements are usually composed of two half-rings.
  • a ring is described, for example, in EP 0 732 891 B1.
  • this ring has a plate-horse-like shape with conically-projecting end abutment surfaces.
  • the ring exerts tensile forces on the circumference of the ring surrounding the cornea section through which the relevant corneal section is stretched and thus smoothed.
  • a support element for compensating for deformations of the cornea of an eye which has a one-piece or multi-part annular support body in a conventional manner.
  • this support body has a cross-section which is flattened on one side.
  • This flattening is arranged according to the invention so that a peripheral end flattening is formed on the support element according to the invention.
  • this flattening forms a contact surface, with which the support element according to the invention bears tightly against the outwardly directed inner wall of the slot-like channel, which has been previously formed, for example by means of a laser beam, into the cornea of the respective treated eye.
  • Outside its flattened portion of the cross section of the support element according to the invention is rounded. In this way, it is ensured that the forces exerted by a support element according to the invention are gently introduced into the sections of the cornea surrounding the support element and local load peaks are avoided.
  • An inventive support element is thus shaped so that the given in the prior art adverse influence on the corneal inner wall by bending and strain stress is minimized.
  • a designed according to the invention support element is therefore predestined for implantation in a by means of a very high-frequency laser, z.
  • a femto-second laser introduced into the cornea of the treated eye slit-like, parallel to Corneal contour and thus in a first approximation conical circular channel whose shape is similar to a divider spring.
  • the orientation of the flattening present on a support element according to the invention is preferably to be selected such that it is adapted to the orientation of the inner surface of the channel slot molded into the cornea in the implanted state.
  • the advantages of the embodiment of the flattening acting as a support surface in the implanted state, which is adapted to the pitch angle of the contact surface of the channel, lie in the low surface pressure and thus low indentation behavior in the cornea in the region of the flattening.
  • the existing in a support member according to the invention flattening can therefore be designed so that the forces transmitted through them is optimally adapted to the locally given their implantation in their respective neighborhood conditions.
  • the flattening formed on the support element may form a conically tapered annular disc surface.
  • Such a shaped support element can be produced particularly easily and inserted precisely into the channel slot molded into the cornea to be treated.
  • a conically shaped flattening results in a relatively large current range relative to the thickness of the cornea for the implantation of the cornea Stutzringes can be selected.
  • a nearly horizontal, ie approximately parallel to the circular plane of the support element extending flattening is preferably limited to the proximal half of the cornea, in order to avoid or exclude the consequences of a fürens the Stutzringes outward.
  • An essential advantage of a support element according to the invention consists in the high centering effect which is achieved on account of its conically shaped flattening in the described cornea channel.
  • the angular position (flattening angle) of the flattening acting as a support surface between about 25 to above the horizontal, in this case 0 ° goes out.
  • the thrust can be adjusted, which is initiated in the implanted state of the socket element in the surrounding cornea.
  • load peaks can be avoided by the flattening angle being> 0 °.
  • the flattening does not run parallel to the channel wall produced in the curved cornea, but at an angle to this, the horizontal flattening exerts a thrust component on the outwardly over the frontal area of the cornea.
  • the dimensions to be selected of a support element according to the invention can be achieved with slot channels introduced into the proximal region of the cornea.
  • this arrangement of the channel to be introduced for the implantation of a support element according to the invention results in a large thickness of the outer with respect to the channel slot area of the cornea in comparison to the thickness of the interior relative to the channel slot area of the cornea.
  • the support body of a support element according to the invention should have a circumferential angle of at least 350 °, in particular up to 360 °.
  • a support element according to the invention offers numerous possibilities for variation, regardless of the particular orientation of the flattening acting as a support surface, while retaining its basic shape according to the invention. Thus, even by a parallel displacement of the flattening in the radial cross-sectional direction while maintaining the diameter of the support body, the volumes occupied by the support element change.
  • the local conditions of the cornea or the forces to be applied locally in the design of a support element according to the invention can be taken into account by varying the thickness of the support body along its circumference.
  • the thickness of the support body may be varied in the direction of its height measured perpendicular to the circle plane.
  • Cross-sectional center is carried out, but it can also be asymmetric indentations or bulges formed on the support element, if this is necessary in view of the desired effect in the implanted state of the support element according to the invention. This available with the invention
  • a particularly gentle embodiment of the invention surrounding the environment of the support element according to the invention is characterized in that the edge of the cross section of the support body extends in a circular arc outside the area of the flattening.
  • convex or concave on or flattening the flattening formed on a support member according to the invention frontally encircling and in the implanted state serving as a support surface while maintaining their basic conical to horizontal orientation, if this in terms of each desired effect as expediently turns out.
  • the wall of the channel formed into the cornea in the implanted state will usually be flat, it is favorable if the flattening itself is also flat.
  • a further advantageous variant of the invention provides that the edge of the cross section of the Stutzkorpers runs in a straight line in the region of its flattening.
  • the transition between the flattening and the adjoining area of the support body should be rounded.
  • the handling of a support element according to the invention during insertion into the slot channel previously molded into the eye can be simplified by forming a flattened step on at least one end of its support body.
  • This paragraph can serve as a point of attack for the tool used by the surgeon.
  • an opening can be formed in the flattened paragraph.
  • the risk of injury to the cornea can be minimized by the fact that in the area of the transition between the flattened paragraph and the support body is formed a slope.
  • a support element according to the invention can be produced from commercially available, well biocompatible plastics from which the already known "intacs" are made use, the support body are composed of more than one part.So it is also possible with a support element according to the invention to assemble the support body, for example, two half-rings.
  • Figure 1 is a support element in plan view.
  • FIG. 2 shows the support element in a section along the section line X-X drawn in FIG. 1;
  • FIG. 3 shows an end section of the support element in an enlarged view corresponding to FIG. 1;
  • FIG. 5 shows the support element in a section along the section line YY drawn in FIG. 4;
  • FIG. 6 shows a section of a cornea of an eye with the support element implanted therein in a sectional view;
  • Fig. 7 is a varied support member in one of Fig. 5 corresponding sectional view.
  • the support element 1 shown in FIG. 1 comprises an annular body 2 which surrounds an angular range of more than 350 ° and is composed of two semi-tubular body halves 2a, 2b and on whose end portions a flattened shoulder 3,4 is formed.
  • the Stutzkorper 2 has a cross-section whose basic shape corresponds to the shape of a circle, but which is obliquely flattened in the region 5 of its the one end face Sl of the support member 1 associated side.
  • a flat flattening 6 is formed on the one end face Sl of the Stutzkorpers 2, which circulates on the one hand to the Stutzkorper 2 and on the other in the direction of the central axis M of the support member 1 tapered at an angle OC relative to the circular plane E of the overall annular Support element 1 is inclined.
  • the transitions 7,8 between the flattening 6 and the adjacent sections of the Stutzkorpers 2 are formed rounded.
  • the flattening 6 is guided over the free ends of the Stutzkorpers 2 also up to the free end of the molded on the Stutzkorper 2 flattened paragraphs 3,4.
  • the heels 3,4 have a thickness which is about half as large as the thickness of the Stutzkorpers 2.
  • the area of the transition U of the heel 3,4 to the neck body 2 is in each case beveled at an angle ⁇ of 45-60 °.
  • the slot-shaped channel K is cut into the cornea H by means of a femtosecond laser known per se in a manner which is also known per se.
  • the walls Wa, Wi delimiting this channel K run essentially parallel to the curved surface Oa of the cornea H.
  • the channel K is thereby positioned such that the thickness Da of the cornea H between it and the external surface Oa of the cornea H remaining corneal area Ba is greater than the thickness of the proximal, remaining between it and the inner surface Oi of the cornea H area Bi.
  • first the first support body half 2a and then the second support body half 2b of the support member 1 is pushed into the channel K.
  • the support body halves 2 a, 2 b forming together the support body 2 of the support element 1 are each aligned so that the flattening 6 abuts the outer wall Wa associated with the surface Oa of the cornea H.
  • the flattening 6 is close to the wall Wa, without deforming them to a greater extent.
  • the proximal region Bi of the cornea H is displaced from the curved region of the support element 1 in the direction of the interior I of the eye, so that outwardly directed tensile forces Z arise in this region in the radial direction of the eye.
  • the free space K 'remaining in the channel K in FIG. 6 at the side of the support element 1 or its respective support body 2 is shown exaggerated for clarity.
  • the width of the channel K will of course be adapted to the width of the support member 1 and its support body 2, that after implantation as low as possible Free space K 'remains laterally of the support element 1 or its support body 2.
  • the selected basic design of the support element according to the invention enables a simple, low-resistance implantation and, because of its generally rounded shape, involves a very low risk of injury to the cornea.
  • this does not exclude that - apart from the flattening which is always to be provided according to the invention - the cross-section of a support element according to the invention may also have cross-sectional shapes other than those expressly mentioned here,
  • the inwardly-lying cross-sectional shape of a support element according to the invention is always designed so that the adverse effect on the corneal inner wall is kept as low as possible by bending and expansion stresses.
  • the channel wall facing outwards offers an advantageous abutment and counterpart surface for the flattening of the neck element. Due to the large-scale support creates a clearly geometrically definable abutment for the forces that result from the tensioning of the thinner inner cornea layer on the advantageously rounded inward and perpendicular to the corneal contour built-ring ring.
  • the extent of the corneal deformation is determined by the size and shape of the cross-sectional area of the support element in addition to the position diameters of the channel and support element.

Landscapes

  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un élément de soutien qui permet de compenser des déformations de la cornée (H) de l'oeil et qui présente un corps annulaire de soutien (2) en une ou plusieurs pièces, qui permet de compenser le kératocône tout en sollicitant au minimum la cornée de l'oeil traité. Selon l'invention, ce résultat est obtenu en ce que le corps de soutien (2) présente une section transversale aplatie sur un côté et pour le reste arrondie, de manière à former un méplat (6) périphérique sur son côté frontal.
EP07727535A 2006-03-30 2007-03-29 Élément de soutien en vue de la compensation des déformations de la cornée de l'oeil Withdrawn EP2004093A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102006015172 2006-03-30
PCT/EP2007/053063 WO2007113225A1 (fr) 2006-03-30 2007-03-29 élément de soutien en vue de la compensation des déformations de la cornée de l'oeil

Publications (1)

Publication Number Publication Date
EP2004093A1 true EP2004093A1 (fr) 2008-12-24

Family

ID=38255183

Family Applications (1)

Application Number Title Priority Date Filing Date
EP07727535A Withdrawn EP2004093A1 (fr) 2006-03-30 2007-03-29 Élément de soutien en vue de la compensation des déformations de la cornée de l'oeil

Country Status (4)

Country Link
US (1) US20100286770A1 (fr)
EP (1) EP2004093A1 (fr)
KR (1) KR20090052834A (fr)
WO (1) WO2007113225A1 (fr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2397473B1 (es) * 2011-05-26 2014-01-10 Imexclinic, S.L. Un segmento intraestromal.
US9974645B2 (en) 2012-08-07 2018-05-22 RegenEye, L.L.C. Method of reducing the occurrence of macular and neuroretinal degenerations by alleviating age related retinal stresses as a contributing factor in a mammalian eye
US10265161B2 (en) 2012-08-07 2019-04-23 Regeneye L. L. C. Ocular collar stent for treating narrowing of the irideocorneal angle
US9308082B2 (en) 2012-08-07 2016-04-12 RegenEye, L.L.C. Ocular collar stent for treating narrowing of the irideocorneal angle
CN105163696A (zh) * 2012-12-07 2015-12-16 赛萨卡股份有限公司 用于眼科手术的飞秒多重射击

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007104068A1 (fr) * 2006-03-16 2007-09-20 Albert Daxer Implant cornéen

Family Cites Families (12)

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Publication number Priority date Publication date Assignee Title
US4452235A (en) * 1982-01-04 1984-06-05 Reynolds Alvin E Method for corneal curvature adjustment
US4833890A (en) * 1988-04-04 1989-05-30 Kelman Charles D Bipartite intraocular lens
AU667342B2 (en) * 1992-01-02 1996-03-21 Chiron Intraoptics, Inc. Corneal ring inlay and methods of use
US5405384A (en) * 1992-09-03 1995-04-11 Keravision, Inc. Astigmatic correcting intrastromal corneal ring
US5300118A (en) * 1992-09-21 1994-04-05 Keravision Adjustable devices for corneal curvature adjustment
US5323788A (en) * 1992-09-21 1994-06-28 Keravision Overlapping split ring device for corneal curvature adjustment
WO1995003755A1 (fr) * 1993-08-02 1995-02-09 Keravision, Inc. Insert preforme segmente destine au stroma corneen
US5722971A (en) * 1995-10-20 1998-03-03 Peyman; Gholam A. Intrastromal corneal modification
US6206919B1 (en) * 1998-01-14 2001-03-27 Joseph Y. Lee Method and apparatus to correct refractive errors using adjustable corneal arcuate segments
FR2787991B1 (fr) * 1998-12-31 2001-05-25 Medicale De Prec S M P Sa Soc Dispositif pour traiter la presbytie ou autre affection oculaire
US7645299B2 (en) * 2001-05-11 2010-01-12 Koziol Jeffrey E Intracorneal lens system having connected lenses
US6623522B2 (en) * 2001-11-07 2003-09-23 Alok Nigam Myopic corneal ring with central accommodating portion

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007104068A1 (fr) * 2006-03-16 2007-09-20 Albert Daxer Implant cornéen

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO2007113225A1 *

Also Published As

Publication number Publication date
KR20090052834A (ko) 2009-05-26
US20100286770A1 (en) 2010-11-11
WO2007113225A1 (fr) 2007-10-11

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