SAFE INTRAVENOUS CANNULA WITH NEEDLE-PROTECTOR MECHANISM
Field of the invention:
Present invention relates to a safe intravenous (I.V.) cannula wherein the said I.V. cannula consists of the I.V. needle with a needle protector device and a safety mechanism involved thereof. The invention particularly relates to proposing a novel safety I.V. Cannula and has for its object a passive involuntary activated safety device which requires no user activation of the safety mechanism involved therein.
Background and object of the present invention:
Cannula normally comes with a trocar attached, which allows puncturing of the body or to get into the intended space. Intravenous cannulae are the most common in hospital use. An I.V. cannula is inserted into a vein, primarily for the administration of intravenous fluids, obtaining blood samples and administering medicines.
In a device comprising of wing assembly and needle assembly (hereinafter referred as I.V. Cannula), the passive safety device incorporated therein, requires no user activation of the safety mechanism. The safety mechanism of the I.V. Cannula towards protecting the distal end of the needle deploys automatically when required during normal use of I.V. Cannula — similarly to an automobile air bag. Unlike a seatbelt, which a driver can choose voluntary to buckle (or not at their own risk/desire), an air bag will instantaneously deploys at the moment it is needed. The already active safety device incorporated in the I.V. Cannula, on the other end requires the user to voluntarily activate the safety mechanism needing an extra step during the normal use of the said Cannula to protect him/her and others from the needle
stick injuries. This extra step can be performed incorrectly, forgotten or altogether ignored. Alternatively, in case of involuntarily activated passive safety device incorporated in the I.V. Cannula, the healthcare worker can't bypass utilizing the said safety mechanism and therefore remains always safe from the needle stick injuries, even if he/she forgets or doesn't choose.
There are various designs of active and passive technologies available in the market to protect the needle's distal end during the normal use of an I.V. Cannula by the healthcare worker. A number of patents were also been given to one or another type of such needle protector devices and certain manufacturers are involved in commercial exploitation of such safe I.V. Cannulae and their patented products. The conventional such devices have been using crimping technology on the cannula to ensure the effectiveness of the safety device. This additional crimping on the cannula is further trauma to the patient. The crimping also reduces the flow of blood to the flash back chamber creating confusion for the healthcare worker, leading to cross-puncturing of vein and further trauma to the patient. Further the conventional designs of needle protector devices, applied in the I.V. Cannulae, usually use 'Z'-shaped metal shield or plastic shield for covering the needle tip.
However, In Indian market usually an I.V. Cannula with no needle protector mechanism is available at a price of around Rs. 50/-, while an I.V. Cannula with the needle protector mechanism can be procured at a retail price of around Rs. 150/-. The difference between the two types of aforesaid I.V. Cannulae is mainly due to the incorporation of a needle protector device with certain kind of safety mechanism.
Therefore, to promote the use of safe I.V. Cannula among the healthcare workers it is very important to develop some economical passive
involuntary activated needle protector device and an effective safety mechanism thereof, along with designing of a novel I.V. Cannula to adopt the said needle protector device.
In light of aforementioned technical as well commercial background of the I.V. Cannula and the needle protector device/mechanism, and under the strict guidelines of the Indian Patent Act towards defining a Patentable Invention, the present invention is primarily objected to propose a very novel and cost effective safe I.V. Cannula which is uniquely incorporated with a passive involuntary activated needle protector device inside it without using the crimping technology, which need not require any activation during the normal use by the healthcare worker.
Another prime objective of the present invention is to propose such a design of safe I.V. Cannula, incorporated with the passive involuntary activated needle protector device, without any crimping on cannula and wherein the said needle protector covers the bevels automatically when the needle is removed from the catheter.
Another objective of the present invention is to propose a 'hammer and tong' shaped passive involuntary activated needle protector device, which is made up of plastic material, and wherein the said needle protector device is snap fit assembled on the I.V. Cannula from the side, in a novel fashion.
Another objective of the present invention is to propose a novel safety mechanism to be incorporated with the I.V. Cannula by way of suitable adoption and incorporation of the passive involuntary activated needle protector device inside it and the effective functioning of the said passive involuntary activated needle protector device, even though it is made of
plastic material, by effectively wrapping-up of the distal end of the needle during the removal of the said needle from the patient's body.
Statement of the present invention:
The present invention is intended to propose a very novel and cost effective safe I.V. Cannula, suitably adopting and incorporated with a passive involuntary activated needle protector device inside it; wherein the said passive involuntary activated needle protector device is preferably of 'hammer and tong' shaped, made up of plastic material; and wherein the said needle protector device is assembled inside the I.V. Cannula from the side, in a novel fashion, and further wherein the said I.V. Cannula involves a novel safety mechanism by way of suitable adoption and incorporation of the passive involuntary activated needle protector device inside it and the effective functioning of the said passive involuntary activated needle protector device by effectively wrapping-up of the distal end of the needle during the removal of the said needle from the patient's body.
Summary of the present invention:
Present description is related to an I.V. Cannula assembly, wherein this assembly has two major components: (i) needle assembly and (ii) wing assembly.
(i) Needle assembly: This component mainly comprises of a sharp needle, firmly pierced & suitably mounted on a needle hub at needle's proximal end. The needle hub portion further facilitated with blood stopper, followed by the Luer Lock Stopper.
(ii) Wing assembly: This is the another important component of the I.V. Cannula, mainly comprising of the wings, cavity for accommodating the needle assembly (mainly the needle hub), the slip ring and the catheter. The
catheter is a very soft and very fine polymeric tube, an integral part of the wing assembly. The said wing assembly may have feature of an additional injection port, which is created with the wing assembly, supported with a silicon tube, provisioned between the slip ring and the cavity for the needle assembly.
In the proposed invention of safe I.V. Cannula, mainly the said wing assembly is modified in such a manner that:
• It gets incorporated with an effective needle protector mechanism; and
• It accommodates a 'Hammer and Tong' shaped needle protector (in passive involuntary activated state), duly pierced with the needle, inside the cavity for the needle assembly.
In a complete set of safe I.V. cannula, the distal end or the tip of the needle remains duly inserted inside the catheter of the wing assembly, wherein the distal end or the tip of the said needle crosses the whole length of the catheter and remains necked there. The needle, duly pierced through the proposed needle protector (in passive involuntary activated state) and held by the ring provisioned inside the said cavity inside the wing assembly, and certain portion of the needle hub remains accommodated/engaged with the wing assembly, mainly at the cavity for the needle assembly. The needle protector, being pierced by the needle takes a position in the cavity for the needle assembly at the proximal end of the said needle.
At the time of use, the catheter, along with the pre-accommodated needle with its necked distal end/tip, gets easily inserted inside the human vein. This is mainly due to the sharp necked tip of the needle therein. Once the needle along with the catheter get inside the vein, the needle is removed back, leaving the catheter inserted the vein. The catheter is then caped or
attached with the tubing for liquid in-flow/out-flow. During the outward movement of the needle, along with the whole needle assembly, the proposed needle protector does not leave its position in the cavity for the needle assembly, though it is pierced by the needle. Thus the needle protector, through out the motion of the needle, remains relatively stationary inside the cavity for needle assembly with respect to the needle in motion. Thus the needle's proximal end goes away from the said needle protector and the tip reaches to the said needle protector. As soon as the needle's tip reaches inside the proposed 'Hammer and Tong' shaped needle protector, the hammer and tong arrangement contracts and it not only holds the needle's tip but also leaves its firm engagement with the cylindrical wall of the cavity for the needle assembly in the wing assembly, towards becoming mobile along with the needle. Thus the needle, properly wrapped with the proposed needle protector comes out of the wing assembly of the proposed safe I.V. cannula. Thus the proposed mechanism and the device therein refrains the health worker from coming in contact with the patient's blood.
Detailed Description of the invention:
The present description hereinafter is with the help of certain schematic drawings depicting one or another structural and functional feature. The drawings, labeled with certain numerical symbols, are basically related to: Figure 1: It represents the complete schematic view of the proposed safe I.V. Cannula assembly without injection port, showing all essential components of the assembly and specifically showing the needle protector device of the assembly properly accommodated inside the cavity of wing-assembly;
Figure 2: It represents the complete schematic view of the proposed safe I.V. Cannula assembly with the injection port, showing all essential components of
the assembly and the injection port as additional feature of the Cannula, and
specifically showing the needle protector device of the assembly
accommodated inside the cavity of the wing assembly;
Figure 3: It represents the schematic view of the needle protector position at
the time of removal of the needle and also showing all essential components
of the proposed safe I.V. Cannula assembly without injection port;
Figure 4: It represents the schematic view of the needle protector position at
the time of removal of the needle and also showing all essential components
of the proposed safe I.V. Cannula assembly with injection port;
Figure 5(a) & (b): Figure 5(a) represents two schematic views of I.V. Wing
with the injection port and the Figure 5(b) represents two schematic views of
I.V. Wing without injection port.
Figure 6(a), (b) & (c): Figure 6 collectively represents 3 dimensional
schematic views of the 'Hammer and Tong' shaped needle protector, which is
incorporated inside the proposed safe I.V. Cannula assembly;
Figure 7: It represents the schematic view of specific components of I.V.
Cannula assembly, namely (i) the cavity of the wing assembly, the space
where the 'hammer and tong' shaped needle protector device is
accommodated in passive state held by providing ring inside the wing
assembly during I.V. Cannula assembly/manufacturing, especially by passing
the needle through the said protector, (ii) the needle protector device
effectively wrapped around the tip or distal end of a needle, when the needle
is removed from the I.V. Cannula assembly during its normal use by a
healthcare worker, and (iii) the needle assembly, rigidly holding the proximal
end of the needle and creating a holder wherein the said holder partially
remains engaged inside the cavity of the wing assembly.
A new pack of safe I.V. Cannula comprises of two main components: The wing assembly, (A) and the Needle assembly (B). The wing assembly (A) mainly comprises of catheter 3, the slip ring 4, the wings 5 and the cavity for needle assembly 6. This cavity 6 is capable of suitably accommodating the proposed needle protector device 7 along with engaging certain portion of the needle hub 8. This cavity 6 is created with a ring 6' towards holding the needle protector device 7 in its passive involuntary active state. The catheter 3 of (A) is duly covered and protected by a needle cover 1. Another component (B) mainly comprises of the needle 2, the needle hub 8, and the blood stopper 9 and the Luer lock stopper 10. The needle 2, pierces mainly two components: the proposed needle protector device 7 through one thin hole provisioned with 7; and the catheter 3 in such a way that the proximal end of 2 stays near 7 and the distal end/ tip of 2, shown as 13 remains uncovered and outside the catheter 3.
Another embodiment of the safe intravenous (I.V.) cannula comprises of the additional injection port 11, created near the wings 5 on the cylindrical part of the wing assembly (B), Beneath 11, inside the cylindrical tube of (B), a silicon tube 12 is provisioned to support the in-flow of any liquid through the port 11. Thus in the complete assembly of safe I.V. cannula, as proposed herein, the needle 2 mainly passes through the cavity 6, the needle protector device 7 in passive involuntary activated state, the silicon tube 12, slip ring 4 and the catheter 3.
The proposed needle protector device 7 is mainly a "Hammer (14) and Tong (15)" shaped tiny component, made up of medical grade plastic material, and wherein the said protector device 7 is snap fit assembled on the cannula from the side. This component 7 is manufactured by molding process and therefore
it is possible to manufacture large number of such components 7 in single stock, preferably 80 to 120 such components. This particular process of manufacturing the component 7 by plastic material only makes the proposed safe I.V. cannula and the needle protector mechanism very economical. Unique structure of the needle protector 7, especially the "hammer and Tong" arrangement makes it capable towards stretching and contraction of the hammer 14 and the tong 15. The needle protector 7 is placed inside the cavity 6, wherein the needle passes through its thin single hole 16 and thus the protector device 7 is positioned inside cavity 6 at around the proximal end of the needle 2, touching the needle hub 8. The portion of needle 2 is accommodated in the void 17 of 7, created between the hammer 14 and the tong 15. It is very clear from the drawing 6(a) that the needle 2, passing through the protector 7 forces the hammer 14 and tong 15 to stretch away from each other. Thus the hammer 14 and tong 15, in their stretched positions, become passive but involuntarily active due to two reasons: (i) inner parts of the heads of the hammer 14 and the tong 15 hold the body of the needle 2 and the outer parts of the heads of the hammer and the tong firmly hold the wall of the cavity for the needle assembly 6, specially at the ring 6' of the said cavity 6. During the outward motion of the needle 2, when the sharp tip 13 reaches into the void 17, heads of the hammer 14 and tong 15 contract suddenly to return back to their normal shape and thus perform following actions: (i) leave their contact with the wall of the cavity 6; (ii) firmly hold the tip 13 of the needle 2; and (iii) initiate its own outward motion along with the needle's motion.
The material selection for preparing the needle protector 7; the unique designing and structure of the needle protector 7, especially the concept of
hammer 14 and tong 15 and their shapes thereof; and the positioning of the said needle protector 7 in the cavity 6 in the stretched and passive involuntary active state mainly involve the novelty and inventive steps and consequently the final product safe I.V. cannula involves considerably less manufacturing cost and thus it gets its industrial application towards promoting the application of such safe I.V. Cannula among the health workers.

We claim:
1. A safe intravenous (I.V.) cannula comprising of wing assembly (A) and a needle assembly (B), wherein the said I.V. cannula is characterized by incorporation of a passive involuntary activated needle protector device 7 inside it; and wherein the said I.V. cannula is further characterized by the needle protector mechanism, associated with the functioning of the said passive involuntary activated needle protector device 7 towards wrapping up of the needle's tip/distal end 13 without involving the crimping technology.
2. A safe intravenous (I.V.) cannula, as claimed in claim 1, wherein the said needle protector device 7 is made up of plastic material, mainly by molding process, and is snap fit assembled on the cannula from the side.
3. A safe intravenous (I.V.) cannula, as claimed in claim 1, wherein the wing assembly mainly comprises of the catheter 3 protected by the cover 1, slip ring 4, silicon tube 12 and additional injection port 11 (optionally), the "hammer and tong" shaped needle protector device 7, the cavity 6 with the inner ring 6' for accommodating the needle assembly and the wings 5.
4. A safe intravenous (I.V.) cannula, as claimed in claim 1, wherein the needle assembly mainly comprises of a needle 2, needle hub 8, the blood stopper 9 and the Luer lock stopper 10; wherein in the complete assembly of the said cannula the needle is kept pierced through the catheter 3 at its distal end and through the needle protector device 7 at its proximal end inside the cavity 6 of the wing assembly (A).
5. A safe intravenous (I.V.) cannula, as claimed in claim 1, wherein the said needle protector device 7 is "hammer and tong" shaped and is mainly positioned inside the cavity for the needle assembly 6 inside the wing assembly (A), supported with a ring 6' provided at the inner wall of the said
cavity 6 and the said needle protector 7 covers the bevels automatically when the needle is removed from the catheter.
6. A safe intravenous (I.V.) cannula, as claimed in claim 1, wherein the said needle protector device 7 is characterized by its positioning inside the said cavity 6 of the wing assembly (A) in the passive involuntary activated state, mainly due to the pre-stretched hammer 14 and tong 15 of the said needle protector 7, firmly holding the inner wall of the said cavity 6 at outer side and the body of the needle 2 at its proximal end at inner side.
7. A safe intravenous (I.V.) cannula, as claimed in claim 1, wherein the said needle protector device 7 is characterized by its involuntary action towards protecting and wrapping-up of the distal end 13 of the needle 2 during the outward motion of the said needle 2, mainly due to the contraction of the heads of said hammer 14 and tong 15 of the said needle protector device 7 towards achieving the normal un-stretched shape and leaving the initially existing firm contact with the inner wall of the cavity 6 of the wing assembly (A).
8. A safe intravenous (I.V.) cannula, as claimed in claim 1, wherein the said needle protector device 7 is an essential component of an I.V. cannula with or without injection port.
9. A safe intravenous (I.V.) cannula, as claimed in claim 1, wherein the cavity for needle assembly 6 of the wing assembly (A), mainly accommodates a ring at its inner wall, the needle protector device 7 with the portion of the needle 2 passing through the said protector device 7, and certain part of the needle hub 8.
10. A safe intravenous (I.V.) cannula with the needle protector
device 7 substantially as herein described and illustrated in the figures of
the accompanying drawings.