Coronet DMEK EndoGlide Gebrauchsanleitung Seite 2

PPRODUCT NAME DMEK ENDOGLIDE
PPRODUCT INFORMATION AND INSTRUCTIONS FOR USE
GB – INSTRUCTIONS FOR USE
Description
The DMEK EndoGlide is a device designed particularly to meet the needs of the corneal graft surgeon performing DMEK (Descemet Membrane Endothelial Keratoplasty) procedures. The device is a sterile
three-part single use only delivery system for the previously prepared donor tissue, which gives the surgeon enhanced donor tissue control and stabilisation of the anterior chamber during donor graft insertion
and minimises any endothelial cell damage and consequent loss of function.
Intended Use
The device is intended solely for the delivery and insertion of previously prepared donor cornea tissue for transplantation during a DMEK procedure..
CAUTIONS
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This device is supplied STERILE and ready to use.
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The device is for SINGLE USE ONLY. Do NOT re-sterilise or re-use.
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Do not use if the packaging has been opened or damaged.
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This device is intended for use by trained medical persons possessing the requisite skill and experience to use the device in accordance with the prevailing standards of medical practice and in
conjunction with the instructions for this device
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After use, the device should be disposed of in accordance with hospital protocol.
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The product comes into contact with bodily fluids, which can be contaminated. Care should be taken in the handling and disposal of the device after use to prevent contamination.
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CAUTION: US Federal law restricts this device to sale by or on the order of a physician.
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Place the preparation base on a flat, sterile surface before use.
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If using the EndoGlide Support Platform, place the preparation base in the mount prior to commencing the procedure.
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CAUTION should be exercised when inserting the cartridge if the patient has an intraocular lens implant.
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Place the corneal button with the tri-folded DMEK graft onto the Preparation well and orientate the trifold graft edge to align with the cartridge opening.
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Before removing the cartridge from the preparation base, ensure that the introducer has engaged correctly and that the two parts are securely locked together.
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The Use of Viscoelastic is not recommended.
Possible Adverse Effects of the Surgical Procedure
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Complications which may occur include but are not limited to: Graft detachment/rejection/ failure, Glaucoma, Retinal detachment, macular hole, epiretinal membrane, raised intraocular pressure,
corneal synechia and pupillary block. Donor-host interface vascularization may occur.
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In some phakic eyes, mild anterior crystalline lens opacities have also been reported. Subepithelial haze and interface pigment deposits have also been reported
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Small areas of interface fluid at the edge of the graft have been known to occur with DSEK/DSAEK procedures.
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With very thin tissue, care should be taken as folds may occur. Partial dehiscence of the posterior lamellar graft may occur.
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There is a risk of a mild hyperopic shift with DMEK.
Incident Reporting
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Any serious incident that has occurred in relation to this device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established
Protocol for surgical technique
Recipient cornea preparation
1 Wound construction
A 2.65mm blade is used to create a clear corneal incision through which the EndoGlide cartridge may be introduced. The wound depth should be at least 1.5mm deep to create a self-sealing wound.
2. Nasal paracentesis
Perform a 1mm paracentesis at the nasal limbus or clear cornea opposite to the temporal incision through which to introduce the Tan EndoGlide Placement Forceps (TEP forceps) to pull the donor tissue
into the AC.
3. AC maintainer
Use an AC maintainer to ensure formation of the AC during insertion. Placement of the AC maintainer could be adjacent to either the superior or inferior aspect of the nasal paracentesis incision so as not
to obstruct the donor incision. BSS flow through the maintainer should be away from the incision and low to moderate during the entire insertion procedure.
Donor Cornea Preparation
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Fully stripped DMEK tissue should be laid flat endothelium up on corneal button
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Perform tri-fold folding with a small amount of BSS fluid present
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Use Kelman forceps to slide the tri-folded donor tissue out towards the scleral edge.
Cartridge preparation and Sizing
The procedure should be performed under the operating microscope with the preparation base positioned on a flat, stable, sterile surface. If using the EndoGlide Support Platform, the preparation base should
be placed in the mount before commencing the procedure. Loading the donor can however be performed without the support platform. Prepare the recipient cornea as above, so that the donor tissue
insertion may be performed immediately after the cartridge is ready. Note that the cartridge is supplied assembled on the preparation base.
1. Positioning of EndoGlide Cartridge
The cartridge is supplied assembled on the preparation base.
2. Donor tissue placement: Tri-fold loading procedure
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Place the corneal button with tri-folded DMEK graft onto the preparation well. Orientate the trifold graft edge to align with the cartridge opening.
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Ensure that there is BSS between the cartridge opening and the DMEK donor edge
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Use the forceps guide bridge, pass the loading forceps through the cartridge and depress the scleral edge of the donor button to bring the DMEK graft directly into the forceps tips.
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Grasp the DMEK graft with the loading forceps and gently advance the graft into the cartridge (keep sclera depressed until graft is inside the cartridge). The anterior edge of the graft should reach the
anterior opening of the cartridge.
The EndoGlide Introducer
1. Removal of donor stromal button
Remove the donor corneal/stromal button from the well of the preparation base and discard.
2. Attachment of the EndoGlide Introducer
The introducer slides into position behind the cartridge using the guiding grooves. Advance the introducer, with word "loading" facing uppermost, into the posterior end of the cartridge until it fully
engages with an audible click.
3. Removal of the EndoGlide Cartridge, Introducer and donor DMEK graft
The loaded cartridge, with the introducer attached, may now be removed in its' entirety from the preparation base by sliding the assembly backwards and out of the grooves of the base. The cartridge is
now ready for insertion into the recipient eye.
EndoGlide Cartridge Insertion
NOTE:After removing the introducer and cartridge from the base, turn the assembly right way up (the word "insertion" printed on the Introducer should now be uppermost) to ensure correct orientation for
insertion into the recipient eye.
1. Grasp the introducer right side up with the thumb and forefinger for easy insertion into the wound (thumb uppermost) – Note this is similar to insertion of a thumbdrive into the USB port of a laptop
computer.
2. Gently insert the anterior tongue (glide) of the cartridge into the temporal wound, and advance into the anterior chamber (AC). The flat surface of the tongue ensures moderate closure of the wound to
reduce egress of AC fluid and prevents iris prolapse through the wound. Moderate flow of BSS from the AC maintainer ensures maintenance of the AC.
3. Introduce the sloping anterior opening of the cartridge through the wound and advance it fully until the uppermost edge of the opening is completely engaged through the wound. More rapid
advancement at this stage ensures minimal egress of BSS and maintenance of the AC. Advance the cartridge further until the anterior opening is seen through the cornea to be fully within the AC. At this
point the forward edge of the cartridge tongue (glide) will be over the nasal iris.
Donor Pull-Through
1 With one hand still holding the introducer and cartridge in position (the EndoGlide can be used to steady the eye at this point), insert the Tan EndoGlide Placement forceps (TEP Forceps) into the AC
through the nasal paracentesis with the other hand. Advance the forceps into the AC, over the cartridge tongue (glide), into the anterior opening of the cartridge to reach the leading stromal edge of the
donor tissue.
2. Use the forceps to grasp the stromal edge of the donor tissue and gently pull the donor tissue out of the cartridge chamber into the AC. Keep the cartridge and introducer in position during this stage.
Once the donor tissue is fully placed in the AC, it will automatically start to uncurl into position, endothelial side down, with both wings of the donor uncurling.
3. Gentle sideways "to-and-fro" shaking of the donor with the forceps will easily assist in uncurling if one wing remains slightly curled. During this process, the ACM flow must be reduced to very low (or
turned off|) to ensure a shallow, non-turbulent AC during the donor pull-through.
4. Donor pull through should be very slow. Ensure a good grasp of the leading edge of the graft and gradually advance it into the AC. Ensure that the AC remains shallow but stable throughout. Once the
donor is ¾ out of the cartridge, and has completely moved beyond the corneal wound, the cartridge can be slowly eased out of the wound (i.e. avoid leaving the back edge of the graft in the corneal
wound.)
Network Medical Products Ltd
Coronet House, Kearsley Road, Ripon,
North Yorkshire, HG4 2SG, UK
Tel: +44 (0)1765 609555 Fax: +44 (0)1765 608476
info@networkmedical.co.uk| www.networkmedical.co.uk
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