CROSS-REFERENCE TO THE RELATED APPLICATION
This application claims priority from Indian Patent Application No. 133/DEL/2011, dated January 19, 2011, the entire disclosure of which is incorporated herein by reference.
FIELD OF THE INVENTION
The present invention relates to a medical device such as, for example a safety I.V. catheter assembly. More particularly, the invention relates to a safety I.V. catheter assembly to prevent blood spillage and/or leakage. The invention, thus, relates to prevention of blood spillage to eradicate inadvertent contact with blood and other safety issues during the use of safety intravenous catheter assembly.
BACKGROUND OF THE INVENTION
A safety intravenous (I.V.) catheter assembly of this kind is generally known and, for example, used to administer intravenous fluids, medications, and blood products or to take blood from a patient. While typical needles and syringes are capable of administering or drawing fluids to and from a patient's blood vessels, a safety I.V. catheter assembly allows for multiple administrations or drawings on the patient through the use of a single puncture to a chosen blood vessel. Intravenous catheter assembly also allows continuous administration or drawing of fluids, allowing convenient lengthy fluid administrations or drawings.
In use typically, the tubular catheter is inserted into a blood vessel of the patient, typically a vein, by means of the needle which will be withdrawn from the catheter after insertion of the tubular catheter into the blood vessel. The separation of the needle assembly from the catheter portions of the catheter assembly presents numerous potential hazards to the health care workers and others in the area. There is a risk of accidental needle sticks if the needle tip is not secured properly in a needle tip guard. Additionally, between the time that the needle assembly is separated from the catheter portions and the time that the catheter portions are

coupled to another medical device, such as an IV drip bag, or are otherwise closed off, there is a risk that blood will exit from the catheter under the pressure of the patient's vascular system. Health care workers are very skilled at occluding the blood vessel through manual pressure and at the transition between removal of the needle assembly and closing the patient's vascular system through one or more of these techniques. Nevertheless, there is a risk that some blood may exit the system even in a perfect transition. For example, blood may follow the needle tip as the needle is withdrawn from the catheter and may splatter, splash, drip, or otherwise exit the proximal end of the catheter. Any blood flow from the proximal end of the catheter risks exposure to health care workers and is to be avoided.
Thus, blood spillage is currently a major problem while administering safety I.V. catheter assembly. Blood spillage can pose significant health risks to the patient, medical professionals, and health care workers who ultimately dispose of the spilled blood. The risks associated with blood spillage stem from the communicable nature of many diseases and conditions which may use the spilled blood as a vehicle for transmission.
A further shortcoming of current safety I.V. catheter assembly is that they are prone to blood clogging in that blood may clot and clog the catheter near its tip, rendering it inoperable, and may even result in a clot of blood being injected into the patient. Such an instance of blood clogging causes unpleasant and unbearable pain to the patient if the process of introducing the catheter will have to be repeated. Fluids such as saline or heparin (anti coagulant agent) can be used to flush the flow path of the catheter. However, the use of saline or heparin does not provide a consistent solution to the problem, rendering the catheter unusable.
Additionally if the IV remains connected to the patient, when the patient is moved particularly if being taken to a hospital, no matter how many precautions are taken by the health care worker if the IV tubing is ripped out, then the patient is able to bleed out through the catheter that v.ill likely remain inserted in the patient and providing a pathway for blood to flow out the patient unless plugged/clogged up or

removed from the patient. If the patient is not conscious or the health care workers are distracted, then the bleeding can add to the loss of blood and increase the likelihood of death.
Furthermore, currently used IV plugs or locks without exception start to leak after any kind of movement, which compromises the IV site on an injured patient both in terms of leakage from the patient and/or IV and containments making there way into the patient via the leak area.
Accordingly a need exists for a device which substantially departs from the conventional concepts and designs o; the prior art, and while doing so provides products primarily developed for the purpose of providing a blood free cannulation process using intravenous and arterial catheters, while preserving the health care worker's ability to affirm free passage to the vessel preventing entirely the instance of blood spillage.
SUMMARY OF THE INVENTION
The invention herein provides a safety I.V. catheter assembly comprising a catheter hub having a proximal end and a distal end defining a interior housing; a catheter attached to the distal end of the said catheter hub; a needle defining an axial direction 'A' capable of being carried into said catheter housing and selectively removable therefrom, said needle having a needle shaft and a proximal end and a distal end defining a needle tip; a needle hub attached to the said catheter hub and a flash back chamber attached to the said needle hub, wherein the needle shaft extends through the catheter such that the needle tip protrudes from the distal end of the tubular catheter, wherein the needle shaft comprises an engagement means adapted to engage with a needle guard slidably arranged on the needle shaft in order to prevent the needle guard from sliding off the needle tip, and wherein the catheter hub defining the said housing have a connection end and a catheter end together defining a flow path, the said housing comprising a stopper assembly having dimensions and shape to fit in the said housing capable

to seal a opening, incision or puncture configured therein when the needle is retracted therefrom.
The stopper assembly has dimensions and shapes to fit in the housing conveniently and easily. The housing includes a plurality of walls arranged in a geometric configuration or alternatively may include a hub wall in a substantially circular configuration. The stopper assembly is made of a resilient, compressible elastomeric material. The resilient, compressible elastomeric material includes, but is not limited to, natural and/or synthetic elastomers such as silicones, soft latex rubber, thermoplastic, or a combination thereof. The shape and/or dimension of the stopper assembly may comprise incision and/or cut allowing needle or IV sets comprising needles to pass through such incision and/or cut. The stopper assembly is capable of being resealed thereby causing it to regain its original, as-assembled shape forming a seal.
Among many others, it is a primary object of the invention to provide an I.V. safety catheter assembly that prevents blood spillage from the assembly during the cannulation procedure reducing the complexity and costs involved in the manufacture of prior known safety I.V. catheter assembly.
Another object of the invention is to provide an I.V. safety catheter assembly that uses the stopper assembly of the invention to prevent blood leakage from the assembly.
Another object of the invention is to provide an IV safety catheter assembly that uses the stopper assembly of the invention being capable of re-sealing itself automatically closing the opening and re-establishing a fluid-tight seal once the needle is retracted from the said stopper assembly.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a cross-sectional side view of one of the embodiments of the invention adapted to an IV catheter assembly showing the stopper assembly as used in this catheter assembly.

FIG. 2 is a front view of one of the embodiments of the invention adapted to an IV catheter assembly showing the stopper assembly as used in this catheter assembly.
DETAILED DESCRIPTION OF THE INVENTION
The invention herein provides an IV safety catheter assembly to prevent blood spillage and/or leakage from the assembly during the cannulation procedure.
As used herein, the term "proximal" refers to a region of the device or a location on the device which is closest to, for example, a medical professional using the device. In contrast to this, the term "distal" refers to a region of the device which is farthest from the medical professional, for example, the distal region of a needle will be the region of a needle containing the needle tip which is to be inserted e.g. into a patient's vein.
According to one embodiment of the present invention, there is provided an IV safety catheter assembly with a terminal end of the catheter hub comprising a stopper assembly to prevent blood from leaking out after the needle is removed. The "stopper assembly" preferably may be pre-pierced resealable and functions by allowing a needle to easily be inserted through the resilient, compressible elastomeric material, spreading open the assembly allowing access to inside of flash chamber. When needle is removed, the stopper assembly re-seals itself automatically closing the opening and re-establishing a fluid-tight seal.
Referring to Figs. 1 and 2, a safety IV catheter assembly 10 is shown comprising a catheter hub 12. The catheter hub 12 comprises a main body of generally tubular form and extending in an axial direction A. The main body 44 has a distal end 16 and a proximal end 14. A catheter 20 is attached to the main body 44 at the distal end 16 of the main body 44. The main body 44 defines an interior housing 18 extending from the proximal end 14 towards the distal end 16 thereof.

The needle 22 extends through the housing 18 and through the catheter 20. In the region of its proximal end 14, a needle hub 26 is attached to the needle 22.
As shown in Fig. 1, preferably the terminal end of the catheter hub 12 housing 18 is provided with a stopper assembly 34 to prevent blood from leaking out after the needle 22 is removed. The stopper assembly 34 may also be arranged and/or positioned in any other suitable position in the catheter housing 18. The stopper assembly 34 is shaped as such to conform and fit into the housing 18 of the catheter hub 12. The size of the stopper assembly 34 depends on the specific needle 22 for which it is to be used and to the inner profile of the catheter hub 12 housing 18. As can be seen in Fig. 1, the stopper assembly 34 has preferably a U shape. However, the present invention encompasses use of different shapes for the stopper assembly 34. The portion forming base 36 of the U shaped stopper assembly 34 preferably may be provided with one or more vertical or horizontal incision or puncture 46 (not shown) to let the needle 22 pass through it. As such, the base portion 36 of the stopper assembly 34 is piercable.
During the cannulation process, when the needle 22 is inserted into the vein, blood flows through the catheter 20 to the stopper assembly 34. Since the stopper assembly 34 is made of suitable compressible elastomeric material, when the needle 22 is retracted the stopper assembly 34 seals automatically the said incision or puncture 46 and prevent any leakage of blood therefrom. Thus, the stopper assembly 34 is capable of being resealed thereby causing it to regain its original, as-assembled shape forming a seal.
The resilient, compressible elastomeric material used for the stopper assembly 34 includes, but is not limited to, natural and/or synthetic elastomers such as silicones, soft latex rubber, thermoplastic, or a combination thereof and has the properties that it is air permeable when it is dry. However, upon exposure to blood or other liquids the stopper assembly 34 is capable of becoming liquid impermeable instantly preferably in micro seconds (i.e. preferably in 0.5 seconds). Further, the elastomeric material used for the stopper assembly 34 is inexpensive and non-toxic and validated to be used with patients i.e. humans. As mentioned,

the elastomeric material used for the stopper assembly 34 is capable of re-sealing itself automatically closing the opening, incision or puncture and re-establishing a fluid-tight seal once the needle 22 is retracted from the said stopper assembly 34.
Preferred embodiments of the present invention comprise providing the outer/side wall 42 of the stopper assembly 34 to be provided with one or more annular protrusions 38 and/or depressions 48. In order to let the stopper assembly 34 be retained in the interior housing 18 of the catheter hub 12, the inner side/wall 50 of the catheter housing 18 is provided with one or more matching depressions 48 and/or protrusions 38 respectively allowing the stopper assembly to be retained therein.
For ease in understanding the invention, as an illustration in one of the embodiments of the invention, there is provided a medical device, in particular an intravenous catheter assembly 10, comprising a needle 22 and a needle tip guard 52 (not shown) which is slidably arranged on the needle 22 for protecting the needle tip 24, wherein the said needle tip guard 52 includes a base portion having a bore extending through it for receiving the needle 22, the bore being adapted to the principal outer profile of the needle 22.
The needle 22 and needle shaft 54 are inserted through the skin and blood vessel of the patient. Once the needle 22 is in the blood vessel, blood "flashes" through the needle 22 fluid passageway or needle shaft 54 into the flash-back chamber 28. The needle 22 is removed from the intravenous catheter assembly 10 by sliding the ridge portion 40 of the sliding needle hub 26 along the sides of the needle tip guard 52 away from the catheter hub 12. This causes the needle 22 to be removed from the catheter hub 12 into the needle tip guard 52 being entrapped therein, where it is locked into place to prevent accidental needle sticks. Thus, the needle tip 24 is secured within the needle tip guard 52. After removal of the needle 22 from the blood vessel, the catheter shaft 20 remains positioned in the blood vessel. With the needle tip guard 52 removed, the catheter hub 12 of the intravenous catheter assembly 10 can receive a needleless device using the connection system already in place. This could be for example, a needleless

device having a mating luer that locks with the luer lock fitting on the catheter hub 12 for further medical procedures.
For the purpose of a simplified and cost-effective production of the stopper assembly 34, it may be made by suitable means known in the art, for example, by plastic mold injection and/or insert moulding.
For ease in understanding the features of the invention, some of the internal portions have been shown in dotted-lines.
Although this invention has been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof.
Thus, from the foregoing description, it will be apparent to one of ordinary skill in the art that many changes and modifications can be made thereto without departing from the spirit or scope of the invention as set forth herein. Accordingly, it is not intended that the scope of the foregoing description be limited to the exact description set forth above, but rather that such description be construed as encompassing all of the features of patentable novelty that reside in the present invention, including all the features and embodiments that would be treated as equivalents thereof by those skilled in the relevant art. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above but should be determined only by a fair reading of the claims appended below.

WE CLAIM:
1. A safety I.V. catheter assembly (10) comprising a catheter hub (12) having a proximal end (14) and a distal end (16) defining an interior housing (18); a catheter (20) attached to the distal end (16) of the said catheter hub (12); a needle (22) defining an axial direction 'A' capable of being carried into said catheter housing (18) and selectively removable therefrom, said needle (22) having a needle shaft (54) and a proximal end (14) and a distal end (16) defining a needle tip (24); a needle hub (26) attached to the said catheter hub (12) and a flash back chamber (28) attached to the said needle hub (26), wherein the needle shaft (54) extends through the catheter (20) such that the needle tip (24) protrudes from the distal end (16) of the tubular catheter (20), wherein the needle shaft (54) comprises an engagement means (56) adapted to engage with a needle guard (52) slidably arranged on the needle shaft (54) in order to prevent the needle guard (52) from sliding off the needle tip (24), and wherein the catheter hub (12) defining the said housing (18) have a connection end (30) and a catheter end (32) together defining a flow path, the said housing (18) comprising a stopper assembly (34) having dimensions and shape to fit in the said housing (18) capable to seal a opening, incision or puncture (46) configured therein when the needle (22) is retracted therefrom.
2. The safety IV catheter assembly (10) as claimed in claim 1, wherein the said stopper assembly (34) is provided with a piercable base portion (36).
3. The safety IV catheter assembly (10) as claimed in claim 1, wherein the said stopper assembly (34) is made of a resilient, compressible elastomeric material.
4. The safety IV catheter assembly (10) as claimed in claim 2, wherein the said resilient, compressible elastomenc material includes, but is not limited to, natural and/or synthetic elastomers such as silicones, soft latex rubber, thermoplastic, or a combination thereof.

5. The safety IV catheter assembly (10) as claimed in any of the preceding claims, wherein the said stopper assembly (34) is air permeable when dry and liquid impermeable upon exposure to blood or other liquids.
6. The safety IV catheter assembly (10) as claimed in any of the preceding claims, wherein the base portion (36) of the said stopper assembly (34) is provided with one or more vertical or horizontal opening, incision or puncture (46) to let the said needle (22) pass through it.
7. The safety IV catheter assembly (10) as claimed in any of the preceding claims, wherein the said stopper assembly (34) is capable of being resealed thereby causing it to regain its original, as-assembled shape forming a seal.
8. The safety IV catheter assembly (10) as claimed in any of the preceding claims, wherein the said stopper assembly (34) on its outer/side wall (42) is provided with one or more protrusions (38) and/or depressions (48).