Port device for introducing a liquid pharmaceutical compound into an intraocular space

Abstract

A port device (110) for introducing at least one liquid pharmaceutical compound into at least one intraocular space (114) is proposed. The port device (110) comprises: a. a port body (120) providing at least one channel (122) fluidically connecting at least one extraocular port (124) of the port device (110) with at least one intraocular port (126) of the port device (110); b. at least one circumferential flange (128) for attaching the port body (120) to a rim of a scleral opening (118); and c. at least one valve (134) for controlling a flow of the pharmaceutical compound through the channel (122), the valve (134) comprising at least one valve member (136) having a default closed position preventing a flow of the pharmaceutical compound through the channel (122) and an open position permitting a flow of the pharmaceutical compound through the channel (122), wherein the valve member (136) is configured to be reversibly brought from the closed position into the open position by exerting an opening force. Further, a kit (150) for introducing at least one liquid pharmaceutical compound into at least one intraocular space (114) is proposed. The kit (150) comprises at least one port device (110) according to the present invention and at least one applicator device (146). The applicator device (146) is configured to engage with the port device (110). The applicator device (146) is configured to introduce the pharmaceutical compound into the intraocular space (114) through the port device (110).

Description

[0001] Port device for introducing a liquid pharmaceutical compound into an intraocular space

[0002] Technical Field

[0003] The present invention relates to a port device and a kit for introducing at least one liquid pharmaceutical compound into at least one intraocular space. Further described and proposed are a method of introducing at least one liquid pharmaceutical compound into at least one intraocular space of an eye and a use of the port device and the kit for the treatment of wet macular degeneration, specifically of age-related macular degeneration (AMD), specifically the wet type of AMD. It shall be noted, however, that the port device, the kit and the method may also be applied for other ophthalmologic purposes.

[0004] Background art

[0005] Some ophthalmologic indications are generally known to require the introduction of one or more liquid pharmaceutical compounds into one or more intraocular spaces. As a non-limiting example, wet age-related macular degeneration (AMD), diabetic retinopathy, and macular edema due to branch retinal vein occlusion or central retinal vein occlusion may be treated with Ranibizumab (CAS number 347396-82-1), a monoclonal antibody fragment (Fab).

[0006] Pharmaceutical compounds can generally reach the intraocular space via systemic application or via local application. To reduce the burden of repeated local application, where the sclera is penetrated with a needle for each application, ocular implant devices have been used. As an example, in the “SUSVIMO” treatment developed by Genentech, Inc., CA, USA, an ocular implant is used having an extrascleral flange, a reservoir for holding approximately 0.02 milliliters, a distal self-sealing septum for injection of the Ranibizumab medication into the reservoir, and a proximal, intraocular release control element made from titanium for slowly releasing the medication over a time period of approximately six months.

[0007] The use of ophthalmologic implants or the insertion of implants into the eye is also generally known from other medical indications. As an example, medical valves are used for controlling the ocular pressure, e.g. for the treatment of glaucoma. Thus, US 5,071,408 A discloses a medical valve comprising a pair of plates holding in tension a membrane folded over to form a chamber with an elongated, slit-like opening along adjoining edges. The plates include interlocking members which interlock the plates together. An inlet tube in communication with the chamber extends outwardly from the plates.

[0008] EP 3 439 591 Al and WO 2017 / 176886 Al disclose implantable devices having reservoirs for the sustained release of therapeutic agents. The devices are configured to be at least partially implanted in an eye and include a retention structure and a penetrable element coupled to and extending within at least a portion of the proximal end region of the device. The device includes a porous drug release element is positioned in fluid communication with an outlet of the device and a reservoir having a volume configured to contain one or more therapeutic agents in fluid communication with the outlet through the porous drug release element. The device is at least partially inserted along an axis of insertion.

[0009] US 2015 / 080846 Al discloses an apparatus to insert an implantable therapeutic device into a patient. The apparatus includes a proximal handle and a distal placement portion coupled to the proximal handle and configured to hold the implantable therapeutic device. The distal placement portion includes a first side having a first engagement structure at a distal end of the first side, the first engagement structure configured to surround at least a first portion of a proximal end region of the implantable therapeutic device. The distal placement portion includes a second, opposite side having a second engagement structure at a distal end of the second side, the second engagement structure configured to surround at least a second, opposite portion of the proximal end region of the implantable therapeutic device.

[0010] US 9 492 315 B2 discloses a therapeutic device to release a therapeutic agent which comprises a porous structure coupled to a container comprising a reservoir. The reservoir comprises a volume sized to release therapeutic amounts of the therapeutic agent for an extended time when coupled to the porous structure and implanted in the patient. The porous structure may comprise a first side coupled to the reservoir and a second side to couple to the patient to release the therapeutic agent. The length of the channels extending from the first side to the second side may comprise an effective length greater than a distance across the porous structure from the first side to the second side. The therapeutic device may comprise a penetrable barrier to inject therapeutic agent into the device when implanted in the patient.

[0011] CN 102 271 632 A discloses an in-situ refillable ophthalmic implant having a refill port in communication with a reservoir and a release control mechanism. The invention also relates to methods of forming and using the ophthalmic implant. Preferably, the control release mechanism include an openingfs] providing for passive passage of pharmaceutical ophthalmic composition, particularly therapeutic agent, out of the reservoir, through the openingfs] and into the eye.

[0012] US 2013 / 165860 Al discloses an injector apparatus comprises an elongate structure having one or more openings positionable near a penetrable barrier of an implantable device so as to receive fluid of the implantable device. The apparatus comprises a needle and a sheath extending over at least a portion of the needle. The elongate structure may comprise a distal tip to penetrate tissue and the penetrable barrier, and a distal opening near the tip to release therapeutic fluid into the implantable chamber. In many embodiments the distal tip, the distal opening, and the plurality of openings are separated from a stop that engages a tissue of the patient and limit penetration depth such that the distal opening and the plurality of openings are located along an axis of the implantable device to increase an efficiency of the exchange.

[0013] Despite the progress made with the means and methods discussed above and the advantages involved, there is still a need for devices and methods for introducing liquid pharmaceutical compounds into an intraocular space, for the indications discussed above or other indications. Specifically, a technical challenge generally may arise from the repeated mechanical interactions with the device, such as by repeated penetrations with a needle. This technical challenge may lead to the situation that an exchange of the device is required more often than generally desirable. Further, the use of a needle in ophthalmologic treatments also generally requires the administration of the medication by a skilled medical practitioner, and a self-medication is generally not possible for safety reasons. There is, thus, still room for further improvements allowing for a reliable and technically simple long-term or repeated administration of liquid pharmaceutical compounds into intraocular spaces.

[0014] Problem to be solved It is therefore desirable to provide devices and methods for introducing at least one liquid pharmaceutical compound into at least one intraocular space which address the above-mentioned technical challenges. Specifically, the devices and methods shall allow for repeated and reliable administrations of the at least one liquid pharmaceutical compound over a long time period.

[0015] Summary

[0016] This problem is addressed by a port device, a kit and a method of introducing at least one liquid pharmaceutical compound into at least one intraocular space, as well as by a use of the port device and the kit, with the features of the independent claims. Advantageous embodiments which might be realized in an isolated fashion or in any arbitrary combinations are listed in the dependent claims as well as throughout the specification.

[0017] As used in the following, the terms “have”, “comprise” or “include” or any arbitrary grammatical variations thereof are used in a non-exclusive way. Thus, these terms may both refer to a situation in which, besides the feature introduced by these terms, no further features are present in the entity described in this context and to a situation in which one or more further features are present. As an example, the expressions “A has B”, “A comprises B” and “A includes B” may both refer to a situation in which, besides B, no other element is present in A (i.e. a situation in which A solely and exclusively consists of B) and to a situation in which, besides B, one or more further elements are present in entity A, such as element C, elements C and D or even further elements.

[0018] Further, it shall be noted that the terms “at least one”, “one or more” or similar expressions indicating that a feature or element may be present once or more than once typically will be used only once when introducing the respective feature or element. In the following, in most cases, when referring to the respective feature or element, the expressions “at least one” or “one or more” will not be repeated, non-withstanding the fact that the respective feature or element may be present once or more than once.

[0019] Further, as used in the following, the terms "preferably", "more preferably", "particularly", "more particularly", "specifically", "more specifically" or similar terms are used in conjunction with optional features, without restricting alternative possibilities. Thus, features introduced by these terms are optional features and are not intended to restrict the scope of the claims in any way. The invention may, as the skilled person will recognize, be performed by using alternative features. Similarly, features introduced by "in an embodiment of the invention" or similar expressions are intended to be optional features, without any restriction regarding alternative embodiments of the invention, without any restrictions regarding the scope of the invention and without any restriction regarding the possibility of combining the features introduced in such way with other optional or non-optional features of the invention.

[0020] In a first aspect, a port device for introducing at least one liquid pharmaceutical compound into at least one intraocular space is disclosed. The port device comprises: a. a port body providing at least one channel fluidically connecting at least one extraocular port of the port device with at least one intraocular port of the port device; b. at least one circumferential flange for attaching the port body to a rim of a scleral opening; c. at least one valve for controlling a flow of the pharmaceutical compound through the channel, the valve comprising at least one valve member having a default closed position preventing a flow of the pharmaceutical compound through the channel and an open position permitting a flow of the pharmaceutical compound through the channel, wherein the valve member is configured to be reversibly brought from the closed position into the open position by exerting an opening force, specifically an external opening force, onto the valve.

[0021] The term “port device” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary device enabling access to an object or system. The port device specifically may be a medical port, and, more specifically, may be or may comprise a device which is insertable into the skin and / or through the skin of the user and in a subcutaneous and / or transcutaneous way and which enables access to the system of the body, such as to at least one body part, specifically for at least one medication to be administered to the system. The term “skin” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term generally may refer to an arbitrary shell, limiting tissue, membrane, layer, layer setup or envelope, specifically an enveloping organ, which is configured to fully or partially surround, confine and / or delimit at least one organ, body part or tissue of a living being and to protect the organ, body part or tissue against external influences. Specifically, the term may refer to one or more of: cutis or derma, sclera, cornea, conjunctiva. The term “introducing” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary type of administering the liquid pharmaceutical compound to the body, such as by one or more of injection, diffusion or the like.

[0022] The term “liquid pharmaceutical compound” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary fluid introducible into the system of the human or animal body having the potential of producing or provoking an effect in the system of the body, specifically an effect of a treatment of a disease and / or a curing effect. The liquid pharmaceutical compound, as an example, may be or may comprise one or more of a pure liquid, a solution of at least one soluble compound in at least one solvent, and emulsion of at least one liquid compound in at least one liquid phase, and a dispersion of at least one compound in at least one liquid phase. Specifically, the liquid pharmaceutical compound, as outlined above, may have the potential of provoking an ophthalmologic effect. More specifically, the liquid pharmaceutical compound may be or may comprise Ranibizumab. It shall be noted, however, that other pharmaceutical compounds may be used alternatively and / or in addition.

[0023] The term “space” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a volume fully or partially enclosed by at least one perceptible boundary. The space may be one of empty space and a space fully or partially filled with at least one material distinguishable from the material of the boundary, such as one or more of a liquid, a gas or a solid. Consequently, the term “intraocular space” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to one or more spaces in the human or animal eye, which may be fully or partially surrounded by one or more skin portions and / or one or more layers of membranes. Specifically, the intraocular space may be fully or partially surrounded or limited by one or more of the sclera, the conjunctiva, the choroid, the retina and the cornea. More specifically, the intraocular space may be or may comprise at least one of the vitreous body, the anterior chamber and the posterior chamber of the human or animal eye. As outlined above, the port device comprises a port body. The term “port body” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an element or a combination of elements providing mechanical stability to the port device. As will be outlined in further detail below, the port body specifically may have an elongated shape, such as one or more of a cylindrical shape and a conical shape, with, as an example a circular, oval or polygonal cross-section. The port body, as an example, and as also will be outlined in further detail below, may be made of at least one material providing mechanical stability to the porch device, such as a rigid or semi-rigid material, which may also have flexible properties.

[0024] The port body provides at least one channel enabling a fluid connection between at least one extraocular port of the port device and at least one intraocular port of the port device. The term “channel” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a fluidic element enabling a fluid exchange between at least one first end and at least one second end of the channel. The channel may be formed by one or more channel walls fully or partially surrounding at least one open lumen of the channel through which the fluid exchange may take place. The channel walls may fully or partially be formed by the port body or the material of the port body. The channel, specifically, may be or may comprise a straight channel, such as a cylindrical channel. In addition, however, the channel may optionally also comprise at least one reservoir. The channel, at the first and second ends, is fluidically accessible via ports, which may be formed by openings in the channel wall. The ports may be entirely open or may, alternatively, be fully or partially covered by one or more elements which may be penetrated by the fluid or a needle, such as one or more of a membrane and a septum. Therein, the distal access to the channel or the access to the channel being located farthest away from the center of the eye when the port device is fully or partially inserted into the eye is referred to as the “extraocular port” notwithstanding the fact that the extraocular port may still fully or partially be covered with one or more layers of tissue of the eye, such as the conjunctiva, which has to be penetrated e.g. with the needle for obtaining access to the extraocular port from the outside of the eye. Consequently, the proximal access to the channel or the access to the channel being located closest to the center of the eye when the port device is fully or partially inserted into the eye is referred to as the “intraocular port” of the port device.

[0025] The port device further comprises at least one circumferential flange for attaching the port body to a rim of a scleral opening. The term “flange” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a protrusion, such as a ridge, lip or rim, protruding from a surface of an object, the protrusion enabling the attachment of the object to another object. Specifically, the protrusion may be a protrusion protruding from an outer surface of an object, enabling the attachment of the object to the rim of an opening through which the object extends. The term “circumferential flange”, thus, specifically may refer to at least one protrusion protruding circumferentially over an outer surface of an object, specifically of the port body. The protrusion may form a closed loop, without interruptions, or may comprise a plurality of protrusions forming a closed circumferential line along the outer surface of the object. The circumferential flange, specifically, may be located in a plane essentially perpendicular to an axis of extension or longitudinal axis of the port body, e.g. precisely perpendicular or with a tolerance of no more than 20°, specifically of no more than 10° and more specifically of no more than 5°. The circumferential flange, thus, may, as an example, have a circular shape, an oval shape or a polygonal shape, depending on the cross-section of the port body.

[0026] As outlined above, the intraocular space specifically generally may comprise any space fully or partially surrounded by one or more of a membrane, a skin or other tissue of the eye. Consequently, the term “scleral opening” as used herein, is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The meaning of the term specifically may be adapted to the type of intraocular space into which the port device is fully or partially inserted or into which the port device protrudes in an implanted or inserted state. Consequently, the scleral opening may be an opening, such as an incision or a puncture, in the specific tissue limiting and / or fully or partially surrounding the intraocular space into which the liquid pharmaceutical compound is to be introduced. Consequently, the scleral opening may be or may comprise, as an example, one or more of an opening in the sclera, the conjunctiva, the choroid, the retina and the cornea. In many cases, however, without limitation, the scleral opening will be an opening in the sclera.

[0027] As further outlined above, the port device comprises at least one valve for controlling a flow of the pharmaceutical compound through the channel. The at least one valve may be located within the channel or in fluid connection with the channel, e.g. at the extraocular port of the port device or the intraocular port of the port device. The term “valve” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a device configured for controlling the flow of a fluid, specifi cally by one or more of opening, closing, or partially obstructing at least one passageway. The valve specifically may be or may comprise at least one check valve preventing the flow of the fluid in one direction in a first state and blocking the flow of the fluid in the same direction in a second state. Specifically, the valve may be or may comprise a flap valve, comprising at least one hinged flap as a valve member. Other options, however, are also feasible, such as other types of check valves, as will be outlined in further detail below.

[0028] Consequently, the term “control”, as used in the context of the valve, is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to the influencing of the amount of the flow of the fluid through the valve. Specifically, the controlling may be or may comprise switching between a first state in which the flow of the fluid is prevented, specifically in a flow direction, a state which may also be referred to as a closed state, and a second state in which the flow of the fluid is enabled, specifically in the flow direction, a state which may also be referred to as an open state.

[0029] As outlined above, the valve comprises at least one valve member having a default closed position preventing a flow of the pharmaceutical compound through the channel and an open position permitting a flow of the pharmaceutical compound through the channel. The term “valve member” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a movable element or a combination of movable elements of a valve which may be moved from a closed position preventing a flow of fluid into an open position permitting a flow of the fluid. Depending on the driving force acting on the valve member, various types of valves may be distinguished and may be used in the context of the present invention. Thus, specifically, the at least one valve may be or may comprise at least one passive valve in which a pressure difference between a first side and a second side of the valve is used as a driving force for driving the at least one valve member, specifically a pressure difference in the liquid between the extraocular port and the intraocular port. Thus, specifically, the valve may be a passive valve which opens when the pressure at the extraocular port is greater than the pressure at the intraocular port or, at least, when the pressure difference between the extraocular port and the intraocular port exceeds a pressure threshold. Additionally or alternatively, the valve may also be an active valve, in which the movement of the valve member is driven by at least one force other than a pressure difference, such as a spring force and / or a magnetic force, as will be outlined in further detail below. As discussed above, the valve is configured such that the closed position of the valve member is the default position, specifically when implanted and exposed to physiological conditions. The term “default position” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to the position which is taken by an object in absence of external forces, such as in absence of external forces other than forces exerted when implanted and exposed to physiological conditions. Specifically, in the default position may be the position of the valve member which is present when no opening pressure difference exerted by an operator acts on the valve member and / or which is present when no external spring force or magnetic force acts on the valve member. The valve may be in the default position, i.e. in the closed position, when a pressure difference between the intraocular pressure and the ambient pressure or air pressure acts on the valve, specifically with the intraocular pressure being greater than the ambient pressure or air pressure. An opening force may be exerted by an operator exerting an external force onto the valve, such one or more of a mechanical force, a hydraulic force and a magnetic or electromagnetic force.

[0030] Specifically, the state in which the port device and / or valve is at the end of manufacturing, i.e. before it is implanted, may correspond to the default position or any other functional state of the valve. Thus, in a pre-implanted or pre-inserted state, the valve may be in an open state or, alternatively, in a closed or semi-closed state.

[0031] The valve member is configured to be reversibly brought from the closed position into the open position by exerting an opening force onto the valve. As outlined above, the opening force specifically may be an external opening force. Thus, the external opening force, as an example, may be the force exerted onto the valve, specifically the valve member, by one or more of the fluid to be controlled by the valve, a spring, a magnetic force. Examples will be outlined in further detail below.

[0032] The port device specifically may be configured for being fully or partially inserted into the intraocular space, subcutaneously or transcutaneously through at least one skin of the eye, with the definition of the term “skin” as given above. As an example, the port device may be inserted into at least one scleral opening of the sclera, with the circumferential flange attaching the port body of the port device to a rim of the scleral opening, and with at least one insertable portion protruding into the intraocular space beneath the sclera. Thus, generally, the port body may comprise at least one insertable portion which, in the inserted state, protrudes into the intraocular space, specifically from the circumferential flange. The insertable portion specifically may fully or partially be made of at least one biocompatible material and / or may be coated with at least one biocompatible material. The length of the insertable portion, e.g. a length of extension along an axis of insertion and / or a longitudinal axis of the porch device, e.g. a length measured starting with the circumferential flange, may, as an example, not exceed 15 mm, specifically may not exceed 10 mm. Thus, as an example, the length of the insertable portion may be 5 mm to 10 mm.

[0033] The port body specifically may fully or partially be made of at least one rigid material. The term “rigid” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to the material of an object which does not deform macroscopically under the influence of its own gravity, e.g. with the dimension tolerance of less than 5% in any dimension, specifically with a dimension tolerance of less than 1%. Specifically, the material may be or may comprise at least one of a rigid plastic material, more specifically at least one rigid thermoplastic material. As an example, one or more of polyethylene, polypropylene, polymethyl methacrylate and / or derivatives thereof may be used. Further, additionally or alternatively, elastomeric materials may be used, such as resins or silicones. Further, additionally or alternatively, one or more metals may be used, such as titanium and / or stainless steel. Thus, generally, the at least one rigid material specifically may be or may comprise at least one of a plastic material, specifically a thermoplastic material; a metal, specifically titanium and / or stainless steel.

[0034] The port body specifically may have an elongated shape, specifically a straight shape with an axis of extension, e.g. an axis of extension parallel to the channel. More specifically, the port body may have an essentially rotationally symmetric shape, more specifically a shape having a rotational symmetry about an axis of rotation essentially parallel to the channel. Thus, as an example, in a plane perpendicular to the axis of extension, the port body may have a cross-section selected from the group consisting of a circular cross-section, and oval cross-section and a polygonal cross-section, such as a rectangular or hexagonal cross-section.

[0035] As outlined above, various types of valves are feasible and may be implemented in the present invention. Specifically, the valve may be selected from the group consisting of a flap valve comprising at least one valve flap; a diaphragm check valve; a swing check valve; a duckbill valve; a reed valve; a check valve comprising at least one spring-biased valve member, specifically at least one spring-biased ball- or otherwise-shaped valve member. The valve member generally may have an arbitrary shape and may be configured for preventing the flow of the liquid pharmaceutical compound by sealing the port device in various ways. Thus, in the closed position, at least one sealing surface of the valve member may rest upon at least one sealing surface of the port body, such as on at least one flat sealing surface and / or at least one conical ceiling surface. The valve member may generally have the shape e.g. of a sealing plate, a plunger, a round shape, a conical shape or any other shape configured for providing a sealing surface of the valve member.

[0036] The valve member may be a member which is performed separate from the port body. However, alternatively, the valve member may also at least partially be formed integrally with the port body, specifically as a structural component of the port body protruding from the port body, more specifically as a valve flap being integrally formed with the port body. Thus, the port body and the valve member may be formed of the same material and / or may be formed in one and the same manufacturing step, such as in a molding step. As an example, the valve member may comprise a valve flap hinged to the port body via at least one material bridge allowing for a pivoting of the valve flap about at least one axis, wherein the port body, the valve flap and the material bridge forming the hinge may be formed integrally.

[0037] The port device may further comprise at least one intraocular reservoir fluidically connected to the channel, such that the pharmaceutical compound may be introducible through the channel into the reservoir. Thus, as an example, the port device may comprise a cavern into which the pharmaceutical compound may be fed through the channel. The cavern, as an example, may be closed towards the intraocular space by at least one closing member which may be permeable by the pharmaceutical compound or by at least one component thereof. Thus, generally, the intraocular reservoir may comprise at least one permeable membrane which may be configured such that the pharmaceutical compound may permeate through the membrane into at least one intraocular fluid in the intraocular space.

[0038] As outlined above, the flange specifically may comprise at least one protrusion, specifically at least one protrusion extending along the outer circumferential surface of the port body. The protrusion specifically may be or may comprise at least one annular protrusion, forming a closed or interrupted ring along the circumferential surface of the port body. The shape of the protrusion, thus, may be adapted to the circumferential surface of the port body. Thus, as an example, the annular protrusion may have a circular, and oval or a polygonal shape. The flange may comprise exactly one annular protrusion which may, in the inserted state of the port device, be located inside or outside the intraocular space. Alternatively, however, the flange may also comprise more than one annular protrusion. Thus, the flange may comprise at least one extraocular annular protrusion and at least one intraocular annular protrusion. Both protrusions may have one and the same shape or may have differing shapes. Thus, as an example, the shape of the extraocular annular protrusion and the shape of the intraocular annular protrusion, independently, each may be selected from the group consisting of a circular shape, and oval shape or a polygonal shape. Other shapes, however, are also feasible. When the flange comprises at least one extraocular annular protrusion and at least one intraocular annular protrusion, the rim of the scleral opening may be embeddable between the extraocular annular protrusion and the intraocular annular protrusion. Thus, in the inserted state, the tissue of the eye into which the port device is inserted may be embedded in between the extraocular annular protrusion and the intraocular annular protrusion.

[0039] The valve specifically may be made of at least one at least partially flexible material, specifically at least one elastic material. The term “flexible” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to the property of a material or a body of being deformable by exerting an external force, such as a compression or expansion, and resuming, at least widely and taking into account the option of hysteresis, its original shape when the external force is removed. The at least one flexible material may be a flexible material selected from the group consisting of a plastic material, such as a thermoplastic and / or elastomeric material, and a metal. The flexible property of the valve may, at least partially, be used for holding the valve member in the default closed position. Thus, generally, the valve may be configured such that the opening force to be exerted to bring the valve member from the closed position into the open position is a force exerted against a spring force exerted by the flexible material. When the opening force is removed, the spring force of the flexible material may act as a restoring force and may move the valve member back into the default closed position.

[0040] As outlined above, the valve member specifically may be configured such that the valve opens due to a pressure gradient between the extraocular port of the port device and the intraocular port of the port device. Thus, the valve may open when the pressure difference between the pressure at the extraocular port of the port device and the pressure at the intraocular port of the port device exceeds a threshold, wherein the threshold may be determined by the properties of the valve, such as by the closing force exerted by a spring element of the valve and / or by a closing force exerted by a spring force exerted by the valve itself, e.g. due to the elastic properties of the valve. Additionally or alternatively, the opening force required for opening the valve may be determined by the geometry of the valve. The valve may comprise at least one element exerting a closing force onto the valve member such that the valve member, in absence of external forces or pressure, is in the default closed position. This closing force may be exerted by the valve member itself, such as by flexible properties of the valve member, e.g. by using one or more elastic materials. Additionally or alternatively, however, the valve may also comprise at least one spring element biasing the valve member, specifically a spring element urging the valve member into the closed position. The spring element, as an example, may be made of at least one metallic material. Additionally or alternatively, however, one or more polymer materials may also be used. The at least one spring element, as an example, may be selected from the group consisting of a coil spring; a cantilever spring; an arc spring; a volute spring; a balance spring; a leaf spring; a V-spring. Other types may be used alternatively or in addition. The spring element, as an example, may abut, at one end, on at least one abutment surface provided by the port body and, at another end, may abut directly or indirectly on the valve member. The valve member, by the spring element, may be pressed onto at least one sealing surface of the valve and / or of the port body. As outlined above, the spring element may be configured such that an opening pressure is set by a spring force of the spring element, e.g. a pressure threshold to be exceeded by the pressure difference between the pressure at the extraocular port of the port device and the pressure at the intraocular port of the port device for the valve to open.

[0041] As outlined above, the opening force to be exerted to bring the valve member from the closed position into the open position may be a hydraulic force exerted by the liquid pharmaceutical compound itself. Additionally or alternatively, however, other kinds of external forces may be exerted onto the valve member in order to bring the valve member from the closed position into the open position. Thus, as an example, one or more of mechanical, electrical and magnetic forces may be exerted. As an example, the valve member may fully or at least partially be made of at least one magnetic material. The term “magnetic material” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a material which is capable of being influenced by a magnetic field, such as of being attracted and / or repulsed by a magnetic field. More specifically, the magnetic material may be or may comprise at least one of a paramagnetic material and a ferromagnetic material. Thereby, the valve member, as will be outlined in further detail below, may be influenced by external magnetic forces, such as by an applicator device exerting and attracting and / or repelling magnetic force onto the magnetic material of the valve member. The external magnetic force onto the valve member may provide the opening force or a part thereof, for opening the valve. Thus, as will be outlined in further detail below, the applicator device may apply an opening force in the form of a magnetic force to the valve member, in order to open the valve.

[0042] As outlined above, the valve may be located in various positions of the port device. Specifically, the valve may be located in the channel of the port device. Therein, the at least one valve may be located at the intraocular port and / or at the extraocular port of the port device. More specifically, a location at the intraocular port within the channel is possible, such that, as an example, a pressure may be exerted by the pharmaceutical compound via the channel onto the valve located at the intraocular port.

[0043] In a further aspect, a kit for introducing at least one liquid pharmaceutical compound into at least one intraocular space is proposed. The kit comprises: at least one port device as described and proposed herein, such as according to any one of the embodiments described above and / or according to any one of the embodiments described in further detail below, and at least one applicator device, wherein the applicator device is configured to engage with the port device and wherein the applicator device is configured to introduce the pharmaceutical compound into the intraocular space through the port device.

[0044] The term "kit" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an assembly of a plurality of components, wherein the components each may function and may be handled independently from each other, wherein the components of the kit may interact to perform a common function.

[0045] The term "applicator device" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a basically arbitrary device configured for applying at least one material or a component to at least one object or other device. More specifically, the applicator device may generally refer to a device configured for applying, by itself or in conjunction with one or more other elements such as one or more syringes and / or pumps, at least one liquid to an object or a device. The applicator device is configured to introduce the pharmaceutical compound into the intraocular space through the port device, specifically by injecting the pharmaceutical compound into the intraocular space through the port device. For this purpose, as an example, the applicator device may comprise at least one hydraulic pumping or transporting device, such as one or more of a syringe, a pump and a hydraulic piston. Additionally or alternatively, however, the applicator device may also be configured for interacting with one or more external application devices, such as one or more external syringes and / or one or more external pumps. Thus, as an example, the applicator device may be configured for providing a connection between a syringe and the port device. Other options are feasible.

[0046] The applicator device is configured to engage with the port device. Specifically, the applicator device may be configured for engaging with the port device at the extraocular port. For the purpose of engagement, the applicator device and / or the port device may comprise one or more engagement elements, also referred to as coupling elements, such as corresponding engagement elements, specifically for a mechanical engagement, such as one or more of a form fit and a force fit connection between the applicator device and the port device. Specifically, the applicator device may comprise at least one first engagement element, and the port device may comprise at least one second engagement element, wherein the first and second engagement elements are configured for engaging with one another, specifically for forming a mechanical connection, e.g. for aligning the applicator device to the porch device and vice a versa, for introducing the pharmaceutical compound, from the applicator device, via the port device, into the intraocular space. The engagement specifically may be a releasable engagement, such that the applicator device, after introducing the pharmaceutical compound into the intraocular space, may be removed from the port device. As an example, the first and second engagement elements may be configured for forming one or more of a bayonet connection, a clip connection, a screw connection, a plug-in connection or the like.

[0047] As already outlined above, the applicator device may also, besides introducing the pharmaceutical compound, be responsible for the opening of the valve of the porch device. Thus, specifically, the applicator device may be configured for exerting the external opening force onto the valve of the port device for reversibly bringing the valve member from the closed position into the open position. Therein, the applicator device may be configured for exerting the external opening force automatically when the applicator device engages with the port device. Additionally or alternatively, however, the applicator device may also comprise at least one trigger element configured for triggering the exertion of the external opening force. As an example for applying the external opening force, the applicator device specifically may comprise at least one magnetic device for exerting a magnetic force onto the valve member, wherein, in this case, the valve member specifically may comprise the at least one magnetic material. The applicator device may comprise at least one channel through which the pharmaceutical compound may be applied. Specifically, the applicator device may comprise at least one through channel for providing the pharmaceutical compound through the through channel to the extraocular port of the port device when the activation device is engaged with, specifically attached to, the port device.

[0048] As outlined above, the applicator device and / or the port device may each comprise, independently, one or more engagement elements, also referred to as coupling elements. Thus, specifically, the applicator device may comprise at least one coupling element configured for engagement with the port device, specifically at least one self-centering coupling device. Additionally and correspondingly, the port device may comprise a corresponding coupling element configured for engaging with the coupling element of the applicator device.

[0049] As outlined above, the applicator device may be a passive applicator device, configured for providing an interconnection between an actual applicator for providing pressurized liquid pharmaceutical compound and the port device, or may also, alternatively, be an active applicator device comprising an actuator for pressurizing the liquid pharmaceutical compound and for providing the pressurized pharmaceutical compound to the port device. Thus, specifically, the applicator device may comprise at least one syringe. Additionally or alternatively, however, other types of actuators may be used, such as one or more pumps or the like.

[0050] In a further aspect, a method of introducing at least one liquid pharmaceutical compound into at least one intraocular space of an eye is proposed. The method uses the kit according to the present invention, such as according to any one of the embodiments described above and / or according to any one of the embodiments described in further detail below.

[0051] The method comprises the following method steps, which specifically may be performed in the given order. However, generally, also another order of the method steps may be envisaged. Further, two or more or even all of the method steps may be performed simultaneously and / or overlapping in time. Further, one, more than one or even all of the method steps may be performed repeatedly, once or several times. The method may comprise additional method steps which are not listed below.

[0052] The method comprises the following steps: i. inserting the port device into a scleral opening of the eye; ii. engaging the applicator device with the port device; iii. actuating the applicator device in order to introduce the pharmaceutical compound into the intraocular space through the port device.

[0053] For further details, options and definitions, reference may be made to the description of the port device and to the description of the kit as given above.

[0054] In a further aspect, a use of the port device and / or of the kit according to the present invention, such as according to any one of the embodiments described above and / or according to any one of the embodiments described in further detail below, is proposed. Therein, the port device and / or the kit are proposed to be used for a purpose of use selected from the group consisting of a treatment of wet macular degeneration, specifically age-related wet macular degeneration; a treatment of glaucoma; a treatment of intraocular bleeding; a treatment of retinal detachment; a treatment of presbyopia; a treatment of cataract; a treatment of uveitis.

[0055] The port device, the kit, the method and the use as proposed herein provide a large number of advantages over known devices and methods of similar kind. Specifically, the port device may be designed without any septum or membrane to be perforated. Thus, the port device may be designed free of any one membrane or septum. Instead, a barrier between the intraocular and the extraocular space may be provided by the at least one valve of the port device. Thus, a perforation for introducing the liquid pharmaceutical compound into the intraocular space is generally not necessary. The avoiding of frequent perforations, thus, may extend the life time of the port device, since destructive processes may be avoided.

[0056] Further, without the need of a sharp needle to penetrate a septum, the risk for accidental injury is reduced. Further, specifically but not limited to implementations where the valve is realized by a flap as part of the port device body, production processes and accordingly costs may be reduced. Also, the reduction of the number of materials used in such an embodiment may improve the biocompatibility of the device.

[0057] Further, the functioning of the valve, the reliability of the valve and the lifetime of the valve may be adapted to the actual needs. Thus, the functioning of the valve may be supported either by one or more active components exerting a dedicated force onto the valve member, such as by one or more spring mechanisms and / or a magnet, and / or passively using e.g. a pressure difference between the eye and a surrounding space as a source of the force exerted onto the valve, e.g. an opening and / or a closing force. Specifically, the valve may be opened by a positive pressure difference, with a pressure at the extraocular port being higher than at the intraocular port. Thereby, as opposed to e.g. valves used for glaucoma treatment and for intraocular pressure reduction, the port device may be closed when the pressure at the intraocular port and / or in the intraocular space is higher than or equal to the pressure at the extraocular port. Further, by balancing the forces, a precise adjustment of a pressure threshold for introducing the liquid pharmaceutical compound is generally feasible.

[0058] Summarizing and without excluding further possible embodiments, the following embodiments may be envisaged:

[0059] Embodiment 1 : A port device for introducing at least one liquid pharmaceutical compound into at least one intraocular space, the port device comprising: a. a port body providing at least one channel fluidically connecting at least one extraocular port of the port device with at least one intraocular port of the port device; b. at least one circumferential flange for attaching the port body to a rim of a scleral opening; c. at least one valve for controlling a flow of the pharmaceutical compound through the channel, the valve comprising at least one valve member having a default closed position preventing a flow of the pharmaceutical compound through the channel and an open position permitting a flow of the pharmaceutical compound through the channel, wherein the valve member is configured to be reversibly brought from the closed position into the open position by exerting an opening force, specifically an external opening force, onto the valve.

[0060] Embodiment 2: The port device according to the preceding embodiment, wherein the port body comprises at least one insertable portion protruding into the intraocular space.

[0061] Embodiment 3 : The port device according to any one of the preceding embodiments, wherein the port body at least partially is made of at least one rigid material, specifically of at least one rigid plastic material, more specifically of at least one rigid thermoplastic material.

[0062] Embodiment 4: The port device according to any one of the preceding embodiments, wherein the port body has an essentially rotationally symmetric shape, more specifically a shape having a rotational symmetry about an axis of rotation essentially parallel to the channel. Embodiment s: The port device according to any one of the preceding embodiments, wherein the valve is selected from the group consisting of a flap valve comprising at least one valve flap; a diaphragm check valve; a swing check valve; a duckbill valve; a reed valve; a check valve comprising at least one spring-biased valve member, specifically at least one spring-biased ball-shaped valve member.

[0063] Embodiment 6: The port device according to any one of the preceding embodiments, wherein the valve member at least partially is formed integrally with the port body, specifically as a structural component of the port body protruding from the port body, more specifically as a valve flap being integrally formed with the port body.

[0064] Embodiment 7: The port device according to any one of the preceding embodiments, further comprising at least one intraocular reservoir, wherein the intraocular reservoir is fluidi- cally connected to the channel, such that the pharmaceutical compound is introducible through the channel into the reservoir.

[0065] Embodiment 8: The port device according to the preceding embodiment, wherein the intraocular reservoir comprises at least one permeable membrane, wherein the permeable membrane is configured such that the pharmaceutical compound may permeate through the membrane into at least one intraocular fluid in the intraocular space.

[0066] Embodiment 9: The port device according to any one of the preceding embodiments, wherein the flange comprises at least one extraocular annular protrusion and at least one intraocular annular protrusion, specifically such that the rim of the scleral opening is embeddable between the extraocular annular protrusion and the intraocular annular protrusion.

[0067] Embodiment 10: The port device according to any one of the preceding embodiments, wherein the valve is at least partially made of at least one flexible material.

[0068] Embodiment 11 : The port device according to the preceding embodiment, wherein the valve is configured such that the opening force to be exerted to bring the valve member from the closed position into the open position is a force exerted against a spring force exerted by the flexible material. Embodiment 12: The port device according to any one of the preceding embodiments, wherein the valve member is configured such that the valve opens due to a pressure gradient between the extraocular port of the port device and the intraocular port of the port device.

[0069] Embodiment 13: The port device according to any one of the preceding embodiments, wherein the valve comprises at least one spring element biasing the valve member, specifically a spring element urging the valve member into the closed position.

[0070] Embodiment 14: The port device according to the preceding embodiment, wherein the spring element is configured such that an opening pressure is set by a spring force of the spring element.

[0071] Embodiment 15: The port device according to any one of the preceding embodiments, wherein the valve member is at least partially made of at least one magnetic material.

[0072] Embodiment 16: The port device according to any one of the preceding embodiments, wherein the valve is located in the channel at the intraocular port.

[0073] Embodiment 17: A kit for introducing at least one liquid pharmaceutical compound into at least one intraocular space, comprising: at least one port device according to any one of the preceding embodiments, and at least one applicator device, wherein the applicator device is configured to engage with the port device and wherein the applicator device is configured to introduce the pharmaceutical compound into the intraocular space through the port device.

[0074] Embodiment 18: The kit according to the preceding embodiment, wherein the applicator device is configured for exerting the external opening force onto the valve of the port device for reversibly bringing the valve member from the closed position into the open position.

[0075] Embodiment 19: The kit according to any one of the preceding embodiments referring to a kit, wherein the applicator device comprises at least one magnetic device for exerting a magnetic force onto the valve member.

[0076] Embodiment 20: The kit according to any one of the preceding embodiments referring to a kit, wherein the applicator device further comprises at least one through channel for providing the pharmaceutical compound through the through channel to the extraocular port of the port device when the activation device is engaged with, specifically attached to, the port device.

[0077] Embodiment 21 : The kit according to any one of the preceding embodiments referring to a kit, wherein the applicator device comprises at least one coupling element configured for engagement with the port device, specifically at least one self-centering coupling device.

[0078] Embodiment 22: The kit according to any one of the preceding embodiments referring to a kit, wherein the applicator device comprises at least one syringe.

[0079] Embodiment 23: A method of introducing at least one liquid pharmaceutical compound into at least one intraocular space of an eye, the method using the kit according to any one of the preceding embodiments referring to a kit, the method comprising: i. inserting the port device into a scleral opening of the eye; ii. engaging the applicator device with the port device; iii. actuating the applicator device in order to introduce the pharmaceutical compound into the intraocular space through the port device.

[0080] Embodiment 24: A use of the port device according to any one of the preceding embodiments referring to a port device, for a purpose of use selected from the group consisting of: a treatment of wet macular degeneration; glaucoma treatment; a treatment of intraocular bleeding; a treatment of retinal detachment; a treatment of presbyopia; a treatment of cataract; a treatment of uveitis.

[0081] Short description of the Figures

[0082] Further optional features and embodiments will be disclosed in more detail in the subsequent description of embodiments, preferably in conjunction with the dependent claims. Therein, the respective optional features may be realized in an isolated fashion as well as in any arbitrary feasible combination, as the skilled person will realize. The scope of the invention is not restricted by the preferred embodiments. The embodiments are schematically depicted in the Figures. Therein, identical reference numbers in these Figures refer to identical or functionally comparable elements.

[0083] In the Figures: Figures 1 A and IB show a first embodiment of a port device comprising a flap valve in a closed position (Figure 1 A) and in an open position (Figure IB);

[0084] Figure 2 shows a second embodiment of a port device comprising an elongated insertable portion and a valve located at an intraocular port of the elongated insertable portion;

[0085] Figures 3 and 4 show third and fourth embodiments of a port device comprising spring-biased valves;

[0086] Figure 5 shows an embodiment of a kit comprising a port device and an applicator device; and

[0087] Figure 6 shows a flowchart of an embodiment of a method of introducing at least one liquid pharmaceutical compound into at least one intraocular space of an eye.

[0088] Detailed description of the embodiments

[0089] In Figures 1 A and IB, a first embodiment of a port device 110 is shown in a cross-sectional view, in different configurations. Therein, Figure 1 A shows the port device 110 in a closed configuration, and Figure IB shows the port device 110 in an open configuration. These Figures, and the following, will be described in conjunction.

[0090] The port device 110 is configured for introducing at least one liquid pharmaceutical compound from an extraocular space 112 into an intraocular space 114 of an eye, e.g. through a sclera 116 of the eye. The port device 110, for this purpose, is configured for being inserted into a scleral opening 118.

[0091] The port device 110, comprises a port body 120, which, as an example, may be made of at least one thermoplastic material. Other materials, however, are also feasible. The port body 120 provides a channel 122 fluidically connecting an extraocular port 124 of the port device 110 with an intraocular port 126 of the port device 110.

[0092] Further, the port device 110, comprises a circumferential flange 128 on an outer surface of the port body 120. The circumferential flange 128 is configured for attaching the port body to a rim of the scleral opening 118. In the embodiment shown in Figures 1A and IB, the circumferential flange 128 comprises an extraocular annular protrusion 130 and an intraocular annular protrusion 132. The rim of the scleral opening 118 is embeddable in between the extraocular and intraocular annular protrusions 130, 132, in order to fixedly mount the port device 110 in the scleral opening 118.

[0093] The port device 110 further comprises a valve 134 for controlling a flow of the pharmaceutical compound through the channel 122. The valve 134 comprises at least one valve member 136. In the embodiment shown in Figures 1A and IB, the valve 134 specifically may be embodied as a flap valve, with the valve member 136 being embodied as a hinged flap 138, which, as an example, may be connected via a hinge 140, the port body 120. More specifically, the port body 120, the flap 138 and the hinge 140 may be made from the same material, e.g. monolithically.

[0094] In the closed configuration of the port device 110 shown in Figure 1A, the valve member 136 is in its default closed position preventing a flow of the pharmaceutical compound through the channel 122. For this purpose, the valve member 136 is pressed, by a closing force, against at least one sealing surface 142, which, as an example, may be formed by a ring-shaped surface in the port body 120. The closing force, as an example, may be exerted via the hinge 140, e.g. by elastic properties of the at least one material from which the port body 120, the hinge 140 and the valve member are made. Thereby, in absence of external forces, the valve member 136 may be held in the closed position. Additionally or alternatively, when the intraocular pressure is higher than the surrounding pressure, the intraocular pressure may press the valve member 136 onto the sealing surface 142.

[0095] In Figure IB, an open configuration of the port device 110 is shown. In this open configuration, the valve member 136 is in an open position, in which the valve member 136 does not rest on the sealing surface 142, thereby permitting a flow of the pharmaceutical compound through the channel 122. The valve member 136 is configured to be reversibly brought from the closed position of Figure 1 A into the open position of Figure IB by exerting an opening force, specifically an external opening force, onto the valve 134. The opening force may counteract the closing force described above. In this embodiment shown in Figures 1 A and IB, the opening force may be an external opening force exerted by the liquid pharmaceutical compound itself, as symbolically indicated by “Ap” in Figure 1 A. Thus, as an example, when a pressure difference between the extraocular space 112 and the intraocular space 114 exceeds a threshold, which, as an example, may be determined by the elastic properties of the materials of the valve 134, the valve 134 may open, permitting the liquid pharmaceutical compound to enter the intraocular space 114.

[0096] In Figure 2, a second embodiment of the port device 110 similar to the embodiment of the port device 110 in Figures 1A and IB is shown in a cross-sectional view. Thus, widely, reference may be made to the description of Figures 1 A and IB above, specifically with reference to the common features. The port device 110 shown in Figure 2 comprises an elongated insertable portion 144 protruding into the intraocular space 114, e.g. protruding from the flange 128. This embodiment, as an example, may permit a part of an applicator device 146 to enter the port body 120. The port device 110 and applicator device 146, together, may form an embodiment of a kit 150. The applicator device, which is schematically depicted in Figure 2, may, as an example, comprise one or more of a pointed, a non-pointed or otherwise shaped needle or syringe. The elongated insertable portion 144 specifically may ease the alignment of the applicator device 146. The applicator device 146 may be configured to engage with the port device 110. Further, the applicator device 146 is configured to introduce at least one pharmaceutical compound into the intraocular space 114 through the port device 110 specifically by providing the external opening force for the valve 134 or by exerting the required opening force via the pharmaceutical compound, thereby opening the valve 134.

[0097] In Figure 3, a third embodiment of the port device 110 is shown in a cross-sectional view. The embodiment of the port device 110 shown in Figure 3 is similar to the embodiment of the port device 110 in Figure 2. Thus, widely, reference may be made to the description of Figures 1A, IB and 2 above, specifically with reference to the common features. The port body 120 in the embodiment shown in Figure 3, again, provides a channel 122 fluidically connecting an extraocular port 124 of the port device 110 with an intraocular port 126 of the port device 110. Further, the port device 110 comprises a circumferential flange 128 on an outer surface of the port body 120. The valve 134 for controlling a flow of the pharmaceutical compound through the channel 122 comprises a spring-biased valve member 148, specifically a spring-biased ball-shaped valve member 136, biased e.g. by a spring element 149, e.g. a coil-shaped spring element. In a closed configuration, as shown in Figure 3, the spring- biased valve member 148 is pressed onto a sealing surface 142, thereby blocking the flow through the extraocular port 124. As soon as a sufficient opening pressure is exerted onto the spring-biased valve member 148, e.g. via the pharmaceutical compound, the valve 134 may be brought into an open configuration and the spring-biased valve member 148 may be lifted off from the sealing surface 142, thereby opening the channel 122. The properties of the spring element 149, as an example, may define a pressure threshold for a sufficient opening pressure.

[0098] In Figure 4, a fourth embodiment of the port device 110 is shown in a cross-sectional view. This fourth embodiment of the port device 110 is similar to the embodiment of the port device 110 in Figure 3. Thus, widely, reference may be made to the description of Figures 1A, IB and 2 above, specifically with reference to the common features. The valve 134 for controlling a flow of the pharmaceutical compound through the channel 122, in the embodiment shown in Figure 4, comprises an inverted spring-biased valve member 148, specifically an inverted spring-biased ball-shaped valve member 136, biased by a spring element 149. In a closed position, the spring-biased valve member 148 is pressed onto a sealing surface 142 blocking the flow through the intraocular port 126. The valve member 136 may at least be partially made of at least one magnetic material.

[0099] For the embodiment shown in Figure 4, an applicator device 146 for exerting the external opening force onto the valve 134 of the port device 110 for reversibly bringing the valve member 136 from the closed position into the open position may be required. The applicator device is not depicted in Figure 4. Reference may be made, as an example, to the embodiment shown in Figure 5 below. Additionally or alternatively, the valve 134 may be configured to open if the intraocular pressure is higher than the surrounding pressure and the pressure resulting from the required force to compress the spring.

[0100] In Figure 5, an embodiment of a kit 150 for introducing at least one liquid pharmaceutical compound into at least one intraocular space 114 is shown in a cross-sectional view. The kit 150 comprises a port device 110 and an applicator device 146. The applicator device 146 is configured to engage with the port device 110. The applicator device 146 is configured to introduce the pharmaceutical compound into the intraocular space 126 through the port device 110. The applicator device 146 may additionally be configured for exerting an external opening force onto the valve 134 of the port device 110 for reversibly bringing the valve member 136 from the closed position into the open position. Specifically, the applicator device 146 may comprise at least one magnetic device 152 for exerting a magnetic force onto the valve member 136, specifically a spring -biased ball-shaped valve member 136, wherein the valve member 136 is at least partially made of at least one magnetic material. The valve 134, in Figure 5, is shown in an open configuration.

[0101] The applicator device 146 specifically may comprise at least one coupling element 153 configured for engagement with the port device 110. Thus, specifically, the coupling element 153, as shown in Figure 5, may comprise a sleeve or collar configured to mechanically engage with the port device 110, specifically with the port body 120. As an example, the coupling element 153 may be designed and / or dimensioned to form a reversible force-fit or form-fit connection.

[0102] In Figure 6, a method of introducing at least one liquid pharmaceutical compound into at least one intraocular space 114 of an eye is shown. The method makes use of a kit 150 for introducing at least one liquid pharmaceutical compound into at least one intraocular space 114, such as according to any one of the embodiments described above, e.g. according to the embodiment shown in Figure 5. The method comprises the following steps, e.g. in the give order: i. in a step 154, inserting the port device 110 into a scleral opening 118 of the eye; ii. in a step 156, engaging the applicator device 146 with the port device 110; and iii. in a step 158, actuating the applicator device 146 in order to introduce the phar- maceutical compound into the intraocular space 114 through the port device 110.

[0103] For further details and possible embodiments, reference may be made to the description of the various embodiments of the port device 110 and / or of the kit 150 given above.

[0104] List of reference numbers port device extraocular space intraocular space sclera scleral opening port body channel extraocular port intraocular port flange extraocular annular protrusion intraocular annular protrusion valve valve member flap hinge sealing surface insertable portion applicator device spring-biased valve member spring element kit magnetic device coupling element inserting the port device engaging the applicator device actuating the applicator device

Claims

Claims1. A port device (110) for introducing at least one liquid pharmaceutical compound into at least one intraocular space (114), the port device (110) comprising: a. a port body (120) providing at least one channel (122) fluidically connecting at least one extraocular port (124) of the port device (110) with at least one intraocular port (126) of the port device (110); b. at least one circumferential flange (128) for attaching the port body (120) to a rim of a scleral opening (118); and c. at least one valve (134) for controlling a flow of the pharmaceutical compound through the channel (122), the valve (134) comprising at least one valve member (136) having a default closed position preventing a flow of the pharmaceutical compound through the channel (122) and an open position permitting a flow of the pharmaceutical compound through the channel (122), wherein the valve member (136) is configured to be reversibly brought from the closed position into the open position by exerting an opening force.

2. The port device (110) according to the preceding claim, wherein the valve (134) is selected from the group consisting of a flap valve comprising at least one valve flap (138); a diaphragm check valve; a swing check valve; a duckbill valve; a reed valve; a check valve comprising at least one spring-biased valve member (148).

3. The port device (110) according to any one of the preceding claims, wherein the valve member (136) at least partially is formed integrally with the port body (120).

4. The port device (110) according to any one of the preceding claims, wherein the flange (128) comprises at least one extraocular annular protrusion (130) and at least one intraocular annular protrusion (132).

5. The port device (110) according to any one of the preceding claims, wherein the valve (134) is at least partially made of at least one flexible material.

6. The port device (110) according to the preceding claim, wherein the valve (134) is configured such that the opening force to be exerted to bring the valve member (136) from the closed position into the open position is a force exerted against a spring force exerted by the flexible material.

7. The port device (110) according to any one of the preceding claims, wherein the valve (134) comprises at least one spring element (149) biasing the valve member (136).

8. The port device (110) according to any one of the preceding claims, wherein the valve member (136) is at least partially made of at least one magnetic material.

9. The port device (110) according to any one of the preceding claims, wherein the valve (134) is located in the channel (122) at the intraocular port (126).

10. A kit (150) for introducing at least one liquid pharmaceutical compound into at least one intraocular space (114), comprising: at least one port device (110) according to any one of the preceding claims, and at least one applicator device (146), wherein the applicator device (146) is configured to engage with the port device (110) and wherein the applicator device (146) is configured to introduce the pharmaceutical compound into the intraocular space (114) through the port device (110), wherein the applicator device (146) is configured for exerting the external opening force onto the valve (134) of the port device (110) for reversibly bringing the valve member (136) from the closed position into the open position, wherein the applicator device (146) comprises at least one magnetic device (152) for exerting a magnetic force onto the valve member (136).

11. The kit (150) according to the preceding claim referring to a kit (150), wherein the applicator device (146) further comprises at least one through channel (122) for providing the pharmaceutical compound through the through channel (122) to the extraocular port (124) of the port device (110) when the activation device is engaged with the port device (110).

12. The kit (150) according to any one of the preceding claims referring to a kit (150), wherein the applicator device (146) comprises at least one coupling element (153) configured for engagement with the port device (110).

13. The kit (150) according to any one of the preceding claims referring to a kit (150), wherein the applicator device (146) comprises at least one syringe.

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