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Heparin Prefillable Syringe Made Of Coc/Rcp

Abstract: The disclosed invention proposes a Heparin Prefilled Syringe Made of Cyclic Olefin Copolymer or Roselene Crystal Clear polymer for exact Heparin dose administration. The present Heparin prefilled syringe made of Cyclic Olefin Copolymer or Roselene Crystal Clear polymer do not retain heparin molecules to the walls of the said syringes as the said syringes are siliconized and do not allow the negatively charged heparin to get attached to the walls of the syringe. Therefore, there are no chances of fluctuation in the dosage. Also, the present Heparin prefilled syringe made of COC or RCP being prefilled, contain premixed Heparin and Sterile Water in the relative amount for the required dose and so do not require them to be mixed from the ampoules prior to administration. Therefore, the possibility of fluctuations in dosage is considerably reduced. Further, there are no risks of dosage fluctuation due to handling errors as it is not required to be filled from the ampoules. Hence, there are no risks of heparin getting contaminated.

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
10 July 2012
Publication Number
22/2014
Publication Type
INA
Invention Field
BIO-MEDICAL ENGINEERING
Status
Email
Parent Application

Applicants

1. AGRAWAL  Pawan
F 22  Akash Tower  Opp: Premchand Nagar  Judges Bunglow Road  Satellite  Ahmedabad  Gujarat State
2. AGARWAL  Zameer
F 22  Akash Tower  Opp: Premchand Nagar  Judges Bunglow Road  Satellite  Ahmedabad  Gujarat State

Inventors

1. AGRAWAL  Pawan
F 22  Akash Tower  Opp: Premchand Nagar  Judge Bunglow Road  Satellite  Ahmedabad-380015  Gujarat State
2. AGARWAL  Zameer
F22  Akash Tower  Opp: Premchand Nagar  Judge Bunglow Road  Satellite  Ahmedabad-380015  Gujarat State

Specification

DESC:FORM – 2
THE PATENTS ACT, 1970
(39 of 1970)
COMPLETE SPECIFICATION
(SECTION 10, RULE 13)
“HEPARIN PREFILLED SYRINGE
MADE OF CYCLIC OLEFIN COPOLYMER OR
ROSELENE CRYSTAL CLEAR POLYMER”
AGRAWAL, Pawan
Indian National
F 22, Akash Tower,
Opp: Premchand Nagar,
Judges Bunglow Road,
Satellite, Ahmedabad-380054,
Gujarat State, INDIA
AGARWAL, Zameer
Indian National
F 22, Akash Tower,
Opp: Premchand Nagar,
Judges Bunglow Road,
Satellite, Ahmedabad-380054,
Gujarat State, INDIA
The following specification particularly describes the nature of
this invention and manner in which it is to be performed:-
2
FIELD OF INVENTION
The present invention relates to Heparin prefilled syringe
made of Cyclic Olefin Copolymer or Roselene Crystal Clear
polymer. In particular, present invention relates to heparin
prefilled syringe made of Cyclic Olefin Copolymer or Roselene
Crystal Clear polymer for exact Heparin dose administration.
BACKROUND AND PRIOR ART
Heparin is a naturally occurring anticoagulant produced
by basophils and mast cells. Heparin acts as an anticoagulant,
preventing the formation of clots and extension of existing clots
within the blood. Heparin is a highly sulfated
glycosaminoglycan, and has the highest negative charge density
of biomolecules identified till date. Due to its large size and
negative charge, heparin cannot be absorbed from the gut and
so is injected intravenously or subcutaneously.
Heparin from ampoules is mixed with relative amount of
sterile water to a dosage concentration and is administered to
the subject (human or animal in need of heparin
administration) with a syringe. Heparin is required to be
3
administered frequently due its short biologic half-life of nearly
one hour.
Two types of syringes are available in the market for
administration of the drug:
1) A glass syringe can be used for the
administration of Heparin. The said syringes
have their barrels made up of glass and
therefore are highly transparent and are
compatible with all types of autoclaving
methods. However, the negatively charged
heparin gets attached to the walls of the glass
syringes which may lead to dosage errors.
Further, glass syringes impart problems of
breakage and material loss. The ampoules used
are also made of glass, and so are difficult to
handle and transport.
2) A plastic syringe or a polymer based, generally
made of polypropylene, available in the market
can be used for the administration of Heparin.
The said syringes have their barrels made up of
plastic or a polymer and hence do not break
easily. However, the said syringes are
4
translucent and do not provide transparency as
much as glass.
Apart from polypropylene, two different polymer blends
are developed that impart high transparency and have high
chemical resistance. The two polymer blends are:
1) Cyclic Olefin Copolymer (herein after referred to as COC),
and
2) Roselene Crystal Clear polymer (herein after referred to as
RCP).
Cyclic Olefin Copolymer is a blend copolymerized from
Norbornene and Ethylene using a metallocene catalyst and
Roselene Crystal Clear polymer is a blend of Polyester,
Polyethylene, and graphted metallocen polymer.
The present invention involves the use of the abovesaid
polymers to manufacture a prefilled syringe for Heparin to
provide a better syringe for Heparin than the syringes available
in the prior art.
5
DISADVANTAGES OF THE PRIOR ART
Syringes available in the market suffer from atleast one of
the following disadvantages:
1. The generally used glass syringes retain heparin
molecules to the walls of the said glass syringe as the
negatively charged heparin gets attached to the walls of
the syringe. Therefore, there are chances of fluctuation in
the dosage.
2. The presently available syringes require mixing of heparin
from the heparin ampoules and sterile water from the
ampoules from sterile water using syringe prior to
administration which increases the possibility of
fluctuations in dosage.
3. The use of presently available syringes lead to dosage
fluctuation due to handling errors while filling the
Heparin from the Heparin ampoules.
4. While using the presently available syringes; there are
chances of heparin getting contaminated while filling the
said drug from the drug ampoules.
6
5. The glass syringes being are difficult to handle due to risk
of breakage.
6. The presently available syringe uses the drug ampoules
that are made of glass that can break easily leading to the
loss of drug.
7. The syringes made up of plastic or polymers like
polypropylene fail to provide transparency as much as
glass. Therefore, in case of any particulate contamination,
sometimes it is not seen leading to its administration
along with the drug resulting into adverse physiological
effects.
8. The syringes available in the market have less chemical
resistance and hence there are chances of chemical
reaction between the walls of the syringe barrel and
heparin.
9. The polypropylene syringes do allow water absorption and
water transmission. This adversely effects the
concentration of the heparin. Water absorption reduces
the water content and thereby increases the
concentration of the heparin whereas water transmission
allows water to be added to the heparin dose solution
7
within the syringe and hence reduces the concentration of
the drug.
Hence, there is an unmet need to provide Heparin prefilled
syringe made of suitable medical grade polymer that obviate the
problems associated with the prior art and provide exact dosage
without any fluctuation.
OBJECTS OF THE INVENTION
The main object of the present invention is to provide
heparin prefilled syringe made of Cyclic Olefin Copolymer or
Roselene Crystal Clear polymer of exact Heparin dose
administration.
Yet another object of the present invention is to provide
heparin prefilled syringe made of Cyclic Olefin Copolymer or
Roselene Crystal Clear polymer has no risk of fluctuations dose
concentration.
Yet another object of the present invention is to heparin
prefilled syringe made of Cyclic Olefin Copolymer or Roselene
Crystal Clear polymer that is contamination free.
8
Yet another object of the present invention is to heparin
prefilled syringe made of Cyclic Olefin Copolymer or Roselene
Crystal Clear polymer that is easy to handle.
DESCRIPTION OF INVENTION
The embodiment of the proposed invention relates to
Heparin Prefilled Syringe Made of Cyclic Olefin Copolymer or
Roselene Crystal Clear polymer for exact Heparin dose
administration. The present Heparin prefilled syringe made of
Cyclic Olefin Copolymer or Roselene Crystal Clear polymer do
not retain heparin molecules to the walls of the said syringes as
the said syringes are siliconized and do not allow the negatively
charged heparin to get attached to the walls of the syringe.
Therefore, there are no chances of fluctuation in the dosage.
Also, the present Heparin prefilled syringe made of COC or RCP
being prefilled, contain premixed Heparin and Sterile Water in
the relative amount for the required dose and so do not require
them to be mixed from the ampoules prior to administration.
Therefore, the possibility of fluctuations in dosage is
considerably reduced. Further, there are no risks of dosage
fluctuation due to handling errors as it is not required to be
filled from the ampoules. Hence, there are no risks of heparin
getting contaminated.
9
The prefilled syringes for administration of Heparin,
disclosed in the present invention include:
(1) Heparin prefilled syringe made of Cyclic Olefin
Copolymer.
(2) Heparin prefilled syringe made of Roselene Crystal
Clear polymer.
(1) Heparin prefilled syringe made of Cyclic Olefin
Copolymer.
The Heparin prefilled syringe made of COC is further a Stacked
Needle type prefilled syringe or a Luer-lock type prefilled
syringe.
The Heparin prefilled syringe made of COC of Stacked Needle
type prefilled syringe mainly comprises of:
• Barrel,
• Plunger Rod,
• Rubber Stopper,
• Needle,
• Rubber Needle Shield, and
• Plastic Needle Shield
10
Heparin prefilled syringe made of COC of Luer-lock type
prefilled syringe mainly comprises of:
• Barrel,
• Plunger Rod,
• Rubber Stopper,
• Plastic Luer Lock,
• Plastic Luer Tip, and
• Rubber Luer Tip.
Reference numerals for the said component parts of the
COC made prefilled syringe of each of the above said types are:
1 : Heparin Prefilled Syringe Made Of COC
1A : Stacked Needle Type Heparin COC Prefilled Syringe
1B : Luer-Lock Type Heparin COC Prefilled Syringe
2 : Barrel
3 : Rubber Stopper
4 : Plunger Rod
5 : Plastic Luer Lock
6 : Plastic Luer Tip
7 : Rubber Luer Tip
8 : Needle
11
Referring to Fig. 1, present Heparin syringe made of COC
(1) of a Stacked Needle Type Heparin COC Prefilled Syringe (1A)
type mainly comprises of a Barrel (2) made of COC, which is a
hollow tube for the drug to be filled and is open at one end, a
Plunger Rod (4) with a Rubber Stopper (3) for filling or emptying
the said Barrel (2), wherein the said Plunger Rod (4) with a
Rubber Stopper (3) on top of it is inserted into the open end of
the Barrel (2) wherein the diameter of the open end of the said
Barrel (2) and the said Rubber Stopper (3) are such that that it
forms a tight seal or a lock such that no leakage occurs from
the lower end of the said Barrel (2) and the said plunger is
pulled back to fill the barrel and is pushed forward for
emptying, a needle (8) for administering the drug in the said
syringe to the subject, a Rubber Needle Shield (9) and a Plastic
Needle Shield (10) to cover the needle and maintain its sterility.
Referring to fig. 2, the Heparin syringe made of COC (1) of
Luer-Lock Type Heparin COC Prefilled Syringe (1B) mainly
comprises of a Barrel (2) which is a hollow tube for the drug to
be filled and is open at one end, a Plunger Rod (4) with a
Rubber Stopper (3) for filling or emptying the said Barrel (2),
wherein the said Plunger Rod (4) with a Rubber Stopper (3) on
9 : Rubber Needle Shield
10 : Plastic Needle Shield
12
top of it is inserted into the open end of the Barrel (2) wherein
the diameter of the open end of the said Barrel (2) and the said
Rubber Stopper (3) are such that that it forms a tight seal or a
lock such that no leakage occurs from the lower end of the said
Barrel (2) and the said plunger is pulled back to fill the barrel
and is pushed forward for emptying, a Plastic Luer Lock (5)
which is a screw lock mechanism to securely holds the needle
in place, and Luer Lock tips.
(2) Heparin prefilled syringe made of Roselene Crystal
Clear polymer.
The Heparin prefilled syringe made of RCP is further a
Stacked Needle Type Of RCP Made Heparin Prefilled Syringe or
a Luer-Lock Type Of RCP Made Heparin Prefilled Syringe.
The Stacked Needle type of RCP made prefilled syringe mainly
comprises of:
• Barrel,
• Plunger Rod,
• Rubber Stopper,
• Needle,
• Rubber Needle Shield, and
• Plastic Needle Shield
13
Whereas the Luer-lock type of RCP made prefilled syringe
mainly comprises of:
• Barrel,
• Plunger Rod,
• Rubber Stopper,
• Plastic Luer Lock,
• Plastic Luer Tip, and
• Rubber Luer Tip.
Reference numerals for the said component parts of the RCP
made prefilled syringe of each of the above said types are:
11 : Heparin Prefilled Syringe Made Of RCP
11A : Luer-Lock Type Of RCP Made Heparin Prefilled Syringe
11B : Stacked Needle Type Of RCP Made Heparin Prefilled Syringe
12 : Barrel
13 : Rubber Stopper
14 : Plunger Rod
15 : Plastic Luer Lock
16 : Plastic Luer Tip
17 : Rubber Luer Tip
18 : Needle
14
Referring to Fig. 3, the Stacked Needle Type Of RCP Made
Heparin Prefilled Syringe (11B) mainly comprises of a Barrel
(12) made of RCP which is a hollow tube for the drug to be filled
and is open at one end, a Plunger Rod (14) with a Rubber
Stopper (13) for filling or emptying the said Barrel (12), wherein
the said Plunger Rod (4) with a Rubber Stopper (13) on top of it
is inserted into the open end of the Barrel (12) wherein the
diameter of the open end of the said Barrel (12) and the said
Rubber Stopper (13) are such that that it forms a tight seal or a
lock such that no leakage occurs from the lower end of the said
Barrel (12) and the said plunger is pulled back to fill the barrel
and is pushed forward for emptying, a needle (18) for
administering the drug in the said syringe to the subject, a
Rubber Needle Shield (19) and a Plastic Needle Shield (20) to
cover the needle and maintain its sterility.
Referring to Fig. 4 the Luer-Lock Type Of RCP Made
Heparin Prefilled Syringe (11A) mainly comprises of a Barrel (12)
which is a hollow tube for the drug to be filled and is open at
one end, a Plunger Rod (14) with a Rubber Stopper (13) for
filling or emptying the said Barrel (12), wherein the said Plunger
Rod (14) with a Rubber Stopper (13) on top of it is inserted into
19 : Rubber Needle Shield
20 : Plastic Needle Shield
15
the open end of the Barrel (12) wherein the diameter of the open
end of the said Barrel (12) and the said Rubber Stopper (13) are
such that that it forms a tight seal or a lock such that no
leakage occurs from the lower end of the said Barrel (12) and
the said plunger is pulled back to fill the barrel and is pushed
forward for emptying, a Plastic Luer Lock (15) which is a screw
lock mechanism to securely holds the needle in place, and Luer
Lock tips.
Siliconization of Heparin prefilled syringe made of COC or
RCP.
The said Stacked Needle Type Heparin COC Prefilled
Syringe (1A), the Luer-Lock Type Heparin COC Prefilled Syringe
(1B), the said Luer-Lock Type Of RCP Made Heparin Prefilled
Syringe (11A) and the said Stacked Needle Type Of RCP Made
Heparin Prefilled Syringe (11B) are silicon layered for the
movement of rubber plunger through the Barrel (2 and 12)
wherein medical grade silicone oil is used as a lubricant.
Silicone oil is sprayed using a diving or static nozzle depending
on the siliconization process. Further, the said syringes are
subjected to baking by hot air that is free from water vapor.
This silicone-coated syringe is baked/heated to a 70-75°C for
50-60 minutes which results in longer chains that gets closely
adhered to the surface they coat. Baking silicone reduces both
the concentration of silicone in the syringe and the chemical
16
reactivity that improves stability of the product. It also reduces
the frequency of the “break loose” effect thereby improving the
gliding force of the plunger stopper. The distribution of the
silicone inside the syringe is homogenous and uniform to
generate a smooth sliding profile for the plunger stopper. The
gliding force of the conventional syringe is 10 N whereas that of
Heparin prefilled syringe made of COC or RCP is in the range of
3-5 N
Coating on Rubber Stopper (3):
The Rubber Stopper (3 and 13) of the said Stacked Needle Type
Heparin COC Prefilled Syringe (1A), the Luer-Lock Type Heparin
COC Prefilled Syringe (1B), the said Luer-Lock Type Of RCP
Made Heparin Prefilled Syringe (11A) and the said Stacked
Needle Type Of RCP Made Heparin Prefilled Syringe (11B) is
coated with silicone oil or with fluorocarbon coating to avoid the
said Rubber Stopper (3 and 13) with the Heparin filled in the
syringe.
Properties of Heparin prefilled syringe made of COC or RCP.
The COC syringes for administration of Heparin imparts
high transparency as proved by the experiments shown in the
optical property tests in Table A1 which shows that the light
17
transmission is 93%. The high transparency of the said syringes
enables one to observe the presence of any foreign particle
within the syringe if any, through the barrel of the said syringe.
Also, the optical tests for Roselene Crystal Clear Polymer made
prefilled syringes for Heparin have been carried out and the said
syringes have high transparency of 92%. Therefore, the
transparency of the said prefilled syringes allows one to clearly
observe for the presence of any particulate contamination
within the said syringes. Optical tests for Roselene Crystal Clear
Polymer made syringes for the administration of Heparin and its
comparison with the existing syringes made of polypropylene is
given in Table A2.
The said COC made prefilled syringes for administration
of Heparin also overcome the problems of breakage associated
with the glass made syringes. The mechanical properties of the
said COC made prefilled syringes for administration of Heparin
are provided in Table B1. Also, the water absorption of RCP
made prefilled syringe for Heparin administration is
considerably lower compared to PP and hence there are no risks
of change in volume of the drug and thereby the concentration
of the drug. Further, Table B2 provides a comparison of
mechanical and physical properties between RCP made prefilled
syringes for administration of Heparin and the existing syringes
made of polypropylene whereby the Tensile strength,
Elongation, Puncture resistance of the Roselene Crystal Clear
18
Polymer made prefilled syringes for Heparin is higher than the
polypropylene. Further, the water absorption of RCP made
prefilled syringe for Heparin administration is considerably
lower compared to PP and hence there are no risks of change in
volume of the drug and thereby the concentration of the drug.
Heparin is highly stable in Heparin prefilled syringe made
of COC as well as Heparin prefilled syringe made of RCP. The
stability tests have been performed to check the stability of the
Heparin in the said Heparin prefilled syringe made of COC
which are shown in the Table C1 which shows that the said
Heparin prefilled syringe made of COC are non toxic i.e. it do
not impart any toxicity to the Heparin by leaching out any toxic
material or allowing any chemical changes to the Heparin. The
pH of the Heparin within the Heparin prefilled syringe made of
COC remains constant showing that there are no chemical
changes Table C1 also shows that the Heparin remains sterile
in the said Heparin prefilled syringe made of COC. Further, for
the said Heparin prefilled syringe made of RCP, various tests
have been conducted including the sterility, stability and
toxicology tests as shown in Table C2 which proves that the
said Heparin prefilled syringe made of RCP maintains sterility,
provides stability of the drug and is non toxic to the subjects.
Also, tests for metal impurities have been conducted for
Heparin prefilled syringe made of COC and the results in the
19
Table D1 were obtained where, as per the standard test the
residue of COC obtained after subjecting it to ignition should
not be more than 0.1% on 5 g and the said Heparin prefilled
syringe made of COC produces the residue of 0.004 g which is
less than the standard value their by complying the test. And,
with respect to the said Heparin prefilled syringe made of RCP
tests for metal impurities were conducted and the results in the
Table D2 were obtained where, as per the standard test the
residue of Roselene crystal clear polymer obtained after
subjecting it to ignition should not be more than 0.1% on 5 g
and the said Heparin prefilled syringe made of RCP produces
the residue of 0.003 g which is less than the standard value
their by complying the test.
The present Heparin prefilled syringe made of COC have
also been proved to be less permeable to water and gases
compared to the other existing polymer based syringes. This
enables to keep the constant concentration of the drug within
the said Heparin prefilled syringe made of COC. It does not
allow the water to enter eliminating the risk of dilution. Further,
the decreased permeability for gases reduces the risks of
oxidation and degradation of the drug within the syringe. The
experimental data for the same is provided in Table E1. Further,
Table E2 provides a comparison of properties like density,
Water transmission and Gas permeability between Heparin
prefilled syringe made of RCP and the existing syringes made of
20
polypropylene. The said table E2 shows that the Water
transmission and Gas permeability of the present Roselene
Crystal Clear Polymer made prefillable syringe is considerably
lower compared to the existing syringes and hence eliminates
the risks of change in volume of the drug and thereby the
concentration of the drug. Further, lowered gas permeability
considerably reduces the risks of oxidation and resulting
degradation of the drug.
Having described what is considered the best form
presently contemplated for embodying the present invention,
various alterations, modifications, and/or alternative
applications of the invention will be promptly apparent to those
skilled in the art. Therefore, it is to be understood that the
present invention is not limited to the practical aspects of the
actual preferred embodiments hereby described and that any
such modifications and variations must be considered as being
within the spirit and the scope of the invention, as described in
the attached claims.
The tables for the experimental data of various tests
mentioned in the description as conducted at Roselabs
Bioscience are as given below:
21
Table A 1
22
Table A2
23
Table B1
24
Table B2
25
Table C1
26
Table C2
27
Table D1
28
Table D2
29
Table E1
30
Table E2
31
ADVANTAGES OF THE INVENTION
Compared to the prior art, the present invention provides
following advantages:
1. The present Heparin prefilled syringe made of Cyclic
Olefin Copolymer or Roselene Crystal Clear polymer do
not retain heparin molecules to the walls of the said
syringes as the said syringes are siliconized and do not
allow the negatively charged heparin to get attached to
the walls of the syringe. Therefore, there are no chances
of fluctuation in the dosage.
2. The present Heparin prefilled syringe made of Cyclic
Olefin Copolymer or Roselene Crystal Clear polymer
being prefilled, contain premixed Heparin and Sterile
Water in the relative amount for the required dose and so
do not require them to be mixed from the ampoules prior
to administration. Therefore, the possibility of
fluctuations in dosage is considerably reduced.
3. The present syringe being prefilled, there are no risks of
dosage fluctuation due to handling errors.
4. The present syringes being prefilled, there are no risks of
heparin getting contaminated.
32
5. The present syringes being made up of RCP or COC have
considerably reduced risks of breakage and loss of drug
and hence are easy to handle.
6. The present syringes provide transparency as much as
glass and hence enable to see if there is any particulate
contamination.
7. The present syringes are highly chemical resistant and
hence there are no chances of chemical reaction between
the walls of the syringe and heparin.
8. The present syringes do not allow water absorption or
water transmission and so the are no chances of
fluctuation in concentration of the drug. Hence, exact
dosage of the drug can be administered.
,CLAIMS:WE CLAIM:
1. Heparin Prefilled Syringe Made of Cyclic Olefin Copolymer
or Roselene Crystal Clear polymer wherein
the said Heparin prefilled syringe made of COC is a
Stacked Needle Type Heparin COC Prefilled Syringe (1A)
or a Luer-Lock Type Heparin COC Prefilled Syringe (1B)
wherein further
the said Heparin prefilled syringe made of COC (1)
of a Stacked Needle Type Heparin COC Prefilled
Syringe (1A) type mainly comprises of a Barrel (2)
made of COC, which is a hollow tube for the drug to
be filled and is open at one end, a Plunger Rod (4)
with a Rubber Stopper (3) for filling or emptying the
said Barrel (2), wherein the said Plunger Rod (4)
with a Rubber Stopper (3) on top of it is inserted
into the open end of the Barrel (2) wherein the
diameter of the open end of the said Barrel (2) and
the said Rubber Stopper (3) are such that that it
forms a tight seal or a lock such that no leakage
occurs from the lower end of the said Barrel (2) and
the said plunger is pulled back to fill the barrel and
is pushed forward for emptying, a needle (8) for
34
administering the drug in the said syringe to the
subject, a Rubber Needle Shield (9) and a Plastic
Needle Shield (10) to cover the needle and maintain
its sterility;
whereas, the Heparin syringe made of COC (1) of
Luer-Lock Type Heparin COC Prefilled Syringe (1B)
mainly comprises of a Barrel (2) which is a hollow
tube for the drug to be filled and is open at one end,
a Plunger Rod (4) with a Rubber Stopper (3) for
filling or emptying the said Barrel (2), wherein the
said Plunger Rod (4) with a Rubber Stopper (3) on
top of it is inserted into the open end of the Barrel
(2) wherein the diameter of the open end of the said
Barrel (2) and the said Rubber Stopper (3) are such
that that it forms a tight seal or a lock such that no
leakage occurs from the lower end of the said Barrel
(2) and the said plunger is pulled back to fill the
barrel and is pushed forward for emptying, a Plastic
Luer Lock (5) which is a screw lock mechanism to
securely holds the needle in place, and Luer Lock
tips; and
the said Heparin prefilled syringe made of RCP is further
a Stacked Needle Type of RCP Made Heparin Prefilled
35
Syringe or a Luer-Lock Type Of RCP Made Heparin
Prefilled Syringe wherein further
the Stacked Needle Type Of RCP Made Heparin
Prefilled Syringe (11B) mainly comprises of a Barrel
(12) made of RCP which is a hollow tube for the
drug to be filled and is open at one end, a Plunger
Rod (14) with a Rubber Stopper (13) for filling or
emptying the said Barrel (12), wherein the said
Plunger Rod (4) with a Rubber Stopper (13) on top
of it is inserted into the open end of the Barrel (12)
wherein the diameter of the open end of the said
Barrel (12) and the said Rubber Stopper (13) are
such that that it forms a tight seal or a lock such
that no leakage occurs from the lower end of the
said Barrel (12) and the said plunger is pulled back
to fill the barrel and is pushed forward for
emptying, a needle (18) for administering the drug
in the said syringe to the subject, a Rubber Needle
Shield (19) and a Plastic Needle Shield (20) to cover
the needle and maintain its sterility;
whereas the Luer-Lock Type Of RCP Made Heparin
Prefilled Syringe (11A) mainly comprises of a Barrel
(12) which is a hollow tube for the drug to be filled
and is open at one end, a Plunger Rod (14) with a
36
Rubber Stopper (13) for filling or emptying the said
Barrel (12), wherein the said Plunger Rod (14) with
a Rubber Stopper (13) on top of it is inserted into
the open end of the Barrel (12) wherein the
diameter of the open end of the said Barrel (12) and
the said Rubber Stopper (13) are such that that it
forms a tight seal or a lock such that no leakage
occurs from the lower end of the said Barrel (12)
and the said plunger is pulled back to fill the barrel
and is pushed forward for emptying, a Plastic Luer
Lock (15) which is a screw lock mechanism to
securely holds the needle in place, and Luer Lock
tips.
2. Heparin Prefilled Syringe Made of Cyclic Olefin Copolymer
or Roselene Crystal Clear polymer claimed in claim 1
wherein the said Barrel (2) is made of COC.
3. Heparin Prefilled Syringe Made of Cyclic Olefin Copolymer
or Roselene Crystal Clear polymer as claimed in claim 1
wherein the said Barrel (12) is made of RCP.
4. Heparin Prefilled Syringe Made of Cyclic Olefin Copolymer
or Roselene Crystal Clear polymer as claimed in claim 1
and 2 wherein the light transmission is 93%.
37
5. Heparin Prefilled Syringe Made of Cyclic Olefin Copolymer
or Roselene Crystal Clear polymer as claimed in claim 1
and 3 wherein the light transmission is 92%.
Dated this 8th day of July 2013.

Documents

Application Documents

# Name Date
1 FORM 2 Complete Specification of 1997MUM2012.pdf 2018-08-11
2 Drawings and Abstract of1997MUM2012.pdf 2018-08-11
3 ABSTRACT1.jpg 2018-08-11
4 1997-MUM-2012-FORM 26(16-7-2012).pdf 2018-08-11
5 1997-MUM-2012-CORRESPONDENCE(16-7-2012).pdf 2018-08-11