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    • 专利摘要:
    An ocular implant system is described herein in which an implant (200) is deployed in a posterior space of the eye, for example, the suprachoroidal space or the subconjunctival space or the nscleral space, with access to the interior of the anterior chamber (160) to reduce intraocular pressure in that chamber. The shunt (200) is implanted using an implant device comprising a hollow shaft (330) mounted on a fixed shaft (320). The shunt (200) is located in a distal end of the hollow shaft (330) and is adjacent to a distal end of the fixed shaft (320), the fixed shaft being shorter in length than the hollow shaft. Once the distal end of the hollow shaft (330) with the shunt (200) is located at the desired depth within the posterior space, the hollow shaft is removed from the fixed shaft in the direction of from the proximal end thereof to leave the shunt in posterior respace with access to the interior of the anterior chamber (160).
    公开号:BE1025056A9
    申请号:E20155847
    申请日:2015-12-24
    公开日:2018-11-06
    发明作者:Nicolas Vandiest；Marco Emiliano De；Cécile Roy
    申请人:Istar Medical Sa；
    IPC主号:
    专利说明:

    (30) Priority data:
    (71) Applicant (s):
    iSTAR Medical SA
    1300, WAVRE
    Belgium (72) Inventor (s):
    VAN DI EST Nicolas 1400 NIVELLES Belgium
    DE MARCO Emiliano 4430 YEARS Belgium
    ROY Cécile
    5024 MARCHE-LES-DAMES Belgium (54) EYE IMPLANT SYSTEMS
    100 '(57) An ocular implant system is described in this document in which an implant (200) is deployed in a posterior space of the eye, for example, the suprachoroidal space or the subconjunctival space or the ntrascleral space, with access to the interior of the anterior chamber (160) to reduce intraocular pressure therein. The shunt (200) is implanted using an implantation device comprising a hollow shaft (330) mounted on a fixed shaft (320). The shunt (200) is located in a distal end of the hollow shaft (330) and is adjacent to a distal end of the fixed shaft (320), the fixed shaft being shorter in length than the hollow shaft. Once the distal end of the hollow shaft (330) with the shunt (200) is located at the desired depth inside the posterior space, the hollow shaft is removed from the fixed shaft towards from the proximal end thereof to leave the shunt in the posterior space with access to the interior of the anterior chamber (160).
    BE2015 / 5847
    - 1 EYE IMPLANT SYSTEMS
    Field of the invention
    The present invention relates to eye implant systems, and more particularly, although not exclusively, relates to devices for delivering eye implants to a predetermined location in the eye.
    Context of the invention
    The mammalian eye has an anterior chamber between the cornea and the iris and the lens. This chamber is filled with a fluid known as an aqueous humor. A trabecular network, comprising a plurality of microscopic passages, is located in the angle between the iris and the cornea. In the normal human eye, aqueous humor is generated at a constant rate, typically around 2.2 to 2.7 microliters per minute (μΙ / min), by the ciliary body behind the iris. In the conventional flow path, this aqueous humor flows beyond the lens and iris and then exits via the trabecular meshwork and is returned to the circulatory system.
    The intraocular pressure (IOP) maintaining this flow from the normal eye tends to stay within a range of 10 mmHg to 20 mmHg. However, there may be significant changes in ΙΊΟΡ in relation to the cardiac cycle, nictation, during the day and other causes. In the most common chronic form of glaucoma when the iridocorneal angle remains open, there is a blockage in the fluid flow path of the trabecular meshwork, which causes excess fluid to accumulate in the eye, and , therefore increases ΙΊΟΡ to a systematically higher value than about 18 mmHg. In some cases, ΙΊΟΡ can be as high as 50 mmHg or more. Over time, this increase in pressure produces irreversible damage to the optic nerve and loss of vision.
    BE2015 / 5847
    - 2 Glaucoma is a leading cause of blindness worldwide and affects more than 80 million people. Glaucoma has been linked to many diseases including high blood pressure, diabetes, steroid use and ethnicity. Many treatments are currently available for glaucoma including drug regimens, trabeculoplasty and laser trabeculectomy, and intraocular drainage implants.
    Drugs are frequently administered in the form of eye drops to control the entry of fluid, i.e., the formation of aqueous humor by the ciliary body, or to facilitate the evacuation of fluid through the trabecular meshwork . Erratic dosages, side effects and poor patient compliance are common problems.
    In an alternative to drug use for the treatment of glaucoma, the surgical creation of bypass passages or drains around or through the blockage of the network is adopted as a means of releasing excess fluid and thus increasing ΙΊΟΡ . In trabeculoplasty, a laser is used to create small openings in the trabecular network of the eye so that aqueous humor can drain through the network to reduce intraocular pressure in the anterior chamber of the eye. This treatment method is mainly used for open angle glaucoma.
    Surgical techniques include trabeculectomy. Trabeculectomy is a surgical technique in which a small opening is created in the trabecular meshwork to allow fluid to flow from the anterior chamber, to collect under the conjunctiva, and to be reabsorbed by the posterior parts of the eye.
    Implanted devices are most often used when other treatment methods have become ineffective. These implants include drainage devices which are inserted within the eye so that the aqueous humor can be removed through a route
    BE2015 / 5847
    -3 drainage and diverted from the anterior chamber. With traditional implants, for example, Molteno implants, Baerveldt shunts, and Ahmed valves, a drainage path is formed by means of a tube placed between the anterior chamber and a fluid dispersion plate located above scleral, below the conjunctiva. Fluid dispersed from the plate forms a pool or bubble which is slowly reabsorbed within the outer layers of the eye. More recently, a new generation of drainage devices has been designed to be implanted through a minimally invasive approach, i.e. limited surgical manipulation of the conjunctiva and sclera, thereby presenting a safer surgical procedure than traditional drainage implants and altering the paradigm for treating glaucoma. These micro-drainage devices, called MIGS (Minimal Invasion Glaucoma Surgery), for example, the Suprachoroidal Micro-Bypass Stent iStent Supra®, the Micro-stent Cypass and the Stent Xen Gel, are designed to reduce intraocular pressure by accessing either the suprachoroidal space or the subconjunctival space.
    In the Suprachoroidal Micro-Bypass Stent iStent Supra® and the Micro-stent Cypass, there is a lumen extending longitudinally through the stent, a guide or a tree being inserted within the lumen for positioning inside the target tissue, and when correctly positioned, the retracting guide or shaft leaves the stent in the targeted tissue. Such an implant is described, for example, in document US-B-8337393.
    US-B-8852136 discloses the implantation of intraocular shunts within the intra-scleral space of the eye. The implantation device includes a hollow shaft configured to hold an intraocular shunt, and is configured for insertion into the eye, and, from which the intraocular shunt is ejected or deployed before the hollow shaft is removed from the eye. The intraocular shunt is positioned so that it forms a passage from the anterior chamber to the intra-scleral space of the eye so that the aqueous humor can be drained from the anterior chamber within a complex of the ship
    BE2015 / 5847
    -4epi-scleral of the eye. The placement of the intraocular shunt also allows diffusion within the subconjunctival or suprachoroidal spaces.
    Document US-B-8388568 also discloses the implantation of an intraocular shunt within an eye. A deployment device is configured to hold an intraocular shunt while it is inserted within the target tissue inside the eye, and once in position inside the target tissue, the intraocular shunt is deployed or ejected from it. In some embodiments of the deployment device, a portion of it is designed to provide resistance indicating that the deployment device has been advanced through the anterior chamber and is properly positioned for deployment of the intraocular shunt. The deployment of the intraocular shunt can be used for the flow of aqueous humor from the anterior chamber within the subconjunctival or suprachoroidal space.
    While devices are known for implanting stents and intraocular implants, they tend to have drawbacks, such that the stent needs to be mounted on a guide or a shaft by means of a lumen for implantation. or the implant needs to be ejected from the device at the right place inside the eye as described in the documents US-8-8852136 and US-B-8388568 described above. In addition, such devices are inserted within the eye, the stent or intraocular implant deployed from the device and the device is removed from the eye.
    Summary of the invention
    It is therefore an object of the present invention to provide an implantation device which does not require an implant to be ejected from the device.
    It is another object of the present invention to provide an implantation device in which the implant does not need to be mounted on a guide during implantation within the eye.
    BE2015 / 5847
    It is yet another object of the present invention to provide an ocular implant system in which the implantation device uses a simple forward and backward movement to deliver the implant into the eye.
    It is a further object of the present invention to provide an ocular implant system in which the implantation device includes an implant in a part thereof and the implant is left in a posterior space of an eye with a part of the implant giving access to the anterior chamber.
    In accordance with one aspect of the present invention, an implantation device is provided for implanting an implant within a posterior space in an eye, the device comprising:
    a housing ;
    a fixed shaft having a proximal end and a distal end, the proximal end being mounted inside the housing and fixed to it, the distal end of the shaft extending from the housing;
    a delivery mechanism comprising a slide element mounted on the fixed shaft and at least partially inside the housing, the slide element being configured to be moved between a first position and a second position relative to the housing and at least by relation to the fixed shaft; and a hollow shaft having a distal end and a proximal end and being configured to be mounted on the distal end of the fixed shaft and to be connected to the slide element at its proximal end, the hollow shaft being configured to retain an implant inside a part thereof at its distal end, the hollow shaft being configured to be retracted on the fixed shaft by movement of the slide element from its first to its second positions to release the implant from the inside of the distal end of the hollow shaft;
    BE2015 / 5847
    - 6 characterized in that the delivery mechanism further comprising a second fixed shaft being mounted inside the housing and configured to be parallel to the fixed shaft, the slide element being mounted on both the fixed shaft and the second fixed shaft.
    The implantation device of the present invention has the advantage that the delivery mechanism operates only on the hollow shaft to remove it from the fixed shaft leaving the implant in place inside the posterior space of the 'eye. Indeed, no contact is necessary with the intraocular implant itself during its deployment from the distal end of the hollow tree.
    In addition, there is no need to eject the implant from the implantation device or to inject the implant into the posterior space of the eye.
    In one embodiment, the hollow shaft has an internal profile which is configured to correspond essentially to the external profile of the fixed shaft.
    By having corresponding internal and external profiles of the hollow shaft and the fixed shaft, the hollow shaft can use the fixed shaft as a guide to ensure easy retraction thereon to release the implant from the distal end of the hollow shaft and leave it in place inside the posterior space.
    In one embodiment, the hollow shaft comprises an essentially transparent plastic material, the essentially transparent plastic material comprising one of: a thermosetting plastic material and a thermoplastic material. The plastic material can be flexible or rigid and can include a biocompatible plastic material. Alternatively, the hollow shaft includes a biocompatible metallic material.
    The use of biocompatible materials prevents eye irritation during the implantation process.
    BE2015 / 5847
    - 7 In another embodiment, the hollow shaft comprises at least one marker indicating an insertion depth for the posterior space relative to an anterior chamber of the eye.
    By using one or more markers on the hollow shaft, one or more indications are provided to ensure that the implant is correctly positioned within the posterior space.
    In a further embodiment, the implantation device includes a light source configured to provide light for visual contrast between the implant and the posterior space of the eye. At least one light emitting source can be provided which is configured to emit at least one color of light.
    The provision of a light source has the advantage that the implant becomes more visible and is easily discernible inside the eye. The selection of the light color allows correct positioning of the implant as there may be a color that is either absorbed or reflected by the implant so that there is a definite contrast with the surrounding tissue. The light color may be chosen in accordance with the surrounding tissue to ensure there is contrast.
    An optical waveguide can be provided which is connected to the light source, the optical waveguide being configured to direct the light emitted from the light source to the distal end of the hollow shaft.
    By using an optical waveguide, light can be directed more appropriately so that light does not overwhelm the eye during implant implantation.
    The optical waveguide can be formed on at least part of the fixed shaft or on at least part of the hollow shaft. This means that no additional compound is required to direct the light towards the distal end of the hollow shaft.
    BE2015 / 5847
    -8 During the manual operation of the implantation device, a button is mounted on the case and is configured to be moved relative to the case, the button being connected to the delivery mechanism and is configured to move the slide element between its first and second positions when moved relative to the case.
    Indeed, the movement of the button in a direction from the distal end to the proximal end of the fixed shaft causes the hollow shaft to retract on the fixed shaft to release the implant from the hollow tree.
    In accordance with another aspect of the present invention, there is provided an ocular implant system configured to implant an implant within a posterior space in an eye, the ocular system comprising:
    an implant configured to be implanted in the posterior space in the eye; and an implantation device as described above, the implant being located in the distal end of the hollow shaft.
    In one embodiment, the ocular implant system can be provided for single use and is assembled so that it is ready to implant the implant within the posterior space of the eye. This has the advantage that there is no need to position the implant inside the hollow shaft or to mount a hollow shaft, with an implant located inside its distal end, on the fixed shaft each time an implant must be implanted.
    In another embodiment, an actuation mechanism configured to be flexibly connected to the implantation device and being configured to move the slide element of the delivery mechanism between its first and second positions.
    BE2015 / 5847
    -9 By having a separate actuation mechanism that is not part of the implantation device, better control can be provided for retraction of the hollow shaft on the fixed shaft. Indeed, a gentle retraction can be provided while the actuation mechanism can be operated using a hand different from that in which the implantation device is held.
    In a further embodiment, the actuating mechanism comprises a pneumatic piston device configured to be connected to an operating mechanism, the operating mechanism being connected to the delivery mechanism and comprising an internal part and an external part at least partially surrounding the internal part, the internal and external parts being configured to be movable relative to each other.
    By having an operating mechanism which includes an internal part and an external part and which connects the actuation mechanism to the implantation device, a part can determine the spacing between the two devices while the relative movement of the other part can activate the slide element of the implantation device. In a preferred embodiment, the operating mechanism includes an internal cable connecting the slide element in the delivery mechanism to the separate actuation mechanism on which an outer sheath is provided. The internal cable is sliding inside the outer sheath.
    The implant may include at least one marker configured to indicate a depth of insertion of the implant within the posterior space relative to the anterior chamber and the eye.
    This has the advantage of providing a means of determining whether the implant is correctly positioned within the posterior space. It is best if the marker includes a color chosen to provide contrast inside the anterior chamber.
    BE2015 / 5847
    - 10 Brief description of the drawings
    To allow a better understanding of the present invention, references will now be made, by way of examples, to the corresponding drawings in which:
    Figure 1 illustrates a sagittal sectional view of an eye;
    Figure 2 illustrates an enlarged cross-sectional view of the eye showing parts of the anterior chamber and the outer layers of the eye;
    Figure 3 illustrates an implantation device in accordance with the present invention;
    Figure 4 illustrates the interior of the implantation device of Figure 3;
    Figure 5 illustrates an exploded view of the implantation device of Figure 3;
    Figure 6 illustrates a hollow shaft forming part of the implantation device of Figure 3 with an implant intended to be implanted;
    Figure 7 illustrates an enlarged view of the implant shown in Figure 6;
    Figure 8 illustrates two alternative configurations for the implant for use in the implantation device of Figure 3;
    Figure 9 illustrates an implantation of the implant using the minimally invasive ab interno method;
    Figure 10 illustrates the elimination of the implantation device;
    Figure 11 illustrates the implant in position in the eye;
    Figure 12 illustrates an actuation mechanism connected to the
    BE2015 / 5847
    - 11 implantation device of Figure 3;
    Figure 13 illustrates the actuation mechanism of Figure 12 with part of its handle removed;
    Figure 14 illustrates an enlarged view of part of the actuation mechanism of Figures 12 and 13; and
    Figure 15 illustrates an exploded view of the actuation mechanism of Figures 12 to 14.
    Description of the invention
    The present invention will be described in relation to particular embodiments and with reference to certain drawings, but the invention is not limited to these. The drawings described are only schematic and are not limiting. In the drawings, the size of some of the elements may be exaggerated and not drawn to scale for illustration.
    The present invention relates to a system that includes a single-use minimally invasive implantation or a deployment device from which an intraocular shunt or implant is deployed within the suprachoroidal space, i.e., the space residing between the sclera and the choroid of the eye, or within the subconjunctival space, that is, the space residing between the conjunctiva and the sclera of the eye. The intraocular shunt or the implant is preloaded inside a part of the implantation or deployment device and is released therefrom as will be described in more detail below. In one embodiment, an implantation or deployment device is for single use, but it will be easily appreciated that the implantation or deployment device can be reusable.
    The intraocular shunt or implant provides a mechanism to provide a drainage route between the anterior chamber of the eye and a posterior part of the eye (the suprachoroidal space, the intrascleral space, or
    BE2015 / 5847
    - 12 the subconjunctival space) as will be described below with reference to the drawings. The intraocular shunt or the implant can be made from a biocompatible material as described in document EP-B-2517619. It will be readily appreciated that the intraocular shunt or the implant can be made from other suitable biocompatible materials, for example, silicone.
    In document EP-B-2517619, the biocompatible material described is porous and comprises a biocompatible polymeric scaffold which defines a set of interconnected pores having similar diameters. In general, the average pore diameter is between about 20pm and about 90pm, preferably between about 25pm and about 75pm. For use in the implant of the present invention, the preferred range is between about 25pm and about 36pm.
    The intraocular shunt or implant can be substantially cylindrical in shape with a rectangular cross section and having a length of 5mm, a width of 1.1mm and a depth of 0.6mm or can be substantially cylindrical with a circular cross section and having a similar length with a particular diameter. The intraocular or implant shunt is perforated with a block or sheet of biocompatible material where the thickness of the block or sheet has a thickness which is equal to or greater than the length of the shunt or implant. It will be readily understood that the intraocular shunt or the implant can be formed in several other ways, for example, but by using suitable cutting means other than perforations.
    The terms targeted tissue or targeted tissues as used in this document refer to the tissue within which the intraocular shunt or the implant is to be positioned, that is to say, the suprachoroid space, the space under -conjunctival or intrascleral space.
    The term natural anchor point as used in this document refers to a component that requires no
    BE2015 / 5847
    - 13 element to hold it in the correct position once delivered or deployed inside the eye.
    The term posterior as used in this document refers to a place behind the anterior chamber of one eye. The term can apply to a space that is present between the layers of tissue in the eye, for example, the suprachoroidal space and the subconjunctival space, or to a space that is created inside a layer tissue in the eye, for example, the intrascleral space.
    The terms deploy and deployment as used in this document refer to the delivery of an intraocular shunt or an implant from an implantation or deployment device within the targeted tissue inside the eye. These terms are not intended to include the injection, ejection, or advancement of the intraocular shunt or implant from an implantation or deployment device where force is used to deliver the shunt or implant within the targeted tissue.
    The terms intraocular shunt, shunt, intraocular implant or implant as used in this document refer to a component that is implanted within the eye. The term implant is more general because it refers to everything that is implanted but is used to also refer to a shunt. The term shunt refers to a component through which aqueous humor can pass from the anterior chamber of the eye into the targeted tissue behind it.
    Components which are the same are referenced in the same way and those which are modifications and / or alternatives are either referenced with a suffix A, B and so on, or with an apostrophe ('), a double apostrophe () And so on.
    Referring initially to Figures 1 and 2, a sagittal section through an eye 100 is shown illustrating the position of the cornea 110, the iris 120, the pupil 130, the lens 140, and the ciliary body 150 (shown more clearly in Figure 2). Bedroom
    BE2015 / 5847
    - the front 160 is located between the lens 140 and the cornea 110.
    In the normal eye, the aqueous humor originates from the ciliary body 150 and, for the conventional flow path, circulates between the iris 120 and the lens 140 within the anterior chamber 160, and then exits via the porous trabecular network 170 located in the iridocorneal angle 240 between the iris 120 and the cornea 110 as indicated by the arrow 180. The sclera 190 and the choroid 195 are also shown.
    In the glaucomatous eye, network 170 is frequently blocked, causing a damaging increase in pressure inside the eye. An intraocular shunt or an implant 200 in accordance with the present invention can be implanted between the sclera 190 and the choroid 195, that is to say, in the suprachoroid space, with access via the anterior chamber 160, to form a fluid path from the anterior chamber 160 to a sub-scleral region 210, bypassing this blockage and restoring the flow of the fluid.
    The shunt or implant can be preloaded and compressed into a hollow shaft forming part of a deployment or implantation device. As the shunt or the implant is compressed before deployment, it will extend, after deployment, once located inside the targeted tissue, that is to say, either between the sclera and the choroid (l suprachoroid space) either between the conjunctiva and the sclera (the subconjunctival space) or inside the sclera (the intrascleral space), and integrate with the surrounding tissue to form a natural anchor point with that -this.
    The shunt or implant may have markers provided thereon so that an operator deploying the shunt or implant can control the depth of the shunt or implant in the target tissue with part of it remaining in the anterior chamber. The positioning of the shunt or implant inside the eye is performed using an implantation or deployment device as will be described in more detail below.
    BE2015 / 5847
    The implantation device includes a minimally invasive device for implanting an intraocular shunt or an implant within the posterior space of the eye with access via the anterior chamber. In one embodiment, the ab interno method, the hollow shaft containing the shunt or the preloaded implant is inserted through the cornea, through the anterior chamber and into the targeted tissue. In a second embodiment, the ab externo method, the hollow shaft containing the shunt or the preloaded implant is inserted from the targeted tissue within the anterior chamber. The implantation device of the present invention can be used for both the ab interno and ab externo methods.
    The implantation device, in its simplest form, includes a hand-operated hand-held device configured to insert a portion thereof through an incision in the cornea which can be made by a sharpened portion of a distal end of the 'hollow tree. Deployment of the shunt or implant is in accordance with the operation of an insertion and deployment mechanism described in more detail below with reference to Figures 9 to 11.
    In one embodiment of the implantation device, an ergonomically shaped handle or housing is provided having a proximal end and a distal end. A delivery mechanism comprising a linear slide is mounted in the handle or the housing for movement in a defined direction between the distal end in the direction of the proximal of the handle or the housing. The delivery mechanism is attached to the handle with a part thereof mounted inside the handle or the housing, the delivery mechanism comprising a shaft mounted inside the handle or the housing and is fixed by compared to this one. The shaft has a proximal end inside the handle or the housing and a distal end extending from the handle or the housing. A hollow shaft can be mounted on the fixed shaft and has a proximal end which can cooperate with the linear slide and a distal end in which the shunt or the implant is preloaded. The hollow shaft can be made of any biocompatible and thermosetting or thermoplastic material
    BE2015 / 5847
    - 16 suitable sterilizable, or alternatively, of a biocompatible and sterilizable metal.
    The hollow shaft is sized to fit around the fixed shaft and to be movable relative to both the handle or the housing and the fixed shaft as will be described in more detail below. The hollow shaft has an internal profile, and the fixed shaft has an external profile, the internal profile of the hollow shaft being configured to correspond essentially to the external profile of the fixed shaft.
    Such internal and external profiles can have any suitable shape of cross section, for example, circular, elliptical, rectangular, square, etc.
    It will be appreciated that the hollow shaft also has an external profile which may be similar to or differ from the internal profile thereof.
    In an alternative embodiment of the device, an actuating mechanism is provided which is connectable to the delivery mechanism inside the handle or the housing by means of a flexible cable. The actuation mechanism comprising a piston which, when activated, operates to retract the hollow shaft on the fixed shaft to deploy, release or leave the shunt or implant in the targeted tissue.
    In an additional embodiment, the piston of the actuating mechanism can be pneumatically or electrically controlled so as to ensure smooth operation thereof. In yet another embodiment, the piston of the actuating mechanism can form part of a controlled friction system including O-rings or springs for smooth movement and / or control of the translation speed.
    The implantation device is configured to position the distal end of the hollow shaft within the space of the targeted tissue and to retract it therefrom, leaving the shunt or implant in position at the inside of it. Linear slide in the handle retracts the shaft
    BE2015 / 5847
    - 17holes on the fixed shaft to leave the shunt or implant correctly positioned in the target tissue without the need to inject the shunt or implant into the target tissue.
    The use of a separate actuation mechanism which is connected to the linear slide in the handle and can be activated by a third party allows a gentle retraction of the hollow shaft while movements of the operator's hand holding the implantation device are minimized.
    In accordance with the present invention, there is no physical deployment of the shunt or of the implant within the eye by the fixed shaft because it only works to hold the shunt or the implant in place while the hollow shaft retracts.
    The hollow shaft may have an internal profile of circular cross section or any other suitable cross section within which the shunt or the implant is housed as described above. In one embodiment, the shunt or the implant may have a cross section similar to that of the internal profile of the hollow shaft at least at the distal end thereof.
    The distal end of the hollow shaft in which the shunt or implant is located for deployment may have the same cross section as or a different cross section from the rest of the hollow shaft. The distal end of the hollow shaft can be flat or curved. The tip of the distal end can be beveled or have a flat or tapered surface. The tip of the distal end of the hollow shaft can be blunt or sharp - if sharp, the tip can be used to make incisions through the tissue in the eye to allow the shunt or implant to '' be correctly positioned in a posterior space of the eye. In addition, the hollow shaft may have markers located thereon to indicate the positioning of the shunt or implant within the distal end thereof. In one embodiment, at least the distal end of the hollow shaft may be transparent.
    BE2015 / 5847
    - 18The handle or case may further include an illumination source incorporated with a light emitting diode (LED) which is coupled to the hollow shaft via a fiber optic cable or an optical waveguide. In one embodiment, the hollow shaft can be configured so that at least at its distal end it is transparent so that the light can be directed towards the intraocular shunt or the implant to be delivered to the targeted tissue . The optical waveguide can be formed in part from either one of the hollow shaft or the fixed shaft.
    The LED illumination source can include at least one LED element which can emit at least one color of light. It may be possible that the color of light emitted by at least one LED element can be selectable so as to provide a visual contrast that allows the location of the shunt or implant to be determined in the targeted tissue.
    If we now consider FIG. 3, an implantation device 300 is shown there which comprises a handle or a housing 310 and a fixed shaft 320 mounted inside the handle or the housing so that a distal end 320a of this extends from the handle or the housing with the proximal end 320b being located inside the handle or the housing 310 (see Figure 4). A hollow shaft 330 is mounted on the fixed shaft 320 with a proximal end thereof (not shown) mounted inside the handle or the housing 310 and a distal end thereof 330a extending beyond beyond the distal end 320a of the fixed shaft 320. A cable 340 is shown which connects the implantation device to an actuation mechanism as will be described in more detail below.
    Figure 4 illustrates the implantation device 300 with a first part 315a of the handle or of the housing 310 removed. As shown, the proximal end 320b of the fixed shaft 320 is connected to a second part 315b of the handle or of the housing 310 by a fixing element 360. The fixed shaft 320 and a sliding shaft 380 pass through an element slide 370 which is configured to slide between a
    BE2015 / 5847
    - 19 first position where it leans against an end wall 310a of the handle or of the housing 310 and a second position where it leans against the fixing element 360.
    The proximal end 330b of the hollow shaft 330 cooperates with the slide member 370 and is configured to slide on the fixed shaft 320 when the slide member 370 is moved from the first position to the second position.
    An exploded view of the implantation device 300 is shown in Figure 5. As shown, the handle or the housing 310 comprises a first part 315a and a second part 315b. As described above, the fixed shaft 320 is mounted inside the handle or the housing 310 by the fixing element 360, the fixing element 360 being fixed to the second part 315b of the handle or the housing 310.
    The slide shaft 380 is located parallel to the fixed shaft 320. The slide shaft 380 may comprise a substantially cylindrical part 385 on which the sliding element 370 can slide from a distal end 385a to a part adjacent to the fixing element 360. At a proximal end 385b of the sliding shaft 380, a head part 385c can be provided which is retained inside a recess 315c of the second part 315b. Similarly, the distal end 385a of the slider shaft 380 is located inside a recess 315d of the second part 315b. Although shown as separate niches in Figure 5, it will be appreciated that niches 315c, 315d may include a uniquely shaped niche extending inside the second part 315b to accommodate the ends 385a, 385b, 385c of the sliding shaft 380.
    Cable 340 includes an external flexible hollow cable 345a and an internal rigid cable 345b. The external cable 345a is connected to a recess 315e of the second part 315b of the handle or of the housing 310 and the internal cable 345b is connected to the slide element 370 through a hole 370a and is configured to actuate the movement of the latter. ci relative to handle or housing 310, i.e. internal cable 345b
    BE2015 / 5847
    -20 works to move the slide element 370 in the direction of the proximal end 310b of the handle or of the housing 310. By moving the slide element 370 in the direction of the proximal end 310b of the handle or of the housing, the shaft hollow 330 is retracted on the fixed shaft 320 leaving the shunt or the implant 200 in place inside the posterior part of the eye as will be described in more detail below.
    When the first part 315a of the handle or of the housing 310 is mounted on its second part 315b, the fixed shaft 320 attached to the fixing element 360, the slide 370 and the slide shaft 380 are retained in the latter.
    The distal end 310a of the handle or of the housing 310 has an elongated opening 390 formed therein through which the distal end 320a of the fixed shaft 320 projects. The proximal end 330b of the hollow shaft 330 is configured to be inserted through the opening 390 and to cooperate with part of the slide element 370 (not shown).
    The hollow shaft 330 is shown in Figure 6 with a shunt or implant 200 which is also shown in Figure 7. In one embodiment, the hollow shaft 330 may have a circular cross section with a circular internal cross section . In another embodiment, the hollow shaft 330 may have an oblong cross section, that is, a cross section having two substantially parallel edges joined by an arc at each end. In a further embodiment, the hollow shaft 330 may have a rectangular cross section with a rectangular internal cross section. In other embodiments, the cross section can be such that the internal cross section is of a different shape compared to the cross section defined by the external shape of the hollow shaft 330.
    The shunt or implant 200 may have a marker 205 located near its proximal end 200a so that it is possible to see its
    BE2015 / 5847
    - 21 position through a substantially transparent hollow shaft 330. It will be easily appreciated that other markers can be provided on the shunt or the implant 200 for better visibility, for example, two markers can be provided at the proximal end 200b of the shunt or implant 200.
    As described above, the shunt or implant 200 is located in the distal end 330a of the hollow shaft 330 before implantation and comprises a suitable biocompatible material as described above. In general, the shunt or implant can be between 4mm and 7mm long and can have a diameter between 0.4mm and 2mm. In one embodiment, the shunt or implant 200 has a circular cross section, but it will be readily appreciated that it can have any suitable cross section which corresponds to the internal cross section of the hollow shaft 330.
    Figures 8a and 8b illustrate two alternative configurations for representing the shunt or implant 200. In Figure 8a, the shunt or implant 200A is flared at its distal end 200b 'with a marker 205' at its proximal end 200a ' ; and in Figure 8b, the shunt or implant 2008 is flared both at its distal end 200b and at its proximal end 200a with a constricted portion 200c therebetween. As before, a marker 205 is provided at its proximal end 200a.
    In one embodiment, the implantation device 300 is provided as a sterilized unit which is ready for use when its sterile packaging has been removed, i.e., the handle or housing 310 (with its internal components as described above with reference to FIGS. 3 to 5), the fixed shaft 320 and the hollow shaft 330 including the shunt or implant 200 inside its distal end 330a.
    When assembled, the part of the fixed shaft 320 extending from the slide element 370 is shorter than the part of the hollow shaft 330 extending from the slide element 370 by at least the length of the shunt or implant 200. This means that the shunt or implant 200
    BE2015 / 5847
    - 22 is located in the distal end 330a of the hollow shaft 330 against one end of the fixed shaft 320 at its distal end 320a in the layout configuration.
    Although not shown, the slide element 370 can be biased at the first position by a resilient element located on the fixed shaft 320 between the slide element 370 and the fixing element 360, and a movement towards the second position is contrary to the action of the resilient element to ensure a smooth movement of the hollow shaft 330 on the fixed shaft 320 during the release of the intraocular shunt or of the implant. It will be appreciated that the resilient member may be located at any convenient location within the handle or the case to provide an appropriate bias of the slide member 370. The resilient member may be a compression spring or any suitable resilient member which is deformable when the slide member 370 is moved from its first to its second position in the handle or the housing.
    Figure 9 illustrates the implantation of an intraocular shunt or a 200 implant using the ab interno method. As indicated, the shunt or the implant 200 is retained inside the hollow shaft 330 which is mounted on the fixed shaft 320 - the total length of the hollow shaft 330 and the fixed shaft 320 n ' not being shown for clarity. In this embodiment, the hollow shaft 330 has a beveled tip 335 at its distal end 330a, the beveled tip being used to facilitate penetration of the hollow shaft through the cornea 110. The hollow shaft 330 is then directed within and through the anterior chamber 160 of the eye towards the iridocorneal angle 240 and within the sub-scleral space 210. As indicated, the bevelled tip 335 at the distal end 330a of the hollow shaft 330 is also configured to provide smooth penetration within the sub-scleral space as shown.
    It will be readily appreciated that the distal end 330a of the hollow shaft 330 does not need to provide the incision within the cornea and this can be done using a separate tool with the hollow shaft being inserted within
    BE2015 / 5847
    -23of the incision made.
    Figure 10 is similar to Figure 9 but illustrates the intraocular shunt or implant 200 in position inside the sub-scleral space 210. The hollow shaft 330 is shown retracted with respect to the fixed shaft 320 During the deployment of the intraocular shunt or of the implant 200 inside the sub-scleral space after it has been correctly positioned, the sliding element 370 is moved inside the handle or the housing. 310 from the distal end 310a thereof towards the fixing element 360. This movement causes the hollow shaft 330, which is connected to the slide element 370, to retract on the fixed shaft 320 leaving the shunt or the implant 200 in position inside the sub-scleral space.
    In the simplest embodiment, part of the slide element 370 may extend through the part 315a of the handle or of the housing 310 and is configured to be manually moved by the practitioner implanting the shunt or the implant 200 in the eye from its first position to its second position. However, in other embodiments, the slide member 370 is located in the handle or in the housing 310 and is configured to be actuated using an actuation mechanism as will be described in more detail below. It is important to have a smooth and controlled retraction of the hollow shaft 330 so that the shunt or the implant 200 is not moved or damaged during the withdrawal of the hollow shaft 330 from the implantation device 300 to from the iridocorneal angle 240 and that there is no damage to the eye itself.
    Figure 11 illustrates the shunt or implant 200 in position with the implantation device removed from the eye. As indicated, the majority of the shunt or implant 200 is positioned in the sub-scleral space 210 with the proximal end 200a thereof in the anterior chamber 160. The aqueous humor flows from the anterior chamber 160 to the suprachoroid space, thereby reducing the eye pressure of the eye.
    BE2015 / 5847
    - 24 As described above with reference to Figures 3 to 5, the implantation device 300 also includes a cable 340 comprising an external flexible hollow cable 345a and an internal rigid cable 345b. Figures 12 to 14 illustrate the connection of the implantation device 300 to an actuation mechanism 400 via the cable 340.
    The actuation mechanism 400 comprises a handle 410 in which a piston 420 is mounted, the actuation mechanism being connected to the handle 410 via the cable 340. The external cable 345a is connected to a niche 410a of the actuation mechanism 400 and the internal cable 345b is connected to a part 430 of the piston 420. the depression of the piston 420, that is to say, the movement of the piston 420 in the direction of the handle 410, causes the internal cable 345b to be pulled of the handle 310 of the implantation device 300 moving the slide element 370 from its first position to its second position and retracting the hollow shaft 330 on the fixed shaft 320. In order to avoid premature depression of the piston 420, a stopper 440 (Figure 12) is provided to prevent movement of the piston until it is removed.
    In Figure 15, a pneumatic actuator 500 is shown which includes a housing or handle that is similar to the housing or handle 410. The housing includes a first portion 515a and a second portion 515b on which a piston (typically shown as 520) is mounted. A piston 530 is connected to the piston 520, and, when the piston 530 is depressed, the piston is actuated and the internal cable 345b is pulled outside the handle 310 of the implantation device 300 to retract the hollow shaft 330 onto the fixed shaft 320 as described above. The stop member 440 is also shown and operates as described above with reference to Figure 12.
    It will be readily understood that a controlled and smooth operation of the actuation mechanism is desired, and, by having the piston of the actuation mechanism pneumatically controlled, a controlled and smooth operation of the latter can be guaranteed. As an alternative, the piston of the actuating mechanism can form part of a controlled friction system comprising seals
    BE2015 / 5847
    -25 toric or springs for smooth movement and / or control of the translation speed (not shown).
    BE2015 / 5847
    权利要求:
    Claims (15)
    [1]
    1. Implantation device for implanting an implant within a posterior space in an eye, the device comprising:
    a housing ;
    a fixed shaft having a proximal end and a distal end, the proximal end being mounted inside the housing and fixed to it, the distal end of the shaft extending from the housing;
    a delivery mechanism comprising a slide element mounted on the fixed shaft and at least partially inside the housing, the slide element being configured to be moved between a first position and a second position relative to the housing and at least by relation to the fixed shaft; and a hollow shaft having a distal end and a proximal end and being configured to be mounted on the distal end of the fixed shaft and to be connected to the slide element at its proximal end, the hollow shaft being configured to retain an implant inside a part thereof at its distal end, the hollow shaft being configured to be retracted on the fixed shaft by movement of the slide element from its first to its second positions to release the implant from inside the distal end of the hollow shaft;
    characterized in that the delivery mechanism further comprising a second fixed shaft being mounted inside the housing and configured to be parallel to the fixed shaft, the slide element being mounted on both the fixed shaft and the second fixed shaft.
    [2]
    2. Device according to claim 1, wherein the hollow shaft has an internal profile which is configured to correspond essentially to the external profile of the fixed shaft.
    BE2015 / 5847
    [3]
    3. Device according to claim 1 or claim 2, wherein the hollow shaft comprises an essentially transparent plastic material, the essentially transparent plastic material comprising one of: a thermosetting plastic material and a thermoplastic material.
    [4]
    4. Device according to claim 1 or claim 2, wherein the hollow shaft comprises a biocompatible metallic material.
    [5]
    5. Device according to any one of the preceding claims, in which the hollow shaft comprises at least one marker indicating an insertion depth for the posterior space relative to an anterior chamber of the eye.
    [6]
    6. Device according to any one of the preceding claims, further comprising a light source configured to provide light for visual contrast between the implant and the posterior space of the eye.
    [7]
    The device according to claim 6, wherein the light source comprises at least one light emitting source configured to emit at least one color of light.
    [8]
    8. Device according to claim 6 or claim 7, further comprising an optical waveguide connected to the light source and configured to direct the light emitted by the light source towards the distal end of the hollow shaft.
    [9]
    9. Device according to claim 8, in which the optical waveguide is formed on one of: at least part of the fixed shaft and at least part of the hollow shaft.
    [10]
    10. Device according to any one of the preceding claims, further comprising a button mounted on the housing.
    BE2015 / 5847
    -28and being configured to be moved relative to the case, the button being connected to the delivery mechanism and is configured to move the slide element between its first and second positions once moved relative to the case.
    [11]
    11. An ocular implant system configured to implant an implant within a posterior space in an eye, the ocular system comprising:
    an implant configured to be implanted in the posterior space in the eye; and an implantation device according to any one of the preceding claims, the implant being located in the distal end of the hollow shaft.
    [12]
    The ocular implant system according to claim 11, further comprising an actuation mechanism configured to be flexibly connected to the implantation device and being configured to move the slide element of the delivery mechanism between its first and second positions.
    [13]
    13. The ocular implant system according to claim 12, wherein the actuating mechanism comprises a pneumatic piston device configured to be connected to an operating mechanism, the operating mechanism being connected to the implanting device and comprising a part internal and an external part at least partially surrounding the internal part, the internal and external parts being configured to be movable relative to each other.
    [14]
    14. The ocular implant system of any one of claims 11 to 13, wherein the implant comprises at least one marker configured to indicate a depth of insertion of the implant inside the posterior space relative to to the anterior chamber and to the eye.
    BE2015 / 5847
    [15]
    15. The ocular implant system according to claim 14, wherein the marker comprises a color chosen to provide contrast inside the anterior chamber.
    BE2015 / 5847
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    同族专利:
    公开号 | 公开日
    BE1025056A1|2018-10-10|
    BE1025056B1|2018-10-15|
    BE1025056B9|2018-11-16|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    法律状态:
    2018-12-05| FG| Patent granted|Effective date: 20181015 |
    优先权:
    申请号 | 申请日 | 专利标题
    BE20155847A|BE1025056B9|2015-12-24|2015-12-24|OCULAR IMPLANT SYSTEMS|BE20155847A| BE1025056B9|2015-12-24|2015-12-24|OCULAR IMPLANT SYSTEMS|
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