CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit under Articles 4 and 8 of the Stockholm Act of the Paris Convention for the Protection of Industrial Property of U.S. Non-Provisional Application No.: 17/657,505, filed March 31, 2021, which application is hereby incorporated by reference herein in its entirety.

FIELD OF THE INVENTION

[0002] The present invention generally relates to a valve structure that is preferably designed for medical infusion devices to control a flow of a fluid pass therethrough.

BACKGROUND

[0003] Infusion devices are well known in the art and encompass a plurality of variations, designs, and methods of administering and controlling a selected fluid flow to a patient. In some designs, a single camera system is utilized to capture a liquid drop passing through a drip chamber wherein a captured image of the drop is processed to determine individual drop size, drop growth, and drop volume. The combination of these measurements affords an on-board computer to process and calculate a flow rate.

[0004] Another issue with these devices is the precision of the valve structure which controls the flow of a fluid from an IV bag to a patient. Traditional stop-cock valves are well known in the art but do not offer the precision needed to minutely adjust flowrate for the particular therapeutic, drug, fluid, or the like, administered by an infusion device.

[0005] There is also a long-felt need for a specialty flow-valve that has a structural configuration that provides for acute fluid flow control to a liquid flow therethrough.

SUMMARY

[0006] The present invention may generally comprise an improved stopcock valve, comprising, a valve body, the valve body having at least one inlet port and at least one outlet port, the valve body having an internal cavity in communication with the at least one inlet port and the at least one outlet port, and, a rotatable interference body having a through-bore therein, the rotatable body having an external surface, the through-bore having a first opening to the surface and a second opening to the surface, said interference body positioned within the internal cavity of the valve body, the external surface including a first tapered groove in communication with the first opening and a second tapered groove in communication with the second opening, the grooves arranged to be in communication with the at least one inlet port and the at least one outlet port upon rotation of the body, wherein the body is arranged to be rotated to occlude fluid flow through the valve or to adjustably regulate fluid flow through the valve via the through-bore.

[0007] In some configurations, the present invention may comprise an improved stopcock valve, the improved stopcock valve having a valve body, the valve body having at least one inlet port and at least one outlet port, the valve body having an internal cavity in communication with the at least one inlet port and the at least one outlet port, and a rotatable interference body having a through-bore therein, the rotatable body having an external surface, the through-bore having a first opening to the surface and a second opening to the surface, the interference body positioned within the internal cavity of the valve body, the external surface including at least one tapered groove in communication with at least one of the first opening and the second opening, the at least one tapered groove arranged to be in communication with at least one of the at least one inlet port and the at least one outlet port upon rotation of the body. The interference body may further comprise a second tapered groove in communication with the second opening.

[0008] In other configurations, the body of the improved stopcock valve is arranged to be rotated to occlude fluid flow through the valve or to adjustably regulate fluid flow through the valve via the through-bore.

[0009] In some embodiments, the at least one groove shaped aperture of the improved stopcock valve includes a tip and an end, the tip increases in width towards the end.

[00010] In other embodiments, the rotatable interference body of the improved stopcock valve includes a rotation-control member, the valve having a pair of rotation-control members, wherein the rotation-control member of the rotatable interference body is arranged to move between the pair of rotation-control members of the valve.

[00011] In further embodiments, the rotatable interference body of the improved stopcock valve is arranged to be actuated via a motor.

[00012] In embodiments of the interference body having a pair of groove shaped apertures, each of the groove shaped apertures have a tip and an end, where the tip increases in width towards the end.

[00013] In other configurations, the present invention may comprise an infusion device arranged for delivering a fluid, the infusion device comprising a control system, a motor, and the aforementioned improved stopcock valve, wherein the control system is arranged to receive at least one user input, the at least one user input initiates the control system to communicate a programable protocol to the motor thereby actuating the improved stock valve according to the programable protocol.

[00014] In alternative configurations, the present invention may generally comprise an infusion device arranged for delivering a fluid, the infusion device comprising a motor and the aforementioned improved stopcock valve.

BRIEF DESCRIPTION OF THE DRAWINGS

[00015] Various embodiments are disclosed, by way of example only, with reference to the accompanying schematic drawings in which corresponding reference symbols indicate corresponding parts, in which:

Figure 1 illustrates a cross-sectional view of an infusion device which includes the valve apparatus of the invention;

Figure 2A illustrates a perspective view of valve apparatus 500;

Figure 2B illustrates a right-side view of valve apparatus 500;

Figure 2C illustrates a top plan view of valve apparatus 500;

Figure 2D illustrates a front view of valve apparatus 500;

Figure 3 illustrates an alternative perspective view of valve apparatus 500;

Figure 4A illustrates a perspective view of valve body 501;

Figure 4B illustrates a left-side view of valve body 501;

Figure 4C illustrates a top plan view of valve body 501;

Figure 5A illustrates a perspective view of valve 550;

Figure 5B illustrates a front view of valve 550;

Figure 6A illustrates a perspective view of flow control portion 552 of valve 550;

Figure 6B illustrates a right-side view of flow control portion 552 of valve 550;

Figure 6C illustrates a front view of flow control portion 552 of valve 550;

Figure 6D is a perspective cross-sectional view of flow control portion 552 of valve 550 taken along lines 6D - 6D in Figure 6 A;

Figure 7 is a cross-sectional view of flow control portion 552 of valve 550 taken along lines 7 - 7 in Figure 6B;

Figure 8 is a focused view of flow control portion 552 of valve 550 taken from Figure 6B; Figure 9A illustrates a cross-sectional view of valve apparatus 500 taken generally along line 9 - 9 in Figure 2B;

Figure 9B illustrates a cross-sectional view of valve apparatus 500 taken generally along line 9 - 9 in Figure 2B, showing the valve rotated with respect to its position in Figure 9A;

Figure 9C illustrates a cross-sectional view taken generally along line 9 - 9 in Figure 2B, showing the valve rotated with respect to its position in Figure 9B; and,

Figure 9D illustrates a cross-sectional view taken generally along line 9 - 9 in Figure 2B, showing the valve rotated with respect to its position in Figure 9C.

DETAILED DESCRIPTION OF THE DRAWINGS

[00016] At the outset, it should be appreciated that like drawing numbers on different drawing views identify identical, or functionally similar, structural elements. It is to be understood that the claims are not limited to the disclosed aspects.

[00017] Furthermore, it is understood that this disclosure is not limited to the particular methodology, materials and modifications described and as such may, of course, vary. It is also understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to limit the scope of the claims.

[00018] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which this disclosure pertains. It should be understood that any methods, devices or materials similar or equivalent to those described herein can be used in the practice or testing of the example embodiments.

[00019] It should be appreciated that the term “substantially” is synonymous with terms such as “nearly,” “very nearly,” “about,” “approximately,” “around,” “bordering on,” “close to,” “essentially,” “in the neighborhood of,” “in the vicinity of,” etc., and such terms may be used interchangeably as appearing in the specification and claims. It should be appreciated that the term “proximate” is synonymous with terms such as “nearby,” “close,” “adjacent,” “neighboring,” “immediate,” “adjoining,” etc., and such terms may be used interchangeably as appearing in the specification and claims.

[00020] It should also be appreciated that the terms “liquid” and “fluid” may be used interchangeably and are both describing a substance that is moving through the present invention. Liquid or fluid may comprise water, saline, a pharmaceutical substance, a combination thereof, or any other liquid or fluid type that one having ordinary skill in the art of medical devices, medical administration, medical treatment, diagnosis, and the like, would readily recognize as usable within an infusion device. However, it should also be appreciated that present invention is not restricted to medical infusion device use, that is, it may be used in a plurality of applications where precise fluid control between two bodies, i.e., containers, is needed.

[00021] Adverting now to the Figures, Figure 1 illustrates a cross-sectional view of a representative infusion device 100. Infusion device 100 has case 101 which houses drip chamber 400. Drip chamber 400 is arranged to receive fluid from an IV bag attached at the upper portion of drip chamber 400. Fluid 425 collects from drop former 410 into the distal end of drip chamber 400. Fluid 425 is a pool of fluid that collects from individual fluid drops. In fluid connection with drip chamber 400, arranged at its distal end, is specialty valve apparatus 500 which controls the flowrate fluid 425 will be delivered to a patient in fluid connection with the distal end of specialty valve apparatus 500. Specialty valve apparatus 500 is preferably driven by a motor shaft of motor 600, which in a preferred embodiment will actuate specialty valve apparatus 500 according to a programmed protocol that corresponds to a selected fluid and/or substance that is arranged to be delivered to a patient.

[00022] Figures 2A - 9D, described infra, generally illustrate the specialty valve component of an infusion device. At the outset, specialty valve apparatus 500 is a fluid and/or liquid flow control mechanism for infusion device 100. Specialty valve apparatus 500 is driven by a motor (shown in Figure 1) according to a programmable protocol that is communicated from a control system, in response to a selected user input, i.e., a selection of a certain drug, liquid, fluid protocol that is inputted into infusion device 100. The actuation of specialty valve apparatus 500 by the motor is further controlled by the control system such that actuation of specialty valve apparatus 500 alters in response to calculations determined by the control system.

[00023] The following description should be taken in view of Figures 2A - 2D. The specialty valve apparatus 500 generally comprises specialty valve body 501 and specialty valve 550. Specialty valve body 501 is arranged to accept specialty valve 550 within, where, in a preferred embodiment, snap-fit elements on both specialty valve body 501 and specialty valve 550 interact and rotatably secure specialty valve 550 within specialty valve body 501. Specialty valve 550 has a rotatable interference body, flow control portion 552 (shown in Figure 3), arranged within specialty valve body 501 such that rotation of valve 500 will either completely hinder a liquid flow through specialty valve apparatus 500, decrease or increase a liquid flow through specialty valve apparatus 500, or provide nominal, or no interference to a liquid flow through specialty valve apparatus 500. These positions are described in greater detail in view of Figures 9A - 9D, infra.

[00024] Figure 3 illustrates an alternative perspective view of specialty valve apparatus 500. Specialty valve body 501 includes valve housing 502 which is arranged to rotatably secure specialty valve 550 therein, specifically flow control portion 552 of specialty valve 550. Specialty valve body 501 also includes flow body 503 which is defined by in-flow end 504 and outflow end 505, whereas valve housing 502 is arranged in between in-flow end 504 and outflow end 505. In a preferred embodiment, valve housing 502 is arranged such that it is positioned more proximate to in-flow end 504 than outflow end 505.

[00025] Specialty valve 550 generally comprises rotation-control portion 551 and flow control portion 552. In a preferred embodiment, rotation-control portion 551 and flow control portion 552 are integral, however it may be contemplated that rotation-control portion 551 and flow control portion 552 may be two separate components that are fixedly secured to one another, e.g., snap-fit, or threading.

[00026] Figure 3 also illustrates rotation-control members 506 and 507 of specialty valve apparatus 500. The rotation-control members prevent specialty valve 550 from over-rotating within specialty valve body 501, that is, specialty valve 550 may only rotate between the rotationcontrol members of specialty valve body 501. Specialty valve body 501 has two rotation-control members, upper rotation-control member 506 and distal rotation-control member 507. Upper rotation-control member 506 is fixedly secured to the outside surface of valve housing 502, proximate in-flow end 504, and proximate rotation-control portion 551 of specialty valve 550. Distal rotation-control member 507 is fixedly secured to the outside surface of valve housing 502, proximate outflow end 505, and proximate rotation-control portion 551 of specialty valve 550. Specialty valve 550 also includes rotation-control member 553. Rotation-control member 553 is preferably arranged on distal face 551a of rotation-control portion 551 of specialty valve 550. When specialty valve 550 is properly engaged within specialty valve body 501, rotation-control member 553 will be positioned in between upper rotation-control member 506 and distal rotationcontrol member 507. In a preferred embodiment, the amount of rotation that specialty valve 550 will be afforded before rotation-control member 553 will contact either upper rotation-control member 506 or distal rotation-control member 507 is less than approximately 180 degrees. [00027] The following description should be taken in view of Figures 4A - 4C, which illustrate various views of specialty valve body 501 without specialty valve 550 inserted therein. Flow control portion 552 of specialty valve 550, as shown in the aforementioned figures, is arranged to snap-fit within valve aperture 509. Flow control portion 552 of specialty valve 550 includes attachment means (shown and described, infra) that are arranged to interact with valve attachment means 509a via snap-fit, e.g., tongue and groove, or other known in the art snap-fit attachment means, to secure flow control portion 552 within valve aperture 509, as shown in Figure 6. Arranged proximate and defining in-flow end 504 of flow body 503 is attachment body 508. Attachment body 508 is arranged to mate with the distal end of a drip chamber of an infusion device, allowing flow from the drip chamber to enter upper flow pathway 510. Upper flow pathway 510 is arranged above valve housing 502 and proximate in-flow end 504, that is, upper flow pathway begins at in-flow end 504 and terminates at its opening to valve housing 502. The specific arrangement of upper flow pathway 510 is described in further detail, infra.

[00028] The following description should be taken in view of Figures 5A and 5B which illustrate a perspective view and a front view of specialty valve 550, respectively. Extending from distal surface 551a of rotation-control portion 551 of specialty valve 550 is flow control portion 552. Arranged on outer surface 552a of flow control portion 552 of specialty valve 550 is valve attachment means 509b of flow control portion 552. Valve attachment means 509b are arranged to mate, engage, etc., with valve attachment means 509a of valve aperture 509 (shown in Figure 4A) via snap-fit, e.g., tongue and groove, or other known in the art snap-fit attachment means, to secure flow control portion 552 within valve aperture 509, as shown in Figure 3. Also arranged on outer surface 552a of flow control portion 552 is first opening 561 of medial flow pathway 560, whereas second opening 562 (shown in Figure 6D), is arranged on an opposite side of outer surface 552a of flow control portion 552. Medial flow pathway 560 is a channel, tube, or the like, that is arranged to connect upper flow pathway 506 (shown in Figure 9 A) and distal flow pathway 507 (shown in Figure 9A), when specialty valve 550 is rotated within valve aperture 509 at a particular angle.

[00029] Shown in Figure 5B are first space 551b and second space 551c, arranged within rotation-control portion 551. First space 551b and second space 551c are voids, spaces, gaps, within rotation-control portion 551 and arranged to accept a motor shaft end member therein. First space 551b and second space 551c allow an engaged motor shaft end member impart force onto the outside surfaces of first space 551b and second space 551c to rotate valve 550 (illustrated in various positions in Figures 9A - 9D), thereby altering the position of first opening 561 and second opening 562 of medial flow pathway 560 (illustrated in hidden lines in Figure 5B) to control the flow of a liquid therethrough. It should be noted that the central through-bore, where medial flow pathway 560 is arranged, may also be used as an engagement location for a motor shaft to engage specialty valve 550 for actuation.

[00030] It should also be appreciated that rotation-control portion 551 may alternatively take the form of a lever body, like a stock-cock or gate valve. Rotation-control portion 551 may alternatively take the form of a handle, crutch head, or the like, where flow control portion 552 would extend therefrom. These alternative embodiments of rotation-control portion 551 would allow for manual rotation of valve 550 for alternative applications of valve 550.

[00031] The following description should be taken in view of Figures 6A - 6D. Figures 6A through 6C illustrate flow control portion 552 removed from specialty valve 550 and Figure 6D is a cross-sectional view of flow control portion 552 taken along lines 6D - 6D shown in Figure 6A. Medial flow pathway 560 intersects a substantially central portion of flow control portion 552, best shown in Figures 6C and 6D. Medial flow pathway 560 includes two oppositely arranged openings, first opening 561 and second opening 562.

[00032] Figure 7 illustrates a cross sectional view of flow control portion 552 taken along lines 7 - 7 shown in Figure 6B. First opening 561 and second opening 562 of flow control portion 552 comprise tapered grooves extending from each respective opening, first tapered groove 561a and second tapered groove 562a. First tapered groove 561a extends from first groove opening 561b at first groove end 561b and terminates at first groove tip 561c. First tapered groove 561a opens on outer surface 552a of flow control portion 552 and terminates at first groove floor 561d and first groove opening 561e. First tapered groove 561a merges into medial flow pathway 560 at first groove opening 561e — allowing first tapered groove 561a to be in flow-communication, i.e., liquid communication of a liquid with first tapered groove 561a and medial flow pathway 560. Second tapered groove 562a extends from second opening 562 at second groove end 562b and terminates at second groove tip 562c. Second tapered groove 562a opens on outer surface 552a of flow control portion 552 and terminates at second groove floor 562d and second groove opening 562e. Second tapered groove 562a merges into medial flow pathway 560 at second groove opening 562e — allowing second tapered groove 562a to be in flow-communication, i.e., liquid communication of a liquid with second tapered groove 562a and medial flow pathway 560.

[000331 The following description should be taken in view of Figures 7 and 8. The following description describes first opening 561 and first tapered groove 561a and applies to second opening 562 and second tapered groove 562a. Figure 8 shows a focused view of flow control portion 552 taken from Figure 6B. As described supra, first tapered groove 561a extends from first groove end 561b and terminates at first groove tip 561c. First tapered groove 561a is defined by a varying depth and width. The depth of first groove end 561b, that is, the distance from outer surface 552a to first groove opening 561e, is greater than the depth of first groove tip 561c, that is, the distance from outer surface 552a to the terminating end proximate first groove tip 561 of first groove floor 561d. The depth of first taper groove 561a gradually decreases from first groove end 561b to first groove tip 561c. First groove floor 561d is arranged to terminate when it reaches first groove tip 561c, which is arranged to be flush with outer surface 552a. First groove opening 561b has a width W1 that is greater than the width W2 of first tapered groove 561a that is proximate first groove tip 561. The width of first tapered groove 561a gradually decreases from first groove end 561b to first groove tip 561c, where first tapered groove 561a terminates, i.e., has no width, at first groove tip 561c.

[00034] The following description should be taken in view of Figures 9 A through 9D which illustrate various positions flow control portion 552 of valve 550 may rotate within valve body 501. It should be appreciated that the positions of flow control portion 552 are merely exemplary, and flow control portion 552 may be rotated in much finer increments to accommodate a particular flow rate of a liquid from upper flow pathway 510 through medial flow pathway 560 to distal flow pathway 511 to then exit distal flow pathway 511 at its respective opening proximate outflow end 505 of valve body 501.

[00035] Figure 9A illustrates a closed position of valve apparatus 500, that is, there is no liquid flow from upper flow pathway 510 through medial flow pathway 560 to distal flow pathway 511. Specifically, outer surface 552a of flow control portion 552 of valve 500 is sealing second opening 510b of upper flow pathway 510 and first opening 511a of distal flow pathway 511.

[00036] Figure 9B illustrates a partially opened position of valve apparatus 500, that is, there is a minimal flow from upper flow pathway 510 through medial flow pathway 560 to distal flow pathway 511. In the partially opened position, liquid may flow into first opening 510a of upper flow pathway 510 and through second opening 510b of upper flow pathway 510 into second tapered groove 262a. Specifically, liquid flows into an area of second tapered groove 262a proximate second groove tip 562c, where the liquid will enter medial flow pathway 560 through second groove opening 562b. Liquid will then travel in a direction within medial flow pathway 560 towards first opening 561 where the liquid will enter distal flow pathway 511 at first opening 511a and exit distal flow pathway 511 from second opening 511b. Specifically, liquid exits medial flow pathway 560 via first opening 561b of first tapered groove 561a and travels towards first groove tip 561a where the liquid will enter distal flow pathway 511 at first opening 511a.

[00037] Figure 9C illustrates a substantially opened position of valve apparatus 500, that is, there is a moderate liquid flow from upper flow pathway 510 through medial flow pathway 560 to distal flow pathway 511. In the substantially opened position, liquid may flow into first opening 510a of upper flow pathway 510 and through second opening 510b of upper flow pathway 510 into second tapered groove 562a second opening 562 of medial pathway. Specifically, liquid flows into an area partially including second tapered groove 562a proximate second groove end 562b and partially-directly into medial flow pathway 560. Liquid will then travel in a direction within medial flow pathway 560 towards first opening 561 where the liquid will enter distal flow pathway 511 at first opening 511a and exit distal flow pathway 511 from second opening 511b. Specifically, liquid exits medial flow pathway 560 partially via first opening 561b of first tapered groove 561a and partially through first groove opening 561b where the liquid will enter distal flow pathway 511 at first opening 511a.

[00038] Figure 9D illustrates a fully opened position of valve apparatus 500, that is, the arrangement shown in Figure 9D affords the maximum liquid flow from upper flow pathway 510 through medial flow pathway 560 to distal flow pathway 511, as these respective flow pathways are all aligned without restriction, as shown in Figure 9D.

[00039] It should be appreciated that the inside surface of valve aperture 509 and either first tapered groove 561a or second tapered groove 562b forms a sealed tunnel such that liquid flowing through flow control portion 522 to either first opening 561 or second opening 562, will not escape. [00040] Thus, it is seen that the objects of the invention are efficiently obtained, although modifications and changes to the invention may be readily imagined by those having ordinary skill in the art, and these changes and modifications are intended to be within the scope of the claims. REFERENCE NUMERALS

Infusion Device

Case of infusion device 100

Drip chamber

Drop former of drip chamber 400

Fluid

Specialty valve apparatus

Specialty valve body of specialty valve apparatus 500

Valve housing of valve body 501

Flow body of valve body 501

In-flow end of flow body 503

Outflow end of flow body 503

Upper rotation- control member

Distal rotation-control member

Attachment body of valve body 501

Valve aperture a Valve attachment means of valve aperture 509 b Valve attachment means of flow control portion 552

Upper flow pathway a First opening of upper flow pathway 510 b Second opening of upper flow pathway 510

Distal flow pathway a First opening of distal flow pathway 511 b Second opening of distal flow pathway 511

Specialty valve

Rotation-control portion of specialty valve 550 a Distal surface of rotation-control portion 551 b First space of rotation-control portion 551 c Second space of rotation-control portion 551

Flow control portion of specialty valve 550 a Outer surface of flow control portion 552 553 Rotation -control member of specialty valve 550

560 Medial flow pathway

561 First opening of medial flow pathway 560 561a First tapered groove of first opening 561 561b First groove end of first tapered groove 561a 561c First groove tip of first tapered groove 561a 561d First groove floor of first tapered groove 561a 561e First groove opening of first tapered groove 561a

562 Second opening of medial flow pathway 560 562a Second tapered groove of second opening 562 562b Second groove end of second tapered groove 562a

562c Second groove tip of second tapered groove 562a 562d Second groove floor of second tapered groove 562a 562e Second groove opening of second tapered groove 562a 600 Gearbox/Motor

W1 First width of first tapered groove 561a

W2 Second width of first tapered groove 561a