Double valve

Abstract

A diaphragm (1) for a non-return valve (2) in the field of devices for medical use allowing the injection of liquids into the human body, comprising at least two opposite faces connected by a first rough axial surface (9), the diaphragm (1) comprising at least: - A central portion (3) comprising a first rough radial central surface (4); - An intermediate annular portion (5) around the central portion (3), the intermediate annular portion (5) comprising a first smooth radial surface (6), the first smooth radial surface (6) surrounding the rough radial central surface (4); - A peripheral annular portion (7) around the second, intermediate portion (5), the peripheral annular portion (7) comprising a first rough peripheral radial surface (8) and the first rough axial surface (9), the first rough peripheral radial surface (8) surrounding the first smooth radial surface (6); the first rough radial central surface (4), the first smooth radial surface (6) and the first rough peripheral radial surface (8) extending radially and being configured to be on a same face of the diaphragm (1).

Description

[0001] Description

[0002] Title of the invention: Double Valve

[0003] Technical field

[0004] [1] The invention relates to a valve, in particular an anti-reflux valve used in the injection of contrast medium, in the field of medical devices allowing the injection of liquids into the human body, in the context of multi-patient use. More specifically, the invention relates to a diaphragm inside an anti-reflux valve.

[0005] State of the art

[0006] [2] A non-reflux valve, also called a one-way non-return valve, is a medical device that allows direct access to the venous line in one direction, always towards the patient, while preventing any reflux upstream of the valve into the infusion line.

[0007] [3] In the context of multi-patient use for an injection of a pharmaceutical product, such as a contrast agent, a valve can be mounted inside a set called a “patient line”. With the help of the valve, said “patient line” makes it possible to block any backflow and thus prevent a risk of contamination of patients who will subsequently be injected with this same consumable.

[0008] [4] Document FR2776742 is known from the state of the art, which discloses an example of an anti-reflux valve which comprises a reinforcing body at least partially enveloping the valve body and which constitutes a single-piece external peripheral envelope.

[0009] [5] Document EP0648513A1 is also known, which discloses an injection system comprising a disposable part and a non-disposable part. Said disposable part comprises an interchangeable removable connector itself comprising a non-return valve. This makes it possible to avoid having to throw away the entire injection device after treating a patient.

[0010] [6] To be effective and ensure a perfect seal, a non-reflux valve may include one or two membranes, also called diaphragms. The membranes must have the most perfect surface finish possible. Ideally, the membranes should have a “mirror polish” type surface finish.

[0011] [7] However, this type of surface presents many difficulties and disadvantages. On the one hand, the surface is very static and therefore more easily attracts light particles such as dust. On the other hand, it is a type of surface that can mark. For example, fingerprints mark the part very easily. Any contact with this type of surface can cause degradation of the latter and can be the cause of a malfunction of the diaphragm or the non-return valve later on.

[0012] [8] Indeed, degradation can occur in the area of ​​the diaphragm that is supposed to create a seal with its contact area. Such degradation can cause a disturbance in such a way as to create an open channel or a small non-sealed area through which any type of microbes or bacteria can pass and cause contamination.

[0013] [9] A malfunction of a non-return valve in multi-patient use can therefore prove critical and create a real risk of contamination of a patient.

[0014]

[0010] Another problem has been identified by the applicant with regard to the production of this type of diaphragm. Indeed, given the very smooth surface of this type of diaphragm, it happens that a smooth surface of a first diaphragm comes into contact with a smooth surface of a second diaphragm. A suction effect can then occur and it is necessary to separate them manually, taking all the risks of marking or degradation previously mentioned.

[0015]

[0011] Industrially, if there is any deterioration on this type of part, no risk can be taken for a patient and the said part must therefore be discarded. This represents a significant industrial cost in addition to the unnecessary loss of materials and resources.

[0016]

[0012] The diaphragms or the manufacturing processes of said diaphragms known from the state of the art do not provide any solution to the problems mentioned above.

[0017]

[0013] There is therefore a real need to develop a diaphragm capable of solving the problems mentioned above, in particular to develop a diaphragm which can ensure a perfect seal while reducing the risks of malfunction which can prove critical for the health of a patient. There is also a need to develop a solution for an industrial process capable of manufacturing such diaphragms.

[0018] Summary of the invention

[0019]

[0014] The invention makes it possible to solve the problems mentioned above.

[0020]

[0015] In particular, the invention proposes a solution of a diaphragm capable of avoiding any risk of disruption between the diaphragm and its contact zone intended to ensure perfect sealing. The invention also proposes a manufacturing solution to achieve this type of diaphragm.

[0021]

[0016] According to one embodiment, the invention relates to a diaphragm for an antireflux valve in the field of devices for medical use allowing the injection of liquids into the human body comprising at least two opposite faces and connected by a first rough axial surface 9, said diaphragm 1 comprising at least:

[0022] - A central portion 3 comprising a first rough radial central surface 4;

[0023] - An intermediate annular portion 5 around said central portion 3, said intermediate annular portion 5 comprising a first smooth radial surface 6, said first smooth radial surface 6 surrounding said rough radial central surface 4;

[0024] - A peripheral annular portion 7 around said second intermediate portion 5, said peripheral annular portion 7 comprising a first rough peripheral radial surface 8 and said first rough axial surface 9, said first rough peripheral radial surface 8 surrounding said first smooth radial surface 6; said first rough radial central surface 4, first smooth radial surface 6 and first rough peripheral radial surface 8 extending radially and configured to be on the same face of said diaphragm 1.

[0025]

[0017] According to an alternative embodiment, said first rough radial central surface 4, first smooth radial surface 6 and first rough peripheral radial surface 8 may extend radially and may be configured according to the same surface orientation of said diaphragm 1.

[0026]

[0018] Thanks to this characteristic, a first rough radial central surface due to its roughness will considerably limit the points of contact with a smooth surface of another part. A suction effect requires an absence of air between two surfaces. The roughness limiting the points of contact between two surfaces will allow the creation of localized micro-pockets of air. This will therefore prevent a suction effect with another surface. The applicant has in particular identified that this portion was not critical to allow sealing.

[0027]

[0019] Thanks to this characteristic, a first smooth radial surface is the most critical part of the diaphragm since it is supposed to ensure sealing and prevent the passage of bacteria or other undesirable organisms. This part must have a polishing that can be described as "mirror polishing".

[0028]

[0020] Thanks to this characteristic, the second rough radial surface and the peripheral surface will also contribute to limiting the suction effect. Thus, the invention makes it possible to limit the smooth surfaces as much as possible to only those surfaces that are critical for ensuring a seal. In this way, all of the rough surfaces will also generally reduce the static effect and therefore generally reduce the attraction of dust, said dust being likely to cause damage to the smooth surface part of the diaphragm and / or to infiltrate towards other internal elements of a non-reflux valve.

[0029]

[0021] According to one embodiment, the diaphragm is characterized in that the central portion, the intermediate annular portion and the peripheral annular portion can be in one piece.

[0030]

[0022] Thanks to this characteristic, a diaphragm having all of its portions constructed from a single piece has the advantage of being simpler to design industrially.

[0031]

[0023] According to one embodiment, the diaphragm is characterized in that the central portion may comprise a material providing a hardness greater than that of the intermediate annular portion and the peripheral annular portion.

[0032]

[0024] Thanks to this characteristic, when a central portion has a greater thickness, the part will be more difficult to deform or bend. The higher the hardness of the central portion, the stiffer the central portion will be and the higher the contact pressure in the sealing area will be. The higher said contact pressure, the stronger the barrier protection against microbes and viruses.

[0033]

[0025] According to one embodiment, the diaphragm is characterized in that the central portion may comprise a hardness of between 20 Shore A and 90 Shore A, preferably between 40 Shore A and 80 Shore A.

[0034]

[0026] According to one embodiment, the diaphragm is characterized in that the central portion may comprise a material providing a thickness greater than that of the intermediate annular portion and the peripheral annular portion.

[0027] Thanks to this characteristic, a greater thickness makes it possible to increase, as with hardness, the contact pressure in the sealing zone.

[0035]

[0028] According to one embodiment, the diaphragm is characterized in that the central portion and / or the peripheral annular portion may be higher than the intermediate annular portion so that the smooth radial surface is set back relative to the first rough radial central surface and / or the second rough radial surface.

[0036]

[0029] According to one embodiment, the diaphragm according to the preceding claim is characterized in that a difference in elevation of a central portion or a peripheral annular portion relative to the intermediate annular portion may be between 0.01 and 0.5 mm, preferably between 0.02 mm and 0.2 mm, more preferably between 0.05 mm and 0.1 mm.

[0037]

[0030] Thanks to this feature, the difference in elevation allows the smooth surface, critical for ensuring sealing, to remain set back relative to at least one of the two neighboring rough surfaces. This eliminates any possibility of a suction effect occurring between two diaphragms. Indeed, in this way, two smooth recessed surfaces belonging to two diaphragms can simply no longer, or only with great difficulty, come into direct contact. Only the rough, non-critical surfaces can come into contact with each other.

[0038]

[0031] According to one embodiment, the diaphragm is characterized in that the first rough radial central surface may not be contiguous with the second smooth radial surface.

[0039]

[0032] According to one embodiment, the diaphragm according to any one of the preceding claims characterized in that the first rough axial surface may be cylindrical, convex or concave in shape or a combination of these shapes.

[0040]

[0033] According to one embodiment, the diaphragm is characterized in that the diaphragm can be composed of silicone of the liquid silicone rubber type or nitrile or silicone gum or an elastomeric material.

[0041]

[0034] In the mounted and assembled state, a needle can deform the diaphragm, which may originally be flat. This deformation makes it possible to bring said smooth surface into contact with the internal wall of the valve and to create a seal by contact pressure.

[0042]

[0035] Thanks to this characteristic, this type of silicone or rubber allows stiffness to be maintained after deformation. Indeed, this type of material allows deformability and a memory effect of the elastomeric material, as well as a reduction in residual deformation after compression. Liquid silicone rubber type silicone has excellent elastic memory, i.e. the part becomes straight again, i.e. not deformed when not under stress even after a long period under stress. Nitrile also has a very low memory effect. This low memory characteristic allows a diaphragm to be found in very good condition for reuse after use.

[0043]

[0036] According to one embodiment, the diaphragm is characterized in that said diaphragm can be cylindrical, truncated cone-shaped or convex or concave.

[0044]

[0037] According to one embodiment, the diaphragm is characterized in that a rough surface can have a surface roughness at least greater than or equal to 6 μm compared to that of a smooth surface.

[0045]

[0038] According to one embodiment, the diaphragm is characterized in that the roughness (Ra) of the first and second rough surfaces can be between 6 pm and 32 pm, preferably between 9.5 pm and 20 pm.

[0046]

[0039] Thanks to this characteristic, a roughness greater than 6 pm makes it possible to avoid or sufficiently reduce the previously mentioned disadvantages linked to a smooth surface. More specifically, the attraction of light particles such as dust, or the risk of marking by fingers and the damage that can result from this. This part of the diaphragm is not the contact surface for achieving the seal. This minimal roughness will also help to prevent the suction effect with the smooth surface of another part.

[0047]

[0040] Thanks to this characteristic, a roughness of less than 32 pm makes it possible to avoid catching between two parts, this time due to their surface condition being too granular.

[0048]

[0041] According to one embodiment, the diaphragm is characterized in that the roughness (Ra) of the smooth surface can be between 0 and 10 pm, preferably between 0 and 3.2 pm, more preferably between 0 and 0.8 pm, even more preferably between 0.01 and 0.1 pm.

[0049]

[0042] Thanks to this characteristic, the smooth surface helps prevent the passage of bacteria or other undesirable organisms. A low roughness close to 0 results in a surface with no or limited microcavities or micro-channels that could harbor, develop and / or allow bacteria and / or viruses to pass through.

[0050]

[0043] According to one embodiment, the diaphragm is characterized in that each of the central portion, the intermediate annular portion and the peripheral annular portion may respectively comprise a second rough radial central surface, a second smooth radial surface and a second rough radial surface, arranged symmetrically and with an opposite surface orientation relative to each of the first surfaces.

[0044] Thanks to this characteristic, the diaphragm comprising a symmetry for each surface, allows ease of use for the user who no longer has to worry about the orientation of the diaphragm during its assembly.

[0051]

[0045] According to one embodiment, the diaphragm is characterized in that said diaphragm can be obtained by Injection Molding.

[0052]

[0046] Thanks to this characteristic, a diaphragm obtained by Injection Molding can be designed to have an alternation of rough surfaces and smooth surfaces. This alternation is much more complicated to obtain with other methods which will require manufacturing a rough diaphragm and then producing the smooth surface by intervention on the pre-designed diaphragm, for example by punching or by polishing. This type of intervention can create induced stresses on the material or the surface of the diaphragm.

[0053]

[0047] Thanks to Injection Molding, the punching or possibly polishing steps are eliminated since the desired shape is obtained directly. There are therefore fewer stress steps, the result is more refined and the materials as well as the manufactured surfaces have fewer induced stresses. This also allows less waste to be generated and therefore lowers manufacturing costs.

[0054]

[0048] A diaphragm obtained by Injection Molding makes it possible, in particular, to intervene on the desired thickness of a portion. Intervening on the wall thickness from the design phase allows better control of the aesthetics, weight and mechanical resistance of the part. Parts that are too thick may have sink marks, i.e. depressions that can lower the surface pressure locally and weaken the sealing properties of an intermediate annular portion, for example. Parts that are too thick may also have deformation, internal cavities or unwanted air pockets.

[0055]

[0049] According to another embodiment, the diaphragm is characterized in that said diaphragm can be obtained by compression.

[0056]

[0050] The invention also admits an anti-reflux valve for the medical field comprising at least one diaphragm according to any one of claims 1 to 14.

[0057]

[0051] According to one embodiment, the anti-reflux valve is characterized in that it can comprise at least two diaphragms (1). Brief description of the figures:

[0058]

[0052] The invention will be better understood, and other aims, details, characteristics and advantages of the invention will appear more clearly during the following description of several particular embodiments of the invention, given solely for illustrative and non-limiting purposes, with reference to the appended drawings.

[0059] Figure 1 shows a diaphragm according to the invention in the unmounted state.

[0060] Figure 2 shows a first variant of a diaphragm according to the invention.

[0061] Figure 3 shows a second variant of a diaphragm according to the invention.

[0062] Figure 4 shows a diaphragm according to the invention, in a longitudinal view, in the mounted state with a non-reflux valve.

[0063] Figure 5 shows the diaphragm according to the invention in a longitudinal sectional view.

[0064] Figure 6 shows a non-reflux valve in the assembled state with two diaphragms according to the invention.

[0065] Figure 7 shows, in an exploded view, a diaphragm according to the invention inside a non-reflux valve.

[0066] Definition(s):

[0067]

[0053] Steaming means the action of subjecting a substance to the heat of an oven.

[0068]

[0054] Punching means the action of removing material by making holes.

[0069]

[0055] Injection Molding means a process for implementing a thermosetting mixture, the material of which is injected in the liquid state into the injection tool and then heated in order to create a polymerization reaction, making the part thus created solid.

[0070]

[0056] A diaphragm may comprise at least two faces. A diaphragm according to the invention will have at least two faces symmetrically opposite each other. A face may comprise the whole of the first rough radial central surface, the first smooth radial surface and the first rough peripheral radial surface.

[0071]

[0057] A surface orientation is understood to mean the selection of an orientation in a 3-dimensional space. To orient a plane, we choose a vector "n" normal to this plane: a basis (i,j) of the plane is then said to be direct if the basis (i, j, n) of the space is.

[0072]

[0058] A face may therefore comprise two or more surfaces having the same surface orientation.

[0073]

[0059] Axial surface is understood to mean a surface which extends axially along a longitudinal axis X. The axially extending surface may admit local discontinuities, said discontinuities being able to take the form of a bump or a hollow.

[0074]

[0060] By radial surface is meant a surface which extends radially from a longitudinal axis X. The surface which extends axially may admit local discontinuities, said discontinuities being able to take the form of a bump or a hollow.

[0075]

[0061] Compression set refers to the permanent change in the shape of a material after being subjected to compression. This property is measured to assess the ability of a material to retain its original shape after being subjected to compressive stress.

[0076]

[0062] Surface roughness RA, also called arithmetic mean roughness, is understood to mean the measurement of the fineness of the surface irregularities of a part or material. It is defined as the arithmetic mean of the absolute values ​​of the surface profile heights relative to a mean line. It is a measurement of the average of the deviations between the peaks and valleys of the surface relative to a reference line. Description of the embodiments and figures:

[0077]

[0063] In the description and the claims, the terms "outer" and "inner" and the orientations "axial" and "radial" may be used to designate, according to the definitions given in the description, elements of the diaphragm. The longitudinal axis X determines the "axial" orientation. The "radial" orientation is directed orthogonally to the longitudinal axis X. The "circumferential" orientation is directed orthogonally to the axis X of rotation and orthogonal to the radial direction, i.e., ortho-radially. The terms "outer" / "external" or "inner" / "internal" may be used to define the orientation or relative position of one component with respect to another, with reference to the longitudinal axis X.

[0078]

[0064] Figure 1 shows a diaphragm 1 having a longitudinal axis X and which is in the form of a disc with two opposite faces. The two opposite faces are connected by an external edge or a rough axial surface 9. Said diaphragm 1 comprises a central portion 3 comprising a first rough radial central surface 4. This central portion 3 extends axially along the axis X and radially from this same axis X and is in the form of a cylinder. The longitudinal axis X passes through the most central point of the portion 3 and of the diaphragm 1.

[0079]

[0065] The diaphragm 1 comprises an intermediate annular portion 5 around said central portion 3. The intermediate annular portion 5 is in the form of a hollow cylinder integral with the central portion 3. The intermediate annular portion 5 comprises a first smooth radial surface 6 which extends radially from the rough radial central surface 4. Said first smooth radial surface 6 surrounds in a non-integral manner said rough radial central surface 4.

[0080]

[0066] The diaphragm 1 comprises a peripheral annular portion 7 around said second intermediate portion 5. Said peripheral annular portion 7 comprises a first rough peripheral radial surface 8 surrounding in a non-jointed manner the first smooth radial surface 6. Said peripheral annular portion 7 is of cylindrical shape surrounding the intermediate annular portion 5 and comprises a first rough axial surface 9 extending axially.

[0067] The central portion 3 has a width greater than that of said intermediate annular portion 5. The intermediate annular portion 5 has a width greater than that of said peripheral annular portion 7.

[0081]

[0068] The first rough peripheral radial surface 8 and the first rough axial surface 9 are joined at their ends. These rough surfaces are configured to bear on internal surfaces of a non-reflux valve in the mounted state, in order to ensure the seat of the diaphragm against the internal wall of a valve.

[0082]

[0069] Said first rough radial central surface 4, first smooth radial surface 6 and first rough peripheral radial surface 8 are present on the same first face of the diaphragm 1.

[0083]

[0070] Said first surfaces 4, 6 extend radially and are configured according to the same surface orientation. This surface orientation is turned in the opposite direction to the normal flow, that is to say so as to face it, inside a non-reflux valve.

[0084]

[0071] The first rough axial surface 9 has a convex shape. This rough axial surface 9 is circular and delimits the circumference of the diaphragm 1.

[0085]

[0072] The diaphragm 1 also comprises a rough basal radial surface 22 opposite the radial surfaces of the central portion, the intermediate portion and the peripheral portion. That is to say that the rough basal radial surface is present on the second opposite face of the diaphragm 1.

[0086]

[0073] In the mounted and assembled state, a needle can deform the diaphragm, which is originally flat. This needle then bears at the level of the rough basal surface 22 of the diaphragm 1. This deformation makes it possible to bring said smooth surface into contact with the internal wall of the valve and seal the seal.

[0087]

[0074] The invention, however, admits a variant (not illustrated) according to which the diaphragm 1 is configured in such a way that each of the central portion 3, the intermediate annular portion 5 and the peripheral annular portion 7 comprises, instead of a simple rough basal surface 22, respectively a second rough radial central surface 40, a second smooth radial surface 60 and a second rough radial surface 80. Said second surfaces 40, 60, 80 are arranged symmetrically and have an opposite surface orientation relative to each of the first surfaces. In this case, in the mounted state, a needle can always bear at the level of the second rough radial central surface.

[0088]

[0075] Such a diaphragm comprising two types of symmetrical surfaces, allows ease of use for the user who no longer has to worry about the orientation of the diaphragm when mounting it.

[0089]

[0076] In the case of Figure 1, the central portion 3, intermediate portion 5 and peripheral portion 7 are of a single piece, and comprise the same type of material. That is to say that the intermediate annular portion 5 is adjacent and integral with the central portion 3 and the peripheral annular portion 7.

[0090]

[0077] However, the invention allows that the diaphragm can comprise separate portions with different materials.

[0091]

[0078] This has the advantage for a manufacturer of selecting different types of materials depending on their cost or of providing a capacity to replace a defective portion for example.

[0092]

[0079] Another advantage is to be able to select a thicker or harder central portion compared to the other intermediate or peripheral portions. Indeed, when a central portion has a greater thickness compared to the other portions, the part will be more difficult to deform or bend. The greater the thickness of the central portion, the higher the opening threshold of the diaphragm will be.

[0093]

[0080] Figure 1 also shows that the central portion 3 and the peripheral annular portion 7 are higher than the intermediate annular portion 5 so that the smooth radial surface 6 is set back relative to the first rough radial central surface 4 and the second rough radial surface 8.

[0094]

[0081] The difference in elevation allows the smooth surface 6, critical for ensuring sealing, to remain set back relative to at least one of the two neighboring rough surfaces. This eliminates any possibility of a suction effect occurring between two diaphragms. Indeed, in this way, two smooth recessed surfaces belonging to two diaphragms according to the invention can simply no longer, or with great difficulty, come into direct contact. Only the rough, non-critical surfaces can come into contact.

[0082] The invention also allows a variant (not illustrated) according to which the diaphragm comprises a central portion 3, an intermediate portion 5 and a peripheral portion 7 having an alignment of their surfaces.

[0095]

[0083] The diaphragm 1 has a difference in elevation of a central portion 3 and the peripheral annular portion 7 relative to the intermediate annular portion 5. This portion is between 0.01 and 0.5 mm, but there are variants in which this difference is between 0.02 mm and 0.2 mm, or between 0.05 mm and 0.1 mm. There are also variants where there is no difference in elevation.

[0096]

[0084] The process of implementation by Injection Molding (also called “Liquid Silicone Rubber” injection) to produce the diaphragm 1 is carried out in the following manner:

[0097]

[0085] LSR (Liquid Silicone Rubber) injection molding is a manufacturing process that produces high-quality, precision silicone rubber parts. It is beneficial for creating complex shapes and designs with excellent detail and consistency. The process involves injecting liquid silicone rubber into a mold cavity, allowing it to cure and solidify into the desired shape. Here is a brief overview of how LSR injection molding works:

[0098]

[0086] Preparation of a mold: Said mold is composed of two halves. A first half called "injection" and the other "clamping" fit together to create a cavity into which liquid silicone rubber will be injected.

[0099]

[0087] Preparation of silicone: Liquid silicone rubber is a two-component material, namely a base silicone and a curing agent. These components are mixed in a precise ratio. The mixture is degassed to remove any air bubbles that could affect the quality of the final part.

[0100]

[0088] Injection: The mixed and degassed liquid silicone rubber is transferred to an injection unit. The injection unit heats the material to a specific temperature to reduce its viscosity and facilitate its flow. The material is injected into the mold cavity through a nozzle or sprue.

[0101]

[0089] Curing: Once the liquid silicone rubber is injected into the mold cavity, it begins to harden. The curing process is usually initiated by heat, although some molds may use other methods, such as UV light. The heat causes the silicone to crosslink and solidify, forming the mold cavity. Curing time varies depending on the part design and the silicone material.

[0090] Cooling and Part Removal: After the curing process, the mold is cooled to allow the silicone to fully set. Once cooled, the mold is opened and the finished part is removed.

[0102]

[0091] The Injection Molding process allows the production of complex geometries, excellent part consistency, high precision. It also provides resistance to extreme temperatures, chemicals and aging.

[0103]

[0092] The Injection Molding process also makes it possible to eliminate post-hardening intervention steps on the diaphragm such as punching or polishing. Punching consists of removing material which can create or induce fragility on the machined part.

[0104]

[0093] Another way of obtaining the diaphragm 1 would be by compression, that is to say that the material in the rubber state is enclosed between two plates provided with shapes. The compression of the material between these two plates, added to the polymerization temperature, creates a shaped part.

[0105]

[0094] Figure 2 shows an alternative embodiment of a diaphragm 1. The same technical characteristics are found as those described for Figure 1, with the only difference being that said diaphragm 1 has a so-called convex or “umbrella” shape.

[0106]

[0095] When mounted in a seat within a check valve, the convex diaphragm flattens against the seat of a check valve. Thus, said diaphragm absorbs a certain amount of irregularities in the seat and creates a seal. The valve allows forward flow once the head pressure creates enough force to lift the convex diaphragm from the seat. It will thus allow flow at a predetermined pressure in one direction and immediately prevent backflow in the other direction.

[0107]

[0096] The invention admits other alternative forms of a diaphragm of concave, cylindrical, truncated cone shape....

[0108]

[0097] Figure 3 shows another variant of the diaphragm of Figure 1 and which differs in that the rough peripheral axial surface 9 comprises a combination of different shapes. Indeed, said rough peripheral axial surface 9 comprises in particular an alternation according to a sequence of a convex shape followed by a concave shape according to a direction of radial rotation. That is to say that the entire peripheral axial surface 9 comprises a series of alternations of concave and convex shapes. The dimensions are equal from one concave shape to another. The dimensions are equal from one convex shape to another. There are variants of the diaphragm with unequal dimensions or different alternations.

[0109]

[0098] This type of alternation can be obtained by Injection Molding from the design stage. This type of complex alternation does not require a baking or punching step which could weaken the diaphragm. This type of alternation can be designed according to the type of internal wall of a non-reflux valve so as to adapt the shape of the diaphragm according to the receiving wall. This allows better anchoring of the diaphragm seat.

[0110]

[0099] Figure 4 shows the diaphragm 1 in the assembled and closed state with a non-reflux valve 2. A needle 25 comes to bear against the diaphragm 1 to exert pressure at the level of the basal part 22 of said diaphragm 1. This pressure will allow the deformation of the central portion 3 and to bring the smooth radial surface 6 into tight contact with a part of the internal wall of a non-reflux valve 26 which will be called the sealing point.

[0111]

[0100] The central and peripheral portions have the same material. The intermediate portion comprises a different material. This result can be obtained by bi-injection molding with one material to make the central and peripheral portions and another to make the intermediate portion.

[0112]

[0101] In normal use of the invention, the unidirectional flow of the fluid to be injected will be able to circulate and create pressure on the diaphragm at its rough and / or smooth surface. The pressure will create an opening at the sealing point. Said opening or the space thus created will break the sealing point and allow the passage of the fluid to the patient. When the injection stops, the diaphragm resumes its position against the internal wall of the valve and the seal is again ensured, thus preventing any possibility of backflow. Indeed, any backflow of liquid will, at best, contribute to adding pressure on the basal part of the diaphragm. This will reinforce the seal of said diaphragm against the internal wall of the valve.

[0113]

[0102] Figure 5 shows a part of the diaphragm 1 in a longitudinal sectional view. Said diaphragm 1 comprises a central portion 3 comprising a surface 4 and an intermediate annular portion 5 comprising a smooth radial surface 6. In this embodiment, the diaphragm 1 has a difference in elevation “d” of a central portion 3 and of the peripheral annular portion 7 relative to the intermediate annular portion 5. This difference in elevation “d” is between 0.01 and 0.5 mm, but there are variants according to which this difference is between 0.02 mm and 0.2 mm, or between 0.05 mm and 0.1 mm.

[0103] Figure 6 shows a non-reflux valve 2 in the assembled state with a diaphragm (not shown) according to the invention.

[0114]

[0104] Figure 7 shows, in an exploded view, a non-reflux valve 2 comprising two diaphragms 1 according to the invention.

Claims

Claims 1. Diaphragm (1) for a non-reflux valve (2) in the field of medical devices allowing the injection of liquids into the human body comprising at least two opposite faces and connected by a first rough axial surface (9), said diaphragm (1) comprising at least: - A central portion (3) comprising a first rough radial central surface (4); - An intermediate annular portion (5) around said central portion (3), said intermediate annular portion (5) comprising a first smooth radial surface (6), said first smooth radial surface (6) surrounding said rough radial central surface (4); - A peripheral annular portion (7) around said second intermediate portion (5), said peripheral annular portion (7) comprising a first rough peripheral radial surface (8) and said first rough axial surface (9), said first rough peripheral radial surface (8) surrounding said first smooth radial surface (6); said first rough radial central surface (4), first smooth radial surface (6) and first rough peripheral radial surface (8) extending radially and configured to be on the same face of said diaphragm (1).

2. Diaphragm (1) according to claim 1, wherein the central portion (3), the intermediate annular portion (5) and the peripheral annular portion (7) are in one piece.

3. Diaphragm (1) according to any one of the preceding claims, wherein the central portion (3) has a hardness greater than the hardness of the intermediate annular portion (5) and the peripheral annular portion (7).

4. Diaphragm (1) according to any one of the preceding claims, in which the central portion (3) has a hardness of between 20 Shore A and 90 Shore A, preferably between 40 Shore A and 80 Shore A.

5. Diaphragm (1) according to any one of the preceding claims, wherein the central portion (3) and / or the peripheral annular portion is / are higher than the intermediate annular portion (5) so that the smooth radial surface (6) is set back relative to the first rough radial central surface (4) and / or the second rough radial surface (8).

6. Diaphragm (1) according to the preceding claim, wherein a difference in elevation of a central portion (3) or of a peripheral annular portion relative to the intermediate annular portion is between 0.01 and 0.5 mm, preferably between 0.02 mm and 0.2 mm, more preferably between 0.05 mm and 0.1 mm.

7. Diaphragm (1) according to any one of the preceding claims, wherein the first rough axial surface (9) is cylindrical, convex or concave in shape or a combination of these shapes.

8. Diaphragm (1) according to any one of the preceding claims, wherein said diaphragm (1) is composed of liquid silicone rubber type silicone or nitrile or silicone gum or any other elastomeric material.

9. Diaphragm (1) according to any one of the preceding claims, wherein said diaphragm (1) is cylindrical, frustoconical, convex or concave in shape.

10. Diaphragm (1) according to any one of the preceding claims, in which a rough surface has a surface roughness at least greater than or equal to 6 pm compared to that of a smooth surface.

11. Diaphragm (1) according to any one of the preceding claims, characterized in that the roughness (Ra) of said first rough radial central surface (4) and / or of said first rough radial peripheral surface (8) is between 6 pm and 32 pm, preferably between 9.5 pm and 20 pm.

12. Diaphragm (1) according to any one of the preceding claims, characterized in that the roughness (Ra) of the smooth radial surface (6) is between 0 and 10 pm, preferably between 0 and 3.2 pm, more preferably, more preferably between 0 and 0.8 pm, even more preferably between 0.01 and 0.1 pm.

13. Diaphragm (1) according to any one of the preceding claims wherein each of the central portion (3), the intermediate annular portion (5) and the peripheral annular portion (7) respectively comprises a second rough radial central surface, a second smooth radial surface and a second rough radial surface, arranged symmetrically and with an opposite surface orientation relative to each of said first surfaces.

14. Diaphragm (1) according to any one of the preceding claims, characterized in that said diaphragm (1) is obtained by Injection Molding.

15. Anti-reflux valve (2) for the medical field comprising at least one diaphragm (1) according to any one of claims 1 to 14.

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