Needle

Abstract

To provide a needle that avoids needlestick injuries by not containing stainless steel but having a rigid needle body.SOLUTION: A needle (1) comprises a cylindrical body (10) extending along a longitudinal axis. At least one end (100) of the cylindrical body (10) is beveled. The body (10) is formed at least from a polymer. The needle (1) comprises at least one reinforcing thread (101) adapted to stiffen the body (10). The reinforcing thread (101) is formed at least from a shape memory material.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to the technical field of needles, and in particular to a syringe equipped with the above-mentioned needle. [Background technology]

[0002] Pyrogens or pyrogens are impurities that, when present in a medicine intended for administration to a patient, cause a fever reaction when the medicine is actually administered. In the medical field, many devices often feature injection and / or piercing needles for the flow of liquid medicines. In addition to being sterile and sterilizable, such needles intended to contain and transport medicines must also be pyrogen-free, i.e., they must not contain pyrogens, and depyrogenizable, i.e., they must be able to undergo a process that eliminates any pyrogens they may contain. To depyrogenize such needles, they must be heated to 253° C. for one hour. This is one of the reasons why needles for injecting medicines into human tissue are generally 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 retaining sufficient strength and rigidity to penetrate the skin and subcutaneous layers. However, once used, metal needles cannot be easily disposed of, which creates health problems due to contamination accidents resulting from contact with these non-sterile, non-pyrogenic needles.To solve the problem of needles for injecting medicines, especially into the human body, plastic needles have been proposed.

[0003] In practice, when medical plastic needles are used, the needles are disposable and are not depyrogenated, but rather manufactured under conditions such that they are pyrogen-free. However, once removed from the package and used, they cannot be depyrogenated. Moreover, since these needles cannot be depyrogenated, it is not possible to depyrogenate them before the first use to ensure that they are in fact non-pyrogenic. In fact, problems in production or during transportation or handling may lead to contamination with pyrogens.

[0004] In particular, needles are known that can be attached to a syringe and are both depyrogenable and easily disposable. In particular, needles of this type can consist of a cylindrical body extending along a longitudinal axis, at least one end of which is beveled and made of a polyaryletherketone polymer reinforced with stainless steel threads. However, one drawback of needles of this type is that they are rigid and not very flexible.

[0005] Therefore, the present invention has been made in this context and seeks to solve all of the aforementioned shortcomings. The object of the present invention is to provide a needle that does not contain stainless steel but has a rigid needle body, thereby avoiding needlestick injuries. Summary of the Invention

[0006] The object of the invention is a needle comprising a cylindrical body extending along a longitudinal axis and at least one end of which is inclined, said body being made at least from a polymer, said needle comprising at least one reinforcing thread adapted to harden said body, said reinforcing thread being made 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 preferably provide a conduit for the flow of liquids, in particular medicinal liquids to be injected or transfused. The needle body may have at least one beveled end, in particular one that may be used to pierce human tissue. In an embodiment where 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 along the entire length of the hollow body. In an embodiment with several reinforcing threads, the body may comprise three reinforcing threads embedded in a polyaryletherketone polymer, extending parallel to the longitudinal axis X-X' over the entire length of the hollow body, equally tensioned, equidistant from each other, and distributed such that pairs of threads define the same angle at the center. The three reinforcing threads may be uniformly tensioned along 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 means that the needle wall thickness may be about 0.25 mm. Such a wall thickness may not provide sufficient stiffness, i.e., resistance to deformation. The needle may have a small thickness as described above to help minimize pain and tissue damage to the patient.

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

[0011] The thread may have a diameter of less than 500 μm, in particular less than 300 μm. Considering this diameter, if the needle is exposed to flame or high temperature heating, the thread may also melt, to avoid rendering the needle unusable and possible perforation from its beveled end, and the health safety of the needle may be maintained.

[0012] The shape memory material may be soft and / or elastic over a first temperature range and rigid over a second temperature range.

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

[0014] The polymer may be one commercially available under the trade name PEEK®. The polymer may be a semi-crystalline aromatic linear polymer. The polymer may have a melting temperature of 343°C. The polymer may have a glass transition temperature of 143°C. The polymer may have an operating temperature of about 260°C. The polymer may have a softening temperature of up to 315°C. The needle containing the polymer may be depyrogenable, i.e., it may be heated to about 253°C, notably for one hour, without undergoing deformation or change in its chemical and mechanical properties. The polymer may be adapted to support a subsequent extrusion process. The coefficient of expansion of the polymer is approximately the same as that of stainless steel, so the polymer solidifies and hardens upon heating and retains the same shape after hardening.

[0015] The polymer may be biocompatible with human tissue. The polymer may be essentially pure, with very low levels of outgassing and extractable ions.

[0016] Advantageously, the reinforcing thread has at least one helical shaped portion around said longitudinal axis.

[0017] The reinforcing threads may be embedded in a polyaryletherketone polymer and extend around an axis of rotation coinciding with the longitudinal axis along the entire length of the hollow body. In an embodiment with three threads, the threads may be arranged such that each extends around an axis of rotation coinciding with the longitudinal axis along the entire length of the hollow body, the threads having the same direction of rotation. The three threads may be evenly spaced from each other.

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

[0019] In this embodiment, multiple threads extend around the longitudinal axis along the entire length of the hollow body such that the threads intertwine to form a mesh. The threads may overlap and cross.

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

[0021] In other words, the thread may be made of the same material throughout its length, but has stiffened and non-stiffened portions. In another embodiment, the thread may include two materials, a first material forming the stiffened portion and a second material forming the non-stiffened portion. A needle may therefore include a flexible portion and a rigid or semi-rigid portion.

[0022] Advantageously, each thread is circular in cross section.

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

[0024] Advantageously, each thread is elliptical in cross section.

[0025] In this embodiment, each thread may have a major axis of about 0.15 mm.

[0026] Advantageously, each thread is triangular in cross section.

[0027] Yarns with a triangular cross section may be used advantageously as they are stiffer than yarns with a circular cross section.

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

[0029] In another embodiment, the thread may form a shape memory cylinder, i.e., the thread may form a hollow cylinder positioned around the needle and within the lumen of the hollow body. In this embodiment, the needle may be disposable and the shape memory cylinder may be reusable, so that the hardened shape memory avoids contact with the product.

[0030] Advantageously, the body of the needle is obtained using a method comprising a first step of extruding a polyaryletherketone polymer and at the same time 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 threads into the extruded channels. The pultrusion process may correspond to the thread insertion process.

[0032] Advantageously, the at least one reinforcing thread is cured simultaneously with the pultrusion process.

[0033] The reinforcing threads may be cured at a temperature above 80° C. In one embodiment, the threads may be cured at a temperature suitable for sterilization.

[0034] Stiffening of the reinforcing yarns may be accomplished by heating the yarns. Once the yarn reaches its stiffening temperature, it may assume a shape and retain this shape upon cooling.

[0035] Once the thread has hardened, sterilization does not affect the stiffness of the body.

[0036] In one embodiment, the needle body is obtained by a method comprising a first step of extruding a polyaryletherketone polymer to form a body with a channel, and a second step of inserting at least one thread into said channel of the body. In this embodiment, the thread may be inserted at the end of the extrusion process to prevent the polymer from melting when the thread is heated, thus preventing the thread from coming into contact with the lumen of the needle body and contaminating the product to be injected.

[0037] In another embodiment, the at least one reinforcing thread is cured following the pultrusion process in a dry heat sterilization process in which the body of the needle incorporating the reinforcing thread is heated to a temperature of at least 160°C.

[0038] Advantageously, following the pultrusion process, the at least one reinforcing thread is hardened in a moist heat sterilisation process in which the body of the needle incorporating the reinforcing thread is heated to a temperature of at least 121°C.

[0039] The reinforcing yarns may be heated using either dry heat or moist heat.

[0040] Advantageously, the body of said needle is obtained using a method comprising a first step of add-on printing the body from a spool of polyaryletherketone polymer thread around at least one reinforcing thread.

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

[0042] Advantageously, the body of said needle is obtained by a method including a first step of subtractive printing said body in a block of polyaryletherketone polymer in which at least one reinforcing thread is disposed.

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

[0044] In this embodiment, the thread may form a sheath having a lumen and the polymer forming the needle body may be inserted into the lumen.

[0045] Advantageously, said needle body is obtained according to a first method and the reinforcing thread is obtained according to a second method forming a sheath inside which the needle body is placed.

[0046] Advantageously, at least one thread is made from a composite material.

[0047] The material may be a shape-memory alloy (SMA), in particular a copper-based alloy (e.g., with formulas CuAIBe, CuAINi, CuAIMn, CuZnAI), a nickel-titanium-based alloy (e.g., with formulas NiTi, NiTiFe, NiTiCu, NiTiCr, NiTiHf, NiTiCo, NiTiNb, etc.), and an iron-based alloy (e.g., with formulas FeMnSi, FeMnCr, FeMnCrSi). Some of these shape-memory alloys may be monocrystalline, i.e., composed of a single grain or composed of several grain boundaries separated by poorly oriented grains.

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

[0049] Another aspect of the present invention relates to an injection syringe comprising a plunger, a pump body equipped with a terminal fitting portion for fitting an injection needle, and an injection needle as described above.

[0050] The syringe may be adapted to inject a medicament, particularly into human tissue. The syringe may include a pump body that serves as a reservoir for the medicament to be injected. The pump body may include an end fitting having a tip adapted to receive an injection needle. The pump body may include a plunger disposed within said pump body adapted to propel the medicament through the needle.

[0051] The needles and syringes of the present invention may be manufactured by any method known to those skilled in the art, such as injection molding, extrusion, or a tension extrusion process known as pultrusion, in which the reinforcing yarns are held under tension as they and the polymer matrix pass through an extrusion die.

[0052] The needles, syringes, and connectors of the present invention may be manufactured by any method known to those skilled in the art, such as injection molding, extrusion, or a tension extrusion process known as pultrusion, in which the reinforcing yarns are held under tension as they pass through an extrusion die.

[0053] Advantageously, the pump body with the end fittings and the plunger are made from a polyaryletherketone polymer.

[0054] The syringe may be made from a polyaryletherketone polymer, which means that the pump body with the plunger and its tip may be made entirely from such a polymer.

[0055] Advantageously, the pump body and plunger equipped with the end fittings are made from a polyaryletherketone polymer containing a filler selected from glass fibers, carbon fibers, graphite granules, polytetrafluoroethylene (PTFE) granules, carbon black granules, and mixtures of two or more of these. [Brief description of the drawings]

[0056] Other advantages and features of the present invention will now be explained, by way of example only, and without limiting the scope of the invention, on the basis of the accompanying drawings, in which different figures represent: [Figure 1] 1 shows a partial view in longitudinal cross section of the end of a needle according to one embodiment of the present invention. [Diagram 2] 13 shows a partial longitudinal view of the end of a needle according to another embodiment of the present invention. [Diagram 3] 1 shows a partial longitudinal view of the end of a needle according to different embodiments of the present invention; [Figure 4]1 illustrates a cross-sectional view along a needle according to one embodiment. [Diagram 5] 1 shows a partial longitudinal cross-sectional view of a syringe with a needle according to the invention;

[0057] In the following description, identical elements by structure or function appearing in different figures retain the same reference numbers unless otherwise specified. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0058] Figure 1 shows a partial view in longitudinal cross section of the end of a needle according to one embodiment of the present invention. The needle is also described in relation to Figures 2 and 3, each of which represents a different embodiment of the needle, and Figure 4, which represents a cross-sectional view of the needle according to one embodiment. The needle is also described in Figure 5, in an embodiment in which the needle is used in a syringe.

[0059] 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 suitable for piercing human tissue. The cylindrical body 10 is hollow and has a central lumen 11. The body 10 has a circular cross section. The body 10 comprises at least one polymer. The polymer is oxy-1,4-phenylene-oxy-1,4-phenylene-carbonyl-1,4-phenylene. The polymer solidifies upon heating, becoming rigid and retaining the same shape after rigidification.

[0060] The needle 1 comprises at least one reinforcing thread 101 adapted to stiffen the body. The reinforcing thread 101 comprises a shape memory material. The material may be a shape memory alloy. The reinforcing thread is embedded in the body polymer. Each reinforcing thread has a diameter of 0.1 mm.

[0061] 1, the body 10 comprises three threads 101 extending parallel to the longitudinal axis along the entire length of the body 10. The threads 101 are equidistant from each other and distributed such that pairs of threads 101 define the same central angle.

[0062] In the embodiment illustrated 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 helical shaped portion extending around the longitudinal axis of the body. The threads 101 have the same direction of rotation. The threads 101 are evenly spaced apart from each other. The reinforcing threads 101 may be embedded in a polymer and extend along the entire length of the body 10 around an axis of rotation coinciding with the longitudinal axis.

[0063] In the embodiment illustrated in Figure 3, the body 10 comprises a plurality of threads 101 that form a mesh. The plurality of threads 101 extend about a longitudinal axis along the entire length of the body 10 such that the threads 101 are interwoven to form the mesh. The threads 101 overlap and cross.

[0064] In the embodiment illustrated in FIG. 4, each thread 101 has a circular cross section and the needle 1 has four reinforcing threads 101 .

[0065] FIG. 5 shows an injection syringe 2 having a pump body 20 fitted with a plunger 21 and a needle 1 .

[0066] The pump body 20 serves as a reservoir for the medicinal product to be injected. The pump body 20 may include an end fitting 200 having a tip adapted to receive an injection needle 1. The pump body 20 may include a plunger 21 disposed within said pump body 20 adapted to propel the medicinal product through the needle 1.

[0067] The pump body 20, end fitting 200 and plunger 21 are made from a polymer. The pump body 20, end fitting 200 and plunger 21 are made from a polyaryletherketone polymer.

[0068] The above description clearly explains how the present invention makes it possible to achieve the stated objective, namely by proposing a needle that is devoid of stainless steel but makes it possible to avoid needlestick injuries due to the rigidity of the needle body, by proposing a needle comprising a cylindrical body extending along a longitudinal axis, at least one end of which is beveled, said body being formed from at least a polyaryletherketone polymer, said needle comprising at least one reinforcing thread adapted to stiffen said body, said reinforcing thread being formed from at least a shape memory material.

[0069] In any case, the invention is not limited to the embodiments specifically described herein, but in particular extends to any equivalent means and any technically operable combination of these means. In particular, the following can be envisaged: - each thread is oval in cross section; -Each thread is triangular in cross section; - the cylindrical body is tapered at both ends; The reinforcing thread is disposed inside the needle body; the thread is capable of forming a shape memory cylinder, i.e. the thread is capable of forming a hollow cylinder positioned around the needle and within the lumen of the hollow body; The thread may be disposed around the needle body to form a sheath having a lumen, and the polymer forming the needle body may be inserted into said lumen.

Claims

1. A needle (1) comprising a cylindrical body (10) extending along a longitudinal axis, at least one end (100) of which is tapered, said body (10) being formed at least from a polymer, said needle (1) comprising at least one reinforcing thread (101) adapted to stiffen said body (10), said reinforcing thread (101) being formed at least from a shape memory material.

2. The needle (1) according to claim 1, characterized in that said polymer is oxy-1,4-phenylene-oxy-1,4-phenylene-carbonyl-1,4-phenylene.

3. 3. The needle (1) according to claim 1 or 2, characterized in that said reinforcing thread (101) has at least one portion in the form of a spiral centered on said longitudinal axis.

4. A needle (1) according to any one of claims 1 to 3, characterised in that it comprises a number of reinforcing threads (101) forming a mesh.

5. The needle (1) according to any one of the preceding claims, characterized in that said thread (101) comprises a stiffening portion and a flexible portion.

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

7. 7. The needle (1) according to claim 6, characterized in that the body (10) of the needle (1) is obtained according to a method comprising a first step of extruding the polyaryletherketone polymer and at the same time a step of pultrusion of at least one reinforcing thread (101) into the extruded polyaryletherketone polymer.

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

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

10. An injection syringe (2), - a plunger (21), - a pump body (20) equipped with an end fitting (200) for adjusting the injection needle (1); An injection syringe (2) comprising an injection needle (1) according to any one of claims 1 to 9.

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