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Leakage Resistant Catheter Assembly

Abstract: An embodiment herein provides a catheter assembly (100) for controlling fluid leakage. The catheter assembly (100) includes a catheter adapter (102) with a lumen (110) defined within the catheter adapter (102). The catheter assembly (100) includes a catheter extending distally from a distal end (104) of the catheter adapter. The catheter assembly (100) includes a fluid control valve (120) positioned within the lumen (110) of the catheter adapter (102). The fluid control valve (120) includes a plus-shaped slit (702) adapted to selectively allow passage of a needle (122) therethrough. The catheter assembly (100) includes an actuator (124) deployed within the catheter adapter (102) and having a generally circular cross-sectional profile. The actuator (124) is sized to engage with the plus-shaped slit (702) of the fluid control valve (120).

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Patent Information

Application #
Filing Date
22 April 2025
Publication Number
20/2025
Publication Type
INA
Invention Field
BIO-MEDICAL ENGINEERING
Status
Email
Parent Application

Applicants

Lars Medicare Private Limited
Killa 16 &17, Sultanpur, Near Bahalgarh Chowk, Sector 29, Sonipat, Haryana, India – 131021

Inventors

1. Surmya Goel
H. No. 3, Steet 4, East Punjabi Bagh, New Delhi, India - 110026

Specification

Description:FORM 2

The Patent Act 1970
(39 of 1970)
&
The Patent Rules, 2003

COMPLETE SPECIFICATION
(SEE SECTION 10 AND RULE 13)

TITLE OF THE INVENTION

“LEAKAGE-RESISTANT CATHETER ASSEMBLY”

APPLICANT:

Name: Lars Medicare Private Limited

Nationality: Indian

Address: Killa 16 &17, Sultanpur, Near Bahalgarh Chowk, Sector 29, Sonipat, Haryana, India – 131021.

The following specification particularly describes the invention and the manner in which it is to be performed: -
FIELD OF INVENTION
[0001] The embodiments herein generally relate to intravenous (IV) catheter assemblies, and in particular, to catheter assemblies with integrated fluid control mechanisms for preventing fluid leakage.
BACKGROUND
[0002] Intravenous (IV) catheter assemblies are widely used in clinical and emergency settings to provide vascular access for administration of fluids, medications, or for blood sampling. These devices typically include a catheter connected to a hub or adapter through which a needle is inserted to gain venous access. Once access is achieved, the needle is withdrawn, leaving the catheter in place for continued fluid delivery or sampling.
[0003] A major challenge associated with conventional catheter assemblies is the risk of fluid leakage such as blood after needle removal. To mitigate this, fluid control valves have been introduced, which close automatically upon needle withdrawal to seal the fluid path. However, many existing valve designs either compromise flow characteristics, are prone to wear and tear, or require complex actuation mechanisms.
[0004] There is therefore a need for an improved catheter assembly that provides reliable fluid sealing, is simple in construction, and maintains optimal performance over repeated use.
OBJECT OF INVENTION
[0005] The principal object of the invention herein is to provide leakage-resistant catheter assembly.
[0006] Another object of the invention is to provide catheter assemblies with integrated fluid control mechanisms for preventing fluid leakage.
SUMMARY
[0007] An embodiment herein provides a catheter assembly for controlling fluid leakage. The catheter assembly includes a catheter adapter having a distal end, a proximal end, a body portion extending between the distal end and the proximal end, and a lumen defined within the catheter adapter. The lumen extends through the body portion between the distal end and the proximal end. The catheter assembly includes a catheter extending distally from the distal end of the catheter adapter. The catheter is in fluid communication with the lumen. The catheter assembly includes a fluid control valve positioned within the lumen of the catheter adapter. The fluid control valve includes a plus-shaped slit adapted to selectively allow passage of a needle therethrough. The catheter assembly includes an actuator deployed within the catheter adapter and having a generally circular cross-sectional profile. The actuator includes a proximal end and a distal end, wherein the distal end is sized to engage with the plus-shaped slit of the fluid control valve and the proximal end has a larger diameter than the distal end. The actuator tapers from the distal end to the proximal end at a predefined angle.
BRIEF DESCRIPTION OF FIGURES
[0008] The features of the disclosed embodiments may become apparent from the following detailed description taken in conjunction with the accompanying drawings showing illustrative embodiments herein, in which:
[0009] FIG. 1 is a cross-sectional view of a catheter assembly for controlling fluid leakage, illustrating an internal structure and spatial relationship of various components of the catheter assembly, in accordance with an embodiment of the present disclosure.
[0010] FIG. 2 is a top view of the catheter assembly of FIG. 1, in accordance with some embodiments of the present disclosure.
[0011] FIG. 3 is a front view of the catheter assembly of FIG. 1, in accordance with some embodiments of the present disclosure.
[0012] FIG. 4 is a side left view of the catheter assembly of FIG. 1, in accordance with some embodiments of the present disclosure.
[0013] FIG. 5 is a side right view of the catheter assembly of FIG. 1, in accordance with some embodiments of the present disclosure.
[0014] FIG. 6 is a perspective view of the catheter assembly of FIG. 1, in accordance with some embodiments of the present disclosure.
[0015] FIG. 7 illustrates a top view of a fluid control valve of the catheter assembly, in accordance with some embodiments of the present disclosure.
[0016] FIG. 8 illustrates a perspective view of the catheter assembly with a luer connector, in accordance with some embodiments of the present disclosure.
DETAILED DESCRIPTION OF INVENTION
[0017] FIG. 1 is a cross-sectional view of a catheter assembly (100) for controlling fluid leakage, illustrating an internal structure and spatial relationship of various components of the catheter assembly (100), in accordance with an embodiment of the present disclosure.
[0018] The catheter assembly (100) includes a catheter adapter (102) having a proximal end (104), a distal end (106), and a body portion (108) extending there between. The catheter adapter (102) includes a lumen (110) that is defined within the catheter adapter (102) and extends longitudinally from the proximal end (104) to the distal end (106). The catheter assembly (100) further includes a catheter (112) with a proximal end (114) and a distal end (116). The catheter (112) may be fixedly secured to and extends distally from the distal end (106) of the catheter adapter (102). The catheter (112) is in fluid communication with the lumen (110) of the catheter adapter (102). The catheter (112) may be supported by a Teflon holder (118) that may be disposed around the catheter (112) at its proximal end or region (114). The Teflon holder (118) acts as a hinge and is configured to provide a supporting structure between the catheter (112) and the catheter adapter (102) that holds the catheter (112) in place relative to the catheter adapter (102).
[0019] The catheter assembly includes a fluid control valve (120) that is positioned coaxially within the lumen (110) of the catheter adapter (102). The fluid control valve (120) comprises a plus-shaped slit (702) (shown in FIG. 7) adapted to permit selective passage of a needle (122) through the fluid control valve (120) while restricting fluid flow when the needle (122) is removed. The fluid control valve (120) may be secured within an annular groove inside the catheter adapter (102) such that axial movement in either a proximal or distal direction is restricted.
[0020] The catheter assembly (100) includes an actuator (124) that may be positioned proximally relative to the fluid control valve (120). The actuator (124) may have a generally circular cross-sectional profile and comprises a distal end (126) sized to engage with the plus-shaped slit (702) of the fluid control valve (120), and a proximal end (128) having a larger diameter. The actuator (124) tapers from the distal end (126) to the proximal end (128) at a predefined angle, which facilitates forward movement and interaction with a luer lock connector to open the fluid control valve during insertion, and to re-seal upon withdrawal of the needle (122). The actuator (124) may be provided with external features to interact with corresponding stop structures within the catheter adapter (102), preventing over-advancement.
[0021] In some embodiments, proximally adjacent to the actuator (124) is a tube (130) which is configured to allow fluid to pass easily toward the catheter smoothly without causing back pressure. The tube (130) is positioned proximally relative to the catheter adapter (102) and is operably connected to a needle hub (132). The needle hub (132) is provided to be configured to receive the proximal portion of the needle (122) and connects to an upstream infusion or injection device. In an embodiment, a port cap (134) may be disposed atop the catheter adapter (102), providing access to internal components for assembly or sterilization purposes. In some other embodiments, the catheter adapter (102) may not have the port cap (134). In some embodiments, the catheter assembly (100) may have the tube (130). In some embodiments, the catheter assembly (100) may not have the tube (130).
[0022] A hub cover (136) may be provided to surround the proximal end or region (104) of the catheter adapter (102) and encases fluid pathway. A thread stopper (138) may be disposed at a proximal-most end of the catheter assembly (100) and is configured to engage with one or more external luer lock connectors to provide a secure threaded coupling. The hub cover (136) and the thread stopper (138) may collectively form a luer-compatible interface. The hub cover (136) is the area where a user can see flashback of blood during needle (122) insertion and ensure proper deployment of the catheter (112) to a patient.
[0023] The needle (122) extends through a needle cover (140) positioned concentrically within the catheter (112) and terminates at a beveled distal tip (142) adapted for vascular penetration. The needle cover (140) may provide a protective guide to minimize damage to internal components during insertion and withdrawal of the needle (122).
[0024] The cross-sectional view of the catheter assembly (100) shown in FIG. 1 illustrates the internal structure and interconnection of each component within the catheter assembly (100), all configured to operate together to allow needle-based access while minimizing fluid leakage through action of the fluid control valve (120) and the actuator (124).
[0025] FIG. 2 is a top view of the catheter assembly of FIG. 1, illustrating the relative placement and alignment of the various components of the catheter assembly (100) in a different view. The catheter (102) is shown extending distally from the catheter adapter (102). The port cap (134) is disposed atop the catheter adapter (102). The actuator (124) and the fluid control valve (120) are disposed within the catheter adapter (102). In embodiments, a plurality of wings (202) are designed and provided on the catheter assembly (100) to facilitate secure grip and stabilization during insertion and maintenance. The wings (202) offer multiple gripping alternatives, allowing for easier manipulation and secure fixation to the skin, minimizing movement and preventing accidental dislodgement.
[0026] FIG. 3 is a front view of the catheter assembly of FIG. 1. The FIG. 3 depicts the various components of the catheter assembly (100) in a different view. Internal components such as the fluid control valve (120) and the actuator (124) are not visible in the front view.
[0027] FIG. 4 is a side view (left) of the catheter assembly (100) of FIG. 1. The figure provides a side elevation profile of the catheter assembly (100). FIG. 5 is a side view (right) of the catheter assembly (100) of FIG. 1, further showing an opposite lateral projection of the catheter assembly (100).
[0028] FIG. 6 is a perspective view of the catheter assembly of FIG. 1, illustrating three-dimensional relationship among the various structural components of the catheter assembly (100). The perspective view highlights geometry and external features of each component and their cooperative interface within the catheter assembly (100).
[0029] FIG. 6 illustrates a top view of the valve (120) showing the slit (702).
[0030] Referring to the FIGS. 1 through 7, the catheter assembly (100) is further described herein in some embodiments.
[0031] In various embodiments, the catheter assembly (100) as disclosed herein incorporates the fluid control valve (120) and the actuator (124) that function in tandem to substantially prevent fluid leakage when the needle (122) is withdrawn, while also ensuring ease of access during the needle (122) insertion. This design achieves this with minimal disruption to flow characteristics and provides structural adaptability for various clinical requirements.
[0032] The fluid control valve (120), positioned coaxially within the lumen (110) of the catheter adapter (102), may comprise a resilient membrane with the plus-shaped slit (702) (also referred to as slit (702) interchangeably without limitations throughout this document) formed therein. This slit (702) is centrally located and intersects in at least four directions, forming a symmetric or asymmetric cross pattern in various embodiments.
[0033] In various embodiments, the slit (702) may include a plurality of slit segments. In an embodiment, the slit segments may intersect orthogonally, creating a symmetrical, perpendicular cross. This configuration may allow for elastic deformation during the insertion of the needle (122) or the actuator (124) and self-retraction to a sealed state upon removal of the needle (122). The elasticity of the material, preferably a biocompatible elastomer such as silicone or thermoplastic elastomer (TPE), may provide dynamic sealing properties.
[0034] In an embodiment, the slit segments may diverge from its center at oblique angles (for example 45°, 60°, or 30° and the like relative to a central axis of the valve (120)), forming an asymmetric or angled plus-shape or cross referred interchangeably without limitations. This angular arrangement may increase sealing pressure in certain orientations, particularly under pulsatile or pressurized flow, thereby enhancing leakage prevention of the fluid such as the blood.
[0035] In embodiments, the slit segments may be formed with variable widths. For example, a central crossing zone may have a narrower width, increasing elasticity at the center, while terminal ends of each slit segment may widen to better accommodate deformation during passage of the needle. This variation may help in controlled expansion and retraction behavior of the valve, particularly for needles with varying gauges.
[0036] In some embodiments, the valve (120) may include multiple layers, where an inner layer is composed of an elastic sealing material and an outer layer provides mechanical reinforcement. The outer layer may be a more rigid polymer or a mesh insert, reducing fatigue during repeated use. This dual-layered construction may improve wear resistance, dimensional stability, and valve lifespan.
[0037] An annular groove may be provided to anchor the valve within the catheter adapter (102), that may be configured to receive a peripheral flange or ridge on a body of the valve (120). This may restrict axial movement during connection or needle manipulation and provide a stable seal interface.
[0038] In some embodiments, the plus-shaped slit (702) may include micro-textures or surface ridges at its contact faces. These features may be designed to interface with corresponding features on the actuator (124), creating interlocking friction or pressure zones that inhibit unintentional valve (120) opening or fluid escape.
[0039] The actuator (124) is positioned proximally to the fluid control valve (120) and is designed to selectively engage with the slit (702) to momentarily open the valve during device connection or fluid administration. The actuator (124) has a generally circular cross-section and a body that tapers distally, reducing in diameter toward a region interfacing with the valve (120). This tapered profile of the adapter (124) is not merely aesthetic or space-saving; instead it is functionally significant. A predefined angle of tapering, typically in the range of 2% to 10% in various embodiments, facilitates gradual interaction with the slit (702), reducing mechanical stress and allowing a progressive seal disruption rather than abrupt rupture. This may minimize damage to edges of the slit (702) and ensure longevity of the structure or body of the valve (120). In accordance with the illustrated embodiments, the predefined angle is 6 degree.
[0040] In embodiments, the actuator (124) may include a stepped diameter design, where a distal region of the actuator (124) is narrow enough to just engage the slit (702) without forcing it open completely, while a proximal region of the adapter (124) is larger to ensure full opening when necessary (e.g., during luer lock connection). This differential geometry may allow for precision control over valve opening depending on insertion depth.
[0041] In some embodiments, the actuator (124) may include external micro-ridges or helical threads along its length. These features may interface with internal wings or stops within the catheter adapter (102), which act as mechanical brakes to restrict over-insertion of the actuator. Such control is necessary to avoid damaging the valve (120) or applying excessive pressure that could distort the fluid path.
[0042] In some other embodiments, engagement features such as key-and-slot structures or radial tabs may be incorporated to align the actuator (124) with the plus-shaped slit (702). This may help the actuator (124) engage symmetrically, providing even force distribution across all four slit segments.
[0043] In embodiments, the actuator (124) may include locking grooves or click-stop features that may align with complementary parts of the catheter adapter (102). These enable snap-fit retention, maintaining the actuator (124) in a stable state when the needle (122) is removed but before the luer connector is attached.
[0044] Similarly, in various embodiments, other mechanisms may be deployed without limiting the scope and spirit of the present invention.
[0045] An interplay between the fluid control valve (120) and the actuator (124) is central to the performance of the catheter assembly (100). When the needle (122) or the luer connector (802) (shown in FIG. 8) is inserted, the actuator (124) advances forward, its tapered distal tip gently pressing against the plus-shaped slit (702) and spreading it open. This allows fluid communication for infusion or sampling. When the needle (122) or the luer connector is removed, the actuator (124) retracts passively or remains in place, allowing the slit (702) to elastically return to its closed state. In an embodiments, the plus-shaped slit (702) has a preloaded configuration which ensures hydrostatic sealing even in the presence of back pressure from a patient’s vasculature.
[0046] In an embodiment, a spring-biased actuator (124) may be employed, where removal of the luer connector or the needle (122) causes the actuator (124) to recoil slightly, reducing prolonged pressure on the slit (702) and improving recovery of the elastic seal.
[0047] To further improve this interaction, in some embodiments, the catheter adapter (102) may include internal wings or protrusions (not shown) that define a maximum travel limit for the actuator (124). These act as physical stops, preventing the actuator (124) from damaging the valve (120) by excessive forward movement. This is particularly useful in cases where users apply additional torque or force during connector engagement.
[0048] In some embodiments, the actuator (124) may include a locking flange that nests within a groove formed at the periphery of the valve (120). This interlocking interface prevents unintentional actuator migration, especially when the catheter assembly (100) is exposed to vibration or movement during transportation or use.
[0049] A few embodiments of the catheter assembly (100) are further presented below without limitations.
[0050] In an embodiment, the catheter assembly (100) may be provided such that the predefined angle may range from 2% to 10% such that it facilitates engagement with the luer lock connector and enables forward movement of the actuator (124) to open the fluid control valve (120) and substantially prevent fluid leakage when the needle (122) is removed.
[0051] In an embodiment, the catheter assembly (100) may further include the luer lock connector at the proximal end (104) of the catheter adapter (102). The luer lock connector may be adapted to engage with a corresponding luer device through a threaded coupling for providing a secure, leak-resistant connection during fluid administration.
[0052] In an embodiment, the plus-shaped slit (702) may include the four intersecting slit segments that may be arranged orthogonally in a perpendicular configuration to form a symmetric cross shape. The four intersecting slit segments may be dimensioned to expand elastically upon insertion of the needle (122) and return to the sealed state upon the removal of the needle (122).
[0053] In an embodiment, the plus-shaped slit (702) may include four angled slit segments arranged in a non-perpendicular configuration, such that the slit segments may diverge radially from a central point in a symmetric or asymmetric pattern, wherein the geometry is configured to enhance sealing performance during needle insertion and withdrawal.
[0054] In an embodiment, each of the four intersecting slit segments of the plus-shaped slit has similar width.
[0055] In an embodiment, each of the four intersecting slit segments of the plus-shaped slit (702) has a variable width such that a central region of the plus-shaped slit (702) may be narrower compared to outer regions of the slit (702), for improving fluid sealing and controlled expansion when the needle is inserted or removed.
[0056] In an embodiment, the four intersecting slit segments of the plus-shaped slit (702) may be oriented at an oblique angle relative to a central axis of the fluid control valve (120), to increase sealing pressure when the needle (122) is removed and reduce leakage under varying fluid pressures.
[0057] In an embodiment, the catheter adapter (102) may be provided with one or more internal wings configured to restrict forward movement of the actuator (102) beyond a predefined limit. The one or more internal wings may be positioned such that when the luer connector is connected with the actuator (102) and an excessive force is applied, the one or more internal wings may prevent the actuator (124) from excessively advancing into the fluid control valve (120).
[0058] In an embodiment, the plus-shaped slit (702) may be configured to vary in width along its length, such that a central portion of the slit (702) may be wider than terminal ends of the slit (702) to facilitate controlled expansion and retraction.
[0059] In an embodiment, the plus-shaped slit (702) may be configured to assume similar width along its length.
[0060] In an embodiment, the actuator may include a tapered profile, wherein tapering may be adapted to provide a gradual sealing effect as it engages with the plus-shaped slit (702).
[0061] In an embodiment, the fluid control valve may include a multi-layered valve structure, with at least one inner elastic sealing layer and an outer reinforcement layer, such that the inner layer may be configured to deform to accommodate needle passage while the outer layer maintains structural integrity to minimize leakage and wear over repeated use. The inner layer and the outer layer may be made of similar or different materials.
[0062] In an embodiment, the fluid control valve (120) may include a peripheral groove. The actuator (124) may be configured to interlock with the groove to restrict unintended movement of the actuator (124) with respect to the fluid control valve (120) and thereby control fluid leakage.
[0063] In an embodiment, the actuator may include a plurality of micro-ridges along its contact surface. The micro-ridges may be configured to interlock with corresponding micro-textures provided within the plus-shaped slit (702) of the fluid control valve (120), to restrict unintended movement of the actuator (124) with respect to the fluid control valve (120) and thereby control fluid leakage.
[0064] In an embodiment, the length of each of the four intersecting slit segments may be same. In another embodiment, the length of one or more of the four intersecting slit segments may be different.
[0065] In an embodiment, the catheter assembly (100) described herein may be adapted for use across a range of clinical scenarios. In neonatal or pediatric settings, where fluid volumes are small and pressure sensitivity is high, the valve (120) may be tuned with softer elastomers and narrower slits to reduce required insertion force. For high-flow infusion applications, the valve (120) and the actuator (124) dimensions may be scaled accordingly, ensuring the slit (702) can expand to accommodate larger bore connectors while maintaining sealing performance.
[0066] In embodiments, the catheter assembly (100) may be adapted to closed IV catheters, safety IV systems, or integrated pressure monitoring lines, where passive sealing mechanisms may be critical. The plus-shaped valve (120) and the actuator (124) mechanism form a platform technology capable of incorporation across diverse fluid delivery systems.
[0067] The catheter assembly (100) may be utilized in clinical settings and constitute a critical component of modern infusion therapy. The catheter assembly (100) may be used in routine IV catheterization and avoid complications, including inadvertent blood spillage. In particular, the catheter assembly (100) may prevent or minimize blood exposure during catheter withdrawal, or upon connection and disconnection with Luer-compatible medical devices.
[0068] The causes of such blood exposure have been identified to include, without limitation, backflow of blood from the catheter hub, inadvertent blood splashes, and inadequate compression of the vein during handling of Luer connectors. Consequently, healthcare professionals are routinely exposed to blood and bodily fluids, which may increase the risk of transmission of bloodborne pathogens such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV). The catheter assembly (100) discussed herein facilitates in avoiding or minimizing such issues.
[0069] In this context, the present catheter assembly (100) provides a mechanism to limit or eliminate blood leakage.
[0070] The valve (120) discussed herein may be operable multiple times, thereby ensuring protection against blood exposure throughout various stages of catheter use.
[0071] The catheter assembly (100) discussed herein helps in reduction or elimination of the need for manual vein compression during catheter placement, thereby minimizing patient discomfort and associated pain.
[0072] Substantial reduction in blood exposure after needle removal improves clinician safety.
[0073] Decrease in the time required for intravenous catheter insertion due to simplified handling and reduced clean-up helps in medical use.
[0074] The catheter assembly (100) helps in minimization of environmental contamination, including contamination of skin, gloves, dressings, clothing, and surrounding surfaces.
[0075] The catheter assembly (100) helps in improvement in the psychological experience of patients, particularly those who may become anxious upon viewing blood.
[0076] The catheter assembly (100) helps in reusability of the valve (120) function across multiple connections and disconnections during the IV therapy process.
[0077] The present catheter assembly (100) with integrated blood control features such as the valve (120) and the actuator (124) is intended for use wherever venous access is required. It may be substituted for conventional IV cannulae in substantially all clinical scenarios involving peripheral IV catheterization. Applications include, but are not limited to, hospitals, emergency care settings, outpatient infusion centers, home care environments, and mobile medical units.
[0078] The disclosed catheter assembly (100) may thus provide a safer, more efficient alternative to conventional IV catheters, with added advantages for both healthcare providers and patients.
, Claims:I claim:
1. A catheter assembly (100) for controlling fluid leakage, the catheter assembly (100) comprising:
a catheter adapter (102) having a distal end (106), a proximal end (104), a body portion (108) extending between the distal end (106) and the proximal end (104), and a lumen (110) defined within the catheter adapter (102), the lumen (110) extending through the body portion (108) between the distal end (106) and the proximal end (104);
a catheter (112) extending distally from the distal end (104) of the catheter adapter (102), the catheter (112) being in fluid communication with the lumen (110);
a fluid control valve (120) positioned within the lumen (110) of the catheter adapter (102), the fluid control valve (120) comprising a plus-shaped slit (702) adapted to selectively allow passage of a needle (122) therethrough; and
an actuator (124) deployed within the catheter hub and having a generally circular cross-sectional profile, the actuator (124) comprising a proximal end (128) and a distal end (126), wherein the distal end (126) is sized to engage with the plus-shaped slit (702) of the fluid control valve (120) and the proximal end (128) has a larger diameter than the distal end (126), the actuator (124) tapering from the distal end (128) to the proximal end (126) at a predefined angle.
2. The catheter assembly (100) as claimed in claim 1, wherein the predefined angle ranges from 2% to 10% such that it facilitates engagement with a luer lock connector and enables forward movement of the actuator (124) to open the fluid control valve (120) and substantially prevent fluid leakage when the needle (122) is removed.
3. The catheter assembly (100) as claimed in claim 1, wherein the catheter assembly (100) further comprising a luer lock connector at the proximal end (104) of the catheter adapter (102), the luer lock connector being adapted to engage with a corresponding luer device through a threaded coupling for providing a secure, leak-resistant connection during fluid administration.
4. The catheter assembly (100) as claimed in claim 1, wherein the fluid control valve (120) is secured within an annular groove in the catheter adapter (102) to restrict movement in a proximal or distal direction.
5. The catheter assembly (100) as claimed in claim 1, wherein the plus-shaped slit (702) and the actuator (124) are adapted to provide a dynamic seal, that is configured to minimize fluid exposure after withdrawal of the needle (122).
6. The catheter assembly (100) as claimed in claim 1, wherein the needle (122) comprises a beveled distal tip (142), the beveled distal tip (142) being adapted to facilitate smooth penetration through the plus-shaped slit (702) of the fluid control valve (120), minimizing deformation of the slit upon removal of the needle (122).
7. The catheter assembly (100) as claimed in claim 1, wherein the plus-shaped slit (702) comprises four intersecting slit segments arranged in a predefined configuration.
8. The catheter assembly (100) as claimed in claim 7, wherein the plus-shaped slit (702) comprises the four intersecting slit segments arranged orthogonally in a perpendicular configuration to form a symmetric cross shape, the four intersecting slit segments being dimensioned to expand elastically upon insertion of the needle (122) and return to a sealed state upon the removal of the needle (122).
9. The catheter assembly (100) as claimed in claim 7, wherein the plus-shaped slit (702) comprises the four angled slit segments arranged in a non-perpendicular configuration, such that the slit segments diverge radially from a central point in a symmetric or asymmetric pattern, the geometry being configured to enhance sealing performance during needle insertion and withdrawal.
10. The catheter assembly (100) as claimed in claim 1, wherein the catheter adapter (102) is provided with one or more internal wings (202) configured to restrict forward movement of the actuator beyond a predefined limit, such that when a luer connector is connected with the actuator (124) and an excessive force is applied, the one or more internal wings (202) prevent the actuator (124) from excessively advancing into the fluid control valve (120).
11. The catheter assembly (100) as claimed in claim 1, wherein the actuator (124) includes a tapered profile.
12. The catheter assembly (100) as claimed in claim 1, wherein the fluid control valve (120) comprises a peripheral groove, the actuator (124) being configured to interlock with the groove to restrict unintended movement of the actuator (124) with respect to the fluid control valve (120) and thereby control fluid leakage.

Documents

Application Documents

# Name Date
1 202511038760-STATEMENT OF UNDERTAKING (FORM 3) [22-04-2025(online)].pdf 2025-04-22
2 202511038760-POWER OF AUTHORITY [22-04-2025(online)].pdf 2025-04-22
3 202511038760-FORM-9 [22-04-2025(online)].pdf 2025-04-22
4 202511038760-FORM-5 [22-04-2025(online)].pdf 2025-04-22
5 202511038760-FORM FOR SMALL ENTITY(FORM-28) [22-04-2025(online)].pdf 2025-04-22
6 202511038760-FORM FOR SMALL ENTITY [22-04-2025(online)].pdf 2025-04-22
7 202511038760-FORM 1 [22-04-2025(online)].pdf 2025-04-22
8 202511038760-FIGURE OF ABSTRACT [22-04-2025(online)].pdf 2025-04-22
9 202511038760-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [22-04-2025(online)].pdf 2025-04-22
10 202511038760-EVIDENCE FOR REGISTRATION UNDER SSI [22-04-2025(online)].pdf 2025-04-22
11 202511038760-ENDORSEMENT BY INVENTORS [22-04-2025(online)].pdf 2025-04-22
12 202511038760-DRAWINGS [22-04-2025(online)].pdf 2025-04-22
13 202511038760-DECLARATION OF INVENTORSHIP (FORM 5) [22-04-2025(online)].pdf 2025-04-22
14 202511038760-COMPLETE SPECIFICATION [22-04-2025(online)].pdf 2025-04-22
15 202511038760-MSME CERTIFICATE [23-04-2025(online)].pdf 2025-04-23
16 202511038760-FORM28 [23-04-2025(online)].pdf 2025-04-23
17 202511038760-FORM 18A [23-04-2025(online)].pdf 2025-04-23
18 202511038760-Proof of Right [05-05-2025(online)].pdf 2025-05-05
19 202511038760-Request Letter-Correspondence [08-09-2025(online)].pdf 2025-09-08
20 202511038760-Power of Attorney [08-09-2025(online)].pdf 2025-09-08
21 202511038760-FORM28 [08-09-2025(online)].pdf 2025-09-08
22 202511038760-Form 1 (Submitted on date of filing) [08-09-2025(online)].pdf 2025-09-08
23 202511038760-Covering Letter [08-09-2025(online)].pdf 2025-09-08