Description:FIELD OF THE INVENTION
[0001] The present invention relates to the field of medical devices, and more particularly to an improved closed IV catheter to deliver IV fluids, medications or blood into a patient’s vascular system.

BACKGROUND OF THE INVENTION
[0002] The subject matter discussed in the background section should not be assumed to be prior art merely as a result of its mention in the background section. Similarly, a problem mentioned in the background section or associated with the subject matter of the background section should not be assumed to have been previously recognized in the prior art. The subject matter in the background section merely represents different approaches, which in and of themselves may also correspond to implementations of the claimed technology.
[0003] An Intravenous (IV) therapy is a procedure of administering IV fluids, medications or blood directly into a vein of a patient. It is a widely used procedure in the healthcare field by medical professionals to administer the fluids in an efficient and quick way. The IV therapy enables fluid and medication delivery directly to the organs of the patient through the bloodstream by bypassing the digestive system.
[0004] There are many different types of devices configured to carry out IV therapy procedure. A conventional catheter is the most common device used across the medical field to carry out IV therapy procedure. The IV catheter conventionally comprises a needle, a valve, wings, a flashback chamber, a needle grip, and a luer connector.
[0005] However, in the existing intravenous (IV) catheter devices, there remains high risk of blood exposure due to the blood backflow upon removal of the needle, thereby risk of transmission of blood-borne pathogens. Further, the existing intravenous (IV) catheter devices lacks integration of needle safety features, which poses significant risk of accidental needle injuries, especially during emergency situations. Additionally, the existing intravenous (IV) catheter devices often lack a patient-centric design, resulting in discomfort during insertion, use, and removal.
[0006] To address the aforementioned drawbacks of conventional IV catheters, closed intravenous (IV) catheter devices were developed. These systems incorporate mechanisms designed to prevent or minimize blood backflow when the needle is withdrawn from the catheter. In particular, such systems utilize a backflow stopper element disposed within a main fluid channel of the needle hub. During use, this backflow stopper redirects fluid flow into a bypass channel rather than allowing it to travel toward the flashback chamber, thereby reducing the likelihood of blood exposure and contamination.
[0007] However, in practice, certain limitations exist with the existing closed IV catheter designs. For example, during the manufacturing or assembly process, the backflow stopper element may be improperly positioned within the needle hub. This misalignment can result in partial or complete blockage of the bypass port, compromising the intended redirection of fluid and leading to functional failure of the closed IV catheter device.
[0008] Additionally, the needle is inserted through the backflow stopper element during the manufacturing or assembling state, which upon extraction, during use, may form a hole or puncture in the backflow stopper member. This may sometime leads to leakage of the fluid, compromising the safety and effectiveness. Furthermore, during assembly, the needle is inserted through the backflow stopper element, and this insertion may not always be axially aligned. Such misalignment can result in uneven penetration of the stopper element, which may cause mechanical instability during both insertion and retraction of the needle. This imbalance can lead to improper sealing, increased friction, or potential damage to the stopper, thereby compromising the performance and reliability of the closed IV catheter device.
[0009] In addition to that, the existing closed IV catheter devices lack integrated needle safety mechanisms, such as automatic needle shielding or tip protection, or accidental removal of the needle protection, thereby exposing healthcare providers to needlestick injuries. These devices also frequently lack ergonomically designed components, resulting in discomfort or difficulty during insertion and secure placement on the patient.
[0010] Therefore, there exist a need of a closed intravenous (IV) catheter device that may completely eliminate the fluid backflow, enhance the safety, and increase the comfort to the patient, when the closed IV catheter is attached to the patient’s body.

SUMMARY OF THE INVENTION
[0011] This summary is provided to introduce a selection of concepts in a simplified form that are further disclosed in the detailed description of the invention. This summary is not intended to identify key or essential inventive concepts of the claimed subject matter, nor is it intended to determine the scope of the claimed subject matter.
[0012] The principle objective of the present disclosure is to provide an improved closed intravenous (IV) catheter device or closed intravenous (IV) catheter that may overcome all the above and other limitations of the existing closed intravenous (IV) catheter systems.
[0013] Another objective of the present disclosure is to provide the closed IV catheter that may include improved design of the flexible wing set that may reduce the skin irritation and enhance comfort of the patient.
[0014] One another objective of the present disclosure to provide the closed IV catheter that may provide a mechanism to prevent obstruction of the bypass port due to the assembly of the blood backflow stopper within a needle hub or a cylindrical hollow hub.
[0015] One more objective of the present disclosure is to provide the closed IV catheter that may be include a guiding channel within the blood backflow stopper member to guide axial insertion and removal of the needle, thereby preventing misalignment of the needle from a central axis and uneven penetration of the blood backflow stopper.
[0016] One more objective of the present disclosure is to provide the closed IV catheter that may include a self-sealing blood backflow stopper member to completely eliminate the possibility of fluid backflow through the stopper.
[0017] One more objective of the present disclosure is to provide the closed IV catheter that may include a needle safety clip that covers a needle tip upon retraction of the needle from the needle hub during use, thereby preventing the possibilities of the injuries caused due to the open needle tip.
[0018] One more objective of the present disclosure is to provide the closed IV catheter that may include an annular protrusion inside the needle hub that may be configured to prevent accidental removal of the needle.
[0019] According to as aspect, the present disclosure discloses a closed IV catheter device for a fluid communication with a patient's vascular system. The closed IV catheter device comprises a cylindrical hollow hub, a catheter, a needle, a backflow stopper member, and a flexible wing set. The cylindrical hollow hub further comprises a distal end, a proximal end opposite to the distal end, and a cavity defined between the distal end and the proximal end. The catheter is connected in a fluid communication to the distal end of the cylindrical hollow hub. Further, the needle is configured within the cylindrical hollow hub. The needle passes across the catheter and extends out of a distal end of the catheter during assembly. Further, the backflow stopper member is configured within the cylindrical hollow hub. The backflow stopper member is configured adjacent to an opening of the bypass outlet within the cylindrical hollow hub to direct the fluid to the bypass outlet and prevent fluid flowing towards the proximal end of the cylindrical hollow hub.
[0020] According to an aspect, the closed IV catheter device comprises the flexible wing set which is connected to an outer surface of the cylindrical hollow hub. The flexible wing set comprises a flexible body having a first surface and a second surface, opposite to the first surface, a plurality of grooves defined on the first surface including a longitudinal groove and a lateral groove, a pair of opposing semi-cylindrical walls extending from around the longitudinal groove to conform to an outer surface of the cylindrical hollow hub, and an opening in the semi-cylindrical wall corresponding to the lateral groove to conform the bypass outlet of the cylindrical hollow hub.
[0021] According to an aspect, the present disclosure discloses a cylindrical catheter hub or a cylindrical hollow hub for a closed IV catheter. The cylindrical catheter hub comprises a cylindrical hollow body having a distal end, a proximal end opposite to the distal end, and a cavity defined between the distal end and the proximal end. The cylindrical catheter hub further comprises a needle guard clip disposed within the cavity and mounted onto a needle during an assembling, and an annular protrusion integrally formed on an inner surface of the cylindrical hollow body. The needle guard clip comprises a distal end, a proximal end comprising a planar surface with an aperture configured to receive a needle, and a first arm and a second arm. The first arm and the second arm are extending distally from opposite lateral edges of the planar surface and crossing one another intermediate the distal end and the proximal end.
[0022] According to an aspect, the present disclosure discloses a self-sealing backflow stopper for a closed IV catheter comprising a cylindrical body comprising a proximal end and a distal end, opposite to the proximal end. Further, the self-sealing backflow stopper comprises a longitudinal guide channel formed within the cylindrical body and an annular groove formed on the cylindrical body on axially centre position. The longitudinal guide channel have an opening at the proximal end of the cylindrical body and extend up to a location short of the distal end, thereby defining an integral sealing membrane at the distal end. In an embodiment, the longitudinal guide channel extends between 60% to 90% of an overall axial length of the cylindrical body. In an embodiment, the longitudinal guide channel is configured to receive a needle which passes through the longitudinal guide channel and penetrates the sealing membrane at the distal end of the cylindrical body to pass through the backflow stopper during an assembling.

BRIEF DESCRIPTION OF FIGURES
[0023] The detailed description is described with reference to the accompanying Figures. In the Figures, the left-most digit(s) of a reference number identifies the Figure in which the reference number first appears. The same numbers are used throughout the drawings to refer like features and components.
[0024] FIG. 1 shows a view of a closed intravenous (IV) catheter, according to an embodiment of the present disclosure.
[0025] FIG. 2 illustrates a perspective view of a cylindrical hollow hub of the closed IV catheter with a configured wing set, according to an embodiment of the present disclosure.
[0026] FIG. 3 illustrates a cut sectional view of the cylindrical hollow hub, according to an embodiment of the present disclosure.
[0027] FIG. 4 illustrates a cut-sectional view of the cylindrical hollow hub, according to an embodiment of the present disclosure.
[0028] FIG. 5A illustrates a perspective view of the wing set, according to an embodiment of the present disclosure.
[0029] FIG. 5B illustrates a front view of the wing set, according to an embodiment of the present disclosure.
[0030] FIG. 5C illustrates a side view of the wing set, according to an embodiment of the present disclosure.
[0031] FIG. 6 illustrates a perspective view of a backflow stopper member, according to an embodiment of the present disclosure.
[0032] FIG. 7A illustrates a side view of the backflow stopper member, according to an embodiment of the present disclosure.
[0033] FIG. 7B illustrates a cut sectional view of the backflow stopper member, according to an embodiment of the present disclosure.
[0034] FIG. 8 illustrates a perspective view of a needle guard clip of the closed IV catheter, according to an embodiment of the present disclosure.

DETAILED DESCRIPTION
[0035] The present disclosure overcomes the aforesaid drawbacks of the above, and other objects, features and advantages of the present disclosure will now be described in greater detail. Before the present apparatus and its components are described, it is to be understood that this disclosure is not limited to the particular apparatus and its arrangement as described, as there can be multiple possible embodiments that are not expressly illustrated in the present disclosure. It is also to be understood that the terminology used in the description is for the purpose of describing the particular versions or embodiments only and is not intended to limit the scope of the present application. This description is not intended to identify essential features of the claimed subject matter nor is it intended for use in detecting or limiting the scope of the claimed subject matter.
[0036] The closed IV catheter assemblies are designed to enhance safety, prevent blood backflow, and reduce needlestick injuries during vascular access procedures. Unlike conventional catheters, the closed IV catheter includes valves or stopper mechanism to maintain closed fluid path upon removal of the needle.
[0037] When the catheter is inserted into the patient’s vein, an introducer needle facilitates the insertion of the flexible catheter tube. The needle extends through a valve or backflow stopper positioned within the cylindrical hollow hub. Upon successful cannulation and subsequent withdrawal of the needle, the valve automatically returns to a closed state, thereby preventing retrograde blood flow or leakage through the proximal opening.
[0038] However, the traditional closed IV catheter assemblies lacks guiding mechanism and self-sealing properties withing the stopper mechanism, to guide the needle for axial insertion within the stopper mechanism during assembling and self-sealing the stopper mechanism post withdrawal of the needle, during use. Thereby, fails to prevent assembling misalignment or accidental leakage of the fluid from the stopper mechanism. Additionally, the traditional closed IV catheter assemblies does not include mechanism for alignment of the backflow stopper member adjacent to the bypass port without partially or fully covering the bypass port which sometimes result in failure of the closed IV catheter. Moreover, the present closed IV catheter assemblies does not include a needle safety mechanism or safety mechanism control structures to prevent accidental activation or removal of the needle safety mechanism. This results in wastage of the closed IV catheter without its use, due to accidental removal.
[0039] The present disclosure provides an improved closed intravenous (IV) catheter. The closed IV catheter device may be configured to administer IV fluids, medications, and blood directly into the vascular system of a patient.
[0040] According to an embodiment of the present disclosure, the closed IV catheter comprises a plurality of components integrated into a single system. The closed IV catheter may be preassembled with all the necessary components which may reduce the work of manual assembly which is required in conventional catheters. According to an embodiment, the closed IV catheter comprises a plurality of components and seals configured to maintain a sterile environment which may reduce the risk of contamination and infection. Simultaneously, the closed IV catheter reduces the risk of blood exposure to the health care provider and reduces the risk of phlebitis or vein inflammation to the patient.
[0041] According to an embodiment, the closed IV catheter of the present disclosure may be configured to administer medications directly into the vein and subsequently into the bloodstream of the patient. The closed IV catheter may ensure a precise control over the dosage of the medication administered to the patient. Further, the medication administered by the closed IV catheter may show the results and effects rapidly as it bypasses the digestive system. Additionally, the closed IV catheter is configured to provide intermediate medications to the patient. The closed IV catheter may also be used to administer extemporaneously compounded medicines to the patient with help of multiple ports and side ports.
[0042] In an embodiment, the closed IV catheter of the present disclosure may be configured to administer blood or blood components such as plasma to a patient. The closed IV catheter may be used to administer blood to the patient in case of immediate blood replacement, as well as in situations such as surgeries, trauma or medical conditions which may require blood transfusions.
[0043] FIG. 1 shows a view of a closed intravenous (IV) catheter, according to an embodiment of the present disclosure. FIG. 2 illustrates a perspective view of a cylindrical hollow hub of the closed IV catheter with a configured wing set, according to an embodiment of the present disclosure.
[0044] Referring to the FIG.1, the closed IV catheter 100 includes a cylindrical hollow hub 102, a needle 110, a catheter 112, and a flexible wing set 116. The cylindrical hollow hub 102 includes a distal end 104, a proximal end 106, and a cavity 302 (as shown in FIG. 3) defined in between. The cylindrical hollow hub 102 further includes a bypass outlet 108 and one or more apertures 114. The bypass outlet 108 is formed on a side of the cylindrical hollow hub 102 between the distal end 104 and the proximal end 106. According to an embodiment, the bypass outlet 108 is formed within the proximity near the distal end 104 of the cylindrical hollow hub 102. Further, the one or more apertures 114 are formed on an outer circumferential surface 202 of the cylindrical hollow hub 102, as shown in FIG. 2.
[0045] It is to be understood that the terms “cylindrical hollow hub 102”, “hollow hub 102”, and “hub 102” refers to the same component and may be used interchangeably, hereinafter. Further, it is to be understood that the “one or more apertures 114” may alternatively be referred to plurally as “apertures 114” or singularly as “aperture 114”, hereinafter.
[0046] The cylindrical hollow hub 102 is a needle hub which comprises an elongated cylindrical hollow body with openings at the distal end 104 and the proximal end 106. Further, the bypass outlet 108 laterally extends from the cylindrical hollow body and is in fluid communication with the cavity 302 to bypass the fluid from the cavity 302 to the bypass outlet 108. The bypass outlet 108 includes a proximal opening 402 that opens within the cavity 302, as shown in FIG. 4. Further, the bypass outlet 108 includes a distal opening connected to a Y-connector 120 through an extension tube 122, as shown in FIG. 1 and explained in details later in the specification.
[0047] It is to be understood that the bypass outlet 108 is integrally formed with the cylindrical hollow body to form an integrated cylindrical hollow hub 102. In one embodiment, the elongated cylindrical hollow body of the cylindrical hollow hub 102 is a tapered in a distal direction. For example, the diameter from the proximal end 106 to the distal end 104 decreases gradually. In another embodiment, the elongated cylindrical hollow body of the cylindrical hollow hub 102 have uniform diameter throughout the length. In one another embodiment, the elongated cylindrical hollow hub 102 comprises two regions having different outer diameters, connected by either a step transition or a tapered transition. For instance, the proximal portion of the hub, adjacent to the proximal end 106, may have a larger diameter, while the distal portion, adjacent to the distal end 104, may have a smaller diameter. The transitioning surface between these regions may be formed as a tapered surface or as a discrete step, depending on the desired fluid dynamics and structural engagement with adjoining components.
[0048] The apertures 114 are configured to provide a visual indicator to guide with the accurate placement of a blood backflow stopper 304 within the cylindrical hollow hub 102, as shown in FIG. 3 and explained in detail later in the specification.
[0049] In an embodiment, the cylindrical hollow hub 102 is made of a transparent material for visual indication of the fluid. In an embodiment, the cylindrical hollow hub 102 is made of one of a polycarbonate (PC), Polypropylene (PP), Acrylonitrile Butadiene Styrene (ABS), Polyethylene (PE), Nylon (Polyamide), Polystyrene (PS), or their combination. In an embodiment, the cylindrical hollow hub 102 may be made of a combination of at least one of the above-mentioned material with the barium sulphate or bismuth compounds to introduce a radiopacity to the closed IV catheter 100. In another embodiment, the cylindrical hollow hub 102 may be made of a combination of at least one of the above-mentioned material with ultraviolet (UV) stabilizers in increase the shelf-life of the closed IV catheter 100. In one another embodiment, the cylindrical hollow hub 102 may be made of a combination of at least one of the above-mentioned material with pigmented polycarbonates for colour coding of the closed IV catheter 100.
[0050] In an embodiment, the catheter 112 is connected at the distal end 104 of the hollow hub 102. The catheter 112 may be an elongated tube that enters within the vein of the patient along with the needle 100 during the use. The catheter 112 is configured to connect the vascular system of the patient with the cylindrical hollow hub 102. The closed IV catheter 100 comprises the needle 110 that passes through the cylindrical hollow hub 102 and the catheter 112 such that a tip of the needle 110 extends out of a distal end of the catheter 112. Further, the opposite end of the needle 110 is connected to the needle grip 124 and the flashback chamber 126. Therefore, during use, the practitioner enters the tip of the needle 110 into the vein with the catheter 112. Further, the needle grip 124 and the flashback chamber 126 is detached to remove the connected needle 110 from the catheter 112. Simultaneously, the flexible catheter 112 is further pushed into the vein to configure the catheter 112 sufficiently inside the vein to enable fluid communication between the closed IV catheter 100 and the vascular system of the patient.
[0051] In an embodiment, the catheter 112 is made of polyurethane material due to the materials soft texture and biocompatibility. The polyurethane material may minimize trauma to the vein as well as may provide flexibility to the catheter 112 and reduce irritation or allergic reactions to the patient.
[0052] In another embodiment, the catheter 112 may be made of silicone material or a polytetrafluoroethylene (Teflon).
[0053] In an embodiment, the catheter 112 may be coated with heparin or non-heparin polymers to reduce the inflammatory response of the patient to the catheter 112.
[0054] In an embodiment, the needle 110 may be a hollow needle 110 with a bevel cut at its proximal end. The hollow needle 110 may be configured to enable the blood from the vein to pass through the hollow needle 110 into the cylindrical hollow hub 102 which may be referred to as the blood flashback. The blood flashback may enlighten the health care provider about the accurate insertion of the needle 110 and the catheter tube 112 into the vascular system of the patient. Further, bevel cut of the needle 110 reduces the penetration force into the skin and vein of the patient.
[0055] In an embodiment, the needle 110 of the closed IV catheter 100 may be made of stainless-steel material. Alternatively, the needle 110 may be made from other standard metals that may be strong and sharp enough to penetrate the skin and vein. Additionally, the needle 110 may be coated with silicone or other lubricants to make smooth insertion into the vein of the patient.
[0056] In an embodiment, the cylindrical hollow hub 102 further comprises symmetrically extended protrusions 204 at a proximal periphery of the hollow hub 102. The symmetrically extended protrusions 204 are configured to set the needle grip 124 and prevent the diagonal movement. Further the symmetrically extended protrusions 204 are configured to provide grip during removal of the needle grip 124 and the flashback chamber 124, thereby remove of the needle 110.
[0057] Further, the flexible wing set 116 is connected to an outer surface 202 of the cylindrical hollow hub 102. The flexible wing set 116 is configured to enhance a grip and control of the close IV catheter 100 during use, improve stabilization of the close IV catheter 100 after insertion, and enhances comfort on a skin of the patient.
[0058] It is to be well understood that the terms “outer surface 202” and “outer circumferential surface 202” may be used interchangeably, hereinafter.
[0059] In an embodiment, the closed IV catheter 100 further comprises a guiding member 118 configured within the cavity 302 (shown in FIG. 3) of the cylindrical hollow hub 102. The guiding member 118 may be configured at the distal end 104 of the hollow hub 102. Further, the guiding member 118 may be a flexible assembly to guide the needle 110 during assembly and use. In an embodiment, the guiding member 118 may be made of a flexible and elastic material such as silicone rubber, Thermoplastic Elastomer (TPE), Polyvinyl Chloride (PVC), Polyurethane (PU), or Ethylene Vinyl Acetate (EVA).
[0060] The closed IV catheter 100 further comprises a needle grip 124, a flashback chamber 126, and a luer lock cap 128 connected at the proximal end 106 of the hollow hub 102. The needle grip 124, the flashback chamber 126, and the luer lock cap 128 may be connected proximally in a same sequence. In one embodiment, the needle grip 124 and the flashback chamber 126 are formed as separate components and connected together with the cylindrical hollow hub 102. In another embodiment, the needle grip 124 and the flashback chamber 126 are formed integrally as a single unit.
[0061] The flashback chamber 126 may be a transparent hollow tube with the needle grip 124 formed at the distal end of the flashback chamber 126. The flashback chamber 126 may be provided for visual confirmation of a fluid backflow during the use of the closed IV catheter 100. The needle grip 124 may be configured as an outwardly extending flange positioned circumferentially around the distal periphery of the flashback chamber 126. Further, the needle 110 may be connected within the flashback chamber 126 to enable insertion and removal of the needle 110 during assembly and use. Further, the needle grip 124 may be configured to facilitate manual handling and needle 110 control during the use of the closed IV catheter 100.
[0062] The luer lock cap 128 may be configured to detachably connect to the proximal end of the flashback chamber 126. For instance, the luer lock cap 128 may include a threaded connection surface for attachment and detachment from the flashback chamber 126. In another instance, the luer lock cap 128 may be connected to the proximal end 106 of the hollow hub 102 after removal of the needle 110 and the flashback chamber 126 connected to the needle 110.
[0063] In one embodiment, the Y-connector 120 may be connected to the bypass outlet 108. The Y-connector 120 may be connected to the bypass outlet 108 through the flexible extension tube 122. In an embodiment, the Y-connector 120 is configured to provide multiple port to the closed IV catheter 100 wherein the multiple ports may be utilized to administer multiple different medical formulations to the patient from a single assembly at a same time. In an embodiment, one arm of the Y-connector 120 may be configured with a vent plug (not shown). The vent plug may allow a fluid flashback during the insertion of the catheter tube 112 along with the needle 110. Further, the vent plug may help to prevent the blood to flow out of the Y-connector 120. This may reduce the risk of the health care provider getting infected by the blood of the patient. Further, the vent plug may remain connected to the Y-connector 120 during the insertion of the catheter 112 along with the needle 110 into the vein of the patient.
[0064] Further, upon insertion of the catheter 112 within the vascular system of the patient, the vent plug may be removed and a needle free connector (not shown) may be configured to administer IV fluids and medicines into the vascular system through the needle free connector.
[0065] Additionally, the second arm of the Y-connector 120 may be configured with an injection port configured to administer medications or fluids into the Y-connector 120. The injection port may typically be made of a self-sealing material such as silicone or a rubber compound. In an embodiment, the injection port may be utilized to administer intermittent medications to the patient.
[0066] Further, the flexible extension tube 122 is connected to the bypass outlet 108 through the first end of the extension tube 122. Further, the extension tube 122 is connected to the Y-shaped member 120 through the second end, opposite to the first end of the extension tube 122. The extension tube 122 is configured to deliver the IV fluids, medication or blood to the bypass outlet 108 of the cylindrical hollow hub 102 from the Y-shaped member 120. Further, the flexible extension tube 122 may be configured to provide an additional length and flexibility to the closed IV catheter 100. Further the extension tube 122 may be utilized when there is a longer distance between the patient and the fluids administering site. Further, the extension tube 122 may enable a patient to make a free movement without any constraints.
[0067] In an embodiment, the extension tube 122 may be made from polyvinyl chloride (PVC) material due to its flexibility, durability and biocompatibility and the resistance to different types of fluids that may pass through the extension tube 122. In another embodiment, the extension tube 122 may be made from other medical grade materials such as but not limited to Polyurethane, Polyethylene (PE), Ethylene-Vinyl Acetate (EVA) or Polypropylene.
[0068] FIG. 3 illustrates a cut sectional view of the cylindrical hollow hub 102, according to an embodiment of the present disclosure. FIG. 4 illustrates a cut-sectional view of the cylindrical hollow hub 102, according to an embodiment of the present disclosure.
[0069] Referring to FIG. 3, the cylindrical hollow hub 102 comprises the cavity 302 defined within the elongated cylindrical body 202. Further, the cylindrical hollow hub 102 comprises the backflow stopper member 304 and a needle guard clip 308 disposed within the cavity 302. Further, The cylindrical hollow hub 102 comprises an annular protrusion 306 integrally formed on an inner surface of the cylindrical hollow hub 102. The annular protrusion 306 is provided to engage with the needle guard clip 308 to prevent unintentional or accidental removal of the needle guard clip 308.
[0070] Further, the apertures 114 are formed on opposite sides of the outer circumferential surface 202 of the cylindrical hollow hub 102 such that the apertures 114 are positioned diametrically opposite to one another. It is to be well understood that the elongated cylindrical body 202 and the outer circumferential surface 202 may be referred with the same reference numeral. Further, the apertures 114 are configured to guide with the positioning of a backflow stopper member 304. For example, the apertures 114 are configured to serve as visual indicators and are strategically positioned to assist in the precise placement of the backflow stopper member 304 within the cavity 302 of the hollow hub 102 during assembly. This correct positioning of the backflow stopper member 304 is essential to ensure its alignment with respect to the opening 402 of the bypass outlet 108 formed within the hollow hub 102.
[0071] Specifically, the backflow stopper member 304 shall be disposed within the cylindrical hollow hub 102, during the assembly, such that a distal end of the backflow stopper member 304 may align with the end of the opening 402 and a body of the backflow stopper member 304 may extend towards a proximal direction. Consequently, the backflow stopper member 304 is positioned adjacent to the opening 402 without partially or fully obstructing the opening 402. For instance, if the backflow stopper member 304 is misaligned during the assembly, it may partially or fully block the opening 402, hence the bypass outlet 108. This may result in disruption of the function and cause failure of the closed IV catheter 100. Alternatively, if the backflow stopper member 304 is inadvertently positioned at a distance from the opening 402 in a proximal direction, a gap may be formed between the backflow stopper member 304 and the opening 402. This gap may act as a recess that can lead to undesired clogging of the fluid within the closed IV catheter 100.
[0072] Therefore, the apertures 114 provides a visual access for accurate positioning and orientation of the backflow stopper member 304 during assembly. This visual alignment step enhances assembly accuracy, reduces the risk of malfunction, and supports consistent device performance across manufacturing batches.
[0073] Further, the annular protrusion 306 is defined within the inner periphery of the hollow hub 102. The annular protrusion 306 is formed to prevent unintentional removal of the needle guard clip 308 from the cylindrical hollow hub 102. For example, the annular protrusion 306 is configured as a retention feature to provide passive resistance against the displacement of the needle guard clip 308. When the needle 110 is retracted or withdrawn, the needle guard clip 308 is also drawn proximally. As the clip 308 approaches the annular protrusion 306, the structure exerts an inward radial force or frictional resistance to temporarily impede the movement of the needle guard clip 308.
[0074] Further, the annular protrusion 306 is defined in a geometry of the ring-shape such that the resistance force excreted by the structure is less than the withdrawal force typically applied by the user when removing the needle 110. Thus, the annular protrusion 306 permits the needle guard clip 308 to pass through once the applied force exceeds a predefined threshold. This design ensures a secure engagement of the needle guard clip 308 during normal use while still allowing reliable release upon intentional withdrawal.
[0075] FIG. 5A illustrates a perspective view of the wing set 116, according to an embodiment of the present disclosure. FIG. 5B illustrates a top view of the wing set 116, according to an embodiment of the present disclosure. FIG. 5C illustrates a side view of the wing set 116, according to an embodiment of the present disclosure.
[0076] Referring to FIG. 5A to FIG. 5C, the flexible wing set 116 comprises a flexible body 502 having a first surface 504a and the second surface 504b. The flexible wing set 116 further comprises a plurality of grooves defined on the first surface 504a. The plurality of grooves include a longitudinal groove 506 and a lateral groove 508. Further, the flexible wing set 116 comprises a pair of opposing semi-cylindrical walls 510 that extend from around the longitudinal groove 506, and an opening 512 in the semi-cylindrical wall 510 corresponding to the lateral groove 508.
[0077] The flexible body 502 is a planar body. The planar body may be of a fan-shaped, rectangular, or triangular with the rounded edges to enhance the patient comfort. Further, the flexible body 502 may include planar surfaces including the first surface 504a and the second surface 504b. The first surface 504a may be a front surface and the second surface 504b may be a rear surface of the flexible body 502. Further, the one or more grooves may be formed to conform to an outer peripheral surface 202 of the hollow hub 102. For instance, the one or more grooves includes the longitudinal groove 506 that conforms the elongated cylindrical body. Whereas, the lateral groove 508 is configured to adapt to the outer peripheral surface of the bypass outlet 108.
[0078] Additionally, the pair of opposing semi-cylindrical walls 510 are formed extending from around the longitudinal groove 506. The pair of opposing semi-cylindrical walls 510 defines a cylindrical channel or housing to receive and retain the hollow hub 102 in aligned manner. In some embodiments, the walls 510 may be flexible to accommodate slight variations in hub 102 diameter to ensure a secure friction fit. Further, the walls 510 includes the opening 512 to conform the bypass outlet 108.
[0079] In an embodiment, the flexible wing set 116 may be made of a soft, biocompatible, and elastomeric material such as thermoplastic elastomer (TPE), silicone rubber, or similar medical-grade polymer that provides flexibility and resilience. The wings are dimensioned to allow manual gripping during catheter insertion and to permit secure fixation to the patient’s skin surface post-insertion using medical adhesive tape.
[0080] In some embodiments, the flexible wing set 116 may include surface texturing, ribs, or perforations to enhance tactile grip and tape adherence. Optionally, preformed slits or suture holes may be provided on flexible wing set 116 to facilitate anchoring of the catheter using sutures or anchoring systems, especially during extended use.
[0081] The flexible wing set 116 helps to stabilize the closed IV catheter 100 at the insertion site, reducing the risk of displacement and minimizing patient discomfort. The flexible wing set 116 also serve as a guide for proper orientation during insertion, and assist in controlling insertion angle and depth.
[0082] In an embodiment, the flexible wing set 116 may be integrally moulded with the hollow hub 102. In another embodiment, the flexible wing set 116 may be affixed to the hollow hub 102 using adhesive or thermal bonding techniques.
[0083] FIG. 6 illustrates a perspective view of a backflow stopper member 304, according to an embodiment of the present disclosure. FIG. 7A illustrates a side view of the backflow stopper member 304, according to an embodiment of the present disclosure. FIG. 7B illustrates a cut sectional view of the backflow stopper member 304, according to an embodiment of the present disclosure.
[0084] Referring to FIG. 6, the backflow stopper member 304 is a self-sealing stopper which is disposed within the cylindrical hollow hub 102 to prevent the fluid backflow upon withdrawal of the needle 110. It is to be well understood that the “backflow stopper member 304” may also be referred to as a “backflow stopper 304”, hereinafter. The backflow stopper member 304 comprises a cylindrical body 602, a longitudinal guide channel 608 formed within the cylindrical body 602, and an annular groove formed on the cylindrical body 602. The cylindrical body 602 of the backflow stopper member 304 is substantially filled cylindrical body which comprises a proximal end 604 and a distal end 606, opposite to the proximal end 604. Further, the longitudinal guide channel 608 is formed coaxially aligned to a central axis of the cylindrical body 602. Further, the longitudinal guide channel 608 have an opening 610 at the proximal end 604 of the cylindrical body 602 and extend only partially through a length of the cylindrical body 602, terminating within the proximity near the distal end 606. Accordingly, the longitudinal guide channel 608 defines an integral sealing membrane or a sealing wall 702, as shown in FIG. 7A and FIG. 7B, at the distal end 606. The defined sealing membrane 702 is continuous with the cylindrical body 602 of the backflow stopper member 304.
[0085] In an embodiment, the backflow stopper 304 is made of a flexible and elastomeric material capable of self-sealing. For instance, backflow stopper 304 may be made of one of medical-grade silicone rubber, thermoplastic elastomers (TPEs), polyisoprene, polyurethane elastomers, or other synthetic rubbers exhibiting sufficient elastic recovery and puncture resistance.
[0086] Further, the longitudinal guide channel 608 with the proximal opening 610 is configured to receive and align the needle 110 during assembly. Further, the longitudinal guide channel 608 permits the needle 110 to effortlessly traverse the channel 608 and pierce through the sealing membrane 702 during assembly. Further, the sealing membrane 702, formed of a self-sealing material, facilitates resealing upon removal of the needle 110 during use. Thereby, preventing fluid backflow through the longitudinal guide channel 608.
[0087] This configuration provides a reliable one-way valve mechanism without requiring complex moving components, and ensures safe and sterile handling by avoiding open fluid exposure during and after needle 110 withdrawal.
[0088] Additionally, the co-axial configuration of the longitudinal guide channel 608 to the central axis of the cylindrical body 602 facilitates axial alignment to the needle 110 during insertion and removal. This axial alignment results in balanced operation of the needle 110 during the use.
[0089] In an embodiment, the diameter of the longitudinal guide channel 608 ranges from 0.3 mm to 1.5 mm.
[0090] Further, the longitudinal guide channel 608 extends between 60% to 90% of an overall axial length of the cylindrical body 602. In another embodiment, the longitudinal guide channel 608 may extend between 20% to 90% of the overall axial length of the cylindrical body 602.
[0091] In an embodiment, the thickness of the integral sealing membrane 702 at the distal end 606 is 10% to 40% of an overall axial length of the cylindrical body 602. In an alternate embodiment, the thickness of the integral sealing membrane 702 at the distal end 606 is 10% to 80% of an overall axial length of the cylindrical body 602.
[0092] In an embodiment, the thickness of the integral sealing membrane 702 at the distal end 606 may be selected between 0.1 mm to 0.4 mm to promote self-sealing upon removal of the needle 110.
[0093] The backflow stopper member 304 further comprises an annular groove 612 on a peripheral surface 614 of the cylindrical body 602. The annular groove 612 is formed on axially centre position on the peripheral surface 614. Therefore, the annular groove 612 divides the cylindrical body 602 into two lobes. Accordingly, backflow stopper member 304 is formed as a bi-lobed or dumbbell like profile. This facilitates flexible compression and secure positioning within the hollow hub 102. Additionally, the annular groove 612 serves as a reference point or alignment feature for accurately positioning the stopper within the cylindrical hollow hub 102 of the hollow hub 102.
[0094] During the assembly, the annular groove 612 is configured to align with a pair of opposing apertures 114 formed on the wall of the hollow hub 102. This alignment ensures accurate positioning of the backflow stopper 304 adjacent to the opening of the bypass outlet 108.
[0095] FIG. 8 illustrates a perspective view of a needle guard clip 308 of the closed IV catheter 100, according to an embodiment of the present disclosure.
[0096] Referring to FIG. 8, the needle guard clip 308 is a guard clip for a tip of the needle 110 which is disposed within the hollow hub 102 between the position of the backflow stopper 304 and the proximal end 106, and mounted onto the needle 110, during assembly. The needle guard clip 308 is configured to protect and shield the tip of the needle 110, during and after use. The needle guard clip 308 comprises a distal end 802 and a proximal end 804, opposite to the distal end 802. The needle guard clip 308 further comprises a planar surface 806 with an aperture 808 at the proximal end 804. The planar surface 806 with the aperture 808 is configured to receive the needle 110. Further, the needle guard clip 308 comprises a first arm 810 and a second arm 812 that extends distally from opposite lateral edges of the planar surface 806. Further, the first arm 810 and the second arm 812 crosses one another between the distal end 802 and the proximal end 804, thus forming a scissoring configuration.
[0097] This cross-over structure provides spring-like biasing behaviour of the needle guard clip 308. This enhances the ability of the needle guard clip 308 to clamp or secure onto a body of the needle 110 during assembly. Further, this structure enables the needle guard clip 308 to return to a default position after removal of the needle 110. This geometry assists in the mechanical engagement and capture of the needle tip once retracted.
[0098] Further, the needle guard clip 308 comprises a distal hook portion 814 integrally formed on the first arm 810, at distal end 802. Further, the needle guard clip 308 comprises a distal hook portion 816 integrally formed on the second arm 812, at distal end 802. The distal hook portions (814, 816) are oriented inwardly toward each other. For example, the distal hook portions (814, 816) are oriented facing a direction of a centre axis of the needle 110. The distal hook portions (814 & 816) are configured to engage and retain the needle tip upon full retraction, thereby preventing re-exposure of the needle tip and minimizing risk of needle stick injuries.
[0099] For instance, during the assembly, distal edges of the arms (810, 812) are displaced outwardly creating space at a crossing location of the arms (810, 812) to receive the needle 110 received through the aperture 808, to configure the needle guard clip 308 onto the body of the needle 110. Further, during the use, once the needle 110 is fully withdrawn into the hollow hub 102, the needle guard clip 308 moves into a locking position, effectively shielding the needle tip to prevent reuse or contact.
[0100] In some embodiments, the needle guard clip 308 may be monolithically formed from a resilient material, such as spring steel, stainless steel, or a biocompatible shape-memory polymer, allowing it to undergo repeated elastic deformation. The overall design of the needle guard clip 308 provides mechanical protection, controlled needle movement, and passive safety locking without requiring additional moving parts.
[0101] Various modifications to the embodiment will be readily apparent to those skilled in the art and the generic principles herein may be applied to other embodiments. However, one of ordinary skill in the art will readily recognize that the present disclosure is not intended to be limited to the embodiments illustrated but is to be accorded the widest scope consistent with the principles and features described herein.
[0102] The foregoing description shall be interpreted as illustrative and not in any limiting sense. A person of ordinary skill in the art would understand that certain modifications could come within the scope of this disclosure.
[0103] The embodiments, examples, and alternatives of the preceding paragraphs or the description and drawings, including any of their various aspects or respective individual features, may be taken independently or in any combination. Features described in connection with one embodiment are applicable to all embodiments unless such features are incompatible.
, Claims:I/We Claim,
1. A closed IV catheter (100) for insertion into a patient's vascular system, comprising:
a cylindrical hollow hub (102) comprising:
a distal end (104), a proximal end (106) opposite to the distal end (104), and a cavity (302) defined between the distal end (104) and the proximal end (106);
a bypass outlet (108) formed on a side of the cylindrical hollow hub (102), between the distal end (104) and the proximal end (106); and
at least one aperture (114) formed on an outer circumferential surface (202) of the cylindrical hollow hub (102);
a catheter (112) connected in a fluid communication to the distal end (104) of the cylindrical hollow hub (102);
a needle (110) configured within the cylindrical hollow hub (102), wherein the needle (110) passes across the catheter (112) and extends out of a distal end of the catheter (112);
a backflow stopper member (304) configured within the cylindrical hollow hub (102), wherein
the backflow stopper member (304) is configured adjacent to an opening (402) of the bypass outlet (108) within the cylindrical hollow hub (102) to direct the fluid to the bypass outlet (108) and prevent fluid flowing towards the proximal end (106) of the cylindrical hollow hub (102);
a flexible wing set (116) connected to an outer surface (202) of the cylindrical hollow hub (102), wherein the wing set (116) comprises:
a flexible body (502) having a first surface (504a) and a second surface (504b), opposite to the first surface (504a);
a plurality of grooves defined on the first surface (504a) including a longitudinal groove (506) and a lateral groove (508);
a pair of opposing semi-cylindrical walls (510) extending from around the longitudinal groove (506) to conform to an outer surface (202) of the cylindrical hollow hub (102); and
an opening (512) in the semi-cylindrical wall (510) corresponding to the lateral groove (508) to conform the bypass outlet (108) of the cylindrical hollow hub (102).

2. The closed IV catheter (100) as claimed in claim 1, wherein the cylindrical hollow hub (102) is a tapered with a diameter decreasing from the proximal end (106) to the distal end (104).

3. The closed IV catheter (100) as claimed in claim 1, wherein the bypass outlet (108) is in fluid communication with the cylindrical hollow hub (102) and extends from within a proximity of the distal end (104).

4. The closed IV catheter (100) as claimed in claim 1, wherein the apertures (114) are formed symmetrically positioning on opposing sides of the outer circumferential surface (202) of the cylindrical hollow hub (102).

5. The closed IV catheter (100) as claimed in claim 1, wherein the apertures (114) are formed to position of the backflow stopper member (304), adjacent to the opening (402) of the bypass outlet (108) during assembly.

6. The closed IV catheter (100) as claimed in claim 1, comprises a guiding member (118) configured within the cylindrical hollow hub (102), adjacent to the distal end (104).

7. The closed IV catheter (100) as claimed in claim 6, wherein the guiding member (118) is configured to guide during configuration of the needle (110) in a manufacturing state or assembling state and removal in a use state.

8. The closed IV catheter (100) as claimed in claim 1, wherein the needle (110) is configured to pass through the backflow stopper member (304) during assembling or a pre-use state.

9. The closed IV catheter (100) as claimed in claim 1, comprises a Y-connector (120) connected to the bypass outlet (108) through an extension tube (122).

10. The closed IV catheter (100) as claimed in claim 1, further comprises an integrated needle grip (124) with a flashback chamber (126) and a luer lock cap (128) connected in a same sequence at the proximal end (106) of the cylindrical hollow hub (102).

11. The closed IV catheter (100) as claimed in claim 10, wherein the integrated needle grip (124) with the flashback chamber (126) are connected with the needle (110) and detachably coupled to the flashback chamber (126) for removal of the needle (110) in a use state.

12. A flexible wing set (116) for a closed IV catheter (100), comprising:
a flexible body (502) having a first surface (504a) and a second surface (504b), opposite to the first surface (504a);
a plurality of grooves defined on the first surface (504a) including a longitudinal groove (506) and a lateral groove (508);
a pair of opposing semi-cylindrical walls (510) extending from around the longitudinal groove (506) to conform to an outer surface (202) of the cylindrical hollow hub (102); and
an opening (512) in the semi-cylindrical wall (510) corresponding to the lateral groove (508) to conform the bypass outlet (108) of the cylindrical hollow hub (102).

13. The wing set (116) as claimed in claim 11, wherein the wing set (116) is configured to attach the close IV catheter (100) to a user body.

14. The wing set (116) as claimed in claim 11, wherein the wing set (116) is made from a flexible material including one of a silicone material, an elastomer material, or a rubber material.