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 to be administered to a patient, cause a febrile reaction upon actual administration of the pharmaceutical product. In the medical field, many devices include injection and / or puncture needles allowing the flow 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 apyrogenic, i.e. they do not contain pyrogens, and must be depyrogenable, i.e. they must be able to undergo a treatment which eliminates any pyrogens they may contain. Indeed, to depyrogenize such needles, they must be heated to 253°C for one hour.This is one of the reasons why needles for injecting a pharmaceutical product into human tissue are usually made of metal. Another reason is that these needles for injection into human tissue must be very thin to limit the pain felt by the patient, while maintaining sufficient strength and rigidity for penetration of the skin and subcutaneous layers. However, metal needles, once used, cannot be easily disposed of, which poses a health problem due to contamination accidents resulting from contact with these non-sterilized and non-depyrogenated needles. To solve this problem of needles for injecting pharmaceutical products, especially into the human body, needles made of plastic material have been proposed.

[0003] In reality, when a plastic needle for medical use is used, it is for single use and not depyrogenated, but manufactured under conditions such that it is apyrogenic. However, once removed from its packaging and used, it is not depyrogenable. In addition, since these needles are not depyrogenable, it is not possible, even before first use, to depyrogenize them to be certain that they are indeed apyrogenic. Indeed, production problems or problems occurring during their transport or handling may have led to contamination by pyrogens.

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

[0005] The invention therefore falls within this context and seeks to resolve all of the aforementioned drawbacks. Thus, the invention seeks to propose a needle that avoids pricking oneself by being free of stainless steel but whose needle body is rigid. Presentation of the invention.

[0006] The subject of the invention is 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 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 section. The hollow body may provide a conduit for the flow, preferably of a liquid, in particular a pharmaceutical liquid to be injected or transfused. The body of the needle may have at least one beveled end capable of allowing the perforation of, in particular, human tissue. In an embodiment in which the needle has a single beveled end, the other end may be adapted to be inserted into a syringe.

[0008] In one embodiment, the body may comprise at least one reinforcing thread embedded in the polymer of said body. The thread may extend parallel to the longitudinal axis over the entire length of the hollow body. In an embodiment comprising several reinforcing threads, the body may comprise three reinforcing threads embedded in the polyaryletherketone polymer, extending parallel to the longitudinal axis XX' over the entire length of the hollow body, being equally stretched and equidistant from each other and distributed so that the threads two by two define an identical central angle. The three reinforcing threads may be uniformly stretched over their entire length.

[0009] The needle may be adapted for injection into human tissue and may have an outer diameter of about 0.7 mm and an inner diameter of about 0.25 mm which therefore means that the wall thickness of the needle may be about 0.25 mm. At such wall thicknesses, the rigidity, i.e. the resistance to deformation, may be insufficient. The needle may have a low thickness as mentioned above to enable pain and tissue damage to the patient to be minimized.

[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, carbon black granules and mixtures of two or more thereof.

[0011] The wire may have a diameter of less than 500 μm, in particular less than 300 μm. In view of this diameter, when the needle is exposed to a flame or high temperature heating, in order to render it unusable and to avoid the possibility of perforation from its beveled end, the wires may also melt and the health safety of the needle can be maintained.

[0012] The shape memory material may be flexible and / or elastic for a first temperature range and may 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 temperature of 343°. 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 temperature of up to 315°C. The needle comprising the polymer may be depyrogenable, i.e. it may 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 expansion of the polymer is substantially the same as that of stainless steel, so it can solidify upon heating to be stiffened and retains the same shape after stiffening.

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

[0016] Advantageously, the reinforcing wire has at least one portion in the form of a spiral around said longitudinal axis.

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

[0018] Advantageously, the needle comprises a plurality of reinforcing threads 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 intertwine to form a mesh. The wires may overlap and cross.

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

[0021] That is to say that the wire can comprise the same material over its entire length but with a stiffened portion and a non-stiffened portion. 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 section.

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

[0026] Advantageously, each wire has a triangular 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 wire may form a shape memory cylinder, i.e. the wire may form a hollow cylinder positioned around the needle and included in the lumen of the hollow body. In this embodiment, the needle may be disposable and the shape memory cylinder reusable, the stiffened shape memory portion therefore avoids being in 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 step of pultrusion of at least one reinforcing thread within said extruded polyaryletherketone polymer.

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

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

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

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

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

[0036] In one embodiment, the body of the needle is obtained according to a method comprising a first step of extruding the polyaryletherketone polymer to form a body provided with a channel and a second step of inserting at least one wire into said channel of the body. In this embodiment, the insertion of the wire can be carried out immediately after the extrusion has finished to prevent the heating of the wire from melting the polymer and thus prevent the wire from being in contact with the lumen of the body of the needle and prevent it from being able to contaminate the products to be injected.

[0037] In another embodiment, the 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 thread is stiffened, subsequently to the pultrusion step, in a wet heat sterilization step in which the body of said needle incorporating the reinforcing thread is heated to a temperature of at least 121°.

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

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

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

[0042] Advantageously, the body of said needle is obtained according to a process comprising a first step of subtractive printing of the body in a block of polyaryletherketone polymer in which the 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 wire may form a sheath having a lumen and the polymer forming the body of the needle may be inserted into said lumen.

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

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

[0047] The material may be a shape memory alloy (SMA or in English for shape memory alloy) particularly based on copper (for example with chemical formula CuAIBe, CuAINi, CuAIMn, CuZnAI), nickel-titanium based (e.g. chemical formula NiTi, NiTiFe, NiTiCu, NiTiCr, NiTiHf, NiTiCo, NiTiNb etc.), and iron-based alloys (e.g. chemical formula FeMnSi, FeMnCr, FeMnCrSi). Some of these shape memory alloys can be monocrystalline, i.e. made up of a single grain, or several grains separated by low-misorientation grain boundaries.

[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 as described previously.

[0050] The syringe may be adapted for injecting pharmaceutical products, in particular into human tissues. The syringe may comprise a pump body acting as a reservoir for a pharmaceutical product to be injected. The pump body may comprise a terminal connector comprising a tip adapted to receive the injection needle. The pump body may comprise a piston arranged in said pump body, adapted to propel the pharmaceutical product through the needle.

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

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

[0053] Advantageously, the pump body equipped with its terminal connection 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 equipped with its tip can be entirely made of such a polymer.

[0055] Advantageously, the pump body equipped with its terminal connection and the piston are made of a polyaryletherketone polymer comprising fillers chosen 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 characteristics of the present invention are now described with the aid of examples which are purely illustrative and in no way limitative of the scope of the invention, and from the appended drawings, drawings in which the various figures represent:

[0057] [Fig-1] represents a partial longitudinal 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 end of a needle according to another embodiment of the invention.

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

[0060] [Fig.4] represents a cross-sectional view of a needle according to a method of rea lization.

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

[0062] In the following description, elements that are identical, by structure or by function, appearing in different figures retain, unless otherwise specified, the same references. Description of an embodiment.

[0063] [Fig. 1] shows a partial longitudinal sectional view of the end of a needle according to one embodiment of the invention. The needle is also described in connection with [Fig. 2] and [Fig. 3] each showing different embodiments of the needle and with [Fig. 4] showing 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 comprises at least one beveled end 100. The beveled end 100 is suitable for perforating human tissue. The cylindrical body 10 is hollow and comprises a lumen 11 in its center. The body 10 has a circular section. The body 10 comprises at least one polymer. The polymer is an oxy-1,4-phenylene-oxy-1,4-phenylene-carbonyl-1,4-phenylene. The polymer solidifies upon heating to be stiffened and retains the same shape after stiffening.

[0065] The needle 1 comprises 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.l], the body 10 comprises three wires 101 extending parallel to the longitudinal axis over the entire length of the body 10. The wires 101 are equally stretched 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 threads 101 extending around the body 10 of the needle 1. The reinforcing threads 101 have at least one spiral-shaped portion extending around the longitudinal axis of the body. The threads 101 have an identical direction of rotation. The threads 101 are equidistant from each other. The reinforcing thread 101 may be embedded in the polymer, extending around an axis of rotation coinciding with the longitudinal axis over 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 over the entire length of the body 10, such that said wires 101 intertwine to form a mesh. The wires 101 overlap and cross.

[0069] In the embodiment described in [Fig.4], each thread 101 has a circular section and the needle 1 comprises four reinforcing threads 101.

[0070] [Fig.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 comprises an end connector 200 comprising a tip adapted to receive the injection needle 1. The pump body 20 comprises a piston 21 arranged in said pump body 20, adapted to propel the pharmaceutical product through the needle 1.

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

[0073] The foregoing description clearly explains how the invention makes it possible to achieve the objectives it has set itself, namely to propose a needle making it possible to avoid pricking oneself by being free of stainless steel but whose needle body is rigid, by proposing 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 cannot be limited to the embodiments specifically described in this document, and extends in particular to all equivalent means and to any technically effective combination of these means. We may par- particular consider: - Each wire has an elliptical section; - Each wire has a triangular section; - The cylindrical body is beveled at both ends; - The reinforcing thread is arranged in the body of the needle; - The wire can form a shape memory cylinder, that is to say that the wire can form a hollow cylinder positioned around the needle and included in the lumen of the cylindrical body; - The wire can be arranged around the body of the needle and form a sheath having a lumen and the polymer forming the body of the needle can be inserted into said lumen.

Claims

Claims

1. Needle (1) comprising a cylindrical body (10) extending along a longitudinal axis of which at least one end (100) 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.

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

3. Needle (1) according to one of the preceding claims, characterized in that the reinforcing thread (101) has at least one portion in the form of a spiral around said longitudinal axis.

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

5. Needle (1) according to one of the preceding claims, characterized in that the thread (101) comprises a stiffened portion and a flexible portion.

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

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

8. Needle (1) according to claim 6, characterized in that the body of said needle (1) is obtained according to a method comprising a first step of additive printing of the body (10) from a coil of polyaryletherketone polymer thread around the at least one reinforcing thread (101).

9. Needle (1) according to claim 6, characterized in that the body (10) of said needle (1) is obtained according to a process comprising a first step of subtractive printing of the body (10) in a block of polyaryletherketone polymer in which the at least one reinforcing thread (101) is arranged.

10. Injection syringe (2) comprising: - A piston (21); - A pump body (20) equipped with a terminal connection (200) for adjusting an injection needle (1); - An injection needle (1) according to any one of the preceding claims.

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