WO2016203480A1 - Appareil d'introduction destiné à être utilisé avec un élément de maintien de tissu - Google Patents

Appareil d'introduction destiné à être utilisé avec un élément de maintien de tissu Download PDF

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Publication number
WO2016203480A1
WO2016203480A1 PCT/IL2016/050641 IL2016050641W WO2016203480A1 WO 2016203480 A1 WO2016203480 A1 WO 2016203480A1 IL 2016050641 W IL2016050641 W IL 2016050641W WO 2016203480 A1 WO2016203480 A1 WO 2016203480A1
Authority
WO
WIPO (PCT)
Prior art keywords
shape memory
memory housing
unflexed
opposite pair
fixation ring
Prior art date
Application number
PCT/IL2016/050641
Other languages
English (en)
Inventor
Joshua Ben Nun
Original Assignee
E.K.-D.D.S. Ltd
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 E.K.-D.D.S. Ltd filed Critical E.K.-D.D.S. Ltd
Publication of WO2016203480A1 publication Critical patent/WO2016203480A1/fr

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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
    • A61F2/148—Implantation instruments specially adapted therefor

Definitions

  • This invention relates to ophthalmic medical devices in general and in particular to ophthalmic medical devices for assisting in insertion of ophthalmic tools through a corneal or corneo-scleral incision.
  • the cornea is a protective dome-shaped layer of clear tissue covering the front of the eye.
  • the innermost layer of the cornea consists of non-replicating single cells layer known as endothelial cells. In normal healthy membranes, there is a cell density of between about 1500 and 2500 cells per mm . Once the population of endothelial cells decreases below a critical number that is about 600 cells per mm , the cornea loses its optical qualities and becomes edematous. This condition is known as corneal edema.
  • corneal edema the cornea becomes overly hydrated with accumulated fluid. Corneal edema may result in deteriorated vision. If such corneal edema becomes severe, blisters can appear on the cornea. Corneal edema is a result of a lack of viable cells in the corneal endothelium. In such cases, surgery may be needed to treat corneal edema. In one technique, the cornea is replaced with a transplanted full thickness cornea.
  • a surgical transplant is to replace a section of the corneal endothelium lacking sufficient healthy cells with a section of donor endothelium having a higher density of healthy cells.
  • the full thickness graft of a damaged cornea has been the treatment for corneal edema for many years.
  • this approach has some disadvantages including a high degree of post-operative astigmatism, a lack of predictable refractive outcome, and disturbance to the ocular surface.
  • the surgical trend has shifted towards removal of only a thin layer of tissue from a diseased eye and replacing it with corresponding donor tissue from a fresh human cadaver eye.
  • the implanted tissue consists of a layer attached to the posterior corneal stroma (the Descemet's membrane) that carries on its surface a monolayer of the endothelial cells known as DMEK. If the implantable tissue consists also a layer of corneal stroma, the procedure is called Descemet Stripping Automated Endothelial Keratoplasty (DSAEK). Both DMEK and DSAEK have dramatically improved the optical outcome of corneal implantation and decreased the rate of transplant rejection. However, during surgical implantation in a recipient eye, endothelial cell damage is massive and it has been documented in various clinical studies that surgical related damage induces 30%-40% endothelial cell death in the first year.
  • DMEK Descemet Stripping Automated Endothelial Keratoplasty
  • a surgical incision made in a patient's cornea for removing his Descemet's membrane and for inserting a donor Descemet's membrane is preferably as short as possible typically about 5 mm long.
  • the diseased Descemet's membrane must be folded to remove it through the short incision.
  • the replacement Descemet's membrane must be folded to introduce it through the incision.
  • the conical inserter is used to enable the insertion of the tissue with its supporting ring into the eye via a short corneal incision.
  • the flat ring is inserted in the wide mouth of the conical inserter which has an inner diameter of about 9.0 mm.
  • the flat ring As the flat ring is pushed through the conical inserter, it gradually curls along its insertion axis and doubles over so that it exits the narrow round side which is around 4.0mm in diameter as a cylinder with 4 mm diameter that may then be inserted into the eye via corneal incision of about 5.0 mm long.
  • the present invention relates to an improved insertion apparatus for use with a tissue holding fixture for assisting in insertion of the tissue holding fixture through a corneal or corneo-scleral incision into an eye.
  • the tissue holding fixture has a leading about 9mm diameter resiliently flexible unflexed flat fixation ring with a Descemet's membrane implant.
  • the insertion apparatus includes a shape memory housing bounding a shape memory housing lumen in an unflexed closed configuration and having an opposite pair of wing-like finger grips.
  • Initial manual compression force to urge the opposite pair of wing-like finger grips towards one another flexes the shape memory housing into a flexed near-flat open configuration for enabling placement of the unflexed flat fixation ring therein.
  • Subsequent release of the compression force enables the shape memory housing to revert to its unflexed closed configuration for curling the fixation ring inside the shape memory housing.
  • the insertion apparatus is designed such that its shape memory housing is shaped and dimensioned for insertion through an about 5mm long corneal or corneo-scleral incision in its unflexed closed configuration and can be urged into a flexed near-flat open configuration having a sufficiently wide span to receive an about 9mm unflexed fixation ring with a Descemet's membrane implant.
  • a tube with a 3 mm diameter has a 3 ⁇ mm perimeter corresponding to a shape memory housing in its unflexed closed configuration and its flexed near- flat open configuration.
  • Fig. 1 is a front perspective view of a tissue holding fixture as shown in commonly assigned PCT International Application No. PCT/IL2015/050049 published under PCT International Publication No. WO 2015/111040 Figure 3g;
  • Fig. 2 is a front perspective view of a first embodiment of an insertion apparatus in accordance with the present invention in an unflexed closed configuration
  • Fig. 3 is a transverse cross section of the insertion apparatus in its unflexed closed configuration along line A-A in Figure 2;
  • Fig. 4 is a front perspective view of the insertion apparatus in a flexed near- flat open configuration
  • Fig. 5 is a transverse cross section of the insertion apparatus in its flexed near-flat open configuration along line C-C in Figure 4;
  • Fig. 6 is a transverse cross section of the insertion apparatus in its unflexed closed configuration along line A-A in Figure 2 accommodating a curled tissue holding fixture;
  • Fig. 7 is a longitudinal cross section of the insertion apparatus in its unflexed closed configuration along line B-B in Figure 2 accommodating a curled tissue holding fixture;
  • Fig. 8 is a transverse cross section of a second embodiment of an insertion apparatus in accordance with the present invention.
  • Fig. 9 is a front perspective view of a third embodiment of an insertion apparatus in accordance with the present invention.
  • FIG 1 shows a tissue holding fixture 10 as disclosed in commonly assigned PCT International Application No. PCT/IL2015/050049 published under PCT International Publication No. WO 2015/111040 and in Figure 3g in particular.
  • the tissue holding fixture 10 has a leading resiliently flexible unflexed flat fixation ring 11 holding a Descemet's membrane implant 12 and a trailing pair of elongated electrodes 13.
  • the fixation ring 11 is formed from electrical and thermal insulating material, for example, silicon, and the like.
  • the fixation ring 11 is mounted on a near circular electrode 14 denoted by dashed lines in a similar manner to a car tire.
  • the near circular electrode 14 is in electrical connection with the trailing pair of electrodes 13.
  • the fixation ring 11 has a diameter D of about 9mm.
  • FIGS 2 to 7 show an insertion apparatus 100 for use with the tissue holding fixture 10.
  • the insertion apparatus 100 includes a resiliently flexible shape memory housing 101 having a longitudinal shape memory housing centerline 102 and bounding a shape memory housing lumen 103 in an unflexed closed configuration.
  • the shape memory housing 101 is formed from suitable bio-compatible shape memory materials including metals, polymer material, and the like.
  • the shape memory housing lumen 103 preferably has a uniform cross section along the longitudinal shape memory housing centerline 102. The cross section can be circular, elliptical, oval, and the like.
  • the shape memory housing 101 has a similar length as the fixation ring's diameter D.
  • the shape memory housing 101 includes a thin walled beveled leading tip 104 for insertion through a corneal or sclero-corneal incision.
  • the shape memory housing 101 includes a stepped outer surface 106 having a small cross section leading section 107, an intermediate shoulder 108 and a large cross section trailing section 109.
  • the intermediate shoulder 108 limits insertion of the shaped memory housing 101 through a corneal or corneo- scleral incision.
  • the intermediate shoulder 108 also acts to seal a corneal or corneo-scleral incision to prevent leakage therefrom.
  • the stepped outer surface 106 is preferably formed by the large cross section trailing section 109 having a thicker wall than the small cross section leading section 107.
  • the shape memory housing 101 is constituted from three integral formed parts as follows: a central panel 111 and an opposite pair of lateral curved walls 112 meeting the central support 111 at longitudinally directed fold lines 113.
  • the central panel 111 extends beyond the opposite pair of lateral curved walls 112 as a position rod 114 having an extension rod free end 116.
  • the opposite pair of lateral curved walls 112 terminate at longitudinal directed rim extensions 117 inwardly directed towards the central panel 111.
  • the opposite pair of lateral curved walls 112 meet the rim extensions 117 at longitudinal directed junctures 118.
  • the rim extensions 117 abut in the unflexed closed configuration to define a longitudinal directed slit 119 opposite the central panel 111.
  • the opposite pair of curved walls 112 has an opposite pair of wing-like finger grips 121 on opposite sides with respect to the longitudinal shape memory housing centerline 102 and equidistanced from the longitudinal slit 119.
  • the wing-like finger grips 121 are preferably an integral part of the shape memory housing 101 but in other embodiments, a separate component can be tightly attached to a shape memory housing 101.
  • the wing-like finger grips 121 are shaped and dimensioned such that a clinical practitioner can readily apply a manual compression force denoted A typically between his thumb and forefinger to urge the wing-like finger grips 121 towards one another such that the shape memory housing 101 assumes a flexed near-flat open configuration.
  • the manual compression force flexes the opposite pair of lateral curved walls 112 at the longitudinally directed fold lines 113 and substantially flattens the curved walls 112 so as to be near co-planar with the central panel 111 such that the flexed shape memory housing 101 assumes a downward facing concave shape in a front elevation view along the shape memory housing centerline 102 with the central panel 111 being above the previous longitudinal slit 119.
  • the shape memory housing 101 has a span S between the longitudinal directed rim extensions 117 slightly greater than the fixation ring's diameter D.
  • the wing-like finger grips 121 are shaped and dimensioned such that they abut in the flexed near-flat open configuration to prevent over flexing of the shape memory housing 101 from its intended near- flat open configuration.
  • the position rod free end 116 is intended for positioning in a device for holding the tissue holding fixture 10.
  • the length of the position rod 114 is set such that the shape memory housing 101 is accurately positioned over the fixation ring 11 on inserting the tissue holding fixture 10 and the insertion apparatus 100 into the device.
  • the use of the insertion apparatus 100 is as follows:
  • a clinical practitioner inserts the tissue holding fixture 10 into a device employed for transplanting its Descemet's membrane implant 12 into a recipient eye.
  • the clinical practitioner holds the insertion apparatus 100 and applies a manual compression force to flex the insertion apparatus 100 into its maximum flexed near-flat open configuration as stopped by the wing-like finger grips 121.
  • the clinical practitioner inserts the position rod free end 116 into the device with open shape memory housing 101 over the leading unflexed flat fixation ring 11.
  • the clinical practitioner ensures opposite sides of the unflexed flat fixation ring 11 are deployed at the longitudinal directed junctures 118 and begins to slowly release his manual compression force such that the shape memory housing 101 begins to revert to its unflexed closed configuration.
  • the slow release of the manual compression force traps the opposite sides of the fixation ring 11 at the junctures 118 and causes the gradual curling of the fixation ring 11 inside the shape memory housing 101 around the shape memory housing centerline 102 to conform to the shape memory housing lumen 103 such that the fixation ring 111 is effectively folded along its diameter extending between the pair of electrodes 13.
  • the clinical practitioner deploys the device to urge the insertion apparatus 100 together with the tissue holding fixture 10 to through a pre-formed incision until insertion is limited by the intermediate shoulder 108 and the incision is sealed. Once insertion and leak blockage are achieved, the positioning rod free end 116 is bent away from the device while continuously maintaining forward pressure sufficient to keep the intermediate shoulder 108 sealing the corneal incision by means of a hand held pincer. Once the positioning rod free end 116 is bent away, the clinical practitioner can slide the tissue holding fixture 10 forward through the insertion apparatus 100 such that the fixation ring 11 is deployed in the recipient eye.
  • the fixation ring 11 uncurls to its unflexed flat state and the clinical practitioner injects air into the recipient eye to force tissue attachment to the cornea and then actuates the device to release the Descemet's membrane implant 12 in the recipient eye. Once the Descemet's membrane implant 12 is released from the fixation ring 11, the fixation ring 11 is retracted into the insertion apparatus 100 and both the insertion apparatus 100 and the fixation ring 11 are withdrawn from the incision.
  • Figure 8 shows an insertion apparatus 200 similar in construction and use as the insertion apparatus 100.
  • the latter 200 differs from the former 100 insofar as the latter includes an additional spring-like element 201 for supplementing the inherent ability of the shape memory housing 101 to revert to its unflexed closed configuration.
  • the spring-like element 201 is molded into the body of the shape memory housing 101 to secure its position.
  • a spring-like element 201 can be attached to the outer surface of the shape memory housing 101 to securely attach the spring like element 201 in position when the insertion apparatus 200 is forced to assume a flexed near flat open configuration.
  • the spring-like element 201 can be formed from nitinol, and the like.
  • Figure 9 shows an insertion apparatus 300 similar in construction and use as the insertion apparatus 100.
  • the latter 300 differs from the former 100 insofar as the latter 300 includes a sealing member 301 mounted on the intermediate shoulder 108.
  • the sealing member 301 is formed from suitable bio-compatible materials, for example, silicon, rubber, and the like.
  • the sealing member 301 assists limiting insertion of the insertion apparatus 300 through a corneal or cornea-scleral incision.

Abstract

L'invention concerne un appareil d'introduction (100) destiné à être utilisé avec un élément de maintien de tissu (10) ayant un anneau de fixation plat non fléchi élastiquement souple avant (11) maintenant un implant de membrane de Descemet (12). L'appareil d'introduction comprend un boîtier à mémoire de forme (101) délimitant une lumière de boîtier à mémoire de forme (103) dans une configuration fermée non fléchie et ayant une paire opposée de prises de doigt en forme d'aile (121). Une force de compression manuelle initiale, pour pousser la paire opposée de prises de doigt en forme d'aile l'une vers l'autre, plie le boîtier à mémoire de forme dans une configuration ouverte quasi-plate fléchie pour permettre le placement de l'anneau de fixation plat non fléchi à l'intérieur de ce dernier. Le relâchement ultérieur de la force de compression permet au boîtier à mémoire de forme de revenir dans sa configuration fermée non fléchie pour courber l'anneau de fixation à l'intérieur du boîtier à mémoire de forme.
PCT/IL2016/050641 2015-06-18 2016-06-17 Appareil d'introduction destiné à être utilisé avec un élément de maintien de tissu WO2016203480A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IL239548A IL239548A0 (en) 2015-06-18 2015-06-18 A device for the controlled deformation of a flat annular element into a tubular shape
IL239548 2015-06-18

Publications (1)

Publication Number Publication Date
WO2016203480A1 true WO2016203480A1 (fr) 2016-12-22

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IL2016/050641 WO2016203480A1 (fr) 2015-06-18 2016-06-17 Appareil d'introduction destiné à être utilisé avec un élément de maintien de tissu

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IL (1) IL239548A0 (fr)
WO (1) WO2016203480A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070208422A1 (en) * 2006-01-26 2007-09-06 Wake Forest University Health Sciences Medical tools for facilitating deep lamellar endothelial keratoplasty and related methods
US20100069915A1 (en) * 2005-01-31 2010-03-18 Yichieh Shiuey Corneal implants and methods and systems for placement
WO2014049591A1 (fr) 2012-09-27 2014-04-03 E.K. - D.D.S. Ltd Procédé et appareil de kératoplastie endothéliale
WO2015111040A1 (fr) 2014-01-21 2015-07-30 E.K. - D.D.S. Ltd Procédé et appareil d'implantation endothéliale améliorée

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100069915A1 (en) * 2005-01-31 2010-03-18 Yichieh Shiuey Corneal implants and methods and systems for placement
US20070208422A1 (en) * 2006-01-26 2007-09-06 Wake Forest University Health Sciences Medical tools for facilitating deep lamellar endothelial keratoplasty and related methods
WO2014049591A1 (fr) 2012-09-27 2014-04-03 E.K. - D.D.S. Ltd Procédé et appareil de kératoplastie endothéliale
WO2015111040A1 (fr) 2014-01-21 2015-07-30 E.K. - D.D.S. Ltd Procédé et appareil d'implantation endothéliale améliorée

Also Published As

Publication number Publication date
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