EP4090285A2 - Procédé de fabrication d'un implant destiné à être introduit dans un oeil, notamment dans le canal de schlemm d'un oeil - Google Patents

Procédé de fabrication d'un implant destiné à être introduit dans un oeil, notamment dans le canal de schlemm d'un oeil

Info

Publication number
EP4090285A2
EP4090285A2 EP21721387.5A EP21721387A EP4090285A2 EP 4090285 A2 EP4090285 A2 EP 4090285A2 EP 21721387 A EP21721387 A EP 21721387A EP 4090285 A2 EP4090285 A2 EP 4090285A2
Authority
EP
European Patent Office
Prior art keywords
implant
canal
schlemm
eye
laser radiation
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.)
Pending
Application number
EP21721387.5A
Other languages
German (de)
English (en)
Inventor
Reinhart Poprawe
Axel Von Wallfeld
Uwe Clasen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Aixtent GmbH
Original Assignee
Aixtent GmbH
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 Aixtent GmbH filed Critical Aixtent GmbH
Publication of EP4090285A2 publication Critical patent/EP4090285A2/fr
Pending legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C03—GLASS; MINERAL OR SLAG WOOL
    • C03C—CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
    • C03C15/00—Surface treatment of glass, not in the form of fibres or filaments, by etching
    • 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
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F9/00825—Methods or devices for eye surgery using laser for photodisruption
    • A61F9/00831—Transplantation
    • 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
    • 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
    • A61F9/00781—Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02—Inorganic materials
    • A61L31/026—Ceramic or ceramic-like structures, e.g. glasses
    • C—CHEMISTRY; METALLURGY
    • C03—GLASS; MINERAL OR SLAG WOOL
    • C03C—CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
    • C03C23/00—Other surface treatment of glass not in the form of fibres or filaments
    • C03C23/0005—Other surface treatment of glass not in the form of fibres or filaments by irradiation
    • C03C23/0025—Other surface treatment of glass not in the form of fibres or filaments by irradiation by a laser beam
    • 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
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F2009/00897—Scanning mechanisms or algorithms
    • 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
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes

Definitions

  • the invention relates to a method for producing an implant, in particular for insertion into an eye and in particular for insertion into Schlemm's canal of an eye.
  • the invention also relates to an implant preferably produced by this method.
  • Such implants are known, for example, from WO 2010/072574.
  • the implant that can be introduced into the lumen of Schlemm's canal consists of a preferably flexible elongated tube with a plurality of openings or recesses that are in communication with an interior space. It can have at least one connecting part which is continuously oriented in the axial direction and has a curved surface, which in the inserted state is arranged in a supporting manner on the inner wall of the lumen.
  • the individual openings and recesses form a direct and permanently open connection between the trabecular tissue and the individual collector canals of the distal drainage system, so that the natural transtrabecular drainage of the aqueous humor is ensured via the episcleral venous system into the bloodstream.
  • the circulating aqueous humor drains from the posterior chamber to the anterior chamber and is drained at the angle of the chamber (angulus iridocomealis) via the trabecular tissue into Schlemm's canal and from there via the episcleral venous system into the bloodstream.
  • the angle of the chamber angulus iridocomealis
  • a T-shaped implant that can be fixed by means of a plate on the sclera provided with an incision is known, which can be surgically inserted directly into the anterior chamber or through the trabecular tissue the anterior chamber comprises an insertable proximal tube piece and two distal tubes which are arranged opposite one another on the tube piece and can be introduced into the exposed Schlemm's canal.
  • the implant designed as a drainage in the case of pathologically occluded trabecular tissue, the permanently renewed aqueous humor is artificially created to avoid increased internal pressure (IOP) from the proximal tube piece inserted into the anterior chamber via the distal tube directly into Schlemm's canal and from there via the episcleral venous system in the bloodstream of the eye derived.
  • IOP internal pressure
  • Further implants for the treatment of glaucoma are known from the two publications (US 2005/0192527 A1 and 2007/0088432 A1), which are either shaped like a T-shape with a thermal or mechanical shape memory effect or largely T-shaped without a shape memory effect.
  • These implants can each be inserted with a proximal tube either directly or surgically through the trabecular tissue into the anterior chamber and with two opposite distal tubes on the proximal tube in Schlemm's canal so that the permanently renewing aqueous humor can also be artificially created from the anterior chamber directly into Schlemm's canal and from there via the episcleral venous system into the blood circulation of the eye.
  • Application DE 100 07 425 A1 describes a method for producing an implant that is based on a photoresist.
  • the selectivity of the subsequent etching process is generated by a chemical reaction in the photoresist.
  • the method is known from the semiconductor industry for the exposure of silicon chips.
  • EP 2 473 311 describes a method in which an opaque base material is used, which promotes material removal with a laser. [11]
  • the known manufacturing processes have the disadvantage that they are relatively expensive for mass production and the implants cannot be manufactured reliably with a constant quality.
  • the invention is based on the object of providing a manufacturing method for such an implant and a new implant with which such implants can be manufactured quickly and inexpensively in a reproducible manner.
  • the implant can also be melted additively from powdered material in layers or material dissolved in liquid is solidified by local heat input in the focus area in such a way that the implant is created. It is advantageous if a continuously radiating laser is used when the implant is melted, the radiation of which is strongly absorbed by the material.
  • a CO2 laser with a wavelength of 10 pm, for example, is suitable for this.
  • the stent is made of a biocompatible material that is produced either additively or subtractively with laser radiation.
  • the selectivity is generated by non-linear absorption in a material that is transparent for the wavelengths used (glass, sapphire, visible light).
  • the absorption is produced by exceeding a swelling intensity which, depending on the material and wavelength, is approx. 10 10 - 10 13 W / cm 2 .
  • the refractive index of the transparent material is changed inelastic, i.e. permanently, and thus changes the etchability / etching rate of the etching agents used (eg KOH) compared to the unchanged material.
  • the application DE 10 2015 115 958 A1 describes a special composition of glass contents which, depending on the application, also influence cell colonization on the implant in the case of the implant according to the invention.
  • the cavities can be removed directly or in a second, subsequent process step only where the exposure with the laser has changed the material accordingly so that the second (etching) process removes the material, for example in a liquid.
  • the implant can be made of different materials.
  • the materials glass, sapphire or plastic are advantageous for the implant.
  • a glass fiber or a hollow glass fiber, which is preferably further processed using the SLE process, can also serve as the starting material.
  • the glass fiber can be shortened to a certain length before or after the treatment.
  • the wavelength of the laser radiation used can be between 150 nm and 1800 nm, preferably 1064 nm or 532 nm or 334 nm or 266 nm.
  • etching pulsed laser radiation is preferably used.
  • the focus radius of the laser radiation should be between 1 pm and 100 pm, preferably around 5 to 10 pm.
  • Preferred values for the radius focus RH are from 0.5 to 5 pm and in particular from 1 to 3 pm.
  • the pulse energy of the laser radiation is preferably between 0.3 pj and 3 pj.
  • the pulse duration T can be 0.5 to 5 ps and in particular 0.8 to 2 ps.
  • the pulse frequency of the laser radiation can be between 1 kHz and 1 MHz, whereby the average power of the laser should be between 1 mW and a few watts.
  • Advantageous intensities I are from 10 12 to 10 14 W / cm 2 and in particular around 10 13 W / cm 2 . Values between 10 kHz and 1 MHz and in particular between 50 kHz and 500 kHz are used for the repetition rate v REP.
  • the mean power P across is then, for example, 1 mW to 1 W and in particular 100 to 500 mW. This can ultimately be, for example, approx. 10 u W / cm 2 x 10 'u sx (5pm) 2
  • Laser radiation is preferably used when polishing the implant.
  • a highly absorbable CO 2 laser beam is suitable here, for example.
  • the surface of the implant should be smoothed with the polish. As a result, the notch effect is avoided or at least reduced in order to achieve a higher flexural fatigue strength and a higher breaking strength as well as an increased elasticity and a reduced risk of breakage.
  • a smooth surface also facilitates the introduction of the implant into the body, such as in particular the eye or Schlemm's canal.
  • the implant can also be polished with an ion etching process.
  • RTA Rapid Thermal Annealing
  • halogen lamps which is followed by very rapid cooling.
  • heating can also be done with a laser.
  • This process can be carried out under vacuum or in an inert gas atmosphere in order to avoid oxidation processes.
  • the time intervals for heating and cooling and the temperatures used are matched to the special stent and its material.
  • the implant is hollow cylindrical and is liquid-permeable on opposite sides of the cylinder jacket surface.
  • the cross section can also be elliptical or designed as a cone.
  • openings are provided, their maximum cross-section should be 10 ⁇ m to 50 ⁇ m.
  • the openings can of course also be larger.
  • openings other than circular or oval-shaped are also possible.
  • the total length of the implant is preferably 0.1 cm to 5 cm, but in particular 2 to 3 cm.
  • the diameter of the implant is preferably between 30 ⁇ m and 300 ⁇ m, preferably around 100 ⁇ m.
  • the implant can have a framework-like structure that extends longitudinally or also transversely to a longitudinal axis of the implant.
  • a particular embodiment provides that the implant has a curved longitudinal axis.
  • a particularly advantageous embodiment can be introduced into Schlemm's canal of an eye up to at least a quarter of the circumferential direction of the lumen of the circular Schlemm's canal.
  • An import length of a quarter is advantageous.
  • the implant can, however, also be shorter and can only be inserted into any part of the circumferential direction of the lumen.
  • the implant has a base body and a tip at one end of the base body.
  • This point does not have to be pointed and can also be dome-shaped, for example.
  • the radius of curvature of the tip is preferably half the diameter of the implant and thus preferably between 15 ⁇ m and 150 ⁇ m.
  • the tip can also be designed asymmetrically. This makes it easier, for example in an embodiment such as a dolphin's snout, to insert the implant into a curved Schlemm's canal.
  • the tip So that the tip does not have to be mounted or connected separately, it is proposed that the tip be made monolithic with the base body.
  • the implant has struts which extend diagonally to the longitudinal axis and to the circumferential direction of the cylinder circumferential surface.
  • a framework structure can be formed in which a strut can also run transversely through a hollow cylinder.
  • the struts are helical, spiral or screw-shaped and form at least part of the cylinder jacket surface.
  • the formation of a winding circumferential line can make it possible to screw the implant into the eye along the circumferential line.
  • the struts can be designed as a single or multi-thread helix, as a spiral with an open or porous core or as a screw.
  • a special variant provides that the implant is opaque.
  • a coating or coloring or even a coloring can be imparted during polishing, which enables visibility during a gonioscopy (chamber angle reflection with special lenses). This would also make it easier to reopen clogged openings in the implant with a laser, such as a Yag laser, if permeability disturbances are detected.
  • a color, such as a red end can also refer to the manufacturer as a brand.
  • the implant has a longitudinal axis and is symmetrical about this axis.
  • the implant In order to facilitate the introduction of the implant into a lumen, it is proposed that it have a longitudinal axis and that the cylinder jacket surface has bearing surfaces radially inward, which are arranged at an acute angle to the longitudinal axis.
  • the inclined contact surfaces press radially inwardly protruding subregions of the lumen outwards, while the implant is pushed into the lumen and in the lumen.
  • the object on which the invention is based is also achieved with an arrangement with an implant according to one of the preceding claims, which has a rod-shaped, spiral-shaped or sleeve-shaped insertion aid that can be detachably connected to the implant.
  • a rod-shaped or spiral-shaped insertion aid can be screwed or pushed into a hollow cylindrical implant and the implant can be held in a sleeve-shaped insertion aid while it is inserted into the eye. During the insertion of the implant, it is connected to the insertion aid and then the insertion aid can be removed without changing the position of the implant. However, the insertion aid can also be used to push the implant into Schlemm's canal by positioning the insertion aid behind the implant.
  • a special embodiment provides that the implant is spiral-shaped and the insertion aid has a correspondingly spiral-shaped counterpart so that the implant can be screwed onto the insertion aid and, after insertion, the insertion aid can be unscrewed from the implant by turning.
  • the insertion aid can also be longer than the cylinder jacket surface and have a handle which makes it possible to move and preferably even to rotate an end of the insertion aid arranged in the implant.
  • FIG. 1 shows a longitudinal section through an eye, shown schematically and on a larger scale
  • FIG. 2 shows a schematically represented front view of the eye with a parabolic incision in the sclera and an opened scleral flap
  • FIG. 3 shows the line AA shown in FIG. 2 in a larger scale Part of the eye shown to scale with partially exposed Schlemm's canal,
  • FIG. 4 shows a section of the eye, shown on a larger scale, with an injection probe inserted into Schlemm's canal,
  • FIG. 5 shows a section of the exposed Schlemm's canal according to FIG. 4, shown on a larger scale, with an implant inserted and released into its lumen,
  • FIG. 6 shows an eye section of the eye while the implant is being inserted
  • FIG. 7 shows an enlarged section from FIG. 6 without an implant
  • FIGS. 8 to 19 different embodiments of implants according to the invention as exemplary embodiments and
  • FIG. 20 an implant with contact surfaces.
  • FIGS. 1 to 5 each show a section of the eye for a better understanding of the problem in connection with glaucoma surgery. Furthermore, the same parts are provided with the same reference symbols in the individual figures and in the description below.
  • FIG. 1 shows, in the representation already known from the publication EP 0 898 947, a schematically represented vertical section of the front section of an eye 10 and one recognizes the cornea 11 (cornea), the iris 12 (iris) with the two areas 12V and 12W, the dermis 13 (sclera), the lens 14 with the pupil 14 ', the zonular fibers 19, the circular Schlemm's canal 15 (sinus venosus sclerae) and the trabecular tissue 18 (trabeculum comeo sclerale) in front of Schlemm's canal 15.
  • FIG. 1 shows, in the representation already known from the publication EP 0 898 947, a schematically represented vertical section of the front section of an eye 10 and one recognizes the cornea 11 (cornea), the iris 12 (iris) with the two areas 12V and 12W, the dermis 13 (sclera), the lens 14 with the pupil 14 ', the zonular fibers 19, the circular Schlemm's canal 15 (sinus
  • Schlemm's canal 15 can close in such a way that the outflow of aqueous humor is obstructed or largely excluded, so that the intraocular pressure rises to such an extent that the blood flow to the retina and, as a result, its function is restricted until the affected eye becomes blind.
  • FIG. 2 shows a representation of the eye 10, also known per se from the publication EP 0 898 947, in a schematic front view and the lens 14 with the pupil 14 ', a section of the dermis 13, a section of Schlemm's canal 15 can be seen and a portion of the associated natural canal system 20, 20 '(aqueous humor canal system).
  • Schlemm's canal 15, shown partially and schematically in FIG. 2 extends in the circumferential direction over an angle of 360 ° and runs circularly around lens 14 lamellar incised and, after a dermis section (not shown) has been severed, the outer flap-shaped section 13 'is unfolded and held for further operative intervention by means not shown.
  • the lamellar incision forms a scleral bed marked 17, which is closed again with the section 13 '(scleral flap) that can be folded down in the direction of arrow 23 (FIG. 3) after the intervention, for example after the insertion and release of an elongated implant will.
  • the trabecular tissue 18 (FIG. 3) in front of the circular Schlemm's canal 15 for the introduction and release of the implant with a cutting instrument or the like introduced into the anterior chamber V (not shown) is at least partially circular is opened.
  • FIG. 3 shows the line AA drawn in FIG. 2 in section as well as part of the eye 10 shown on a larger scale and one recognizes the cornea 11, the first area 12 'of the iris 12, the dermis 13 with the opened scleral flap 13', the lens 14, the zonular fibers 19, the posterior chamber H and the anterior chamber V. with the chamber angle V ' , the trabecular tissue 18 and Schlemm's canal 15 with the implant 35 arranged therein.
  • Schlemm's canal 15 which is oriented circularly around the cornea, extends, as shown schematically and on a larger scale in FIG of the chamber angle V 'has a substantially tapering shape in the direction of the other end.
  • the trabecular tissue is, so to speak, the inner wall of Schlemm's canal to the eye.
  • the trabecular meshwork separates the inside of the eye from the canal and ensures that the water does not flow off without resistance.
  • FIG. 3 the scleral bed 17 exposed by the incision with the inner surface 17 ′′ and the contact surface 17 ′ for the scleral flap 13.
  • a tube-shaped probe 33 arranged on a connection piece 32 is inserted into the lumen 16 of the exposed Schlemm's canal 15 in a manner known per se to expand Schlemm's canal 15.
  • the connection piece 32 is connected to an injection device 30, which is shown schematically, via a supply line (not shown).
  • a hydrophilic liquid 29 is injected into Schlemm's canal 15 in the direction of arrow 31 via the tubular probe 33 'provided at the distal end with at least one outlet opening 33', and as a result, a circumferentially oriented section 15 'of Schlemm's canal 15 is hydraulically expanded .
  • the section 15 ′′ of Schlemm's canal 15 opposite the already treated section 15 ' can be treated analogously and hydraulically stretched in a circular direction.
  • openings that may arise in the wall are opened and stretched at the same time as the hydrophilic liquid 29, so that these collectors are also reactivated and ensure the outflow of aqueous humor.
  • a suitable, biologically compatible gaseous medium or a mixture of the hydrophilic liquid and the gaseous medium can also be used to expand Schlemm's canal.
  • an implant 35 is introduced into the lumen 16 of the circular Schlemm's canal 15.
  • the implant 35 consists of an elongated, flexible tube 36 and is preferably made of biocompatible, elastic material and is introduced into the lumen 16 of Schlemm's canal 15 by appropriate means, not shown in detail, for example by means of a probe (inserting instrument) or the like.
  • FIG. 5 also shows a section of the implant 35 introduced into Schlemm's canal 15, which is detachably arranged on the probe (inserting instrument) with the proximal end (not shown) (nearest to the inserting instrument). At the other, distal end (farthest from the inserting instrument) the implant 35 is provided with an abutment collar 37 resting against the inside 13V of the dermis 13 ′′ and having an opening 35f.
  • the implant 35 introduced into the lumen 16 extends from one inner side 13 ′′ of the exposed Schlemm's canal 15 in a manner not shown in detail to at least quarter, half, three-quarters or preferably in the entire circumferential direction up to the opposite inner side of the lamellar incision (FIG. 2 ).
  • FIG. 5 also shows the scleral bed 17 formed by the lamellar incision between the two opposite inner sides 13 ′′, which when the scleral flap 13 ′ is folded down and placed on the parabolic support surface 17 ′ and is appropriately sutured to the dermis 13 is a subscleral space or forms a collecting basin (reservoir) for the aqueous humor.
  • the scleral bed is connected to the interior space 35e of the implant 35 via the two oppositely arranged openings 35f (only one opening 35f shown) of the implant 35.
  • FIG. 5 one recognizes a section of the implant 35 introduced into Schlemm's canal 15, which lies against the inner wall 16 ′ of the lumen 16 in a supporting manner with ring parts 35c arranged at a distance from one another. Openings or recesses 35a arranged between the individual ring parts 35c form, as shown in FIG Aqueous humor from the anterior chamber V via the trabecular tissue 18 into the circular Schlemm's canal 15 or into the interior 35e of the implant 35 and from there via the episcleral venous system into the bloodstream.
  • the implant can also be introduced “from intemo” via a clear cornea access tangential to Schlemm's canal.
  • the Schlemm's canal is opened at the point opposite the incision by a minimal opening of the trabecular meshwork and from here the implant is pushed tangentially into the possibly pre-stretched Schlemm's canal. This is shown in FIGS. 6 and 7.
  • an access is made through the clear cornea, as in the cataract operation, which leads tangentially to Schlemm's canal.
  • Schlemm's canal is punctured and the implant introduced through this opening into Schlemm's canal.
  • the implant can be inserted with a stylet or simply pushed into the canal.
  • the implant should be so rigid or firm in its longitudinal extension that it can be pushed into the canal, and it should be so elastic or flexible transversely to the longitudinal extension that it follows the canal.
  • FIGS. 8 to 19 show different possible embodiments of implants, the implants preferably having a longitudinal axis and being symmetrical along this longitudinal axis.
  • the implant is preferably designed as a helical spring.
  • the helical spring should be designed in such a way that when the implant is pushed into Schlemm's canal, the coils have sufficient rigidity not to be pushed into a block, and the spring has enough flexibility to be pushed into a curved canal and thereby move to adapt to the shape of a curved channel.
  • FIG. 10 shows how one end of the implant can be designed. However, it is more advantageous if the end is dome-shaped or designed like a dolphin's snout, so that the implant can easily be pushed into a channel.
  • the base body can be in the form of a band and guided around a longitudinal axis as in FIG. 11.
  • a band as shown in FIG. 12 can also be rotated about a longitudinal axis in order to form a screw. The edges of this band then form a double helix.
  • FIGS. 13 and 14 Further screw shapes for producing the implant are shown in FIGS. 13 and 14, a central axis of these screws preferably being hollow. This is shown, for example, in FIG. 15, in which a double helix is held in place by annular shoulders.
  • FIGS. 16 to 18 are reminiscent of a hair curler or yarn dye bobbins.
  • the implant can also have a shape known as iStent inject from the Glaukos company.
  • FIG. 20 shows a longitudinal section through an implant 11, designed like a helical spring and inserted into a lumen 10, which is in contact with the lumen 10 Points 12.
  • the areas 12 of the helical spring 13 that come into contact with the lumen 10 are already rounded.
  • these rounded areas already form a cylinder jacket surface with contact surfaces 14 which are bent radially inward and which are arranged at an acute angle 15 to the longitudinal axis 16 of the implant 11.
  • FIG. 20 shows, exaggerated, contact surfaces 17 which make it easier to push the implant 11 into the lumen 10.

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
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  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Biomedical Technology (AREA)
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  • Transplantation (AREA)
  • Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Optics & Photonics (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Organic Chemistry (AREA)
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  • General Chemical & Material Sciences (AREA)
  • Geochemistry & Mineralogy (AREA)
  • Materials Engineering (AREA)
  • Toxicology (AREA)
  • Ceramic Engineering (AREA)
  • Inorganic Chemistry (AREA)
  • Epidemiology (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un procédé de fabrication d'un implant, en particulier destiné à être introduit dans un oeil, notamment dans le canal de Schlemm d'un oeil. Selon le procédé, au moins une zone d'une ébauche composée du matériau de l'implant est d'abord irradiée avec un rayonnement laser, puis la zone irradiée est éliminée (attaquée) avec un liquide, de sorte qu'il ne reste que l'implant, l'ébauche étant perméable au rayonnement laser. L'invention concerne en outre un implant en forme de cylindre creux et perméable aux liquides sur des côtés opposés de la surface d'enveloppe cylindrique, ainsi qu'un dispositif comprenant un implant, qui comporte une aide à l'introduction en forme de tige, de spirale ou de manchon, pouvant être reliée de manière amovible à l'implant.
EP21721387.5A 2020-04-09 2021-03-30 Procédé de fabrication d'un implant destiné à être introduit dans un oeil, notamment dans le canal de schlemm d'un oeil Pending EP4090285A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102020002231.6A DE102020002231B4 (de) 2020-04-09 2020-04-09 Verfahren zur Herstellung eines Implantats zum Einführen in den Schlemmschen Kanal eines Auges, Implantat und Anordnung mit einem Implantat
PCT/DE2021/000057 WO2021204312A2 (fr) 2020-04-09 2021-03-30 Procédé de fabrication d'un implant destiné à être introduit dans un oeil, notamment dans le canal de schlemm d'un oeil

Publications (1)

Publication Number Publication Date
EP4090285A2 true EP4090285A2 (fr) 2022-11-23

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Application Number Title Priority Date Filing Date
EP21721387.5A Pending EP4090285A2 (fr) 2020-04-09 2021-03-30 Procédé de fabrication d'un implant destiné à être introduit dans un oeil, notamment dans le canal de schlemm d'un oeil

Country Status (12)

Country Link
US (1) US20230174415A1 (fr)
EP (1) EP4090285A2 (fr)
JP (1) JP2023521413A (fr)
KR (1) KR20220166826A (fr)
CN (1) CN115666446A (fr)
AU (1) AU2021252037A1 (fr)
BR (1) BR112022020372A2 (fr)
CA (1) CA3174371A1 (fr)
DE (2) DE102020002231B4 (fr)
IL (1) IL297574A (fr)
MX (1) MX2022012668A (fr)
WO (1) WO2021204312A2 (fr)

Families Citing this family (7)

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WO2021072315A1 (fr) 2019-10-10 2021-04-15 Shifamed Holdings, Llc Shunts de glaucome à débit réglable et systèmes et méthodes associés
JP2023514234A (ja) 2020-02-14 2023-04-05 シファメド・ホールディングス・エルエルシー 回転ベースの流動制御アセンブリを有するシャントシステム、ならびに関連するシステムおよび方法
US11737920B2 (en) 2020-02-18 2023-08-29 Shifamed Holdings, Llc Adjustable flow glaucoma shunts having non-linearly arranged flow control elements, and associated systems and methods
WO2021188952A1 (fr) 2020-03-19 2021-09-23 Shifamed Holdings, Llc Dérivations intraoculaires à éléments d'actionnement extra-plats et systèmes et procédés associés
WO2021212007A2 (fr) 2020-04-16 2021-10-21 Shifamed Holdings, Llc Dispositifs réglables de traitement de glaucome, ainsi que systèmes et méthodes associés
WO2022159723A1 (fr) 2021-01-22 2022-07-28 Shifamed Holdings, Llc Systèmes de dérivation réglables avec ensembles plaques, systèmes et procédés associés
CN114533387A (zh) * 2022-01-14 2022-05-27 南京普立蒙医疗科技有限公司 一种青光眼治疗用的引流装置及制作方法

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AT409586B (de) 2001-04-26 2002-09-25 Clemens Dr Vass Drainageimplantat zur ableitung von kammerwasser aus der vorderen augenkammer in den schlemm'schen kanal
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CH700161A2 (de) 2008-12-22 2010-06-30 Grieshaber Ophthalmic Res Foun Implantat zum einführen in den schlemmschen kanal eines auges.
US8435437B2 (en) 2009-09-04 2013-05-07 Abbott Cardiovascular Systems Inc. Setting laser power for laser machining stents from polymer tubing
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Publication number Publication date
MX2022012668A (es) 2023-01-11
CN115666446A (zh) 2023-01-31
AU2021252037A1 (en) 2022-11-03
IL297574A (en) 2022-12-01
WO2021204312A3 (fr) 2021-12-02
DE102020002231A1 (de) 2021-10-14
DE102020002231B4 (de) 2022-02-17
KR20220166826A (ko) 2022-12-19
BR112022020372A2 (pt) 2022-11-29
WO2021204312A2 (fr) 2021-10-14
DE112021002241A5 (de) 2023-02-02
CA3174371A1 (fr) 2021-10-14
JP2023521413A (ja) 2023-05-24
US20230174415A1 (en) 2023-06-08

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