DESC:FIELD

The present disclosure relates generally to catheter assembly for vascular access that can be used with medical devices including, for example, intravenous (IV) catheter assemblies or any medical device with male and female luer connections. More particularly, the present disclosure relates to a multi-use catheter assembly for vascular access comprising valve assemblies including a valve assembly and a valve actuator assembly with enhanced features and abilities to selectively allow flow of fluids through the catheter assembly while preventing leakage of fluids from the proximal end of the medical device.

BACKGROUND

Catheters serve as versatile medical devices that enable healthcare professionals to administer infusion or removal of fluids from patients. They function as conduits for infusing fluids such as normal saline solution, therapeutic substances, and nutritional fluids, or withdrawing fluids like blood or other bodily fluids as required by specific medical procedures. When positioning a catheter into a vessel, healthcare practitioners look for a flow of blood back into the catheter or in the needle hub ("flashback") to verify the correct placement of the catheter opening within the vessel. Various catheter insertion procedures and techniques exist, which may involve the use of a needle, dilator, stylet, or other medical devices within the catheter during the placement process.

Once properly positioned, the catheter's hub or any medical device within the catheter can be coupled to an adapter, typically a luer fitting, to enable fluid connection between the catheter and the source of fluids or reservoir. However, maintaining a sanitary point of access is crucial during catheter insertion, regardless of the application. The period between catheter insertion and adapter coupling or after repeated insertion and removal of medical instruments through the valve assembly often leads to the escape of bodily fluids through the catheter, creating an unsanitary condition for the medical practitioner who must handle the catheter for adapter coupling and/or removal of any inserted medical devices and a non-sterile environment which may impact the patient safety.

Catheter assembly for vascular access comprising valve assemblies are known. Some of the catheter assemblies use spring mechanisms to actuate the valve. While spring-based designs can be effective, they can also be more complex and prone to mechanical failure over time compromising the valve’s functionality. Such complex designs may incorporate multiple components, increasing the risk of mechanical issues and making the assemblies more difficult to use smoothly. Some designs are limited to single time actuation i.e. the valve can only be opened and closed once and may not effectively control blood flow. Such a limitation can be problematic, as it may not allow for effective control of blood flow during the entire procedure. Patients may require a new catheter assembly if the valve needs to be actuated multiple times. Such limitations and shortcomings of current catheter assemblies can also lead to inadequate control of blood flow. This can be a significant issue, as uncontrolled blood flow can increase the risk of complications and make the procedure more challenging for the healthcare provide. Such assemblies may also suffer from the problem of fluid leakage that can occur in catheter assemblies with valve assemblies and valve actuators. In such catheter assemblies, the valve actuator is responsible for facilitating the opening of the flow path when medical instruments are inserted. However, over time and with repeated use, the valve actuator can become stuck or jammed with the valve itself. Such malfunction of the valve actuator can prevent the proper opening of the flow path, leading to the valve assembly not functioning as intended. As a result, fluid leakage can occur around the inserted medical instruments, compromising the sterile environment and potentially causing complications for the patient. The improved valve assemblies of the present disclosure address such issues by providing a reliable and durable design that prevents the valve actuator from getting stuck with the valve, ensuring consistent and effective sealing even after repeated use.

The catheter assembly with selective flow control is particularly useful in situations where precise fluid management is critical, such as in critical care settings, oncology treatments, and pediatric care.

There remains a need to provide a further improved catheter assembly for vascular access comprising valve assemblies including a valve assembly and a valve actuator assembly with enhanced features and abilities to selectively allow flow of fluids through the medical device while preventing leakage of fluids from the proximal end of the medical device and which helps healthcare professionals in enhancing the patient safety and improve the overall quality of care.

SUMMARY AND OBJECTS

Certain exemplary aspects of the present disclosure are provided below. It should be understood that these aspects are presented merely to provide the reader with a brief summary of certain forms the disclosure might take and that these aspects are not intended to limit the scope of the disclosure. Indeed, the invention may encompass a variety of aspects that may not be set forth below. The illustrations and variations described herein are meant to provide examples of the devices and methods of disclosure. It is contemplated that combinations of aspects of specific embodiments or variations or combinations of the specific embodiments or variations are within the scope of the present disclosure.

In one example, the present disclosure relates to a catheter assembly for vascular access for use with a luer device. The catheter assembly comprises valve assemblies, including a valve assembly and a valve actuator assembly, configured for use with a male luer. The valve assembly and the valve actuator assembly are designed to be used as a part of a catheter assembly where both components fit within a catheter hub. The present disclosure thus relates to a catheter assembly for vascular access comprising: a catheter hub having an interior housing extending between a proximal end and a distal end thereof, wherein the catheter hub has an inner surface and an outer surface; a catheter tube is attached to the distal end of the catheter hub; a needle with a needle tip connected to a needle hub is movably received within the catheter hub exposing the needle tip out of the catheter tube; a valve assembly located within the housing which selectively permits or blocks a flow of fluid through the catheter; and a valve actuator assembly wherein at least a part/portion of the valve actuator assembly slidably retained by the valve assembly.

The valve actuator assembly configured to move between a first position wherein at least a part/portion of the valve actuator assembly is securely retained with/by the valve assembly when the valve assembly is in a closed position and a second position when the valve assembly is in an open position wherein a luer connector being inserted push the valve assembly with the valve actuator assembly to the open position.

The valve assembly is a key component of the catheter assembly as it is designed to work in conjunction with the valve actuator assembly to provide efficient vascular access. The valve assembly is constructed to fit seamlessly within the catheter hub in a stable manner, ensuring a compact and streamlined design. The valve actuator assembly is the second essential component of the catheter assembly which is designed to work in harmony with the valve assembly to facilitate vascular access preventing any leakage. The valve actuator assembly is likewise designed to fit within the catheter hub in a seamless and stable manner.

The valve assembly having a proximal end and a distal end, a sidewall therebetween, an inner space and a barrier layer at the distal end to prevent fluid flow and wherein the barrier layer has one or more pre-formed openings or slits forming one or more flaps or leaflets. The sidewall of the valve assembly comprises one or more projections/protrusions forming compressible features which act as a spring. The proximal end of the valve assembly has an opening to receive the valve actuator assembly.

The valve actuator assembly comprises a body having a proximal end and a distal end, a flow path surrounded by the body running therethrough having an opening at the distal end, and wherein the body of the valve actuator assembly has a top section, a mid-section and a bottom section.

It is to be understood that the valve assembly and the valve actuator assembly of the present disclosure can be used in any assembly, especially those where valve deformation rather than fluid pressure, is the primary mechanism for opening the valve.

In one example, the present disclosure relates to a catheter assembly for vascular access. The catheter assembly comprises valve assemblies, including a valve assembly and a valve actuator assembly, configured for use with a male luer.

In one example, the present disclosure relates to a catheter assembly for vascular access. The catheter assembly comprises valve assemblies, including a valve assembly and a valve actuator assembly, configured for use with a male luer and a needle guard housed within the catheter hub which further enhances the safety feature of the catheter assembly. The needle guard is slidably arranged on the needle shaft and retained within the housing of the catheter hub in a ready position. Once the needle tip is withdrawn out of the catheter hub, the needle tip being securely covered/protected by the needle guard comes out of the catheter hub in a protected position.

In some examples, the valve assemblies including a valve assembly and a valve actuator assembly described in the present disclosure which can be utilized as a connection point for various medical devices and components beyond their application in catheter assemblies for vascular access. The valve assemblies of the present disclosure can serve as a connection interface for needles, such as fistula needles commonly used in hemodialysis procedures. They can also be integrated into hemodialysis circuits, enabling a secure and controlled connection between different components of the dialysis system.

In some examples, the valve assemblies of the present disclosure can be adapted for use with feeding tubes, providing a reliable means of administering nutrients and medications directly into the gastrointestinal tract. Similarly, these valve assemblies can be incorporated into urinary drain catheters, facilitating the controlled drainage of urine from the bladder while preventing backflow and minimizing the risk of infection.

In some examples, the versatility of the valve assemblies of the present disclosure allows them to be seamlessly integrated into a wide range of medical devices and applications, beyond their primary use in catheter assemblies for vascular access. Such a adaptability expands the potential applications of the valve assemblies, making them a valuable component in various healthcare settings and procedures.

It is an object of the present disclosure to provide a multi-use catheter assembly for vascular access comprising a valve assembly and a valve actuator assembly with enhanced features and abilities to selectively allow flow of fluids through the medical device while preventing leakage of fluids from the proximal end of the medical device when such medical device is connected to a patient being under treatment or medical care.

Another object of the present disclosure is to provide improved valve assemblies comprising a valve assembly and a valve actuator assembly to address the problem of fluid leakage that can occur in catheter assemblies with valve assembly and a valve actuator assembly.

Another object of the present disclosure is to provide improved valve assemblies that prevent leakage of fluids and inadequate control of blood flow after repeated insertion and removal of medical instruments through the valve assembly.

Another object of the present disclosure is to provide improved valve assemblies that prevent leakage of fluids after repeated insertion and removal of medical instruments through the valve, such as catheters, introducers, tubes, lines, and ports that can be used for vascular or other devices. These valve assemblies are designed to maintain a secure and reliable seal, ensuring the prevention of fluid leakage during multiple uses, for example, the insertion and removal of medical instruments for vascular access therethrough.

Another object of the present disclosure is to provide improved valve assemblies that can be used with any other suitable means for medical applications where the prevention of fluid leakage during the insertion and removal of instruments is crucial to maintain a sterile environment and ensuring patient safety.

Another objective of the present disclosure is to provide a catheter assembly for vascular access that can be used with a wide range of medical devices. This includes, but is not limited to, intravenous (IV) catheter assemblies, as well as any medical device with male and female luer connections. The catheter assembly is designed to be compatible with various types of mating connections, not just limited to luer fittings. Other types of mating connections that are contemplated include, for example Enfit for feeding applications, NRFit for neuroaxial procedures, and any other types of mating connections between two components. Such versatility allows the catheter assembly to be integrated into a diverse array of medical applications, providing healthcare professionals with a flexible solution for vascular access and patient care.

Another object of the present disclosure is to provide catheter assembly for vascular access comprising improved valve assemblies that minimize the blood exposure for the caregiver at the time of insertion, removal or a change in catheters.

Yet another object of the present disclosure is to provide catheter assembly for vascular access comprising improved valve assemblies that permit controlled fluid flow which also reduces risk of infection.

A still further object of the present disclosure is to provide valve assemblies which serve the purpose of functioning as a blood and/or fluid block valve in catheter applications, for example in peripheral IV catheters. The valve assembly is positioned within the catheter hub or in fluid communication with the flow path to prevent blood flow from the patient's vein during initial venipuncture. Such a feature lowers the risk of blood exposure from the hub and contamination of the access site. Such an improvement allows medical professionals or caregivers to maintain a clean access site, thereby avoiding the transfer of bloodborne pathogens. Additionally, the devices described in the present disclosure can be utilized in various other applications, such as check valves, needleless injection ports, backflow prevention devices, and even non-medical fluid applications.

Other examples, features and advantages of the present disclosure will become apparent from the following more detailed description, taken in conjunction with the accompanying drawings which illustrate, by way of example, the principles of the present disclosure or may be apparent by the practice of the examples of the disclosure as set forth hereinafter.

These and other objects and features of the present disclosure will become more readily apparent from the following description which strives to improve the overall performance, safety, and efficiency of catheter assembly for vascular access comprising valve assemblies, ultimately benefiting both healthcare providers and patients undergoing medical treatment.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

Embodiments of the present disclosure now will be described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the present disclosure are shown. The present disclosure may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Like numbers refer to like elements throughout. The embodiments of the invention are described in the following description and in the accompanying drawings, wherein:

Fig. 1A illustrates a cross-sectional view of a catheter assembly for vascular access comprising valve assemblies as shown in detail A according to some examples of the present disclosure;

Fig. 1B illustrates detail A of Fig. 1;

Fig. 2 illustrates a cross-sectional view of a catheter assembly for vascular access comprising valve assemblies in a closed position for use with catheters or other medical devices/introducers according to some examples of the present disclosure;

Fig. 3 illustrates a cross-sectional view of the catheter assembly for vascular access comprising valve assemblies with a luer connecter inserted pushing the valve assembly with the valve actuator assembly in an open position for use with catheters or other medical devices/introducers according to some examples of the present disclosure;

Figs. 4A & 4B illustrate a top and perspective view respectively of a valve assembly according to some examples of the present disclosure;

Figs. 4C - 4G illustrate a bottom, perspective, side views and top view respectively of the valve assembly of Figs. 4A showing schematic of its open position according to some examples of the present disclosure;

Figs. 5A & 5B illustrate a top and perspective view respectively of another variation of a valve assembly according to some examples of the present disclosure;

Figs. 6A & 6B illustrate a top and perspective view respectively of another variation of a valve assembly according to some examples of the present disclosure;

Figs. 7A, 7B & 7C illustrate a perspective, side and front view respectively of a valve actuator assembly according to some examples of the present disclosure;

Figs. 7D & 7E illustrate a top and bottom view respectively of the valve actuator assembly of Fig. 7A according to some examples of the present disclosure;

Figs. 8 & 9 illustrate a side view respectively of another variations of valve actuator assembly according to some examples of the present disclosure;

Figs. 10A & 10B illustrate valve assemblies comprising a valve assembly and valve actuator assembly according to some examples of the present disclosure.

Fig. 11A illustrates a cross-sectional view of a catheter assembly for vascular access comprising valve assemblies in a closed position for use with catheters or other medical devices/introducers according to some examples of the present disclosure;

Fig. 11B illustrates a cross-sectional view of the catheter assembly for vascular access comprising valve assemblies with a luer connecter inserted pushing the valve assembly with the valve actuator assembly in an open position for use with catheters or other medical devices/introducers according to some examples of the present disclosure;

Figs. 11C to 11I illustrate a left, front, right, cross-sectional, bottom, top and perspective view respectively of a valve actuator assembly according to some examples of the present disclosure;

Figs. 11J to 11P illustrate a left, front, right, cross-sectional, bottom, top and perspective view respectively of a valve assembly according to some examples of the present disclosure;

Fig. 12A illustrates a cross-sectional view of a catheter assembly for vascular access comprising valve assemblies in a closed position for use with catheters or other medical devices/introducers according to some examples of the present disclosure;

Fig. 12B illustrates a cross-sectional view of the catheter assembly for vascular access comprising valve assemblies with a luer connecter inserted pushing the valve assembly with the valve actuator assembly in an open position for use with catheters or other medical devices/introducers according to some examples of the present disclosure;

Figs. 12C to 12I illustrate a cross-sectional, right, front, left, perspective, bottom and top view respectively of a valve assembly according to some examples of the present disclosure;

Fig. 13A illustrates a cross-sectional view of a catheter assembly for vascular access comprising valve assemblies in a closed position for use with catheters or other medical devices/introducers according to some examples of the present disclosure;

Fig. 13B illustrates a cross-sectional view of the catheter assembly for vascular access comprising valve assemblies with a luer connecter inserted pushing the valve assembly with the valve actuator assembly in an open position for use with catheters or other medical devices/introducers according to some examples of the present disclosure;

Figs. 13C & 13D illustrate a front and cross-sectional view respectively of a valve actuator assembly according to some examples of the present disclosure;

Figs. 13E to 13H illustrate a front, cross-sectional, top and perspective view respectively of a valve actuator assembly according to some examples of the present disclosure;

Fig. 14A illustrates a cross-sectional view of a catheter assembly for vascular access comprising valve assemblies in a closed position for use with catheters or other medical devices/introducers according to some examples of the present disclosure;

Fig. 14B illustrates a cross-sectional view of the catheter assembly for vascular access comprising valve assemblies with a luer connecter inserted pushing the valve assembly with the valve actuator assembly in an open position for use with catheters or other medical devices/introducers according to some examples of the present disclosure;

Figs. 14C & 14D illustrate a front and cross-sectional view respectively of a valve actuator assembly according to some examples of the present disclosure;

Figs. 14E to 14H illustrate a front, cross-sectional, top and perspective view respectively of a valve actuator assembly according to some examples of the present disclosure;

Fig. 15A illustrates a cross-sectional view of a catheter assembly for vascular access comprising valve assemblies in a closed position for use with catheters or other medical devices/introducers according to some examples of the present disclosure;

Fig. 15B illustrates a cross-sectional view of the catheter assembly for vascular access comprising valve assemblies with a luer connecter inserted pushing the valve assembly with the valve actuator assembly in an open position for use with catheters or other medical devices/introducers according to some examples of the present disclosure;

Figs. 15C to 15I illustrate a cross-sectional, right, front, left, perspective, bottom and top view respectively of a valve assembly according to some examples of the present disclosure.
DETAILED DESCRIPTION

Those skilled in the art will appreciate that the disclosed aspects and features of the present disclosure are not limited to any particular embodiment of catheter assembly for vascular access comprising valve assemblies. It will be readily understood that the parts/components of the present disclosure, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. The catheter assembly for vascular access comprising valve assemblies incorporating the innovative aspects and features herein described, can be tailored for use with a variety of medical articles/devices.

Fig. 1A illustrate an example of a catheter assembly 10 for vascular access comprising a catheter hub 12 having an interior housing 14 extending between a proximal end 16 and a distal end 18 thereof; a catheter tube 20 is attached to the distal end 18 of the catheter hub 12; a needle 22 with a needle tip 24 connected to a needle hub 26 is movably received within the catheter hub 12 exposing the needle tip 24 out of the catheter tube 20; a valve assembly 28 located within the housing 14 which selectively permits or blocks a flow of fluid through the catheter 20; and a valve actuator assembly 30 wherein at least a part/portion of the valve actuator assembly 30 slidably retained by the valve assembly 28 as shown in further detail in Fig. 1B.

Referring to Fig. 1B and 2, the catheter hub 12 has a distal end 18, a proximal end 16, an inner surface 38 and an outer surface 40. The distal end 18 includes a catheter opening that connects to the proximal end of the catheter tube 20 which in turn is connected to the catheter hub 12 ensuring a seamless transition for fluid flow. The proximal end 16 includes a tapered opening 42, for example a luer connector opening. The inner surface 38 of the catheter hub 12 surrounds a channel 46 that runs through the length of the catheter hub 12, enabling fluid passage through the catheter hub 12.

The inner surface 38 includes one or more projections 48a that serve to securely hold the valve assembly 28 in place. These projections 48a are positioned to provide a stable and secure fit for the valve assembly 28, preventing any unwanted movement or dislodgement during use.

The outer surface 40 also includes one or more projections 48b to secure a luer connector 32 or a male luer as shown in Fig. 3 to the catheter hub 12. The luer connector 32 or male luer is widely used medical device that allows for the attachment of various components, such as IV tubing or syringes to the catheter hub 12. The projections 48b on the outer surface 40 may form a threaded connection with the luer connector 32 allowing for a secure and easily removable attachment. Alternatively, the projections 48b may connect to the luer connector 32 or other medical articles/devices through a snap fit or other twisting connection, providing a quick and efficient means of attachment without the need for threading. The projections 48b thus forms a secure connection with the luer connector 32 ensuring a tight and reliable fit.

A venipuncture method begins by inserting the needle 22 into a patient’s vein. The needle 22 is typically made of a rigid material, for example metal material, and has a sharp tip 24 to facilitate penetration into the vein. The needle 22 is carefully inserted at an appropriate angle and location, taking into account the patient’s anatomy and the desired placement of the catheter tube 20. Once the needle 22 is in place within the patient’s vein, the catheter tube 20 pushed along the needle 22 into the patient’s vein. The catheter tube 20 is typically made of a flexible material, such as polyurethane or polytetrafluoroethylene or other flexible plastic material and is configured to slide smoothly over the needle 22.

After the catheter tube 20 is fully inserted into the patient’s vein, the needle 22 is carefully removed from the patient’s vein and the catheter hub 12. The catheter hub 12 serves as a connection point for various medical devices, such as luer connectors, IV tubing or syringes. Once the needle 22 is removed, the catheter tube 20 remains in the patient’s vein, secured by the catheter hub 12. The used needle 22 is safely discarded in an appropriate sharps container or biohazard receptacle.

The valve actuator assembly 30 configured to move between two distinct positions in relation to the valve assembly 28. The valve actuator assembly 30 configured to move between a first position wherein at a part/portion of the valve actuator assembly 30 is securely retained with/by the valve assembly 28 when the valve assembly 28 is in a closed position 36 as shown in Figs. 2, 10A & 10B and a second position when the valve assembly 28 is in an open position 34 wherein a luer connector 32 being inserted push the valve assembly 28 with the valve actuator assembly 30 to the open position 34 as shown in Fig. 3. The insertion of the luer connector 32 causes the valve assembly 28 to transition from the closed position 36 to the open position 34, allowing the valve actuator assembly 30 to move to its second position. This movement is facilitated by the interaction between the luer connector 32 and the valve actuator assembly 30, which causes the opening of the valve assembly 28. Once the luer connector 32 is retracted or removed, the valve actuator assembly 30 automatically retracts to its first position, causing the valve assembly 28 to close and return to the closed position 36, as depicted in Fig. 2 ensuring that the valve assembly 28 remains securely closed when not in use, preventing any leakage or unintended flow.

At least a part/portion of the valve actuator assembly 30 is configured to be engageably retained by/with the valve assembly 28 in both the first position (closed) and the second position (open) during multiple usage cycles. Such features maintain the cycle of open and closed positions, allowing for repeated and reliable operation of the valve without compromising its integrity or functionality. The engageable retention of the valve actuator assembly 30 in both the first and second positions allows for reliable and consistent operation of the valve assembly 28 without compromising the integrity of the actuator-valve connection.

Referring to Figs. 4A-4B, a valve assembly 28 is positioned within the interior housing 14 of the catheter hub 12 as shown in Figs. 1B & 2 forming a fluid-tight seal and which is configured to selectively allow fluid to or from the catheter tube 20. The valve assembly 28 blocks or permits the flow of fluid through the catheter tube 20. As depicted in Figs. 1B & 2, the valve assembly 28 is held in a position securely against an internal wall 50 formed on the inner surface 38 of the catheter hub 12, preventing any movement of the valve assembly 28 while being so secured. The valve assembly 28 is further held by one or more projections 48a to retain the valve assembly 28 in place limiting or preventing any proximal or distal movement thereof ensuring safe retention of the valve assembly 28 within the interior housing 14 of the catheter hub 12.

Figs. 4A and 4B depict a valve assembly 28 having a proximal end 16a and a distal end 18a, a sidewall 56 therebetween, an inner space 60 as shown in Fig. 2 and a barrier layer 58 at the distal end 18a to prevent fluid flow. The proximal end 16a of the valve assembly 28 has an opening 88 having a diameter to receive the valve actuator assembly 30 as shown in Figs. 4B, 4C & 4D. The inner space 60 has a proximal end and a distal end defining a space. The barrier layer 58 of valve assembly 28 has one or more pre-formed openings or slits 52 forming one or more flaps or leaflets 54 as shown in Figs. 4A, 4D, 4F & 4G. The sidewall 56 has an inner sidewall 56b and an outer sidewall 56a as shown in Fig. 4C. The sidewall 56 comprises one or more projections/protrusions 48c positioned on the outer sidewall 56a of the valve assembly 28. Projections/protrusions 48c can be circular, intermittent circular, or of other shapes. Alternatively, one or more projections/protrusions 48c can be positioned on either side of the wall 56 or any other location thereof. The projections/protrusions 48c form compressible features which act as a spring. The valve assembly 28 further comprises a recessed portion 86 in between the one or more projections 48c. The projections 48a of the catheter hub 12 are received in the recessed portion 86 which keeps the valve assembly 28 securely in place within the catheter hub 12 as shown in Fig. 2. The placement and the location of the valve assembly 28 and the valve actuator assembly 30 within the catheter hub 12are critical factors in the operation of the catheter assembly 10. As shown in Fig. 1B, the valve assembly 28 is positined and located in a distal most end of the interior housing 14 of the catheter hub 12. The illustrated location of the valve assembly 28 within the catheter hub 12 determines the point where the force starts to be applied on the actuator assembly 30 by the male luer 32. This affects the force distribution and the overall efficiency of the valve assembly 28 operation. The illustrated placement and location of the valve assembly 28 and the actuator assembly 30 within the catheter hub 12 ensure that there is sufficient clearance to prevent interference with other components of the catheter assembly 10. The valve assembly 28 being so positioned determines the distance the actuator assembly 30 must travel to open and close the flaps or leaflets 54. Such distance directly impacts the force required to effectively open and close the valve assembly 28.

In some examples, the valve assembly 28 is positioned within the catheter hub 12 in a position that allows the actuator assembly 30 to travel the minimum distance necessary to open and close the flaps or leaflets 54. Such an optimized placement minimizes the force required for valve assembly 28 operation. It is to be understood that the distance the actuator assembly 30 must travel to open the valve assembly 28 is directly related to the placement of the valve assembly 28 within the catheter hub 12. If the flaps or leaflets 54 of the valve assembly 28 is positioned closer to the actuator assembly 30, the travel distance will be shorter, requiring less force to operate the valve assembly 28. Conversely, if the flaps or leaflets 54 of the valve assembly 28 are positioned further from the actuator assembly 30, the travel distance will be longer, necessitating greater force for valve assembly 28 operation. It is to be further understood that the force required to open and close the valve assembly 28 is inversely proportional to the actuator assembly 30 travel distance. If the travel distance increases, the force required to overcome the resistance of the flaps or leaflets 54 also increases. Thus, an optimized placement of the valve assembly 28 in relation to the valve actuator assembly 30 within the catheter hub 12 minimizes the force required for reliable valve assembly 28 operation allowing for controlled vascular access and fluid flow management during medical procedures. The optimized placement of the valve assembly 28 and the valve actuator assembly 30 within the catheter hub 12 leads to improved ease of use, reduced user fatigue, and enhanced patient comfort during medical procedures.

As depicted in Figs. 4A-4B, the barrier layer 58 of valve assembly 28 has one or more pre-formed openings or slits 52 forming one or more flaps or leaflets 54 as shown in Figs. 4A, 4D, 4F & 4G. The slits 52 and the flaps 54 formations designed to selectively allow fluid or to selectively prevent unwanted fluid flow therefrom. In one example, as shown in Figs. 4A-4B, the valve assembly 28 has at least three intersecting slits 52 forming three flaps 54 as depicted in Figs. 4C-4G that open when engaged by a valve actuator 32. In other variations, as shown, for example in Figs 5A & 5B, the valve assembly 28 has at least four intersecting slits 52 and in Figs. 6A & 6B, the valve assembly 28 has at least two intersecting slits 52. It is to be understood that the number of slits 52 is not limited to the illustrated examples and may vary with various numbers and positions of slits 52 being contemplated. It is to be understood that the barrier layer 58 comprising the variations of the slits 52 are opened through elastic deformation rather than pressure within the catheter assembly 10. For example, the variation of the slits 52 require the luer connector 32 or a male luer to elastically deform the valve assembly 28 and/or the barrier layer 58 comprising the slits 52 to selectively permit fluid flow through the valve assembly 28 as shown in Fig. 3. In an example, the barrier layer 58 may comprise at least one slit 52. Alternatively, the barrier layer 58 may comprise a plurality of slits 52 forming a plurality of flaps 54 that open upon deformation of the valve assembly 28.

The barrier layer 58 comprises a flexible or semi-flexible material that is compatible with exposure to blood, medicaments, and other fluids commonly encountered during catheterization and infusion procedures. In some examples, the barrier layer 58 is fabricated from a medical-grade elastomeric material such as silicone rubber or thermoplastic elastomer (TPE) or any other flexible material. These materials provide the necessary flexibility, resiliency, and fluid compatibility for the barrier layer 58 to function effectively as a protective membrane. The barrier layer 58 is configured to maintain a sealed configuration when the valve assembly 28 is in closed state/position 36. In such a closed position 36, the barrier layer 58 is designed to withstand the pressures and stresses encountered during typical catheterization and infusion procedures without compromising its sealing properties.
The inner sidewall 56b of the valve assembly 28 at its proximal end 16a comprises a retaining member 62 as shown in Figs. 1B & 10B. The retaining member 62 keeps at least a portion of the valve actuator assembly 30 securely retained with the valve assembly 28 in the first position as shown in Fig. 1B.
It is also important to note that the distance the valve actuator assembly 30 and/or a part/portion of the valve actuator assembly 30 moves within the valve assembly 28 is a key factor in the operation of the catheter assembly 10. The force required to close the flaps or leaflets 54 of the valve assembly 28 is directly related to the distance the actuator assembly 30 and/or a part/portion of the valve actuator assembly 30 travels within the valve assembly 28. The force required to open or close the flaps or leaflets 54 is inversely proportional to the distance the actuator assembly 30 and/or a part/portion of the valve actuator assembly 30 travels in a distal or a proximal direction within the valve assembly 28. As the actuator assembly 30 travel distance increases, the force needed to overcome the resistance of the flaps or leaflets 54 decreases, and vice versa.

Referring to Fig. 2 both the valve assembly 28 and the actuator assembly 30 comprise distinct dimensions including a width and a length. As shown in Fig. 2, the length of valve assembly 28 includes a length L1 and the length of actuator assembly 30 includes a length L2. Whereas the length of L1 is greater than the length of L2. The length L1 is measured from the proximal end of the inner space 60 to the top end of the valve assembly 28. In contrast, the length L2 extends from a point adjacent to the skirt portion 80 upward till a point of the top end part of the actuator assembly 30 which remains exposed out of the valve assembly 28 when securely retained within the valve assembly 28 in its closed position 36 as shown in Fig. 2. Thus, it is to be understood that the valve actuator assembly 30 comprises dimensions having a shape, a width and a length including height, wherein the height of the actuator assembly 30 and/or the height of any part/portion of the actuator assembly 30 and its placement within the valve assembly 28 are critical factors that determine the distance the actuator assembly 30 will move the flaps or leaflets 54 to open or close. The actuator assembly 30 length or height being within the valve assembly 28 directly influences the range of motion and the force applied to open or close the flaps or leaflets 54 of the valve assembly 28. At the same time, the actuator assembly 30 is dimensioned so that it must be able to return to its original position i.e. the first position on its own automatically after the male luer 32 is removed and/or no pushing force in a distal direction is applied on the actuator assembly 30. By optimizing the height, placement, and overall dimensions of the valve actuator assembly 30, the catheter assembly 10 is designed to provide effective and controlled vascular access while maintaining the ability to consistently open and close the valve assembly 28 as needed during the medical procedures.

The other dimensions of the valve actuator assembly 30, in addition to its height or length, are crucial in determining the effective opening or closing of the flaps or leaflets 54. For example, the shape and curvature of the actuator assembly 30 plays an important role in affecting its ability to open and close the flaps or leaflets 54 effectively. The actuator assembly’s dimensions are designed to ensure that the actuator assembly 30 must be able to apply adequate force to fully or partially open the flaps or leaflets 54, allowing for unobstructed fluid flow. Also, the dimensions of the actuator assembly 30 are designed to maintain proper alignment with the valve assembly 28 to ensure that the flaps or leaflets 54 are properly opened and closed to the extent that the top end of the actuator assembly 30 never moves in the distal or forward direction out from the flaps or leaflets 54 once the valve assembly 28 is in open position as shown in Fig. 3. The actuator assembly 30 being so dimensioned ensures that the catheter assembly can be optimized to provide reliable and effective valve assembly 28 operation, ensuring controlled vascular access and fluid flow management during medical procedures. It is to be also understood that the material properties of the actuator assembly 28, such as its stiffness and flexibility, also influence its ability to apply the necessary force and return to its original position.

Additionally, it is to be understood that the back pressure exerted by the fluid/blood flow can also contribute to the force needed to close the valve assembly 28. By carefully designing the actuator assembly 30 movement and considering the forces exerted by the silicone leaflets 54 and blood back pressure, the catheter assembly 10 is, thus designed to provide reliable and effective valve assembly 28 closure. This ensures that the valve assembly 28 can be consistently opened and closed, allowing for controlled vascular access and fluid/blood flow management during medical procedures.

The valve assembly 28 further comprises a plurality of flow channels 64. The flow channels 64 are disposed on the outer sidewall 56a of the valve assembly 28. These flow channels 64 are designed to facilitate the controlled release of air while preventing the undesirable flow of fluid/blood through the valve assembly 28. The flow channels 64 are equidistantly spaced around the circumference of the outer sidewall 56a of the valve assembly 28, from each other as illustrated in Figs. 4A & 4B. Such a uniform distribution ensures an even and efficient release of air from the valve assembly 28. The numbers and positions of the flow channels 64 may vary in alternate examples to accommodate different design requirements or specific applications. The strategic placement of the flow channels 64 can be adjusted to optimize air release while preventing flow of fluid/blood therefrom. The flow channels 64 have an appropriate depth and width to allow for the effective escape of air only while preventing the flow of fluid/blood therethrough. With these flow channels 64 with its optimized dimensions and distribution, the valve assembly 28 can effectively release air while maintaining its primary function of preventing the backflow of fluid/blood.

The valve assembly 28 is designed to selectively open and close the fluid pathway to allow the passage of fluids when desired, while maintaining a sealed configuration to prevent unintended fluid flow and contamination. In some examples, the valve assembly 28 is fabricated from a medical-grade elastomeric material such as silicone rubber or thermoplastic elastomer (TPE) or any other flexible material. These materials provide the necessary resilience and stability for the valve assembly 28 to function effectively as a fluid control mechanism even during multiple usage cycles.

Figs. 7A to 7E illustrate an example of a valve actuator assembly 30 which can be positioned being wherein at least a part/portion of the valve actuator assembly 30 retained by the valve assembly 28 within the interior housing 14 of the catheter hub 12 as shown in Fig. 2 and movable axially to engage and open the slits 52 as shown in Fig. 3. The valve actuator assembly 30 has a top section 72, a mid-section 74 and a bottom section 76. The valve actuator assembly 30 comprises a body 66 having a proximal end 16b and a distal end 18b, a flow path 68 surrounded by the body 66 running therethrough having an opening 70 at the distal end 18b as shown in Fig. 7D. The flow path 68 facilitates fluid to flow through the valve assembly 28 and through the valve actuator assembly 30 when the valve assembly 28 is opened or penetrated by the valve actuator assembly 30 when the male luer 32 creates a pushing force as shown in Fig. 3.

The valve actuator assembly 30 comprises one or more retaining protrusions 78 to keep at least a part/portion, in particularly a distal part of the valve actuator assembly 30 securely retained within the inner space 60 of the valve assembly 28. The top section 72 of the valve actuator assembly 30 forms the distal end 18b with a flat top surface. In one example, the top section 72 comprises a retaining protrusion 78 forming a conical section on its outer periphery. The retaining protrusion 78 keeps at least a part/portion, in particularly a distal part of the valve actuator assembly 30 securely retained within the inner space 60 of the valve assembly 28 through the retaining member 62 as shown in Fig. 2 & 10B when the retaining protrusion 78 abuts the retaining member 62 in the first position. The mid-section 74 of the valve actuator assembly 30 is substantially tubular. The bottom section 76 of the valve actuator assembly 76 comprises a skirt portion 80 further extending into formation of legs 82 which forms the proximal end 16b of the valve actuator assembly 30 as shown in Fig. 7C. As shown in Fig. 3, when the valve assembly 28 is in open position, the skirt portion 80, in particularly top end part of the skirt portion 80 abuts the proximal end of the valve assembly 28. Such an abutment ensures that the flaps or leaflets 54 are properly opened and closed to the extent that the top end of the top section 72 of the actuator assembly 30 never moves in the distal or forward direction out from the flaps or leaflets 54 even when a pushing force is exerted by the male luer 32 to open the flaps or leaflets 54. The skirt portion 80 of the valve actuator assembly 30 has a diameter which is equal to or greater than the diameter of the opening at the proximal end of the valve assembly 28. The legs 82 comprises one or more alignment features 84 to keep the valve actuator assembly 30 in its designated location within interior housing 14 of the catheter hub 12.

The shape and structure of valve actuator assembly 30 is not limited only to the example as shown in Figs. 7A-7E and may include other variations as shown in Figs. 8 & 9. As illustrated, each of the valve actuator assembly 30 may comprise a top section 72, a mid section 74 and a bottom section 76 wherein at least the shape and dimension of the top section 72 has varying shapes and dimensions. Additionally, the actuator assembly 30 may be configured in a tubular shape. These and other variations may incorporate different geometries, sizes and features compared to the examples shown in Figs. 7A-7E. The specific shape and structure chosen for the actuator assembly 30 may be tailored to meet the requirements of different catheter assembly designs, other medical devices, medical applications and user preferences.

When the luer connector or male luer 32 is inserted into the valve actuator assembly 30 creating a push force through the top section 72, the resilient nature of the valve material allows it to stretch and deform to an open position 34 as shown in Fig. 3. Such deformation creates a fluid pathway through the valve assembly 28 and through flow path 68 of the valve actuator assembly 30, enabling the passage of fluids. Upon removal of the male luer 32, the inherent resiliency of the valve material causes the valve actuator assembly 30 to its original first position i.e. in a closed position 36 as shown in Fig. 2, effectively closing the fluid pathway and preventing unintended fluid flow. It is to be noted that when fluid/blood flows through the catheter assembly 10, it creates a back pressure that pushes against the valve assembly 28. In some examples, the back pressure exerted by the fluid/blood flow can assist in the closure of the valve assembly 28. However, it is important to note that the back pressure is not necessarily required for effective valve assembly closure in all situations. In some examples, this back pressure may help to close the valve assembly 28, particularly when the actuator assembly 30 is in retraction in absence of pushing force being exerted by the male luer 32. In some examples, the valve assembly 28 is designed to close automatically upon removal of the actuator force. The back pressure helps to seal the valve assembly 28 and prevent fluid/blood leakage or backflow.

It is to be understood that while blood back pressure can be beneficial in some cases, it is not an essential requirement for valve assembly 28 closure in all catheter assembly 10 designs. The valve assembly 28 can be designed to close effectively using only the force provided by the actuator mechanism, without relying on blood back pressure. This ensures that the valve assembly 28 can function properly even in situations where blood back pressure is minimal or absent, such as when the catheter 20 is not actively being used for blood withdrawal or infusion. Such flexibility in design provides robust and effective vascular access solutions that can adapt to various clinical scenarios and user preferences.

Referring to Fig. 11A, it illustrates a cross-sectional view of a catheter assembly 110 for vascular access comprising a catheter hub 112 having an interior housing 114 extending between a proximal end 116 and a distal end 118 thereof; a catheter tube 120 is attached to the distal end 118 of the catheter hub 112; a needle 122 (not shown) with a needle tip 124 connected to a needle hub 126 is movably received within the catheter hub 112 exposing the needle tip 122 out of the catheter tube 120. The catheter hub 112 comprises valve assemblies including a valve assembly 128 and a valve actuator assembly 130 in a closed position for use with catheters or other medical devices/introducers according to some examples of the present disclosure. The valve assembly 128 is fixedly located within the housing 114 which is configured to selectively permit or block a flow of fluid through the catheter 120. At least a part/portion of the valve actuator assembly 130 is slidably retained by the valve assembly 128 as shown in Fig. 11A.

The catheter hub 112 has an inner surface 138 and an outer surface 140. The distal end 118 of the catheter hub 112 includes a catheter opening that connects to the proximal end of the catheter tube 120 which in turn is connected to the catheter hub 112 ensuring a seamless transition for fluid flow. The proximal end 116 of the catheter hub includes a tapered opening 142, for example a luer connector opening. The inner surface 138 of the catheter hub 112 surrounds a channel 146 that runs through the length of the catheter hub 112, enabling fluid passage through the catheter hub 112. The inner surface 138 includes one or more projections 148a that serve to securely hold the valve assembly 128 in place. These projections 148a are positioned to provide a stable and secure fit for the valve assembly 128, preventing any unwanted movement or dislodgement during use.

The valve actuator assembly 130 is designed to transition between two distinct operational positions i.e. a closed position 136 and an open position 134, relative to the valve assembly 128. In its closed position 136, the valve actuator assembly 130 is configured such that at least a part/portion of the valve actuator assembly 130 is securely retained with/by the valve assembly 128 effectively preventing fluid flow through the catheter assembly 110 as shown in Fig. 11A. When transitioning to the open position 134, the operation is initiated by the insertion of a luer connector 132 into interior housing 114 which exerts a force on the valve assembly 128, which in turn facilitates the movement of both the valve assembly 128 and the valve actuator assembly 130. As a result, such a coordinated movement causes the leaflets 154 of the valve assembly 128 to open, thereby allowing fluid to flow through the catheter assembly 110 as depicted in Fig. 11B. It is important to note that throughout this operational cycle, at least a part or portion of the valve actuator assembly 130 remains securely retained or locked within the valve assembly 128, providing stability and control during operation, ensuring that even under varying pressures or forces applied via the luer connector 132, the integrity of both assemblies is maintained. As force is applied through the luer connector 132, it compresses the sidewall 156 of the valve assembly 128 as shown in Fig. 11M. Such compression is a critical aspect of the design, as it facilitates the valve actuator assembly 130 to open the leaflets 154 of the valve assembly 128 by creating sufficient clearance for fluid passage as depicted in Fig. 11B.

As illustrated in Fig. 11B, the insertion of the luer connector 132 in the direction of the catheter tube 120 causes the valve assembly 128 to transition from the closed position 136 to the open position 134. The movement causing the valve assembly 128 to the open position 134 is facilitated by the interaction between the luer connector 132 and the valve actuator assembly 130. Once the luer connector 132 is retracted or removed from the interior housing 114 in a direction opposite to the catheter tube 120, the sidewall 156 of the valve assembly 128, which had previously been compressed during the valve assembly 128 opening phase, is allowed to return to its original decompressed shape or state causing the valve actuator assembly 130 to automatically retract to its first position. As the sidewall 156 expands back to its original configuration, it exerts a restoring force on the valve actuator assembly 130. Such a force effectively drives the actuator assembly 130 to retract, thereby repositioning it into its first position. Consequently, such a retraction leads to the closure of the valve assembly 128, transitioning it back to the closed position 136, as illustrated in Fig. 11A. Thus, the withdrawal of the luer connector 132 causes the valve assembly 128 to close and return to the closed position 136, as depicted in Fig. 11A. The automatic nature of this retraction mechanism is an essential feature of the design, ensuring that once fluid flow is no longer required—such as when the luer connector is disengaged or removed—the catheter assembly 110 reverts to a secure and closed state without requiring additional manual intervention. Such automatic closure of the valve assembly 128 not only enhances user convenience but also significantly reduces the risk of accidental fluid leakage or contamination during procedures ensuring that the valve assembly 128 remains securely closed when not in use, preventing any leakage or unintended flow. Further, at least a part/portion of the valve actuator assembly 130 is configured to be engageably retained by/with the valve assembly 128 in both the first position (closed) and the second position (open) during multiple usage cycles. Such features maintain the cycle of open and closed positions, allowing for repeated and reliable operation of the valve without compromising its integrity or functionality. Further, the engageable retention of the valve actuator assembly 130 in both the first and second positions allows for reliable and consistent operation of the valve assembly 128 without compromising the integrity of the actuator-valve connection.

Figs. 11C to 11I illustrate an example of a valve actuator assembly 130 which can be positioned being within the interior housing 114 of the catheter hub 112 wherein at least a part/portion of the valve actuator assembly 130 is retained by the valve assembly 128 as shown in Figs. 11A & 11B. Being partially retained by the valve assembly 128, the valve actuator assembly 130 is movable in an upward and a downward direction and, thus movable axially to engage and open the slits 152 as shown in Fig. 11B. The valve actuator assembly 130 has a top section 172, a mid-section 174 and a bottom section 176. The valve actuator assembly 130 comprises a body 166 having a proximal end 116b and a distal end 118b, a flow path 168 surrounded by the body 166 runs therethrough having an opening 170 at the distal end 118b as shown in Fig. 11G. The flow path 168 facilitates fluid to flow through the valve assembly 128 and through the valve actuator assembly 130 when the valve assembly 128 is opened or penetrated by the valve actuator assembly 130 when the male luer 132 creates a pushing force as shown in Fig. 11B.

The valve actuator assembly 130 comprises one or more retaining protrusions 178 to keep at least a part/portion, in particularly a distal part of the valve actuator assembly 130 retained within the inner space 160 of the valve assembly 128 as depicted in Fig. 11A. The top section 172 of the valve actuator assembly 130 forms the distal end 118b with a substantially flat top surface. In one example, the mid-section 174 comprises a retaining protrusion 178 which engages with and retained by a recessed portion 186 of the valve assembly 128. The retaining protrusion 178 keeps at least a part/portion, in particularly a distal part of the valve actuator assembly 130 securely retained within the inner space 160 of the valve assembly 128 through the retaining member 162 as shown in Fig. 11A when the retaining protrusion 178 is securely received by the recessed portion 186. The top section 172 and mid-section 174 of the valve actuator assembly 130 is substantially tubular. The bottom section 176 of the valve actuator assembly 130 comprises a skirt portion 180 which forms the proximal end 116b of the valve actuator assembly 130 as shown in Figs. 11C to 11I. Once retained by the valve assembly 128, the skirt portion 180 may or may not be in contact with the inner surface 138 of the catheter hub 112. The shape and structure of the valve actuator assembly 130 is not limited only to the example as shown in Figs. Figs. 11C to 11I and may include other variations, shapes and dimensions. These and other variations may incorporate different geometries, sizes and features compared to the examples shown in Figs. 11C to 11I. The specific shape and structure chosen for the actuator assembly 130 may be tailored to meet the requirements of different catheter assembly designs, other medical devices, medical applications and user preferences.

Referring now to Figs. 11J-11P, the valve assembly 128 is positioned within the interior housing 114 of the catheter hub 112 as shown in Figs. 11A & 11B forming a fluid-tight seal being configured to selectively allow fluid to or from the catheter tube 120. As depicted in Figs. 11A & 11B, the valve assembly 128 is held in a position against an internal wall 150 formed on the inner surface 138 of the catheter hub 112, preventing any movement of the valve assembly 128. The valve assembly 128 is further held by one or more projections 148a to retain the valve assembly 128 in place limiting or preventing any proximal or distal movement thereof ensuring safe retention of the valve assembly 128 within the interior housing 114 of the catheter hub 112.

Referring further to Figs. 11J-11P, the valve assembly 128 has a proximal end 116a and a distal end 118a, a sidewall 156 therebetween, an inner space 160 and a barrier layer 158 at the distal end 118a to prevent fluid flow as depicted in Fig. 11M. The proximal end 116a of the valve assembly 128 has an opening 188 having a diameter to receive the valve actuator assembly 130 as shown in Figs. 11M & 11N. The valve assembly 128, not being limited to has a tubular body and a rectangular outer profile. It is to be understood that the valve assembly 128 may have other outer profiles such as square, or any other geometrical shapes etc.
The sidewall 156 has an inner sidewall 156b and an outer sidewall 156a as shown in Fig. 11M. The sidewall 156 comprises one or more projections/protrusions 148c forming compressible features which act as a spring. Projections/protrusions 148c can be circular, intermittent circular, or of other shapes. The inner sidewall 156b of the valve assembly 128 further comprises a recessed portion 186 in the proximal end 116a region adjoining projections/protrusions 148c. The valve assembly 128 is fixedly retained by one or more projections 148a of the catheter hub 112 which keep the valve assembly 128 securely in place within the catheter hub 112 as shown in Fig. 11A. Further, the inner sidewall 156b of the valve assembly 128 at its proximal end 116a comprises a retaining member 162 as shown in Figs. 11A & 11B, Fig. 11M. The retaining member 162 together with the recessed portion 186 keeps at least a portion of the valve actuator assembly 130 securely retained with the valve assembly 128 as shown in Figs. 11A & 11B.
As depicted in Figs. Figs. 11J-11P the valve assembly 128 further comprises a plurality of flow channels 164. The flow channels 164 are disposed on the outer sidewall 156a of the valve assembly 128. These flow channels 164 are designed to facilitate the controlled release of air while preventing the undesirable flow of fluid or blood through the valve assembly 128. In one example, as depicted in Figs. 11N & 11O, the flow channels 164 are equidistantly spaced around the circumference of the outer sidewall 156a of the valve assembly 128, from each other. Such uniform distribution ensures an even and efficient release of air from the valve assembly 128. Alternatively, the flow channels 164 may be without having any equidistance arrangement. The numbers and positions of the flow channels 164 may vary in alternate examples to accommodate different design requirements or specific applications. The strategic placement of the flow channels 164 can be adjusted to optimize air release while preventing flow of fluid or blood therefrom. The flow channels 164 have an appropriate depth and width to allow for the effective escape of air only while preventing the flow of fluid or blood therethrough. With these flow channels 164 with its optimized dimensions and distribution, the valve assembly 128 can effectively release air while maintaining its primary function of preventing the backflow of fluid/blood.

Furthermore, as depicted in Fig. 11O, the valve assembly 128 has one or more pre-formed openings or slits 152 forming one or more flaps or leaflets 154 as shown in Fig. 11B. The slits 152 and the flaps 154 formations designed to selectively allow fluid or to selectively prevent unwanted fluid flow therefrom. In one example, as shown in Fig. 11O, the valve assembly 128 has at least three intersecting slits 152 forming three flaps 154 that open when engaged by a valve actuator 132 as depicted in Fig. 11B. In one example, the barrier layer 158 may comprise at least one slit 152. Alternatively, the barrier layer 158 may comprise a plurality of slits 152 forming a plurality of flaps 154 that open upon deformation of the valve assembly 128. It is to be understood that the number of slits 152 is not limited to the illustrated examples and may vary with various numbers and positions of slits 152.

The barrier layer 158 comprising the variations of the slits 152 are opened through elastic deformation rather than pressure within the catheter assembly 110. For example, the variation of the slits 152 require the luer connector 132 or a male luer to elastically deform the valve assembly 128 and/or the barrier layer 158 comprising the slits 152 to selectively permit fluid flow through the valve assembly 128 as shown in Fig. 11B. To this end, as depicted in Fig. 11B, when the luer connector or male luer 132 is received within the catheter hub 112, it pushes the valve actuator assembly 130 upward in the direction of the catheter tube 120, opening the slits 152 of the valve assembly 128. The retaining protrusion 178 of the valve actuator assembly 130 which engages with and retained by the recessed portion 186 of the valve assembly 128 regulates the upward and downward movement of the valve actuator assembly 130. Once the luer connector or male luer 132 disconnected or removed from the catheter hub 112, the retaining protrusion 178 returns to its original position causing the slits 152 of the valve assembly 128 to close stopping the flow of fluid therethrough as depicted in Fig. 11A.

Referring now to Figs. 12A & 12B, which illustrate cross-sectional views of a catheter assembly 210 for vascular access comprising valve assemblies including a valve assembly 228 and a valve actuator assembly 230 in an open and closed position respectively for use with catheters or other medical devices/introducers according to some examples of the present disclosure, wherein except for the valve assembly 228, all other part, components, features and mechanism of the catheter assembly 210 is similar to the catheter assembly 110 shown in Figs. 11A & 11B. Being similar to the arrangement shown in Figs. 11A & 11B and apparent in Figs. 12A & 12B, the valve actuator assembly 230 comprises a body 166 having a proximal end 216b and a distal end 218b, a flow path 268 surrounded by the body 266 runs therethrough having an opening 270 at the distal end 218b, wherein body 166 of the valve actuator assembly 230 has a top section 272, a mid-section 274 and a bottom section 276.

Referring now to Figs. 12C-12I, the valve assembly 228 is positioned within the interior housing 214 of the catheter hub 212 as shown in Figs. 12A & 12B forming a fluid-tight seal being configured to selectively allow fluid to or from the catheter tube 220. As depicted in Figs. 12A & 12B, the valve assembly 228 is held in a position against an internal wall 250 formed on the inner surface 238 of the catheter hub 212, preventing any movement of the valve assembly 228. The valve assembly 228 is further held by one or more projections 248a to retain the valve assembly 228 in place limiting or preventing any proximal or distal movement thereof ensuring safe retention of the valve assembly 228 within the interior housing 214 of the catheter hub 212.

Referring further to Figs. 12C-12I, the valve assembly 228 has a proximal end 216a and a distal end 218a, a sidewall 256 therebetween, an inner space 260 and a barrier layer 258 at the distal end 218a to prevent fluid flow as depicted in Fig. 12C. The proximal end 216a of the valve assembly 228 has an opening 288 having a diameter to receive the valve actuator assembly 230 as shown in Figs. 12C & 12G. The valve assembly 228, not being limited to has a tubular body and a rectangular outer profile. It is to be understood that the valve assembly 228 may have other outer profile such as square, or any other geometrical shapes etc.
The sidewall 256 has an inner sidewall 256b and an outer sidewall 256a as shown in Fig. 12C. The sidewall 256 comprises one or more projections/protrusions 248c forming compressible features which act as a spring. In one example, not being limited to, as depicted in Figs. 12C to 12G, the compressible features are formed in a region of the distal end 218a. Projections/protrusions 248c can be circular, intermittent circular, or of other shapes. The inner sidewall 256b of the valve assembly 228 further comprises at least one recessed portion 286 in the proximal end 216a thereof. The valve assembly 228 is fixedly retained by one or more projections 248a of the catheter hub 212 which keep the valve assembly 228 securely in place within the catheter hub 212 as shown in Fig. 12A. Further, the inner sidewall 256b of the valve assembly 228 at its proximal end 216a comprises a retaining member 262 as shown in Fig. 12C. The retaining member 262 together with the recessed portion 286 keeps at least a portion of the valve actuator assembly 230 securely retained with the valve assembly 228 as shown in Figs. 12A & 12B.
As depicted in Figs. 12C-12I, the valve assembly 228 further comprises a plurality of flow channels 264. The flow channels 264 are disposed on the outer sidewall 256a of the valve assembly 228. These flow channels 264 are designed to facilitate the controlled release of air while preventing the undesirable flow of fluid or blood through the valve assembly 228. In one example, as depicted in Fig. 12C, the flow channels 264 are equidistantly spaced around the circumference of the outer sidewall 256a of the valve assembly 228, from each other. Such a uniform distribution ensures an even and efficient release of air from the valve assembly 228. Alternatively, the flow channels 264 may be without having any equidistance arrangement. The numbers and positions of the flow channels 264 may vary in alternate examples to accommodate different design requirements or specific applications. The strategic placement of the flow channels 264 can be adjusted to optimize air release while preventing flow of fluid or blood therefrom. The flow channels 264 have an appropriate depth and width to allow for the effective escape of air only while preventing the flow of fluid or blood therethrough. With these flow channels 264 with its optimized dimensions and distribution, the valve assembly 228 can effectively release air while maintaining its primary function of preventing the backflow of fluid/blood.

Furthermore, as depicted in Fig. 12I, the valve assembly 228 has one or more pre-formed openings or slits 252 forming one or more flaps or leaflets 254 as shown in Fig. 12B. The slits 252 and the flaps 254 formations designed to selectively allow fluid or to selectively prevent unwanted fluid flow therefrom. In one example, as shown in Fig. 12I, the valve assembly 228 has at least three intersecting slits 252 forming three flaps 254 that open when engaged by a valve actuator 232 as depicted in Fig. 12B. In one example, the barrier layer 258 may comprise at least one slit 252. Alternatively, the barrier layer 258 may comprise a plurality of slits 252 forming a plurality of flaps 254 that open upon deformation of the valve assembly 228. It is to be understood that the number of slits 252 is not limited to the illustrated examples and may vary with various numbers and positions of slits 252.

The barrier layer 258 comprising the variations of the slits 252 are opened through elastic deformation rather than pressure within the catheter assembly 210. For example, the variation of the slits 252 require the luer connector or a male luer 232 to elastically deform the valve assembly 228 and/or the barrier layer 258 comprising the slits 252 to selectively open to an open position 234 permitting fluid flow through the valve assembly 228 as shown in Fig. 12B. To this end, as depicted in Fig. 12B, when the luer connector or male luer 232 is received within the catheter hub 212, the insertion of the luer connector 232 in the interior housing 214 exerts force on the valve assembly 228, thereby pushing both the valve assembly 228 and the valve actuator assembly 230 to open the leaflets 254 as shown in Fig. 12B. The valve actuator assembly 230 remains securely retained or locked within the valve assembly 228, providing stability during operation. As the user applies force via the luer connector 232, it exerts force on the compressible features of the sidewall 256 of the valve assembly 228 as shown in Fig. 12C, which in turn opens the leaflets 254 of the valve assembly 228, allowing fluid to pass through as shown in Fig. 12B. The luer connector 232 thus exerts force on the compressible features of the valve assembly 228, wherein the compressible features act as a spring allowing the valve actuator assembly 230 to open the slits 252 of the valve assembly 228.

The retaining protrusion 278 of the valve actuator assembly 230 which engages with and retained by the recessed portion 286 of the valve assembly 228 regulates the upward and downward movement of the valve actuator assembly 230. Once the luer connector or male luer 232 disconnected or removed from the catheter hub 212, the sidewall 256 of the valve assembly 228 returns to its original decompressed shape causing the valve actuator assembly 230 to automatically retract to its first position, causing the valve assembly 228 to close and return to the closed position 236 stopping the flow of fluid therethrough as depicted in Fig. 12A.

Referring now to Figs. 13A & 13B, which illustrate cross-sectional views of a catheter assembly 310 for vascular access comprising valve assemblies including a valve assembly 328 and a valve actuator assembly 330 in an open and closed position respectively for use with catheters or other medical devices/introducers according to some examples of the present disclosure, wherein except for the valve assembly 328 and the valve actuator assembly 330, all other part, components, features and mechanism of the catheter assembly 310 is similar to the catheter assembly 210 shown in Figs. 12A & 12B.

Figs. 13C and 13D illustrate an example of a valve actuator assembly 330 which can be positioned being within the interior housing 314 of the catheter hub 312 wherein at least a part/portion of the valve actuator assembly 330 is retained by the valve assembly 328 as shown in Figs. 13A & 13B. Being partially retained by the valve assembly 328, the valve actuator assembly 330 is movable in an upward and a downward direction and, thus movable axially to engage and open the slits 352 as shown in Fig. 13B. The valve actuator assembly 330 has a top section 372, a mid-section 374 and a bottom section 376. The top section 372 and the mid-section 374 have a tapered profile corresponding to a tapered profile of an inner space 360 of the valve assembly 328 as shown in Fig. 13F. Further, the valve actuator assembly 330 comprises a body 366 having a proximal end 316b and a distal end 318b, a flow path 368 surrounded by the body 366 runs therethrough having an opening 370 at the distal end 318b as shown in Fig. 13D. The flow path 368 facilitates fluid to flow through the valve assembly 328 and through the valve actuator assembly 330 when the valve assembly 328 is opened or penetrated by the valve actuator assembly 330 when the male luer 332 creates a pushing force being exerted by a user as shown in Fig. 13B.

The valve actuator assembly 330 comprises one or more retaining protrusions 378 to keep at least a part/portion, in particularly a distal part of the valve actuator assembly 330 securely retained within the inner space 360 of the valve assembly 328. The top section 372 of the valve actuator assembly 330 forms the distal end 318b with a substantially flat top surface. In one example, the mid-section 374 comprises a first retaining protrusion 378 which engages with and retained by a retaining member 362 of the valve assembly 328. The first retaining protrusion 378 keeps at least a part/portion, in particularly a distal part of the valve actuator assembly 330 securely retained within the inner space 360 of the valve assembly 328 through the retaining member 362 as shown in Figs. 13A & 13B. The mid-section 374 of the valve actuator assembly 330 further comprises a second retaining protrusion 378a. The top section 372 and mid-section 374 of the valve actuator assembly 330 are substantially tubular. The bottom section 376 of the valve actuator assembly 330 comprises a skirt portion 380 which forms the proximal end 316b of the valve actuator assembly 330 as shown in Figs. 13C and 13D. The skirt portion 380 further extending into formation of legs 382 comprising one or more alignment features 384 to keep the valve actuator assembly 330 in its designated location within interior housing 314 of the catheter hub 312.

Once retained by the valve assembly 328, the skirt portion 380 may or may not be in contact with the inner surface 338 of the catheter hub 312. The shape and structure of the valve actuator assembly 330 is not limited only to the example as shown in Figs. Figs. 13C and 13D and may include other variations, shapes and dimensions. These and other variations may incorporate different geometries, sizes and features compared to the examples shown in Figs. 13C and 13D. The specific shape and structure chosen for the actuator assembly 330 may be tailored to meet the requirements of different catheter assembly designs, other medical devices, medical applications and user preferences.

Referring now to Figs. 13E-13H, the valve assembly 328 is positioned within the interior housing 314 of the catheter hub 312 as shown in Figs. 13A & 13B forming a fluid-tight seal being configured to selectively allow fluid to or from the catheter tube 320. As depicted in Figs. 13A & 13B, the valve assembly 328 is held in a position against an internal wall 350 formed on the inner surface 338 of the catheter hub 312, preventing any movement of the valve assembly 328. The valve assembly 328 is further held by one or more projections 348a to retain the valve assembly 328 in place limiting or preventing any proximal or distal movement thereof ensuring safe retention of the valve assembly 328 within the interior housing 314 of the catheter hub 312.

Referring further to Figs. 13E-13H, the valve assembly 328 has a proximal end 316a and a distal end 318a, a sidewall 356 therebetween, an inner space 360 having a tapered profile and a barrier layer 358 at the distal end 318a to prevent fluid flow as depicted in Figs. 13E & 13F. The proximal end 316a of the valve assembly 328 has an opening 388 having a diameter to receive the valve actuator assembly 330 as shown in Figs. 13F & 13H. The valve assembly 328, not being limited to has a tubular body and a rectangular outer profile. It is to be understood that the valve assembly 328 may have other outer profile such as square, any other geometrical shapes etc.
The sidewall 356 has an inner sidewall 356b and an outer sidewall 356a as shown in Fig. 13F. The sidewall 356 comprises one or more projections/protrusions 348c forming compressible features which act as a spring. In one example, not being limited to, as depicted in Figs. 13E to 13G, the compressible features are formed in a region of the proximal end 318a. Projections/protrusions 348c can be circular, intermittent circular, or of other shapes. The valve assembly 328 is fixedly retained by the engagement of compressible features and one or more projections 348a of the catheter hub 312 which keep the valve assembly 328 securely in place within the catheter hub 312 as shown in Figs. 13A & 13B. Further, the inner sidewall 356b of the valve assembly 328 comprises a retaining member 362 as shown in Fig. 13F. The retaining member 362 together with the first retaining protrusion 378 keeps at least a portion of the valve actuator assembly 330 securely retained with the valve assembly 328 as shown in Figs. 13A & 13B. Prior to use or before actuation as shown in Fig. 13A the compressible features of the valve assembly 328 are arranged in between the first retaining protrusion 378 and the second retaining protrusion 378a of the valve actuator assembly 330.
As depicted in Figs. 13E-13H, the valve assembly 328 further comprises a plurality of flow channels 364. The flow channels 364 are disposed on the outer sidewall 356a of the valve assembly 328. These flow channels 364 are designed to facilitate the controlled release of air while preventing the undesirable flow of fluid or blood through the valve assembly 328 during use. In one example, as depicted in Fig. 13G, the flow channels 364 are equidistantly spaced around the circumference of the outer sidewall 356a of the valve assembly 328, from each other. Such a uniform distribution ensures an even and efficient release of air from the valve assembly 328. Alternatively, the flow channels 364 may be without having any equidistance arrangement. The numbers and positions of the flow channels 364 may vary in alternate examples to accommodate different design requirements or specific applications. The strategic placement of the flow channels 364 can be adjusted to optimize air release while preventing flow of fluid or blood therefrom. The flow channels 364 have an appropriate depth and width to allow for the effective escape of air only while preventing the flow of fluid or blood therethrough. With these flow channels 364 with its optimized dimensions and distribution, the valve assembly 328 can effectively release air while maintaining its primary function of preventing the backflow of fluid/blood.

Furthermore, as depicted in Fig. 13G, the valve assembly 328 has one or more pre-formed openings or slits 352 forming one or more flaps or leaflets 354 as shown in Fig. 13B. The slits 352 and the flaps 354 formations designed to selectively allow fluid or to selectively prevent unwanted fluid flow therefrom. In one example, as shown in Fig. 13G, the valve assembly 328 has at least three intersecting slits 352 forming three flaps 354 that open when engaged by a valve actuator 332 as depicted in Fig. 13B. In one example, the barrier layer 358 may comprise at least one slit 352. Alternatively, the barrier layer 358 may comprise a plurality of slits 352 forming a plurality of flaps 354 that open upon deformation of the valve assembly 328. It is to be understood that the number of slits 352 is not limited to the illustrated examples and may vary with various numbers and positions of slits 352.

The barrier layer 358 comprising the variations of the slits 352 are opened through elastic deformation rather than pressure within the catheter assembly 310. For example, the variation of the slits 352 require the luer connector or a male luer 332 to elastically deform the valve assembly 328, in particularly the compressible features of the valve assembly 328 as depicted in Fig. 13B and/or the barrier layer 358 comprising the slits 352 to selectively permit fluid flow through the valve assembly 328 as shown in Fig. 13B. To this end, as depicted in Fig. 13B, the insertion of the luer connector or male luer 332 into the catheter hub 312 exerts a force on the valve assembly 328, effectively pushing both the valve assembly 328 and the valve actuator assembly 330 to open the leaflets 354 thereby allowing fluid to flow through as shown in Fig. 13B. The valve actuator assembly 330 is designed such that at least a part or portion thereof remains securely retained or locked within the valve assembly 328, providing stability during operation. Such a secure retention is helpful in maintaining operational integrity, especially under varying pressures that may be encountered during use. As the user applies force via the luer connector 332, it exerts force on the compressible features of the sidewall 356 of the valve assembly 328 as shown in Fig. 13F, which in turn opens the leaflets 354 of the valve assembly 328, allowing fluid to pass through as shown in Fig. 13B. The compressible features of the valve assembly 328 are engineered to function similarly to a spring mechanism wherein they store potential energy when compressed and release it to facilitate controlled movement. This unique design allows for a precise opening of the leaflets 354 of the valve assembly 328, enabling fluid passage while ensuring that the leaflets 354 return to their closed position when not actuated. The luer connector 332 thus exerts force on the compressible features of the valve assembly 328, wherein the compressible features act as a spring allowing the valve actuator assembly 330 to open the slits 352 of the valve assembly 328.

Further, a part or portion of the valve actuator assembly 330 located above the first retaining protrusion 378 as depicted in Figs. 13C & 13D, is constructed with a specific length that plays a crucial role in preventing overextension during operation. When upward force is applied by the luer connector 332, causing the first retaining protrusion 378 to move upwards, this design ensures that the top end of the valve actuator assembly 330 does not exceed its intended range of motion beyond the leaflets 354 when they are in the open position 334, as shown in Fig. 13B. Thus, the first retaining protrusion 378 in combination with said specific length of the valve actuator assembly 330 prevents the top end thereof to move beyond the leaflets 354 in the open position 334.

The second retaining protrusion 378a of the valve actuator assembly 330 which supports and engages with the valve assembly 328 regulates the upward and downward movement of the valve actuator assembly 330. Once the luer connector or male luer 332 is disconnected or removed from the catheter hub 312, the sidewall 356 of the valve assembly 328 returns to its original decompressed shape or state causing the valve actuator assembly 330 to automatically retract to its first position, causing the valve assembly 328 to close and return to the closed position 336 stopping the flow of fluid therethrough as depicted in Fig. 13A.

Referring now to Figs. 14A & 14B, which illustrate cross-sectional views of a catheter assembly 410 for vascular access comprising valve assemblies including a valve assembly 428 and a valve actuator assembly 430 in an open and closed position respectively for use with catheters or other medical devices/introducers according to some examples of the present disclosure, wherein except for the valve actuator assembly 430, all other part, components, features and mechanism of the catheter assembly 410 is similar to the catheter assembly 310 shown in Figs. 13A & 13B.

Figs. 14C and 14D illustrate an example of a valve actuator assembly 430 which is positioned being within the interior housing 414 of the catheter hub 412 wherein at least a part/portion of the valve actuator assembly 430 is retained by the valve assembly 428 as shown in Figs. 14A & 14B. Being partially retained by the valve assembly 428, the valve actuator assembly 430 is movable in an upward and a downward direction and, thus movable axially to engage and open the slits 452 as shown in Fig. 14B. The valve actuator assembly 430 has a top section 472, a mid-section 474 and a bottom section 476. The top section 472 and the mid-section 474 have a tapered profile corresponding to a tapered profile of an inner space 460 of the valve assembly 428 as shown in Fig. 14F. Further, the valve actuator assembly 430 comprises a body 466 having a proximal end 416b and a distal end 418b, a flow path 468 surrounded by the body 466 runs therethrough having an opening 470 at the distal end 418b as shown in Fig. 14D. The flow path 468 facilitates fluid to flow through the valve assembly 428 and through the valve actuator assembly 430 when the valve assembly 428 is opened or penetrated by the valve actuator assembly 430 when the male luer 432 creates a pushing force being exerted by a user as shown in Fig. 14B.

The valve actuator assembly 430 comprises one or more retaining protrusions 478 to keep at least a part/portion, in particularly a distal part of the valve actuator assembly 430 securely retained within the inner space 460 of the valve assembly 428. The top section 472 of the valve actuator assembly 430 forms the distal end 418b with a substantially flat top surface. In one example, the mid-section 474 comprises at least one retaining protrusion 478 which engages with and retained by a retaining member 462 of the valve assembly 428. The retaining protrusion 478 keeps at least a part/portion, in particularly a distal part of the valve actuator assembly 430 securely retained within the inner space 460 of the valve assembly 428 through the retaining member 462 as shown in Figs. 14A & 14B. The top section 472 and the mid-section 474 of the valve actuator assembly 430 are substantially tubular in shape. The bottom section 476 of the valve actuator assembly 430 comprises a skirt portion 480 as shown in Figs. 14C and 14D. The skirt portion 480 further extend into formation of legs 482 comprising one or more alignment features 484 to keep the valve actuator assembly 430 in its designated location within interior housing 414 of the catheter hub 412. As shown in Fig. 14B, when the valve assembly 428 is in an open position, the skirt portion 480, in particularly top end part of the skirt portion 480 abuts the proximal end of the valve assembly 428. Such an abutment ensures that the flaps or leaflets 454 are properly opened and closed to the extent that the top end of the top section 472 of the actuator assembly 430 never moves in the distal or forward direction out from the flaps or leaflets 454 even when a pushing force is exerted by the male luer 432 to open the flaps or leaflets 454. Once the luer connector 432 is retracted or removed, the valve actuator assembly 430 automatically retracts to its first position, causing the valve assembly 428 to close and return to the closed position 436, as depicted in Figs. 14A & 14B ensuring that the valve assembly 428 remains securely closed when not in use, preventing any leakage or unintended flow.

Referring now to Figs. 14E-14H, the valve assembly 428 is positioned within the interior housing 414 of the catheter hub 412 as shown in Figs. 14A & 14B forming a fluid-tight seal being configured to selectively allow fluid to or from the catheter tube 420. As depicted in Figs. 14A & 14B, the valve assembly 428 is held in a position against an internal wall 450 formed on the inner surface 438 of the catheter hub 412, preventing any movement of the valve assembly 428. The valve assembly 428 is further held by one or more projections 448a to retain the valve assembly 428 in place limiting or preventing any proximal or distal movement thereof ensuring safe retention of the valve assembly 428 within the interior housing 414 of the catheter hub 412.

Referring further to Figs. 14E-14H, the valve assembly 428 has a proximal end 416a and a distal end 418a, a sidewall 456 there between, an inner space 460 having a tapered profile and a barrier layer 458 at the distal end 418a to prevent fluid flow as depicted in Figs. 14E & 14F. The proximal end 416a of the valve assembly 428 has an opening 488 having a diameter to receive the valve actuator assembly 430 as shown in Figs. 14F & 14H. The valve assembly 428, not being limited to has a tubular body and a rectangular outer profile. It is to be understood that the valve assembly 428 may have other outer profile such as square, or any other geometrical shapes etc.
The sidewall 456 has an inner sidewall 456b and an outer sidewall 456a as shown in Fig. 14F. The sidewall 456 comprises one or more projections/protrusions 448c forming compressible features which act as a spring. In one example, not being limited to, as depicted in Figs. 14E to 14G, the compressible features are formed in a region of the proximal end 418a of the valve assembly 428. Projections/protrusions 448c can be circular, intermittent circular, or of other shapes. The valve assembly 428 is fixedly retained by the engagement of compressible features and one or more projections 448a of the catheter hub 412 which keep the valve assembly 428 securely in place within the catheter hub 412 as shown in Figs. 14A & 14B. Further, the inner sidewall 456b of the valve assembly 428 comprises a retaining member 462 as shown in Fig. 14F. The retaining member 462 together with the retaining protrusion 478 keeps at least a portion of the valve actuator assembly 430 securely retained with the valve assembly 428 as shown in Figs. 14A & 14B. Prior to use or before actuation as shown in Fig. 14A the compressible features of the valve assembly 428 are arranged in between the retaining protrusion 478 and the skirt portion 480 of the valve actuator assembly 430.
As depicted in Figs. 14E-14H, the valve assembly 428 further comprises a plurality of flow channels 464. The flow channels 464 are disposed on the outer sidewall 456a of the valve assembly 428. These flow channels 464 are designed to facilitate the controlled release of air while preventing the undesirable flow of fluid or blood through the valve assembly 428 during use. In one example, as depicted in Fig. 14G, the flow channels 464 are equidistantly spaced around the circumference of the outer sidewall 456a of the valve assembly 428, from each other. Such a uniform distribution ensures an even and efficient release of air from the valve assembly 428. Alternatively, the flow channels 464 may be without having any equidistance arrangement. The numbers and positions of the flow channels 464 may vary in alternate examples to accommodate different design requirements or specific applications. The strategic placement of the flow channels 464 can be adjusted to optimize air release while preventing flow of fluid or blood therefrom. The flow channels 464 have an appropriate depth and width to allow for the effective escape of air only while preventing the flow of fluid or blood therethrough. With these flow channels 464 with its optimized dimensions and distribution, the valve assembly 428 can effectively release air while maintaining its primary function of preventing the backflow of fluid/blood.

Furthermore, as depicted in Fig. 14G, the valve assembly 428 has one or more pre-formed openings or slits 452 forming one or more flaps or leaflets 454 as shown in Fig. 14B. The slits 452 and the flaps 454 formations designed to selectively allow fluid or to selectively prevent unwanted fluid flow therefrom. In one example, as shown in Fig. 14G, the valve assembly 428 has at least three intersecting slits 452 forming three flaps 454 that open when engaged by a valve actuator 430 as depicted in Fig. 14B. In one example, the barrier layer 458 may comprise at least one slit 452. Alternatively, the barrier layer 458 may comprise a plurality of slits 452 forming a plurality of flaps 454 that open upon deformation of the valve assembly 428. It is to be understood that the number of slits 452 is not limited to the illustrated examples and may vary with various numbers and positions of slits 452.

The barrier layer 458 comprising the variations of the slits 452 are opened through elastic deformation rather than pressure within the catheter assembly 410. For example, the variation of the slits 452 require the luer connector or a male luer 432 to elastically deform the valve assembly 428, in particularly the compressible features of the valve assembly 428 as depicted in Fig. 14B and/or the barrier layer 458 comprising the slits 452 to selectively permit fluid flow through the valve assembly 428 as shown in Fig. 14B. To this end, as depicted in Fig. 14B, when the luer connector or male luer 432 is received within the catheter hub 412, the insertion of the luer connector 432 in the interior housing 414 exerts force on the valve assembly 428, thereby pushing both the valve assembly 428 and the valve actuator assembly 430 to open the leaflets 454 as shown in Fig. 14B. The valve actuator assembly 430 remains securely retained or locked within the valve assembly 428, providing stability during operation. As the user applies force via the luer connector 432, it exerts force on the compressible features of the sidewall 456 of the valve assembly 428 as shown in Fig. 14F, which in turn opens the leaflets 454 of the valve assembly 428, allowing fluid to pass through as shown in Fig. 14B. The luer connector 432 thus exerts force on the compressible features of the valve assembly 428, wherein the compressible features act as a spring allowing the valve actuator assembly 430 to open the slits 452 of the valve assembly 428. A part or portion of the valve actuator assembly 430, situated above the retaining protrusion 478 as depicted in Figs. 14C & 14D, is designed with a specific length that plays a critical role in the operational dynamics of the valve assembly 428. When the luer connector 432 exerts an upward force on the valve actuator assembly 430, this force causes the retaining protrusion 478 to move upwards as well. However, due to the predetermined length of the valve actuator assembly 430, the top end of the valve actuator assembly 430 is mechanically constrained from moving beyond the leaflets 454 when they are in the open position 434, as depicted in Fig. 14B. The retaining protrusion 478 acts as a physical stop, effectively preventing the top end of the valve actuator assembly 430 from exceeding its intended range of motion. By limiting this movement, the retaining protrusion 478 ensures that the leaflets 454 remain properly aligned and securely positioned within their designated opening, thereby facilitating optimal fluid flow while preventing potential damage or misalignment that could arise from excessive movement. Such a configuration provides a fail-safe mechanism that contributes to the overall stability and performance of the valve assembly 428, allowing for consistent operation even under varying pressures or conditions.

The skirt portion 480 of the valve actuator assembly 430 which supports and engages with the valve assembly 428 regulates the upward and downward movement of the valve actuator assembly 430. Once the luer connector or male luer 432 is disconnected or removed from the catheter hub 412, the sidewall 456 of the valve assembly 428 returns to its original decompressed shape or state causing the valve actuator assembly 430 to automatically retract to its first position, causing the valve assembly 428 to close and return to the closed position 436 stopping the flow of fluid therethrough as depicted in Fig. 14A.

Referring now to Figs. 15A & 15B, which illustrate cross-sectional views of a catheter assembly 510 for vascular access comprising valve assemblies including a valve assembly 528 and a valve actuator assembly 530 in an open and closed position respectively for use with catheters or other medical devices/introducers according to some examples of the present disclosure, wherein except for the valve actuator assembly 530, all other part, components, features and mechanism of the catheter assembly 510 is similar to the catheter assembly 210 shown in Figs. 12A & 12B.

Referring further to Figs. 15A and 15B, the valve actuator assembly 530 is positioned being within the interior housing 514 of the catheter hub 512 wherein at least a part/portion of the valve actuator assembly 530 is retained by the valve assembly 528. Being partially retained by the valve assembly 528, the valve actuator assembly 530 is movable in an upward and a downward direction and, thus movable axially to engage and open the slits 552 as shown in Fig. 15B. The valve actuator assembly 530 has a top section 572, a mid-section 574 and a bottom section 576. The top section 572 and the mid-section 574 have a profile corresponding to the profile of an inner space 560 of the valve assembly 528 as shown in Fig. 15C. Further, the valve actuator assembly 530 comprises a body 566 having a proximal end 516b and a distal end 518b, a flow path 568 surrounded by the body 566 runs therethrough having an opening 570 at the distal end 518b as shown in Figs. 15A & 15B. The flow path 568 facilitates fluid to flow through the valve assembly 528 and through the valve actuator assembly 530 when the valve assembly 528 is opened or penetrated by the valve actuator assembly 530 when the male luer 532 creates a pushing force being exerted by a user as shown in Fig. 15B.

The valve actuator assembly 530 comprises one or more retaining protrusions 578 to keep at least a part/portion, in particularly a distal part of the valve actuator assembly 530 securely retained within the inner space 560 of the valve assembly 528. The top section 572 of the valve actuator assembly 530 forms the distal end 518b with a substantially flat top surface. In one example, the mid-section 574 comprises a first retaining protrusion 578 which engages with and retained by a retaining member 562 of the valve assembly 528. The retaining protrusion 578 keeps at least a part/portion, in particularly a distal part of the valve actuator assembly 530 securely retained within the inner space 560 of the valve assembly 528 through the retaining member 562 as shown in Figs. 15A & 15B. The mid-section 574 of the valve actuator assembly further comprises a second retaining protrusion 578a. The top section 572 and the mid-section 574 of the valve actuator assembly 530 are substantially tubular in shape. The bottom section 576 of the valve actuator assembly 530 comprises a skirt portion 580 which forms the proximal end 516b of the valve actuator assembly 530 as shown in Figs. 15A and 15B. As shown in Fig. 15B, when the valve assembly 528 is in an open position, the second retaining protrusion 578a abuts the proximal end of the valve assembly 528. Such an abutment ensures that the flaps or leaflets 554 are properly opened and closed to the extent that the top end of the top section 572 of the actuator assembly 530 never moves in the distal or forward direction out from the flaps or leaflets 554 even when a pushing force is exerted by the male luer 532 to open the flaps or leaflets 554. Once the luer connector 532 is retracted or removed, the valve actuator assembly 530 automatically retracts to its first position, causing the valve assembly 528 to close and return to the closed position 536, as depicted in Fig. 15A ensuring that the valve assembly 528 remains securely closed when not in use, preventing any leakage or unintended flow.

Referring now to Figs. 15C-15I, the valve assembly 528 is positioned within the interior housing 514 of the catheter hub 512 as shown in Figs. 15A & 15B forming a fluid-tight seal being configured to selectively allow fluid to or from the catheter tube 520. As depicted in Figs. 15A & 15B, the valve assembly 528 is held in a position against an internal wall 550 formed on the inner surface 538 of the catheter hub 512, preventing any movement of the valve assembly 528. The valve assembly 528 is further held by one or more projections 548a to retain the valve assembly 528 in place limiting or preventing any proximal or distal movement thereof ensuring safe retention of the valve assembly 528 within the interior housing 514 of the catheter hub 512.

Referring further to Figs. 15C-15I, the valve assembly 528 has a proximal end 516a and a distal end 518a, a sidewall 556 therebetween, an inner space 560 and a barrier layer 558 at the distal end 518a to prevent fluid flow as depicted in Fig. 15C. The proximal end 516a of the valve assembly 528 has an opening 588 having a diameter to receive the valve actuator assembly 530 as shown in Figs. 15C & 15G. The valve assembly 528, not being limited to having a tubular body and a rectangular outer profile. It is to be understood that the valve assembly 528 may have other outer profile such as square, or any other geometrical shapes etc.
The sidewall 556 has an inner sidewall 556b and an outer sidewall 556a as shown in Fig. 15C. The sidewall 556 comprises one or more projections/protrusions 548c forming compressible features which act as a spring. In one example, not being limited to, as depicted in Figs. 15C to 15G, the compressible features are formed in a region of the distal end 518a of the valve assembly 528. Projections/protrusions 548c can be circular, intermittent circular, or of other shapes. The inner sidewall 556b of the valve assembly 528 further comprises at least one recessed portion 586 in the proximal end 516a thereof. The valve assembly 528 is fixedly retained by one or more projections 548a of the catheter hub 512 which keep the valve assembly 528 securely in place within the catheter hub 512 as shown in Fig. 15A. Further, the inner sidewall 556b of the valve assembly 528 at its proximal end 516a comprises a retaining member 562 as shown in Fig. 15C. The retaining member 562 together with the recessed portion 586 keeps at least a portion of the valve actuator assembly 530 securely retained with the valve assembly 528 as shown in Figs. 15A & 15B.
As depicted in Figs. 15C-15I, the valve assembly 528 further comprises a plurality of flow channels 564. The flow channels 564 are disposed on the outer sidewall 556a of the valve assembly 528. These flow channels 564 are designed to facilitate the controlled release of air while preventing the undesirable flow of fluid or blood through the valve assembly 528. In one example, as depicted in Fig. 15C, the flow channels 564 are equidistantly spaced around the circumference of the outer sidewall 556a of the valve assembly 528, from each other. Such a uniform distribution ensures an even and efficient release of air from the valve assembly 528. Alternatively, the flow channels 564 may be without having any equidistance arrangement. The numbers and positions of the flow channels 564 may vary in alternate examples to accommodate different design requirements or specific applications. The strategic placement of the flow channels 564 can be adjusted to optimize air release while preventing flow of fluid or blood therefrom. The flow channels 564 have an appropriate depth and width to allow for the effective escape of air only while preventing the flow of fluid or blood therethrough. With these flow channels 564 with its optimized dimensions and distribution, the valve assembly 528 can effectively release air while maintaining its primary function of preventing the backflow of fluid/blood.

Furthermore, as depicted in Fig. 15I, the valve assembly 528 has one or more pre-formed openings or slits 552 forming one or more flaps or leaflets 554 as shown in Fig. 15B. The slits 552 and the flaps 554 formations designed to selectively allow fluid or to selectively prevent unwanted fluid flow therefrom. In one example, as shown in Fig. 15I, the valve assembly 528 has at least three intersecting slits 552 forming three flaps 554 that open when engaged by a valve actuator 532 as depicted in Fig. 15B. In one example, the barrier layer 558 may comprise at least one slit 552. Alternatively, the barrier layer 558 may comprise a plurality of slits 552 forming a plurality of flaps 554 that opens upon deformation of the valve assembly 528. It is to be understood that the number of slits 552 is not limited to the illustrated examples and may vary with various numbers and positions of slits 552.

The barrier layer 558 comprising the variations of the slits 552 are opened through elastic deformation rather than pressure within the catheter assembly 510. For example, the variation of the slits 552 require the luer connector or a male luer 532 to elastically deform the valve assembly 528 and/or the barrier layer 558 comprising the slits 552 selectively open permitting fluid flow through the valve assembly 528 bringing it to an open position 534 as shown in Fig. 15B. To this end, as depicted in Fig. 15B, the insertion of the luer connector or male luer 532 into the catheter hub 512, exerts a force on the valve assembly 528, effectively pushing both the valve assembly 528 and the valve actuator assembly 530 to open the leaflets 554, enabling fluid to flow through as shown in Fig. 15B. At least a part or portion of the valve actuator assembly 530 remains securely retained or locked within the valve assembly 528, providing stability during operation. As the user applies force via the luer connector 532, it exerts force on the compressible features of the sidewall 556 of the valve assembly 528 as shown in Fig. 15C, which in turn opens the leaflets 554 of the valve assembly 528, allowing fluid to pass through as shown in Fig. 15B. The compressible features are engineered to function akin to a spring mechanism; they store potential energy when compressed and release it to facilitate movement. This characteristic allows for a controlled opening of the leaflets 554 of the valve assembly 528, thereby permitting fluid passage through designated pathways. The interaction between the luer connector 532 and the compressible features of the valve assembly 528 is fundamental to the actuation process. As pressure is applied through the luer connector 532, it not only opens the leaflets 554 but also ensures that they return to their original position once the force is removed, thus maintaining a reliable sealing mechanism when not in use. The luer connector 532 thus exerts force on the compressible features of the valve assembly 528, wherein the compressible features act as a spring allowing the valve actuator assembly 530 to open the slits 552 of the valve assembly 528.

The retaining protrusion 578 of the valve actuator assembly 530 which engages with and retained by the recessed portion 586 of the valve assembly 528 regulates the upward and downward movement of the valve actuator assembly 530. Once the luer connector or male luer 532 disconnected or removed from the catheter hub 512, the sidewall 556 of the valve assembly 528 returns to its original decompressed shape or state causing the valve actuator assembly 530 automatically to retract to its first position, causing the valve assembly 528 to close and return to the closed position 536 stopping the flow of fluid therethrough as depicted in Fig. 15A.

As used herein, the term “proximal”, “bottom”, “down” or “lower” refers to a location on the device that is closest to the medical practitioner using the device and farthest from the patient in connection with whom the device is used when the device is used in its normal operation. Conversely, the term “distal”, “top”, “up” or “upper” refers to a location on the device that is farthest from the clinician using the device and closest to the patient in connection with whom the device is used when the device is used in its normal operation. For example, the distal region of a needle will be the region of the needle containing the needle tip which is to be inserted e.g. into a patient's vein.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the present disclosure. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. As used herein, the term "and/or" includes any and all combinations of one or more of the associated' listed items.

It will be further understood that the terms "comprises" "comprising," "includes" and/or "including" when used herein, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present disclosure belongs. It will be further understood that terms used herein should be interpreted as having a meaning that is consistent with their meaning in the context of the present disclosure and the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

The term “coupled”, “connected”, “fitted”, as used herein, is defined as connected, although not necessarily directly, and not necessarily mechanically.

Reference throughout the present disclosure to “some embodiments”, “one embodiment”, “certain embodiments”, and “an embodiment” or “some examples” or “one example” similar terms means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearances of such phrases or in various places throughout the present disclosure specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments without limitation.

The foregoing summary and description are illustrative only and is not intended to be in any way limiting. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features will become apparent by reference to the complete specification to follow.
,CLAIMS:1. A catheter assembly for vascular access comprising:
a catheter hub with an interior housing extending between a proximal end and a distal end thereof;
a catheter tube attached to the distal end of the catheter hub;
a needle with a needle tip connected to a needle hub and is movably received within the catheter hub, allowing the needle tip to be exposed outside of the catheter tube;
a valve assembly located within the interior housing that selectively permits or blocks a flow of fluid through the catheter; and
a valve actuator assembly wherein at least a part or a portion of the valve actuator assembly is slidably retained by the valve assembly.

2. The catheter assembly as claimed in claim 1, wherein the catheter hub includes an inner surface and an outer surface, and the inner surface surrounds a channel that extends along the length of the catheter hub, thereby facilitating fluid passage through the catheter hub.

3. The catheter assembly as claimed in claim 1, wherein the valve actuator assembly is configured to move between a first position, in which at least a part/portion of the valve actuator assembly is retained with/by the valve assembly when the valve assembly is in a closed position, and a second position, in which the valve assembly is in an open position; wherein a luer connector, when inserted, pushes the valve assembly along with the valve actuator assembly to transition to the open position.

4. The catheter assembly as claimed in claim 1, wherein the valve assembly is held in a position securely against an internal wall formed on the inner surface of the catheter hub by one or more projections, which limit or prevent any proximal or distal movement of the valve assembly, thereby ensuring its safe retention within the interior housing of the catheter hub.

5. The catheter assembly as claimed in claim 1, wherein the valve assembly includes a proximal end, a distal end, and a sidewall therebetween, defining an inner space; the distal end has a barrier layer designed to prevent fluid flow, which comprises one or more pre-formed openings or slits forming one or more flaps or leaflets, and the proximal end of the valve assembly has an opening having a diameter to movably receive at least a part/portion of the valve actuator assembly.

6. The catheter assembly as claimed in claim 5, wherein the sidewall of the valve assembly includes one or more projections or protrusions forming compressible features which act as a spring.

7. The catheter assembly as claimed in claim 1, wherein the valve assembly is positioned within the catheter hub to enable the actuator assembly to travel the minimum distance necessary to open and close one or more flaps or leaflets, and wherein the force required to open and close the valve assembly is inversely proportional to the travel distance of the actuator assembly.

8. The catheter assembly as claimed in claim 1, wherein the valve assembly further comprises a plurality of flow channels disposed on an outer sidewall of the valve assembly.

9. The catheter assembly as claimed in claim 1, wherein the valve actuator assembly comprises a body having a proximal end and a distal end, with a flow path running through the body and having an opening at the distal end, and wherein the body of the valve actuator assembly includes a top section, a mid-section and a bottom section.

10. The catheter assembly as claimed in any of the preceding claims, wherein the valve actuator assembly comprises one or more retaining protrusions to keep at least a part/portion, particularly a distal part of the valve actuator assembly retained within the inner space of the valve assembly.

11. The catheter assembly as claimed in any of the preceding claims, wherein the bottom section of the valve actuator assembly includes a skirt portion that has a diameter equal to or greater than the diameter of the opening of the valve assembly.