WO2023139468A2 - Devices and methods for injecting medication substances towards a target site in a body tissue - Google Patents

Abstract

An injection device has a longitudinal axis X that defines distal and proximal axial directions. The device also includes a needle that extends at least initially along or generally parallel to axis X, and the device further includes an abutment member at its distal side and the needle. The needle being movable to project in a distal direction beyond the abutment member along an axis T that is inclined relative to longitudinal axis X.

Description

DEVICES AND METHODS FOR INJECTING MEDICATION SUBSTANCES TOWARDS A TARGET SITE IN A BODY TISSUE

TECHNICAL FIELD

[001] Embodiments of the invention relate to devices and methods for injecting medication substances towards a target site in a body tissue, for example beneath a tissue layer and/or towards a space between two tissue layers.

BACKGROUND

[002] Medication substances, such as drugs protein based substances (and the like) may be injected by physicians towards various target sites within the body Some examples may include target sites between the dermis and the hypodermis, muscles below the facial skin (or the like). A medication substance such as botulinum toxin injected for example towards muscles under facial wrinkles is used for relaxing those muscles and smoothing the overlying skin.

[003] Target sites within the eye provide a further example. Ophthalmic drug delivery for example is typically administrated by injecting such medication substances into the eye with a needle, and has been found to be a useful method for treating many retinal diseases, such as diabetic retinopathy, neovascular age-related macular degeneration (AMD), retinal vein occlusion (and the like).

[004] This method is advantageous in providing a confined delivery of medications to a targeted site, as the needle can directly pass through the anatomical eye barrier (e.g. cornea, conjunctiva), while in turn minimizing unintended drug effects to other body tissues.

[005] The suprachoroidal space (SCS) is one example of a site within the eye that can be targeted in an ophthalmic drug delivery procedure. The SCS is a space that can be formed between the sclera and the choroid, and therefore can be used for targeting e.g. the choroid, retinal pigment epithelium and retina, while substantially avoiding penetration of such medication substances to other regions of the eye.

[006] US2010152646 provides an example of an intravitreal injection device that includes a cutting and spreading mechanism. This device can be applied to an eye surface during an intravitreal injection procedure in order to provide an access window free of the conjunctival layer and through which an injection needle can be inserted.

SUMMARY

[007] The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope.

[008] In a broad aspect, various injection device embodiments of the present invention may be defined as being suitable for injecting medication substances towards a target site within, in-between and/or beneath a tissue layer.

[009] The examples mainly discussed herein may be seen relating to ophthalmic injection devices, which are suitable for injecting medication substances such as drugs towards a target site within the eye, however the majority of the discussed embodiments may be also suitable for administrating medication substances in relation to other body tissues, such as towards skin layers, muscles below the facial skin (or the like).

[010] In an embodiment there is provided an injection device having a longitudinal axis X generally defining distal and proximal axial directions and comprising a needle member that extends at least initially along or generally parallel to axis X, the device further comprising a pair of abutment members at its distal side, wherein the abutment members are movable one in relation to the other from a gathered state where they are closer together towards an expanded where they are spaced and spread apart one in relation to the other, and wherein a distal tip of the needle member being movable to project in a distal direction beyond the abutment members at least in their expanded state.

[Oi l] In an embodiment there is also provided an injection device having a longitudinal axis X generally defining distal and proximal axial directions and comprising a needle member that extends at least initially along or parallel to axis X before extending towards a relative distal tip of the needle member along an axis T that is inclined relative to axis X.

[012] In yet a further embodiment there is provided a method for administrating a medication substance into a target layer within an eye that comprises the steps of: providing an injection device having a longitudinal axis X generally defining distal and proximal axial directions and comprising a needle member that extends at least initially along or parallel to axis X towards a relative distal tip of the needle member, the device further comprising a pair of abutment members at its distal side, engaging the conjunctiva of the eye with the abutment members while orienting the device such that its axis X is generally oriented in a way that pressure applied via the device along axis X onto the eye is generally countered by the backwards support provided by the eye socket, urging the abutment members to stretch the conjunctiva by moving them one in relation to the other from a gathered state where they are closer together towards an expanded where they are spaced and spread apart one in relation to the other, and advancing the needle member to penetrate the eye and position the distal tip of the needle member within the target layer of the eye.

[013] In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the figures and by study of the following detailed descriptions.

BRIEF DESCRIPTION OF THE FIGURES

[014] Exemplary embodiments are illustrated in referenced figures. It is intended that the embodiments and figures disclosed herein are to be considered illustrative, rather than restrictive. The invention, however, both as to organization and method of operation, together with objects, features, and advantages thereof, may best be understood by reference to the following detailed description when read with the accompanying figures, in which:

[015] Fig. 1A schematically shows an injection device in accordance with various embodiments of the present invention being used for administrating a medication substance towards a target site within a patient’s body tissue, in this example within a skin tissue;

[016] Fig. IB schematically shows an injection device in accordance with various embodiments of the present invention being used for administrating a medication substance towards a target site within a patient’s eye, hence being embodied in the example as an ophthalmic injection device;

[017] Fig. 2A and 2B schematically show respective non-exploded and partial exploded perspective side views of an embodiment of an injection device generally similar to the ones seen in Figs. 1A and IB;

[018] Fig. 3 A and 3B schematically show a perspective side view and a top view of the injection device seen in Figs. 2A and 2B, with the top view of Fig. 4 showing the injection device targeting an eye of the patient;

[019] Fig. 4A and 4B schematically show stopper and a lower side of a syringe of an embodiment of the injection device;

[020] Fig. 5A and 5B schematically show respective bottom views of an embodiment of an injection device with the view of Fig. 6B being shown in partial cross section;

[021] Fig. 6A to 6C schematically show a terminal region of a needle member of an injection device in accordance with various embodiments of the present invention, during different stages of penetration into a tissue layer;

[022] Figs. 7A to 7C schematically show assembled and partial exploded views of an injection device embodiment generally similar to the one shown in the former figures;

[023] Fig. 8 schematically shows a distal region of an injection device embodiment; [024] Figs. 9A and 9B schematically show a possible embodiment of an injection device with a needle having a pre-formed curvature;

[025] Figs. 10A and 10B schematically show another possible embodiment of a needle of an injection device that includes a flexible portion that is attached to a more rigid tip portion;

[026] Figs. 11A and 11B schematically show an injection device in accordance with another embodiment of the present invention, that as seen in Fig. 11A is approaching an eye to be treated and hence being embodied as an ophthalmic injection device;

[027] Figs. 12A, 12B, 13A, 13B, 13C, 114A, 14B, 15A, 15B, 16 and 17 schematically show an injection device, such as that seen in Fig. 1, during various stages of operation;

[028] Fig. 18 schematically shows an injection device in accordance with various embodiments of the present invention, during a treatment step of an eye;

[029] Fig. 19 schematically shows an injection device in accordance with yet a further embodiment of the present invention, during a treatment step of an eye;

[030] Figs. 20A, 20B, 21A, 21B, 22A and 22B schematically show an injection device, such as that seen in Fig. 15, during various stages of operation;

[031] Fig. 23 schematically shows an embodiment of an injection device in accordance with yet another embodiment of the present invention; and

[032] Figs. 24A and 24B schematically show a distal vicinity of an injection device in accordance with yet another embodiment of the present invention.

[033] It will be appreciated that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals may be repeated within the figures to indicate like elements. DETAILED DESCRIPTION

[034] Attention is drawn to Fig. 1A schematically showing an injection device 1100 in accordance with various embodiments of the present invention being used for administrating a medication substance towards a target site within a patient’s body tissue, in this example within a skin tissue.

[035] Examples of such target sites within a skin tissue may include sites between the dermis and the hypodermis, muscles below the facial skin (or the like). A medication substance such as botulinum toxin injected e.g. towards muscles under facial wrinkles can be used for relaxing those muscles and smoothing the overlying skin.

[036] Attention is additionally drawn to Fig. IB schematically showing an injection device (similar to device 1100 seen in Fig. 1A and hence being indicated with same numeral). Injection device 1100 in accordance with various embodiments of the present invention may be used for administrating a medication substance towards a target site within a patient’s eye, hence being embodied in this example as an ophthalmic injection device.

[037] It is noted that in a broad aspect, various injection device embodiments of the present invention that are disclosed herein - may be defined as being suitable for injecting medication substances towards a variety of target sites within, in-between and/or beneath one or more body tissue layers.

[038] It is noted that while the examples mainly discussed herein below may be seen as relating to ophthalmic injection devices, which are suitable for injecting medication substances such as drugs towards a target site within the eye, the majority of the discussed embodiments may be also suitable for administrating drugs in relation to other body tissues, such as towards skin layers, muscles below the facial skin (or the like).

[039] Due to the costly nature of medication substances that may be used in such procedures and, e.g. in the case of an ophthalmic injection device, due to the widths and dimensions of the eye layers that may be targeted (which may be in the range of about 100 micron in width in certain cases), design considerations of the various injection device embodiments disclosed herein may be tailored for accurate and precise targeting of such target sites with the required medication substance doses.

[040] Attention is drawn to Figs. 2A and 2B schematically showing respective non-exploded and partial exploded perspective side views of an embodiment of an injection device 1100 generally similar to the ones seen in Figs. 1A and IB.

[041] Injection device 1100 is generally formed along a longitudinal axis X defining proximal and distal axial directions, and includes a main body 1101 generally formed about axis X. In Fig. 2B a side portion 11012 of the main body 1101 is shown removed - revealing a syringe member 1102 that is fitted at its barrel 11021 to the main body in a maimer that permits the barrel to be axially slidable relative to the body through an axial passage 11011 that is formed within the body.

[042] The syringe member in this example includes a widening 11022 at a relative distal side of the barrel and a flange 11023 at an upper proximal side of the barrel. The injection device further includes an actuator 1103 that is secured in this example at its proximal side to the barrel’s flange with a resilient member 8 of the device (here in form of a compression spring) being located between an inner proximal side of the actuator (here below the syringe’s flange) and the syringe’s body. [043] Actuator 1103 as seen in this example at least partially surrounds an upper proximal region of the device’s main body 1101 and is adapted to axially slide along the outer side of the main body. A plunger 11024 of the syringe member projects in a proximal direction through the actuator 1103 away from the syringe’s barrel.

[044] The injection device further includes a needle member 1005 attached to a distal side of the syringe member. The needle member 1005 at its proximal side includes a hub 11050 with guiding means 10051 that are aimed at resisting rotation of the needle member about axis X as it is urged to slide along same axis X. In this example, the guiding means 10051 are formed as axially extending wing members that project radially outwards away from axis X and hub 11050.

[045] Injection device 1100 in Fig. 2B is also seen including a stopper 1104 at a distal lower side of main body 1101. With attention additionally drawn to Fig. 3 A, stopper 1104 can be seen here being formed at its lower distal side with a thread 10041 that is threadingly engaged within a corresponding thread formed at a distal lower side the main body 1101. Rotation of the stopper in opposing directions about axis X is arranged to respectively lower or elevate the axial location of stopper within the lower side of the main body

[046] Stopper 1104 also includes at its upper side a toggle 11042 with markings, which as seen in Fig. 2A can be exposed to an exterior of the injection device here through a window 11013 formed at a relative lower distal side of the side portion 11012 of device’s body. A physician or operator using the injection device may manually rotate the stopper via toggle 111042 in order to lower or elevate its location. [047] With attention still drawn to Fig. 3A, needle member 1005 can be seen projecting with its needle 10055 in a distal direction away from a distal end 10052 (see visible in Fig. 4A) of the needle member’s hub 11050. The needle 10055 in its distal extension outside of the main body passes through a curved guiding channel 11061 (see visible in Fig. 5B) formed within an abutment member 1106 of the injection device, which is located at a distal lower side of the injection device.

[048] The curved guiding channel 11061 is adapted towards its end to extend along a generally straight section to direct a terminal region 24 of the needle 10055 to extend (also on its route outside of the guiding channel) along an axis T that is transverse and/or inclined to the central axis X of the device. This extension along axis T may be along a vector direction that extends in combination generally in the axial distal direction and also towards a given one of the lateral sides ‘Ls’ of the device.

[049] The needle 10055 may be threaded through a low friction tube (not shown) that is located within guiding channel 11061. The low friction tube (e.g. made from Teflon or the like) may facilitate smooth passage of the needle through the guiding channel as it is urged to moved and slide there through. The needle may be formed in one example from nitinol.

[050] Attention is drawn to Fig. 4A and 4B showing (see Fig. 4A) the needle 1105 that is fitted to the lower side of the syringe member. The stopper 1104 as seen in the cross section at the left-hand side of Fig. 4B has in this example a generally upward open cup shape formation for receiving therein from above a distal lower side of the needle member.

[051] A floor 11043 with an aperture 11044 at its center is located in this example at a distal lower side of the stopper’s cup shape formation - and the needle member is adapted when being urged to axially slide within the injection device, to distally move until it engages the stopper’s floor 11043 with its distal end 10052, while the needle 10055 projects in the distal direction beyond the stopper via aperture 11044.

[052] With attention drawn to Figs. 5A and 5B, abutment member 1106 can be seen including an axial distal facing abutment face 11062. The abutment face 11062 may be formed to have a shape that generally corresponds to the outer shape of the body part or tissue that the injection device is intended to be used for injecting medication substances therein.

[053] In the case where the injection device is intended for use e.g. for administrating medication substances into an eye tissue, the abutment face 11062 (at least in a cross section including or parallel to axes X and Y) may be designed to follow a general radius Rb by having e.g. a generally concave cylindrical or spherical or conical shape. The abutment member 1106 as seen may also be provided with a cut-away face 11063 formed at a lateral side of the abutment member, which may be as seen in this example at an opposite side to the given lateral side ‘Ls’ towards which axis T slants. A marking line 11064 may be formed at an intersection between cutaway face 11063 and abutment face 11062. It is noted that cut-away face 11063 (and consequently marking line 11064) may also formed at other lateral sides of the abutment member, such as at those generally parallel to an imaginary surface including axes X and T in these views.

[054] As seen in Fig. 3B, this marking line 11064 may assist a physician in certain cases in positioning the injection device at a desired position with respect to observed body structures 999 in order to reach a targeted layer within a body tissue in proximity to such structures. In this example, where the targeted layer may be the choroid, which is located within the eye - such as an observed body structure 99 may be the limbus. [055] The abutment member may possibly further be formed with a viewing port 11065 that is generally located at the given lateral side ‘Ls’ of the device. The viewing port 11065 in embodiments where the abutment member is formed from transparent material may be formed from said same transparent material in order to provide to a physician using the injection device a glancing view (see ‘dashed’ arrow in Fig. 5B) towards the area where the tip of the needle is arranged to eject the medication substances.

[056] An upper viewing face Vf of the viewing port may be designed to be generally parallel to axis T along which the terminal region 24 of the needle 10055 extends or moves. Viewing port 11065 may thus be aimed at reducing reflections that may obscure views of the needles tip, and in cases where viewing face Vf is generally parallel to axis T may assist in reducing the angle of incidence between the line of sight of the physician towards the needle’s tip (see ‘dotted line’ in Fig. 5A) as it passes through the viewing face Vf.

[057] Finally, the abutment member 1106 may be formed with one or more barb members 11066, preferably two or more of such barb members, which distally project beyond the abutment face 11062. The barb members 11066 may be formed at the opposing lateral side to lateral side ‘Ls’ in order to resist stretching/movement of the tissue through which the needle penetrates as it extends out of abutment face 11062 along axis T.

[058] Attention is drawn to Figs. 6A to 6C showing a terminal region 24 of a needle 10055 of an injection device in accordance with various embodiments of the present invention, during different stages of penetration into body tissue layers. The explanation here provided is similar to explanations provided further below with respect to the needles of the injection device embodiments shown in Figs. 20A, 20B, 22A, 22B, 24A and 24B - and hence is generally a repetition of those discussions with respect to the needle structures and usage during penetration into tissue layers.

[059] In Fig. 6 A the injection device can be seen approaching a target area of a body tissue with its abutment face 11062 leading, while Fig. 6B shows the injection device already abutting and bearing against the target area of the body tissue with abutment face 11062. The biasing contact of abutment face 11062 that bears against the targeted body tissue - is arranged to urge the body tissue (and possibly tissue layers immediately below it) to conform to radius Rb of the abutment face 11062.

[060] As indicated in Fig. 6 A, axis T along which the terminal region 24 extends is tilted or inclined by an angle “beta” relative to the central axis X of the injection device. In other words, rotation of the injection device about axis X can be defined as forming with its axis T an imaginary coned surface that tapers upwardly (proximally) towards an apex O of the cone where axes X and T intersect, where said cone is defined as having a cone angle of “beta” between axes X and T.

[061] The needle 10055 can be seen including an internal channel 77 that opens out at a distal aperture 33 of the channel, and an internal bevel angle “alpha” of a chamfer formed at a tip of the needle is defined in a cross sectional plane that includes axis T and is perpendicular to the chamfer plane. Such angle “alpha” can be seen being formed as a generally small angle, e.g. smaller than about 45 degrees and preferably smaller than about 25 or possibly 15 degrees.

[062] As seen in Figs. 6A and 6B, the distal tip of the needle as it advances towards a targeted layer 1 for example of the choroid, initially exposes its sharped edged tip in this example towards the outer side in this example of the sclera 2 in a position/orientation suitable for penetrating into the sclera.

[063] As seen in Fig. 6C, as the needle advances along axis T within the sclera 2 towards the targeted layer 1 of the choroid, the chamfer of the tip reaches targeted layer 1 (and/or a position within this ~100 micron thin layer 1 in the example of it being the choroid) at a position where it is generally tangent to layer 1. In this position the needle is suited to release medication substances towards and/or into the targeted layer 1 with reduced likelihood of penetrating unintentionally through layers beyond targeted layer 1 such as the retina (or more precisely the RPE layer between the retina and choroid) - since its sharp edge is accordingly now less positioned in an ideal orientation to penetrate layer 1 (and in particular in this example retina 6). The aforementioned stopper may assist in setting a limit for the needle to not advance too much, e.g. to a position where in may penetrate into the retina 6. [064] It is noted that the guiding means 10051, which resist rotation of the needle member about its axis - assist in ensuring that the tip of the needle is located initially with its sharped edged tip exposed towards the outer side of the body tissue in a position suitable to penetrate through it, and when reaching the targeted layer - in a position generally tangent to the targeted layer suitable for releasing medication substances towards this layer, while avoiding further penetration though the targeted layer.

[065] Since in injection device 1100 the curvature of the body tissue to be treated is generally dictated by radius Rb of abutment face 11062 that bears against the body tissue - an additional parameter of the body tissue that should preferably be known in order to successfully reach a targeted layer within the body tissue, is the thickness of penetration into the body to reach the targeted layer.

[066] In an example where the eye is the body tissue to be treated as seen in Figs.

6A to 6C - this may mean obtaining thickness W of the sclera 2 in order to assist in deriving a travel distance Td that the needle should preferably advance in its terminal region 24 along axis T beyond abutment face 11062 - to position aperture 33 of the device’s needle generally adjacent and/or within the targeted layer 1 e.g. of the choroid. Additional structural parameters that may assist in obtaining travel distance Td may include the device’s angle “beta”.

[067] Thickness W of penetration into the body tissue may be obtained in various techniques, such as by Optical Coherence Tomography (OCT) imaging, by a pachymeter device, by Ultrasound Biomicroscopy (UBM) technique (or the like).

[068] Arriving at the travel distance Td may be obtained in various ways, such as by inserting the discussed parameters into the following equation.

[070] In the following discussion, the operation of injection device 1100 will be described. Injection device is designed to be held by a physician with at least one hand engaging the device’s actuator 1103. The biasing member 8 that is located inbetween main body 1101 and the actuator 1103 - is arranged to urge the actuator together with the syringe member in an upward proximal direction until the syringe’s widening 11022 reaches the narrower entry into passage 11011 to stop this upward motion. In this position, the injection device is maintained in a non-activated state ready for use.

[071] An initial step of operating the injection device may be performed by first positioning the stopper of the device at a position defined by the travel distance Td that is expected in order to reach the targeted layer. This may be performed by manipulating the stopper’s toggle according to the desired travel distance Td.

[072] After this initial step, the device’s abutment member 1106 may be urged to a position over a target location where injection is planned to take place. A physician operating the device may glance through viewing port 11065 to ensure that the injection device is suitably placed over the target site where injection of the medication substance is intended.

[073] Once in place, activation of injection may start by urging the actuator in the distal direction in order to press the injection device towards the target site. The distal relative movement of the actuator against the biasing means 8 urges the barrel of the syringe member to move/slide together with it in the distal direction within main body until the distal end 11026 of the syringe member engages the floor of the stopper 1004. This in turn urges the needle to advance along axis T out and beyond the abutment face 11062 towards the target site within the body tissue.

[074] Once this step has been accomplished and the needle’s tip is in place, the physician - while holding the actuator pressed towards the patient - may urge the syringe’s plunger in the distal direction relative to the barrel and by that urge the medication substance within the syringe’s barrel to be emitted out of the needle’s tip towards the target site.

[075] By releasing the pressure applied upon the actuator, the physician may allow the actuator to be biased back upwards by the biasing means together with the barrel of the syringe member and the needle member that is attached to the syringe. This motion allows the needle to be retreated backwards until its tip reaches a position proximal to abutment face 11062 where it does project not project in the distal direction beyond the abutment face 11062. [076] Attention is drawn to Figs. 7A to 7C showing assembled (Fig. 7A) and partial exploded (Figs. 7B and 7C) views of an injection device embodiment generally similar to the one shown in the former figures.

[077] In this embodiment, the syringe member 1102 and actuator 1103 can be seen forming a sub-assembly that is detachable from the remainder of the device that here includes the main body 1101 of the device and the needle member 1105, stopper 1104 (and the like).

[078] This injection device embodiment may facilitate drawing of medication substances into the syringe member when detached, and then fitting the syringe member into the remainder of the device to assume an assembled state of the device ready for use, where the syringe member is secured (e.g. via a lure lock or the like) within main body 1101 and fitted at its distal end to the needle member.

[079] In this optional example a removable safety lock 1008 may be seen being placed between the needle member and the stopper 1104 while the syringe member is manipulated into its position within the assembled injection device - in order to avoid unintentional displacement of the needle member in the distal direction that may position it beyond the abutment member of the device during this assembly phase. Once the syringe member is in place, the safety lock 1008 may be removed when the device is to be used. It is noted that other mechanisms, some of which nonremovable, may be equally feasible for functioning as a safety lock. For example, the safety lock may be embodied as a toggle (not shown) that may be toggled between an activated state where it resists unintentional displacement of the needle member in the distal direction and a non-activated state where displacement of the needle member in the distal direction can be performed when the actuator 1103 is pressed in the distal direction against a body tissue.

[080] Attention is drawn to Fig. 8 showing a distal region of an injection device embodiment, illustrating an option where axes X and T may be designed to substantially intersect at the location where the needle is adapted to project out of the abutment member beyond its abutment face 11062. Such a design in certain cases may assist in stability of the device during initial penetration of the needle into a body tissue, due inter alia to axis X along which force is applied towards the body tissue being generally perpendicular to the abutment face at the point of needle penetration into the body tissue.

[081] Figs. 9A and 9B demonstrate a possible embodiment of an injection device where the needle may be formed from relative rigid and inflexible material such as stainless steel. As seen in this example it may be formed with a pre-designed curvature at a distal region thereof. In such a design, urging the needle to penetrate beyond the device’s abutment face along axis T may be seen in this example implemented by providing a slanted face 11067 against which the curved region of the needle is pressed. Face 11067 functions as a rail that guides movement of the needle along a distal inclined direction of axis T.

[082] Figs. 10A and 10B demonstrate another possible embodiment where a needle 10055 may include a flexible more proximal portion 100551 possibly made from flexible material, such as polymeric material (e.g. PET), and a more rigid tip portion 100552 that is attached to its distal end and possibly formed from relative rigid and inflexible material such as stainless steel.

[083] Attention is drawn to Figs. 11A and 11B schematically illustrating an injection device 10 in accordance with another embodiment of the present invention. [084] In is noted that at least certain features described with respect to this embodiment are applicable and common also to other embodiments described herein. [085] As already previously noted, the injection device embodiments described herein may be suitable for injecting medication substances towards a target site within, in-between and/or beneath a tissue layer and may be used in various therapeutic procedures, such as for injecting medication substances towards skin layers, muscles below the facial skin (etc.) - or as seen in this example for ophthalmic drug delivery where drugs and/or other substances may be administrated by injection into specific layers of the eye, such as the suprachoroidal space (SCS) or the like.

[086] As already aforementioned, due to the costly nature of medication substances that may be used in such procedures and, e.g. in the case of an ophthalmic injection device, due to the widths and dimensions of the eye layers that may be targeted (which may be in the range of about 100 micron in width in certain cases), design considerations of the various injection device embodiments disclosed herein may be tailored for accurate and precise targeting of such target sites with the required medication substance doses.

[087] Injection device 10 in the example seen in Figs. 11 A and 11B is shown having a hollow body 12 that extends along an axis X between proximal and distal axial ends 121, 122, and axis X defines a central axis of the body and of the injection device. The injection device has in addition an injection head 27 that includes an insert 14 and a hollow needle member (or needle) 18.

[088] Insert 14 extends through body 12 to position its distal tip adjacent to the body’s distal end 122, preferably distal to the body’s distal end 122 - and the needle member 18, which in this example may optionally be fitted to an internal lumen of the insert - is arranged to project beyond the insert’s distal tip in order to inject medication substances into a target site e.g. within an eye.

[089] Injection device 10 includes in addition a syringe member 16 that extends also generally along axis X with a distal portion thereof within the body 12 of the device. Syringe member 16 is fitted to and extends away from a proximal region of the insert in the proximal direction to extend, inter alia, with its plunger 161 out of the body at its proximal end 121.

[090] With attention briefly drawn to Fig. 13C, an embodiment of a needle member 180 can be seen that is of a microneedle type. Needle member 180 can be fitted to a seat 13 formed at a distal end of the insert 14, and in this case - medication substances communicated from the syringe member to be injected into a patient’s eye via needle member 180 can be arranged to flow towards needle member 180 via a lumen formed within the insert.

[091] Attention is drawn to Fig. 17 illustrating a possible tip formation 5 of such a microneedle type needle member (or needle) 180 located within a targeted layer 1 of an eye where medication substance delivery is required. The needle member 180 that accordingly generally extends in this embodiment along the device’s central axis X can be seen having an internal channel 7 that also extends along axis X to open out at a distal aperture 3 of channel 7 into layer 1.

[092] An internal bevel angle “alpha” of a chamfer formed at a tip of such an axially extending needle member is defined in a cross sectional plane that includes axis X and is perpendicular to the chamfer plane. Such angle “alpha” can be seen being formed to be generally large, for example of about 45 degrees, so that the aperture 3 through which medication substances are ejected out of the needle member may be located substantially within the targeted layer 1 of the eye. An example of such a microneedle may be the MicronJet™ device of NanoPass Technologies Ltd.

[093] Attention is drawn back to Figs. 11A and 11B. A regulator 20, in this example formed as an external ring like member about body 12, may be arranged to control axial movement of the insert 14 relative to the body, and consequently also of the needle member that is fitted to the insert. Such axial movement of the insert (and needle) is arranged, in the example shown, to urge also similar axial movement of the syringe member 16 that is fitted and anchored to the insert’s proximal end.

[094] Injection device 10 includes also two levers 22 here being hinged to the body of the device at respective hinges H. The hinges H and levers 22 are displaced in this example one in relation to the other about axis X by about 180 degrees, to thereby position the levers at opposing lateral sides of the device.

[095] Each lever 22 here has a ring member 221 at its proximal side and an abutment member 222 at its distal side. Possibly each abutment member 222 may be formed with one or more barb members at its distal facing side for engaging an outer side of the body organ to be penetrated during use - such as in this example an eye, e.g. the conjunctiva of the eye.

[096] In addition, each lever may be formed with an engagement portion 223 here at an inner side of the lever facing the body of the device. The engagement portions 223 are arranged to engage and detachably attach to anchoring members 17 that are coupled in this example to an external threaded region 19 of the body.

[097] Attachment of the engagement portions 223 to the anchoring members 17 (see said attachment in the transition from Fig. 14A to Fig. 14B) is arranged to urge the abutment members 222 towards an ‘expanded state’ where the abutment members are spaced and spread apart one from the other. This expanded state may be defined according to an optimal gap G (see G indicated in Fig. 15A) between the abutment member that is required e.g. in order to suitably stretch the conjunctiva of the eye prior to insertion of the needle member into the eye.

[098] The position of the anchoring members 17 may be adjusted along the axis of the device, in this example by a tuning mechanism 23 (see indicated in Figs. 14A and 14B) that interacts in this example with the threaded region 19 of the body. Such adjusted of the location of the anchoring members 17 by tuning mechanism 23 along the device’s axis X may assist in fine tuning an optimal required gap G between the abutment members 222.

[099] In this example, urging the ring members 221 towards each other is arranged to tilt the levers about the hinges H in such a way that the abutment members 222 are urged away from each other towards the ‘expanded state’, and urging the ring members 221 one away from the other is arranged to tilt the levers in such a way that the abutment members 222 are urged towards a ‘gathered state’ where the abutment members 222 are adjacently, possibly touching, one the other.

[0100] Figs. 12A and 12B provide closer views of the abutment members 222 of the device and barb members 15 that are here seen projecting in the distal direction beyond the abutment members. The abutment members 222 in these views are seen in the ‘gathered state’, which is suitable as a first possible step in a procedure for administering a medication substance into a patient’s eye.

[0101] Once in the ‘gathered state’, a subsequent second step of administering medication substances in this example into an eye may be performed as seen in Fig. 13 A by pressing the abutment members of an injection device in accordance with the various embodiments of the present invention - against the sclera of the eye in this example in a region of the sclera that is in between eye muscles.

[0102] After being pressed against the sclera to a position where the barb members of the abutment members are embedded within the conjunctiva, the barb members may be urged towards the ‘expanded state’ as seen in Fig. 13B in order to stretch the conjunctiva to a state that is suitable for penetration by the needle member (or needle).

[0103] Insertion of the needle member through the sclera and into the eye may be performed in this shown example by manipulating the regulator 20 in order to axially advance the insert and needle member in the distal direction. This advancement may be performed and controlled by a physician using the device according to a known distance to a target site within the eye where e.g. a medication substance is intended to be injected.

[0104] Prior measurements performed on an eye to be treated, such as optical coherence tomography (OCT) measurements, may assist in determining the required depth of penetration into the eye. Figs. 15A and 15B illustrate this step of axially advancing the needle member (or needle) towards its target site within the eye.

[0105] Indication that the needle member reached a target site within the eye where medication substance delivery is aimed at - may be provided by observing blood flowing back through the needle member and possibly also the insert. Such emittance of blood may be assisted by capillary forces and by exposing the interior of the needle/insert to the ambient environment via a vent 9 as seen in Fig. 15B.

[0106] One or more windows 11 provided along the needle member and/or insert may assist in observing the presence of the emitted blood, so that a physician can be provided with indication that the needle’s tip reached its desired location within the eye.

[0107] The suprachoroidal space (SCS) is one example of a site (i.e. the mentioned targeted layer 1) within the eye that can be targeted e.g. in an ophthalmic drug delivery procedure performed by the various device embodiments of the present invention. Typically, when the suprachoroidal space (SCS) is reached - blood tends to seep back through the needle member and/or insert as discussed.

[0108] As seen in Fig. 16, once verifying that the target site within the eye has been reached, the plunger of the syringe member may be pressed in order to release the medication substance stored within the syringe member into the eye. [0109] Fig. 18 illustrates a typical orientation that an injection device of the presently disclosed invention may be held by a physician when administering a medication substance into a patient’s eye. An orientating of the axially extending structure of the presently disclosed injection device may be such that it is preferably held with its axis X generally aligned or forming a small angle (e.g. about 10 or 15 degree) with an axis F generally perpendicular to the human’s face. Approaching an eye in such a way may be preferable in particular in treatment procedures where pressure applied onto the eye generally along such an axis F can be countered by the backwards support provided by the eye socket. It is noted that the various injection device embodiments disclosed herein (such as those in Figs. 1 to 6) may be similarly used in such a maimer, where pressure applied by such devices onto the eye may be generally along such an axis F and can be countered by the backwards support provided by the eye socket.

[0110] In an aspect of the present invention, certain embodiments of the present invention may accordingly be directed to injection devices with axially extending structures that include a needle member (or needle) with a tip region that is arranged to penetrate into the eye along an injection axis that is transverse and/or inclined to the device’s central axis.

[0111] Attention is drawn to Figs. 19, 20A and 20B showing an embodiment of an injection device 100 that includes a needle member (or needle) with an example of such a tip region. Elements that are common to both injection device 10 and 100 are marked with similar numerals, with minor modifications (such as the common hinge H in device 100) being applicable to both embodiments.

[0112] Injection device 100 has an injection head 270 that includes a needle member (or needle) 1800, an insert 140 and an angular adjustment mechanism 26 for directing a terminal region 24 of the needle to extend along an axis T that is transverse and/or inclined to the central axis X of the device.

[0113] Angular adjustment mechanism 26 in this example includes three fulcrum members 261, 262, 263. The needle member 1800 has a proximal region that extends generally along axis X and a distal region where it passes between the fulcrum members, which in turn in this example bend the needle member in this region to form the needle’s terminal region 24 that extends along axis T. In this example, one of the fulcrum members 262 is optionally movable in order to adjust the angle of tilt of terminal region 24 relative to the device’s axis X.

[0114] Fig. 20B provides a closer view of a distal vicinity of a device where the terminal region 24 is located. As seen, axis T along which the terminal region 24 extends is tilted or inclined by an angle “beta” relative to the central axis X of the device. In addition, in the enlarged section at the upper side of Fig. 20B, a possible tip formation 55 of needle member (or needle) 1800 can be seen being located within a targeted layer 1 of an eye where medication substance delivery is required.

[0115] The needle can be seen including an internal channel 77 that opens out at a distal aperture 33 of the channel substantially into targeted layer 1. An internal bevel angle “alpha” of a chamfer formed at a tip of the needle is defined in a cross sectional plane that includes axis T and is perpendicular to the chamfer plane. Such angle “alpha” can be seen being formed as a generally small angle, e.g. smaller than about 45 degrees and preferably smaller than about 25 or possibly 15 degrees.

[0116] As seen, the tilting of the terminal region 24 of needle 1800 at angle “beta” relative to the device’s central axis X, assists in locating aperture 33 through which medication substances are ejected out of the needle - in a position where it is substantially located within the targeted layer 1 of the eye. In a non-binging example, needle 1800 may be formed from highly elastic material, such as nitinol, that assists in maintaining the needle within its terminal region 24 extending along a generally straight line, here defined by axis T.

[0117] Attention is drawn to Figs. 24A and 24B illustrating a distal vicinity of an embodiment of a device that includes another form of an angular adjustment mechanism 26. In this embodiment, the angular adjustment mechanism 26 includes an insert 2611, a sway member 2613 and a pendel 2612. The needle 1800 in a section thereof still extending generally along axis X is arranged to pass through the insert 2611 before curving over the pendel 2612 to extend through the sway member 2613 along axis T towards a distal tip thereof. [0118] The needle 1800 in this example is fitted to move with the insert 2611 along axis X such that axial movements activated e.g. by a toggle such as 20, are arranged to control corresponding axial movements of the insert 2611 and consequently also of the needle that is fitted to the insert.

[0119] The needle 1800 is also coupled to a tip region 4 of the pendel 2612 such that the axial movements of the needle 1800 along axis X are arranged to tilt pendel 2612 as indicated by the “dotted” double sided arrow in these figures. Such tilting of pendel 2612 is designed to control suitable curvature of the needle in this region of the angular adjustment mechanism 26 so that it does not exceed a curvature that may cause undesired deformations in the needle.

[0120] In the enlarged section provided in upper right hand side of Fig. 24A, the tip region 4 of the pendel can be seen including two optional convex faces 41, 42 that each bulge towards opposing sides of the needle 1800 (here indicated in dashed lines) in order to provide in this example the mentioned coupling of the tip region 4 with the needle 1800. Such convex faces 41, 42 that taper away from contact with the needle 1800 may assist in providing the needle with suitable “freedom” to pivot and curve and by that assist in further avoidance of such undesired deformations at the needle 1800 as it curves.

[0121] Adjusting angle 0 between axes T and X in this example may be performed by tilling sway member 2613 to the required angle 0 as indicated by the “dashed” double sided arrow provided in Figs. 24A and 24B. Once setting the required angle 0, the needle 1800 may be advanced along axis T as aforementioned by axially moving the needle in a more proximal region thereof along axis X while suitably adjusting/controlling the needle’s curvature via pendel 2612 that continues to advance along axis T while sliding along said direction of axis T through a passage formed within the sway member 2613.

[0122] In the following passages, advancement of a needle that includes a relative small or pointed angle at its distal tip region will be discussed in a broad context relevant to all embodiments including such type of sharped edged needle. Such small or pointed angle “alpha” is typically defined as being smaller than about 45 degrees and preferably smaller than about 25 or possibly 15 degrees. This discussion in addition will be made with respect to an example where the targeted layer 1 is the choroid and the needle penetrates initially through the sclera 2 on route to the choroid. [0123] As seen in the enlarged section at the left hand side of Fig. 24A, the distal tip of the needle as it advances towards its targeted layer 1 of the choroid, initially exposes its sharped edged tip towards the outer side of the sclera 2 in a position/orientation suitable to penetrate into the sclera. As seen in the enlarged section at the left hand side of Fig. 24B, as the needle advances along axis T within the sclera towards the targeted layer 1 of the choroid, the chamfer of the tip reaches targeted layer 1 at a position where it is generally tangent to the choroid. In this position the needle is suited to release medication substances towards the targeted layer of the choroid 1 with reduced likelihood of penetrating unintentionally through and in particular beyond the thin layer of the choroid since its sharp edge is now less positioned in an ideal orientation to penetrate layer 1.

[0124] Attention is drawn back to the injection device 100 as seen in Figs. 19, 21A and 2 IB. Injection device here is seen including a secondary toggle 28, a handle 30 and a movable core 141 that is included within an internal passage of insert 140. Secondary toggle 28 is arranged to advance a stopper 281 along axis X and stopper 281 includes a proximal projecting hook 282. Needle 1800 passes through movable core 141 and is fixed for movement together therewith, and handle 30 is attached to a proximal side of the movable core 141 and is arranged to axially move the movable core 141 and needle 1800 that is attached to it relative to insert 140.

[0125] Adjusting the extent that the needle can advance along axis X and along axis T at its terminal region is controlled by axially adjusting the position of the stopper 281 along axis X via secondary toggle 28. Axially advancing the movable core 141 may be controlled by handle 30, and the needle 1800 can advance until movable core 141 engages stopper 281 and attaches to its hook 282. Once attached to stopper 281, fine tuning of the axial position of the needle can be controlled via secondary toggle 28. [0126] Figs 22A and 22B provide additional views illustrating axial movement of the terminal region of needle along axis T towards a targeted layer 1 within an eye where medication substance delivery is required.

[0127] Dimension of an eye to be treated, such as the scleral 2 radius R and scleral thickness W, at least in some cases may dictate certain structural parameters of an injection device, so that the device may be suitably configured to successfully guide the distal aperture 33 of the device’s needle generally to within the targeted layer 1 of the eye.

[0128] Such structural parameters may include the device’s angle “beta” and the actual length L that the needle should advance in its terminal region 24 along axis T from an imaginary point I where axes X and T intersect to a position where the distal aperture 33 of the device’s needle is generally located within or upon the targeted layer 1 of the eye.

[0129] In order to adapt such structural parameters to the specific eye dimensions to be treated, certain injection device embodiments may accordingly be equipped with adjustment mechanisms for adapting the device to the eye. The injection device 100 shown in Figs. 19 to 18 and 20 provides an example of such an embodiment, where angle “beta” may be adjusted by tilting axis T via angular adjustment mechanism 26 and length L may be controlled via toggle 28.

[0130] In certain embodiments, another approach may be taken to that seen in device 100. Attention is drawn to Fig. 23 showing an embodiment of an injection device 1000 that includes a device holder 1001 and a kit 1002 of several removable heads 1003 that are each suited to provide a certain pre-defined angle “beta”. In this example, each head 1003 includes a toggle, such as toggle 28, for adjusting the length L that the needle may advance along its respective axis T. Such toggle, may in turn be located in other parts of the device such as in the holder.

[0131] Upon determining the dimensions of the eye to be treated, a physician may choose the most suitable head 1003 from the kit 1002 for the subject eye and attach the tip to holder 1001 in order to perform the required procedure. [0132] In the description and claims of the present application, each of the verbs, “comprise” “include” and “have”, and conjugates thereof, are used to indicate that the object or objects of the verb are not necessarily a complete listing of members, components, elements or parts of the subject or subjects of the verb.

[0133] Further more, while the present application or technology has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and non- restrictive; the technology is thus not limited to the disclosed embodiments. Variations to the disclosed embodiments can be understood and effected by those skilled in the art and practicing the claimed technology, from a study of the drawings, the technology, and the appended claims.

[0134] In the claims, the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. A single processor or other unit may fulfill the functions of several items recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures can not be used to advantage. [0135] The present technology is also understood to encompass the exact terms, features, numerical values or ranges etc., if in here such terms, features, numerical values or ranges etc. are referred to in connection with terms such as “about, ca., substantially, generally, at least” etc. In other words, “about 3” shall also comprise “3” or “substantially perpendicular” shall also comprise “perpendicular”. Any reference signs in the claims should not be considered as limiting the scope.

[0136] Although the present embodiments have been described to a certain degree of particularity, it should be understood that various alterations and modifications could be made without departing from the scope of the invention as hereinafter claimed.

Claims

CLAIMS:

1. An injection device having a longitudinal axis X generally defining distal and proximal axial directions and comprising a needle that extends at least initially along or generally parallel to axis X, the device further comprising an abutment member at its distal side and the needle being movable to project in a distal direction beyond the abutment member along an axis T that is inclined relative to the longitudinal axis X.

2. The injection device of claim 1, wherein the abutment member comprises an at least partially concave distally facing abutment face.

3. The injection device of claim 2, wherein in a cross section including axes X and T the abutment face follows a contour defined by a radius Rb.

4. The injection device of claim 2, wherein axes X and T generally intersect at the abutment face.

5. The injection device of claim 1, wherein the needle comprising a proximal section being formed from relative flexible material, for example polymeric material, and a distal tip that is attached to the proximal section that is formed from more rigid material, for example stainless steel.

6. The injection device of claim 2 and comprising a main body and an actuator located at a proximal side of the main body, the device further comprising a syringe member that is slidable through the main body and coupled at its barrel to move together with the actuator.

7. The injection device of claim 6, wherein the needle being coupled to a distal side of the barrel and distal movement of the actuator relative to the main body is configured to urge a tip of the needle to project beyond the abutment face.

8. The injection device of claim 7 and comprising a biasing member located between the main body and the actuator for applying a biasing force acting to urge the actuator and the syringe member in the proximal direction relative to the main body

9. The injection device of claim 8, wherein at least the syringe member, the actuator and the biasing member form a sub-assembly that is detachable at least from the main body and the needle, for example in order to permit filling of the syringe member when in a detached state.

10. The injection device of claim 9 and comprising a safety lock for resisting distal displacement of the needle, for example to avoid unintentional distal displacement of the needle when the sub-assembly is attached to its location in the injection device and to the needle.

11. The injection device of claim 10, wherein the safety lock being configured to be toggled between an activated state where it resists axial displacement of the needle and a non-activated state where distal displacement of the needle is possible.

12. The injection device of claim 2, wherein the inclination of axis T relative to axis X is along vector direction that extends in combination generally downwards and also towards a given one of the lateral sides ‘Ls’ of the device.

13. The injection device of claim 12, wherein the abutment member further comprises a cut-away face at a lateral side of the abutment member that is opposite to the given lateral side ‘Ls’ of the device, wherein the cut-away face generally tapers downwards towards axis X.

14. The injection device of claim 12, wherein the abutment member further comprises a viewing port at the given lateral side ‘Ls’ of the device, wherein the viewing port being formed form transparent material.

15. The injection device of claim 2 and comprising a curved guiding channel formed through the abutment member, wherein moving the needle to project in the distal direction beyond the abutment member comprises moving the needle through the guiding channel.

16. The injection device of claim 15, wherein a distal portion of the curved guiding channel extends along and defines axis T.

17. The injection device of claim 12 and comprising one or more barb members that distally project beyond the abutment face.

18. The injection device of claim 17, wherein the one or more barb members are formed at an opposing lateral side of the abutment face relative to the lateral side ‘Ls’.

19. The injection device of claim 2 and comprising an adjustable stopper for defining a maximal distance that the needle can project beyond the abutment face of the abutment member.

20. The injection device of claim 1 wherein an internal bevel angle of a chamfer formed at a distal tip of needle forms an angle smaller than about 45 degrees and preferably smaller than about 25 or possibly 15 degrees.

21. An injection device having a longitudinal axis X generally defining distal and proximal axial directions and comprising a needle that extends at least initially along or parallel to axis X before extending towards a relative distal tip of the needle along an axis T that is inclined relative to axis X.

22. The injection device of claim 21, wherein the needle comprises an internal throughgoing lumen via which liquid, for example medication substances, can be injected out of the needle.

23. The injection device of claim 22, wherein the distal tip of the needle comprises a chamfer and the internal throughgoing lumen opens out at the tip of the needle at the chamfer.

24. The injection device of claim 23 and comprising an internal bevel angle where the chamfer meets the distal most point of the needle that is a relative small angle typically smaller than about 45 degrees and preferably smaller than about 25 or possibly 15 degrees.

25. The injection device of claims 21, wherein the needle is movable along axis X and therefore also along axis T.

26. The injection device of any claims 21 and comprising an abutment member located at a distal end of the device.

27. The injection device of claim 26, wherein the distal tip of the needle is movable to a position where it projects beyond the distal side of the abutment member.

28. The injection device of claim 27, wherein the abutment member comprises barb members at its distal side.

29. A method for administrating a medication substance into a target layer within a body tissue that comprises the steps of: providing an injection device having a longitudinal axis X generally defining distal and proximal axial directions, the device comprising a needle and an abutment member at its distal end, engaging an outer side of the body tissue with the abutment member, and then urging the needle along axis X to result in the needle penetrating into the body tissue towards the targeted layer along an axis T that is inclined to axis X.

30. The method of claim 29, wherein the abutment member comprises an at least partially concave distal facing abutment face.

31. The method of claim 30, wherein in a cross section including axes X and T the abutment face follows a contour generally defined by a radius Rb.

32. The method of claim 31, wherein urging the abutment face against the body tissue is arranged to urge the body tissue, and possibly tissue layers immediately below it, to generally conform to radius Rb of the abutment face.

33. The method of claim 30 and comprising a main body and an actuator located at a proximal side of the main body, the device further comprising a syringe member that is slidable through the main body and coupled at its barrel to move together with the actuator.

34. The method of claim 33, wherein the needle being coupled to a distal side of the barrel and distal movement of the actuator relative to the main body is configured to urged a tip of the needle to project beyond the abutment face.

35. The method of claim 34 and comprising a biasing member located between the main body and the actuator for applying a biasing force acting to urge the actuator and the syringe member in the proximal direction relative to the main body

36. The method of claim 29 wherein an internal bevel angle of a chamfer formed at a distal sharp edged tip of the needle forms an angle smaller than about 45 degrees and preferably smaller than about 25 or possibly 15 degrees.

37. The method of claim 36 wherein as the needle advances towards the outer side of the body tissue it exposes its sharped edged tip to the outer side of body tissue in a position/orientation suitable for penetrating into the body tissue.

38. The method of claim 36 or 37, wherein as the sharped edged tip reaches the targeted layer its chamfer is at a position where it is generally tangent to the targeted layer.

39. An injection device having a longitudinal axis X generally defining distal and proximal axial directions and comprising a needle that extends at least initially along or generally parallel to axis X, the device further comprising a pair of abutment members at its distal side, wherein the abutment members are movable one in relation to the other from a gathered state where they are closer together towards an expanded where they are spaced and spread apart one in relation to the other, and wherein a distal tip of the needle being movable to project in a distal direction beyond the abutment members at least in their expanded state.

40. The injection device of claim 39, wherein each abutment member comprising one or more barb members at its distal facing side for engaging an eye, e.g. the conjunctiva of the eye, during use.

41. The injection device of claim 40 and comprising a tuning mechanism for fine timing an optimal required gap G between the abutment members.

42. The injection device of claim 39 and being arranged to indicate that the needle reached a target site e.g. within an eye

43. The injection device of claim 42, wherein the indication comprises observing blood flowing back through the needle.

44. The injection device of claim 43, wherein flow of blood back through the needle is assisted by capillary forces and by exposing the interior of the needle to the ambient environment via a vent.

45. The injection device of claim 39 and comprising a regulator for controlling axial movement of the needle.

46. The injection device of claim 39, wherein an internal bevel angle of a chamfer formed at a distal tip of needle forms an angle of about 45 degrees.

47. The injection device of claim 39, wherein an internal bevel angle of a chamfer formed at a distal tip of the needle forms a relative small angle typically smaller than about 45 degrees and preferably smaller than about 25 or possibly 15 degrees.

48. The injection device of claim 47, wherein the needle comprises a distal section that extends towards a relative distal tip of the needle along an axis T that is inclined relative to axis X.

49. The injection device of claim 48, wherein the inclination angle of axis T relative to axis X is adjustable.

50. The injection device of claim 49, wherein adjusting the inclination angle of axis T relative to axis X is by affecting changes in curvature of a section of the needle.

51. The injection device of claim 50, wherein the section of the needle where changes in curvature are affected is located between a more proximal section that generally extends along axis X and a more distal section that defines axis T.

52. An injection device having a longitudinal axis X generally defining distal and proximal axial directions and comprising a needle that extends at least initially along or parallel to axis X before extending towards a relative distal tip of the needle along an axis T that is inclined relative to axis X.

53. The injection device of claim 52, wherein the needle comprises an internal throughgoing lumen via which liquid, for example medication substances, can be injected out of the needle.

54. The injection device of claim 53, wherein the distal tip of the needle comprises a chamfer and the internal throughgoing lumen opens out at the tip of the needle at the chamfer.

55. The injection device of claim 54 and comprising an internal bevel angle where the chamfer meets the distal most point of the needle that is a relative small angle typically smaller than about 45 degrees and preferably smaller than about 25 or possibly 15 degrees.

56. The injection device of claim 55, wherein the inclination angle of axis T relative to axis X is adjustable.

57. The injection device of claim 56, wherein adjusting the inclination angle of axis T relative to axis X is by affecting changes in curvature of a section of the needle.

58. The injection device of claim 57, wherein the section of the needle where changes in curvature are affected is located between a more proximal section that generally extends along axis X and a more distal section that defines axis T.

59. The injection device of claim 52, wherein the needle is movable along axis X and therefore also along axis T.

60. The injection device of claim 52 and comprising a pair of abutment members located at a distal end of the device, wherein the abutment members are movable between an expanded state where the abutment members are spaced and spread apart one from the other and a gathered state where the abutment members are closer one to the other.

61. The injection device of claim 60, wherein the distal tip of the needle is movable to a position where it projects beyond the distal side of the abutment members.

62. The injection device of claim 61, wherein the abutment members comprise barb members at their distal side.

63. The injection device of claim 52, wherein the needle is comprised in a head section that is detachable and removable from a holder section of the device.

64. The injection device of claim 63 and comprising or being associated with a kit comprising several head sections, wherein the needle in each head section extends along an axis T that is inclined in relation to axis X by a unique inclination angle that is different to inclination angles in other head sections.

65. A method for administrating a medication substance into a target layer within an eye that comprises the steps of: providing an injection device having a longitudinal axis X generally defining distal and proximal axial directions and comprising a needle that extends at least initially along or parallel to axis X towards a relative distal tip of the needle, the device further comprising at least one abutment member at its distal side, engaging the conjunctiva of the eye with the at least one abutment member while orienting the device such that its axis X is generally oriented in a way that pressure applied via the device along axis X onto the eye is generally countered by the backwards support provided by the eye socket, and advancing the needle to penetrate the eye along an axis T that is inclined to axis X and position the distal tip of the needle within or adjacent to the target layer of the eye.

66. The method of claim 65, wherein the at least one abutment member is two abutment members and prior to advancing the needle into the eye the method comprising a step of urging the two abutment members to stretch the conjunctiva by moving them one in relation to the other from a gathered state where they are closer together towards an expanded where they are spaced and spread apart one in relation to the other,

67. The method of claim 65 or 66, wherein the distal tip is chamfered and comprises an internal bevel angle where the chamfer meets the distal most point of the needle that is a relative small angle typically smaller than about 45 degrees and preferably smaller than about 25 or possibly 15 degrees.

68. The method of claim 65, wherein the inclination angle of axis T relative to axis X is adjustable.