Needle for intravitreal injection
The needle design for intravitreal injections addresses the issue of IOP spikes by incorporating an auxiliary passage for vitreous humour exit, enhancing the safety and efficacy of the procedure.
Patent Information
- Application Number
- PCT/EP2024/082147
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-11-13
- Filing Date
- 2024-11-13
- Publication Date
- 2025-05-22
AI Technical Summary
Intravitreal injections lead to temporary increases in intraocular pressure (IOP), which can cause acute damage to the optic nerve and potentially contribute to chronic glaucoma over time.
A needle design featuring a main passage for medicament injection and an auxiliary passage alongside it, allowing liquefied vitreous humour to exit the eye, thereby reducing IOP increases during the injection procedure.
The needle effectively mitigates IOP spikes during intravitreal injections, making the procedure safer and potentially allowing for higher doses of medication to be administered.
Smart Images

Figure EP2024082147_22052025_PF_FP_ABST
Abstract
Description
[0001] Title: Needle for intravitreal injection
[0002] TECHNICAL FIELD
[0003] The aspects and embodiments thereof relate to the field of needles for intravitreal injection of liquid medicament.
[0004] BACKGROUND
[0005] Intravitreal injections of antibody-based biologies are the most commonly performed ophthalmic procedure worldwide. However, for many patients these injections must be repeated every 4-12 weeks for years. In addition, during the procedure the intraocular pressure (IOP) temporarily increases when the liquid medicament is injected into the eye. The IOP is determined by the liquefied vitreous humour equilibrium in the eye, i.e., the balance between the rate of production in the eye and the rate of outflow from the eye. A sudden increase in IOP may impede retinal circulation and cause acute damage to the optic nerve. There are also indications that repeated IOP spikes might over time chronically damage the optic nerve and give rise to glaucoma. Accordingly, intravitreal injections harbour a risk of lOP-related adverse effects. An effective mitigating strategy against the lOP-rise could make the intravitreal injection procedure safer and allow for the injection of higher doses of medicine, making the treatment more effective.
[0006] SUMMARY
[0007] It is an object of the present disclosure to mitigate increase of intraocular pressure (IOP) in connection with intravitreal injections. In particular, the present disclosure aims to provide for a needle that allows for injection of liquid medicament into an eye with a reduced or even absent increase of IOP.
[0008] A first aspect of the present disclosure provides a needle for intravitreal injection of a medicament. The needle comprises a needle body, which is made up of a main passage extending through the needle body between a proximal end of the needle body and a distal end of the needle body, the main passage arranged for in use allowing liquid medicament to pass there through. The needle body further comprises a sharp tip at the distal end of the needle body for penetrating through the conjunctiva and sclera of an eye, for example a human or animal eye.
[0009] According to the present disclosure, the needle further comprises an auxiliary passage generally alongside the main passage, which auxiliary passage has an entrance and an exit, wherein the auxiliary passage is arranged for in use allowing liquefied vitreous humour to pass there through.
[0010] In use of the needle, while the main passage is used to inject liquid medicament into the eye, liquefied vitreous humour from inside the eye can exit the eye via the auxiliary passage of the needle. The flow of liquid through the auxiliary passage can be constituted by virtue of a pressure difference between the IOP at the entry of the auxiliary passage, and the ambient pressure surrounding the needle at the exit of the auxiliary passage.
[0011] When the entrance of the auxiliary passage is positioned at a distance from the tip of the needle body, it may be prevented that medicament injected through the main passage leaves the eye through the auxiliary passage.
[0012] The auxiliary passage being alongside the main passage implies that at least part of the auxiliary passage is positioned radially relative to the main passage. In general, the radial direction is defined relative to the elongation direction of the needle body. The auxiliary passage being alongside the main passage in use allows both the main passage and the auxiliary passage to simultaneously extend through the eye, in particular through the sclera, when the needle is inserted into the eye. This in turn simultaneously allows a flow of medicament into the eye via the main passage and a flow of liquefied vitreous humour out of the eye through the auxiliary passage. For any needle disclosed herein, the needle may comprise a single auxiliary passage, or multiple auxiliary passages, for example two, three, four, five, or even more. Options and features disclosed in conjunction with a single auxiliary passage may be readily applied to any other auxiliary passage. Auxiliary passages may be identical or different.
[0013] When a needle comprises multiple auxiliary passages, the multiple auxiliary passages may be generally parallel to and / or alongside the main passage, each auxiliary passage with an entrance and an exit. Preferably, each entrance is positioned at a distance from the tip of the needle body. Additionally, the auxiliary passages may be disposed around a centreline of the needle body.
[0014] The inventors have found that when inserting the needle through the sclera of the eye, a hole in the relatively rigid sclera can be formed that temporarily holds essentially the same shape. As such, when the auxiliary passage is open in a direction radially outward relative to the main passage, the sclera may remain at least partially outside the auxiliary passage, instead of the sclera radially moving into the auxiliary passage and sealing off the auxiliary passage, thereby potentially blocking the flow through the auxiliary passage. Any auxiliary passage may for example be formed as a groove into an outer wall of the needle body.
[0015] It is generally envisioned that in at least one longitudinal section plane through the needle, an outer dimension of the needle body at or near the tip is larger than an outer dimension of the needle body between the entrance and the exit of the auxiliary passage. The outer dimension of the needle body at or near the tip may define a size of an opening formed in the sclera when puncturing through the sclera with the needle, whereas the outer dimension of the needle body between the entrance and the exit of the auxiliary passage at least in part defines a cross-sectional area between the opening through the sclera and the needle, through which cross-sectional area liquefied vitreous humour can flow. In any example of a needle according to the first aspect, the auxiliary passage may be positioned at a further radius from a centreline of the needle body than the main passage.
[0016] For any needle, the auxiliary passage may pass through the needle body. However, it is also envisioned that an auxiliary body is connected to the needle body, for which the auxiliary body comprises a bevelled end that faces the tip and is positioned at a distance from the tip. The auxiliary body may a separate body connected to the needle body, or the auxiliary body may be connected to the needle body by virtue of being formed by the same body as the needle body.
[0017] Since the needle is designed for medical purposes, the needle should be sterile, and for example packaged in a sterile packaging. The tip of the needle should be designed for puncturing the sclera of the eye. Dimensions of the needle, such as an outer diameter and / or needle length, may be tailored to use of the needle for intravitreal injection. A maximum length of the needle may be below 20 mm, in particular below 16 mm, to prevent the needle from accidentally puncturing the retina of the eye. In general, the needle body is in use not surrounded by any further elements, such as a sleeve, to allow the needle body to be inserted into the eye.
[0018] In general, the main passage is arranged for allowing liquid medicament to pass there through. For any needle of the present disclosure, the main passage may have an essentially constant cross-sectional shape, for example a circular, square, hexagonal, or any other convex or concave shape. When the main passage has a circular cross-sectional shape, a diameter of the main passage may be between .05 mm and 0.80 mm, in particular between 0.08 mm and 0.21 mm.
[0019] For any needle disclosed herein, an outer diameter of the needle body may be between 0.20 mm and 0.5 mm, in particular between 0.18 mm and 0.41 mm. For any needle body of any needle disclosed herein, a minimum wall thickness, regarded in any cross-sectional view, may be at least 0.05 mm, for example at least 0.06 mm.
[0020] It is generally known to cover the entire needle body of a needle with a lubricant, such as silicone, to reduce friction between the needle body and the part of the body in which needle body is inserted. For any needle disclosed herein, as an option, it is envisioned that only a section of an outer surface of the needle body is covered with a lubricant, such as silicone, which section is at a distance from the proximal end of the needle body. When only a section of the outer surface of the needle body is covered with the lubricant, a person inserting the needle body into the eye may notice an increased resistance against insertion when the entire section of the outer surface covered with the lubricant has been inserted into the eye.
[0021] A transition location between the section of the outer surface of the needle body which is covered with the lubricant and a further section of the outer surface of the needle body which is not covered with the lubricant may be aligned with the auxiliary passage. As such, the increased resistance against insertion may be noticed when the auxiliary passage is aligned with the sclera - in other words, when the exit and the entry of the auxiliary passage are positioned on opposite sides of the sclera.
[0022] A second aspect of the present disclosure provides an assembly of a needle and a needle hub, the assembly comprising a needle according to the first aspect and a needle hub that is arranged to be connected to a syringe, for example to the syringe barrel. The needle is connected to the needle hub at or near a proximal end of the needle. Part of the needle may extend into the needle hub. For any assembly, the exit of the auxiliary passage may be positioned at a distance from the needle hub.
[0023] Generally, the needle hub may be a plastic needle hub. The needle may be formed for example from a metal. Generally, the needle hub and the needle are formed as separate bodies, which can be connected via an interference fit, threaded connection, adhesive, weld, using friction and / or any other type of connection. To connect the needle hub to a syringe, the needle hub may comprise a radially outward facing protrusion, such as a thread or wing, for example according to the luer lock standard ISO 80369-7-2021. Additionally or alternatively, any needle hub may comprise a skirt part defining a pocket therein, such that part of a syringe, in particular part of a barrel of a syringe, can be inserted into this pocket.
[0024] A third aspect of the present disclosure provides a kit of parts for forming a syringe assembly. The kit of parts comprises an assembly according to the second aspect and a syringe. The syringe typically comprises a barrel for holding a volume of liquid and a piston that is moveable in the barrel. The needle hub is arranged to be connected to the syringe, such that the needle is in fluid communication with the barrel.
[0025] A fourth aspect of the present disclosure provides a syringe assembly for intravitreal injection of a medicament, in particular a liquid medicament used in treatment of retinal disease in an eye, in particular a human or animal eye. The syringe assembly comprises a syringe, comprising a barrel and a piston, which piston is moveable in the barrel. The syringe assembly further comprise a needle assembly according to the second aspect.
[0026] According to the fourth aspect, the needle hub of the needle assembly is connected to the barrel of the syringe, such that the needle is in fluid communication with the barrel, and the barrel of the syringe is at least partially filled with a liquid medicament, in particular an eye medicament.
[0027] A fifth aspect of the present disclosure provides a method of injecting a medicament into an eye. The method comprises steps of inserting a needle according to the first aspect into the eye, in particular through the sclera of the eye. The method further comprises injecting a volume of medicament into the eye via a main passage of the needle and allowing flow of liquid from the inside of the eye out of the eye via at least one auxiliary passage of the needle. The flow of liquid from the inside of the eye out of the eye via the auxiliary passage or passages of the needle may occur simultaneously and / or shortly after injecting at least part of the volume of medicament into the eye via the main passage of the needle.
[0028] BRIEF DESCRIPTION OF THE FIGURES
[0029] In the drawings,
[0030] Fig. 1A and IB show an assembly of a needle and a needle hub, respectively in an isometric view and a side view.
[0031] Fig. 1C and ID show an assembly of a needle and a needle hub, respectively in a longitudinal section view and a detailed longitudinal section view.
[0032] Figs. 1E-1H show cross-sectional views of different needles.
[0033] Figs. 2A-2C show another assembly of a needle and a needle hub, respectively in an isometric view, side view, and longitudinal section view.
[0034] Figs. 3A and 3B show a syringe assembly with a needle inserted into an eye, respectively in a schematic overview and a detailed section view.
[0035] It will be appreciated that in the drawings only a limited number of examples are depicted of one or more of the aspects disclosed herein. The examples depicted in the drawings may be readily modified with one or more of the optional and / or general features disclosed herein. The drawings are not necessarily to scale.
[0036] DETAILED DESCRIPTION OF THE FIGURES
[0037] Fig. 1A and IB show an assembly 101 of a needle 100 and a needle hub 200, wherein the needle 100 is according to a first example of the present disclosure. The needle 100 is connected to the hub 200 at or near a proximal end of the needle. Fig. 1C shows a section view of the assembly 101 over line A-A indicated in Fig. IB, and Fig. ID shows a detailed view B of the needle, as indicated in Fig. 1C. The needles 100 of the present disclosure comprise a needle body 102, which is typically an elongated body with a main passage 110 extending there through between a distal end 105 and a proximal end of the needle body 102. The main passage 110 is best visible in the section view of Fig. 1C. The main passage 110 generally extends between a distal end of the needle body 102 and a proximal end of the needle body 102. The main passage is arranged for allowing liquid medicament to pass there through.
[0038] In general, as is possible for any other needle 100 disclosed herein, the needle comprises a sharp tip 104 at the distal end of the needle 100. The tip 104 of any needle can be a bevelled tip, for example a single bevelled tip, or a multiple bevelled tip, such as a double-bevelled tip, triple -bevelled tip, or a five-bevel tip. In general, the tip 104 is arranged for penetrating through the conjunctiva and sclera of a human or animal eye.
[0039] Furthermore, in general, for any needle, at the proximal end, the needle 100 can be inserted into the needle hub 200, for example with a press- fit, to form the assembly 101. The needle hub 200 is designed to be connected to a syringe, for example using a threaded connection, such as a luer lock, or a press-fit connecting, such as a luer slip.
[0040] The needle hub 200 as depicted for example in Fig. 1C and Fig. 2C comprises a skirt part 203 surrounding a pocket 206. The skirt part 203 may be comprised by any needle hub disclosed herein. The pocket 206 may in use accommodate part of a barrel 306 of a syringe 301, as for example indicated in Fig. 3A.
[0041] As a further option generally applicable for any needle and needle hub, part of the needle body 102 extends into the needle hub 200, as for example shown in Fig. 1C and 2C. The part of the needle body 102 extending into the needle hub 200 may be held in place by virtue of friction, glue, one or more wedges, and / or any other means for holding the needle body 102 in place. In the example of the needle 100 of Figs. 1A-1D, the needle 100 comprises four auxiliary passages 112, formed by four grooves 113 into an outer wall of the needle body 102. For clarity of the figures, not all auxiliary passages and grooves are provided with a reference numeral. This needle, and any other needle disclosed herein, may be readily modified to comprise less than four or more than four grooves 113.
[0042] As an option for any groove and any auxiliary passage, the grooves of the needle 100 depicted in Figs. 1A-1D are oriented parallel to the main passage 110 and the centreline 103 of the needle body 102. The grooves 113 are furthermore disposed around the centreline 103 of the needle body 102.
[0043] As best depicted in Fig. ID, the grooves 113 are open in a direction radially outward relative to the main passage 110. This results in the auxiliary passages 112 formed by the respective grooves 113 to be open in the direction radially outward relative to the main passage 110. Alternatively, as an option depicted in Fig. 1H, any auxiliary passage 112 can be closed in the radial direction, for example by virtue of part 102’ of the needle body 102 enclosing the auxiliary passage 112.
[0044] A distance - indicated as d in Fig. 1C - between the tip 104 of the needle 100 and the entry 114 into the auxiliary passage 112 may determine a minimal insertion depth with which the needle 100 has to be inserted into the eye to position the entry 114 into the eye, and with that allow passage of liquefied vitreous humour through the auxiliary passage. A further distance D between the tip 104 of the needle 100 and the exit 115 of the auxiliary passage 112 may determine a maximum insertion depth with which the needle 100 can be inserted into the eye to allow passage of liquefied vitreous humour through the auxiliary passage 112. The length of the auxiliary passage 112 is determined by the difference between distance D and distance d. Preferably, the length of the auxiliary passage 112 between the entry 114 and the exit 115 in a direction generally parallel to the centreline 103 is at least 2 mm, for example between 2 mm and 10 mm or at most 5 mm. In general, a minimal value for the distance d between the tip 104 of the needle 100 and the entry 114 into the auxiliary passage 112 may be 3 mm, or even 5 mm. It has been found that this distance may ensure that no or essentially none of the medicament injected through the tip 104 of the needle 100 accidentally flows out of the eye through any auxiliary passage 112. Within the context of the present disclosure, some flow of liquid medicament from inside the eye through any auxiliary passage may accidentally occur. In general, for example for the purpose of determining distance d or distance D, the tip 104 may be defined as the outermost point of the needle 100.
[0045] In Fig. ID and Fig. IF, two distances x and X are indicated. Distance X corresponds to an outer dimension of the needle body 102 at or near the tip 104, and distance x corresponds to an outer dimension of the needle body 102 at a location between the entry 114 and the exit 115 of the auxiliary passage 112 or auxiliary passages. When the distance x is smaller than the distance X at a particular location on the needle body 102, a flow path for liquefied vitreous humour can be provided through the auxiliary passage 112. The outer dimension of the needle body 102 at or near the tip 104 may define the size of the opening punctured into the sclera of the eye.
[0046] Indicated in Fig. 1C is a transition location t. Between the transition location t and the tip 104, an outer surface of the needle body 102 may be covered with a lubricant, such as silicone. At least part of the needle body 102 between the transition location t and the proximal end may not covered with lubricant. The transition location t is aligned with the auxiliary passage 112.
[0047] Figs. 1E-1H show cross-sectional views of examples of needles 100, over line C-C indicated in Fig. IB. These four examples are used to indicate several envisioned optional features, one or more of which can be applied to any needle disclosed herein. In the example of Fig. IE, six grooves 113 are formed in an outer surface 117 of the needle body 102, and as such six auxiliary passages 112 are obtained that are generally parallel to and / or alongside the main passage 110. Side walls 118 of the grooves 113 are as an option oriented generally radially relative to the centreline 103 of the needle body 102.
[0048] In the example of Fig. IF, four grooves 113 are formed in the outer surface 117 of the needle body 102, and as such four auxiliary passages 112 are obtained that are generally parallel to and / or alongside the main passage 110. The grooves 113 have a cross-sectional shape, which resembles part of a circle. In the examples of Figs. IE, IF, and 1H, the main passage 110 has a generally circular cross-sectional shape.
[0049] In the example of Fig. 1G, as an option applicable to any needle, the main passage 110 through the needle body 102 has a rectangular cross- sectional shape. Next to a circular and rectangular cross-sectional shape, the main passage 110 of any needle disclosed herein may have any other cross- sectional shape, such as, but not limited to, triangular, rectangular, pentagonal, hexagonal, oval, any other polygon, or any other shape, or any combination of shapes.
[0050] A further option depicted in Fig. 1G, as an option applicable to any needle independently of the cross-sectional shape of the main passage 110, the cross-sectional shape of any auxiliary passage may be generally triangular. Conceivably, whenever a needle comprises two or more distinct auxiliary passages, these auxiliary passages may have a different cross- sectional shape and / or cross-sectional area.
[0051] Fig. 1H shows yet another example of a cross-sectional shape of a needle 100 according to the present disclosure. As an option depicted in Fig. 1H, but applicable to any needle for any auxiliary passage, any auxiliary passage 112 may be at least partially enclosed by part 102’ of the needle body 102 in the cross-sectional view. When all auxiliary passages of the needle are enclosed by the needle body 102, a substantially smooth outer surface of the needle may be obtained.
[0052] From the cross-sectional views of needles shown in Figs. 1E-1H, it becomes apparent that for the flow of medicament through the main passage 110, a particular cross-sectional area is available. For the flow of liquefied vitreous humour through the auxiliary passage(s), a separate cross-sectional area is available. An increase in the cross-sectional area through the auxiliary passage(s) increases the flow rate of liquefied vitreous humour through the auxiliary passage(s). Preferably, the cross-section diameter of each of the auxiliary passage(s) is between 0.07 and 0.15 mm. Within this range, the cross-section area through the auxiliary passage may be sufficient to effectively reduce the IOP, while being small enough to prevent hypotonia in connection with the injection.
[0053] Figs. 2A-2C show an assembly 101 of a needle 100 and a needle hub 200, wherein the needle 100 is according to a second example of the present disclosure. In general, the auxiliary passage 112 may be positioned at a further radius from a centreline 103 of the needle body 102 than the main passage 110. Furthermore, in general, the main passage 110 may be aligned with the centreline 103 of the needle body 102. According to the second example, the auxiliary passage 112 may be formed through an auxiliary body 140 which is connected to the needle body 102. The auxiliary body 140 may be formed by the same body as the needle body 102, or it may be formed by a separate body, which is connected to the needle body 102.
[0054] As depicted in Figs. 2A-2C, a distal end 141 of the auxiliary body 140 may be positioned at a distance from the tip 104 of the needle, and a proximal end of the auxiliary body 140 may be positioned at a distance from the proximal end of the needle body 102 and / or at a distance from the needle hub 200. At the distal end of the auxiliary body 140, the auxiliary body 140 may comprise a bevelled end 142. By virtue of the bevelled end 142, the auxiliary body 140 may pass through the sclera more conveniently, for example with a reduced chance of damaging the sclera. The bevelled end 142 may be formed by one, two, three, four, five, or even more bevelled surfaces.
[0055] The auxiliary body 140 defines an entry 114 into the auxiliary passage 112 and an exit 115 out of the auxiliary passage 112. As such, liquefied vitreous humour can flow into the auxiliary passage 112 through the entry 114, which entry 114 in use is positioned inside the eye. Subsequently, liquefied vitreous humour can flow out of the auxiliary passage 112 through the exit 115, which exit 115 in use is positioned outside the eye, thereby allowing lowering of the IOP.
[0056] In general, for any needle disclosed herein, it may be advantageous if the total resistance through the one or more auxiliary passages generally equals the resistance of the main passage, to balance fluid influx and efflux. Ideal dimensions may be determined by combining Poiseuille’s law and Ohm’s hydraulic analogy.
[0057] Although in the figures the one or more auxiliary passages are shown essentially parallel to the centreline of the needle and / or essentially parallel to the main passage, it is also envisioned that at least part of any auxiliary passage is at an angle relative to the centreline of the needle and / or at an angle relative to the main passage. For example, any auxiliary passage may be generally helically shaped, for example when the auxiliary passage revolves around the centreline of the needle and / or the main passage. Any auxiliary passage may revolve with one or more turns around the centreline of the needle and / or the main passage.
[0058] Figs. 3A and 3B show a syringe assembly 300 with a needle 100 inserted into an eye 400, respectively in a schematic overview and a detailed section view in which the eye 400 is partially opened up. The syringe assembly 300 is depicted during a method of injecting a medicament into an eye 400, wherein a volume of medicament is injected into the eye via a main passage 110 of the needle 100, and liquefied vitreous humour 405 flows from the inside of the eye out of the eye via an auxiliary passage 112 of the needle 100. In particular, the needle 100 is inserted through the sclera 402 of the eye. For any method and syringe disclosed herein, the volume of medicament to be injected may be 0.5 mL or less, 0.1 mL or less, or even 0.05 mL or less.
[0059] The syringe assembly 300 further comprises an assembly of a needle 100 and a needle hub 200, wherein the needle hub 200 is connected to the syringe 300, in particular to the barrel 306. In the example of Fig. 3A, the needle hub 200 is connected to the barrel 306 via a slip fitting, for example a luer slip. It will be understood that for any syringe assembly 300 disclosed herein, a slip fitting or threaded connection may be used to connect any needle hub to any barrel.
[0060] The syringe assembly 300 comprises a syringe 301 comprising a barrel 306 and a piston 304, which is moveable through the barrel 306. The piston 304 is connected to a plunger 302, or conceivably can be integrally formed with the plunger 302. The plunger 302 allows a user to move the piston 304 through the barrel 306, and to force liquid medicament 308 from the barrel 306 through the main passage 110 of the needle 100 into the eye. The flow of liquid medicament is schematically indicated as a dashed arrow in Fig. 3B.
[0061] As indicated in Fig. 3B, in use, preferably, the entry 114 into the auxiliary passage 112 is positioned inside the eye 400, and the exit 115 out of the auxiliary passage 122 is positioned outside the eye 400.
[0062] As the IOP increases because of the volume of liquid medicament being injected into the eye, flow of liquefied vitreous humour 405 is allowed through the one or more auxiliary passages of the needle 100. The flow of liquefied vitreous humour 405 is schematically indicated as arrows 407 in Fig. 3B.
[0063] Although the needle 100 depicted in Fig. 3B is a specific example of a particular needle 100 according to the present disclosure, it will be appreciated that the method may be executed using any other needle disclosed herein, for example, but not limited to, the needle disclosed in conjunction with Figs. 2A-2C.
Claims
Claims1. Needle for intravitreal injection of a medicament, comprising a needle body (102), the needle body comprising: a main passage (110) extending through the needle body between a proximal end of the needle body and a distal end of the needle body, the main passage arranged for in use allowing liquid medicament to pass there through; a sharp tip (104) at the distal end of the needle body for penetrating through the conjunctiva and sclera of an eye; wherein the needle further comprises an auxiliary passage (112) generally alongside the main passage, which auxiliary passage has an entrance (114) and an exit (115), wherein the auxiliary passage is arranged for in use allowing liquefied vitreous humour to pass there through and exit out of the eye.
2. Needle according to claim 1, wherein the entrance of the auxiliary passage is positioned at a distance (d) from the tip of the needle body.
3. Needle according to claim 1 or 2, comprising multiple auxiliary passages generally alongside the main passage, each auxiliary passage with an entrance (114) and an exit (115), preferably wherein each entrance is positioned at a distance from the tip of the needle body.
4. Needle according to claim 3, wherein the auxiliary passages are disposed around a centreline (103) of the needle body.
5. Needle according to any of the preceding claims, wherein in at least one longitudinal section plane through the needle, an outer dimension (X) of the needle body at or near the tip is larger than an outer dimension (x) of the needle body between the entrance and the exit of the auxiliary passage.
6. Needle according to any of the preceding claims, wherein the auxiliary passage is open in a direction radially outward relative to the main passage, for example wherein the auxiliary passage is formed as a groove in the outer wall of the needle body.
7. Needle according to claim 1 or 2, wherein the auxiliary passage is positioned at a further radius from a centreline of the needle body than the main passage.
8. Needle according to claim 1, 2 or 7, wherein the auxiliary passage is formed through an auxiliary body (140) connected to the needle body.
9. Needle according to claim 8, wherein the auxiliary body comprises a bevelled end (142) positioned at a distance from the tip (104).
10. Needle according to any of the preceding claims, wherein a length of the auxiliary passage between the entry and the exit is between 2 mm and 10 mm.
11. Needle according to any of the preceding claims, wherein the length of the needle body is below 20 mm.
12. Needle according to any of the preceding claims, wherein an outer diameter of the needle body is between 0.20 mm and 0.5 mm.
13. Needle according to any of the preceding claims, wherein a distance (d) between the tip (104) and the entry (114) into the auxiliary passage is at least 3 mm, in particular between 3 and 10 mm.
14. Needle according to any of the preceding claims, wherein only a section of an outer surface of the needle body is covered with a lubricant, suchas silicone, which section is at a distance from the proximal end of the needle body.
15. Assembly (101) of a needle (100) and a needle hub (200), the assembly comprising: a needle according to any of the preceding claims; and a needle hub, arranged to be connected to a syringe (300), wherein the needle is connected to the needle hub at or near a proximal end of the needle.
16. Assembly according to claim 15, wherein the needle hub comprises a radially outward facing protrusion, such as thread or wing.
17. Kit of parts for forming a syringe assembly, the kit of parts comprising: an assembly according to any of the claims 15-16; and a syringe, comprising a barrel (306) and a piston (304), which is moveable in the barrel, wherein the needle hub is arranged to be connected to the syringe, such that the needle is in fluid communication with the barrel.
18. Syringe assembly (300) for intravitreal injection of a liquid medicament, the syringe assembly comprising: a syringe (301), comprising a barrel (306) and a piston (304), which piston is moveable in the barrel; en a needle assembly according to any of the claims 15-16; wherein the needle hub of the needle assembly is connected to the barrel of the syringe, such that the needle is in fluid communication with the barrel, and the barrel of the syringe is at least partially filled with a liquid medicament, in particular an eye medicament.
19. Method of injecting a medicament (308) into an eye (400), the method comprising steps of: inserting a needle according to any of the claims 1-14 into the eye, through the sclera (402) of the eye; - injecting a volume of medicament into the eye via a main passage of the needle; and allowing a flow of liquid from the inside of the eye out of the eye via an auxihary passage of the needle.
Citation Information
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