Needle

Abstract

The invention relates to a needle (1) comprising a cylindrical body (10) extending along a longitudinal axis, at least one end (100) of which is beveled, said body (10) being formed at least from a polymer, said needle (1) being characterized in that it comprises at least one reinforcing wire (101) adapted to stiffen said body (10), said reinforcing wire (101) being formed at least from a shape-memory material. Figure to be published with the abbreviation: Fig. 1

Description

Title of the invention: Needle technical field

[0001] The invention relates to the technical field of needles. The invention relates in particular to a syringe comprising said needle. State of the art

[0002] Pyrogens, or pyrogenic substances, are impurities which, when present in a pharmaceutical product intended for administration to a patient, cause a fever reaction upon actual administration of the pharmaceutical product. In the medical field, many devices include injection and / or puncture needles for the delivery of a pharmaceutical product, generally a liquid. Such needles intended to contain and transport a pharmaceutical product must not only be sterile and sterilizable, but also pyrogen-free, meaning they do not contain pyrogens, and depyrogenable, meaning they must be able to undergo a treatment that eliminates any pyrogens they may contain. Indeed, to depyrogenate such needles, they must be heated to 253°C for one hour.This is one of the reasons why needles for injecting pharmaceuticals into human tissue are generally made of metal. Another reason is that these injection needles must be very thin to minimize pain for the patient, while still maintaining sufficient strength and rigidity for penetration of the skin and subcutaneous layers. However, metal needles, once used, cannot be easily disposed of, posing a public health concern due to the risk of contamination from contact with these unsterilized and unpyrogenized needles. To address this problem with needles for injecting pharmaceuticals, particularly into the human body, plastic needles have been proposed.

[0003] In reality, when a plastic medical needle is used, it is for single use only and is not depyrogenated, but is manufactured under conditions such that it is pyrogen-free. However, once removed from its packaging and used, it cannot be depyrogenated. Furthermore, since these needles cannot be depyrogenated, it is not possible, even before first use, to depyrogenate them to ensure that they are indeed pyrogen-free. This is because production problems or problems occurring during transport or handling may have led to contamination by pyrogens.

[0004] Needles for mounting on an injection syringe are known, in particular, which are both depyrogenable and easily disposable. This type of needle may, in particular, consist of a cylindrical body extending along a longitudinal axis, at least one end of which is beveled, and made of polyaryletherketone polymer and reinforced with stainless steel wires. However, a disadvantage of this type of needle is that it is rigid and not very adaptable.

[0005] The invention therefore falls within this context and seeks to resolve all the aforementioned drawbacks. Thus, the invention aims to provide a needle that prevents needle sticks by being made without stainless steel but having a rigid needle body. Presentation of the invention.

[0006] The invention relates to a needle comprising a cylindrical body extending along a longitudinal axis, at least one end of which is beveled, said body being formed at least from a polymer, said needle being characterized in that it comprises at least one reinforcing wire adapted to stiffen said body, said reinforcing wire being formed at least from a shape memory material.

[0007] The cylindrical body may be hollow. The hollow body may have a circular cross-section. The hollow body may provide a conduit for the flow, preferably of a liquid, in particular a pharmaceutical liquid for injection or transfusion. The needle body may have at least one beveled end that allows for perforation, in particular of human tissues. In an embodiment in which the needle has only one beveled end, the other end may be adapted for insertion into a syringe.

[0008] In one embodiment, the body may include at least one reinforcing wire embedded in the polymer of said body. The wire may extend parallel to the longitudinal axis along the entire length of the hollow body. In an embodiment comprising several reinforcing wires, the body may include three reinforcing wires embedded in the polyaryletherketone polymer, extending parallel to the longitudinal axis XX' along the entire length of the hollow body, being equally stretched and equidistant from each other, and distributed such that the wires, in pairs, define the same central angle. The three reinforcing wires may be uniformly stretched along their entire length.

[0009] The needle can be adapted for injection into human tissues and can have an external diameter of approximately 0.7 mm and an internal diameter of approximately 0.25 mm, which consequently means that the wall thickness of the needle can be approximately 0.25 mm. At such wall thicknesses, the rigidity, i.e., the resistance to deformation, may be insufficient. The needle can have a thin wall thickness. as mentioned above to minimize pain and tissue damage for the patient.

[0010] The polymer may be polyaryletherketone, polyethylene, polycarbonate, or polypropylene. The polymer may comprise fillers selected from carbon fibers, glass fibers, graphite granules, polytetrafluoroethylene (PTFE) granules, black carbon granules, and mixtures of two or more of these.

[0011] The thread may have a diameter of less than 500 µm, in particular less than 300 µm. Given this diameter, when the needle is exposed to a flame or high-temperature heating, in order to render it unusable and prevent the possibility of perforation from its beveled end, the threads may also melt and the sanitary safety of the needle may be maintained.

[0012] The shape memory material can be flexible and / or elastic for a first temperature range and can be rigid for a second temperature range.

[0013] Advantageously, the polymer is an oxy-1,4-phenylene-oxy-1,4-phenylene- carbonyl-1,4-phenylene.

[0014] The polymer may be marketed under the name PEEK® (registered trademark). The polymer may be a semi-crystalline aromatic linear polymer. The polymer may have a melting point of 343°C. The polymer may have a glass transition temperature of 143°C. The polymer may have an operating temperature of approximately 260°C. The polymer may have a softening point of up to 315°C. The needle containing the polymer may be depyrogenable, meaning that it can be heated to approximately 253°C for, in particular, one hour without undergoing deformation or alteration of its chemical and mechanical properties. The polymer may be adapted to withstand a subsequent extrusion step. The coefficient of thermal expansion of the polymer is substantially the same as that of stainless steel, so it can solidify upon heating to become rigid and retains the same shape after rigidification.

[0015] The polymer can be biocompatible with human tissues. The polymer can be intrinsically pure, with very low levels of release of extractable gases and ions.

[0016] Advantageously, the reinforcing wire has at least one spiral-shaped portion around said longitudinal axis.

[0017] The reinforcing wire can be embedded in the polyaryletherketone polymer by extending around an axis of rotation coinciding with the longitudinal axis along the entire length of the hollow body. In the embodiment comprising three wires, said wires can be arranged so that each extends around an axis of rotation coinciding with the longitudinal axis along the entire length of the hollow body, said wires having the same direction of rotation. The three wires can be equidistant from each other.

[0018] Advantageously, the needle comprises a plurality of reinforcing wires forming a mesh.

[0019] In this embodiment, the plurality of wires extends around the longitudinal axis along the entire length of the hollow body, such that said wires interlace to form a mesh. The wires may overlap and cross each other.

[0020] Advantageously, the wire comprises a stiffened portion and a flexible portion.

[0021] That is to say, the wire can be made of the same material along its entire length but with a stiffened section and a non-stiffened section. In another embodiment, the thread may comprise two materials, a first material forming a stiffened portion and a second material forming a non-stiffened portion. A needle may thus comprise a flexible portion and a rigid or semi-rigid portion.

[0022] Advantageously, each wire has a circular cross-section.

[0023] In this embodiment, each wire may have a diameter of approximately 0.1 mm.

[0024] Advantageously, each wire has an elliptical cross-section.

[0025] In this embodiment, each wire may have a main axis of approximately 0.15 mm.

[0026] Advantageously, each wire has a triangular cross-section.

[0027] The triangular section wire can be advantageously used since it can be more rigid than a circular section wire.

[0028] Advantageously, the reinforcing thread is arranged in the body of the needle.

[0029] In another embodiment, the thread can form a shape-memory cylinder, that is, the thread can form a hollow cylinder positioned around the needle and contained within the lumen of the hollow body. In this embodiment, the needle can be disposable and the shape-memory cylinder reusable; the rigid, shape-memory portion thus avoids contact with the product.

[0030] Advantageously, the body of said needle is obtained according to a process comprising a first step of the polyaryletherketone polymer simultaneously with a pultrusion step of at least one reinforcing yarn within said extruded polyaryletherketone polymer.

[0031] Polymer extrusion can be simultaneous with wire insertion into the extruded channel. The pultrusion step can correspond to a wire insertion step.

[0032] Advantageously, said at least one reinforcing wire is stiffened, simultaneously with the pultrusion step.

[0033] The reinforcing wire can stiffen at a temperature above 80°. In one embodiment, the wire can stiffen at a temperature suitable for sterilization.

[0034] The stiffening of the reinforcing wire can be done by heating said wire; once the wire has reached its stiffening temperature, it can take its shape and, upon cooling, retain this shape.

[0035] Once the wire is rigidified, sterilization has no impact on the rigidity of the body.

[0036] In one embodiment, the needle body is obtained by a process comprising a first step of extruding the polyaryletherketone polymer to form a body having a channel and a second step of inserting at least one wire into said channel of the body. In this embodiment, the wire insertion can be carried out immediately after extrusion to prevent the heating of the wire from melting the polymer and thus prevent the wire from coming into contact with the lumen of the needle body and contaminating the products to be injected.

[0037] In another embodiment, at least one reinforcing wire is stiffened, subsequent to the pultrusion step, in a dry heat sterilization step in which the body of said needle incorporating the reinforcing wire is heated to a temperature of at least 160°.

[0038] Advantageously, said at least one reinforcing wire is stiffened, subsequent to the pultrusion step, in a moist heat sterilization step in which the body of said needle incorporating the reinforcing wire is heated to a temperature of at least 121°.

[0039] The reinforcing wire can be heated in dry heat or in moist heat.

[0040] Advantageously, the body of said needle is obtained according to a process comprising a first step of additive printing of the body from a spool of polyaryletherketone polymer yarn around at least one reinforcing yarn.

[0041] The cylindrical body may have a circular cross-section which may help to minimize pain when inserting the needle into human tissues.

[0042] Advantageously, the body of said needle is obtained according to a process comprising a first subtractive printing step of the body in a block of polyaryletherketone polymer in which at least one reinforcing thread is arranged.

[0043] Advantageously, the reinforcing thread is arranged around the body of the needle.

[0044] In this embodiment, the thread can form a sheath having a light and the polymer forming the body of the needle can be inserted into said light.

[0045] Advantageously, the body of said needle is obtained according to a first process, and the reinforcing thread is obtained according to a second process to form a sheath in which the body of the needle is arranged.

[0046] Advantageously, at least one wire is made of composite material.

[0047] The material can be a shape memory alloy (SMA) for Shape memory alloys) are notably copper-based (for example, with the chemical formulas CuAIBe, CuAINi, CuAIMn, CuZnAI), nickel-titanium-based (for example, with the chemical formulas NiTi, NiTiFe, NiTiCu, NiTiCr, NiTiHf, NiTiCo, NiTiNb, etc.), and iron-based alloys (for example, with the chemical formulas FeMnSi, FeMnCr, FeMnCrSi). Some of these shape memory alloys can be single-crystal, meaning they consist of a single grain, or of several grains separated by grain boundaries with low misorientation.

[0048] The activation temperature of the composite material during heating, i.e. in the transition from the martensite phase to the austenite phase, can be between 45°C and 450°C.

[0049] Another aspect of the invention relates to an injection syringe comprising a piston; a pump body equipped with a terminal fitting for adjusting an injection needle; an injection needle according to any one of the preceding claims.

[0050] The syringe can be adapted for injecting pharmaceutical products, particularly into human tissues. The syringe may include a pump body acting as a reservoir for the pharmaceutical product to be injected. The pump body may include a terminal fitting with a nozzle adapted to receive the injection needle. The pump body may include a piston arranged within said pump body, adapted to propel the pharmaceutical product through the needle.

[0051] The needle and syringe of the invention can be made by any process known to a person skilled in the art, such as an injection molding process, an extrusion process or a tension extrusion process called a pultrusion process in which the reinforcing wires are kept under tension during their passage, and that of the polymer matrix, through the extrusion die.

[0052] The needle, syringe and connector of the invention can be made by any process known to a person skilled in the art, such as an injection molding process, an extrusion process or a tension extrusion process called a pultrusion process in which the reinforcing wires are kept under tension as they pass through the extrusion die.

[0053] Advantageously, the pump body equipped with its terminal fitting and the piston are made of a polyaryletherketone polymer.

[0054] The syringe can be made of a polyaryletherketone polymer, which means that the piston and the pump body fitted with its nozzle can be entirely made of such a polymer.

[0055] Advantageously, the pump body equipped with its terminal fitting and the piston are made of a polyaryletherketone polymer comprising fillers selected from glass fibers, carbon fibers, graphite granules, polytetrafluoroethylene (PTFE) granules, carbon black granules and mixtures of two or more of them. Brief description of the figures.

[0056] Other advantages and features of the present invention are now described by means of purely illustrative and in no way limiting examples of the scope of the invention, and from the accompanying drawings, in which the various figures represent:

[0057] [Fig-1] represents a partial longitudinal cross-sectional view of the end of a needle according to an embodiment of the invention.

[0058] [Fig.2] represents a partial longitudinal view of the tip of a needle according another embodiment of the invention.

[0059] [Fig.3] represents a partial longitudinal view of the tip of a needle according a different embodiment of the invention.

[0060] [Fig.4] represents a cross-sectional view of a needle according to a mode of realization.

[0061] [Fig. 5] shows a partial longitudinal cross-sectional view of a syringe comprising a needle according to the invention.

[0062] In the following description, identical elements, by structure or by function, appearing on different figures retain, unless otherwise specified, the same references. Description of a method of implementation.

[0063] Fig. 1 shows a partial longitudinal cross-sectional view of the tip of a needle according to one embodiment of the invention. The needle is also described in relation to Fig. 2 and Fig. 3, each representing different embodiments of the needle, and to Fig. 4, which shows a cross-sectional view of a needle according to one embodiment. The needle is also described in Fig. 5, in an embodiment in which the needle is used in a syringe.

[0064] The needle 1 comprises a cylindrical body 10 extending along a longitudinal axis. The needle 1 has at least one beveled end 100. The beveled end 100 is adapted for piercing human tissue. The cylindrical body 10 is hollow and has a lumen 11 in its center. The body 10 has a circular cross-section. The body 10 contains at least one polymer. The polymer is an oxy-l,4-phenylene-oxy-l,4-phenylene-carbonyl-l,4-phenylene. The polymer solidifies upon heating to become rigid and retains the same shape after rigidification.

[0065] The needle 1 includes at least one reinforcing wire 101 adapted to stiffen the body. The reinforcing wire 101 comprises a shape-memory material. The material may be a shape-memory alloy. The reinforcing wire is embedded in the polymer of the body. Each reinforcing wire has a diameter of 0.1 mm.

[0066] In the embodiment described in [Fig.1], the body 10 comprises three wires 101 extending parallel to the longitudinal axis along the entire length of the body 10. The wires 101 are equidistant and equidistant from each other and distributed so that the wires 101 two by two define an identical central angle.

[0067] In the embodiment described in [Fig. 2], the body 10 comprises four wires 101 extending around the body 10 of the needle 1. The reinforcing wires 101 have at least one spiral-shaped portion extending around the longitudinal axis of the body. The wires 101 have the same direction of rotation. The wires 101 are equidistant from each other. The reinforcing wire 101 can be embedded in the polymer by extending around an axis of rotation coinciding with the longitudinal axis along the entire length of the body 10.

[0068] In the embodiment described in [Fig. 3], the body 10 comprises a plurality of wires 101 forming a mesh. The plurality of wires 101 extends around the longitudinal axis along the entire length of the body 10, such that said wires 101 intertwine to form a mesh. The wires 101 overlap and cross each other.

[0069] In the embodiment described in [Fig.4], each wire 101 has a circular cross-section and the needle 1 has four reinforcing wires 101.

[0070] Figure 5 describes an injection syringe 2 comprising a piston 21, a pump body 20 equipped with the needle 1.

[0071] The pump body 20 acts as a reservoir for a pharmaceutical product to be injected. The pump body 20 has a terminal fitting 200 having a nozzle adapted to receive the injection needle 1. The pump body 20 has a piston 21 arranged within said pump body 20, adapted to propel the pharmaceutical product through the needle 1.

[0072] The pump body 20, equipped with its terminal fitting 200, and the piston 21 are made of polymer. The pump body 20, the terminal fitting 200, and the piston 21 are made of polyaryletherketone polymer.

[0073] The preceding description clearly explains how the invention achieves its objectives, namely to provide a needle that prevents needle sticks by being made without stainless steel but having a rigid needle body, by providing a needle comprising a cylindrical body extending along a longitudinal axis of which at least one end is beveled, said body being formed at least from a polyaryletherketone polymer, said needle being characterized in that it comprises at least one reinforcing wire adapted to stiffen said body, said reinforcing wire being formed at least from a shape memory material.

[0074] In any event, the invention is not limited to the embodiments specifically described in this document, and extends in particular to all equivalent means and to any technically feasible combination of these means. In particular, one may consider: - Each wire has an elliptical cross-section; - Each wire has a triangular cross-section; - The cylindrical body is beveled at both ends; - The reinforcing thread is arranged in the body of the needle; - The thread can form a shape memory cylinder, that is to say, the thread can form a hollow cylinder positioned around the needle and contained within the lumen of the cylindrical body; - The thread can be arranged around the body of the needle and form a sheath having a light and the polymer forming the body of the needle can be inserted into said light.

Claims

Demands

1. Needle (1) comprising a cylindrical body (10) extending along a longitudinal axis, at least one end (100) of which is beveled, said body (10) being formed at least from a polymer, said needle (1) being characterized: - in that it comprises at least one reinforcing wire (101) adapted to stiffen said body (10), said reinforcing wire (101) being formed at least from a shape-memory material; - in that the wire (101) comprises a stiffened portion and a flexible portion.

2. Needle (1) according to the preceding claim characterized in that the polymer is an oxy-l,4-phenylene-oxy-l,4-phenylene-carbonyl-1,4-phenylene.

3. Needle (1) according to any one of the preceding claims characterized in that the reinforcing wire (101) has at least one spiral-shaped portion around said longitudinal axis.

4. Needle (1) according to any one of the preceding claims characterized in that it comprises a plurality of reinforcing wires (101) forming a mesh.

5. Needle (1) according to any one of the preceding claims, characterized in that the reinforcing thread (101) is arranged in the body (10) of the needle.

6. Needle (1) according to claim 5, characterized in that the body (10) of said needle (1) is obtained by a process comprising a first step of extruding the polyaryletherketone polymer simultaneously with a step of pultrusion of at least one reinforcing yarn (101) within said extruded polyaryletherketone polymer.

7. Needle (1) according to claim 5, characterized in that the body of said needle (1) is obtained by a process comprising a first step of additive printing of the body (10) from a spool of polyaryletherketone polymer yarn around at least one reinforcing yarn (101).

8. Needle (1) according to claim 5, characterized in that the body (10) of said needle (1) is obtained by a process comprising a first subtractive printing step of the body (10) in a block

9. of polyaryletherketone polymer in which is arranged at least one reinforcing wire (101). Injection syringe (2) comprising: - A piston (21); - A pump body (20) equipped with a terminal fitting (200) for adjusting an injection needle (1); - An injection needle (1) according to any one of the preceding claims.

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