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 or corneal implants; 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

• Cartridge for injecting a flexible intraocular implant and device for packaging and installing such an implant in this cartridge.
• the present invention relates to a cartridge for injecting a flexible intraocular implant in the anterior chamber or posterior chamber of an eye, replacing a lens losing its transparency. It also relates to a device for packaging and installing an intraocular implant in this
• the replacement of the natural lens by a flexible intra-ocular implant (called I. O. L. in specialized circles) is a very common surgical procedure practiced to give a good view to people with cataracts. For this, the surgeon must make a small incision in the cornea, extract the opacified original lens and introduce, in its place, an artificial lens having the desired characteristics whose optical qualities are defined by the ophthalmologist surgeon.
• This instrumentation includes an injection cartridge for guiding the intraocular implant to its functional location in the eye.
• an intraocular lens injection cartridge (WO-00/62712) comprising: a body having an asymmetrical bore which is rounded in cross-section on a first side and which is in ramp on another side; an injection nozzle formed integrally with the body, said nozzle having a bore which communicates with the asymmetrical bore of the body; and said bore tapering gently into an oval or a circle, in cross-section, near said base.
• This cartridge makes it possible to inject symmetrical and asymmetrical intraocular implants, which is not the case of the so-called “butterfly” cartridges (by for example: US-5,499,987, US-5,735,858, US-6,129,733).
• the cartridge described in WO-00/62712 nevertheless has two major drawbacks which are the obligation to use a clamp to position the flexible lens in the injection cartridge and the difficulty of removing the clamp when you have placed the implant at the entrance of the cartridge.
• a folding device for folding an intraocular lens which has a resiliently deformable optic
• said folding device comprising: a tubular member having a bore and at least one open end leading to said bore, said a bore being dimensioned and adapted to receive an intraocular lens adapted to be folded and to maintain the intraocular lens in a folded condition; said tubular member having a peripheral wall having an opening leading to said bore, said opening being sized and adapted to allow passage of an intraocular lens in the folded state through the opening and into the bore; and said tubular member having a generally opposed first slot and second slot opening at said open end of the tubular member and being sized to receive first and second arms, respectively, of a forceps, said first slot and said second generally opposed slot being arranged such that an intraocular lens in the folded state in said tubular member can be held between first and second arms of a forceps received in said first slot and in said second slot, usually opposite, respectively.
• the invention proposes to make available to practitioners, on the one hand, a universal injection cartridge of intraocular implants (IOL), that is to say an injection cartridge compatible with all crystalline implants currently available on the market, and to solve the problems causing the previously described drawbacks, and, secondly, a dedicated device usable for the packaging and positioning of a crystalline implant, for example of the tripod type, in said injection cartridge, embodiments of an implant of this kind being, for example, described in the document SU-1.553.109 A1 or in the document FR-2.792.825.
• IOL intraocular implants
• the injection cartridge according to the invention comprises: a tubular reception chamber of oblong section open at the rear and delimited by a wall, part of which is arranged to constitute a receiving surface or area for an intraocular implant (IOL ) flexible introduced into said chamber and an injection cannula disposed in the extension thereof with which it communicates via a compaction chamber in the form of a funnel, this cartridge being particularly remarkable in that the wall delimiting the receiving chamber of the implant is provided with two longitudinal slots whose media are arranged in a plane passing through the middle of said reception range, these slots allowing the passage of the jaws of the pinching instrument used for the introduction of said implant into the cartridge.
• IOL intraocular implant
• the slot formed in the upper part of the wall delimiting the receiving chamber has a greater width than that of the slot in the lower part of said wall which constitutes the reception range of the implant.
• the injection cartridge comprises, on the upper part of the wall delimiting the closed distal portion of the receiving chamber, a longitudinal guide groove disposed in the extension of the upper slot formed in the split proximal portion of said wall.
• the advantage of the injection cartridge according to the invention is that it allows the implant to be easily clipped into the receiving chamber by means of a clamp known per se or by means of the dedicated device described. hereinafter, so that said implant is positioned stably and perfectly oriented at the entrance of the cartridge and, secondly, to allow the release of the clamp without risk of displacement or alteration of the implant.
• the invention also relates to a dedicated device for packaging and installing a flexible lens implant in the claimed injection cartridge.
• the packaging device for the installation of a crystalline implant, for example of the tripod type, in an injection cartridge according to the invention comprises a flexible tongue of clipping and a flexible pushing tab arranged vis-à-vis and whose distal ends can be spaced from each other and have concave surfaces facing each other, so as to constitute an oval shaped housing to allow the passage and retention of a diametral portion of the central lens of said implant, the clipping tongue preferably having a greater width than that of the thrust tongue, which is provided with a thrust pin disposed behind its concave surface, the tongue of clipping being housed in a longitudinal opening that has a flexible positioning plate whose distal end is provided with a recess, preferably circular formed in its inner face to receive the lateral parts of the implant
• This device can be sterilized with a 1OL positioned in its distal portion, and thus serve as means of packaging, presentation and manipulation of the implant.
• This device eliminates any direct manipulation of the implant after opening the packaging in which said device and the sterilized implant are kept waiting for use. In this way, all risks associated with possible poor grip or manipulation of the implant when it is inserted into the injection cartridge are discarded.
• Figure 1 is a perspective view of an injection cartridge according to the invention.
• Figure 2 is a plan view, on an enlarged scale, of this injection cartridge.
• Figure 3 is a side view of Figure 2.
• Figure 4 is a rear view, on a larger scale, of the injection cartridge.
• FIG. 5 is a sectional view, on a larger scale, along the line 5-5 of FIG. 2.
• FIG. 6 is a sectional view, on a larger scale, along the line 6-6 of FIG. 2.
• Figure 7 is a sectional view along the line 7-7 of Figure 3.
• FIG. 8 is a plan view of a tripod type crystalline implant that can be used for the implementation of the injection cartridge and the packaging device according to the invention.
• Figure 9 is a bottom view of the packaging device according to the invention.
• Figure 10 is a side view of Figure 9.
• Figure 11 is a top view of Figure 9.
• Figure 12 is a detail view, in perspective and downwardly, showing the distal ends of the positioning plate and the clipping tab.
• Figure 13 is a detail view, in perspective and dive, of the distal ends of said plate and tongue.
• Figure 14 is a detail view, in perspective and dive, showing the distal end of the push tab.
• FIGS. 15A to 15E illustrate the steps of placing a tripod-type crystalline implant packaged in the device according to the invention in an injection cartridge.
• Figs. 16A-16C are sectional views taken along lines 16A-16A, 16B-16B, 16C-16C, Figs. 15A, 15B, and 15C, respectively.
• This cartridge may be formed in one piece, by molding, of any suitable thermoplastic material such as polypropylene or other.
• the receiving chamber 2 has a symmetrical oblong section delimited by the lower receiving region 3a having a concave bearing surface and two symmetrical sides.
• the compacting chamber 4 has, in its part connecting to the receiving chamber 2, an oblong section which decreases progressively in the direction of the injection cannula 5, to present, at the point of its connection to the here, a section almost circular or slightly oval.
• the injection cannula 5 has a beveled distal end (FIG. 3).
• the tubular wall 3 delimiting the reception chamber 2 of the injection cartridge is provided with two longitudinal slots 6 and 7, the media of which are arranged in a plane PP passing through the middle of the reception zone 3a. , in the direction of the length (figure 4). These slots open at the open proximal end or entrance of the cartridge.
• the slot 6 formed in the upper part of the wall 3 delimiting the receiving chamber 2 has a width L plus important that the width I of the slot 7 formed in the lower part of said wall which constitutes the receiving range 3a of the implant ( Figure 4).
• This width L is determined to allow the introduction of the flexible implant by a lateral pressure movement exerted on said implant perpendicular to the axis of the cartridge.
• the upper slot 6 may have a width L of the order of 4.30 mm, while the lower slot may have a width of the order of 1, 20 mm.
• the upper slot 6 preferably has a length less than the length of the lower slot 7.
• the upper slot 6 may have a length of the order of 11.5 mm, while the lower slot 7 may have a length of length of 12.5 mm.
• the universal injection cartridge according to the invention is compatible with all the currently available crystalline implants on the market, such as implants known as tripod, 3 pieces, shuttle, monobloc.
• the invention also relates to a device for packaging and installing a crystalline implant, for example of the tripod type, in the universal injection cartridge described above.
• This device can be used for the packaging and installation of crystalline implants in the injection cartridge 1 and is described below, by way of example, the application of this device to the packaging and installation of a tripod type implant, implant 16 of this kind having a central optical element or lens elements 16a and the haptic ⁇ " ⁇ dozens ⁇ roire ⁇ iques T6B in form of" anserétitf ⁇ ⁇ illustrated by way of example, in Figure 8.
• the injection cartridge 1 comprises, on the upper part of the wall 3 delimiting the closed distal portion of the receiving chamber 2, a longitudinal guide groove 8 arranged in the extension of the upper slot 6 formed in the split proximal portion of said wall ( Figures 1 and 2) and, for example, delimited by two parallel ribs 9.
• the packaging device 10 comprises two retaining tabs 11 and 12 which will be called, respectively, the clipping tab and the push tab, in the remainder of this description, in connection with one of their specific function. .
• These tongues 11 and 12 are arranged one against the other and their distal ends 11a and 12a can be spaced from each other.
• the surfaces disposed opposite these ends have a concave shape, so that when the tongues 11 and 12 are in the approaching position, said concave surfaces 11b, 12b delimit an oval or approximately oval shaped housing 13 allowing to contain, without significant play, a diametrical portion of the optics of an implant positioned between said ends.
• the distal portion 11a of the clipping tab 11 has a larger width than that of the distal portion 12a of the thrust tongue 12, as can be seen in Figures 16A-16C.
• the clipping tab 11 is housed in a longitudinal opening 14 that has a positioning plate 15 ( Figures 12 and 13).
• the inner face of the distal end 15a of this plate is provided with a recess 15b, preferably of circular shape, whose bottom is provided with a diametrical slot 15d in which is engaged the distal end 12a of the pushing tongue 12.
• This depression 15b is intended to receive the lateral portions and the haptic elements 16b of the implant 16 disposed on either side of its diametral portion placed in the housing 13.
• the device may be implemented by molding, in any plastic r-igide-and-flexible-suitable ⁇ De la ⁇ so thanks to this Flexibility T-distale- -la-portion 15a of the positioning plate 15 may be spaced from the distal portion 11a of the clipping tab 11, while the distal portion 11a of said clipping tab 1 1 may be spaced from the distal portion of the thrust tongue 12.
• the positioning plate 15 and the clipping tab 11 can be molded in one piece and made integral at their proximal end, while the thrust tongue 12 can be attached to the plate-15 assembly 11 by means of a tenon assembly or by gluing.
• the distal ends of the tongues 11 and 12 are provided with a spout 11c, 12c, respectively, whose end surfaces are sloped and converge towards the housing 13.
• the tongue 12 is provided with a thrust pin 12d (FIG. 14). Faced with this lug 12d, the clipping tab 11 is provided with a centering light 11d in which is engaged said thrust pin.
• the distal end of the positioning plate 15 is provided with a support nose 15c extending in front of the distal ends of the tongues 11 and 12.
• the tripod type crystalline implant 16 is hooked by means of one of its haptic elements 16b, around the "bridging" constituted by the noses 11c and 12c of the clipping and thrust tongues 12, respectively, the diametrical portion of its lens 16a is enclosed in the housing 13, and said lens sits against the thrust pin 12d, by a portion of its edge between its two other haptic elements 16b.
• the projecting lateral portions of the implant are positioned in the circular recess 15b of the positioning plate 15, as can be seen in FIGS. 15A and 16A.
• the implant thus very stably positioned, without load, and the conditioning device are sterilized and housed in a suitable sealed packaging (not shown) for the conservation of qualities ⁇ O ⁇ ptics and physical properties of the implant in the state " desirable, this package may contain, if necessary, an aqueous solution.
• FIGS. 15A and 16A illustrate the first step of the process of positioning the implant 16 in an injection cartridge 1.
• the spout 15c of the positioning plate 15 is placed in abutment on the bottom of the groove 8 of the cartridge, at the proximal end of said groove.
• the implant 16 is pushed into the proximal portion of the receiving chamber 2 of the cartridge, under the pressing action exerted by the clipping tab 11.
• a pushing movement of the device forwards makes it possible to bring the implant 16 into the closed distal part of the reception chamber 2, through via the thrust pin 12d of the tongue 12 (FIG. 16E). It is observed that the thrust pin 12d has a width greater than that of the lower slot 7, so as to remain inside the receiving chamber 2 during its translation towards the distal portion of said chamber.
• the forward movement of the transfer device is limited by a stop, for example constituted by the pin 12d which abuts thrust limtre_le_fo_nd_de_la__fe.rjte_Z, _en_fin._de_course-de - displacement ⁇ -In-Gette- position, the implant 16 is positioned and pre-compacted in the distal portion of the receiving chamber 2 of the cartridge and the device can be released from the cartridge by a backward movement.
• the practitioner can then proceed with the transfer of the crystalline implant into the patient's eye using a pushing instrument or injector known per se.
• the invention also relates to packages consisting of a device 10 as described above, in which a crystalline implant 16 is positioned in the manner previously described, said device and I 1 IOL thus positioned being housed in the sterilized state in a hermetic package containing or not an aqueous solution for the conservation of the optical and physical qualities of the implant.
• the invention also relates to a device for packaging and introducing a crystalline implant into the capsular bag of an eye, comprising, on the one hand, an injection cartridge as described above and, on the other hand, on the one hand, a conditioning device having the above-mentioned features, the upper and lower slots 6 formed in the proximal portion of the injection cartridge 1, and the distal portions 11a, 12a, clipping and thrust tabs 12, respectively , having widths such that the thrust tongue 12 can pass through the upper and lower slots 7 of the cartridge, while the clipping tab 11 can pass through said upper slot 6, but can not pass through said lower slot 7.

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• 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)

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• 2004
  • 2004-09-16 FR FR0409852A patent/FR2875126A1/fr active Pending
• 2005
  • 2005-09-15 WO PCT/FR2005/002289 patent/WO2006032763A2/fr not_active Ceased
  • 2005-09-15 EP EP05802430A patent/EP1858448A2/de not_active Withdrawn

Non-Patent Citations (1)

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