DESC:FIELD

The present disclosure relates generally to fluid delivery systems and infusion pump assemblies. More particularly, the present disclosure relates to a fluid flow assembly for medical fluid administration and methods of fabrication thereof.

BACKGROUND

Medical connections are essential components in a wide range of fluid delivery systems used in various healthcare settings, for example those used in connection with intravenous fluid lines, blood access, enteral feeding etc. These connections facilitate the secure and reliable transfer of fluids between different medical devices and tubing. One common example of such medical connections is the luer connector or a NRfit connector assemblies which are used in a variety of medical applications where there is a desire to interconnect together male and female connector parts onto tubing material that is connected in fluid flow path, for example an intravenous (IV) fluid delivery/therapy, blood access, enteral feeding and other applications involving the administration of fluids to patients.

Typical fluid flow assemblies include flow regulators and luer connector assemblies. In a medical setting, the devices often utilize luer connections to establish fluid communication between components. A luer connector or connection typically comprises a male luer connector that is inserted into a female luer connector. The male luer connector is threaded onto corresponding threads of the female luer connector to engage the two, so that fluid may be passed between them without escaping or leaking from the connection. Such typical fluid flow assemblies are made of multiple-parts and may involve a number of connections in fluid flow administration which may lead to failures such as leakage, inadequate fluid flow and occlusion. The typical fluid flow assemblies also do not address adequately controlled fluid flow during fluid administration, which can result in fluid administration failures. The contemporary designs of such luer connectors and flow regulators may not accommodate the varying needs of different medical applications. This lack of flexibility can lead to complications and inefficiencies in fluid delivery, potentially compromising patient safety and treatment outcomes.

There remains a need to provide a further improved fluid flow assembly for medical fluid administration that integrates advanced features to enhance both the security and control of fluid flow. There is also a need for a fluid assembly that can be arranged anywhere in the fluid flow path between a patient and a fluid source, providing a versatile and reliable solution for medical fluid administration. There is also a need for a fluid assembly which incorporates enhanced means for controlling and regulating the fluid flow, enabling precise delivery of medical fluids to the patient. Additionally, there is a need for a fluid assembly that incorporates standardized connection interfaces, allowing it to be easily integrated with existing medical devices and tubing.

SUMMARY AND OBJECTS

Certain exemplary aspects and examples 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 and examples 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 and/or examples or variations or combinations of the specific embodiments and/or examples or variations are within the scope of this disclosure.

According to one aspect of the present disclosure there is provided a fluid flow assembly for medical fluid administration, comprising: a main body having a proximal and a distal end, the main body including a main tube, a luer and a lock skirt; a channel configured inside the main tube for fluid flow wherein the channel includes an internal wall having a proximal face and a distal face; and wherein at least one micro-hole(s) formed thoroughly passing through said proximal and distal face. The fluid flow assembly can be arranged anywhere in the fluid flow path between the patient and fluid source. In some examples, the main body comprises one or more membrane filter(s). By providing both the connector interface and the internal flow control features, the fluid assembly provides a compact, all in one solution for managing the secure connection and precise delivery of medical fluids. The modular design allows the fluid assembly to be seamlessly integrated into a variety of fluid administration setups, such as intravenous therapy, infusion pump systems, wound irrigation systems or the like.

According to one aspect of the present disclosure there is provided a fluid flow assembly for medical fluid administration, comprising: a main body that defines a thickness extending from a proximal end to a distal end thereof in an axial direction, wherein the main body includes a proximal face and a distal face wherein at least one micro-hole(s) formed passing thoroughly through the thickness of said proximal and distal face enabling passage of fluid therethrough. The fluid flow assembly may be configured in the form of a disk and capable of being arranged in a fluid flow path for medical fluid administration. The fluid flow assembly may be integrally formed and/or attached to a fluid administration device and/or placed within the fluid flow path. The fluid flow assembly can be arranged anywhere in the fluid flow path between the patient and fluid source. In some examples, the main body comprises one or more membrane filter(s). In some examples, the fluid flow assembly may be configured in the form of a disk or a member being integrated at various points in the fluid administration pathway being attached directly to a fluid administration device, such as an IV bag or infusion pump, to precisely control the fluid delivery and/or placed within the fluid flow path between the patient and the fluid source to regulate the flow before it reaches the patient and/or incorporated as a component within a larger fluid administration system to enable fine-tuned flow control. By optimizing the micro-hole(s) design and strategically integrating the fluid flow assembly, the medical fluid delivery can be precisely tailored to meet the specific needs of various fluid delivery applications, whether that involves adjusting the flow rate, or other critical parameters allowing the fluid assembly to be adapted for use across a wide range of medical fluid administration scenarios.

According to one aspect of the present disclosure there is provided a method of formation of micro-hole(s) in a fluid flow assembly.

In some examples, the fluid flow assembly for medical fluid administration comprises luer connectors to control the rate of fluid flow. The luer connectors includes a male and female component that lock together to create a secure fluid-tight seal. When the male and female luer components are locked together, a secure fluid pathway is established between the connected tubing or devices.

In some examples, the fluid flow assembly for medical fluid administration comprises flow regulators to control the rate of fluid flow. The fluid flow assembly may be integrated into the flow regulator design or as a separate component. The flow regulators are designed to provide precise control over flow-rates, allowing for accurate dosing of medications or other fluids.

In some examples, the fluid flow assembly for medical fluid administration comprises flow regulators to control the rate of fluid flow including one or more internal walls having a proximal and a distal face. The internal wall may be provided with at least one micro-hole(s) formed passing thoroughly through said proximal and distal face enabling passage of fluid therethrough to control the rate of fluid flow.

In some examples, the fluid flow assembly for medical fluid administration comprises other type of connectors, such as a push to connect fittings which may use an internal gripping mechanism to secure tubing without the need for threading or twisting, a barbed connector with barbed ends that may grip the tubing to create a secure seal, a quick-release coupling that allow rapid attachment and detachment of tubing through a push-button or lever mechanism.

It is to be understood that by incorporating both luer connectors for secure fluid connections and flow regulators for precise flow control, the fluid flow assembly enables accurate delivery of medical fluids while maintaining a safe and reliable interface between components. The specific design of the luer connectors and flow regulators can be optimized based on the intended application, required flow rates, pressure ranges, and compatibility with other medical equipment. This flexibility allows the fluid flow assembly to be adapted for use in a wide variety of medical fluid administration scenarios, such as intravenous (IV) fluid delivery, enteral feeding, blood and blood product administration, medication infusion, wound irrigation and drainage, dialysis and extracorporeal therapies or the like.

In some examples, the micro-hole(s) of the fluid assembly can be sized and positioned to create a desired pressure, restricting fluid flow and maintaining a controlled flow rate. This flow regulation capability is beneficial for accurately delivering medications, enteral feeds, or other medical fluids to the patient. The specific dimensions, number, and placement of the micro-hole(s) can be optimized based on the intended application and required flow characteristics. This flexibility enables the fluid flow assembly to be tailored for use across a wide range of medical fluid delivery scenarios and systems.

In some examples, the diameter, depth, and shape of the micro-hole(s) can be adjusted to control the flow rate and flow pattern of the fluid passing through the fluid assembly. Smaller diameter holes, for example, can be used to achieve a lower flow rate, while larger holes can enable higher flow rates. The depth and position of the holes may also be varied to adjust the fluid residence time within the fluid assembly, which impacts factors for example like mixing, heating/cooling, and bubble information.

In some examples, the number of micro-hole(s) can be optimized based on the desired total flow rate and the individual flow rate per hole. Increasing the number of holes allows for a higher overall flow rate while maintaining a lower individual flow rate per hole.

In some examples, the spatial arrangement and distribution of the micro-hole(s) across the surface of the fluid assembly can be tailored to achieve the desired flow characteristics. For example, the holes can be positioned in a uniform grid pattern, or a radial arrangement, or in an arrangement following a specific pattern, or in an irregular formation without having any pattern, or more complex custom layout. This may allow the flow to be precisely directed and shaped to meet the specific needs of the application, such as ensuring even coverage, minimizing turbulence, or creating a specific release for a wide range of medical fluid delivery applications.

In some examples, by varying the diameter of the micro-hole(s), the number of holes, thickness, and/or length of the holes, the resistance value for the fluid flow is controlled. This precise control is achieved due to the accuracy of the holes and the linear relation with pressure. The micro-hole(s) are fabricated using advanced techniques such as excimer laser drilling, which allows for the creation of extremely small-diameter holes with exceptional accuracy and repeatability. The diameter and number of holes can be adjusted to obtain any resistance value, enabling the assembly to generate pressure-controlled flows with high precision and stability. This design ensures that the fluid flow can be accurately controlled, even in scenarios where the upstream or downstream pressures may fluctuate, making it particularly suitable for medical applications where precise fluid delivery is critical. The integration of these micro-hole(s) into the fluid flow assembly provides a versatile and customizable solution for medical fluid administration, allowing for the optimization of flow characteristics such as flow rate.

In some examples, the improved fluid flow assembly incorporates a unique micro-hole(s) design that enables ultra-low, pressure-controlled fluid flows for medical applications. By precisely engineering the size, number, and arrangement of the micro-hole(s), the fluid flow assembly can achieve continuous flow rates of less than 5 milliliters per hour. This level of flow control is critical in various medical scenarios, such as pain management, pediatric care, and long-term infusion therapies, where the delivery of small, consistent volumes of fluids is essential for patient safety and treatment efficacy. This level of precision flow control is a key advantage of the improved fluid flow assembly, as it enables medical professionals to administer critical fluids, medications, and therapies with a high degree of accuracy and reliability. The ability to deliver such small, consistent volumes of fluids can have a significant impact on patient outcomes, particularly in scenarios where even minor deviations in fluid delivery could have serious consequences.

In some examples, one or more membrane filter(s) may be designed to control fluid rates without necessarily having distinct micro-hole(s) or perforations for a fluid assembly of the present disclosure. These types of membranes achieve flow regulation through their inherent pore density, rather than relying on discrete openings. It is to be understood that membrane material of such filter(s) engineered to have a specific pore density, meaning the number of pores per unit area. This porous structure, even without visible micro-hole(s), creates a resistance to fluid that can be precisely tuned. By adjusting the pore density, the membrane may act as a flow restrictor, limiting the volumetric flow rate of the fluid passing through it. The pore density determines the degree of flow restriction achieved. The membrane’s flow restricting properties can be further tailored by cutting the membrane to a specific area and/or of a specific size as per need. This allows to have membranes that deliver accurate, predetermined flow rates based on the combination of pore density and membrane area.

It is an object of the present disclosure to provide an improved fluid flow assembly comprising one or more micro holes that enable precise regulation and control of the fluid flow. These micro-hole(s) are designed to provide pressure-controlled fluid flow capabilities, allowing for accurate and reliable delivery of medical fluids.

Another object of the present disclosure is to provide an improved fluid flow assembly arranged in a fluid flow line.

Another object of the present disclosure is to provide an improved fluid flow assembly having one or more micro-hole(s) for fluid flow and/or controlling fluid flow. Micro-hole(s) are formed, not being limited to, by drilling with an excimer laser.

Another object of the present disclosure is to provide an improved fluid flow assembly having one or more micro holes wherein by varying the diameter of the holes, the number of holes, thickness and/or length of the holes, the resistance value for the fluid flow is controlled. It is to be noted that pressure-controlled flow is generated due to the accuracy of the holes and the linear relation with pressure.

Another object of the present disclosure is to provide an improved fluid flow assembly having ultra-low pressure-controlled flows capabilities for medical applications for example, a continuous flow of less than 5 ml of medical fluid per hour.

Another object of the present disclosure is to provide an improved fluid flow assembly having a construction which is robust and easy to fabricate in production preventing mix-up problems in production as well as preventing administration failures during use.

Another object of the present disclosure is to provide an improved fluid flow assembly fabricated of biocompatible material including thermoplastic material or materials suitable for medical use and which can be sterilized by various methods such as EO, gamma and steam etc.

Another object of the present disclosure is to provide an improved fluid flow assembly for precise flow control and secure connections contributing to patient safety. Accurate dosing and the prevention of unintended fluid delivery help mitigate the risks associated with over or under infusion, which is critical for patient wellbeing.

Yet another object of the present disclosure is to provide an improved fluid flow assembly which prevents passage of any particles or foreign elements during fluid administration.

A further object of the present disclosure is to provide an improved fluid flow assembly which saves time and cost in production thereof and reduces the chances of failures such as leakage, inadequate fluid flow and occlusion during fluid administration.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

The above and other objects, examples, features and advantages of the present disclosure will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, in which like reference numerals refer to like parts throughout, and wherein:

Fig. 1A, 1B, 1C & 1D illustrate a perspective, front and cross-sectional front views respectively of a fluid flow assembly according to some examples of the present disclosure;

Fig. 2 illustrate a perspective view of a fluid flow assembly according to some examples of the present disclosure;

Fig. 3 illustrates a top view of the fluid flow assembly according to some examples of the present disclosure;

Fig. 4 illustrates a bottom view of the fluid flow assembly according to some examples of the present disclosure;

Fig. 4A illustrates detail A of Fig. 3;

Fig. 5A & 5B illustrate a fluid flow assembly according to some examples of the present disclosure;

Fig. 6 illustrates a side view of a fluid delivery system according to some examples of the present disclosure;

Figs. 7A, 7B & 7C illustrate a perspective view and a view of a part thereof and an exploded view having micro-hole(s) respectively of a flow regulator assembly according to some examples of the present disclosure.

DETAILED DESCRIPTION

Referring to Figs. 1A, 1B, 1C & 1D a fluid flow assembly 10, for example a male luer connector assembly according to one of the examples of the present disclosure is illustrated. It is to be understood that the fluid flow assembly 10 comprises a fluid flow connector assembly. The fluid flow assembly 10 comprises a main body 12 having a proximal end 14 and a distal end 16. The main body 12 includes a main tube 18, a luer 20 and a lock skirt 22. The main tube 18 may comprise a tubular shape and a channel 24 configured inside the main tube 18 for fluid flow. The channel 24 may run through in an axial direction AD from the proximal 14 to distal end 18 of the main body 12. Main tube 18 may include a connection opening part 28 and a conduit part 30. The channel 24 includes an internal wall 26 dividing the channel 24 in two parts as illustrated in Figs. 1C & 1D. The internal wall 26 comprises a proximal face 32 and a distal face 34. The internal wall 26 may be provided with at least one micro-hole(s) 44 formed passing thoroughly through said proximal 32 and distal 34 face enabling passage of fluid therethrough. The fluid flow within the flow assembly 10 may be controlled and regulated through said micro-hole(s) 44. The internal wall 26 may be arranged at an angle to the fluid flow, for example in a transverse manner. The internal wall 26 may be integrally formed or bonded or attached in the flow path of the fluid flow assembly 10.

In some examples, as illustrated in Fig. 2, the internal wall 26 may be configured at the distal end 18 of the channel 24. The internal wall 26 comprises a proximal face 32 and a distal face 34. The internal wall 26 may be provided with at least one micro-hole(s) 44 formed passing thoroughly through said proximal 32 and distal 34 face enabling passage of fluid therethrough. The fluid flow within the flow assembly 10 may be controlled and regulated through said micro-hole(s) 44.

It is to be understood that the internal wall 26 may be provided with a plurality of micro-hole(s) 44 formed passing thoroughly through said proximal 32 and distal 34 face enabling passage of fluid therethrough. The micro-hole(s) 44 may be positioned in a uniform grid pattern, or a radial arrangement, or in an arrangement following a specific pattern, or in an irregular formation without having any pattern, or more complex custom layout.

The conduit part 30 may be formed in the side of proximal face 32 of the internal wall 26 and may have a hollow, round, tubular shape with the channel 24 extending in axial direction AD. The connection opening part 28 having an outer diameter may be formed in the side of distal face 34 of the internal wall 26 and may have a hollow, round, tubular shape with the channel 24 extending in axial direction AD. In some examples, the conduit part 30 may be formed in the side of the distal face 34 of the internal wall 26 and the connection opening part 28 may be formed in the side of distal face 34 of the internal wall 26. The outer diameter of the conduit part 30 may be larger than the outer diameter of the connection opening part 28. A first opening 40 that connects to one end of the channel 24 may be formed on the connection opening part 34 side of the main tube 18. A second opening 42 that connects to the other end of the channel 24 may be formed in the conduit part 30 side of the main tube 18.

The connection opening part 28 has a tapered outer wall 28a having a tapered shape such that the outer diameter of the outer circumferential surface becomes smaller extending from the internal wall 26 in axial direction AD. It is to be understood that the taper angle and diameter of tapered outer wall 28a may be basically uniform according to the applicable standards. In some embodiments, the inner diameter of the luer side taper part 28a may be approximately uniform in the direction of the channel 24 extending in the axial direction AD.

The lock skirt 22 has a round, tubular shape and formed attached to the main tube 18 to be able to rotate around channel 24. A threaded part 36 may also be formed around the inner circumference of the lock skirt 22. Threads may be formed in the threaded part 36 to facilitate screwing onto a projecting part of a another luer connector (not shown), for example a male or female luer connector assembly to facilitate coupling, for example of coupling of a male luer connector with a female luer connector assembly in a leak proof arrangement. The outer circumference of the lock skirt 22 may be provided with finger grips feature 38 which facilitate using the fluid flow connector assembly 10 during use effectively.

Referring to Fig. 3, a top view of the fluid flow assembly 10 according to some examples of the present disclosure is illustrated. The fluid flow assembly 10 as shown has a main body 12 including a main tube 18, a luer 20 and a lock skirt 22. The top view illustrates the first opening 40 side that connects to one end of the channel 24 formed on the connection opening part 34 side of the main tube 18 having the lock skirt 22. It further shows the distal face 34 of the internal wall 26 formed within the channel 24.

Referring now to Figs. 4 and 4A, a bottom view of the fluid flow assembly 10 according to some examples of the present disclosure is illustrated. The top view illustrates the second opening 42 side that connects to the other end of the channel 24 formed in the conduit part 30 side of the main tube 18. It further shows the proximal face 32 of the internal wall 26 formed within the channel 24. In some examples, the internal wall 26 may have a thickness of less than 5 mm.

As stated above, the internal wall 26 may be provided with at least one micro-hole(s) 44 formed passing through said proximal 32 and distal 34 face and through said thickness of internal wall 26. The fluid flow within the fluid flow connector assembly 10 is controlled through said at least one micro-hole(s) 44. It is to be noted that the present disclosure embodies formation of one or more micro-hole(s) 44 as shown in greater detail in Figs. 4A & 5A. In some examples, not being limited to, the micro-hole(s) 44, 144 are configured by drilling through laser. The micro-hole(s) 44, 144 may be made through other means and methods as well. The micro-hole(s) 44, 144 may have a structure having slightly tapered cut hole defining an entry and exit diameter of the micro-hole(s) 44, 144 and wherein the entry and exit diameter is not having the same dimensional value. It is to be noted that forming the micro-hole(s) through laser results in a slightly tapered cut hole. In some examples, the entry and exit diameter of the micro-hole(s) 44, 144 may be in a range of 0.1 to 100 microns. In some examples, the entry and exit diameter of the micro-hole(s) 44, 144 may be in a range of 0.1 to 200 microns. In some examples, the entry and exit diameter of the micro-hole(s) 44, 144 may be less than 200 microns and/or 100 microns and at least more than 1 micron. The taper angle between the entry and exit diameter of the micro-hole(s) 44, 144 may be in a range of 0 to 20 degree. In some examples, the taper angle between the entry and exit diameter of the micro-hole(s) 44, 144 may be 4 degree. In some examples, the taper angle between the entry and exit diameter of the micro-hole(s) 44, 144 may be in a range of 0 to 45 degrees. The taper angle of the micro-hole(s) 44, 144 is not limited to the disclosed ranges and may further vary in further examples.

In some examples, the micro-hole(s) 44, 144 may have a structure having a straight cut hole. It is to be understood, that the location of micro-hole(s) 44, 144 on the internal wall 26 is not at specific location and the micro-holes 44, 144 may be made anywhere and any number, not being limited to specific number of micro-holes 44, 144, on the proximal 32 or distal 34 faces of the internal wall 26. The micro-holes 44, 144may be formed anywhere within the fluid flow assembly 10 governing the fluid flow and fluid control through the fluid flow assembly 10. For example, the micro-holes 44, 144 may be formed within the walls adjoining the internal wall 26, or the micro holes 44, 144 may be formed in one or more internal wall(s) and/or internal surface(s) 64 of a flow regulator as illustrated in Fig. 7B which enables precise regulation and control of the fluid flow.

Fig. 5A & 5B illustrate a fluid flow assembly 110 according to some examples of the present disclosure wherein the fluid flow assembly 110 for medical fluid administration, comprising: a main body 112 defining a thickness extending from a proximal end 114 to a distal end 116 thereof in an axial direction AD, the main body 112 having a proximal face 132 and a distal face 134 wherein at least one micro-hole 144 formed passing thoroughly through the thickness of said proximal 132 and distal face 134 enabling passage of fluid therethrough.

It is to be understood (referring to the appended Figures of the present disclosure) that, the fluid flow assembly 10, 110 can be designed in various configurations to control and manage fluid flow in a variety of applications. In some examples, the fluid flow assembly 110 may be structured as a disk shaped component that can be arranged and/or integrated in a fluid flow path and/or incorporated in a medical device including any part thereof for medical fluid administration. The fluid flow assembly 110 may take on different geometric shapes such as oval, rectangular, square, any other geometrical shape and/or a combination thereof allowing it to be customized for specific use cases. The fluid flow assembly 110 can be formed as a single, integral component or attached to a fluid administration device or any part thereof, and it may be positioned and/or placed and/or bonded within a fluid flow path. It is to be noted that the present disclosure contemplates formation of one or more micro-holes 144 i.e. including formation of plurality of micro-holes 144. The fluid flow assembly 110 may be arranged at an angle to the fluid flow, for example in a transverse manner to control and regulate the fluid flow.

In some examples, not being limited to, the micro-holes 44, 144 are made by drilling through laser. The micro-holes 144 may be made through other means and methods as well. The micro-holes 144 may be structured having a slightly tapered cut hole, defining an entry and exit diameter that are not identical, but rather have a slight difference in their dimensions. It is to be understood that the entry and exit diameter of the micro-hole 144 is not having the same dimensional value. It is to be noted that forming the micro-holes through laser results in a slightly tapered cut hole, rather than a perfectly cylindrical hole. The gradual transition from the entry to the exit diameter helps to minimize the formation of cracks or other structural defects during the laser drilling process. The difference in entry and exit diameters allows for fine tuning of the fluid flow characteristics, such as flow rate, pressure drop, and flow pattern. Further, the tapered design helps to improve the consistency and repeatability of the micro-hole(s) fabrication process, ensuring more reliable and predictable fluid flow performance. Thus, the fluid flow assembly 10,110 having micro-holes 44,144 can be optimized to meet the specific requirements of the intended application, whether it is for medical fluid administration or other fluid handling systems.

In some examples, the entry and exit diameter of the micro-hole(s) 44, 144 may be in a range of 0.1 to 100 microns, or 0.1 to 200 microns. In some examples, the entry and exit diameter of the micro-hole(s) 44, 144 may be less than 200 microns and at least more than 1 micron. In some examples, the taper angle between the entry and exit diameter of the micro-holes 144 may be in a range of 0 to 20 degree. In some examples, the taper angle between the entry and exit diameter of the micro-hole(s) 44, 144 may be 4 degree. In some examples, the taper angle between the entry and exit diameter of the micro-hole(s) 44, 144 may be in a range of 0 to 45 degrees. The taper angle of the micro-hole(s) 44, 144 is not limited to the disclosed ranges and may include further variations in further examples. The exemplary ranges allow for flexibility in designing the optimal micro-hole(s) 44, 144 size for the specific application and fluid flow requirements. The exemplary ranges further ensures that the micro-holes 44, 144 are not too small, which could lead to clogging or excessive pressure drop, not too large, which could compromise the precise control over the fluid flow.

In some examples, the micro-holes 44, 144 may have a structure having a straight cut hole. In some examples, the micro-holes 44, 144 may have a structure having a hole slanted at an angle. It is to be understood, that the location of micro-holes 44, 144 on the surface of the proximal 132 and the distal 134 face of the fluid flow assembly 110 may be at a pre-determined location. In some examples, the location of the micro-hole(s) 44, 144 on the surface of the proximal 132 and the distal 134 face may not be pre-determined being at any specific location having a specific arrangement or pattern and the micro-holes 44, 144 may be made thereon anywhere and any number, not being limited to specific number of micro-holes 144.

It is to be understood that the micro-holes 44, 144 may be formed anywhere within the fluid flow assembly 10, 110 governing the fluid flow and fluid control through the fluid flow assembly 10, 110. For example, the micro-holes 44, 144 may be formed within the walls defining the thickness of the main body 112 and/or on the outer periphery of the main body 112. The micro-hole(s) 144 within the fluid flow assembly 110 can be strategically positioned in different locations to achieve the desired fluid flow characteristics. These micro-holes may be formed within the walls that define the thickness of the main body 112 of the assembly. This allows the micro-holes 44, 144 to be integrated directly into the structural components of the fluid flow assembly 10, 110, enabling precise control over the fluid flow through the thickness of the main body 112.

Additionally, the micro-holes 44, 144 may also be formed on the outer periphery of the main body 112. This placement along the outer edges of the assembly can provide additional points of fluid entry or exit, allowing for more complex and customized flow patterns. By incorporating micro-holes both within the walls and on the outer periphery of the main body 112, the fluid flow assembly 10, 110 can be designed with a high degree of flexibility to meet the specific requirements of the intended application, such as medical fluid administration or other fluid handling systems.

In some examples, the fluid flow assembly 10, 110 incorporates one or more micro holes 44, 144 to enable and/or regulate fluid flow. These micro holes 44,144 are formed using advanced manufacturing techniques, such as drilling with an excimer laser. An excimer laser is a type of ultraviolet (UV) laser that uses reactive gases, such as argon fluoride (AfF) or krypton fluoride (KrF), to produce high-energy UP light pulses. When focused onto a material surface, the intense UV radiation from the excimer laser can precisely ablate and remove material, creating micro-scale features with expectational accuracy and repeatability. This laser drilling process allows for the formation of micro-holes 44, 144 with extremely small diameters, which may range from a few microns to hundreds of microns, depending on specific laser parameters and material properties. The use of an excimer laser for micro-hole 44, 144 is advantageous over traditional mechanical drilling methods, including higher precision, reduced thermal damage to the surrounding material, and the ability to create complex hole geometries. By leveraging the capabilities of excimer laser drilling, the fluid flow assembly 10, 110 incorporate micro-holes 44, 144 with precise dimensions, spacing, and pattern to optimize fluid flow characteristics, such as flow rate. Thid advanced micro-hole fabrication method enables the development of highly customizable and performance-enhanced fluid flow assembly 10, 110 for a wide range of applications, particularly in the medical and pharmaceutical industries where precise fluid control is critical.

In some examples, the fluid flow assembly 10, 110 may be formed of any material suitable for medical use, such as elastomer, silicon, steel, plastic, glass, thermoplastic material, metallic alloys and/or a combination thereof. In some examples, the improved fluid flow assembly 10, 100 is fabricated using biocompatible materials that are suitable for medical applications and can be sterilized through various methods. The use of biocompatible materials is a crucial design consideration to ensure the safety and compatibility of the assembly 10, 110 when used in medical fluid delivery systems. The selection of the appropriate material will depend on factors such as mechanical properties, chemical resistance, and compatibility with the specific medical fluids and sterilization methods.

In some examples, the micro-holes 44/144 is integrated into a flow regulator 56 design and/or in a luer connector 10 and/or in a connector 54 and/or in a fluid flow path 50 as shown in Fig. 6 between a patient and a fluid source to provide precise control over flow rates allowing for accurate dosing of medications or other fluids. Referring now to Fig. 6, a side view of a fluid delivery system 46 is illustrated according to some examples of the present disclosure. The fluid delivery system 46 comprises at least one pump 48 for pumping liquid along a fluid path 50 to a patient. A filter is connected to the fluid path 50 to remove any contaminants from the fluid before it reaches the patient. One or more connectors 54 are included along the fluid path 50 to allow branching of the fluid path 50 into one or more separate fluid paths 50. One or more fluid assembly 10 comprising luer connectors are included along the fluid path 50 being an integral part thereof and/or being as a separate component to enable easy connection and disconnection of tubing, catheters, or other fluid delivery components as needed. At least one variable flow regulator 56 is connected to the fluid path 50 to allow adjustment and control of the fluid flow rate as per requirement. Additionally, at least one bolus 58 is included along the fluid path to allow rapid delivery of a specific volume of fluid as per requirement. A flow restrictor 60 is slidably mounted on the flow path 50 to further adjust the flow resistance and rate. An outlet 62 is connected to the end of the fluid path 50, leading to the patient and delivering the fluid. The outlet 62 and flow assembly 10 including the luer connectors comprise a male and a female luer connector and/or a connector. It is to be understood that the micro-holes 44, 144 may be incorporated in a male and/or a female luer connector 10.

The pump 48 may include an elastomeric infusion pump or any other type of infusion pump. Elastomeric infusion pumps utilize an elastic balloon filled with the fluid to be delivered. As the balloon expands, it exerts pressure on the fluid, causing it to flow through the fluid path to the patient. Elastomeric pumps are simple, lightweight, and do not require batteries or external power. Alternatively, the pump 48 may be an electric or battery-powered infusion pump. These pumps use a motor-driven mechanism to push the fluid through the tubing. Electric pumps offer precise flow rate control and can be programmed to deliver fluids at varying rates over time. The choice of pump 48 depends on factors such as the type of fluid being delivered, the required flow rate, the treatment duration, and the patient's mobility needs. Regardless of the pump type, the fluid delivery system 46 utilizes the pump 48 to controllably deliver the liquid medication or solution to the patient along the fluid path.

The variable flow regulator 56 as shown in Figs. 7A, 7B & 7C is provided with one or more micro-holes 44, 144. These micro-holes serve as flow restrictors that can be selectively opened or closed to precisely regulate the fluid flow rate. Micro-holes 44, 144 may be incorporated into an adjustable mechanism within the flow regulator 56, such as a flexible member and/or membrane, a sliding plate or a rotating disk. In some examples, the micro-holes 44, 144 may be provided on one or more internal wall(s) and/or internal surface(s) 64 of the flow regulator 56 as shown in Figs. 7B & 7C with the capabilities to be optimized to achieve the desired flow regulation characteristics. Alternatively, the micro-holes 44, 144 may be fabricated on a separate member, for example a separate plate, a separate disc can be integrated into the flow regulator 56 assembly. By manipulating or regulating the sliding and/or rotating mechanism, a user can control the alignment of the micro-holes 44, 144 within the flow regulator 56 with the fluid path, varying the effective flow area and resistance providing a simple and effective way for a clinician to fine-tune the flow rate as needed. Thus, the micro-holes 44, 144 can be positioned on the internal surface of the flow regulator 56, on a flexible member or membrane, on a separate member, for example a plate, or integrated into an adjustable mechanism. The specific configuration depends on the flow regulator design and the desired functionality.

The variable flow regulator 56 may incorporate a dial, slider, or other adjustment mechanism that the user can manipulate to control the degree of opening of the micro-holes 44,144. By adjusting the micro-hole(s) 44,144 aperture size, the user can fine-tune the fluid flow rate to meet the specific needs of the patient and treatment. This level of flow control is particularly important when delivering sensitive medications or when maintaining a specific infusion rate. The micro-holes 44, 144 provide a simple yet effective way to vary the flow resistance and achieve the desired flow rate, without the need for complex electronic flow control systems. The variable flow regulator 56 with its adjustable micro-holes 44, 144 gives the clinician the flexibility to adapt the fluid delivery to changing patient conditions or treatment requirements.

The connectors 54 may include a Y connector, a U connector or other types of connectors 54. It is to be understood that the micro-holes 44, 144 may be incorporated in the connectors 54. The Y connector allows the fluid path to split into two separate paths, enabling the delivery of fluids to multiple locations or patients simultaneously from a single source. The U connector can be used to combine two fluid paths back into a single path, such as when delivering fluids from multiple sources to a single patient. Other types of connectors, such as T-connectors or manifolds, may also be used to create more complex branching of the fluid path as needed. These connectors 54 provide the flexibility to customize the fluid delivery setup to meet the specific requirements of the treatment or patient. By strategically placing the connectors 54 along the fluid path 50, the clinician can easily modify the fluid delivery configuration to suit the evolving needs of the patient.

While this invention is susceptible of embodiments in many different forms, the description provided above includes specific embodiments and/or examples with the understanding that the present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the invention to the embodiments and/or examples detailed herein.

As used herein, the term “proximal” refers to a region of the device or a location on the device which is closest to, for example, a user using the device. In contrast to this, the term “distal” refers to a region of the device which is farthest from the user, for example, the distal region of a needle will be the region of a needle containing the needle tip which is to be inserted e.g. into a patient’s vein.

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 this 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 this specification and the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

While aspects of the present disclosure have been described in detail with reference to the illustrated embodiments and/or examples, those skilled in the art will recognize that many modifications may be made thereto without departing from the scope of the present disclosure. The present disclosure is not limited to the precise construction and compositions disclosed herein; any and all modifications, changes, and variations apparent from the foregoing descriptions are within the spirit and scope of the disclosure as defined in the appended claims. Moreover, the present concepts expressly include any and all combinations and sub combinations of the preceding elements and features. The description is provided for clarification purposes and is not limiting. Words and phrases are to be accorded their ordinary, plain meaning unless indicated otherwise.

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, examples, and features described above, further aspects, embodiments, and features will become apparent by reference to the appended claims.

List of reference numerals:

10, 110 fluid flow assembly
12, 112 main body
14, 114 proximal end
16, 116 distal end
18 main tube
20 luer
22 lock skirt
24 channel
26 internal wall
28 connection opening part
28a tapered outer wall
30 conduit part
32, 132 proximal face
34, 134 distal face
36 threaded part
38 finger grips feature
40 first opening
42 second opening
44, 144 micro holes
46 fluid delivery system
48 pump
50 fluid path
52 air filter
54 connector
56 variable flow regulator
58 bolus
60 flow restrictor
62 outlet
64 internal surface of flow regulator
AD axial direction

,CLAIMS:WE CLAIM:

1. A fluid flow assembly for medical fluid administration, comprising:
a main body that defines a thickness extending from a proximal end to a distal end thereof in an axial direction; wherein the main body includes a proximal face and a distal face, wherein at least one micro-hole(s) formed passing thoroughly through the thickness of said proximal and distal face enabling passage of fluid therethrough.

2. The fluid flow assembly according to claim 1, wherein the fluid flow assembly is integrally formed and/or attached and/or bonded to a fluid administration device and/or placed within a fluid flow path.

3. The fluid flow assembly according to claim 1, wherein the fluid flow assembly is configured in the form of a disk and capable of being arranged and/or integrated in a fluid flow path and/or incorporated in a medical device including any part thereof for medical fluid administration.

4. The fluid flow assembly according to claim 1, wherein the thickness of the main body having a dimension of less than 5 mm.

5. The fluid flow assembly according to claim 1, wherein the micro-hole(s) comprises a structure having a slightly tapered cut hole defining an entry diameter and an exit diameter each having a tapered angle, wherein the entry diameter and the exit diameter not having the same dimensional value.

6. The fluid flow assembly according to claim 5, wherein the entry diameter and the exit diameter of the micro-hole(s) being in a range of 01.1 to 100 microns or 0.1 to 200 microns.

7. The fluid flow assembly according to claim 5, wherein the entry diameter and the exit diameter of the micro-hole(s) being less than 200 microns and at least more than 1 micron.

8. The fluid flow assembly according to any of the preceding claims, wherein the taper angle between the entry diameter and the exit diameter of the micro-hole(s) being in a range of 0 to 20 degree.

9. The fluid flow assembly according to any of the preceding claims, wherein the fluid flow assembly arranged at an angle to the fluid flow path in a transverse manner.

10. The fluid flow assembly according to claim 1, wherein the fluid flow assembly structured in the form having an oval, rectangular, square, any other geometrical shape and/or a combination thereof.

11. The fluid flow assembly according to claim 1, wherein the micro-hole(s) being positioned in a uniform grid pattern, or a radial arrangement, or in an arrangement following a specific pattern, or in an irregular formation without having any pattern, or more complex custom layout.

12. The fluid flow assembly according to claim 1, wherein the main body is integrated into a flow regulator design or in a luer connector or in a connector or in a fluid flow path between a patient and a fluid source to provide precise control over flow rates allowing for accurate dosing of medications or other fluids.

13. The fluid flow assembly according to claim 1, wherein the main body comprises one or more membrane filter(s).