DESC:FIELD OF THE INVENTION
The present invention relates to intravenous (IV) catheter assemblies, specifically focusing on a two-way catheter assembly equipped with a novel blood control mechanism. This invention overcomes the limitations of traditional IV catheter assemblies, which typically offer only single-directional flow and limited blood control. It provides a multi-infusion capability and a robust, repetitive blood control feature, addressing the specific needs in healthcare environments where multi-infusion is common and blood spillage needs to be prevented, particularly during Luer disconnections or replacements.

PRIOR ART
Most conventional IV catheter assemblies feature a single-use blood control system designed to restrict blood flow immediately after the catheter is inserted into a patient's vein. However, this system is only temporarily effective, typically for around 10 seconds, and is limited in its ability to prevent blood spillage during subsequent procedures, such as Luer replacements or accidental disconnections.

Existing solutions have tried to address this limitation by incorporating elastic membranes to block blood flow, but these designs often suffer from high failure rates due to the lack of a robust re-closing mechanism. In addition, traditional designs provide only one-way flow, which limits their usability in scenarios where multiple medications need to be administered through the same catheter.

This invention builds on previous designs by introducing a spring-based mechanism that reliably controls blood flow during disconnections and replacements, and by enabling two-way infusion capabilities. These innovations significantly reduce the risk of blood spillage and improve the catheter’s utility in modern medical settings.

In the prior art, an US patent specification US4753640A discloses catheter tubes of elastomeric material having novel lumen shapes which prevent occlusion and accommodate continued liquid flow even when kinked. Also, catheter tube slit valves are disclosed, the walls of which are not chemically weakened. Symmetrical and asymmetrical versions of said slit valves are disclosed. Combinations of highly reliable slip valves and catheter tubes are disclosed. Independently operable multi-lumen catheter assemblies of synthetic material, such as silicone rubber are disclosed, wherein the distal end of each lumen is normally closed by a three-position slit valve formed in a catheter tube covering. Multi-lumen catheters, and related methods, are also disclosed wherein the lumens are internal at the proximal and distal ends of the catheter tube but comprise separate tubes in between whereby, following placement of the distal end of the catheter tube in the body cavity of a patient, the unified proximal end of the tube is manipulated, sometimes subcutaneously, with the ultimately exposed tubes being thereafter severed and each equipped with a hub at a convenient exposed body site for selective independent passage of influent and effluent liquid along each lumen.

In another prior art, an US patent specification US20230099120A1 discloses systems and methods for facilitating instrument delivery through a peripheral intravenous catheter including a catheter adapter having a proximal end, a distal end, and a lumen extending there through. The catheter adapter may include a side port. The system may include an extension tube extending from the side port. The system may include a blood control valve disposed in the lumen of the catheter adapter. The system may include a peripheral intravenous catheter extending distally from the catheter adapter.

In yet another prior art an US specification US20230057569A1 discloses a flow restriction device may include a proximal housing including an internal fluid channel, a distal housing including an internal fluid channel, and an intermediate housing interposed between the proximal and distal housings. The intermediate housing may include an internal chamber, and a slider reciprocally disposed in the internal chamber. The slider may include an internal fluid channel and a seal overlaying an outer surface of slider excluding the fluid channel, and may be reciprocally movable between (i) a first position where the internal fluid channel of the slider is axially aligned with the internal fluid channels of the proximal and distal housings to allow a fluid to flow there through, and (ii) a second position where the internal fluid channel of the slider is not aligned with the internal fluid channels of the proximal and distal housings and the seal blocks fluid connection between the proximal and distal housings.

SUMMARY OF THE INVENTION

The herein disclosed invention address an advanced intravenous catheter assembly equipped with a blood control mechanism that restricts blood flow in cases of Luer disconnection or replacement. The invention uses a re-closing spring system and a blood control septum, which work together to ensure that blood flow is restricted whenever the Luer connection is not in place, thereby preventing unwanted blood spillage. The spring-loaded mechanism ensures that the system can be used repeatedly, providing consistent performance over multiple uses.

Additionally, this catheter assembly supports two-way infusion, allowing healthcare providers to administer multiple medications simultaneously through the same catheter. The invention is designed to work with a wide variety of intravenous therapies, making it an ideal solution for critical care environments where multi-infusion and blood control are paramount.

Key Innovations:
1. Re-closing Spring Mechanism: The spring allows the blood control septum to close and prevent blood flow upon Luer disconnection, and it re-opens upon reconnection. This system provides reliable and repeatable functionality.
2. Two-way Infusion: The catheter assembly includes a second port for the simultaneous infusion of additional medications. The blood control mechanism prevents backflow and leakage from either port.
3. Enhanced Reliability: Compared to designs that use elastic membranes, this invention employs a robust spring-based system, which reduces failure rates and improves longevity.
4. Reduced Risk of Blood Spillage: By ensuring that the septum closes immediately upon Luer disconnection, the invention minimizes the risk of contamination due to blood spillage.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1: Illustrates the components of the catheter assembly, including the catheter body (101), spring (102), and blood control septum (103) in accordance with the present invention;
Fig. 2 illustrates the catheter assembly in a loaded state, with the spring compressed after insertion of the Luer connection, allowing fluid flow in accordance with the present invention;
Fig. 3 illustrates the assembly after Luer removal, showing the spring expanding and the blood control septum closing to prevent blood spillage in accordance with the present invention;
Fig. 4 illustrates the two-way catheter assembly, including the blood control valve and injection port, allowing for multi-infusion functionality in accordance with the present invention;

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to a two-way intravenous catheter assembly designed to provide enhanced blood control and multi-infusion capabilities. The invention incorporates a re-closing spring mechanism that restricts blood flow upon Luer disconnection and enables repetitive functionality over multiple uses. Additionally, the catheter assembly supports two-way infusion, allowing for the administration of multiple medications simultaneously while maintaining strict blood control. This innovation addresses the limitations of traditional IV catheter systems and offers improved safety and reliability in clinical settings.

Components of the Catheter Assembly:
Catheter Body (101): The primary structure housing the internal mechanisms, including the spring, septum, and actuator.
- Material: The catheter body should be made of biocompatible polymers such as polyurethane (PU) or silicone elastomer. These materials are flexible, non-reactive with body fluids, and allow for smooth insertion and manoeuvrability within veins.
- Restrictions: The material must be non-toxic, non-pyrogenic, and latex-free to avoid allergic reactions. It must also comply with ISO 10993 standards for biological evaluation of medical devices.
- Sterility: The catheter body material must withstand sterilization methods such as ethylene oxide (EO) or gamma irradiation without degrading.
Spring (102): A re-closing spring configured to ensure repetitive blood flow restriction when the Luer connection is removed. The spring provides continuous mechanical action to open and close the septum as needed.
- Material: The spring is made of silicone rubber. This material is chosen for its flexibility, biocompatibility, and ability to maintain its shape and functionality after repeated mechanical stress.
- Restrictions: The silicone rubber used must meet the ISO 10993 standard for biocompatibility, particularly focusing on cytotoxicity, sensitization, and irritation. It should also resist degradation when exposed to blood, saline, and other IV solutions.
- Durability: The silicone rubber must retain its elastic properties after repeated loading and unloading cycles, ensuring reliable blood flow restriction over multiple uses.

Blood Control Septum (103): A valve-like structure within the catheter body that opens and closes depending on the position of the Luer connection, restricting or allowing fluid flow.
- Material: The blood control septum should be made from medical-grade silicone or thermoplastic elastomer (TPE). These materials provide the necessary flexibility to allow the septum to open and close reliably.
- Restrictions: The material should be biocompatible and meet USP Class VI standards. It should also be chemically resistant to the fluids commonly encountered in IV therapy.

Actuator (104): The mechanical component that moves in response to the insertion or removal of the Luer connection, triggering the opening and closing of the blood control septum.
- Material: The actuator should be made from high-density polyethylene (HDPE) or polypropylene (PP) for durability and non-reactivity in medical environments.
- Restrictions: It should be capable of withstanding multiple cycles of mechanical strain without becoming brittle. It must also comply with ISO 10993 standards for biocompatibility.

Needle (105): The component is used for the initial insertion of the catheter into the patient’s vein and withdrawn once the catheter is in place.
- Material: Medical-grade polycarbonate (PC) or acrylonitrile butadiene styrene (ABS) are recommended for the Luer connection components.
- Restrictions: The material must conform to ISO 80369 standards for small-bore connectors in healthcare settings to ensure compatibility with other infusion systems

Operational Process:
After the catheter is successfully inserted into the vein, the needle is withdrawn, and the blood control septum automatically closes, preventing blood from flowing out of the catheter. When a Luer connection is inserted into the catheter, the actuator moves forward, compressing the spring and opening the septum to allow fluid infusion.

If the Luer connection is removed—whether intentionally for replacement or due to accidental disconnection—the spring expands, pushing the actuator out of the septum and causing the valve to close, restricting further blood flow.

This spring mechanism allows the catheter to operate multiple times without failure, a significant improvement over existing designs that rely on single-use elastic membranes.

Two-Way Infusion:
The catheter assembly also incorporates a two-way infusion system. A second port allows for the simultaneous administration of multiple medications. The blood control valve ensures that blood does not leak from the injection port, and it prevents backflow into the primary infusion line. This dual functionality makes the catheter suitable for use in complex medical scenarios where multiple drugs need to be administered simultaneously, without requiring additional access points.

Examples:

EFFICACY DATA (Updated)
1. Blood Flow Restriction Efficacy:
- Test Overview: Multiple tests were conducted to assess the performance of the silicone rubber spring in controlling blood flow during Luer disconnection. These tests simulated accidental and intentional disconnections under clinical conditions.
- Results: The silicone rubber spring successfully restricted blood flow within 0.4 seconds of Luer disconnection in 99.9% of tests. The faster response time and reliability of silicone rubber showed improved performance compared to prior art using alternative spring materials.
- Reusability: The spring maintained its performance over 20 cycles of disconnection and reconnection without any significant loss in elasticity or functionality far surpassing the traditional membrane based mechanism which loses its functionality after just 2 cycles.

2. Multi-Infusion Capability:
- Test Overview: The catheter was evaluated for its ability to handle the infusion of two different medications simultaneously. The tests measured fluid flow rates and checked for any backflow or cross-contamination between the two infusion lines.
- Results: The catheter successfully facilitated simultaneous infusion, with flow rates remaining stable at 20-30 mL/min. No backflow was detected, demonstrating the efficacy of the blood control septum in maintaining a closed system during multi-infusion procedures.

3. Mechanical Fatigue Testing (Spring and Actuator) (Updated):
- Test Overview: Fatigue testing was performed on the silicone rubber spring and the HDPE actuator to verify their durability under repeated use.
- Results: The silicone rubber spring demonstrated resilience, maintaining its elastic properties for 3,000 load/unload cycles. This surpasses the performance of traditional metal springs, which often degrade after around 1,000 cycles. The actuator showed no signs of mechanical failure after 2,500 cycles, proving its reliability.

4. Sterilization Testing:
- Test Overview: The catheter assembly, including the silicone rubber spring, underwent testing with standard sterilization procedures, including ethylene oxide (EO) and gamma radiation.
- Results: The silicone rubber spring and other materials retained their physical and mechanical properties post-sterilization, confirming that the device can safely undergo these processes without any degradation.

5. Patient Safety Testing:
- Test Overview: Biocompatibility testing in accordance with ISO 10993 was conducted to ensure the safety of the catheter and its components, particularly focusing on the silicone rubber spring and blood control septum.
- Results: No adverse reactions such as irritation, sensitization, or cytotoxicity were observed, demonstrating the safety of the materials used in prolonged patient contact scenarios.

6. Failure Rate Comparison to Prior Art:
- Test Overview: A comparison was conducted between the new silicone rubber spring design and prior designs that used metal springs or elastic membranes.
- Results: The silicone rubber spring had a 99.9% success rate in preventing blood spillage, compared to a 92% success rate for elastic membrane-based designs and 96% for metal spring-based designs. The superior flexibility and resilience of silicone rubber accounted for the improved performance, especially after repeated use.

Although the field of the invention has been described herein with limited reference to specific embodiments, this description is not meant to be construed in a limiting sense. Various modifications of the disclosed embodiments, as well as alternate embodiments of the invention, will become apparent to persons skilled in the art upon reference to the description of the invention.
,CLAIMS:
1 A two-way intravenous catheter assembly, comprising:
- a catheter body;
- a re-closing spring mechanism configured to load and unload in response to Luer insertion and removal, enabling the repetitive restriction of blood flow;
- a blood control septum that restricts blood flow upon removal of the Luer connection and allows fluid flow upon Luer insertion; and
- an actuator that interacts with the Luer connection to move the blood control septum between its open and closed states.

2. The catheter assembly as claimed in Claim 1, wherein the said spring mechanism is configured to function repeatedly across multiple Luer disconnections and replacements.

3. The catheter assembly as claimed in Claim 1, wherein said catheter body includes a primary infusion port and a secondary injection port.

4. The catheter assembly as claimed in Claim 1, wherein said assembly further includes a blood control valve positioned adjacent to the injection port, allowing for simultaneous infusion of multiple medications while preventing backflow into the infusion line.

5. The catheter assembly as claimed in Claim 1, wherein said blood control septum prevents blood spillage during accidental disconnection, ensuring minimal contamination risk.

6. The catheter assembly as claimed in Claim 1, wherein the said spring and septum components are made of biocompatible materials to ensure safe and long-term use in medical applications.

7. The catheter assembly as claimed in Claim 1, wherein under condition that the catheter is successfully inserted into the vein, the needle is withdrawn, and the blood control septum automatically closes, preventing blood from flowing out of the catheter.

8. The catheter assembly as claimed in Claim 7, wherein under condition that a Luer connection is inserted into the catheter, the actuator moves forward, compressing the spring and opening the septum to allow fluid infusion.

9. The catheter assembly as claimed in Claim 8, wherein under condition that the said Luer connection is removed, whether intentionally for replacement or due to accidental disconnection, the said spring expands, pushing the actuator out of the septum and causing the valve to close, restricting further blood flow.

10. The catheter assembly as claimed in Claim 1, wherein said assembly incorporates a two-way infusion system, where second port allows for the simultaneous administration of multiple medications and it prevents backflow into the primary infusion line.