FORM 2
THE PATENT ACT 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(See section 10 and rule 13)
1. TITLE OF THE INVENTION:
“ENTERAL CONNECTOR WITH DIRECTIONAL FLOW REGULATION”
2. APPLICANT:
(a] Name: Consure Medical Pvt. Ltd.
(b] Nationality: India
(c] Address: 7/4626, Dangi Sheri No 3,
Mahatma Gandhi Road, Delhi Gate, Surat, Gujarat-395003,
India
3. PREAMBLE TO THE INVENTION
COMPLETE
The following specification particularly describes the invention and the manner in which it is to be performed.

Enternal Connector with Directional Flow Rwgulation
Field of the Invention
[001] The invention relates to the domain of medical devices. In particular, the invention provides a novel enteral connectors for having directional flow regulation capabilities.
Background
[002] In healthcare facilities, like emergency departments and intensive care units, patients are often connected to several medical devices, such as various catheter tubes, with different intended functions. They may provide nutrients to the gastrointestinal tract, administer medications to the bloodstream, gather health and physiology data, or enable numerous other therapeutic or diagnostic modalities. These products often interact with syringes, needles, and with each other via connectors, many of which are compatible or identical. As interventions are often required to be performed quickly, in high-stress situations, most connectors are designed to interact with each other or are exchangeable, which reduces the risk of delayed in treatment. Inherently, this leads to an increased risk for unintended connection between devices with distinct indications of use and/or administration of medications to incorrect anatomy. Administration of improper fluids through unintended products to sensitive bodily systems or locations can result in severe adverse events and, in certain cases, lead to morbidity or mortality.
[003] In order to reduce the risk of potential medical device misconnections, general methods of color coding, labeling, and rigorous training of healthcare professionals have been widely implemented. Unfortunately, these methods are inconsistent across healthcare settings, clinicians often work in multiple facilities simultaneously, and healthcare staff tend to change position and facility throughout their career. As a result, these control methods have not proven to be effective in eliminating user errors and resulting adverse events. Therefore, there is an increasing need for a better design-based approach where connectors are only compatible with related products.
[004] Clinicians, device designers, and international regulators have collaborated with these challenges in mind, resulting in the International Standard Organization (ISO) 80369 series of standards. These standards are specifically focused towards avoiding misconnections between divergent delivery systems, where unique designs that physically prevent misconnection were developed. Each unique design is used for different medical applications, resulting in a small number of distinct connection options. Under the ISO 80369-3: 2016, (Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications) ENFit® connector technology has been introduced to healthcare facilities and is intended to be used for connections on enteral medical devices and accessories.
[005] When implemented fully within a healthcare facility, the current ENFit® enteral connector design reduces the risk of misconnections, though does not diminish other known problems. In fact, compared to the common Luer-lock design and associated design variations, which include mechanisms for flow control such as valves and self-closing lumens, many use cases may become more challenging. Most specifically, the current ENFit® design does not control backflow of tubing contents and does not ensure

a closed system at all times. Inadvertent backflow can lead to leakage at or around the connector interfaces during exchange procedures resulting in loss of fluid contents and contamination of surroundings. Additionally, open systems are associated with risk of bacterial contamination of the device itself and subsequently the patient. The following list incorporates the most generally known resulting complications:
1 Bacterial contamination of the fluid delivery channel
2 Bacterial contamination of the patient (bacterial infection)
3 Inadequate dosage received by the patient
4 Loss of materials (nutrition, medication, etc.) intended for the patient
5 Extended patient recovery
6 Soiling of patient clothes or bed linens
7 Contamination of patient surroundings and environment
8 Increase of healthcare professional work load
[006] There is accordingly a need for enteral connectors having an ability to control directional flow and/or ensure a closed system at all times.
Summary
[007] The invention described herein relates to enteral connector systems configured as per ISO 80369-3 (E1 connectors) or any other similar standard or configuration.
[008] In an embodiment, the invention provides an E1 connector system according to ISO 80369, comprising a directional flow regulator between the male-opposing side of the female E1 connector and the female-opposing side of the male E1 connector.
[009] In a specific embodiment of the E1 connector system, the directional flow regulator is coupled with or disposed within the male E1 connector.
[0010] The directional flow regulator may be located at least partially within the center lumen of the male E1 connector. The opening lumen of the directional flow regulator may be within the range of 0.25 - 8.70mm2.
[0011] In an embodiment, the directional flow regulator maybe located at least partially between the outside surface of the inner wall and the inside surface of the outer wall of the male E1 connector. In a specific embodiment, the opening lumen of the directional flow regulator is within the range of 28.73 - 76.74mm2.
[0012] In another embodiment, the directional flow regulator is coupled with or disposed within the female E1 connector. The directional flow regulator may be located at least partially within the lumen of the female E1 connector. In a specific embodiment, the opening lumen of the directional flow regulator is within the range of 0.25 -32.95mm2.
[0013] In a specific embodiment, the directional flow regulator is a spring loaded valve or a resilient member. The resilient member may comprise single, multiple, or combination of the following valves: duckbill valve, flutter valve, check valve, dome valve, slit valve, cross-slit valve. The directional flow regulator may be affixed within the male

enteral small-bore connector using one or combination of the following processes: mechanical joints using welding, fastening; physical joints using adhesives, tapes.
Brief Description of the Accompanying Drawings
[0014] Figure 1A illustrates a cross-section view of a male enteral connector.
[0015] Figure 1B illustrates a cross-section view of a female enteral connector.
[0016] Figure 1C illustrates a cross-section view of an enteral connector system comprising the male enteral connector and the female enteral connector in engagement with each other.
[0017] Figure 2 illustrates a male enteral connector with a directional flow regulator disposed therein.
[0018] Figures 3A and 3B illustrate a male enteral connector with a directional flow regulator disposed between an outer wall and an inner wall thereof.
[0019] Figures 4A and 4B illustrate a female enteral connector with a directional flow regulator disposed therein.
[0020] Figures 5A to 5D illustrate embodiments of a directional flow regulator.
[0021] Figures 6A to 6C illustrate different embodiments of a directional flow regulator disposed within a male enteral connector.
Detailed Description
[0022] The invention described herein relates to enteral connector systems configured as per ISO 80369-3 (El connectors) or any other standard or configuration.
[0023] An El enteral connector system consists of a male E1 connector, and a female E1 connector.
[0024] As shown in Figure 1A the male E1 connector 102 is a double-walled cylindrical design comprising an outer wall 104 and an inner wall 106 with threads 108 incorporated on the inner surface of the outer wall 104. The male El connector 102 includes a probe 105 having a central lumen 107 defined therewithin, said central lumen 107 having a first open end 103 and a second open end 109 at opposite ends thereof.
[0025] As shown in Figure 1B, the female E1 connector 110 is a single-walled cylindrical design comprising a cylindrical wall 112 with threads 114 incorporated on the outer surface of said cylindrical wall 112. Cylindrical wall 112 defines a receiving lumen 111 for permitting probe 105 of male El connector to be positioned or housed therewithin, said receiving lumen 111 having an open first end 113 and an open second end 115 at opposite ends of the receiving lumen 111.

[0026] Figure 1C shows a cross-section view of an E1 enteral connector system 116 which comprises the male E1 connector 102, and the female E1 connector 110 assembled together.
[0027] While a recommended orientation is for the male E1 connector 102 to be the patient-access side and the female E1 connector 110 be on the clinician/administration side, it should be noted that the orientation of these connectors may be interchanged. As such, the orientation of any described system herein may also be interchanged. This is important because the male and female E1 connectors inherently have different abilities to ensure accordance with the ISO 80369 standard while also incorporating features that enable flow control and closed systems.
[0028] As shown in Figure 2, the invention provides an E1 connector or an E1 connector system with a regulator for control of directional flow. As shown in Figure 2, the directional flow regulator 202 may be introduced at least partially within a center lumen 204 of the male El connector 200. The directional flow regulator 202 may comprise a flow regulator that permits fluid flow through the male E1 connector or through the E1 connector system in only one direction - and restricts fluid flow through the male E1 connector or through the E1 connector system in an opposite direction.
[0029] As shown in Figures 3A and 3B, an alternate embodiment is also possible, where the directional flow regulator 302 is positioned at least partially between the inner 304 and outer 306 walls of the male El connector 300.
[0030] As shown in Figure 4A and 4B, another embodiment is also possible, where the directional flow regulator 402 is at least partially or wholly located within the receiving lumen 404 of a female E1 connector 400.
[0031] The directional flow regulator illustrated and discussed in connection with Figures 2 to 4B may comprise, but is not limited to, any of a spring loaded valve or a resilient member controlling the directional flow of tubing contents. The resilient member may be comprised of a single, multiple, or combination of any of, but not limited to, the following variants of uni-directional valves: duckbill valve 602A (Figure 6A), flutter valve 602B (Figure 6B), check valve 602C (Figure 6C), dome valve, slit-valve, and cross-slit valve. The location and open lumen diameter of the uni-directional valve or valves have different constraints based on their relative orientation to the El connectors.
[0032] When the directional flow regulator is positioned partially or wholly within a center lumen of a male El connector (see for example, Figure 2), said directional flow regulator it may be introduced anywhere within the center lumen and/or may extend up to 5.00mm from the female-facing open end of the male El connector.
[0033] Further, when the directional flow regulator is positioned partially or wholly within a center lumen of a male E1 connector the lumen size of said directional flow regulator may have a cross-sectional area that ranges between 0.25mm2 and 8.70mm2 (0.5mm - 2.95mm diameter circle).
[0034] Figure 5A to 5D respectively show a (a) top view 500A, (b) front view 500B, (c) side view 500C, and (d) isometric view 500D of a duckbill valve, which is one of the

variants of a uni-directional valve that could be integrated with the male enteral small¬bore connector.
[0035] When the directional flow regulator is positioned partially or wholly between the inner and outer walls of the male E1 connector (see for example, Figures 3A and 3B), said directional flow regulator may be introduced anywhere between the outside surface of the inner wall and the inside surface of the outer wall and/or may extend up to 5.00mm from the female-facing open end of the male E1 connector. Additionally, the lumen size of said directional flow regulator may have a cross-sectional area that ranges between 28.73mm2 and 76.74mm2 (5.36mm - 8.75mm diameter circle).
[0036] When the directional flow regulator is positioned partially or wholly within a receiving lumen of the female E1 connector (see for example, Figures 4A and 4B), it may be positioned anywhere within the receiving lumen and/or may extend up to 5.00mm from the male-facing open end of the female E1 connector. In a particular embodiment of this arrangement, the lumen size of the directional flow regulator may have a cross-sectional area that ranges between 0.25mm2 and 32.95mm2 (0.5mm - 5.74mm diameter circle).
[0037] The locations mentioned above would avoid or minimize any interference with the current mating and user interaction of the E1 connector system.
[0038] The directional flow regulator may be fixed, temporarily or permanently to either the male E1 connector or female E1 connector using any individual or combination of, but not limited to, the following: mechanical coupling, material welding or sealing, use of adhesives, use of tapes.
[0039] In a specific embodiment, this disclosure contemplates the employment of a duck-bill valve within the lumen of the male enteral small-bore connector to avoid back-flow of the tubing contents and ensure unidirectional flow.
[0040] While the exemplary embodiments of the present invention are described and illustrated herein, it will be appreciated that they are merely illustrative. It will be understood by those skilled in the art that various modifications in form and detail may be made therein without departing from or offending the spirit and scope of the invention as defined by the appended claims. Additionally, the invention illustratively disclose herein suitably may be practiced in the absence of any element which is not specifically disclosed herein - and in a particular embodiment that is specifically contemplated, the invention is intended to be practiced in the absence of any one or more element which are not specifically disclosed herein.

We Claim:
1. An E1 connector system according to ISO 80369 comprising a directional flow regulator between the male-opposing side of the female El connector and the female-opposing side of the male E1 connector.
2. The E1 connector system according to claim 1, wherein the directional flow regulator is coupled with the male E1 connector.
3. The E1 connector system according to claim 2, wherein the directional flow regulator is located at least partially within the center lumen of the male E1 connector.
4. The E1 connector system according to claim 3, wherein the opening lumen of the directional flow regulator is within the range of 0.25 - 8.70mm2.
5. The E1 connector system according to claim 2, wherein the directional flow regulator is located at least partially between the outside surface of the inner wall and the inside surface of the outer wall of the male E1 connector.
6. The E1 connector system connector according to claim 5, wherein the opening lumen of the directional flow regulator is within the range of 28.73 - 76.74mm2.
7. The El connector system according to claim 1, wherein the directional flow regulator is coupled with the female E1 connector.
8. The E1 connector system according to claim 7, wherein the directional flow regulator is located at least partially within the center lumen of the female E1 connector.
9. The E1 connector system according to claim 1, wherein the directional flow regulator is a spring loaded valve or a resilient member.
10. The E1 connector system according to claim 9, wherein the resilient member is a single, multiple, or combination of the following valves: duckbill valve, flutter valve, check valve, dome valve, slit valve, cross-slit valve.
11. The E1 connector system according to claim 1, wherein the directional flow regulator is fixated to the enteral small-bore connector using one or combination of the following processes: mechanical joints using welding, fastening; physical joints using adhesives, tapes.