WO2013068994A1

WO2013068994A1 - Device for delivering fluids

Info

Publication number: WO2013068994A1
Application number: PCT/IB2012/056313
Authority: WO
Inventors: Gianfranco De Paoli Ambrosi
Original assignee: Gianfranco De Paoli Ambrosi
Priority date: 2011-11-09
Filing date: 2012-11-09
Publication date: 2013-05-16
Also published as: ITBS20110153A1

Abstract

The invention concerns a device for delivering fluids under the human or animal skin comprising at least one main body and a corresponding delivering body coupled removably to said main body, wherein the delivering body comprises at least one delivering needle of fluids and one element for protecting the at least one delivering needle movable between a first position, at which the at least one delivering needle is completely contained inside the protecting element and a second position at which at least a portion of said at least one delivering needle comes out from the protecting element, characterized by comprising adjustable means of the travel of said protecting element between said first position and said second position. The device allows adjusting the depth at which delivering needles being in the device penetrate into the human or animal body, for example the skin, muscles, articulations, and in a wide meaning in every body part in which a liquid has to be injected.

Description

"DEVICE FOR DELIVERING FLUIDS"

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DESCRIPTION FIELD OF THE INVENTION

The present invention concerns a device for delivering fluids into the human or animal body, for example intramuscularly, intra-articularly, subcutaneously . In particular it concerns a device provided with one or more injection needles.

State of the Art

Devices provided with needles for injecting fluids into the human or animal body are known. By means of such devices it is possible to delivery fluids both immediately under the skin and more deeply, in a so-called "intramuscular" way. In case of intramuscular injections a specific depth, at which a fluid has to be injected, can be required. In intra-articular injections pre-calculating at which depth a fluid has to be injected could be very useful as well. In the same way the injection of fluids subcutaneously at a specific and pre-calculated depth could be useful; it has to be noticed, for example, that human skin can have different thickness depending on whether it is a child skin, having a thinner skin, or an adult or old person skin, having a thicker skin. In addition, animal skin could be considerably thicker that the human skin.

In known devices it is not possible to adjust the penetration level of needles into the skin; this is a problem because in some cases having such information could be helpful. In fact, for example in plastic surgery field, where filling subcutaneous areas or paralyzing temporarily some muscles is normal practice, it is very important to known at which depth the liquid has to be injected, to avoid the formation of an edema localized at the infiltration point. Equally in case of intramuscular or intra-articular injections.

In consequence, inventors tackle the problem of providing a device provided with needles for delivering fluids which, on the one hand, allows the user of such a device to simply adjust the penetration depth of such needles into the human or animal skin, and on the other hand, which is easily handy and user safe at the same time.

SUMMARY OF THE INVENTION

Then, according to a first aspect the present invention concerns a device for delivering fluids according to claim 1.

In particular, the device according to the present invention comprises at least one main body and a corresponding delivering body removably coupled to said main body, wherein the delivering body comprises at least one delivering needle of fluids and one protecting element of the at least one delivering needle movable between -a first position, at which the at least one delivering needle is completely contained inside the protecting element and a second position at which at least a portion of said at least one delivering needle comes out from the protecting element, characterized by comprising adjustable means for adjusting the travel of said, protecting element between said first position and said second position.

With the term "adjusting the travel" it is meant an adjustment of the extent of the travel itself. In this way, by adjusting the travel of the needle protecting element, the length of the delivering needle part coming out from said protection and then inserted into the skin is adjusted consequently. The user is then able to adjust exactly the depth of the needle penetration into the skin, muscle or articulation and in general into the human or animal skin, in order to inject a desired liquid amount into a well defined area.

Preferably, the delivering body of the device of the present invention further comprises a needle-holder device, inside said protecting element, for directly supporting one or more delivering needles.

Preferably, said needle-holder device supports three delivering needles, disposed so that to constitute the vertices of a triangle, even if embodiments wherein the needle-holder device also supports groups of 5 - 10 delivering needles, and wherein delivering needles are disposed linearly or in a different way, are provided.

In this way, it is possible to carry out simultaneously a number of liquid injections with doses of known and calibrated amounts in the same interest area, the number of such injections being equal to the number of delivering needles present in the needle-holder device; thereby saving time and obtaining a greater amount of liquid injected in the same time into the same area.

Preferably, said needle-holder device is interchangeable; in this way a needle-holder device can be easily applied to the main body of the device of the present invention supporting the convenient needle amount for the specific desired application. Preferably, each of said delivering needles present in the needle-holder device is able to deliver the same liquid amount per each delivery.

Preferably, said main body of the device of the present invention extends along a longitudinal direction, said protecting element of the at least one delivering needle comprises an ending surface provided with through holes at each delivering needle, and said ending surface lies on a geometric plane tilted of an angle comprised in the range of 10°-90°, preferably in the range of 40°-90°, with respect to said longitudinal direction.

In the preferred embodiment, said geometric plane on which the ending surface of the protecting elements lies, is placed at 90° with respect to said longitudinal direction.

In this way all delivering needles reach the same depth under the skin, so that the liquid delivered from the needles reach the same area with the same depth.

In a second embodiment, said geometric plane is placed at 45° with respect to said longitudinal direction.

In this way all delivering needles, each having the same length, and each being disposed at the same height in the needle-holder device, reach a different depth one from another under the skin, based on the tilt of such an ending surface. Alternatively, delivering needles could be arranged at different heights in the needle-holder device so that the delivering needle which is placed in the needle-holder device at a lower height with respect to the skin will penetrate more deeply into the skin itself with respect to a delivering needle present in the same needle- holder device but positioned at a greater height.

In this way, thanks to the tilt of the ending surface from which delivering needles come out or to different heights at which delivering needles are arranged in the needle-holder device, it is possible to delivery liquids under the skin at different depths, at the same time by means of several needles.

Preferably, the adjustable means of the travel of said protecting element comprise at least one stop element, operatively interposed between said main body and said protecting element, and wherein the position of said stop element with respect to said main body could be adjusted by the user.

Preferably, said stop element is a circular ferrule screwable with respect to said main body.

In this way, by rotating the ferrule in one way, the latter is moved and comes near the protecting element; vice versa, by rotating the ferrule in an opposite way, the latter moves away from the protecting element.

Preferably, said ferrule comprises a narrowing section and said protecting element comprises at least . one outer side countercheck projection, designed for displacing in abutment against said narrowing section. Preferably, said ferrule comprises two, more preferably three, outer side projections.

Preferably, the needle protecting element could move axially along at least one guide, preferably at least two guide arranged on the needle-holder device; in addition, preferably, the needle protecting element is provided with a stopping hook for each of said guides which prevent the needle protecting element itself from coming out from the guides .

In this way, by screwing or unscrewing the ferrule, it is possible to adjust the travel of the needle protecting element axially connected to the ferrule and, consequently, the penetration depth of the delivering needles into the skin. As a matter of fact, based on the screwing degree of the ferrule the user selected, during use the needle protecting element could move from the first position, in which each delivering needle is completely inside the protecting element, to the second position in which a portion of each delivering needle, proportional to the screwing degree of the ferrule, . comes out from the protecting element itself.

Preferably, the adjusting means of the travel of the needle protecting device allows the penetration depth of the delivering needle into the skin to be adjusted up to 3 mm, more preferably up to 5 mm.

Preferably, . the needle protecting element is provided with a central spring which return the protecting element into the first position after the use, preventing . the at least one delivering needle from protruding from the protecting element. In this way, there is a .greater safety for users which are not likely to contact with needles when the device for delivering fluids of the present inventions is at rest, that is when it is not used for delivering fluids .

Preferably, the device for delivering fluids of the present invention is provided with a display, like a window positioned on the upper part of the device itself, which shows the travel adjusting level of the protecting element.

In this way, the user has a practical instrument which allows having a visual verification of the real adjusting level of the travel of the protecting element and, consequently, of the effective depth the delivering needles reach under the skin.

Preferably, an interchangeable vial containing the liquid to be delivered is associated with the delivering body of the device for delivering fluid of the present invention.

In this way it is possible to change the amount to be delivered by changing the vial section; in fact, by increasing the vial section, the dose to be delivered is increased, and vice versa.

Preferably, the maximum capacity of the vial is of

0.08 ml per each delivery, shared out equally among each of the delivering needles present in the needle-holder device.

Preferably said vial is coupled to said needle-holder device .

In this way the delivering body, combined with said vial and comprising said needle-holder device and said delivering needles, is coupled to the main body of the device for delivering fluid of the present invention without interfering with said adjustable^" means of the travel of the protecting element.

According to a second aspect, the present invention concerns a method for adjusting the travel between a first position and a second position of a protecting element of at least one delivering needle in a device for delivering fluids under the human or animal skin, according to claim 9.

In particular, such a method is characterized by rotating a stop element operatively interposed between the main body and the protecting element of such a device for delivering fluids as afore described, around a longitudinal direction along which the main body extends.

Preferably, in such a method, the stop element is a circular ferrule apt to be screwed with respect to said main body, and wherein said ferrule comprises a narrowing section and said protecting element comprises at least one outer side countercheck projection, designed for displacing in abutment against said narrowing section, so that the ferrule moves closer or away from the protecting element by screwing or unscrewing said ferrule around the longitudinal axis of the device.

Detailed description of the invention

Further characteristics and advantages of the present invention will be more evident from a review of the following description of a preferred, but not exclusive, embodiment, shown for illustration purposes only and without limitation, with the aid of the attached drawings, in which:

- Figure 1 is a perspective view of a device for delivering fluids according to the present invention;

- Figure 2 is a perspective view of the delivering body of the device of Figure 1 not protected by the protecting element;

- Figure 3 is a perspective view of the delivering body of Figure 2 protected by the protecting element showing two different situations, the first in which the- delivering needles are inside the delivering body (Fig. 3a) and the second in which the delivering needles comes out from the delivering body (Fig. 3b);

- Figure 4a is a perspective view of a delivering device combined with a delivering body in an embodiment having the protecting element with a tilted surface;

- Figure 4b is a section view of a portion of the device shown in figure 4a;

- Figure 5 is a. partial perspective view of the device of Figure 1 showing the adjustable means of the travel of the protecting element;

- Figure 6 is a partial view similar to Figure 5 in which the adjustable means of the travel of the protecting element takes a position different from Figure 5;

- Figure 7 is a top view of the needle-holder device and the protecting element of the device of Figure 1.

- Figure 8 is a section view of the delivering body of the device of Figure 6.

The following detailed description refers to a particular embodiment of the device for delivering fluid according to the present invention.

Referring to Figures 1 - 8 a device 1 for delivering fluids is visible, which comprises a main body 2, extending along a longitudinal direction A. - A, and a corresponding delivering body 3, removably coupled therewith. As can be better seen in Fig. 2, the delivering body 3 comprises a needle-holder device 6 supporting directly three delivering needles 4 for delivering fluids in equal measure per each needle 4.

Further a vial 12 containing the treating fluid can be combined with the delivering body 3.

Both the needle-holder device 6 and the possible vial 12 can be removed to be replaced, respectively, with other needle-holder devices 6 and other vials 12 with convenient dimensions and flow rates according to needs.

As can be better seen in Figure 3a, 3b the delivering body 3 is protected by a protecting element 7 to protect such delivering needles 4 and such a needle-holder device 6. The protecting element 7 is movable, in the longitudinal direction A -A, from a first to a second position. In Figure 3a the protecting element 7 takes such a first position at which the delivering needles 4 are completely contained inside the protecting element 7; vice versa, in Figure 3b, the protecting element 7 takes such a second position at which the delivering needles 4 come out at least partially from the protecting element 7.

The protecting element 7 has an ending surface .5 provided with through holes at each delivering needle 4 and lying on a geometric plane tilted with respect to the longitudinal direction A - A according to an angle a comprised between 30° and 90°. Preferably and as shown in figures 1, 3 and 6, said ending surface 5 lies on a geometric plane tilted with respect to the longitudinal direction A - A according to an angle a of 90°, than being orthogonal to the needles.

In Figures 4a and 4b a particular embodiment of a protecting element 7 is shown, in which said ending surface 5 lies on a geometric plane tilted with respect to the longitudinal direction A - A according to an angle a of 45°. Such a tilt allows different portions of each delivering needle 4 to come out with respect to the others and then to be able to penetrate into the skin at different depths during injection.

The device 1 for delivering fluids of the present invention is further provided with adjustable means of the travel, that is the displacement extent B in the longitudinal direction A - A, of the protecting element 7 from the first to the second position, and vice versa. Referring to Figures 5, 6 and 8, such adjustable means of the travel of the protecting element 7 comprise a stop element, in particular a circular ferrule 10, operatively interposed between the main body 2 and the protecting element 7. The position of the ferrule 10 with respect to the main body 2 is adjustable by the user; in fact, the ferrule 10 is screwable with respect to the main body 2 by means of spiral - shaped guides (not shown) : by rotating the ferrule 10 in a way, the latter comes near the protecting element 7; vice versa, rotating the ferrule 10 in the opposite way, the latter moves away from the protecting element 7.

Such a ferrule 10 comprises a narrowing section 9 cooperating with outer side countercheck projections 8, positioned on the outer surface of the protecting element 7, arranged to come into abutment against the narrowing section 9 when the device is in use.

As. can be better seen in Figure 7, the protecting element 7 of the delivering needles 4 could move axially along three guides 11, at each of which the protecting element 7 is provided with a stopping hook 13 so that to prevent the protecting element 7 itself from coming out from the guides 11.

The user, by screwing or unscrewing the ferrule 10, adjusts the travel extent of the protecting element 7 of the delivering needles 4 connected to the ferrule and movable axially with respect thereto. By acting on the ferrule 10, it is then possible to adjust the travel of the protecting element 7 of the delivering needles 4 and, conseguently, the penetration depth of the delivering needles 4 into the skin up to 4 mm. As a matter of fact, based on the screwing degree of the ferrule the user selected, during use the protecting element 7 of the delivering needles 4 could move from the first position, in which each delivering needle 4 is completely inside the protecting element 7, to the second position in which a portion of each delivering needle 4, proportional to the screwing degree of the ferrule 10, comes out from the protecting element 7 itself.

The ferrule 10 is positioned so that not to be an obstacle when the user wants to couple the delivering body 2 to the main body 3 of the device 1, or to the respective following removal of the delivering body 2 itself.

As can be better seen in Figure 1, the device 1 for delivering fluids of the present invention is provided with a display 14 showing the adjusting level of the travel of the protecting element 7.

For its use the device 1 contacts the area to be treated; as a conseguence of a pressure made onto the device in the skin direction, the protecting element 7, which is in the first position, moves towards the second position, held by the skin itself, with a pre-set determined travel by acting on the adjusting means, thereby exposing a predetermined portion of each delivering needle 4 which penetrates into the skin injecting the treatment fluid.

Preferably, the protecting element 7 of the delivering needles is combined with a return elastic means, such as a central spring, - not illustrated - which returns the element in the first position after the use, preventing each delivering needle 4 from protruding from the protecting element 7 and thereby avoiding the user from contacting the delivering needles when the device 1 is in the rest step, that is when it is not used for delivering fluids .

Many modifications and variations of the preferred embodiments will be certainly evident to those skilled in the field, without departing from the scope of the invention. Therefore, the present invention is not limited to the described preferred embodiment, shown for purposes of illustrations only and without limitation, but it is defined by the following claims.

Claims

"DEVICE FOR DELIVERING FLUIDS" * * * * CLAIMS

1 . Device (1) for delivering fluids intramuscularly, intra-articularly, subcutaneously for both human and animal use, comprising at least one main body (2) and a corresponding delivering body (3) removably coupled to said main body (2), wherein the delivering body (3) comprises at least one delivering needle (4) and one protecting element (7) of the at least one delivering needle (4) movable between a first position, at which the at least one delivering needle (4) is completely contained inside the protecting element (7) and a second position at which at least a portion of said at least one delivering needle (4) comes out from the protecting element (7), characterized it that said device (1) comprises adjusting means of the travel of said protecting element (7) between said first position and said second position.

2 . Device (1) according to claim 1, wherein said delivering body (3) further comprises a needle-holder device (6), inside said protecting element (7), for directly supporting each provided needle (4).

3 . Device (1) according to claim 2, wherein said needle-holder device (6) supports three delivering needles (4).

4. Device (1) according to any one of the claims 2 to 3, wherein the main body (2) extends along a longitudinal direction (A - A) , wherein the protecting element comprises an ending surface provided with through holes at each delivering needle (4), and wherein said ending surface lies on a geometric plane tilted of an angle (a) comprised in the range of 30°-90° with respect to said longitudinal direction (A - A) .

5. Device (1) according to any one of the preceding claims, wherein said adjusting means of the travel of said protecting element (7) comprise at least one stop element (10), operatively interposed between said main body (2) and said protecting element (7), and wherein the position of said stop element (10) with respect to said main body (2) is adjustable.

6. Device (1) according to claim 5, wherein said stop element (10) is a circular ferrule (10) apt to be screwed with respect to said main body (2) to adjust the travel of said protecting element (7).

7. Device (1) according to claim 6, wherein said ferrule (10) comprises a narrowing section (9) and said protecting element (7) comprises at least one outer side countercheck projection (8), designed for displacing in abutment against said narrowing section (9).

8 . Device (1) according to any one of the preceding claims, further comprising a display (14) apt to showing the travel adjusting level of the protecting element (7).

9. Method for. adjusting the travel ;between a first position and a second position of a protecting element (7) of at least one delivering needle (4) in a device (1) for delivering fluids intramuscularly, intra-articularly, subcutaneously for both human and animal use, wherein said device (1) comprises at least one main body (2) and a corresponding delivering body (3) coupled removably to said main body (2), wherein the at least one delivering needle (4) is comprised inside the delivering body (3), and wherein at the first position the at least one delivering needle (4) is completely contained inside the protecting element (7) and at the second position at least a portion of the at least one delivering needle (4) comes out from the protecting element (7), the method characterized by rotating a stop element (10) operatively interposed between said main body (2) and said protecting element (7) around a longitudinal direction (A - A) along which the main body

(2) extends.

10. Method according to claim 9, wherein said stop element (10) is a circular ferrule (10) apt to be screwed with respect to said main body (2) , and wherein said ferrule (10) comprises a narrowing section (9) and said protecting element (7) comprises at least one outer side countercheck projection (8), designed for displacing in abutment against said narrowing section (9), so that the ferrule (10) moves closer or away from the protecting element (7) by screwing or unscrewing said ferrule (10) around the longitudinal axis of the device (1) .