WO1997039701A1 - Emballage pour le pliage des implants intraoculaires - Google Patents
Emballage pour le pliage des implants intraoculaires Download PDFInfo
- Publication number
- WO1997039701A1 WO1997039701A1 PCT/FR1997/000717 FR9700717W WO9739701A1 WO 1997039701 A1 WO1997039701 A1 WO 1997039701A1 FR 9700717 W FR9700717 W FR 9700717W WO 9739701 A1 WO9739701 A1 WO 9739701A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- folding
- implant
- packaging
- intraocular implants
- optical part
- Prior art date
Links
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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/16—Intraocular lenses
- A61F2/1691—Packages or dispensers for intraocular lenses
-
- 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/16—Intraocular lenses
- A61F2/1662—Instruments for inserting intraocular lenses into the eye
- A61F2/1664—Instruments for inserting intraocular lenses into the eye for manual insertion during surgery, e.g. forceps-like instruments
Definitions
- the present invention relates to a package comprising a device for folding intraocular implants composed of a flexible optical part and a haptic part and having a folding axis.
- Intraocular implants constitute an optical system that corrects the vision of the human eye and which can, in a certain number of cases, replace contact lenses or external corrective lenses.
- An intraocular implant essentially consists of an optical part of generally circular or slightly oval shape which constitutes the corrective optical system proper, and by a haptic part which is used for positioning, fixing and maintaining the correct position of the optical part inside the eye.
- the operating technique known as phacoemulsification allows the ablation of the opaque lens by the introduction into the eye of an ultrasound probe having an irrigation / aspiration system .
- the lens is removed by emulsification.
- This operating technique has the advantage, in particular compared to previous techniques, of requiring only the making of a reduced-size incision in the cornea using a knife pre-calibrated at 3.2 mm to introduce the instruments into the eye. necessary for this ablation.
- a first solution consists in using an implant which has been previously folded and which is kept folded in its packaging. This solution is not satisfactory because the shelf life of the implant before its use can go up to five years and it is very likely that the implant has undergone a deformation with a residual component which is catastrophic in terms of the variation of the optical characteristics of the implant; moreover, the problem of gripping the implant before it is introduced into the eye is still not resolved.
- Another solution is to place the folded implant in a pipe and guide this implant into the eye by pushing it.
- the implant undergoes multiple mechanical stresses and its placement in the eye is difficult to control.
- the currently most used solution uses a pair of pliers: a simple pliers with parallel arms makes it possible to hold the implant according to a diameter of its optical part which will be chosen as close as possible to the folding axis which makes it possible to obtain a folded implant of smaller width; the second forceps is a forceps with crossed jaws which initially makes it possible to initiate the curvature of the optical part then to fold it symmetrically before holding the folded implant alone.
- This technique requires perfect synchronization between the two hands which perform reverse movements due to the types of clamps present and perfect positioning of each of the two clamps.
- An objective of the invention is to provide a packaging comprising a device for folding intraocular implants composed of a flexible optical part and a haptic part which allows the implant to be folded simply and securely before it is put in place. place in the eye so that the folding, the grip and the placement of the implant are fast and precise.
- the device for folding intraocular implants according to the invention is characterized in that it comprises
- - Folding support means of the optical part integral with the base having a longitudinal rib comprising a folding edge substantially parallel to the base, capable of coming into contact with a part of the lower face of the optical part and forming a longitudinal axis intended to be disposed in the same vertical plane as the axis of folding of the implant so as to allow the folding of the implant along said axis of folding on either side of the folding edge and
- positioning means integral with the base and intended to cooperate with at least part of the peripheral zone of the optical part of the implant to support the implant, these positioning means making it possible to maintain the folding axis of 1 ' implant in the same vertical plane as the longitudinal axis of the folding support means,
- said base of the device for folding carries and connects between them the folding support means and the positioning means and also constitutes the bottom of the packaging.
- this device makes it easier to fold the implant, to grip the folded implant and subsequently to place the implant in the eye. Indeed, the surgeon will only need a single clamp as a folding tool, the implant bearing, during the folding operation, on the folding support means which may be in the form of a longitudinal rib. .
- the device which is the subject of the invention does not by itself allow the optical part of the implant to be folded, but it makes it possible to do so in an easy and simple manner using a single pliers.
- the positioning means are shaped so as to temporarily maintain the mean plane of the optical part of the implant perpendicular to the vertical plane containing the folding axis and the folding edge.
- the mean plane of the optical part as the plane on which the two spherical caps constituting the two convex faces of the optical part intersect.
- the positioning means comprise means for radial retention of at least part of the edge of the optical part of the implant to be folded, intended to place the optical center of the implant on the longitudinal axis folding support means and to prevent any rotation between the implant and said device for folding.
- marks will be provided allowing the precise positioning of the implant relative to the device for folding. The surgeon will then have to concentrate only on the handling of this single clamp to obtain good retention of
- the folded implant by choosing a correct position of the clamp, that is to say a distance between the clamp and the folding axis sufficient to hold the folded implant and not too great to prevent the implant from slipping out of the clamp.
- the invention further comprises stop means for limiting the vertical stroke of the folding tool, that is to say the clamp, in a position suitable for gripping the folded implant.
- the invention also relates to a package for an intraocular implant comprising the device for folding according to the invention where the base of the device for folding constitutes the bottom of the packaging box in which the implant is placed during its packaging.
- FIG. 1 is a schematic perspective of the principle of the folding operation of an intraocular implant with flexible optics using the device according to the invention
- FIG. 2 is a top view of the device according to the invention with the folding tool and the intraocular implant, in the position preceding the folding operation;
- FIG. 3 is a cross section along III-III of Figure 2;
- FIG. 4 is an axial section along IV-IV of Figure 2 where, for clarity, the folding tool has not been shown;
- FIG. 5 is a view identical to that of Figure 2 of an alternative embodiment of the device according to the invention.
- FIG. 6 is a cross section along VI-VI of Figure 5;
- FIG. 7 is an axial section along VII-VII of Figure 5 where, for clarity, the folding tool has not been shown;
- FIG. 8 is a view identical to that of Figure 2 of another alternative embodiment of the device according to the invention.
- Figure 9 is a cross section along IX-IX of Figure 8.
- FIG. 10 is an axial section along X-X of Figure 8 where, for clarity, the folding tool and the implant have not been shown;
- FIG. 11 is a schematic vertical section of a packaging box incorporating the device for folding implants.
- the device according to the invention can be used with an intraocular implant 20 comprising a haptic part 22, for example but not exclusively, in the form of two symmetrical loops and an optical part 24 necessarily flexible.
- the handles 22 are connected to the periphery or edge 26 of the optical part 24.
- One of the diameters of the optical part forms a preferred folding axis 28 which generates a folded implant with the smallest possible width.
- the principle of the device according to the invention consists, as can be seen in FIG.
- FIGS. 2 to 4 show a device for folding the intraocular implants in cooperation with the clamp 40 and the intraocular implant 20, in the position preceding the folding operation.
- the device for folding comprises the longitudinal rib 30 of axis 32 and four identical point supports 50 spaced circumferentially outside a fictitious circle around the rib 30, the center of this circle being on the same vertical as the geometric center of the rib 30.
- the rib and the supports will not have sharp angles so as not to damage the optical part of the implant and they project at right angles to the base 31 which carries them and connects them.
- the main direction of the section of the rib 30 is perpendicular to the plane of the base 31, the length of the rib represents at least a substantial part of the diameter of the optical part of the implant (the rib may be a little more or a little shorter than the measurement of the diameter of the optical part), the width of the rib is of the order of 1 mm so as to be wide enough to bend the optical part without damaging it and so as to be thin enough to allow the optical portion to be folded in half large enough so that the folded implant can be held between the two arms of the forceps, and the rib edge or the rib folding edge is curved.
- the supports 50 are arranged on the base 31 to 90 * from each other and include a shoulder 52 on the radially internal side of the fictitious circle, the radius of this fictitious circle passing from a value RI to a value R2> R1 at the level of 1 shoulder 52 from the lower part of the supports 50 to their upper part.
- the radius R2 is of the order of magnitude of the radius of the optical part 24 of the implant so that the edge 26 of this implant rests on the shoulders 52.
- the shoulders 52 make it possible, on the one hand, to maintain the horizontal implant, that is to say substantially parallel to the base 31 and, on the other hand, to center the optical part of the implant on the folding edge 34 of the rib.
- the mean plane of the optical part of the implant is therefore temporarily perpendicular to the vertical plane containing the folding axis 28 of the implant and the folding edge 34 of the rib.
- the vertical wall of the shoulders 52 is placed on the fictitious circle of radius R2 where R2 is slightly smaller than the diameter of the optical part of the implant so as to retain the implant radially before folding and the width of the shoulder is small so as to allow separation or detachment, during folding, between the edge 26 of the optical part and the supports 50.
- R2 is slightly smaller than the diameter of the optical part of the implant so as to retain the implant radially before folding and the width of the shoulder is small so as to allow separation or detachment, during folding, between the edge 26 of the optical part and the supports 50.
- the vertical wall of the shoulders 52 retains by a contact with friction the periphery of the optical part of the implant, which prevents any rotational movement between the implant and the device for folding and makes it possible to keep until the time of folding the configuration where the preferred folding axis of the implant coincides with 1 longitudinal axis 32 or edge of the rib.
- the height separating the fictitious circle from the top of the rib is at least equal to the half thickness at the center of the optical part.
- the two parallel arms of the clamp 40 are positioned on either side of the rib 30, above the implant 20. It then suffices to lower the clamp in a movement of downward vertical translation so that the implant folds, that is to say that the optical part curves diametrically along the folding axis 28 with its edge 26 which escapes from the shoulder 52 of the supports 50.
- FIGS. 5 to 10 the same reference numerals have been used to designate the elements identical to those of FIGS. 2 to 4.
- the variant embodiment of the device according to the invention shown in FIGS. 5 to 7 consists in that two of the supports 50 lie in the extension of the longitudinal axis 32 of the rib 30 and materially extend this rib, the other two supports 50 have, instead of the shoulder 52, a notch 56 shaped to receive the edge 26 of the optical part of the implant.
- This configuration always allows the clamp 40 to pass on either side of the rib 30 to fold the implant 20 along its folding axis 28.
- the notches 56 more securely hold the implant in its relative position relative to to the device that drives the smallest width once it is folded.
- notches 56 form means for retaining at least part of the edge 26 of the optical part of the implant to be folded.
- the notches 56 have the same functions as the shoulders as they have been described previously and also allow the implant to be held vertically by preventing the edge of the optical part of the implant from moving away from the base 31. Thanks to such notches it is possible to transport the implant on its folding device without the pre-positioning carried out during the positioning of the implant on said device being modified.
- the other alternative embodiment of the device according to the invention shown in FIGS. 8 to 10 consists in that, on the one hand, at least some of the positioning means have a contour in a horizontal plane which is substantially identical to the contour of the corresponding zone of the periphery of the optical part of the implant to be folded and in that, on the other hand, the device further comprises stop means intended to limit the vertical stroke of the folding tool (the clamp ) in a position suitable for gripping the folded implant.
- the two supports 60 have a vertical section identical to that of supports 50: a shoulder 62 allows the edge of the optical part of the implant to be supported.
- These supports 60 are arranged symmetrically with respect to the longitudinal axis of the rib and their outline is, in a horizontal plane, in the form of an arc of a circle so as to follow the outline of the optical part of the implant.
- the supports 60 make it possible to retain the edge of the optic before folding and its release during the effective folding of the optics
- This variant embodiment also comprises a vertical stop 64 projecting from the base 31 intended to limit the stroke of the clamp 40 when folding the implant.
- This stop 64 is placed in alignment with the rib 30, is wider than the rib 30 and less tall than the latter so as to limit the stroke of the clamp 40 to a height conducive to the proper maintenance of the implant by the clamp when the clamp tightens the folded optics. Then it will suffice to release the implant out of the folding device.
- FIG. 11 schematically represents a preferred embodiment of the invention where the device described above is incorporated in a packaging box 70, the bottom 72 of which is formed by the base 31 of the device for folding the implants. To form a box, the bottom is extended by vertical walls 74 and a removable cover 76.
- the device described without departing from the scope of the invention. It is possible, for example, to provide a different number of point supports, at least three, or the upper face of the rib may have a bowl shape and also serve as a support zone for part of the central zone of the optical part. of the implant.
- the use of at least one notch 56 in the positioning means allows the implant to be held more securely in the case of the packaging case 70.
- the height of the rib 30 is at least of the order of magnitude of half the diameter of the optical part of the implant.
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE0895464T DE895464T1 (de) | 1996-04-22 | 1997-04-22 | Verpackung zum falten von intraokularen implantaten |
US09/171,060 US5941390A (en) | 1996-04-22 | 1997-04-22 | Package for folding intraocular implants |
EP97920799A EP0895464A1 (fr) | 1996-04-22 | 1997-04-22 | Emballage pour le pliage des implants intraoculaires |
JP9537786A JP2000508568A (ja) | 1996-04-22 | 1997-04-22 | 眼内インプラントを折りたたむパッケージ |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR9605004A FR2747564B1 (fr) | 1996-04-22 | 1996-04-22 | Emballage pour le pliage des implants intraoculaires |
FR96/05004 | 1996-04-22 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1997039701A1 true WO1997039701A1 (fr) | 1997-10-30 |
Family
ID=9491429
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/FR1997/000717 WO1997039701A1 (fr) | 1996-04-22 | 1997-04-22 | Emballage pour le pliage des implants intraoculaires |
Country Status (7)
Country | Link |
---|---|
US (1) | US5941390A (fr) |
EP (1) | EP0895464A1 (fr) |
JP (1) | JP2000508568A (fr) |
CA (1) | CA2251739A1 (fr) |
DE (1) | DE895464T1 (fr) |
FR (1) | FR2747564B1 (fr) |
WO (1) | WO1997039701A1 (fr) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
BE1011907A3 (fr) * | 1998-05-13 | 2000-02-01 | Innovative Investments S A | Conditionnement pour implant intraoculaire souple. |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6976584B2 (en) * | 2002-06-26 | 2005-12-20 | Bausch & Lomb Incorporated | Package for surgical implant |
JP5276762B2 (ja) * | 2002-07-25 | 2013-08-28 | ビジオゲン、 インク. | 眼内レンズ系 |
US20040154946A1 (en) * | 2002-11-06 | 2004-08-12 | Kenneth Solovay | Storage apparatus for surgical implant device |
US20150114855A1 (en) * | 2013-10-24 | 2015-04-30 | Aaren Scientific Inc. | Hydrophilic iol packaging system |
AU2017267658A1 (en) * | 2016-05-18 | 2019-01-17 | Sandeep Samudre | Corneal transplant systems, methods, and apparatuses |
Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4844093A (en) * | 1987-11-30 | 1989-07-04 | Kresge Eye Institute | Tool for folding and inserting intraocular lenses |
US4906247A (en) * | 1989-03-06 | 1990-03-06 | Fritch Charles D | Intraocular lens insertion system |
US4911158A (en) * | 1989-04-27 | 1990-03-27 | Skia International Incorporated | Lens folding block |
DE4039119C1 (fr) * | 1990-12-07 | 1991-09-05 | Dieter Dr.Med. 8904 Friedberg De Klaas | |
FR2673526A1 (fr) * | 1991-03-05 | 1992-09-11 | Plancon Instr Sa | Dispositif pour la preparation de l'insertion d'une lentille intraoculaire souple. |
EP0503136A1 (fr) * | 1991-03-14 | 1992-09-16 | Chiron Adatomed Pharmazeutische und Medizintechnische Gesellschaft mbH | Procédé et dispositif pour plier une lentille intraoculaire souple |
US5201763A (en) * | 1992-02-28 | 1993-04-13 | Allergan, Inc. | Thin intraocular lens |
Family Cites Families (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5578042A (en) * | 1994-03-14 | 1996-11-26 | Cumming; J. Stuart | Ophthalmic kit and method for lens insertion |
US5556400A (en) * | 1994-12-27 | 1996-09-17 | Tunis; Scott W. | Methods of preparing and inserting flexible intraocular lenses and a configuration for flexible intraocular lenses |
US5615770A (en) * | 1995-08-10 | 1997-04-01 | Smith & Nephew, Inc. | Implant package insert delivery system |
-
1996
- 1996-04-22 FR FR9605004A patent/FR2747564B1/fr not_active Expired - Fee Related
-
1997
- 1997-04-22 US US09/171,060 patent/US5941390A/en not_active Expired - Fee Related
- 1997-04-22 JP JP9537786A patent/JP2000508568A/ja active Pending
- 1997-04-22 CA CA002251739A patent/CA2251739A1/fr not_active Abandoned
- 1997-04-22 EP EP97920799A patent/EP0895464A1/fr not_active Withdrawn
- 1997-04-22 DE DE0895464T patent/DE895464T1/de active Pending
- 1997-04-22 WO PCT/FR1997/000717 patent/WO1997039701A1/fr not_active Application Discontinuation
Patent Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4844093A (en) * | 1987-11-30 | 1989-07-04 | Kresge Eye Institute | Tool for folding and inserting intraocular lenses |
US4906247A (en) * | 1989-03-06 | 1990-03-06 | Fritch Charles D | Intraocular lens insertion system |
US4911158A (en) * | 1989-04-27 | 1990-03-27 | Skia International Incorporated | Lens folding block |
DE4039119C1 (fr) * | 1990-12-07 | 1991-09-05 | Dieter Dr.Med. 8904 Friedberg De Klaas | |
FR2673526A1 (fr) * | 1991-03-05 | 1992-09-11 | Plancon Instr Sa | Dispositif pour la preparation de l'insertion d'une lentille intraoculaire souple. |
EP0503136A1 (fr) * | 1991-03-14 | 1992-09-16 | Chiron Adatomed Pharmazeutische und Medizintechnische Gesellschaft mbH | Procédé et dispositif pour plier une lentille intraoculaire souple |
US5201763A (en) * | 1992-02-28 | 1993-04-13 | Allergan, Inc. | Thin intraocular lens |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
BE1011907A3 (fr) * | 1998-05-13 | 2000-02-01 | Innovative Investments S A | Conditionnement pour implant intraoculaire souple. |
Also Published As
Publication number | Publication date |
---|---|
FR2747564B1 (fr) | 1999-01-29 |
JP2000508568A (ja) | 2000-07-11 |
US5941390A (en) | 1999-08-24 |
DE895464T1 (de) | 2000-10-05 |
FR2747564A1 (fr) | 1997-10-24 |
EP0895464A1 (fr) | 1999-02-10 |
CA2251739A1 (fr) | 1997-10-30 |
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