DESC:FIELD OF THE INVENTION

The present invention relates to an intravenous infusion set providing delivery of intravenous fluid to patients. More particularly, the invention relates to an intravenous infusion set with a drip chamber having a flow regulating and stopping member to administer continuous air free delivery of intravenous fluid to patients. The flow regulating and stopping member is configured to allow the delivery of continuous air free intravenous fluid till the time it does not come into contact with air. As such, said member is configured to prevent air entering the flexible infusion line through the drip chamber as soon as it comes into contact with air. The flow regulating and stopping member is a hydrophilic membrane which is permeable to fluid and impermeable to air.

BACKGROUND OF THE INVENTION

Intravenous infusion sets with a drip chamber having flow regulating and stopping members are already known and used to administer controlled quantities of intravenous fluid (for example glucose solution, saline solution, medicine, blood, blood components, etc.) into a patient’s body seeking treatment. Such infusion sets are either pump driven or gravity driven infusion devices.

Gravity driven infusion devices typically include a drip chamber with or without a flow regulating and stopping member, a length of flexible infusion line to connect the lower end of the drip chamber to a standard connector. The connector is then connected via conventional access means such as a needle, a catheter or the like to a patient. The upper end of the drip chamber is provided with a spike which is used to pierce a fluid source such as a bag or bottle containing a specified infusion fluid.

Generally, the whole assembly comprising the fluid source, the spike and the drip chamber is hung on a hanger to provide sufficient height so that the infusion fluid is driven by gravitational force allowing the infusion fluid to flow downward towards the patient from the fluid source. A standard fluid flow adjustment device, for example a roller clamp, is provided on the flexible infusion line between the drip chamber and the connector for regulating the rate of flow of the infusion fluid. The roller clamp can be used to stop the flow of fluid through the flexible infusion line as soon as the fluid source containing the fluid is near to being empty or is empty.

However, various problems and disadvantages are associated with such infusion devices comprising a drip chamber with or without a flow regulating and stopping member. One of the major problems commonly faced is that certain amount of air in the form of bubbles may get into the blood circulation of the patient accidently during the infusion procedure which may lead to air embolism. The air embolism in a patient may cause breathlessness, chest pain, stroke, wheezing, fast heartbeat, loss of consciousness or the like and may lead to death.

The air embolism in such infusion devices may be caused by fast dripping of the intravenous fluid or due to improper priming of the flexible infusion line at the start of the infusion procedure or when the fluid source runs empty and the infusion process is not stopped or in the like instances. In such instances, continuous monitoring by a medical practitioner or an attendant becomes necessary to check presence of air bubbles in the flexible infusion tube and manually push the air bubbles out of the infusion tube if found. This manual watch takes up much of the medical staff time and may be crucial in medical condition. In case, where re-priming is needed, it also may increase the chances of catheter infection. Moreover, improper priming may lead to ineffective working of the intravenous infusion sets and can be crucial in critical medical conditions.

Accordingly, it is desired to provide an improved intravenous infusion set having a drip chamber with a flow regulating and stopping member to administer continuous air free delivery of intravenous fluid to patients which overcomes the above-discussed disadvantages and is inexpensive to manufacture, efficient, effective and simple in its construction and use.

SUMMARY AND OBJECTS OF THE INVENTION

A primary object and advantage of the present invention is to provide an improved intravenous infusion set having a drip chamber with a flow regulating and stopping member to administer continuous air free delivery of intravenous fluid to patients.

Another object and advantage of the present invention is to provide an improved intravenous infusion set which is inexpensive to manufacture, efficient, effective and simple in its construction and use.

Another object and advantage of the present invention is to provide an improved intravenous infusion set which prevents the instances of air embolism ensuring that the flexible infusion line never runs dry.

Another object and advantage of the present invention is to provide an improved intravenous infusion set having a drip chamber with a flow regulating and stopping member which prevents the air from entering the flexible infusion line through the drip chamber as soon as it comes into contact with air.

Another object and advantage of the present invention is to provide an improved intravenous infusion set having a drip chamber with a flow regulating and stopping member which prevents infusion related infection.

Another object and advantage of the present invention is to provide an improved intravenous infusion set having a drip chamber with a flow regulating and stopping member which prevents contaminants, microorganism, infectious agents or the like to enter in the flexible infusion line.

Another object and advantage of the present invention is to provide an improved intravenous infusion set which helps reducing work load with respect to its installation and use and ensures safe priming which may be crucial in critical conditions.

Another object and advantage of the present invention is to provide an improved intravenous infusion set which can help in preparing a series of infusions at once which is quicker and more hygienic than ever before.

The flow regulating and stopping member is a hydrophilic membrane which is permeable to fluid and impermeable to air. Preferably the material of hydrophilic membrane may be flexible and may be sheet or film, tube or fiber, or plug form. The material may be a fabric, such as a nonwoven, woven, or knit fabric, or a scrim.

The material may be made of paper such as filter paper, or a cloth, or a metal mesh. It can also be made of fiberglass, cellulosic, ceramic or the like. The material can also be a porous polymeric film or membrane, synthetic or natural, where the pores form the interstices or passageways. Representative polymers useful in the material include polyamide, polyurethane, polyester, polycarbonate, polyvinylidene fluoride, polyacrylic, polyolefins such as polyethylene and polypropylene, polytetrafluoroethylene, polyvinyl chloride and the like.

Accordingly, the present invention relates to an intravenous infusion set to administer continuous air free delivery of intravenous fluid to a patient, said intravenous infusion set comprising: a drip chamber, a flexible infusion line of sufficient length connecting a lower end of the drip chamber to a standard connector at the patient end so that a needle or a catheter could be connected to the patient; a roller clamp arranged between the drip chamber and the standard connector being movable along the length of the flexible infusion line, said drip chamber has a spike on the upper end and a flow regulating and stopping member at its lower end configured to administer continuous air free delivery of intravenous fluid to patients.

The invention also relates to a flow regulating and stopping member which is a hydrophilic membrane sealed onto a movable disc. The disc is arranged to seat in the lower end of the lower chamber in a close fit arrangement. No air passes when the disc with the flow regulating and stopping member is close fit. The disc has a proximal face and a distal face. The proximal face of the disc includes a sealing ring. The hydrophilic membrane is sealed onto said sealing ring. The sealed hydrophilic membrane covers the outlet so that air bubbles and contaminants are prevented from entering the body of the patient during infusion therapy.

The lower end of the lower chamber ends in a conical connector resulting into an outlet. The outlet is connected to a flexible infusion line. The disc containing hydrophilic membrane covers the outlet so that air bubbles and contaminants are prevented from entering the body of the patient during infusion therapy.

In one embodiment, the flow regulating and stopping member i.e. the hydrophilic membrane is sealed on the proximal face of the disc. Alternatively, the flow regulating and stopping member i.e. the hydrophilic membrane can be sealed on the distal face of the disc. Further alternatively, the hydrophilic membrane can be sealed on both the proximal face and distal face of the disc.

The present invention embodies that the structure of the drip chamber may comprise shapes and configurations such as square, oval, rectangular, triangular, combinations thereof or the like etc. either wholly or partly along the length of the drip chamber.

The present invention embodies that the structure of the flow regulating and stopping member which is permeable to fluid and impermeable to air may comprise shapes and configurations such as square, oval, rectangular, triangular, combinations thereof or the like etc.

The drip chamber may normally be made of a suitable chemically inert plastic material. The present invention embodies that the drip chamber may also be made of other suitable materials such as ceramic, wood, metals and combinations thereof etc.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS:

The foregoing and other objects, features, and advantages of the invention will be apparent from the following detailed description taken in conjunction with the accompanying drawings, wherein:

Fig. 1 is a schematic drawing of the intravenous infusion set of the present invention with an automatic fluid flow stopping mechanism provided in the drip chamber;
Fig. 2 is a cross-sectional view of the drip chamber according to one embodiment of the present invention.
Fig. 3 is a cross-sectional view of the drip chamber according to one embodiment of the present invention.
Figs. 4A and 4B are views illustrating a schematic drawing of the intravenous infusion set including a measured volume intravenous set with a drip chamber having an automatic fluid flow stopping mechanism according to the present invention;
Figs. 5 is a side view of the drip chamber according to one embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Generally speaking, the term “proximal” refers to a region of the device or parts thereof or a location on the device which is closest to, for example, a user using the device. In contrast to this, the term “distal” refers to a region of the device which is farthest from the user, for example, the distal region of a needle will be the region of a needle containing the needle tip which is to be inserted e.g. into a patient's vein.

According to a first aspect of the present invention and referring to FIG. 1, one of the embodiments of an intravenous infusion set 10 is illustrated. The intravenous infusion set 10 comprises a drip chamber 12, said drip chamber 12 has a spike 14 on the upper end 16 and a flow regulating and stopping member 18 at its lower end 20. A flexible infusion line 22 of sufficient length connects a lower end 20 of the drip chamber 12 to a standard connector 24 at the patient end so that a needle or a catheter could be connected to the patient.

A fluid flow adjustment device such as a roller clamp 26 is arranged between the drip chamber 12 and the standard connector 24 being movable along the length of the flexible infusion line 22. The roller clamp 26 could be gradually adjusted so that the infusion tube could be squeezed proportionally to change the infusion rate and may also help in changing the fluid source i.e. bottle or bag for multiple infusion procedures.

A clip 28 (not shown) may also be arranged between the drip chamber 12 and the roller clamp 26 along the length of the flexible infusion line 22. The clip 28 is configured to stop the flow of infusion fluid instantly by a clipping action. A Y-connector 28 may also be provided between the drip chamber 12 and the standard connector 24.

As shown in Figs. 1 and 5, the drip chamber 12 is provided with at least two chambers comprising a lower chamber 12a and a upper chamber 12b. In this embodiment, the lower chamber 12a is flexible and upper chamber 12b is rigid. Both the chambers 12a, 12b are connected by a connecting means such as a ring 32 defining a passage. The flexible lower chamber 12a is used for the purposes of priming.

In another embodiment, the lower chamber 12a is rigid and upper chamber 12b is flexible. In yet another embodiment, both the chambers 12a, 12b are flexible or rigid or a combination thereof.

The drip chamber 12 is provided with a spike 14 on the upper end 16. The spike 14 has a pointed tip which is used to pierce a fluid bag/bottle (now shown) so that the infusion fluid will be pulled by gravity into the drip chamber 12. The spike 14 is provided with slits or holes for fluid to flow in to the drip chamber 12 from the fluid bag/bottle to the patient.

Referring now to Fig. 2 and 3 a lower end 20 of the lower chamber 12a is provided with a flat sealing ring 34 and a conical connector 36 resulting into an outlet 38. The outlet 38 is connected to flexible infusion line 22. A flow regulating and stopping member 18 which is a hydrophilic membrane is sealed onto said sealing ring 34. The sealed hydrophilic membrane covers the outlet 38 so that air bubbles and contaminants are prevented from entering the body of the patient during infusion therapy.

As illustrated in Fig. 3, a flow regulating and stopping member 18 which is a hydrophilic membrane is sealed onto a movable disc 30. The disc 30 is arranged to seat in the lower end 20 of the lower chamber 12a in a close fit arrangement. No air passes when the disc 30 with the flow regulating and stopping member 18 is close fit. The disc 30 has a proximal face 40 and a distal face 42. The proximal face 40 of the disc 30 includes a sealing ring 34. The hydrophilic membrane is sealed onto said sealing ring 34. The sealed hydrophilic membrane covers the outlet 38 so that air bubbles and contaminants are prevented from entering the body of the patient during infusion therapy. The lower end 20 of the lower chamber 12a ends in a conical connector 36 resulting into an outlet 38. The outlet 38 is connected to a flexible infusion line 22. The disc 30 containing hydrophilic membrane covers the outlet 38 so that air bubbles and contaminants are prevented from entering the body of the patient during infusion therapy.

Alternatively, the flow regulating and stopping member 18 i.e. the hydrophilic membrane can be sealed on the distal face 42 of the disc 30. Further alternatively, the hydrophilic membrane 18 can be sealed on both the proximal face 40 and distal face 42 of the disc.

The hydrophilic membrane can be sealed to said sealing ring by heat sealing, adhesive sealing, ultrasonic welding, heated die, radio frequency, mechanical seal, insert molding, laser welding, press/snap fit, annular ring with groove fitment etc.

The flow regulating and stopping member 18 which is a hydrophilic membrane of the present invention has a strong affinity for fluid/liquid while restricting air from attaching to its surface. As a result, the membrane is permeable to fluid/liquid and impermeable to air. A fully wetted hydrophilic membrane will allow fluid/liquid to flow through while acting like a barrier to air bubbles passing across it. Under normal conditions, flow of fluid/liquid from a fully wetted membrane is expected to start under gravity pull more readily. Hence with the present membrane setup, the fluid in the drip chamber will be ready to flow once it is filled up. No milking of the roller clamp is required to initiate the flow.

As shown in Figs. 4A and 4B the intravenous infusion set includes a measured volume intravenous set 44 with a drip chamber 12 having an automatic fluid flow stopping mechanism. In one of the embodiments, a flow regulating and stopping member 18 which is a hydrophilic membrane is sealed onto a movable disc 30. The disc 30 is arranged to seat in the lower end 20 of the drip chamber 12. The lower end 20 of the drip chamber 12 ends in a conical connector 36 resulting into an outlet 38. The outlet 38 is connected to a flexible infusion line 22. The disc 30 containing hydrophilic membrane covers the outlet 38 so that air bubbles and contaminants are prevented from entering the body of the patient during infusion therapy.

In the present invention, said hydrophilic membrane will automatically stop the fluid flow once the fluid in the drip chamber 12 is empty and as long as the membrane is still totally wet. As such no air will get into the flexible infusion line 22 during and at the end of the infusion procedure. Furthermore because the same intravenous infusion set 10 can be used for multiple infusions, the material cost and clinical waste is greatly reduced and this is one of the advantages of the present invention.

Although this invention has been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. Thus, from the foregoing description, it will be apparent to one of ordinary skill in the art that many changes and modifications can be made thereto without departing from the spirit or scope of the invention as set forth in the claims.

Accordingly, it is not intended that the scope of the foregoing description be limited to the exact description set forth above, but rather that such description be construed as encompassing such features that reside in the present invention, including all the features and embodiments that would be treated as equivalents thereof by those skilled in the relevant art.

Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above but should be determined only by a fair reading of the appended claims.

List of Reference numerals:

10 Intravenous infusion set
12 drip chamber
12a lower chamber
12b upper chamber
14 spike
16 upper end
18 flow regulating and stopping member
20 lower end
22 flexible infusion line
24 standard connector
26 roller clamp
28 Y-connector
30 disc
32 ring
34 sealing ring
36 conical connector
38 outlet
40 proximal face
42 distal face
44 measured volume intravenous set

,CLAIMS:WE CLAIM:

1. An intravenous infusion set (10) to administer continuous air free delivery of intravenous fluid to a patient, said intravenous infusion set (10) comprising: a drip chamber (12), a flexible infusion line (22) of sufficient length connecting a lower end (20) of the drip chamber (12) to a standard connector (24) at the patient end so that a needle or a catheter could be connected to the patient; a roller clamp (26) arranged between the drip chamber (12) and the standard connector (24) being movable along the length of the flexible infusion line (22), said drip chamber (12) provided with a spike (14) on the upper end (16) and a flow regulating and stopping member (18) at its lower end (20) configured to administer continuous air free delivery of intravenous fluid to patients.

2. The intravenous infusion set (10) as claimed in claim 1, wherein said flow regulating and stopping member (18) is a hydrophilic membrane.

3. The intravenous infusion set (10) as claimed in claim 1, wherein the drip chamber (12) is provided with at least two chambers comprising a lower chamber (12a) and a upper chamber (12b) connected by a connecting means such as a ring (32) defining a passage.

4. The intravenous infusion set (10) as claimed in claim 3, wherein a lower end (20) of said lower chamber (12a) is provided with a flat sealing ring (34) and a conical connector (36) resulting into an outlet (38) which in turn is connected to flexible infusion line (22).

5. The intravenous infusion set (10) as claimed in claim 1 to 4, wherein said flow regulating and stopping member (18) is sealed onto said sealing ring (34).

6. The intravenous infusion set (10) as claimed in claim 1, wherein said flow regulating and stopping member (18) is sealed onto a movable disc (30) arranged to seat in the lower end (20) of the lower chamber (12a).

7. The intravenous infusion set (10) as claimed in claim 6, wherein the disc (30) has a proximal face (40) and a distal face (42) and the proximal face (40) of the disc (30) includes a sealing ring (34).

8. The intravenous infusion set (10) as claimed in claim 6 and 7, wherein said flow regulating and stopping member (18) is sealed onto said sealing ring (34).

9. The intravenous infusion set (10) as claimed in claim 1 to 8, wherein the hydrophilic membrane can be sealed to said sealing ring by heat sealing, adhesive sealing, ultrasonic welding, heated die, radio frequency, mechanical seal, insert molding, laser welding, press/snap fit, annular ring with groove fitment etc.

10. The intravenous infusion set (10) as claimed in claim 6 and 7, wherein said flow regulating and stopping member (18) is sealed onto the distal face (42) of the disc (30).

11. An intravenous infusion set (10) to administer continuous air free delivery of intravenous fluid to a patient, said intravenous infusion set (10) comprising: a drip chamber (12), a flexible infusion line (22) of sufficient length connecting a lower end (20) of the drip chamber (12) to a standard connector (24) at the patient end so that a needle or a catheter could be connected to the patient; a roller clamp (26) arranged between the drip chamber (12) and the standard connector (24) being movable along the length of the flexible infusion line (22), said drip chamber (12) provided with a spike (14) on the upper end (16) and a flow regulating and stopping member (18) at its lower end (20) in a close fit arrangement configured to administer continuous air free delivery of intravenous fluid to patients.

Dated this 27th day of June 2015.