Title of Invention	A CONTROLLED FLOW ADMINISTRATION SET
Abstract	A flow control device (10) includes a connector (12) defining a first receiving formation (14) for receiving a first conduit, a second receiving formation (18) for receiving a second conduit and a cross member (22) separating the first receiving formation (14) and the second receiving formation (16). An orifice plate (24) is received in the cross member to control flow of fluid, in use, through the conduits received in the first and the second receiving formations (14, 18) of the connector (12), the orifice plate (24) defining at least one substantially frustoconical orifice (34). Figure 1

Title of Invention

A CONTROLLED FLOW ADMINISTRATION SET

Abstract

A flow control device (10) includes a connector (12) defining a first receiving formation (14) for receiving a first conduit, a second receiving formation (18) for receiving a second conduit and a cross member (22) separating the first receiving formation (14) and the second receiving formation (16). An orifice plate (24) is received in the cross member to control flow of fluid, in use, through the conduits received in the first and the second receiving formations (14, 18) of the connector (12), the orifice plate (24) defining at least one substantially frustoconical orifice (34). Figure 1

Full Text	FIELD OF THE INVENTION This invention relates to a flow control device. More parlicularty the invention relates to a How control device particularly, but not necessarily exclusively. tor use in an intravenous (IV) administration set. to an orifice plate for a (low control device and to a component lor an IV administration set. BACKGROUND OF THE INVENTrON At presenl- infusion of fluids into a patient is managed bv medical personnel. fluids are infused parenterally into a patient for a variety of reasons. It is often critical that the fluid being administered is infused into the patient's bt>dy in the required doses and flow rales. fhis is usually done either manually using a roller clamp or automalically using an infusion pump, Manual roller clamps are inaccurate and are difficult to set to maintain an accurate flow rate. In addition, when applied to a length of plastics conduit, the plastics conduit itself may. in due course. plastically deform resulting in a loss of clamping action of the roller clamp. This could have the potentially serious consequences of an unregulated supply of fluid into the patient's body. Infusion pumps, while maintaining an accurate How rate, are expensive items. In addition, because an inllision pump is an electromechanical device, there is a risk of failure of the infusion pump which, once again, has potentially extremely serious consequences, further, with the increasing age of the population there is more prcssure for bed places in hospitals resulting in an increasing homecare market. providing homecare patients with infusion pumps is expensive and has attendant risks as well. In addition. in large parts of the world, there are insufficient funds to make infusion pumps available to patients, whether in hospitals or in homecare. Also, in the case of roller clamps, there is a continuous need for vigilance by medical personnel to ensure that the fluid is being infused at the desired How rate. Often, in parts of (he world, medical personnel are in short supply and are unable to provide the requisite duty of caree. In still another embodiment of the present invention, the separating element is a gasket of a resiliently flexible material, the gasket defining the orifices. The How control devices 10 may be made available with housings 12 of various colours. The flow control devices 10 are therefore colour coded with the colours of the housings Further. where the conduits 16. 20 are of a silicone material it makes them easy to join to other silicone components by use of a silicone adhesive and. for joining to non-elasU)merie coponents. are able to seal with the use of sealing rings, etc. It will be appreciated by persons skilled in the art that numerous variatitions and or modifications may be made to the invention as shown in the specific embodiments without departing from the spirit or scope of the invention as broadly described, the present embodiments are. therefore, to be considered in all respects as illustrative and not restrictive. 1. A flow control device, comprising: a connector defining a first receiving formation for receiving a first conduit, a second receiving formation for receiving a second conduit and a cross member separating the first receiving formation and the second receiving formation; and an orifice plate received in the cross member to control flow of fluid in use through the conduits received in the first and the second receiving formations of the connector, the orifice plate defining at least one substantially frustoconical orifice. 2. The device as claimed in claim 1 wherein the connector comprises a cylindrical housing defining a pair of opposed sockets, the sockets forming the receiving formations with a transersely extending web defining the cross member. 3. 1 he device as claimed in claim 2 wherein at least the web is of a resiliently flexible material. 4. The device as claimed in claim 2 or claim 3, wherein housing is a one-piece unit of the resilientlx flexible material which facilitates lateral deformation of the housing for pruning purposes. 5. The device as claimed in and one of the preceding claims, wherein the orifice plate is of a rigid material. 6. I he device as claimed in and one of the preceding claims, wherein the orifice is formed m the plate by laser drilling. 7. The device as claimed in and one of the preceding claims, wherein for any given angle of frustum of the orifice, flow rate through the orifice is directly proportional to cross-sectional area of smaller opening of the orifice. 8. The device as claimed in claim 7, wherein flow rate through the orifice is governed by a linear relationship of the form: y=mx+c where: y is flow rate in ml/hr: x is cross-sectional area of the smaller end of orillce in microns": and In and e are constants governed by the angle of the frustum. 9. The device as claimed in claim 7 or claim 8 wherein the angle of trustum of the orifice is in the range of about 15°C in the range of about 1 5° to 50°. 10. The de\ice as claimed in claim 9 wherein the angle of frustum of the orifice is in the range of about 20° to 28°. Is. 11. The device as claimed in claim 9 or claim 10 wherein the angle of frustum of the orifice is about 24. 12. The device as claimed in any one of the preceding claims, wherein the oritice has a diameter (as measured at its smaller opening) in the range from about 1 to about 700 microns. 13. The device as claimed in any one of the preceding claims, wherein oritice has an aspect ratio which is less than or equal to 10. 14. The device as claimed in any one of the preceding claims, wherein the connector is of a coloured material. 15. The he device as claimed in claim 14 wherein the connector is colour coded with each colour being associated with a particular flow rate. 16. How control device, comprising: a connector defining a first receiving formation for receiving a first conduit, a second receiving formalion for receiving a second conduit and a cross member separating the first receiving formation and the second receiving formation, the connector being a one piece unit of a resiliently flexible material which facilitates lateral deformation of the connector for priming purposes: and an orifice plate, dellning at least one orifice. received in the cross member to control How of fluid, in use. through the conduits received in the first and the second receiving formations of the connector. 17. The device as claimed in claim 16. wherein the orilice plate is a rigid member received in the cross member, lateral deformation of the connector causinu the formation of priming ports between the orillee plate and the cross member. 18. the device as claimed in claim 16 or claim 17. wherein the connector comprises a cylindrical housing dellning a pair of opposed sockets, the sockets forming the receiving formations with a transversely extending web defining the cross member. 19 The device as claimed in any one of claims 16 to 18 wherein the oritice plate is of a rigid material 20. The device as claimed in any one of claims 16 to 19 wherein the oritice is formed in the plate by aser drilling. 21 I he device as claimed in claim 20 wherein the orilice is a Irustoeonieal orifice and, for any givem angle of frustum of the orillee flow rate through the orifice is direcllx proportional to a cross-sectional area of a smaller opening of the orillee. 22. 1 he device as claimed in any one of claims 16 to 21. wherein the connector is of a coloured material. 23. The device as claimed in claim 22, wherein the connector is colour coded with colour being associated with a particular flow rate. 24. An adjustable flow rate flow control device. a fluid delivery arrangement having an inlet and detining a plurality of spaced orifices in communication with the inlet: a passage defining member displaceably arranged relative to the delivery arrangement. the passage dellning member defining a passage which is able to be brought into How communication with a desired number of orifices to achieve a desired How rale through the outlet by adjusting the position of the passage defining member relative lo the delivery arrangement: and an oullel in communication with the passage of the passage defining member. 25. The device as claimed in claim 24. wherein said device includes a supply duct in How communication with the passage detuning member. 26. The device as claimed in chum 24 or claim 25 wherein fluid delivery arrangement includes a housing defining a first flow path, the passage of the passage defining member viefining a second (low path. 27. The device as claimed in claim 26 wherein the fluid delivery arrangement includes a separating element separating the first flow path from the second How path, the separating element having the orifices. 28. The device as claimed in claim 27 wherein the separating element is a gasket of a resiliently flexible material, the gasket defining orifices. 29. The device as claimed in claim 28 wherein the orifices are defined in the gasket by a plurality of rigid orifice plates, each orifice plate defining at least one orifice. 30. The device as claimed in claim 29 wherein the outlet is defined in the housing and in which the gasket has an opening defined through it in alignment with the outlet so that fluid that has passed through the orifices is able to flow out through the outlet via the passage of the passage defining member. 31.The device as claimed in claim 29 or claim 30 wherein the passauc dellninu mcinhc!-mcliicles a rolan' aclualor which is rolatably arranged relative lo the housing, the passage being dellned in a body of the rotary aclualor. 32. The device as claimed in any one of claims 24 to 30, wherein the supply duel eonsiituies ihe passage defining member, the supply duct being slidably arranged relalite the delier arrangement to bring the desired number of orifices into liuid communication with the passage. 33. The device as claimed in an\- one of claims 24 lo 32 wherein each orifice is formed h\ laser drilling. 34. The device as claimed in any one of claims 24 lo 32. wherein each orifke is a frus'ioeonica! orillce. 35. The device as claimed in claim 34 wherein for and given angle of frustum of each orifice. How rale through the ortice is directly proportional to a cross-sectional area of a mailer (Opening of the orifice. 36. The device as claimed in claim 35 wherein How rate through each orifice is governed h\ a linear relationship of the form: y = mx ± c where: y is flow rale in ml/hr; v is cross-sectional area of the smaller end of orifice in microns: and m and c are constants govermed by the angle of the frustum. 37. The device as claimed in claim 35 or claim 36 wherein the angle of frustum of each orifice is in the range of about 15° to 50°. 38. The device a s claimed in claim 37, wherein the angle of frustum of each orifice is in the range of abut 20° to 28°. 39. The device as claimed in claim 37 or claim 38 wherein the angle of frustum of each orifice is about 24°. 40. The device as claimed in any one of claims 34 to 39 wherein each orifice has a diameter (as measured at its smaller opening} in range from about 30 to about 700 microns. 41. the device as claimed in any one of, claims 34 to 40 wherein each orifice has an aspect ratio which is less than or equal to 10). 42. A component for an intravenous (IV) set. the said component comprising a conduit of a silicone material. 43. The component as claimed in claim 42 wherein the silicone material is reinforced to inhibit kinking and to enhance the elasticity of the conduit. 44. The component as claimed in claim 43 wherein the reinforcing is a heiically wound reinforcing member carried in a wall of the conduit. 45. The component as claimed in claim 44 wherein the reinforcing member is selected from a group comprising, a plastic material, and a shape memory alloy. 46. The component of any one of claims 42 lo 46 which includes a flow control de\ice for interconnecting two lengths of conduit, the flow control device being as claimed in any one of claims 1 to 23 the connector of the flow control device being of a silicone material. 47. 1 he component as claimed in any one of claims 42 to 46 wherein it includes a How control device for interconnecting two lengths of conduit, the flow control device being as claimed in any one of claims 24 to 36 at least one of the passage defining member and the supply duct being of a silicone material. 48 A component for an intravenous (IV) set said component comprising a conduit of a reinforce polymeric material. 49. The component as claimed in claim 48 wherein the reinforcing is a helically wound reinforcing member carried in a wall of the conduit. 50. The component as claimed in claim 49 wherein the reinforcing member is selected from a group comprising a plastic material, a metal material, and a shape memory alloy. 51. The flow control devices, the adjustable flow rate flow control device and the component for an intravenous (IV) set as substantially herein described along with

Full Text

FIELD OF THE INVENTION
This invention relates to a flow control device. More parlicularty the invention relates to a How control device particularly, but not necessarily exclusively. tor use in an intravenous (IV) administration set. to an orifice plate for a (low control device and to a component lor an IV administration set.
BACKGROUND OF THE INVENTrON
At presenl- infusion of fluids into a patient is managed bv medical personnel. fluids are infused parenterally into a patient for a variety of reasons. It is often critical that the fluid being administered is infused into the patient's bt>dy in the required doses and flow rales.
fhis is usually done either manually using a roller clamp or automalically using an infusion pump, Manual roller clamps are inaccurate and are difficult to set to maintain an accurate flow rate. In addition, when applied to a length of plastics conduit, the plastics conduit itself may. in due course. plastically deform resulting in a loss of clamping action of the roller clamp. This could have the potentially serious consequences of an unregulated supply of fluid into the patient's body.
Infusion pumps, while maintaining an accurate How rate, are expensive items. In addition, because an inllision pump is an electromechanical device, there is a risk of failure of the infusion pump which, once again, has potentially extremely serious consequences, further, with the increasing age of the population there is more prcssure for bed places in hospitals resulting in an increasing homecare market. providing homecare patients with infusion pumps is expensive and has attendant risks as well. In addition. in large parts of the world, there are insufficient funds to make infusion pumps available to patients, whether in hospitals or in homecare.
Also, in the case of roller clamps, there is a continuous need for vigilance by medical personnel to ensure that the fluid is being infused at the desired How rate. Often, in parts of (he world, medical personnel are in short supply and are unable to provide the requisite duty of caree.

In still another embodiment of the present invention, the separating element is a gasket of a resiliently flexible material, the gasket defining the orifices.

The How control devices 10 may be made available with housings 12 of various colours. The flow control devices 10 are therefore colour coded with the colours of the housings

Further. where the conduits 16. 20 are of a silicone material it makes them easy to join to other silicone components by use of a silicone adhesive and. for joining to non-elasU)merie coponents. are able to seal with the use of sealing rings, etc.
It will be appreciated by persons skilled in the art that numerous variatitions and or modifications may be made to the invention as shown in the specific embodiments without departing from the spirit or scope of the invention as broadly described, the present embodiments are. therefore, to be considered in all respects as illustrative and not
restrictive.

1. A flow control device, comprising:
a connector defining a first receiving formation for receiving a first conduit, a second receiving formation for receiving a second conduit and a cross member separating the first receiving formation and the second receiving formation; and
an orifice plate received in the cross member to control flow of fluid in use through the conduits received in the first and the second receiving formations of the connector, the orifice plate defining at least one substantially frustoconical orifice.
2. The device as claimed in claim 1 wherein the connector comprises a cylindrical
housing defining a pair of opposed sockets, the sockets forming the receiving formations
with a transersely extending web defining the cross member.
3. 1 he device as claimed in claim 2 wherein at least the web is of a resiliently flexible material.
4. The device as claimed in claim 2 or claim 3, wherein housing is a one-piece unit of the resilientlx flexible material which facilitates lateral deformation of the housing for pruning purposes.
5. The device as claimed in and one of the preceding claims, wherein the orifice plate is

of a rigid material.
6. I he device as claimed in and one of the preceding claims, wherein the orifice is formed m the plate by laser drilling.
7. The device as claimed in and one of the preceding claims, wherein for any given angle of frustum of the orifice, flow rate through the orifice is directly proportional to cross-sectional area of smaller opening of the orifice.

8. The device as claimed in claim 7, wherein flow rate through the orifice is governed by a linear relationship of the form:
y=mx+c
where:
y is flow rate in ml/hr:
x is cross-sectional area of the smaller end of orillce in microns": and
In and e are constants governed by the angle of the frustum.
9. The device as claimed in claim 7 or claim 8 wherein the angle of trustum of the orifice is in the range of about 15°C in the range of about 1 5° to 50°.
10. The de\ice as claimed in claim 9 wherein the angle of frustum of the orifice is in the range of about 20° to 28°.
Is.
11. The device as claimed in claim 9 or claim 10 wherein the angle of frustum of the orifice is about 24.
12. The device as claimed in any one of the preceding claims, wherein the oritice has a diameter (as measured at its smaller opening) in the range from about 1 to about 700 microns.
13. The device as claimed in any one of the preceding claims, wherein oritice has an aspect ratio which is less than or equal to 10.
14. The device as claimed in any one of the preceding claims, wherein the connector is of a coloured material.
15. The he device as claimed in claim 14 wherein the connector is colour coded with each colour being associated with a particular flow rate.
16. How control device, comprising:

a connector defining a first receiving formation for receiving a first conduit, a second receiving formalion for receiving a second conduit and a cross member separating the first receiving formation and the second receiving formation, the connector being a one piece unit of a resiliently flexible material which facilitates lateral deformation of the connector for priming purposes: and
an orifice plate, dellning at least one orifice. received in the cross member to control How of fluid, in use. through the conduits received in the first and the second receiving formations of the connector.
17. The device as claimed in claim 16. wherein the orilice plate is a rigid member received in the cross member, lateral deformation of the connector causinu the formation of priming ports between the orillee plate and the cross member.
18. the device as claimed in claim 16 or claim 17. wherein the connector comprises a cylindrical housing dellning a pair of opposed sockets, the sockets forming the receiving formations with a transversely extending web defining the cross member.
19 The device as claimed in any one of claims 16 to 18 wherein the oritice plate is of a rigid material
20. The device as claimed in any one of claims 16 to 19 wherein the oritice is formed in the plate by aser drilling.
21 I he device as claimed in claim 20 wherein the orilice is a Irustoeonieal orifice and, for any givem angle of frustum of the orillee flow rate through the orifice is direcllx proportional to a cross-sectional area of a smaller opening of the orillee.
22. 1 he device as claimed in any one of claims 16 to 21. wherein the connector is of a coloured material.
23. The device as claimed in claim 22, wherein the connector is colour coded with colour being associated with a particular flow rate.

24. An adjustable flow rate flow control device.
a fluid delivery arrangement having an inlet and detining a plurality of spaced orifices in communication with the inlet:
a passage defining member displaceably arranged relative to the delivery arrangement. the passage dellning member defining a passage which is able to be brought into How communication with a desired number of orifices to achieve a desired How rale through the outlet by adjusting the position of the passage defining member relative lo the delivery arrangement: and
an oullel in communication with the passage of the passage defining member.
25. The device as claimed in claim 24. wherein said device includes a supply duct in How communication with the passage detuning member.
26. The device as claimed in chum 24 or claim 25 wherein fluid delivery arrangement includes a housing defining a first flow path, the passage of the passage defining member viefining a second (low path.
27. The device as claimed in claim 26 wherein the fluid delivery arrangement includes a separating element separating the first flow path from the second How path, the separating element having the orifices.
28. The device as claimed in claim 27 wherein the separating element is a gasket of a resiliently flexible material, the gasket defining orifices.
29. The device as claimed in claim 28 wherein the orifices are defined in the gasket by a plurality of rigid orifice plates, each orifice plate defining at least one orifice.
30. The device as claimed in claim 29 wherein the outlet is defined in the housing and in which the gasket has an opening defined through it in alignment with the outlet so that fluid that has passed through the orifices is able to flow out through the outlet via the passage of the passage defining member.

31.The device as claimed in claim 29 or claim 30 wherein the passauc dellninu mcinhc!-mcliicles a rolan' aclualor which is rolatably arranged relative lo the housing, the passage being dellned in a body of the rotary aclualor.
32. The device as claimed in any one of claims 24 to 30, wherein the supply duel eonsiituies ihe passage defining member, the supply duct being slidably arranged relalite the delier arrangement to bring the desired number of orifices into liuid communication with the passage.
33. The device as claimed in an\- one of claims 24 lo 32 wherein each orifice is formed h\ laser drilling.
34. The device as claimed in any one of claims 24 lo 32. wherein each orifke is a frus'ioeonica! orillce.
35. The device as claimed in claim 34 wherein for and given angle of frustum of each orifice. How rale through the ortice is directly proportional to a cross-sectional area of a mailer (Opening of the orifice.
36. The device as claimed in claim 35 wherein How rate through each orifice is governed h\ a linear relationship of the form:
y = mx ± c
where:
y is flow rale in ml/hr;
v is cross-sectional area of the smaller end of orifice in microns: and
m and c are constants govermed by the angle of the frustum.
37. The device as claimed in claim 35 or claim 36 wherein the angle of frustum of each orifice is in the range of about 15° to 50°.

38. The device a s claimed in claim 37, wherein the angle of frustum of each orifice is in the range of abut 20° to 28°.
39. The device as claimed in claim 37 or claim 38 wherein the angle of frustum of each orifice is about 24°.
40. The device as claimed in any one of claims 34 to 39 wherein each orifice has a
diameter (as measured at its smaller opening} in range from about 30 to about 700
microns.
41. the device as claimed in any one of, claims 34 to 40 wherein each orifice has an
aspect ratio which is less than or equal to 10).
42. A component for an intravenous (IV) set. the said component comprising a conduit of a silicone material.
43. The component as claimed in claim 42 wherein the silicone material is reinforced to inhibit kinking and to enhance the elasticity of the conduit.
44. The component as claimed in claim 43 wherein the reinforcing is a heiically wound reinforcing member carried in a wall of the conduit.
45. The component as claimed in claim 44 wherein the reinforcing member is selected from a group comprising, a plastic material, and a shape memory alloy.
46. The component of any one of claims 42 lo 46 which includes a flow control de\ice for interconnecting two lengths of conduit, the flow control device being as claimed in any one of claims 1 to 23 the connector of the flow control device being of a silicone material.
47. 1 he component as claimed in any one of claims 42 to 46 wherein it includes a How control device for interconnecting two lengths of conduit, the flow control device being as claimed in any one of claims 24 to 36 at least one of the passage defining member and the supply duct being of a silicone material.

48 A component for an intravenous (IV) set said component comprising a conduit of a reinforce polymeric material.
49. The component as claimed in claim 48 wherein the reinforcing is a helically wound reinforcing member carried in a wall of the conduit.
50. The component as claimed in claim 49 wherein the reinforcing member is selected from a group comprising a plastic material, a metal material, and a shape memory alloy.
51. The flow control devices, the adjustable flow rate flow control device and the component for an intravenous (IV) set as substantially herein described along with

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Patent Number

279206

Indian Patent Application Number

1667/CHENP/2008

PG Journal Number

03/2017

Publication Date

20-Jan-2017

Grant Date

13-Jan-2017

Date of Filing

03-Apr-2008

Name of Patentee

ACU RATE PTY LIMITED

Applicant Address

ACN 111 867 479 OF 73 RAGLAN STREET MOSMAN, NEW SOUTH WALES 2088

Inventors:

#	Inventor's Name	Inventor's Address
1	MILIJASEVIC, ZORAN	5 JACQUELENE CLOSE BAYVIEW, NSW 2104

PCT International Classification Number

A61M 39/08

PCT International Application Number

PCT/AU2006/001465

PCT International Filing date

2006-10-05

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1	2005905494	2005-10-05	Australia