Title of Invention

TIP PROTECTIVE SAFETY INTRAVENOUS CATHETER

Abstract An Intravenous Catheter device with retractable needle comprising: i) a needle hub (5) with arms encaged between the two arms (6) is the tip protective housing and ii) a retractable needle (7) different from ordinary needle having at a distance from the tip, where the tip protective (4) housing slides into the butterfly portion (2) and iii) the retractable needle (7) runs its length between the tip protective housing and the butter fly portion (2) and iv) the needle tip gets locked in the cylindrical portion and the stainless steel clip is provided in the hollow portion of the tip protector (4) and v) a plastic capsule (1) which is flat on the front and contains a hollow and approachable from the bottom
Full Text FIELD OF THE INVENTION
This invention relates to a safety intravenous (I.V.) Catheter and, in particular, to a
safety intravenous (I.V.) Catheter device with retractable needle. In particular, the
intravenous catheter device for the invention has been provided to reduce needle
stick injuries, spread of hospital acquired infections and also avoid environmental
concerns / hazards in its use and disposal. Importantly also apart from being safe
and user friendly the intravenous catheter device is cost effective to favour wide
scale application and use of the catheter device.
BACKGROUND ART
It is well known that in health care, one of the most relevant concerns relate to
provision of safe hospital environment, in particular, members of hospital and
medical staff are required to be assured that they are not subject to any unwanted
infection while caring for patients. Such adequate care and concern for safe
medical attention and treatment is important not only in hospitals but also for any
health care environments such as those required in nursing homes, health homes
and related health care facilities and provisions.
Intravenous (I.V.) Catheters are well known medical devices used to obtain
continuous vascular access in patients. Such a device generally consists of a
hollow-bore needle and an over-the-needle plastic tubing used to access the lumen
of a blood vessel of a patient. The intravenous (I.V.) Catheter for such purpose is
advanced into the vessel and is used in administering intravenous fluids,
medications or blood products. Importantly, in such application and use since the
(I.V.) Catheter is placed percutaneously, the hollow-bore needle stylet becomes
blood contaminated and when the blood vessel lumen is accessed, the needle-
stylet becomes blood -filled.
In the conventional Catheter units presently in use, the basic steps followed in
catheter application/use include (i) using alcohol wipes (ii) puncturing skin using
needle tip enclosed in a thin plastic tube (iii) moving needle tip forward to
puncture vein (iv) blood flashback in the blood collection chamber (v) initiating
withdrawal of the needle out from the cannula and leaving the tubing inside the
body (vi) The butterfly portion attached to the tubing is fixed by tape to the body
of the patient and medicines etc. are given through the opening provided in this
portion, (vii) discarding needle with the tip remaining exposed in the sharp's
container. Thus the exposed needle remains a potential source for contamination
and infection. Infection from such needle stick injuries is a greatest risk for the
medical and paramedical staff.
Needle stick injuries from intravenous (I.V.) Catheter stylets are in the high risk
category for potential transmission of blood borne pathogens to the injured health
care worker, since the same are hollow bore needles which are usually filled with
undiluted blood. The blood borne pathogens of greatest concerns include human
immuno deficiency virus (HIV), the etiologic agent of the acquired immuno
deficiency syndrome (AIDS), hepatitis B virus and hepatitis C virus.
As per hospital reports, one-third nurses and laboratory staff suffer from needle
stick injuries every year. HIV transmission through needle injuries is 0.3% of all
modes of contaminations. The rate of HIV transmission through needle stick
injuries is 2-7% of all means. Injuries from used needle or contact with infected
blood on the needle pose serious dangers to health care workers. The nurses are
most vulnerable to needle stick injuries among health workers. Apart from health
care workers, cleaners, laundry workers, porters, ragpickers etc. are also prone to
health hazards caused by improper waste disposal methods. Blood exchange
through needle stick injuries can pass on over about 20 deadly pathogens and
microorganisms. Health staff with significant exposure to HIV is 6-30% risk of
getting infected. Atleast one in eight, health care workers is exposed to fatal
infection through needle stick injuries.
To avoid the above hazards of needle stick injuries guidelines have also been
provided to benefit medical staff, laboratory staff and employees for protection
and minimizing the risk of such contamination / transmission of infection through
needle. However, it is obvious that the effectiveness of such precautionary
guidelines would depend on accountability, education, training and vigilant
compliance. Such precautionary guidelines while being important and most
certainly required to be followed, negligence and non-compliance of such
guidelines can and usually lead to the afore-discussed problems and complexities
of needle stick injuries and hospital acquired infection. It is, therefore, important
not only to provide the guidelines but also human care systems/devices, which
would minimize the risk of such unwanted contamination especially due to human
lapses which can take place any moment and lead to injuries / contaminations of
even serious nature such as the HIV / HCB transmission.
OBJECTS OF THE INVENTION
It is thus the basic object of the present invention to provide a safety intravenous
(I.V.) Catheter with retractable needle which would favour safe and user friendly
application and disposal of a catheter device.
Another object of the present invention is directed to provide a safety (I.V.)
Catheter device adapted to reduce needle stick injuries, spread of hospital
acquired infection and the like and thereby ensure safety for the staff involved in
the hospital and medical care facilities.
Another object of the present invention is directed to provide for an intravenous
(I.V.) Catheter device which would favour safety and effective use of (I.V.)
Catheter which would not be subject to any high risk in its use and application as
a potential vehicle for transmission of blood borne pathogen to the health care
workers.
A further object of the present invention is directed to an intravenous (I.V.)
Catheter device which would be simple and cost effective to manufacture and
would also be safe for wide scale application and use without fear or
accompanying hazards of needle stick injuries or spread of hospital acquired
infection.
SUMMARY OF THE INVENTION
Thus according to the basic aspect of the present invention there is provided an
intravenous (I.V.) Catheter safety device with retractable needle comprising:
a needle hub (5) capable of holding the needle and two arms (6) on the outer
edges of the hub. Encaged between the two arms (6) is the housing which is the
tip protector (4) when in use. The needle (7) is a different from the ordinary
needle as the needle (7A) is having a forming at a distance from the tip.
Importantly, the intravenous (I.V.) Catheter device comprises a one way valve
adapted to facilitate extra medication and prevent back flow. The said one way
valve preferably comprises a silicone tube. Also, the said one way valve is
provided with cap means incorporating a recessed plug with protective skirt to
effectively prevent contamination when the valve is not in use. Advantageously
also the said one way valve cap is adapted for resting the finger to facilitate
effective two-point grip for cannulation.
In accordance with yet further aspect of the invention, the intravenous (I.V.)
Catheter device comprises colour coded pot cap (3) for gauge size identification.
Also, preferably, the intravenous (I.V.) Catheter device comprises angled and
grooved wings adapted for easy fixation and prevent pistoning and rolling of
cannula over the patient's body.
It would be apparent from the above that the above disclosed intravenous (I.V.)
Catheter device with retractable needle (7) of the invention is adapted to ensure
safe and user friendly application and use of such catheter devices.
The tip protector housing (4), encaged between the two arms (6) of the hub (5)
protector is a plastic capsule (1), which is flat on the front and contains a hollow
which is approachable from the bottom. This hollow is in form of a rectangle and
contains a cylindrical projection and the needle (7) is made to pass through this
portion of the housing. The steel strip is in the form of 'L' shaped having a hole
on one side. The steel strip is fitted between the outer wall of the housing and the
cylindrical projection. The hollow is covered by a cap (3) which contain two male
members which fit into the female portion provided in the wings of the cylindrical
projections.
In particular, the catheter device of the invention apart from serving the basic need
of a catheter essentially takes care of problems of needle stick injuries and spread
of hospital acquired infection through the needle used for cannulation.
Importantly, the above catheter device is adapted such that when the needle (7) is
withdrawn out from the butterfly portion (2), the needle tip gets enclosed within
the housing by means of the stainless steel clip and the tip is not able to come out
of the cylindrical projection i.e. it will be engaged between the cylindrical
projection and the clip. The tip protector housing will disengage itself from the
two arms of the needle hub (5) and disposed off accordingly.
As also provided by way of invention, the safety (I.V.) Catheter is a safety device
adapted to protect the user against needle stick injuries.
Importantly, in accordance with preferred aspect, the safety (I.V.) Catheter
includes a one-way valve (Silicon tube) to facilitate extra medication and to
prevent back flow. Advantageously, the valve is provided with selectively
adapted pot cap (3) incorporating a recessed plug with protective skirt to
effectively prevent contamination when the valve is not in use. Moreover the pot
cap (3) is also adapted for resting the finger to facilitate effective two-point grip
for cannulation. It offers safe and convenient needleless methods of atraumatic
administration of medicines.
In accordance with further preferred aspect the intravenous catheter device
comprises colour coded pot cap (3) for gauge size identification. Moreover, the
provision is made for angled and grooved wings adapted to offer easy fixation and
prevent pistoning and rolling cannula over the patient's body. More importantly,
the above disclosed intravenous catheter device is adapted to facilitate simple and
safe use of catheter without the need for specialized training for such range of
safety intravenous (I.V.) Catheter.
The details of the invention, its objects and advantages are explained hereunder in
greater detail in relation to non-limiting exemplary illustration as per the
following accompanying figures:
BRIEF DESCRIPTION OF THE ACCOMPANYING FIGURES
Figure 1 illustrates an embodiment of the intravenous (I.V.) catheter with tip
protective housing.
Figure 2 is the complete intravenous (I.V.) catheter wherein the individual parts
have been numbered as below:
1. Portion marked as 1 is plastic tubing
2. Portion marked as 2 is butterfly portion.
3. Portion marked as 3 is Pot cap
4. Portion marked as 4 is tip protector housing
5. Portion marked as 5 is needle hub
6. Portions marked as 6 are the arms of the needle hub
7. Portion marked as 7 is needle and portion marked as 7A is the needle
forming.
Figure 3 is an illustration of the tip housing formation separated form the arms.
Figure 4 illustrates the intravenous catheter device with the needle (7) retracted
within the tip protector housing (4), detached from the butterfly portion (2).
Figure 5 shows the clip to be fitted inside the hollow between the outer wall of the
housing and the projection.
Reference is first invited to accompanying figure 1, which shows the intravenous
(I.V.) Catheter device in accordance with the present invention wherein the
product I.V. Catheter has arms on the needle hub and there is an apparent encaged
tip protective housing. It would be apparent from figure 1 that in this position that
the tip protective housing is fitted between the arms of the needle hub. The needle
is fitted in the needle hub and passes through the housing (and steel stip inside the
housing, which is not visible) and the butterfly into the plastic tubing.
Reference is now invited to Figures 3 and 4, which go to illustrate the manner of
working of the invention. In figure 3, the housing remain with the butterfly
portion (2) and needle (7) runs its full length between the needle protective
housing and the needle hub (6). In figure 4, the housing is detached from the
butterfly portion (2) and the needle tip (7) is locked inside the tip protective
housing.
Reference is now invited to accompanying figure 5, which shows the portion of
the needle protective housing.
Figure 5 shows the needle tip locked within the stainless steel clip and the tip is
not able to come out of the cylindrical projection i.e. it will be engaged between
the cylindrical projection and the clip.
Such a provision of the intravenous (I.V.) catheter device therefore achieves the
required safety in IV cannulation and adapted to protect the user against needle
stick injuries.
The method of application and use of the above safety (I.V.) Catheter of the
invention is further detailed hereunder:-
Thus in use of the catheter device initially the position of the catheter insertion is
cleaned using alcohol wipes. Thereafter, the skin is punctured by using the needle
tip which is inside a thin plastic tubiage. The needle tip is moved forward to
puncture the vein. Immediately blood flash back is noticed in the blood collection
chamber.
Subsequently, the needle withdrawing action is initiated by withdrawing the
needle out from the cannula and leaving the plastic tubing inside the body. The
butterfly portion of the catheter remains outside for giving medication. In this
process, the tip protective housing is slided from the arms of the needle hub and
reaches the butterfly portion. In this position, the needle run its full length
between the tip protective housing and the needle hub. The needle tip then gets
locked inside the tip protective housing by means of stainless steel clip.
As would be apparent from the above, the intravenous (I.V.) safety catheter thus
achieves the locking of the needle tip within the tip protective housing free of any
exposure to avoid needle stick injury and / or any spread of hospital acquired
infection by way of unwanted needle contamination. Finally, by way of the above
safe and convenient locking of the needle within tip protective housing of the
catheter system of the invention, it is possible to safely discard the needle with tip
protective housing in the sharps container.
Advantageously, the above (I.V.) Catheter is adapted to function as safe device to
protect the user against needle stick injuries. The above safe catheter device
involving the tip protective housing (4) can be obtained of simple materials
including polypropylene, low density poly ethylene, poly carbonate, stainless
steel, acronytrle butadiene styrene, silicon rubber, Floropolymer/ Poly urathene.
The tip protective housing, needle hub, flash back, hub pusher and arms of the
needle hub back are made of polypropylene. The needle and clip are made of
stainless steel and pot cap is made of low density polyethylene.
The one way valve can be obtained of silicon tube and adapted to facilitate extra
medication and prevent back flow. The valve is specifically adapted to incorporate
a recessed plug with protective skirt to effectively prevent contamination when the
valve is not in use. Advantageously also pot cap is adapted for resting the finger to
facilitate effective two-point grip for' cannulation. The system offers safe and
convenient needle less method for atraumatic administration of medicines.
Moreover, it is possible to provide color coded pot cap for gauge size
identification. Angled and groove wings can be provided to offer easy fixation and
prevent positioning and rolling of cannula over the patient's body. The catheter
device so introduced to this invention is user friendly and provide a safe and
simple catheter device for doctors and paramedical staff.
WE CLAIM:
1) An Intravenous Catheter device with retractable needle comprising:
i) a needle hub (5) with arms encaged between the two arms (6) is the tip
protective housing and
ii) a retractable needle (7) different from ordinary needle having at a
distance from the tip, where the tip protective (4) housing slides into
the butterfly portion (2) and
iii) the retractable needle (7) runs its length between the tip protective
housing and the butter fly portion (2) and
iv) the needle tip gets locked in the cylindrical portion and the stainless
steel clip is provided in the hollow portion of the tip protector (4) and
v) a plastic capsule (1) which is flat on the front and contains a hollow
and approachable from the bottom
Characterized in that this device comprises a one way valve (silicon tube)
with selectively adapted pot cap (3) incorporating a recessed plug with
protective skirt to effectively prevent contamination when the valve is not in
use and to facilitate extra medication and to prevent back flow.
2. An intravenous (I. V.) Catheter device as claimed in claim 1 wherein the needle
hub (5) is provided with arms (6).
3. An intravenous catheter device as claimed in claim 1 the needle (7) runs its
length between the tip protective housing and the needle hub (5).
4. An intravenous catheter device as claimed in claim 1 where the hollow of the
tip protective housing (4) contains a stainless steel clip inside the cylindrical
portion.
5. An intravenous (I.V.) Catheter device as claimed in claim 1 where the needle
tip forming gets locked in the cylindrical portion and the stainless steel clip
provided in the hollow of the tip protective housing (4).
6. An intravenous (I.V.) Catheter device as claimed in claim 1 wherein the
needle (7) has a forming at a distance from the tip.
7. An intravenous (I.V.) Catheter device as claimed in claim 1 wherein said one
way pot cap (3) is adapted for resting the finger to facilitate effective two-point
grip for cannulation.
8. An intravenous (I.V.) Catheter device as claimed in anyone of claims 1 to 7
comprising colour coded pot cap (3) for gauge size identification.
9. An intravenous (I.V.) Catheter device as claimed in anyone of claims 1 to 7
comprising angled and grooved wings adapted for easy fixation and prevent
pistoning and rolling of cannula over the patient's body.
10. An intravenous (I.V.) Catheter device with needle substantially as herein
described and illustrated with reference to the accompanying figures.


An Intravenous Catheter device with retractable needle comprising:
i) a needle hub (5) with arms encaged between the two arms (6) is the tip
protective housing and
ii) a retractable needle (7) different from ordinary needle having at a
distance from the tip, where the tip protective (4) housing slides into
the butterfly portion (2) and
iii) the retractable needle (7) runs its length between the tip protective
housing and the butter fly portion (2) and
iv) the needle tip gets locked in the cylindrical portion and the stainless
steel clip is provided in the hollow portion of the tip protector (4) and
v) a plastic capsule (1) which is flat on the front and contains a hollow
and approachable from the bottom

Documents:

00724-kol-2007-abstract.pdf

00724-kol-2007-claims.pdf

00724-kol-2007-description complete.pdf

00724-kol-2007-drawings.pdf

00724-kol-2007-form 1.pdf

00724-kol-2007-form 2.pdf

00724-kol-2007-form 3.pdf

00724-kol-2007-form 5.pdf

00724-kol-2007-form-9.pdf

724-KOL-2007-ABSTRACT.pdf

724-KOL-2007-CLAIMS.pdf

724-KOL-2007-CORRESPONDENCE 1.2.pdf

724-KOL-2007-CORRESPONDENCE 1.3.pdf

724-KOL-2007-CORRESPONDENCE-1.1.pdf

724-KOL-2007-CORRESPONDENCE.pdf

724-KOL-2007-DESCRIPTION COMPLETE.pdf

724-KOL-2007-DRAWINGS.pdf

724-KOL-2007-FORM 1.pdf

724-KOL-2007-FORM 2.pdf

724-KOL-2007-FORM 26.pdf

724-kol-2007-granted-abstract.pdf

724-kol-2007-granted-claims.pdf

724-kol-2007-granted-description (complete).pdf

724-kol-2007-granted-drawings.pdf

724-kol-2007-granted-examination report.pdf

724-kol-2007-granted-form 1.pdf

724-kol-2007-granted-form 18.pdf

724-kol-2007-granted-form 2.pdf

724-kol-2007-granted-form 26.pdf

724-kol-2007-granted-form 3.pdf

724-kol-2007-granted-form 5.pdf

724-kol-2007-granted-reply to examination report.pdf

724-kol-2007-granted-specification.pdf

724-KOL-2007-OTHERS 1.2.pdf

724-KOL-2007-OTHERS 1.3.pdf

724-KOL-2007-OTHERS-1.1.pdf

724-KOL-2007-OTHERS.pdf

724-KOL-2007-REPLY TO EXAMINATION REPORT.pdf


Patent Number 238502
Indian Patent Application Number 724/KOL/2007
PG Journal Number 07/2010
Publication Date 12-Feb-2010
Grant Date 08-Feb-2010
Date of Filing 10-May-2007
Name of Patentee EASTERN MEDIKIT LIMITED
Applicant Address 5/1A, CENTRAL ROAD, JADAVPUR KOLKATTA
Inventors:
# Inventor's Name Inventor's Address
1 NARANG KARUN RAJ 3, DR. G.C. NARANG MARG, DELHI- 110 007
2 PAUL SANJEEV 3, DR. G.C. NARANG MARG, DELHI- 110 007
PCT International Classification Number A
PCT International Application Number N/A
PCT International Filing date
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 NA