TECHNICAL FIELD

The present invention relates to a flow regulator for a gravity operated intravenous fluid infusion utilized to measure and regulate fluid flowrate.

PRIOR ART

Drip-adjusted infusion sets are frequently used to correct electrolyte imbalances in the body, to deliver drugs to the body that the patient should take intravenously, to provide parenteral nutrition, to reduce pain in patients with pain and to treat cancer. Drop setting sets are used especially in patients where controlled fluid delivery is required. It is vital to administer medications given in critical patient groups at the correct dosages. Therefore, flow regulators are used, which have an inlet and outlet in the direction of the liquid flow and allow the flow to be adjusted. Flow regulator generally comprises an adjustment element to change settings by rotation, a flow rate adjustment mechanism constricting the passage area by rotation of the adjustment element, an inlet from which the infusion fluid enter into the flow rate adjustment mechanism the and an outlet with attached to tube reaching to the patient to deliver the infusion fluid. It is known that one of the common causes of intravenous flow deviations in researches and feedbacks is that patients or their relatives adjust the flow regulator arbitrarily and change the flow rate according to their own wishes.

US6551279 explain a liquid medicament dispenser for controlled infusion delivery of liquid medication to a patient, a flow regulator for controlling flow rate of the liquid medication through the infusion tube includes a flow rate adjuster with a manually operable adjuster knob for setting flow rate and an encasement housing releasably securable about the adjuster knob for impeding access to the adjuster once the proper rate has been set. The housing engages the perimeter of a top cover of the flow regulator by friction fit and by a perimeter lip that resides beneath the perimeter of the top cover, thereby intentionally making its removal difficult and impeding access to the adjuster knob. Fabricating the housing of an opaque material can further reduce potential access to the adjuster knob since a patient may not even realize that the thus non-viewable adjuster knob exists. BRIEF DESCRIPTION OF THE INVENTION

The object of the invention is to impede unauthorized access to the flow regulator in the gravity-operated fluid infusion device.

To achieve the aforementioned objective the invention relates to a flow regulator for a gravity operated intravenous fluid infusion comprising first body having an inlet and an outlet connected to the inlet in a fluid transmitting manner and a second body rotatably mounted to the first body such that adjusting the flow rate of the outlet to a predetermined value when rotated relative to the other. Invention further comprises a sleeve extending from the first body to the second body, at least partially covering the periphery of the first body and the second body in a manner that block rotational movement relative to each other. The sleeve extends from the first body to the second body and prevents the first body from rotating relative to the second body, for example by not leaving an area for rotation, or by blocking the part where the rotation takes place.

In a preferred embodiment of the invention, the sleeve is directly mounted over the first body and the second body. While the first body adjusts the flow rate with a relative rotational movement with the second body when the sleeve is not attached, it is possible to block the rotational movement by taking up the least space by covering the first and second body by directly lying on them.

In a preferred embodiment of the invention, the sleeve comprises an upper part that rests on the outer periphery of the first body and a lower part covering the periphery of the second body by extending down from the upper part. The upper part leans against the first body and provides a support inside the sleeve, and the lower part extends towards the second body and blocks the movement.

In a preferred embodiment of the invention the flow regulator comprises a locking element is provided on the sleeve and engaging to the second body. The locking element impede dismounting the sleeve by unauthorized persons. Since the sleeve utilize the first body as a support, the locking element that engages the second body also blocks the relative movement of the first body relative to the second body, for example the rotational movement.

In a preferred embodiment of the invention, the locking element comprises a tab provided at a distal end and holding the second body from a lower edge. The tab allows snap-fit connection. Thus, it is possible to transverse the sleeve over on the first body and lock it on the second body. This allows the operator to easily mount the sleeve.

In a preferred embodiment of the invention, the lower part adjacent to the upper part of the sleeve lean completely against the second periphery of the second body by a circumferential manner. Therefore, the lower part rests on the second body to form a compact sleeve.

A preferred embodiment of the invention comprises an upper part of the sleeve that comprises a top part leaning from the upper edge to the first body. The top part allows the first body to be visually blocked substantially and allows the top part of the sleeve to be positioned correctly when it is overlaid by resting on the top edge.

A preferred embodiment of the invention comprises an inlet opening that is provided on the top part and reaching to the inlet underneath. The inlet opening allows a pipe with infusion fluid to reach the inlet despite the sleeve. At the same time, when the sleeve is removed, it remains mounted to the tube from the inlet and is prevented from getting lost.

A preferred embodiment of the invention comprises a flow regulator that comprises a porthole provided on the sleeve and is aligned with a display section of the second body. By means of the porthole, the flow rate of the flow regulator is visible even when a sleeve is attached.

In a preferred embodiment of the invention, the sleeve is in one-piece bucket-like form. The bucket form can be easily produced, for example, by plastic injection. Moreover, it can be easily fit to the first and second body by a single action.

In a preferred embodiment of the invention, the sleeve is essentially made of an opaque material. Since the first and second bodies are not visible under the sleeve when the cover is inserted, it is hidden from an unauthorized person that it has an adjustable structure.

In a preferred embodiment of the invention, the length of the sleeve to one opening is greater than sum of the height of the first body and the second body. In this way, in the regulators where the first body and the second body are mounted on top of each other, the sleeve can be easily dressed from the mouth opening through the tops and include the first and second bodies. BRIEF DESCRIPTION OF THE FIGURES

Figure 1 is a disassembled perspective view of a representative embodiment of the flow regulator of the subject matter comprising a protective tab with sleeve.

Figure 2 is a bottom isometric view of the protective sleeve as shown in Figure 1.

Figure 3 is a bottom perspective view of a representative embodiment of the flow regulator including a protective sleeve with a lock assembly in the unlocked position.

Figure 4 is a perspective view of the flow regulator as shown in Figure 3 with the protective sleeve in locked position.

Figure 5 is a perspective view of protective sleeve of an embodiment of the flow regulator including the longitudinal mold channel.

Figure 6 is a perspective view of an embodiment from below of the protective sleeve comprising an alternative lateral porthole structure.

Figure 7, bottom perspective view of an alternative embodiment of a tower lock system of the protective sleeve in mounted open position.

Figure 8 is a perspective view from below of the slide-lock system sleeve shown in Figure 7 in the locked position.

DETAILED DESCRIPTION OF THE INVENTION

In this detailed description, the inventive subject matter has been described with reference for examples, without any restriction and only to better describe the subject matter.

In Figure 1 , a representative embodiment of the flow regulator according to the invention is shown in perspective view. The adjustment assembly (10) of the flow regulator connected to the intervenous fluid infusion system (not shown) comprises a first body (1 1 ) and a second body (13) that are mounted rotatably to one another. The first body (1 1 ) is located in the upper part and has a hollow triangular-like cross-sectional shape with rounded corners. The first body (1 1 ) has a circular cross section from its bottom part, which coincides with the circular form that forms the upper part of the second body (13). The edges of the triangular form are concave and form a recess (16). The first body (1 1 ) and the second body (13) have approximately equal diameters in their respective regions where they pass with rotatable freedom and thus define a measuring part (15). The first body (1 1 ) comprises a tubular inlet (17) extending inwardly from its upper part. A supply tube (not shown) of the infusion system is attached to the inlet (17) surrounding from the outside. The inlet (17) is in an upright position within the wall bounded by the upper edge (12) near the upper edge (12) of the first body (1 1 ). Furthermore, an outlet (18) in fluid connection with the inlet (17) reaching through an access channel extends outwardly from center of the second body (13) distant to a lower edge (14) of the second body (13) at the bottom side of the second body (13) the and in a manner that fits into the outer boundary of a lower edge (14) of the second body (13) On the lower edge of the first body (1 1 ), a display (19) is provided indicating the measuring part (15). The sleeve (20) enters the adjustment assembly (10) in a complete manner such that it is attached to the lower edge (14) by means of the locking element (29) that it transverses over the first body (1 1 ) and the second body (13) like a hat. Thus, the first body (1 1 ) is limited within the sleeve (20) so as to correspond to an upper part (21 ) of the sleeve (20), a middle part (23) of the measuring part (15) and a lower part (25) of the second body (13). The circular top part (26) of the sleeve (20) is circumferentially connected to the upper part (21 ) to form a shoulder with an edge radius (27). On the top part (26), there is an opening (22) aligned with the inlet (17) in the form of cut-out and adjacent portholes (24).

In Figure 2, the sleeve (20) is shown isometrically from the bottom. The sleeve (20) has a bucket-like structure with the rim (28) part in a circular form. A tab (293) is provided between the two parallel slots (292) inwardly on the rim (28). The tab (293) is an integral extension of the lower part (25) from a connection part (295) with a proximal end. At the distal end of the tab (293) there is a lower end (294) aligned with the rim (28). Each auxiliary tab (291 ) is provided with the tab (293) in the same form and equidistant on the rim (28). The tabs (291 , 293) are formed by grasping from the inside to the lower edge (14).

In Figures 3 and 4, a sleeve (20) with a film hinged lock assembly (30) at one end is shown isometric from below. In Figure 3, the lock assembly (30) is open. In this case, the sleeve (20) includes a strip (35) that forms the lock assembly (30). A cap (32) is formed at a proximal end (34) of the strip (35). The cap (32) has an expanded printing surface structure. On the other hand, a distal end (36) that is opposite to the proximal end (34) of the strip (35) is film hinged from the edge of the sleeve (20). The cap (32) is in a form that can fit into a corresponding hole. As shown in Figure 4, in the locking position that occurs when the cap (32) fits into the corresponding hole, the lock assembly (30) traps the adjustment device (10) in the sleeve (20) by means of the strip (35) which blocks the rim (28). In Figure 5, a sleeve (20) with an elongated mold window (241 ) is shown from above in perspective. The sleeve (20) is in the form of a slightly conical bucket that expands downwardly. A mold window (241 ) in L shape extending from the top part (26) reaching the radial edge (27) pass throughout upper side (21 ) is in a rectangle like window form provide a gap for a core of a mold (not shown) allowing plastic injection molding of the locking element (29). On the other hand, in Figure 6, a narrow porthole (24) extending in the upper part (21 ) and the middle part (23) is shown. In these applications, the sleeve (20) has a locking element (29) at its lower part comprising the tab (293) in a form similar to that given in Figure 2.

Figure 7 and Figure 8 are also bottom perspective views of the lock assembly (30) in a slide structure on the sleeve (20), in the open and closed position, respectively. As shown in Figure 7, the T-like lock assembly (30) comprises the cap (32). The cap (32) is in a radial form with an inner radius compatible with the outer radius of the sleeve (20), as shown in Figure 8 in the locked position. The strip (35) passing through the first hole (297), which is in accordance with the cross-sectional form of the strip (35), is supported at both ends by passing away from the second end (29) through a second hole (299) at the opposite end. Thus, the strip (35) blocks the rim (28) and prevents the exit of the second body (13) from its lower edge (14). The lock assembly (30), which is pulled out radially outwardly from the cap (32), goes into the open position, releasing the rim (28) and the adjustment assembly (10) can be taken out by exiting the rim (28) from the sleeve (20).

Before the sleeve (20) is placed in the first body (1 1 ) as shown in Figure 1 , the inlet opening (22) is aligned to the inlet (17) located in the first body (1 1 ) and thus it is attached to the adjustment device (10) like a hat. Thus, although the sleeve (20) is covered, the inlet (17) can be accessed and fed into the inlet (17) with an intravenous infusion fluid tube. The first body (1 1 ) rotated relative to the second body (13) the value is red from measuring part (15) by means of the display (19) to set the fluid infusion flowrate before mounting the sleeve (20) and sleeve (20) is mounted to the adjustment assembly (10) of which the first body (1 1 ) and the second body (14) position is preset without changing their position by aligning the inlet opening (22) according to the inlet (17). Thus, the position of the first body (1 1 ) and the second body (13), which remain in the sleeve (20) when the liquid is fed, becomes irreversible and access from outside is limited. The flow regulator is made adjustable again by opening the lock assembly (30) according to the type of sleeve (20) and / or by locking the locking element (29) into the open state by removing the adjustment assembly (10). REFERENCE NUMBERS

10 Adjustment assembly 25 Lower part

1 1 First body 26 T op part

12 Upper edge 27 Radial edge

13 Second body 28 Rim

14 Lower edge 29 Locking element

15 Measuring part 291 Auxiliary tab

16 Recess 292 Slot

17 Inlet 293 Tab

18 Outlet 294 Lower end

19 Display 295 Connection part

20 Sleeve 297 First hole

21 Upper part 299 Second hole

22 Inlet opening 30 Lock assembly

23 Middle part 32 Cap

24 Porthole 34 Proximal end

241 Mold window 35 Strip

36 Distal end