US20220354634A9 - Handheld implantation devices for implantation or retinal tissue implant - Google Patents
Handheld implantation devices for implantation or retinal tissue implant Download PDFInfo
- Publication number
- US20220354634A9 US20220354634A9 US16/764,972 US201816764972A US2022354634A9 US 20220354634 A9 US20220354634 A9 US 20220354634A9 US 201816764972 A US201816764972 A US 201816764972A US 2022354634 A9 US2022354634 A9 US 2022354634A9
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- US
- United States
- Prior art keywords
- implant
- implantation
- retinal tissue
- carrier
- implant holder
- 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.)
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Classifications
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- 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
-
- 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
- A61F2/148—Implantation instruments specially adapted therefor
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- 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
- A61F9/00736—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments
-
- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0071—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof thermoplastic
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0526—Head electrodes
- A61N1/0543—Retinal electrodes
Abstract
Description
- The invention relates to handheld implantation devices for implantation of retinal tissue implants.
- The human retina, as in many other vertebrates, has evolved as a layered configuration with an interior retina constituting a neuronal component and an outer retina constituting a light sensing component. The light sensing component is further layered and includes a monolayer of specialized cells known as Retinal Pigment Epithelium (RPE) and a photoreceptor layer. Light entering a human eye passes through a transparent neuronal component before being captured by the photoreceptor layer, transformed to nerve stimuli and sent “backwards” to the neuronal component and from there to the brain. The light sensing component includes over 150 million photoreceptors. The neuronal component organizes the enormous stimuli input to a coded message and converges it to 1.5 million ganglion cells that transfer the coded message to the brain via the optic nerve which is a bundle of all the axons originating from the ganglion cells—one axon per each ganglion cell. The human fovea includes about half of the total number of photoreceptors and is responsible for visual acuity.
- Transformation of light photons to nerve stimuli involves biochemical reactions generating large amount of biological waste that must be removed instantaneously and efficiently to maintain uninterrupted visual function. The waste removal is performed by the Retinal Pigment Epithelium (RPE) cells. The apexes of these cells are physically interdigitating with the leading active surfaces of the photoreceptors where the photochemical reactions occur enabling instantaneous removal of the consumed photoreceptor tips and exposure of the segments behind them for further reaction.
- Some blinding disorders are caused by pathologic processes largely limited to the outer retina, Such disorders include Age-Related Macular Degeneration (ARMD or AMD) and Retinitis Pigmentosa (RP). Since an inner retina remains functional long after disappearance of a damaged outer retina, vision recovery seems possible by stimulation of a survived inner retina. The concept has been confirmed using electrodes that stimulate an inner retina with electrical pulses. However, the ability to create a sustainable electro-biological interface at the level of organization required for reasonable vision is beyond current knowledge and technology. It was logical to attempt to implant a retinal graft of normal outer-retinal tissue taken from a human cadaver eye or laboratory cultivated from stem cells. Clinical studies conducted over the last decade demonstrate the feasibility of using viable tissue implantation to treat outer retina blinding disorders by encouraging results. However, regardless of the composition of an outer-retinal tissue implant be it human embryonic retinal tissue or laboratory cultivated outer retinal layer tissue, the transfer of such a delicate implant to a human eye has been found to be a major obstacle further emphasized by recent findings that the accurate and stable interface between an outer-retinal tissue implant and a recipient inner retina is a critical factor for successful implantation.
- The present invention is directed toward handheld implantation devices for implantation of retinal tissue implants and in particular outer-retinal tissue implants. The retinal tissue implant can be either full thickness embryonic tissue or partial thickness or full thickness laboratory cultivated tissue. The handheld implantation devices include an elongated handheld implantation tool, an implant holder for peripherally holding a retinal tissue implant, and a clinician-operated attachment arrangement for initial attaching the implant holder to the implantation tool and subsequent detaching the implant holder together with its retinal tissue implant therefrom at an implantation site. Different attachment arrangements can be employed for detachably attaching an implant holder to a handheld implantation tool. In the case of an outer-retinal tissue implant, an implant holder is preferably oval shaped having a major axis between about 6 mm to about 8 mm and a minor axis between about 3 mm to about 5 mm and is intended to be implanted such that its center is implanted at a human eye's fovea.
- In order to understand the invention and to see how it can be carried out in practice, preferred embodiments will now be described, by way of non-limiting examples only, with reference to the accompanying drawings in which similar parts are likewise numbered, and in which:
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FIG. 1A is a front perspective view of an assembled handheld implantation device including a handheld implantation tool and a detachable implant holder peripherally holding an outer-retinal tissue implant in accordance with a first embodiment of the present invention; -
FIG. 1B is a longitudinal cross section of the implantation tool alongline 1B-1B inFIG. 1A ; -
FIG. 1C is a transverse cross section of the implantation tool alongline 1C-1C inFIG. 1B ; -
FIG. 2A is a front perspective view of the implantation tool and the implant holder subsequent to detachment of the implant holder therefrom; -
FIG. 2B is a longitudinal cross section of the implantation tool alongline 2B-2B inFIG. 2A ; -
FIG. 3 is a top plan view of an implant carrier of the implant holder; -
FIG. 4 is a front elevation view of the implant carrier of the implant holder; -
FIG. 5 is an exploded, view of the implant holder including its implant carrier, its outer-retinal tissue implant and its implant carrier surround; -
FIG. 6 is a transverse cross section showing an initial step in the preparation of the implant holder; -
FIG. 7 is a transverse cross section showing the implant holder before trimming the downward depending edge of its outer-retina tissue implant; -
FIG. 8 is a transverse cross section of the implant holder along line 8-8 inFIG. 1A ; -
FIG. 9 is a front perspective view of a pre-assembled handheld implantation device including a handheld implantation tool and a detachable implant holder in accordance with a second embodiment of the present invention; -
FIG. 10 is a top plan view of an implant carrier of theFIG. 9 implant holder; -
FIG. 11 is a bottom plan view of the implant carrier of theFIG. 9 implant holder; -
FIG. 12 is a front elevation view of the implant carrier of theFIG. 9 implant holder; -
FIG. 13 is a front perspective view of a leading implantation tool end of the implantation tool on attachment of the implant holder thereto; and -
FIG. 14 is a front perspective view of the leading implantation tool end of the implantation tool after detachment of the implant holder therefrom. - The present invention is described for implanting an outer-retinal tissue implant hereinafter abbreviated as ORTI but can be equally used for implanting other retinal tissue implants. Retinal tissue implants can have a thickness T from between about 15 microns to about 250 microns depending on their intended implantation site, intended therapeutic action, and the like.
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FIG. 1 toFIG. 8 show ahandheld implantation device 10 has a longitudinalimplantation device centerline 11 and includes ahandheld implantation tool 12, a generallyplanar implant holder 13 peripherally holding an ORTI 14 and areleasable clamping arrangement 16 constituting a clinician-operated attachment arrangement for attaching theimplant holder 13 to theimplantation tool 12 for enabling its selective detachment therefrom together with the ORTI 14 at an implantation site. Thehandheld implantation tool 12 has a leadingimplantation tool end 12A and a trailingimplantation tool end 12B. The ORTI 14 has uppermost viableretinal tissue 14A and alowermost basement membrane 14B. Thehandheld implantation tool 12 includes ahandle 17 having a leadinghandle end 17A and atrailing handle end 17B. Thehandle 17 has ablind recess 17C extending rearwards from the leadinghandle end 17A towards thetrailing handle end 17B. Theblind recess 17C has a transverse circular cross section. Thehandle 17 supports ashaft 18 inserted into theblind recess 17C for insertion into a recipient's eye through an incision formed in the eye's scleral wall at the pars plana. Theshaft 18 has a transverse circular cross section, a leadingshaft end 18A and a trailingshaft end 18B at the base of theblind recess 17C Thetrailing shaft end 18B is screw threaded into thehandle 17 or similarly attached thereto. - The
implant holder 13 preferably has an oval shape for implanting an ORTI but equally can have other shapes suitable for peripherally holding an ORTI. Accordingly, theimplant holder 13 has amajor axis 19A co-axial with the longitudinalimplantation device centerline 11 defining a leadingimplant holder end 13A remote from thehandheld implantation tool 12 and a trailingimplant holder end 13B adjacent thehandheld implantation tool 12, and aminor axis 19B. Theimplant holder 13 includes animplant carrier 21 and a closedimplant carrier surround 22 for snugly peripherally mounting on theimplant carrier 21 for peripherally holding theORTI 14 thereon. Theimplant carrier 21 is manufactured from suitable biocompatible load bearing material, for example, nitinol and the like, having shape memory properties. Theimplant carrier 21 has a leadingimplant carrier end 21A and a trailingimplant carrier end 21B. Theimplant carrier 21 is resiliently flexible about amajor axis 23A and aminor axis 23B as correspondingly denoted by arrows A and B (seeFIG. 5 ). Theimplant carrier surround 22 is manufactured from suitable biocompatible resiliently flexible material, for example, silicon, and the like. Theimplant carrier surround 22 has a generally C-shaped transverse cross section with an internal implantcarrier surround groove 24 intended to snugly receive theimplant carrier 21 therein thereby peripherally entrapping theORTI 14, Theimplant carrier 21 has a segment-like carrier plate 26 at its trailingimplant carrier end 21B. The segment-like carrier plate 26 is preferably parallel to theminor axis 23B and distanced therefrom to occupy a relatively small area of theimplant carrier 21. The segment-like carrier plate 26 has a spaced apart pair of clamping throughgoing bores 27. - The
implantation tool 12 includes a normal openclamping jaw pair 28 at the leadingshaft end 18A. The normal openclamping jaw pair 28 includes anuppermost clamping jaw 28A and alowermost clamping jaw 28B. Theimplantation tool 12 includes asleeve 29 mounted on theshaft 18. Thesleeve 29 has a transverse peripheral circular cross section for snug sliding displacement in theblind recess 17C. Therecess 17C includes a biasingmember 17D in the form a compression spring, and the like, for biasing thesleeve 29 to a forward position for urging the normal openclamping jaw pair 28 into a clamping position for clamping on the segment-like carrier plate 26 (seeFIG. 1A andFIG. 1B ). Thesleeve 29 includes afinger grip 29A for urging thesleeve 29 to a rearward position in therecess 17C for compressing the biasing member 1711) thereby enabling the normal openclamping jaw pair 28 to revert to its normal open position for releasing the segment-like carrier plate 26 (seeFIG. 2A andFIG. 2B ). - The
uppermost clamping jaw 28A includes a spaced apart pair of clampingpins 31 for insertion though the spaced apart pair of clamping throughgoing bores 27. Thelowermost clamping jaw 28B includes a spaced apart pair of clamping bores 32 for receiving the spaced apart pair of clamping pins 31, The spaced apart pair of clampingpins 31 do not protrude through the spaced apart pair of clamping bores 32 so as not to damage delicate eye tissue on implantation of theimplant holder 13. Releasing the clampingarrangement 16 at an implantation site in an implanted eye, leaves theimplant holder 13 and theORTI 14 at the implantation site on withdrawal of theimplantation tool 12. -
FIG. 6 toFIG. 8 show preparation of theimplant holder 13 as follows: TheORTI 14 is laid on theimplant carrier 21 with itslowermost basement membrane 14B resting thereon. TheORTI 14 is typically supplied in the same shape as theimplant carrier 21 but larger such that it overhangs theimplant carrier 21 to leave a downward depending edge. TheORTI 14 covers the segment-like carrier plate 26. Theimplant carrier 21 is compressed and is slowly released to entrap the ORTI 14 in the internal implantcarrier surround groove 24 as denoted by arrows C (seeFIG. 6 ) such that theORTI 14 is taut (seeFIG. 7 ). TheORTI 14's downward depending edge is preferably trimmed after securing in theimplant holder 13 such that theimplant holder 13 presents a streamline profile for implantation purposes (seeFIG. 8 ). On clamping theimplant holder 13 in theimplantation tool 12, the spaced apart pair of clamping pins 31 traverses theORTI 14 overlying the segment-like carrier plate 26. -
FIG. 9 toFIG. 14 show ahandheld implantation device 40 similar to theimplantation device 10 and therefore similar parts are likewise numbered. Theimplantation device 40 is intended for use with a user operatedelectrical power source 50 having anelectrical plug 51. Theelectrical power source 50 can be operated by a user foot pedal, and the like. - The
handheld implantation device 40 includes a thermoplastic holdingelement 41 underlying the segment-like carrier plate 26 in theFIG. 12 front elevation view such that the thermoplastic holdingimplant 41 faces in the same direction as thelowermost basement membrane 14B. Thethermoplastic holding element 41 has a generally U-shapedelectrical heating filament 42 including acrosspiece 43 and a spaced apart pair of outwardlyprotruding connectors implant holder end 13A. Thecrosspiece 43 can be glued or otherwise attached to the thermoplastic holdingelement 41. Theconnectors shaft end 18A includes a spaced apartsocket pair protruding connectors socket pair electrical socket 47 at the trailinghandle end 17B intended for receiving theelectrical plug 51. Theelectrical heating filament 42 closes an electrical circuit with theelectrical power source 50 such that, on activation of theelectrical power source 50, theelectrical heating filament 42 heats the thermoplastic holdingelement 41 whereupon theelectrical heating filament 42 is detached therefrom. Theelectrical heating filament 42 remains inserted in the leadingshaft end 18A on withdrawal of theimplantation tool 12 from an implanted eye leaving theimplant holder 13 with itsORTI 14 at an implantation site. - While the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications, and other applications of the invention can be made within the scope of the appended claims.
Claims (9)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US16/764,972 US11540915B2 (en) | 2014-01-21 | 2018-11-18 | Handheld implantation devices for implantation or retinal tissue implant |
Applications Claiming Priority (9)
Application Number | Priority Date | Filing Date | Title |
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IL230567 | 2014-01-21 | ||
IL230567A IL230567A0 (en) | 2014-01-21 | 2014-01-21 | Method and appartus for improved endothelial implatation |
PCT/IL2015/050049 WO2015111040A1 (en) | 2014-01-21 | 2015-01-14 | Method and apparatus for improved endothelial implantation |
US201615111996A | 2016-07-15 | 2016-07-15 | |
IL255796A IL255796A0 (en) | 2017-11-21 | 2017-11-21 | Handheld implantation devices for implantation of retinal tissue implant |
IL255796 | 2017-11-21 | ||
PCT/IL2018/051241 WO2019102455A1 (en) | 2017-11-21 | 2018-11-18 | Handheld implantation devices for implantation of retinal tissue implant |
US16/764,972 US11540915B2 (en) | 2014-01-21 | 2018-11-18 | Handheld implantation devices for implantation or retinal tissue implant |
US16/501,078 US11065106B2 (en) | 2014-01-21 | 2019-02-19 | Tissue holding apparatus |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US16/501,078 Continuation-In-Part US11065106B2 (en) | 2014-01-21 | 2019-02-19 | Tissue holding apparatus |
Publications (3)
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US20200323625A1 US20200323625A1 (en) | 2020-10-15 |
US20220354634A9 true US20220354634A9 (en) | 2022-11-10 |
US11540915B2 US11540915B2 (en) | 2023-01-03 |
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US16/764,972 Active US11540915B2 (en) | 2014-01-21 | 2018-11-18 | Handheld implantation devices for implantation or retinal tissue implant |
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Family Cites Families (21)
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US3911925A (en) * | 1974-05-23 | 1975-10-14 | Jr Joe B Tillery | Ear trimming forceps |
US5098439A (en) | 1989-04-12 | 1992-03-24 | Allergan, Inc. | Small incision intraocular lens insertion apparatus |
NZ256280A (en) | 1993-03-16 | 1997-05-26 | Photogenesis Inc | Eye graft; method and surgical instrument for forming a volute from donor eye tissue and inserting it into a host eye |
US6156042A (en) | 1997-11-17 | 2000-12-05 | Aramant; Robert B. | Retinal tissue implantation instrument |
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ES2329669T3 (en) | 2003-04-29 | 2009-11-30 | Medical Technology Transfer Holding B.V. | DEVICES AND METHODS TO PREPARE DESCEMET MEMBRANES. |
US20060173539A1 (en) | 2005-01-31 | 2006-08-03 | Yichieh Shiuey | Corneal implants and methods and systems for placement |
CN101495063B (en) | 2006-01-26 | 2015-04-22 | 韦克福里斯特大学健康科学院 | Medical tools for facilitating deep lamellar endothelial keratoplasty and related methods |
ITPC20060025A1 (en) | 2006-05-15 | 2007-11-16 | Claudio Malacuso | SURGICAL INSTRUMENT TO MANIPULATE AND INSERT A CELL LAMINA IN THE EYE, IN PARTICULAR A THIN SUPPORT OF STROMA WITH ENDOTHELIAL CELLS, FOR CORNEAL TRANSPLANT |
US7365233B2 (en) | 2006-05-31 | 2008-04-29 | Stauffer John E | Methyl mercaptan process |
US20070282313A1 (en) | 2006-06-01 | 2007-12-06 | University Of Southern California | Method and apparatus to guide laser corneal surgery with optical measurement |
WO2008141309A1 (en) | 2007-05-11 | 2008-11-20 | Ension, Inc. | Apparatus and method for endothelial keratoplasty donor tissue transport and delivery |
EP2224881B1 (en) | 2007-10-16 | 2014-04-23 | Donald Tan | Ophthalmic surgical device for endothelial keratoplasty for descemet's stripping automated endothelial keratoplasty (dsaek) surgery |
WO2010119692A1 (en) | 2009-04-16 | 2010-10-21 | Keio University | Transplantation device |
EP2332494A1 (en) | 2009-12-09 | 2011-06-15 | Neoptics AG | Applicator for inserting lenses |
EP2601996A4 (en) | 2010-08-03 | 2017-05-10 | Hoya Corporation | Therapeutic instrument and attachment thereof |
US10478206B2 (en) * | 2011-04-29 | 2019-11-19 | University Of Southern California | Instruments and methods for the implantation of cell-seeded substrates |
US20130085567A1 (en) * | 2011-09-30 | 2013-04-04 | Donald Tan | Method and apparatus for performing DMEK surgery |
IL222183A (en) | 2012-09-27 | 2016-12-29 | E K -D D S Ltd | Apparatus for improved endothelial implantation in the eye |
IL230567A0 (en) | 2014-01-21 | 2014-04-30 | E K D D S Ltd | Method and appartus for improved endothelial implatation |
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2018
- 2018-11-18 US US16/764,972 patent/US11540915B2/en active Active
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US20200323625A1 (en) | 2020-10-15 |
US11540915B2 (en) | 2023-01-03 |
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