One-way valve with deaerator for medical lines

Abstract

One-way valve (1) for medical infusion lines and the like which comprises a first and a second tubular element (2, 3) between which an elastic diaphragm (7) is disposed transversely, cooperating in fluid-tight manner with an annular seat (13). The valve (1) is provided with a deaerator device (11) disposed between the diaphragm (7) and the first tubular element (2) and comprising at least one hole (12) communicating with the outside through an annular membrane (15) which is hydrophobic and air-permeable.

Description

[0001] One-way valve with deaerator for medical lines

[0002] Field of the invention

[0003] The present invention relates to one-way valves for medical infusion lines and the like .

[0004] Such valves traditionally comprise a first and a second tubular element defining respectively an upstream passage and a downstream passage which are coaxial with each other and between which a diaphragm of elastically deformable material is disposed transversely. The diaphragm is arranged to cooperate in fluid-tight manner with an annular valve seat of the first tubular element to normally keep the one-way valve closed. A predetermined fluid pressure in the upstream passage causes a deflection of the diaphragm and the consequent opening of the one-way valve .

[0005] In applications with anti-siphon function these valves, normally closed, must be able to open promptly when the pressure in the upstream passage ("cracking pressure" ) reaches a predetermined threshold value .

[0006] State of the prior art

[0007] From patents EP 1093828B1 and EP2679273B1 in the name of the same Applicant, such an anti-siphon valve is known .

[0008] During the first filling or priming of a medical line with a liquid ("priming" ) , there is a need to expel the air present in the line which could cause malfunctions of the system or damage to the health of a patient undergoing treatment with such a medical line . Currently, there is a need for an operator to act manually to purge air from the line before it is connected for its use .From documents WO2021 / 067316A1, EP3223883B1 and JP2009273775A medical devices provided with a deaerator device to eliminate air from the medical line are known. These systems are not immediately adaptable to the oneway valve according to the present invention.

[0009] Summary of the invention

[0010] The primary obj ect of the present invention is to overcome the aforementioned drawback, and more particularly to provide a valve of the aforementioned type, arranged to eliminate the need for manual interventions for priming the medical line to which it is applied.

[0011] Another obj ect of the present invention is to provide a valve of the aforementioned type configured so as to satisfy this requirement with a simple and low-cost realization, even in connection with to its assembling .

[0012] A further obj ect of the invention is to produce a one-way valve that allows gravity priming of the medical line to which it is connected without the need for an air purge intervention by an operator .

[0013] According to the invention, these obj ects are achieved thanks to a valve of the type defined in the preamble of claim 1, whose primary characteristic lies in the fact that it comprises a deaerator device as defined in the characterizing part of claim 1.

[0014] Thanks to this solution idea, a medical line equipped with such a valve does not require manual purging during priming because the air present in the circuit is pushed by the liquid towards the deaeration device which allows its exit through the membrane or membranes and the hole or holes . When priming is finished, the membrane prevents the liquid from escaping and the line, free of air, is ready for use for medicaltreatment .

[0015] In a preferred embodiment of the invention, an air collection chamber is disposed between said at least one vent hole and said hydrophobic membrane .

[0016] In applications with check valve function, the valve of the invention advantageously incorporates a filter formed by a hydrophilic membrane interposed between the hydrophobic and air-permeable membrane and the diaphragm.

[0017] In a variant of the invention, the deaerator device comprises a plurality of holes and the hydrophobic and air-permeable membrane is annular .

[0018] According to an advantageous configuration of the valve according to the invention, a removable cap provided with an end hydrophobic membrane is provided at the downstream passage .

[0019] According to a further variant, the valve can also be provided with an intermediate annular element on which the hydrophobic membrane rests and formed with labyrinth passages which form restrictions of the liquid flow and a consequent pressure increase that favors the exit of air through the hydrophobic membrane .

[0020] The invention also concerns a method for performing the first filling ("priming" ) of a medical line which provides for the use of a one-way valve according to the invention .

[0021] Brief description of the drawings

[0022] Further characteristics of the invention will be evident from the detailed description that follows with reference to the accompanying drawings, provided by way of non-limiting example only, in which:

[0023] figure 1 is a perspective view showing an embodiment of the one-way valve provided with a deaeration device according to the invention,- figure 2 is a side elevation view of the valve of figure 1,

[0024] - figure 3 is a schematic axial sectional view along line III-III of figure 2,

[0025] - figure 4 is a perspective view showing a first variant of figure 1,

[0026] - figure 5 is a schematic axial sectional view of figure 4,

[0027] - figure 6 is a partial enlargement of figure 5, - figure 7 exemplifies the priming modes of the line equipped with the valve of figure 3,

[0028] - figure 8 exemplifies the connection of the valve of figure 3 to a medical line,

[0029] figure 9 is a perspective view of a further variant of the one-way valve provided with a deaeration device according to the invention,

[0030] - figure 10 is an axial sectional view of the valve of figure 9,

[0031] - figure 11 is an exploded perspective view from above of the valve of figure 9,

[0032] - figure 12 is an exploded perspective view from below of the valve of figure 9,

[0033] - figure 13 shows on a larger scale a part of figure 10,

[0034] - figure 14 is a side elevation view of a further variant of the one-way valve according to the invention, - figure 15 is a top plan view of figure 14,

[0035] - figure 16 is an axial sectional view along line A-A of figure 15,

[0036] - figure 17 is an axial sectional view along line B-B of figure 15,

[0037] - figure 18 is a transverse sectional view along line C-C of figure 17,

[0038] - figure 19 is an exploded perspective view from above of the valve of figure 14, and- figure 20 is an exploded perspective view from below of the valve of figure 14.

[0039] Detailed description of the invention

[0040] Referring initially to figure 1 and figure 2 , numeral 1 indicates as a whole a one-way valve for medical lines for tube-to-tube connection for medical infusion, transfusion and similar lines . It should be noted that the valve could also be arranged for luer-tube connections or tube-luer or luer-luer connections .

[0041] The valve 1 is configured, for example, for antisiphon function and comprises, in a manner generally known per se from the aforementioned document EP 1093828B1, a first tubular element 2 and a second tubular element 3 both normally made of a suitable molded thermoplastic material, for example polycarbonate, and permanently joined together coaxially, for example by ultrasonic welding, or gluing or equivalent systems .

[0042] The first and second tubular elements 2, 3 define respectively an upstream passage or inlet passage 4 and a downstream passage or outlet passage 5 connectable to respective tubing sections of a medical infusion line or the like, for example in the manner shown in figure 7 which will be discussed later .

[0043] Now referring to figure 3, between the upstream passage 4 and the downstream passage 5 is disposed an elastic shutter constituted by a cup-shaped diaphragm 7, depicted in its undeformed rest condition. Diaphragm 7 comprises a circular bottom wall 8 and a j acket or side wall 9 of cylindrical shape, more conveniently with a conical surface diverging from the side opposite the wall 8 .

[0044] The peripheral zone of the circular bottom wall 8 cooperates with an annular valve seat 13 of the first tubular element 2 .Between the upstream passage 4 and the diaphragm 7, a liquid chamber 40 is defined.

[0045] The first tubular element 2 has a radial annular coupling flange 14 to the second tubular element 3 which forms a lid and delimits an annular collection chamber 10. This collection chamber 10 has, as will be seen, the function of an air manifold.

[0046] According to the invention, the one-way valve 1 is further provided with a deaerator device, indicated as a whole by 11, arranged between the diaphragm 7 and the first tubular element 2. The deaerator device 11 comprises at least one vent hole 12 which is formed through the flange 14 and is in communication with the air collection chamber 10, and a hydrophobic and air-permeable membrane 15 disposed below the air collection chamber 10. Such membranes, also defined as semipermeable membranes, are well known in the art and are normally made of a porous synthetic (e . g. , polytetrafluoroethylene) or natural material that allows the passage of gases while remaining impermeable to liquids .

[0047] In the embodiment of the invention shown in figure 3, the deaerator device 11 comprises two holes 12, 12 formed at diametrically opposite positions through the flange 14 and which place the chamber 10 in communication with the outside through the membrane 15, which is annular and is applied inside the flange 14 in correspondence with the holes 12, coaxially with the upstream passage 4.

[0048] In operation, the liquid coming from the inlet passage 4 enters the chamber 40 : when its pressure reaches a threshold value, the diaphragm 7 deforms elastically so as to open communication towards the outlet passage 3. Before opening, any air present in the liquid within the chamber 40 is pushed by the pressuretowards the hydrophobic membrane 15, passing through it, thus reaching the collection chamber 10 and evacuating to the outside through the outlet holes 12.

[0049] The variant of the valve according to the invention illustrated in figures 4-6, indicated as a whole by reference 1A, is generally similar to the embodiment described previously and only the differences will be described in detail, using the same numerical references for identical or similar parts .

[0050] The valve 1A has a check valve function and incorporates, in an integrated manner, a filter 16 disposed across the flow line between the upstream passage 4 and the downstream passage 5, and more precisely interposed between the hydrophobic and air-permeable membrane 15 and the diaphragm 7. Said filter 16 consists of a transverse membrane, of a suitable hydrophilic filtering material, disposed on an intermediate annular element 17 blocked axially between the radially outer annular flange 14 provided on the first tubular element 2 and the second tubular element 3, in the manner described for example in document EP 13170589.

[0051] Also in this case, any air present in the line can evacuate to the outside through the hydrophobic membrane 15, the collection chamber 10 which acts as an air collector, and the holes 12.

[0052] Through this configuration of the valve, an improved deaeration function is obtained during the priming of the medical line : when the hydrophilic membrane 16 is not wet, it stops the liquid flow until the air has exited from the deaerator device 11. When the membrane 16 is wet, the liquid flow is activated. In this way, priming can be performed both by gravity and with a pump connected to the line so that, during use, the deaeration function can also occur at relativelyhigh flows .

[0053] According to the arrangement illustrated in figure 7, a cap 18 provided with a transverse hydrophobic membrane 19 is applied at the downstream passage 5, removably secured to the free end thereof . This configuration is particularly advantageous for priming the medical line, as will be better described later .

[0054] Figure 8 shows an example of how the valve 1 is connected to a medical line during use : the tubular fitting 2 is connected to a flexible tube 20, and the tubular fitting 3 is connected to a luer lock fitting 21 .

[0055] The operation of the one-way valve 1 provided with the deaerator device 11 in accordance with the invention during liquid filling of a medical line to which said valve 1 is connected will now be explained in greater detail .

[0056] Initially, inside the medical line there is air at atmospheric pressure . When the liquid is introduced by gravity from the medical line into valve 1, any air present within the line is compressed within the chamber 40 to a pressure value lower than the predetermined threshold value for the opening of the diaphragm 7 ("cracking pressure" ) , which therefore remains closed. In the chamber 40, a backpressure therefore occurs due to the closed position of the diaphragm 7 which forces the air to pass through the membrane 15, the collection chamber 10 and the holes 12 so that it can exit into the external environment . The deaeration process takes place until the liquid completely fills the chamber 40 and is retained therein thanks to the hydrophobic property of the membrane 15 and the closed condition of the diaphragm 7 .

[0057] When a pressure of magnitude greater than the predetermined threshold value ("cracking pressure" ) ofthe anti-siphon valve, for example on the order of 1-5 psi, is generated inside the chamber 40, the one-way valve 1 promptly passes from the closed condition to the open condition due to the deflection of the bottom wall 8 of the diaphragm 7. This deflection causes the peripheral edge of the diaphragm 7 to move away from the annular valve seat 13, which produces the generation of an annular gap . The upstream passage 4 is thus placed in communication with the downstream passage 5 through said annular gap, allowing the normal operation of the medical line purged of all air.

[0058] Advantageously, a medical line equipped with the device according to the invention at the line end does not need to be manually purged during the first filling ("priming" ) because, when the liquid begins to flow into the line, the deaeration function is activated and continues until the liquid reaches the diaphragm 7. At this point, if priming is done 'by gravity' , the diaphragm 7 blocks the flow and the primed line can be connected to the user .

[0059] In the valve configuration shown in figure 7, the hydrophobic membrane 19, provided at the end of the cap 18, allows priming to be performed even for moderate flows on the order of 20-30 ml / minute, also allowing deaeration of the liquid downstream of the diaphragm 7 through the membrane 19. Subsequently, the cap 18 is removed and the tubular element 3 can be connected to the line for infusion of the liquid.

[0060] The variant of the valve according to the invention illustrated in figures 9-13, in which the same numerical references are also used for designating parts identical or similar to those already described with reference to the previous embodiments, is configured so as to achieve a localized increase of the pressure on the liquid coming from the inlet fitting, thus favoring the exit of airthrough the hydrophobic and air-permeable membrane 15. In detail, the valve is indicated as a whole by IB and comprises an intermediate annular element 22 which forms the annular valve seat 13 and is blocked axially between the radially outer annular flange 14 of the first tubular element 2 and the second tubular element 3. The intermediate annular element 22 is formed with restricted passages 23, tortuous and substantially labyrinthine, terminating into restricted holes 24 having the function of forming restrictions of the liquid flow entering the valve IB . The radially outer annular flange 14 which forms the lid is provided with a pair of diametrically opposite through holes 12, and the membrane 15 is annular and is interposed between the annular flange 14 and the intermediate annular element 22 .

[0061] The inlet fitting 4 is formed with a hollow axial appendage 25 which engages through the membrane 15 and the intermediate annular element 22 and is formed with lateral passage apertures 26 in communication with the labyrinth passages 23 and the related holes 24 of the intermediate annular element 22, below the membrane 15.

[0062] In use, the liquid entering the valve IB through the inlet fitting 4 and the lateral apertures 26 of the appendage 25 travels through the labyrinth passages 23 and the holes 24 : a pressure increase is thereby produced as a result of which any air present in the liquid is pushed with greater energy and therefore more effectively through the hydrophobic membrane 15, venting to the outside of the valve 1 through the collection chamber 10 and the holes 12.

[0063] The variant of the one-way valve indicated by 1C and illustrated in figures 14-20, in which also parts identical or similar to those previously described are indicated with the same numerical references, isconfigured to be usable indifferently in the position shown in the figures or in an inverted position, taking into account the fact that any air contained in the valve during use obviously tends to exit upwards . It is to be noted that while in figures 14-17 the tubular element 4 is configured for direct connection to a line tubing, in the case of figures 19 and 20 the tubular element 4 is configured as a female luer lock.

[0064] Also in this variant, an intermediate element 30 that forms the annular valve seat 13 is blocked axially between the radially outer annular flange 14 of the first tubular element 2 and the second tubular element 3. The intermediate element 30 is formed on one part with the valve seat 13 for the diaphragm 7 and on the opposite part is hollow and provided with integral formations 31, better visible in figure 19, surrounded by a peripheral axial flange 32 within which it is inserted, resting on the formations 31, a second hydrophobic membrane 35 parallel to and spaced from the hydrophobic membrane 15. The hydrophobic membrane 35 is continuous, that is, it is not annular as the hydrophobic membrane 15.

[0065] The intermediate element 30 has, in correspondence with the axial flange 32, at least one radial hole 33, more preferably two diametrically opposite radial holes 33, plugged at their distal ends by the radial annular flange 14 and in communication at their proximal ends with the diaphragm 7 . At least one radial outlet hole 34, more preferably two diametrically opposite radial outlet holes 34 ( figure 18 ) , are formed in a portion 36 of the intermediate element 30 interposed between the first tubular element 2 and the second tubular element 3 and in communication with the outside of the valve 1C .

[0066] The intermediate element 30 delimits the chamber 40 and is configured so as to achieve a localized increase in the pressure of the liquid coming from the inletfitting 4, thus favoring the exit of air through the hydrophobic and air-permeable membrane 15.

[0067] In the position shown in figures 16 and 17, the operation of the valve 1C is analogous to that already described in relation to the other embodiments : any air present in the medical line can evacuate to the outside through the annular hydrophobic membrane 15, the collection chamber 10 and the axial holes 12. In the case where valve 1C is used in an inverted position relative to that shown in figures 16 and 17, the air can evacuate to the outside through the second hydrophobic membrane 35 and the radial holes 34.

[0068] Naturally, the construction details and the embodiments can be widely varied with respect to what has been described and illustrated, without thereby departing from the scope of the present invention as defined in the claims that follow. Thus, for example, the general conformation and arrangement of the holes 12 could be different from that represented in the drawings .

Claims

CLAIMS1 . One-way valve ( 1 ) for medical infusion lines and the like , comprising a first and a second tubular element ( 2 , 3 ) defining respectively an upstream passage ( 4 ) and a downstream passage ( 5 ) which are coaxial with each other and between which a diaphragm ( 7 ) of elastically deformable material is disposed transversely, cooperating in fluid-tight manner with an annular valve seat ( 13 ) of said first tubular element ( 2 ) to normally keep said one-way valve ( 1 ) closed, wherein the first tubular element ( 2 ) has a radial flange ( 14 ) for coupling to the second tubular element ( 2 ) and wherein a predetermined fluid pressure in said upstream passage ( 4 ) causes a deflection of said diaphragm ( 7 ) and the consequent opening of said one-way valve ( 1 ) , characteri zed in that it comprises a deaerator device ( 11 ) disposed between said diaphragm ( 7 ) and said first tubular element ( 2 ) and comprising at least one vent hole ( 12 ) formed through said radial flange ( 14 ) and communicating with the outside through an annular membrane ( 15 ) which is hydrophobic and air-permeable and arranged within said radial flange ( 14 ) coaxially with said upstream passage ( 4 ) .2 . Valve ( 1 ) according to claim 1 , characteri zed in that it is an anti-siphon valve .3 . Valve ( 1 ) according to claim 1 or 2 , characteri zed in that it is a check valve .4 . Valve ( 1 ) according to one or more of the preceding claims , characteri zed in that an air collection chamber ( 10 ) is provided between said at least one vent hole ( 12 ) and said hydrophobic membrane ( 15 ) .5 . Valve ( 1 ) according to one or more of the preceding claims , characteri zed in that it incorporatesa filter ( 16 ) interposed between the hydrophobic and air-permeable membrane ( 15 ) and said diaphragm ( 7 ) .

6. Valve ( 1 ) according to claim 5 characteri zed in that said filter ( 16 ) is a hydrophilic membrane .7 . Valve ( 1 ) according to claims 5 or 6 characteri zed in that said filter ( 16 ) is arranged on an intermediate annular element ( 17 ) blocked axially between said annular flange ( 14 ) of said first tubular element ( 2 ) and the second tubular element ( 3 ) .8 . Valve ( 1 ) according to claims 5-7 , characteri zed in that said intermediate annular element ( 17 ) forms said annular valve seat ( 13 ) .

9. Valve ( 1 ) according to one or more of the preceding claims , characteri zed in that a removable cap ( 18 ) provided with an end transverse hydrophobic membrane ( 19 ) is provided at the downstream passage ( 5 ) .10 . Valve ( 1 ) according to one or more of the preceding claims , characteri zed in that said first and second tubular elements ( 2 , 3 ) are arranged for tube-to-tube connections , or luer-to-tube , or tube-to-luer , or luer-to-luer connections of said medical line .11 . Valve ( 1 ) according to claim 1 , characteri zed in that it comprises an intermediate annular element ( 22 ) blocked axially between said annular flange ( 14 ) of said first tubular element ( 2 ) and the second tubular element ( 3 ) and is formed with restricted passages ( 23 , 24 ) which form restrictions of the liquid flow, and in that said membrane ( 15 ) is interposed between said radially outer annular flange ( 14 ) and said intermediate annular element ( 22 ) .12 . Valve ( 1 ) according to claim 11 , characteri zed in that said upstream passage ( 4 ) is formed with a hollow axial appendage ( 25 ) which engages through said membrane ( 15 ) and said intermediate annular element ( 22 ) and is formed with lateral passage apertures ( 26 ) incommunication with said restricted passages (23, 24) of the intermediate annular element (22 ) below said membrane ( 15) .

13. Valve ( 1 ) according to claim 11 or 12, characterized in that said intermediate annular element (22 ) forms said annular valve seat ( 13) .

14. Valve ( 1C) according to claim 1, characterized in that it comprises an intermediate annular element (30) blocked axially between said annular flange ( 14 ) of said first tubular element (2 ) and the second tubular element (3) and is formed with passages (34 ) in communication with the outside of the valve through a second hydrophobic membrane (35) parallel to said hydrophobic membrane ( 15) .

15. Method for performing the first filling ("priming" ) of a medical line characterized in that it provides for the use of a one-way valve ( 1 ) according to any one of the preceding claims .

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