Device for infusion of fluids

Abstract

A device for infusion of medical fluids is provided. It has an internal reservoir for a fluid to be administered made of a first flexible base material to vary its volume as a function of the quantity of fluid present thereinside; and an outer casing containing the reservoir, having a side wall made of a second elastic base material suitable to make elastically deformable the casing to vary the geometry and internal volume thereof as a function of the volume of the reservoir.

Claims

1. A device for infusion of fluids, comprising: an internal reservoir for a fluid to be administered made of a first flexible base material to vary its volume as a function of the quantity of fluid present thereinside, said first base material being a non-elastomeric thermoplastic material, said reservoir being fluidically connectable to an infusion line adapted for administering the fluid; and an outer casing containing said reservoir, wherein said outer casing comprises a side wall made of a second, elastic base material, suitable to make elastically deformable said casing to vary the geometry and internal volume thereof as a function of the volume of said reservoir, and a pair of front walls respectively made of a third rigid or semi-rigid base material, wherein a first front wall of said pair is positioned on top of the side wall and a second front wall of said pair is positioned on bottom of the side wall, wherein said side wall and said pair of front walls together surround said reservoir in a manner such that said reservoir is not exposed to an outer environment except through said infusion line, wherein said reservoir has an opening adapted to be placed selectively in fluidic communication with said infusion line to allow both the introduction of the fluid thereinside and the administration of the fluid at the outside, wherein each one of said front walls has a recess, said recesses being mutually mirrored structures about a shared plane, implemented at said opening, and configured so that in a configuration of minimum overall dimensions of said device said opening is surrounded in a compartment defined by said recesses, the configuration being such that the filling-in with the fluid causes an increase in volume of said internal reservoir, which, in turn, causes an increase in volume of said outer casing and correspondingly, after the fluid administration, the volume of said outer casing, and thus the volume of the device, decreases proportionally to the volume of supplied fluid.

2. The device according to claim 1, wherein said front walls comprise respective joint elements for connecting to said side wall.

3. The device according to claim 1, wherein said front walls comprise respective perimeter seats for the insertion of a respective edge of said side wall and the mutual coupling therewith.

4. The device according to claim 1, wherein said first base material of said reservoir is free of silicone materials.

5. The device according to claim 1, wherein said first base material of said reservoir is selected from the group consisting of: polyethylene terephthalate (PET), polyethylene (PE), high-molecular-density polyethylene (PEHD), polypropylene (PP), ethylene-vinyl acetate(EVA), polyvinyl chloride free of phtalate (PVC DHEP FREE), ultra-density polyethylene (PEUHD), Polystyrene (PS) and the like.

6. The device according to claim 1, having an overall polyhedral, in particular parallelepiped or box-like configuration.

7. The device according to claim 1, wherein said reservoir is divided into two or more sections, optionally independent therebetween, connected to the same infusion line.

Description

BRIEF DESCRIPTION OF THE FIGURES

(1) The enclosed figures will be referred to, wherein:

(2) FIG. 1 is a perspective view of the device under a first undeformed condition in absence of fluid thereinside and wherein the not visible internal portions are illustrated with dash line;

(3) FIG. 2 is a side view of the device of FIG. 1;

(4) FIG. 3 is a front view of the device of FIG. 1;

(5) FIG. 4 is a perspective view of the device under a second deformed condition in presence of the maximum quantity of fluid thereinside;

(6) FIG. 5 is a side view of the device of FIG. 4;

(7) FIG. 6 is a front view of the device of FIG. 4;

(8) FIG. 7 is a perspective view of the device under the second deformed condition wherein the not visible internal portions are illustrated with dash line;

(9) FIG. 8 is a top view of the device of FIG. 7;

(10) FIG. 9 is a side view of the device of FIG. 7;

(11) FIG. 10 is a front view of the device of FIG. 7;

(12) FIGS. 11 to 13 show a front, side and exploded view of the device of FIG. 1, respectively; and

(13) FIGS. 14 to 17 show a front, side, front perspective and exploded view of the device of FIG. 4, respectively.

(14) The above-mentioned figures are to be meant exclusively by way of example and not for limitative purposes.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

(15) By referring to the enclosed figures a preferred, but not exclusive, configuration of the device for infusion of fluids according to the present invention is illustrated, suitable to allow the administration of medical fluids inside the human body, for example by intravenous, intramuscular, subcutaneous route or the like.

(16) The device could be used with any type of fluid or mixture of medical fluids, such as physiological or pharmacological solutions, without particular limitations.

(17) FIG. 1 illustrates the device according to the invention, designated as a whole with 1, in an undeformed configuration of minimum overall dimensions corresponding to a condition of substantial absence of fluid, that is in a configuration preceding the filling-in or subsequent to the whole emptying thereof.

(18) In order to improve understanding of the invention, additional exemplifying drawings of a preferred embodiment of the device according to the present invention in an undeformed configuration of minimum overall dimensions are shown in FIGS. 11 to 13.

(19) Still by referring to FIG. 1, the device 1 comprises an internal reservoir 2, drawn with dash line, intended to include a predetermined and variable volume of the fluid to be administered. The reservoir 2 is made of a first flexible base material to vary the volume thereof as a function of the quantity of fluid introduced thereinside.

(20) In typical way for this type of infusion devices, commonly defined also elastomeric pumps, the reservoir 2 has an opening 3 adapted to be fluidically connected to a standard infusion line, not illustrated as known, which can have also flow-regulating function.

(21) According to preferred embodiments of the invention, the reservoir can be divided into two or more sections, preferably independent therebetween, and connected to the same infusion line.

(22) The reservoir 2 is included inside an outer casing 4 having at least a portion made of a second elastic, preferably elastomeric, base material, adapted to make elastically deformable the casing 4.

(23) The casing 4 having a minimum overall dimensions, under undeformed conditions, is considered substantially similar to the minimum overall dimensions of the reservoir 2 under conditions of absence of liquid thereinside.

(24) In other words, in absence of liquid, the total overall dimensions of the device coincides with the minimum overall dimensions of the undeformed casing. Therefore, under this condition, the device results to be particularly compact.

(25) By inserting the fluid inside the reservoir 2 an expansion thereof will be produced, and such increase in volume will cause the consequent elastic deformation of the casing 4 including it. The casing 4 will vary both the geometry and internal volume thereof as a function of the volume of the reservoir 2.

(26) FIG. 4 illustrates the device 1 in the configuration thereof of maximum volume, corresponding to the maximum volume of the outer casing 4 when inside the inner reservoir 2 the maximum quantity of fluid is included.

(27) In order to improve understanding of the invention, additional drawings exemplifying a preferred embodiment of the device according to the present invention in a deformed configuration of maximum overall dimensions are shown in FIGS. 14 to 17.

(28) In the preferred, but not exclusive, configuration, shown in the enclosed FIGS. 4 to 10—with particular reference to FIG. 4—the outer casing 4 comprises a side wall 5 made of the second base material with elastomeric nature, having a substantially annular shape, to surround the reservoir 2.

(29) The side wall 5 is closed both on the top and on the bottom by a pair of front walls 6, 7 preferably substantially plane, the mutual distance thereof d will vary as a function of the expansion of the side wall 5.

(30) The height h of the wall 5 will vary as a consequence of the variation in the volume of fluid present in the reservoir 2.

(31) Preferably, the casing 4 has a prismatic shape, with height h variable as a function of the filling-in of the reservoir 2. The volumetric increase of the casing 4 will be comprised between 100% and 300% of the original sizes with empty reservoir.

(32) Overall, as it can be appreciated by the enclosed figures, the configuration of the device 1 preferably is polyhedral, in particular parallelepiped or box-like.

(33) The front walls 6, 7 can be made of a third base material different from that of the side wall 5, such as a rigid or half-rigid plastic material, or the same material of the side wall 5.

(34) Preferably, the front walls 6, 7 comprise means for the joint quick connection with the side wall 5.

(35) In particular, in the illustrated configuration, the front walls 6, 7 comprise respective perimeter seats 8, 9 for the quick insertion of a respective edge 10, 11 of the side wall 5 and the mutual coupling therewith.

(36) In this way the assembly of the portions is simplified, by making it however stable, and a quick and simple replacement of the side wall 5 would be allowed, if it deteriorated and the elastic properties thereof were not so as to guarantee the correct supply of fluid.

(37) The perimeter seats 8, 9 could be constituted by both blind and through grooves, extending substantially for the whole periphery of the respective front walls 6, 7, with possible discontinuity areas.

(38) The front walls 6, 7 are further equipped with preferably semi-circular, mutually faced and specular, recesses 12, 13, implemented in the respective edges 14, 15, placed at the opening 3 of the reservoir 2.

(39) In this way, in the undeformed configuration in absence of fluid, the cylindrical opening 3 of the reservoir 2 is limited in the compartment defined between the two recesses 12, 13, allowing the two front walls 6, 7 to arrive at a distance d with minimum value, by further reducing the total overall dimensions of the device, as it can be seen in FIG. 3.

(40) According to a possible variant of the invention, the first base material of the reservoir 2 can be an elastomeric material, such as for example a silicone-based material or the like.

(41) The first elastomeric base material not necessarily will be of the same type of the second elastomeric base material.

(42) However, in a particular configuration, the two materials could be the same and the reservoir 2 and the side wall 5 of the casing 4 could be obtained by means of one single processing, for example an extrusion or moulding processing, to be integral therebetween and define one single body.

(43) Advantageously, the two front walls 6, 7 will have substantially the same shape, so as to be able to be implemented with the same mould.

(44) In this way, the device 1 according to this first variant can be implemented by moulding and by using only two moulds, according to a particularly cheap and quick processing.

(45) Preferably, the reservoir 2 has a hollow elongated shape deriving from the deformation following the fluid entrance, with walls having a substantially constant thickness and preferably with value directly proportional to the maximum volume of fluid which can be included thereinside.

(46) According to a preferred variant of the invention, the first base material of the reservoir 2 is a not elastically deformable material, but however flexible to allow the variation in volume after the insertion and discharge of fluid.

(47) In this case, the first base material can be selected among the materials commonly used for the infusion bags currently on the market. In particular, the used material can be a thermoplastic material, preferably free of silicone, a non-elastomeric material. In particular, it can be in the shape of a single- or multi-layer film, comprising at least one of the following polymers: polyethylene terephthalate (PET), polyethylene (PE), high-molecular-density polyethylene (PEHD), polypropylene (PP), ethylene-vinyl acetate (EVA), polyvinyl chloride free of phtalate (PVC DHEP FREE), ultra-density polyethylene (PEUHD), Polystyrene (PS) and the like.

(48) From an operative point of view, one proceeds with filling-in the reservoir 2, which will increase the volume thereof and will come in contact with the walls of the outer casing 4, by causing the deformation of the elastomeric portion 5 of the casing 4, which will increase its own volume too, whereas the elastomeric portion 5 will accumulate mechanical energy during the deformation thereof.

(49) After having inserted the maximum quantity provided for the fluid and after having eliminated possible air inside the system by means of the known techniques, the device will be ready for use.

(50) In this way, under the push exerted by the casing 4 on the reservoir 2 after the elastic return of the casing 4 to the original position, the fluid will start to outflow from the reservoir 2 and will flow into the infusion line connected thereto.

(51) The outflow rate could be adjusted during the planning phase both by suitably selecting the materials of the reservoir 2 and of the casing 4 and by adjusting the rate outgoing from the capillary flow regulator placed downwards of the device.

(52) In case even the reservoir 2 is made of elastomeric material, the outflow pressure will be given by the sum of the single pressures generated by the elastic return of the reservoir 2 and of the casing 4. In the preferred case of non-elastomeric reservoir 2, the push will be produced only by the casing 4.

(53) From what described, it appears evident that the device according to the invention achieves the pre-fixed objects, in particular that of reducing the overall dimensions, above all under condition of absent fluid or lower fluid than the maximum quantity which can be included. Furthermore, it is underlined that the device advantageously provides an outer casing carrying out both a function of passive type for protecting the reservoir and an active function for the supply of fluid.

(54) The device according to the invention can be subjected to several modifications and variants, all within the inventive concept expressed in the enclosed claims.

(55) All details could be replaced by other technically equivalent elements, and the materials could be different according to needs, without leaving the scope of protection of the present invention.

(56) Even if the device has been described with particular reference to the enclosed figures, the reference numbers used in the description and in the claims are used to improve the understanding of the invention and they do not constitute any limitation to the claimed protection scope.

(57) The present invention has been so far described with reference to preferred embodiments. It will be appreciated that other embodiments belonging to the same inventive idea may exist, as defined by the scope of protection of the claims set forth below.