Title of Invention

SAFETY I.V. CATHETER WITH SELF-LOCKING DEVICE

Abstract This invention relates to a medical safety intravenous (I.V.) catheter and in particular, a safety intravenous (I.V.) catheter device with a locking device wherein a self locking device provided between the said hub pusher front and the needle hub adapted such that while withdrawing the needle during cannulation a bracket is created wherein the needle and self locking unfolds device which with needle hub on one side and hub pusher front on the other side.
Full Text 2
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

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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 trough the opening provided in this portion. (vii) discarding needle with the tip remaining exposed in the sharp's container. The thus 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

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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.

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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:

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a needle hub capable of holding the needle and adapted to cooperate with a hub pusher front such as to favour extending and retracting the needle through a catheter cannula adapted to cooperate with said needle hub;
a self locking device which is a guard unit provided between the said hub pusher front and the needle hub adapted such that while withdrawing the needle during cannulation the said self locking device slidably extends and the needle gets withdrawn and gets locked between the hub pusher front and the needle hub adopter.
According to an aspect of the intravenous (I. V.) Catheter device of the invention, the self locking device during its slidable extension, its retraction is adapted to get locked between the hub pusher front and the needle hub adopter thereby provide for secured and locked housing for the needle therein.
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 for gauge size identification. Also, preferably, the intravenous (I.V.) Catheter device comprises angled and

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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 of the invention is adapted to ensure safe and user friendly application and use of such catheter devices.
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 is withdrawn out from the cannula, the needle tip gets enclosed within a non folding bracket consisting of the needle hub on one side and hub pusher back and front on the other. The needle and the self locking device would run parallel to each other with ends secured between the two ends of the bracket namely needle hub and hub pusher front.
As disclosed above in accordance with the preferred aspect the catheter device involves a selective locking system to safely house and lock the needle after cannulation which is provided in a convenient and effective to operate as a non folding bracket between the needle hub and the hub pusher front. Importantly, the self locking device for the needle is provided between the hub pusher front and the needle hub such that while withdrawing the needle during cannulation this locking device slides as needle get withdrawn by creation of an unfolding bracket with needle hub on the one end and hub pusher on the other end.

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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 incorporating a recessed plug with protective skirt to effectively prevent contamination when the valve is not in use. Moreover the pot cap 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 coated pot cap 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 details in relation to non-limiting exemplary illustration as per the following accompanying figures:

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BRIEF DESCRIPTION OF THE ACCOMPANYING FIGURES
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 (wings)
3. Portion marked as 3 is Pot cap
4. Portion marked as 4 is hub pusher back
5. Portion marked as 5 is needle hub
6. Portion marked as 6 is self locking devise in locked form
7. Portion marked as 7 is leur back
8. Portion marked as 8 is hub pusher front
9. Portion marked as 9 is needle
Figure 1 illustrates an embodiment of the intravenous (I.V.) catheter with retractable needle in accordance with the invention;
Figure 3 is an illustration of the intravenous catheter device of Figure 2 shown with the pusher unit activated in the extended position; and
Figure 4 illustrates the intravenous catheter device with the needle retracted within the safety housed and locked within the bracket for safe disposal. Reference is first invited to accompanying figure 1, which shows the intravenous (I.V.) Catheter device in accordance with the present invention with the provision of the self locking device there between the hub pusher and the needle hub. It would be apparent from figure 1 that in this position, the self locking device is

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provided in its collapsed condition wherein the plurality of tubular members of the self locking device are accommodated inside one and another within the tubular unit between hub pusher front and needle hub.
Reference is now invited to accompanying figure 3, which shows the manner of retraction of the needle involving the expanded opening of the self locking device whereby the needle is enclosed between the needle hub and hub pusher front. As clearly shown in Figure 3 in such condition the self locking device assumes the open extended condition with the tubular members opening up to provide for extended disposition of the tubular unit.
Reference is now invited to Figures 3 and 4, which go to illustrate the manner of retracting the needle whereby it can be attended by way of a safe and hazard free retraction without problems of unwanted needle stick exposure and injuries. In particular, during the retracted motion while withdrawing the needle during cannulation the self locking device slides as needle gets withdrawn and gets locked between and creates an unfolding bracket. The tip of the needle gets locked in the hub pusher front.
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:-

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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 needle tip is adapted to get enclosed with in the unfolding bracket. Such bracket is achieved as apparent from the above figures of the intravenous (I.V.) safety catheter by way of provision of the self locking device as described above.
As would be apparent from the above, the intravenous (I.V.) safety catheter thus achieves the locking of the needle tip within the bracket 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 the bracket in the catheter system of the invention, it is possible to safely discard the needle with tip cover 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 bracket can be obtained of simple materials including

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polypropylene, low density poly ethylene, poly carbonate, stainless steel, acronytrle butadiene styrene, silicon rubber, Floropolymer/ Poly urathene.
The self locking device, needle hub, flash back, hub pusher front and hub pusher back are made of polypropylene. The needle is 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.

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WE CLAIM:
1. An intravenous (I. V.) Catheter device with retractable needle comprising:
a needle hub adapted to cooperate with a hub pusher front such as to favour extending and retracting the needle through a thin plastic tubing adapted to cooperate with said needle hub;
a self locking device provided there between the said hub pusher front and the needle hub adapted such that while withdrawing the needle during cannulation, a bracket is created wherein the needle and self locking device which unfolds with needle hub on one side and hub pusher front on the other side.
2. An intravenous (I. V.) Catheter device as claimed in claim 1 wherein the self
locking device during its slidable extension creates a bracket wherein the needle
runs paralles to the self locking device.
3. An intravenous catheter as claimed in claim 1 wherein the self locking devices
consisting of different sleaves packed inside one and another and once opened are
locked and is not retractable.
4. An intravenous catheter as claimed in claim 1 wherein the needle is locked in
a non-folding bracket consisting of needle hub on one side and hub pusher on the
other.
5. An intravenous (I.V.) Catheter device as claimed in claim 1 comprising a one
way valve adapted to facilitate extra medication and prevent back flow.

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6. An intravenous (I.V.) Catheter device as claimed in claim 1 wherein said one
way valve comprises a silicone tube.
7. An intravenous (I. V.) Catheter device as claimed in anyone of claim 1 wherein
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.
8. An intravenous (I.V.) Catheter device as claimed in claim 1 wherein said one
way pot cap is adapted for resting the finger to facilitate effective two-point grip
for cannulation.
9. An intravenous (I.V.) Catheter device as claimed in anyone of claims 1 to 6
comprising colour coded pot cap for gauge size identification.

10. 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.
11. An intravenous (I.V.) Catheter device with retractable needle substantially as
herein described and illustrated with reference to the accompanying figures.

This invention relates to a medical safety intravenous (I.V.) catheter and in particular, a safety intravenous (I.V.) catheter device with a locking device wherein a self locking device provided between the said hub pusher front and the needle hub adapted such that while withdrawing the needle during cannulation a bracket is created wherein the needle and self locking unfolds device which with needle hub on one side and hub pusher front on the other side.

Documents:

00245-kol-2007 form-18.pdf

00245-kol-2007-claims-1.1.pdf

00245-kol-2007-correspondence.pdf

00245-kol-2007-description(complete)-1.1.pdf

00245-kol-2007-drawings-1.1.pdf

00245-kol-2007-form-1-1.1.pdf

00245-kol-2007-form-2-1.1.pdf

00245-kol-2007-form-9.pdf

0245-kol-2007 abstract.pdf

0245-kol-2007 claims.pdf

0245-kol-2007 description(complete).pdf

0245-kol-2007 drawings.pdf

0245-kol-2007 form-1.pdf

0245-kol-2007 form-2.pdf

0245-kol-2007 form-26.pdf

0245-kol-2007 form-3.pdf

0245-kol-2007 form-5.pdf

245-KOL-2007 Dt.10-06-2008 CANCELLED DOCUMENT.pdf

245-KOL-2007 Dt.10-06-2008 CLAIMS.pdf

245-KOL-2007 Dt.10-06-2008 DESCRIPTION COMPLETE.pdf

245-KOL-2007 Dt.10-06-2008 DRAWINGS.pdf

245-KOL-2007 Dt.10-06-2008 FORM 1.pdf

245-KOL-2007 Dt.10-06-2008 FORM 2.pdf

245-KOL-2007 Dt.10-06-2008 REPLY FIRST EXAMINATION REPORT.pdf.pdf

245-kol-2007-granted-abstract.pdf

245-kol-2007-granted-claims.pdf

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

245-kol-2007-granted-drawings.pdf

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

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

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

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

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

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

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

245-kol-2007-granted-letter patent.pdf

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

245-kol-2007-granted-specification.pdf


Patent Number 223943
Indian Patent Application Number 245/KOL/2007
PG Journal Number 39/2008
Publication Date 26-Sep-2008
Grant Date 24-Sep-2008
Date of Filing 19-Feb-2007
Name of Patentee EASTERN MEDIKIT LIMITED
Applicant Address 5/1A, CENTRAL ROAD, JADAVPUR, KOLKATA-700032
Inventors:
# Inventor's Name Inventor's Address
1 NARANG KARUN RAJ 3, DR. G.C. NARANG MARG, DELHI-110007
2 PAUL SANJEEV 3, DR. G.C. NARANG MARG, DELHI-110007
PCT International Classification Number A61M25/06
PCT International Application Number N/A
PCT International Filing date
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 NA