Patent Application
20240366426
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.
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.
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).
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.
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.
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.
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.
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.
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).
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.
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.
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.
In the present disclosure, it is to be understood that use of the injection device embodiments disclosed herein, typically includes a preparation step of ensuring that substantially no air bubbles are present in liquid medication or substances intended to be administered by the injection device and its syringe.
This may be accomplished by slowly pushing the syringe's plunger to expel air bubbles and a small amount of liquid out of the tip of the injection device's needle, to ensure that the syringe and liquid passages leading to the needle's tip are filled with substantially only the medication to be administered.
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.
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:
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.
Attention is drawn to
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.
Attention is additionally drawn to
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.
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).
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.
Attention is drawn to
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
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 biasing member (or spring) 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.
Actuator 1103 as seen in this example has a shroud 11031 that 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.
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.
Injection device 1100 in
Stopper 1104 also includes at its upper side a toggle 10042 with markings, which as seen in
With attention still drawn to
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 11055 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.
The needle 11055 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.
Attention is drawn to
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 11055 projects in the distal direction beyond the stopper via aperture 11044.
With attention drawn to
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 edge 11064 may be formed at an intersection between cut-away face 11063 and abutment face 11062. It is noted that marking edge 11064 (with or without such intersection with a cut away face) may also be formed at other side edges of the abutment member, such as at those located on opposing ‘normal’ sides of the abutment face (where the ‘normal’ direction being orthogonal to the ‘lateral’ direction). Such a marking edge at a normal side of the abutment member or face may be generally parallel to an imaginary surface including axes X and T in these views (see example provided in
As seen in
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
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 11055 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
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.
Attention is drawn to
In
As indicated in
The needle 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.
As seen in
As seen in
It is noted that various technical measures as disclosed herein, such as the optional guiding means 10051 or bend 87 or glue (or the like), which resist rotation of the needle about its axis—may 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 through the targeted layer.
Since the curvature of the body tissue to be treated may be generally dictated in this example by radius Rb of abutment face 11062 that bears against the body tissue—an additional parameter of the body tissue that may optionally assist in order to successfully reach a targeted layer within the body tissue, may be the thickness of penetration into the body to reach the targeted layer.
In an example where the eye is the body tissue to be treated as seen in
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).
Arriving at the travel distance Td may be obtained in various ways, such as by inserting the discussed parameters into the following equation.
In the following discussion, the operation of the optional example of injection device 1100 will be described. In is noted that the other injection device embodiments disclosed herein may slightly differ in operation and/or in technical elements from injection device 1100, which is here provided as a mere example of one manner of operating of a certain optional embodiment of an injection device.
Injection device is designed in this optional example to be held by a physician with at least one hand engaging the device's actuator such as actuator 1103. The biasing member 8 that is located in-between 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.
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.
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.
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 10052 of the syringe member engages the floor of the adjustable 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.
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.
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 not project in the distal direction beyond the abutment face 11062.
Attention is drawn to
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).
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.
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 non-removable, 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.
Attention is drawn to
As seen in this example, the needle 11077 may optionally be formed with a pre-designed curvature or bend at a distal region thereof defining a generally straight section forming a terminal region 24 of the needle leading to the needle's chamfered or beveled tip. Beveling of the needle's tip and use of the needle by the injection device embodiments seen in
In such a design, urging the needle's terminal region 24 to penetrate via an opening 333 at the abutment face beyond the injection device's abutment face 11062 along axis T may be seen being implemented by providing a generally straight needle guide 11067, here exemplified as an angled generally straight tubular needle guide defining axis T, through which the needle passes as it is urged beyond the device's abutment face. Tubular guide may be a separate guide member placed within the device's distal frame/region for guiding the needle along axis T or may be formed as an integral part of the device.
Needle guide 11067 functions as a rail that guides movement of the needle's terminal region 24 along the distal inclined direction of axis T (as seen e.g. in
Attention is additionally drawn to
In
Attention is drawn to
The axial distance Ad between the stopper and the shroud's distal lower end defines the travel distance Td (see
The outer housing 777 in this example as seen in
A minimal volume connecting tubing 1110, possibly made from silicon, Teflon, thermoplastic PVC (or the like)—can be seen extending in this example optionally through a lumen 1113 formed in pusher 881 to connect at its lower side to an upstream proximal side of needle 11077 and at its upper side to a syringe member (not shown) of or associated with the injection device. The syringe in one optional example may be located at a proximal side of the pusher possibly encased within the shroud 1108 to be moved together with the pusher as it is pressed to urge the needle to protrude beyond the device's abutment face. In other examples, the syringe may be located in other locations.
A first pin 1111 threaded through a distal lower end of the pusher 881 and through the vertical slots 7771v constrains movement of the lower end of the pusher 881 along the vertical slots 7771v and a second pin 1112 threaded through the sliding carriage 883 and through the slanted slots 7771s constrains movement of the sliding carriage 883 along the slanted slots 7771s. The first pin 1111 is also threaded through a first end of the link rod 882 and the second pin 1112 is also threaded through a second opposing end of the link rod 882 in order to link between movements of the push arm 881 and sliding carriage 883.
As seen, in this example the distal lower end of the pusher 881 where first pin 1111 connects the pusher 881 to link rod 882, protrudes slightly in a first lateral direction of the device in order to orient link rod 882 such that it slants downwards and in an opposing lateral direction towards the location where second pin 1112 couples it to sliding carriage 883. Such positioning of first pin 1111 above the second pin 1112 and to its lateral right, together here with the resulting downward slanting link rod 882, assists in promoting movement of the sliding carriage 883 along a direction generally parallel to axis T.
The needle 11077 is fitted here at or adjacent its bend to the sliding carriage 883 so that movement of the sliding carriage 883 generally along an axis T defined by the needle guide 11067—is adapted to move the terminal region 24 of the needle along same axis T.
The needle is fitted to the sliding carriage here with assistance of the bend to maintain the chamfer/bevel formed at the needle's tip in an orientation where it faces distally away from the abutment face of the injection device towards a body tissue it aims to penetrate as seen e.g. in
As seen in the cross section of
Axially urging the pusher 881 in the distal direction is adapted to urge the needle's terminal region 24 via the sliding carriage 883 to advance along axis T to position the needle's distal tip beyond the injection device's abutment face. Retracting the pusher 881 back up in the proximal direction is adapted to urge the needle's terminal region 24 via the sliding carriage 883 to retract back along axis T to position the needle's distal tip at a position where it does not protrude beyond the injection device's abutment face.
Attention is drawn to
This results in movement of the sliding carriage 883 generally along axis T, which is defined by the generally straight needle guide 11067 and in turn in movement of the needle 11077 that is fixed to the carriage along axis T to position its tip at a location beyond the abutment face 11062. The angled generally straight tubular guide 11067, possibly formed as an at least partially covered groove or channel, may be an integral part of the distal region or a separate part embedded within the distal region of the device. A biasing member 1109 is here seen being pressed between a forward side of the sliding carriage 883 and a bearing face 11091 within the device's distal region.
As seen in the cross section of
When pressure applied upon the pusher 881 is released, the biasing member 1109 is adapted to urge sliding carriage 883 back and by that retract also the needle back to a position where its tip does not protrude beyond the abutment face. The retracting sliding carriage 883 is adapted to also urge pusher 881 back up through interaction between the faces 8831, 8811.
Although not shown, a minimal volume connecting tubing such as 1110 is also included in this injection device embodiment for channeling medication substances during activation of the device from a syringe (also not shown) through needle 11077 towards a targeted layer within a body tissue.
Attention is drawn to
Rotating the pinion in a first rotational direction is adapted to urge the sliding carriage 883 generally along axis T, which is defined by a generally straight guide needle 11067 through which the needle passes. The angled generally straight tubular guide 11067, possibly formed as an at least partially covered groove or channel, may be an integral part of the distal region or a separate part embedded within the distal region of the device. The needle 11077, which is fixed to the carriage moves together with it along axis T to position its tip at a location beyond the abutment face 11062.
As seen in the cross section of
Rotating the pinion in a counter second rotational direction is adapted to urge the sliding carriage 883 back and by that retract also the needle back to a position where its tip does not protrude beyond the abutment face. The rotation of the pinion in the counter second rotational direction may be urged by a spring (not shown), possibly a torsion spring wrapped in a coil about the pinion's axis.
Although not shown, a minimal volume connecting tubing such as 1110 is also included in this injection device embodiment for channeling medication substances during activation of the device from a syringe (also not shown) through needle 11077 towards a targeted layer within a body tissue.
Attention is drawn to
As seen in the cross section of
A biasing member 1109 pressed between a forward side of the sliding carriage and a bearing face within the device's distal region, is adapted when pressure applied upon the sliding carriage is released, to urge sliding carriage back together with the needle that is attached thereto—in order to retract it back to a position where its tip does not protrude beyond the abutment face.
As seen by the ‘dashed’ lines added in
Instead, for maintaining the desired orientation, the needle may be fixed to the sliding carriage by other means such as glue (or the like), and in this example a guide 1114 that is possibly fixed at one end e.g. to the sliding carriage and at its other end may be arranged to slide through a bore formed in the device's distal region—may assist in maintaining the suitable preferable orientation of the needle's chamfer during movement of the sliding carriage.
Although not shown, a minimal volume connecting tubing such as 1110 is also included in this injection device embodiment for channeling medication substances during activation of the device from a syringe (also not shown) through needle 11077 towards a targeted layer within a body tissue.
Attention is drawn to
The injector member 1220 may include a needle 11077 (see
The syringe hub member 1210 includes a receiving side 1211 to which a Luer of a syringe (not seen) may be attached and the tubing 1230 connects in this example to a different, here opposing, emitting side 1212 of the syringe hub member, in order to communicate medication substance emitted by a syringe towards the injector member 1220.
A distal terminal region of injector member 1220 has an outer housing 1222 in this example including generally parallel housing faces 12221 (in
Attention is additionally drawn to the cross section of
A lower side of the outer housing is also seen including in this example a concave the abutment face 11062 of the injector member 1220 from which optionally several (here possibly two) barb members may project in the distal direction.
In this embodiment, the injector member 1220 can be seen including an actuating mechanism 88 generally similar e.g. to the one seen and described in
The actuating mechanism 88 accordingly includes a pusher 881, a link rod 882 and a sliding carriage 883. Also seen in this view is the adjustable stopper 1223 against which the shroud 12211 of the actuator 1221 is adapted to engage when being pressed axially distally downwards.
The axial distance Ad between the stopper 1223 and the shroud's 12211 distal lower end defines the travel distance Td (see
Axial distance Ad in the various embodiments disclosed herein may be generally the same or different to travel distance Td depending on the mechanism used for actuating movement of the needle.
A spring 1224 pressed between the adjustable stopper and an upper section of the actuator may be configured to retract the device's needle back so it does not substantially protrude beyond the abutment face when no force is applied downwards upon the actuator e.g. by a physician.
The outer housing 1222 in this example includes two optional generally axially extending parallel vertical slots 7771v each formed in a respective one of the housing faces 12221 and two optional generally parallel slanted slots 7771s each formed in a respective one of the housing faces 12221.
In the cross section of
The minimal volume connecting tubing 1230, possibly made from silicon, Teflon, thermoplastic PVC (or the like)—can be seen extending in this example optionally through a lumen 1113 formed in pusher 881 to connect at its lower side to an upstream proximal side of needle 11077.
A first pin 1111 threaded through a distal lower end of the pusher 881 and through the vertical slots 7771v restricts or constrains movement of the lower end of the pusher 881 along the vertical slots 7771v and a second pin 1112 threaded through the sliding carriage 883 and through the slanted slots 7771s restricts or constrains movement of the sliding carriage 883 along the slanted slots 7771s.
The first pin 1111 is also threaded through a first end of the link rod 882 and the second pin 1112 is also threaded through a second opposing more distal end of the link rod 882 in order to link between movements of the push arm 881 and the sliding carriage 883.
As seen, in this example the distal lower end of the pusher 881 where first pin 1111 connects the pusher 881 to link rod 882, protrudes slightly in a first lateral direction of the device in order to orient link rod 882 such that it slants downwards and in an opposing lateral direction towards the location where second pin 1112 couples it to sliding carriage 883. Such positioning of first pin 1111 above the second pin 1112 and to its lateral right hand side, together here with the resulting downward slanting link rod 882, assists in promoting movement of the sliding carriage 883 along a direction generally parallel to axis T.
The needle 11077 is fitted here at or adjacent its bend 87 to the sliding carriage 883 so that movement of the sliding carriage 883 generally along an axis T defined by the generally straight needle guide 11067—is adapted to move the terminal region 24 of the needle along same axis T.
The needle is fitted to the sliding carriage here with assistance of the bend to maintain the chamfer/bevel formed at the needle's tip in an orientation where it faces distally away from the abutment face of the injection device towards a body tissue it aims to penetrate as seen e.g. in
As seen in the cross section of
Axially urging the pusher 881 in the distal direction is adapted to urge the needle's terminal region 24 via the sliding carriage 883 to advance along axis T to position the needle's distal tip beyond the injection device's abutment face. Retracting the pusher 881 back up in the proximal direction is adapted to urge the needle's terminal region 24 via the sliding carriage 883 to retract back along axis T to position the needle's distal tip at a position where it does not substantially protrude beyond the injection device's abutment face.
Attention is drawn to
Here the injector member 10220 is positioned to direct its needle when protruding beyond its abutment face, to extend along axis T in a posterior direction of the eye in order to direct medication substances e.g. generally towards the eye's macula.
With attention drawn to
In this example, the injection device can be seen having a marking edge 11064 (such as the one seen and discussed with respect e.g. to
In this view, the injection device is oriented relative to the eye by abutting the eyeball's outer side with its abutment face and placing one of its marking edges 11064 generally tangent to the eye's limbal ring (which here serves as an observed body structure 999).
Also indicated in
In this example, the ‘latitudinal’ line 753 being indicated generally passes through the opening in the device's adjustment face through which the device's needle is designed to protrude towards its targeted layer within the eye along axis T.
Along such a ‘latitudinal’ line the width of the eye's sclera is typically generally similar. As a result, orienting the device to protrude its needle into the eye generally tangent to such a ‘latitudinal’ direction provides a higher degree of certainty for a physician operating the injection device as to the depth to which the device's needle needs to penetrate into the eye in order to reach with its tip a targeted layer within the eye, such as the choroid that is beneath the sclera. Introducing a needle into this region of the eye adjacent the limbal ring as seen (e.g. about 3 mm from the limbal ring) is also a relatively safer target for various ophthalmic procedures.
Attention is drawn to
The injector member 1320 may include a needle 11077 that may be formed from relative rigid and inflexible material such as stainless steel. Such a relative rigid needle may be understood as meaning a hypodermic needle, which is commonly used in medical settings and is designed to penetrate the body tissue and/or underlying tissues.
The syringe hub member 1310 accordingly includes a receiving side 1311 to which a Luer of a syringe (not seen) may be attached and the tubing 1330 connects in this example to a different, here opposing, emitting side 1312 of the syringe hub member to communicate medication substance emitted by such a syringe towards the injector member 1320.
A distal terminal region of injector member 1320 has an outer housing 1322 in this example including generally parallel housing faces 13221 (in
As best seen in the cross section of
A lower side of the outer housing is also seen including in this example a concave abutment face 11062 of the injector member 1320 from which optionally several barb members may project in the distal direction.
In this embodiment, the injector member 1320 can be seen including an actuating mechanism 88. While actuating mechanism 88 may be generally similar e.g. to the one seen and described in
As seen in the cross section of
With attention additionally drawn to the exploded cross sectional view of
In the embodiment of
A spring 1324 (see
The outer housing 1322 in this example includes two optional generally axially extending parallel vertical slots 7771v each formed in a respective one of the housing faces 13221 and two optional generally parallel slanted slots 7771s each formed in a respective one of the housing faces 13221. In the cross section of
The minimal volume connecting tubing 1330, possibly made from silicon, Teflon, thermoplastic PVC (or the like)—may extend within housing 1322 to connect at its lower side to an upstream proximal side of the needle 11077.
The link rod 882 as seen in this embodiment includes two linkage bars 8821. Each linkage bar 8821 as seen couples via a living hinge 21 at its upper side to the pusher 881 and at its lower side to the sliding carriage 883.
A first pin 1111 threaded through a distal lower end of the pusher 881 and through the vertical slots 7771v restricts or constrains movement of the lower end of the pusher 881 along the vertical slots 7771v and a second pin 1112 threaded through the sliding carriage 883 and through the slanted slots 7771s restricts or constrains movement of the sliding carriage 883 along the slanted slots 7771s.
Such positioning of first pin 1111 above the second pin 1112 and to its lateral right hand side hand side, assists in promoting movement of the sliding carriage 883 along a direction generally parallel to axis T.
The needle 11077 includes a bend 87 and is fitted at said bend to the sliding carriage 883 so that movement of the sliding carriage 883 generally along an axis T defined by the generally straight needle guide 11067—is adapted to move the needle's terminal region 24 along same axis T.
The needle may be fitted to the sliding carriage with assistance of the bend to maintain the chamfer/bevel formed at the needle's tip in an orientation where it faces distally away from the abutment face of the injection device towards a body tissue it aims to penetrate as seen e.g. in
Axially urging the pusher 881 in the distal direction is adapted to urge the needle's terminal region via the sliding carriage 883 to advance along axis T to position the needle's distal tip beyond the injection device's abutment face.
Retracting the pusher 881 back up in the proximal direction is adapted to urge the needle's terminal region via the sliding carriage 883 to retract back along axis T to position the needle's distal tip at a position where it does not substantially protrude beyond the injection device's abutment face.
Attention is drawn to
The injector member 1420 may include a needle 11077 that may be formed from relative rigid and inflexible material such as stainless steel. Such a relative rigid needle may be understood as meaning a hypodermic needle, which is commonly used in medical settings and is designed to penetrate the body tissue and/or underlying tissues.
A lower side of the injector member's outer housing is seen including a concave abutment face 11062 from which optionally several barb members may project in the distal direction.
In this embodiment, as in the former embodiment seen in
The injector member of
In this example, the injector member 1420 can be seen being provided with a removable stopper 1440 for controlling the protrusion of the needle's tip beyond the device's abutment face 11062.
It is noted that in absence of the removable stopper 1440 (see right-hand side of
With attention additionally drawn to
The removable stopper 1440 as seen in this example includes in a side view a generally V shaped formation having two arms 14402, 14403 of unequal length that meet at an apex 14401. The two arms 14402, 14403 in this example can be flexed one in relation to the other generally about the apex.
The longer arm 14403 can be seen extending to an interface 59 at its free end, which is designed to engage with the sliding carriage 883 during use in order to limit the distance that the device's needle can protrude beyond the abutment face. The shorter arm 14402 is deigned to remain outside of the injector member when the removable stopper 1440 is assembled to the injector member, and includes two tabs 57 adjacent its free end.
As seen in
Attention is drawn to
In this example, the shorter arm 14402 of the removable stopper can be seen being flexed slightly outwards away from the device by flexing it away from the removable stopper's longer arm (which is still within the device), in order to assist in removing the removable stopper from the injector member.
Attention is drawn back to
In the middle view of
Designing the removable stopper to substantially avoid ‘tolerance stack-up’—by configuring the removable stopper to engage the needle adjacent to where it is designed to protrude out of the injection device (here via engagement between interface 59 and sliding carriage 883)—provides a higher degree of certainly that the needle will protrude from the device's abutment face the distance D1 that was intended and designed.
In the right-hand side view of
Provision of such two controlled pre-defined distances D1 and D2 for the needle to protrude beyond the device's abutment face, may assist a physician in targeting a desired targeted layer within the eye that the device is aimed at. This may be accomplished by first attempting to reach such targeted layer at distance D1 and if the needle's tip has not yet reached such targeted layer, the second distance D2 can be tested.
Attention is drawn to
In is noted that at least certain features described with respect to this embodiment are applicable and common also to other embodiments described herein.
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.
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.
Injection device 10 in the example seen in
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.
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.
With attention briefly drawn to
Attention is drawn to
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.
Attention is drawn back to
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.
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.
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.
Attachment of the engagement portions 223 to the anchoring members 17 (see said attachment in the transition from
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
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.
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
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
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.
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.
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
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.
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.
As seen in
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.
Attention is drawn to
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.
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.
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.
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.
Attention is drawn to
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.
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.
In the enlarged section provided in upper right hand side of
Adjusting angle β between axes T and X in this example may be performed by tilling sway member 2613 to the required angle β as indicated by the “dashed” double sided arrow provided in
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.
As seen in the enlarged section at the left hand side of
Attention is drawn back to the injection device 100 as seen in
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.
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.
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.
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
In certain embodiments, another approach may be taken to that seen in device 100. Attention is drawn to
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.
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.
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.
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 cannot be used to advantage.
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.
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.
| Number | Date | Country | |
|---|---|---|---|
| 63527099 | Jul 2023 | US | |
| 63300272 | Jan 2022 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/IB2023/050364 | Jan 2023 | WO |
| Child | 18772181 | US |
