WO2013041916A1

WO2013041916A1 - A drip set

Info

Publication number: WO2013041916A1
Application number: PCT/IB2011/054456
Authority: WO
Inventors: Nileththi Janaka WICKRAMASINGHE
Original assignee: Wickramasinghe Nileththi Janaka
Priority date: 2011-09-20
Filing date: 2011-10-10
Publication date: 2013-03-28

Abstract

A drip set with a unique shape, that ends with a "U" shape and a floater device (6) inside the collecting compartment with a unique shape made of two parts (12, 13). The top part and the lower part are made into one unit, with a larger size ball (12) on top with an air trapped compartment (11) in the centre occupying 75% - 80 % of volume of the larger floater ball and the lower part with a solid smaller ball (13). The air trapped compartment in the larger ball will enable the floater unit to float on the fluid, while the smaller ball will guide the floater. The accumulated air inside the saline bottle will enter into the drip set compartment when the fluid runs out, the floater would prevent air leaked into the drip set compartment from leaking into the drip set tube set by floating down with fluid and blocking the drip set tube thus preventing air leaking in to the patient's blood circulation once the saline bottle and the drip set collecting compartment runs out of fluid.

Description

A drip set

Description

In the field of medicine, substance in fluid form (normal saline, dissolved antibiotics, etc.) need to be given to patients by using a drip set which will be attached to a saline bottle. This bottle will act as the reservoir for fluid storage and in order to administer the fluid stored in the saline bottle, a drip set is used. The drip set is then connected to the patient by a needle introduced into the patient's vein. Thus, by the release of the drip set regulator, fluid can be introduced to the patient's circulatory system.

Flaws of the present day saline bottle with regard to air leakage

Air comes into the saline bottle (19) via the drip set air intake window (5) as shown in Fig 1. This is a must in order to facilitate the passing of fluid (7) inside the saline bottle (19) into the drip set collecting compartment (2). For every drop of fluid that passes from the saline bottle (19) to the drip set collecting compartment (2), an equal amount of air should flow back into the saline bottle (19) via the drip set air intake window (5) from the outside atmosphere thus accumulating air inside the bottle for the amount of fluid (7) dispensed from the saline bottle.

The accumulated air inside the saline bottle (19) can then flow back into the drip set once the fluid (7) runs out and instead of fluid (7), air in the bottle will flow into the patient via the drip set.

The current invention will overcome the flow of air into the patient via the drip set once the fluid (7) runs out.

In order to overcome the above mentioned flaw, a safe drip set is required only to deliver fluid (7) and to prevent air leaking into the drip set tube (10) and to the patient's circulation.

The drip set

The drip set (1) will have a unique shape at the end of the drip set collecting compartment (2). Inside the drip set collecting compartment (2) will be a uniquely shaped floater (6). The drip set tube filter (17) would be situated further down the drip set tube (10) as explained below.

On top of the drip set collecting compartment (2) would be the air intake chamber (4) with an air inlet window (5), as in conventional drip sets in existence today. Fixed onto the top of the air intake chamber (4) would be the drip set connector (3).

The function of the drip set connector (3), would be to fix the drip set (1) to the saline bottle (19) through the saline bottle rubber lid (20). On the opposite side to the drip set connector (3) would be the drip set tube (10) fixed to the drip set collecting compartment (2).

The drip set collecting compartment (2) as mentioned above would have a unique shape at the end where the drip set tube (10) is fixed. Going down from the drip set connector (3) end till the drip set tube end (10), the shape of the drip set collecting compartment (2) would change from a cylindrical shape indentified as drip set cylinder (8) as seen in most of the drip sets in use today, to a unique "U" shaped end, named as the drip set "U" shaped end (9). Attached to drip set "U" shaped end (9) at the end would be the drip set tube (10). The drip set "U" shaped end (9) will act as a slide to guide the floater (6) towards the floater landing site (16).

The proposed invention is drip set (1) having a floater (6) in the collecting compartment (2) as mentioned above. The floater (6) inside would be uniquely shaped and built. The floater (6) would be made out of two circular balls as seen in Fig (2). These would be identified as floater ball one (12) and floater ball two (13). The differences between the two would be that floater ball one (12) would be larger than floater ball two (13) and floater ball one (12) would have an air trapped compartment in its centre occupying 75% - 80 % of the volume of floater ball one (12) as shown by Fig 2. This would be identified as the floater ball air trapped compartment (11). The reason to have a floater ball air trapped compartment (11) is to enable the floater (6) to float on the fluid (7) inside the drip set collecting compartment (2) and to move down with the fluid (7) level (7) without sinking and to have lighter weight than floater ball two (13), in order to always have floater ball two (13) pointing downwards due to its heavier weight in comparison to floater ball two (12). Floater (6) is shown in Fig 1.

The floater (6) disclosed above may be made of plastic or any other material that can be and is being used for the manufacture of saline bottles. The manufacturing process could be by moulding and/or other manufacturing processes known by those who have a skill of the art.

Floater ball one (12) will come and land on the floater ball landing site (16) with the aid of drip set "U" shape end (9) acting as a slide Fig 1 and (3) . The length of the latter portion of floater ball one (12) as shown by floater ball one length (14) will be merely a fraction lesser than the length of the floater landing site (16) enabling (16) and (13) to form a perfect bond in order to prevent air from leaking into the drip set tube (10).

Floater ball two (13) will have a diameter which is a fraction lesser than the diameter of the drip set tube (10) as shown by floater ball two diameter (15). The reason for this is for the complete floater ball two (13) to sink inside the tube set (10) once the fluid (7) runs out of the floater compartment (2) as shown by Fig 3 and to stop air from passing into the rest of the drip set tube (10).

The idea of having a floater (6) with two distinguished structures is to achieve the following functions

1. Floater ball one (12) will act as the "first air barrier" by stopping any air from passing onto the drip set tube (10), once the fluid (7) runs out of the collecting compartment (2).

2. Floater ball one (12) and floater ball two (13) are a combined unit bound together, thus floater ball one (12) will hold on to floater ball two (13), without letting floater ball two (13) to slip into the drip set tube (10), thus acting as a safety device.

3. Floater ball two (13) will act as the second air barrier" by preventing the slightest chance of air leakage into drip set tube (10).

4. It will make certain that this locking mechanism created by floater ball two (13) and the drip set tube (10) will enable floater ball one (12) and the drip set "U" shaped end (9) to align to perfection. The drip set filter (17) would not be located at the junction between the drip set collecting compartment (2) and drip set tube (10). Instead it would be situated further down. Therefore, until the end of drip set filter (17), the tube set wall will be non flexible but firm with continuation of the same material as the drip set compartment (2) in order to prevent damaging drip set filter (17) and to prevent dislodging floater ball two (13). This portion would be identified as the firm portion of the drip set (18) as shown by fig 3.

The floater (6) will act as a fail-safe valve and prevent any chance of air passing onto the drip set tube (10) and via that to the patient.

The drip set (1) and the floater (6) will be made of material which will be able to withstand the sterilisation/disinfection methods in existence today. (Same materials that make the present day saline bottles plus syringes can be utilised)

The workings of the drip set with a floater

As described above, the drip set collecting compartment (2) would have a floater (6) with a unique shape that would enable it to float on the fluid (7) as shown by Fig 1, and as per the floater (6) features described above. As the fluid inside the saline bottle (19) runs out, the flow of fluid (7) to the drip set collecting compartment (2) would stop and the level of fluid (7) inside would move down as the fluid (7) left inside the drip set compartment (2) would run into the patient's circulation, and the floater (6) would go down with the declining fluid (7) level in drip set collecting compartment (2) as shown in Fig 1.

As the fluid (7) level declines, air would flow from the saline bottle (19) into drip set collecting compartment (2) instead of fluid (7) via drip set connector (3). As the fluid level reaches the latter part of drip set collecting compartment (2), to the drip set "U" shaped end (9), the unique shape of drip set "U" shaped end (9) would glide the floater (6) into the floater landing site (16) as the fluid runs out of the drip set collecting compartment (2). This will engage floater ball two

(12) on top of floater landing site (16) forming the "first air barrier" and sinking floater ball two

(13) inside the drip set tube (10) and forming the "second air barrier" as shown in Fig 3 and thus preventing any air from going into the patient's circulation via the drip set tube (10).

Prior art

In the field of medicine, substance in fluid form (normal saline, antibiotics, etc) need to be given to patients by using a drip set which will be attached to a bottle. The bottle will act as the reservoir for the fluid while the drip set would deliver the fluid to the patient.

The main problem with this system is that once the fluid runs out, air inside the bottle will enter the drip set and from the drip set to the patient's blood circulation, thereby creating a risk to all patients who are on intravenous drips, especially those with cardiac defects and paediatric patients who have a higher risk of air embolism in comparison to other patients.

Though there are different views in regard to the amounts of air suggested that could cause an air embolism via a peripheral intravenous line, the fact remains that "prevention is better than cure". As we practice in medicine in general, if the patient is on a central line, the result of an empty saline bottle could be fatal if an embolism takes place.

Patients too are very anxious when they are connected to an intravenous line and they tend to keep an eye on the saline bottle in order to monitor the fluid level. This may cause anxiety, and deprive sleep and rest which is much needed by the patient, since patients do not wish to see air bubbles pass into their circulation.

If the flow of air is detected by the staff (doctor/nurse), the air should be removed and then only can a new bottle be attached thereby consuming time and resulting in overloading the staff with unnecessary work.

This new inventive mechanism can help to save time and reduce the workload of the staff by preventing them from constantly checking the intravenous fluid levels and would give reassurance to patients on intravenous lines that air passing into their circulation is not a possibility.

In US Patent No. 7,722 517 a drip set was invented to filter any air bubbles that would be formed during priming. When drops of saline land on the surface of the saline reservoir, the formed bubbles as per the invention would be prevented from going into the patient's circulation, whilst keeping negligible levels of bubbles out of the system while the fluid is running in the system. The said invention failed to address the air inside the bottle leaking to the patient's circulation when the fluid runs out of the saline bottle.

Claims

1. A drip set for use in the administration of fluids comprising:

A fluid collecting compartment ending in a "U" shape, floater inside the collecting compartment and a floater landing site

2. The drip set claimed in 1 above comprising:

A drip set connector as the inlet and the drip set tube set as the out let; and

3. A floater inside the collecting compartment as claimed in 1 above made with the harmonisation two structures, the structures would be in the form of two balls , one larger in size in comparison to the other ball; and

4. The larger ball as claimed in 2 above will have its complete structure whereas the smaller ball as claimed in 2 above would only have 60% - 75% of its structure, whereas the remaining portion of the smaller ( 60%- 75%) ball would be affixed or moulded to the larger ball lower pole thus forming one unit, ; and

5. The larger ball claimed in 2 above would have a larger diameter than the drip set tube set, and would have a diameter fraction lesser to that of the "U" shape end of the collecting compartment as claimed in 1 above enabling the larger ball to fit perfectly in to the "U" shape landing site of the collecting compartment; and

6. Larger ball as claimed in 2 above having an air trapped compartment inside occupying 75 to 80 % of its volume inside, enabling the larger ball to float along with attached smaller ball as claimed in 2 above on the fluid and to reduce its weight with the aid of the air trapped compartment; and

7. A smaller ball and claimed in 2 above with a diameter a fraction lesser than the drip set tube set enabling it to sink into the drip set tube set connected to the drip set compartment at the "U" shaped end and having a higher weight than the larger ball as claimed in 2 above with an air trapped compartment.

SUBSTITUTE SHEET (RULE 26)