Medical device for infusion and transfusion lines

Abstract

Medical device for infusion or transfusion lines comprising a tubular spike (2) for insertion into a liquid container and a flow regulator (3) for the manual control of the passage by gravity of the liquid from the spike (2) to a drip chamber (1), comprising a control wheel (11) rotatable around an axis (A) orthogonal to the axis (B) of the spike ( 2 ).

Description

[0001] "Medical device for infusion and transfusion lines"

[0002] Field of the invention

[0003] The present invention relates to medical devices for infusion and trans fusion lines of the type comprising a tubular spike for insertion into a liquid container and designed to be connected to a drip chamber in a fluid line .

[0004] State of the prior art

[0005] There are known devices of the type speci fied above provided with an integrated flow regulator for the manual control of the passage of liquid by gravity from the spike to the drip chamber . Documents EP1747787A1 and EP1731185A1 in the name of the Applicant describe and illustrate a device thus made in which the flow regulator, arranged between the drip chamber and the spike , includes a control member rotatable around an axis coinciding with the axis of the drip chamber .

[0006] Despite being functionally ef fective , this arrangement reveals the drawback lying in the fact that the flow regulation by turning the control member is not entirely easy and normally requires the use of both hands of the user : one hand for gripping the drip chamber and holding the device , and the other hand for turning the control member .

[0007] Documents US 7232420B1 , AU 2020367791A1 and DE 8312029U1 describe medical devices generally corresponding to the pre-characterising part of claim 1 , provided with a flow regulator having a control wheel . Such devices are generally complicated given that they consist of a large number of components . Summary of the invention

[0008] The obj ect of the present invention is to overcome such drawback and provide a medical device of the type defined above configured so as to make the operation of the flow regulator more practical and easier .

[0009] According to the invention, this obj ect is obtained due to the fact that the flow regulator comprises a body made of a single piece with the spike , with lateral thrust wings located on the side opposite to the control wheel , and with an appendage for the angular positioning of the control wheel .

[0010] Thanks to this solution idea, the device can be regulated in a practical and functional manner using one hand, holding the drip chamber on the palm and controlling the wheel using the thumb of the same hand .

[0011] In a preferred embodiment of the invention the flow regulator is of the turbulent flow type in which the passage of liquid takes place through an ori fice in the form of a variable opening narrow slot through the control wheel .

[0012] The spike may be of the one-way type or of the two- way type with air filter .

[0013] Brief description of the drawings

[0014] The invention wil l now be described in detail with reference to the attached drawings , provided purely by way of non-limiting example , wherein :

[0015] - figure 1 is a front perspective view of a first embodiment of the medical device according to the invention,

[0016] - figure 2 is a rear perspective view of the device of figure 1 , figure 3 is a front elevational view of the device ,

[0017] - figure 4 is a side elevational view of the device figure 1 ,

[0018] - figure 5 is a longitudinal cross-sectional view and in larger scale of the device of figure 1 ,

[0019] - figure 6 is a front perspective view of a second embodiment of the device according to the invention,

[0020] - figure 7 is a rear perspective view of the device of figure 6 ,

[0021] - figure 8 is a front elevational view of the device of figure 6 ,

[0022] - figure 9 is a side elevational view of the device figure 6 ,

[0023] - figure 10 is a longitudinal cross-sectional view and in larger scale of the device of figure 6 ,

[0024] - figure 11 is an enlarged detail of figure 10 , and

[0025] - figure 12 is a view in larger scale of a detail of figure 7 .

[0026] Detailed description of the invention

[0027] Initially with re ference to figures 1 to 5 a first embodiment of the medical device according to the invention essentially comprises a drip chamber 1 , a tubular spike 2 and a flow regulator 3 interposed between the drip chamber 1 and the spike 2 .

[0028] In a known manner, the drip chamber 1 consists of an elongated container made of plastic material that is normally transparent provided at the bottom with an outlet tubular connector 4 which can be connected to a flexible duct of an infusion or trans fusion line , and provided at the top with an annular flange 5 .

[0029] The spike 2 , provided with an axially removable protection cap 6 , consists of a rigid hollow pin which is formed at its bottom in a single piece made of moulded plastic material with a body 7 of the flow regulator 3 . The body 7 is formed with an annular flange 8 that is designed to be sealingly permanently coupled and fixed, using any suitable system, to the annular flange 5 of the drip chamber 1 . However it is to be pointed out that the device of the invention can also be available with the spike 2 and relate body 7 without a drip chamber .

[0030] The flow regulator 3 is of the turbulent flow type in a per se known manner provided with an ori fice 9 consisting of a variable opening narrow slot , placed in communication with a duct 10 formed integrally j oined with the body 7 and proj ecting axially into the drip chamber 1 . This type of turbulent flow regulator di f fers from the conventional laminar flow regulators due to the fact that the flow rate of the regulated flow is directly proportional to the square root of the pressure drop and it does not depend on the viscosity of the fluid . Therefore , it allows a more ef ficient regulation of the liquid supplied by the spike 2 to the drip chamber 1 .

[0031] The opening of the ori fice 9 of the flow regulator 3 may be varied by operating a control wheel 11 , graduated at the front part and knurled along its circumference , which can be rotated around an axis A orthogonal to the axis B ( Figure 5 ) of the drip chamber 1 , which is parallel to the axis of the spike 2 . The wheel 11 is snap-coupled in a rotatable and sl idable manner on a hollow shaft 20 , in turn integrally j oined with the support 7 , and it is provided with a bushing 19 coaxial to the hollow shaft 20 and whose free end interacts with the ori fice 9 . An appendage 18 also integrally j oined with the body 7 cooperates with the knurling of the wheel 11 so as to angularly position or index it in a precise fashion after a regulation rotation thereof .

[0032] The structural and functional characteristics of the flow regulator 3 are not further described herein in detail given that the methods with which it allows to obtain the turbulent flow are generally known to the person skilled in the art : an example of a flow regulator thus made on the market is manufactured and marketed by Phoenix R&D S . r . l . under the trade name " I . V . Regulator Dosy 2010" .

[0033] The embodiment described above with reference to figures 1-5 relates to the case in which the device according to the invention is of the one-way type , consisting of the passage of the liquid through the spike 2 . This solution can be typically used should the liquid container in which the spike 2 can be inserted be opened or flexible or elastically deformable like a bag .

[0034] Should the medical device be intended to be used with closed and undeformable container ( for example glass bottles ) , it may take the configuration shown in figures 6- 11 , wherein parts identical or similar to the ones already described are indicated with the same reference numerals . In this variant , the device is of the two-way type , that is the spike 2 is formed with a first axial passage 12 for the liquid and with a second axial passage 13 for air placed in communication with a ventilation opening 14 with which there are associated a filter 15 and a safety cap closure 16 .

[0035] The ventilation opening 14 is formed in a socket also integrally j oined with the body 7 of the flow regulator 2 which, as shown in detail in figure 12 , further has a pair of thrust wings 17 located on the side opposite to the wheel 11 and having the function of facilitating the introduction of the spike 2 into the pierceable cap of a liquid bottle . The thrust wings 17 are also provided for in the embodiment of the one-way type described above with reference to figures 1 -5 so as to facilitate the introduction of the spike 2 into a bag containing the liquid to be trans ferred to the drip chamber 1 .

[0036] Lastly, it should be observed that the arrangement of the medical device according to the invention is such that the axis B of the drip chamber 1 with the relative inlet duct 10 is of fset with respect to the spike 2 .

[0037] Thanks to the arrangement described above , the medical device according to the invention, both in the one-way configuration and in the two-way configuration, has the advantage lying in the fact that it can be easily handled and regulated by the user using only one hand . The drip chamber 1 can be held on the palm of the hand while the wheel 11 of the flow regulator 2 , as well as the opening of the safety cap closure 16 of the ventilation opening 14 in the two-way version of the device , can be controlled easily using the index finger or the thumb of the same hand .

[0038] Furthermore , the conformation of the turbulent flow regulator 2 confers to the medical device according to the invention a high precision and continuity of the liquid flow by gravity from the spike 2 to the drip chamber 1 , irrespective of the viscosity of the liquid flow .

[0039] Obviously, the construction details and the embodiments may widely vary with respect to what has been described and illustrated, without departing from the scope of protection of the present invention as defined in the claims that follow . Namely, it is to be pointed out that the device of the invention can also be available with the spike and relate body without any drip chamber, which can be provided separately and then secured to spike body .

Claims

CLAIMS1. Medical device for infusion or transfusion lines comprising a body (7) having a tubular spike (2) for insertion into a liquid container and designed to be connected to a drip chamber (1) in a fluid line, said device being integrated with a flow regulator (3) for the manual control of the passage by gravity of the liquid from the spike (2) to the fluid line, wherein the flow regulator (3) comprises a control wheel (11) rotatable around an axis (A) orthogonal to the axis of the spike (2) , characterised in that the body (7) is made in a single piece with the spike (2) , with lateral thrust wings (17) located on the side opposite to said control wheel (11) of the flow regulator (3) , and with an appendage (18) for the angular positioning or indexing of said control wheel (11) .

2. Medical device according to claim 1, characterized in that the flow regulator (3) is of the turbulent flow type in which the passage of liquid takes place through a narrow orifice (9) with variable opening through said control wheel (11) .

3. Medical device according to any one of the preceding claims, characterised in that the spike (2) is of the one-way type.

4. Medical device according to any one of claims 1 and 2, characterised in that the spike (2) is of the two-way type (12, 13) with associated ventilation opening (14) , air filter (15) and relative safety cap closure (16) .

5. Medical device according to one or more of thepreceding claims, characterised in that in that it is integrated with the drip chamber (1) within which an inlet duct (10) made of a single piece with the body (7) of the flow regulator (3) projects and is offset with respect to the spike (2) .

6. Medical device according to one or more of the preceding claims, characterised in that said control wheel (11) of the flow regulator (3) is peripherally knurled to cooperate with said angular positioning appendage (18) .