WO2012117409A1

WO2012117409A1 - A needle-free dispending pin for safe drug administration

Info

Publication number: WO2012117409A1
Application number: PCT/IN2011/000125
Authority: WO
Inventors: Natrajan S. IYER; Anju Gupta Kaudanya
Original assignee: VHB PHARMACEUTICALS PRIVATE Ltd
Current assignee: VHB PHARMACEUTICALS PRIVATE Ltd
Priority date: 2011-02-28
Filing date: 2011-02-28
Publication date: 2012-09-07
Anticipated expiration: 2013-08-28

Abstract

Needle free dispensing is a low cost, simple device for drug administration that eliminates the commonly-occurring problems of contamination by ambient impure air and exposure of drug administrator to aerosolized drug molecules. It employs a hydrophobic filter, held firmly and in air tight manner in between two wings of a C-shaped seal. The other components of the assembly are a conical, hollow, V-shaped body and a sharp-edged cannula. The filter is pressed against upper surface of the C-shaped seal by the V-shaped body and the cannula during assembly, thereby forming a leak-proof joint.

Description

Title of the Invention:

A needle free dispensing pin for safe drug administration

Field of the Invention:

This invention relates to the field of intravenous administration of drug injectables and more particularly to the field of ensuring safety to drug administrators in terms of preventing release of aerosolized drug particles in the immediate environment without affecting sterility of drug being administered.

Background of the Invention:

Following works are cited to pinpoint inherent drawbacks encountered in the use of conventional dispensing pins.

US Patent 5,899,877 - It relates to a connector with barbed surfaces, a conduit with a stop valve. The valve is engaged between two containers. The cited work is different from the present invention that employs a cartridge, a hydrophobic filter and wings for pressure equalization. US Patent 6,085,943 - It describes a device, employing a pair of closable valves and a housing with an inner chamber. The present invention has none of the features of the cited, prior work.

US Patent 4,768,568 It provides a septum-sealed medicament chamber, divided into a vented, variable volume, chamber and a vented, sealed, variable volume chamber. A hydrophobic filter is fitted on vented control chamber. The present work has none of the features of the cited work except a hydrophobic filter.

WO 2007/079048 - This prior work describes a vial adapter, comprised of a port each for vent and medicament. It employs, in different embodiments thereof, hydrophobic and anti-bacterial filters in vent port to regulate flow of fluid, liquid and air-borne agents. The prior work is different from the present invention, which employs the filter in and around medicament port.

WO 99/08036 - This prior work describes a needle assembly and is substantially different from the present invention.

U.S. Application 2007/0244461 - This prior work relates to a vial adapter, comprised of an inflatable bag, which is absent in the present invention. The former has no features found in the present work.

U.S. Patent 5242411 - This prior work is substantially different from the present invention in terms of employing a pair of needles, situated in separate hubs, a valve disc and a rod member. A vent filter is positioned in internal cavity of outer needle hub. None of the features of the prior work is found in the present invention.

US Patent 4,747,518 It describes a device with a dispensing valve and is useful for squeeze bottle. The present invention has no similarities with the cited work. No other prior works of the type of the present invention are found in the patent databases. Objects of the Invention:

An object of the present invention is to provide a cost effective dispensing pin that balances air pressure during reconstitution or withdrawal of injectable fluids, while maintaining sterile conditions.

Another object of the present invention is to prevent contamination of the immediate environment with aerosolized drug particles that would adversely affect health of personnel administering drug.

Another object of the present invention is to prevent potential contamination of drug being administered due to air entering through conventional dispensing pins.

Another object of the present invention is to eliminate occurrence of needlestick injury to drug administrators.

Lastly, another object of the present invention is to rid dispensing pin of dynamic/ moving parts such as valves, springs and to provide a simple device. IN2011/000125

Summary of the Invention:

Brief Description of the Drawings:

Figure # 1 illustrates general working of the needle-free

dispensing pin (100) during restitution of drug.

Figure # 2 illustrates working of the needle free dispensing pin

( 100) during withdrawal of drug prepared.

Figure # 3 illustrates plan view of hydrophobic filter media (50) assembled and firmly held in between C-shaped wings

(10, 10- A).

Figure # 4 illustrates an exploded view of needle- free dispensing pin (100).

DETAILED DESCRIPTION OF THE INVENTION:

Needle-free dispensing pin (100) is a safe and effective device for use on sealed vial and intravenous bags. It is commonly observed that reconstitution of dry, sterile or lyophilized powder generates drug aerosol molecules, which are let out along with outgoing air from vial or bag into surrounding atmosphere, thereby not only exposing physicians and healthcare practitioners administering drug to dangerous effects of drug being administered but losing also potency of the drug. It is dangerous to expose daily the health personnel to this hazard. The surrounding air that enters vial or intravenous bag during reconstitution of the drug may adversely affect sterility of the drug being administered on account of being itself contaminated with atmospheric bacteria and viruses.

The needle- free dispensing pin ( 100), as illustrated in the accompanying figure # 4, effectively retains the aerosolized particles in the vial (20) by means of hydrophobic filter (50) having 0.2 micron pores, while filtering out the bacterial and endotoxin contents of air rushing in during withdrawal of drug. Patient is thus provided sterile medication.

An inventive feature of the present invention lies in the provision of a hydrophobic filter (50) in the passage of incoming air to filter out bacteria and other toxins of the surrounding air and to trap the aerosolized molecules during air pressure equalization stage. The difference in air pressure while reconstitution of the product. p' represents the air pressure inside the vial which is higher than p_a which represents the air pressure outside the vial. Therefore, the total air pressure difference is given by,

Δρ = ρ'- ρ₃.

When a fluid is withdrawn from the vials or i.v. bags, a negative air pressure builds up in the container. Thus a provision of air to enter the system is necessary which in turn would balance the air pressure and allow the fluid to flow in a faster rate. As maintaining the sterility of the drug is an important aspect for injectables, it becomes necessary to provide sterile air entry. Thus a filter fitted needle can be used to provide the required sterile conditions

The difference in air pressure when the liquid is withdrawn from the vial or the i.e. bag.

p' represents the air pressure in the container which is lower than p_a which represents the air pressure outside the container. Therefore, the total air pressure difference is given by,

Δρ - p_a - p'.

Currently there are two procedures available for protecting drug administrator from the hazardous aerosols of the cytotoxic drugs. The first method that is used is so-called glove box where the administrator inserts his hands into the gloves through which the access to the syringe containing the diluents or reconstitution solvent and the vial containing the drug is gained as they are placed in an enclosed box. This procedure is tedious and time consuming. The second method is use of vial adaptors having a spike for piercing the elastomeric stopper, a vent lumen with filter for providing air passage and a fluid lumen where syringe is attached to withdrawal of fluids. There are certain disadvantages with these vial adaptors like these are relatively expensive and there is no guarantee that the filter would always be efficient in blocking the aerosol particles to get in contact with the outer environment especially when the filter is wet when the diluent is introduced into the vial, thus causing outward flow of gas which in turn might cause entrain the drug particles into the filter. Due to wet filters, the particles might stick to the filter media, which eventually might cause its blockage. These disadvantages are overcome by the present invention, as the device is used only for air filtration and thus does not come in contact with liquid flow. Also, this device is to be disposed after every use, the efficiency of the filter media is thus maintained.

Numerous drugs have to be admixed quickly, all at the same time. Patients need their medicines, treatment regimes to be started as quickly as possible. Also, busy practitioners require simple convenient and safe procedures for administration of medicaments. Considering these aspects, it is made simple, convenient and safe device for the benefit of mankind.

The needle free dispensing pin is a device having a filter for maintaining sterile airflow while reconstitution and withdrawal procedures. Access pores for injecting fluid into or removing fluid from a system, such as a drug vial generally involves a pierceable rubber stopper formed using elastomeric material e.g. butyl rubber, natural rubber etc are placed in the opening of the vial. A metal crimped closes the sealing area of the rubber bung and the vial sitting area. The closure has opening or axis port, through which stopper and vial opening may be accessed. 0.2 μ or 0.45μ filter is inserted into the access port. The cannula pierces the rubber stopper to make fluid connection with the interior of the vial.

The needle-free dispensing pin ( 100) is particularly beneficial to oncologists, administering hazardous drugs to several cancer- stricken patients a day. It is a cost effective device, meant to be used as air pressure balancer during reconstitution and withdrawal of drugs, while maintaining sterile conditions. It can be used for vials as well as intravenous bags and is easily sterilized with ethylene oxide. It is a low-cost product, freed from needle to prevent needle stick injuries.

According to Centre for Disease Control & Prevention, the needle sticks form a source in transmission of blood-borne diseases like HIV, hepatitis-B and hepatitis-C. Thousands of healthcare professionals worldwide are infected by such diseases due to the needle stick injuries.

According to WHO reports, out of 35 million healthcare workers, 2 million experience percutaneous exposure to infectious diseases every year. They also report that 37.6% of hepatitis-B, 39% of hepatitis-C and 4.4% of HIV/AIDS in healthcare workers around the world are afflicted due to needle stick injuries.

The needle- free dispensing pin (100) does not have moving part like springs, valves and levers. It is comprised of three

components:

( 1) a C-shaped seal (10) with twin wings - one upper wing (11), and the other lower wing (12). The upper wing (1 1) - looking at the C-shaped seal from top - is peripherally broader to have larger surface area in contact with the filter media (50), whereas the lower wing (12) is peripherally narrower in the plan view and allows a peripheral void (13).

(2) a circular-shaped, hydrophobic filter (50), firmly held in place in between the upper wing ( 1 1) and the lower wing (12) of the C-shaped seal (10).

(3) a hollow, V-shaped body (30), having a flanged upper end

(31 ) and apex (32), integrally joined with a sharp-edged, tubular cannula (32)

As illustrated in the accompanying figure # 4, the C-shaped seal (10) ensures that the hydrophobic filter (50) does not crumble under the air pressure exerted during drug reconstitution and withdrawal procedure.

The second inventive feature of the present invention is the C- shaped seal (10) for uniform, peripheral support to the hydrophobic filter (50). The wings (11, 12) firmly hold the filter (50) after a heat and press-fit procedure.

As illustrated in the accompanying figure # 4, the cannula (40) is disproportionately long in relation to said V-shaped body (30) and tapers at the other open end (33) thereof. The dissimilarity between functioning of a conventional pierceable rubber stopper and the needle-free dispensing pin (100) of the present invention is that the former facilitate passage of contaminated air through punctured area of the rubber stopper, whereas the latter facilitates the passage of air through firstly the hydrophobic filter (50). The filter (50) is hydrophobic, sterilizable, has pore size of 0.2 micron and made of whatman filter paper. The material of construction for the V-shaped body (30), integrally moulded with sharp cannula (40) and the C-shaped wings (10, 10- A) is food grade olycarbonate plastic, which is moulded in the respective moulds, heated at 250 degree Celsius temperature.

Assembly of needle-free dispensing pin (100):

Procedure for assembling the needle-free pin (100) comprises: (1 ) heating C-shaped seal (10) to 50 degree Celsius;

(2) applying a thin coat of cyano acrylate glue (food grade)

internally on the upper wing (1 1 ) of the C-shaped seal (10); (3) applying a thin coat of the cyano acrylate glue on the flanged end (31 ) of the V-shaped body (30) and pasting a cut-to- size, circular filter media (50) on the flanged end (31) of the V-shaped body (30);

(4) sliding inwardly the assembly of the V-shaped body (30) and the pasted filter media (50) onto the lower wing (12) of the C-shaped seal (10) and under mild pressure, fitting the assembly between the upper wing (1 1) and lower wing (12) of the C-shaped seal (10).

Best Method of Operating the Invention:

To achieve the required results,

The needle-free dispensing pin (100) must be sterilized with ethylene oxide before use.

Claims

Claims:

We claim,

1. A needle-free dispensing pin ( 00), for safe administration of drug, comprising:

(a) a C-shaped seal ( 10) with twin wings - one upper wing (1 1 ), and the other lower wing ( 12), said upper wing (1 1) - looking at the C- shaped seal from top - being peripherally broader to have larger surface area in contact with the filter media (50), and said lower wing (12) being peripherally narrower in the plan view and allowing^' a peripheral void (13);

(b) a circular- shaped, hydrophobic filter (50), firmly held in place in between said upper wing (1 1) and said lower wing (12) of the C-shaped seal (10); a hollow, V-shaped body (30), having a flanged upper end (31) and apex (32), integrally joined with a sharp-edged, cylindrical cannula (32).

2. A needle-free dispensing pin (100) as claimed in claim 1 ,

Wherein said C-shaped seal ( 10) latches to said flanged, upper end (31) of said V-shaped body (30) under mild pressure during assembly of the needle-free dispensing pin (100).

A needle- free dispensing pin (100) as- claimed in claim 1, wherein said C-shaped seal (10) and said V-shaped body (30) are made by moulding of food grade polycarbonate plastic.

4. A needle-free dispensing pin (100) as claimed in claim 1, wherein said hydrophobic filter media (50) is made of whatman filter paper having 0.2 micron pore size and is circular in shape.

10. 5. A needle-free dispensing pin (100) as claimed in claim 1 , wherein said upper, flanged end (31 ) -during assembly of said needle-free dispensing pin (100) - is given a thin coat of food grade cyano acrylate glue and said circular filter media (50) is pasted on said flanged end (31 ) of said V-shaped body

15. (30).

6. A needle-free dispensing pin ( 100) as claimed in claim 1 , wherein said upper, broader wing ( 1 1 ) of said C-shaped seal ( 10) is heated to 50 degree Celsius temperature during assembly of said needle-free dispensing pin (100), interiorly is given a thin coat of food-grade cyano acrylate glue and said sub- assembly of said filter media (50) with said V-shaped body (30) is slid under mild pressure onto said lower, narrower wing (12) of said C-shaped wing (10) into said space (13) between said wings (1 1 , 12) of said C-shaped seal (10).