DESC:FIELD OF THE INVENTION
The present invention relates generally to the field of medical devices and procedures. More particularly, the present invention relates to an improved connector for enteral feeding tubes, extension tubes, and/or other fluid delivery conduit connections, as well as to associated systems and methods utilizing such a connector.
BACKGROUND OF THE INVENTION
Fluid delivery systems, such as enteral, nasogastric and/or gastric feeding tubes, are used to deliver nutrients and medicine to patients who cannot obtain sufficient nutrition by eating through the mouth by swallowing. The state of being fed by a feeding tube is known in the art as enteral feeding or tube feeding. Nasogastric feeding tubes are inserted through the nares (nostril), through the esophagus, and into the stomach of the patient. Gastric feeding tubes may be percutaneously inserted into the stomach. As used herein, enteral, nasogastric, gastric and other nutrient delivery components are collectively referred to as enteral components. The proximal end of the feeding tube is positioned externally for connection to a nutrient source, while the distal or discharge end of the feeding tube is positioned internally and delivers liquid nutrients into the stomach of the patient.
Once placed, a feeding tube may remain in the patient for several weeks or more, depending upon the continued need for enteral feeding; whereas the nutrient source is typically replaced more frequently, for example on a daily basis. For example, in a neo-natal unit, infants are often fed enterally. A tube is inserted in the mouth or nasal opening of the infant and through the esophagus for delivery of the fluid to is the stomach or intestinal region of the body. The breast milk or formula are delivered by syringe into an enteral delivery system, such as an enteral tube, for delivery into the infant's stomach. The enteral feeding systems can also be for adult use. Sometimes a peristaltic pump is used to deliver fluids from a feeding bag.
A connector at the proximal end of the feeding tube that is external to the patient is used for connecting the enteral feeding extension set or syringe to the feeding tube. To facilitate replacement of the nutrient source without disturbing the placement of the feeding tube, the proximal or external end of a feeding tube commonly comprises a female enteral connector hub which is generally covered by a cap or cover. In use a male connector element such as an enteral feeding set or enteral-only syringe may be removably coupled to the female enteral connector hub, typically by an interference fit. These parts are typically exposed to being handled by the user.
While prior feeding tubes with connectors generally have been acceptable, there have been shortcomings with their use. Repeated insertions and removals of such connectors and or into such connectors can cause connection between two elements to become somewhat stretched and deformed over time. For example, a repeated replacement of the nutrient source can lead to stretching of the female enteral connector hub by the male connector element such as an enteral feeding set or enteral-only syringe, potentially resulting in loss of the interference fit required for a reliable connection at the enteral coupling between the hub and male connector element. Over-insertion of the male connector element into the female connector hub can exacerbate the potential for stretching and permanent deformation of the hub. Loss of a reliable connection at the enteral coupling typically necessitates replacement of the feeding tube, which may be traumatic for some patients or interfere with a normal feeding regimen, and is generally undesirable.
The cover or cap which is used to cover female enteral connector hub also face a problem of reliable connection. The absence of a reliable connection may lead to contamination. A contaminated enteral feeding system may lead to problems for the patient, resulting in diarrhea, septicaemia, as well as gastrointestinal infections, vomiting, pneumonia, urinary tract infections or weight loss of the patient. Furthermore, a lack of air circulation and fluid draining areas in the fluid delivery system may promote bacterial growth.
Even with the advent of feeding tubes incorporating connectors, the variety of connectors which are frequently used therewith can still lead to the forcing of the connector and its component together to make a secure connection. Depending on the tube and connector being used this forcing still may not be sufficient to create a connection which retains the connector and its components so as to avoid an unintentional and/or undesired disconnection. Further, if sufficient force is applied during the connection of the prior connectors and its components it may be such that the components are difficult to separate when desired. Such difficulties in separation may result in displacement of the feeding tube and/or discomfort to the patient during the attempted separation or even after the connector is ultimately separated from the tube. Replacement of a feeding tube causes inconvenience, cost and trauma and pain associated with such procedures.
Thus, there has been a need for a device to permit any of a variety of different shapes and sizes of connectors to be inserted into or removed from an inlet port of a feeding tube without the need to use excessive force and substantially without deforming the feeding tube inlet port while still providing for the retention of the connector.

Hence, it can be seen that needs exist for improvements to enteral feeding systems and methods. Improvements in enteral connectors are driven by the desire for increased safety, usability and improved performance. It is therefore desirable to provide an improved enteral connector which results into an improved feeding systems and methods meeting these and other needs that the present invention is primarily directed to.
SUMMARY OF THE INVENTION
In order to address the difficulties and problems discussed above, an improved connector for use with a syringe, enteral feeding tube, or extension set is provided. The connector and its component of the present invention advantageously can reduce or minimize undesired disconnections or separations from a second member.
According to one aspect, there is provided an enteral connector for use with an enteral feeding tube, syringe or extension set comprising: a body having at least one passageway allowing the medical fluid to pass therethrough, the body comprising: an inlet port having an inlet opening of the passageway suitable for connection with an enteral feeder or male connector element; an outlet port having an outlet opening of the passageway having a mating portion or tube connecting portion for connecting to an enteral feeding tube; a first cap having an external wall for covering the inlet port being integrally connected to the body by a first flexible part and having a plug with an opening, the plug being shaped and sized to fit into the inlet opening; a second cap removably receivable in the opening being integrally connected to the first cap by a second flexible part.

The first and second caps and the body of enteral connector are provided with engagement means including one or more protrusion(s) and/or depression(s).

The internal diameter of external wall sized approximately equal or slightly larger to the external diameter of the inlet port to have a close fit ratio therewith to provide a leak proof engagement.

The enteral connector outer diameter of the plug shaped and sized approximately equal or slightly smaller to the internal diameter of the opening to have a close fit ratio therewith to provide a leak proof engagement.

The enteral connector further comprising a flange portion being disc shaped to be abutted by a distal face of the first cap when the first cap is releasably received in the inlet opening. The inlet port, the flange portion, the mating portion and outlet port are all co-axial and together form the passageway through the body.

The second flexible part extends outwardly from the external wall of the first cap in a direction that is generally perpendicular to the axis of the first flexible part. The second cap has a proximal face, a distal face and a wall extending therebetween in a direction opposite to the axial direction from the distal face to the proximal face.

The wall forming the outer diameter of the second cap is shaped and sized approximately equal or slightly smaller to the internal diameter of the opening. The first cap is provided with at least one protrusion at an inner surface of the external wall. The inlet port provided with at least one depression on an outer wall thereof. The depression provided on an outer wall of the inlet port may releasably interconnect with the protrusion.

The second cap provided with at least one protrusion at an outer surface of the wall. The plug of the first cap provided with at least one depression in an inner surface thereof. The depression provided in the plug of the first cap may releasably interconnect with the protrusion.

The alternative embodiments of the caps and body may not include protrusion and/or depression or may contain either the protrusion or depression or a combination thereof.

Further aspects of the invention relate to associated systems and methods utilizing the enteral connector.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS:

The foregoing and other objects, features, and advantages of the invention will be apparent from the following detailed description taken in conjunction with the accompanying drawings, wherein:

FIG. 1 is a perspective view of an enteral connector according to one embodiment of the present invention;

FIG. 2 is another perspective view of an enteral connector according to one embodiment of the present invention showing the caps of the connector in open position;

FIG. 3 is another perspective view of an enteral connector according to one embodiment of the present invention showing the caps of the connector in closed position;

FIG. 4 is a sectional view of an enteral connector of Figs. 1 to 3;

FIG. 5 with portions of the connector shown in section for the purpose of illustration;

FIG. 6 illustrates a perspective view of the enteral connector connected to a feeding tube according to the present invention;

FIG. 7 illustrates a perspective view of the enteral connector with a feeding tube in use with an enteral-only syringe according to the present invention;

FIG. 8 illustrates a perspective view of the enteral connector with a feeding tube in use with an enteral feeding extension set according to the present invention;

DETAILED DESCRIPTION OF THE INVENTION

In accordance with the present invention, an improved connector for enteral, nasogastric and/or gastric feeding tubes, extension tubes, and/or other fluid delivery conduit connections, as well as to associated systems and methods utilizing such a connector is provided. While this invention is susceptible of embodiments in many different forms, there will be described herein specific embodiments 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 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 clinician using the device. In contrast to this, the term “distal” refers to a region of the device which is farthest from the clinician, 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.

Reference is first made to FIGS. 1, 2, 3, 4 and 5 to describe an enteral connector according to one aspect, the enteral connector being indicated generally by the numeral 10. As illustrated, the enteral connector 10 has a body 12 defining at least one passageway allowing the medical fluid to pass therethrough. The body 12 has an inlet port 14 defining an inlet opening 16 of the passageway, suitable for connection with an enteral feeder or male connector element such as an enteral-only syringe 68 or an enteral feeding extension set 70. The inlet port 14 is cylindrical in shape. However, inlet port 14 is not limited to cylindrical shape and may have other shapes. The inlet opening 16 may be used as a connection to a source of medicine or port to various or different connectors typically used with various sources of medicine. The body 12 also has an outlet port 18 defining an outlet opening 20 of the passageway. The outlet port 18 defines a mating portion or tube connecting portion 40 for connecting to an enteral feeding tube 22 or to an enteral feeding extension set tube. The internal diameter of both the inlet opening 16 and outlet opening 20 is consistent. Alternatively, the internal diameter of both the inlet opening 16 and outlet opening 20 may be of varying size and dimension.

The enteral connector 10 is provided with a first cap 24 having an external wall 26 for covering the outside of the inlet port 14. The internal diameter of the external wall 26 is shaped and sized approximately equal or slightly larger to the external diameter of the inlet port 14 or has a close fit ratio therewith to provide a leak-proof engagement.

The first cap 24 is integrally connected to the body 12 by a first flexible part 32. The external wall 26 of the first cap has a plug 40 integral therewith for inserting into the inlet opening 16. The plug 40 has an opening 28 therethrough, preferably in center that is sized and shaped to mate with a tip of enteral-only syringe 68 or a catheter syringe. The plug 40 is integral with the first cap 24 and extends from the proximal face 44 to the distal face 46 in an axial direction A. The plug 44 is sized to snugly fit into the inlet opening 16 of the body 12. The outer diameter of the plug 44 is sized approximately equal or slightly smaller to the internal diameter of the opening 16 or has a close fit ratio therewith to provide a leak-proof engagement.

The first cap 24 can be removably receivable on the inlet port 14 providing an opening 28 for receiving a catheter syringe or a tip of enteral-only syringe 68. The enteral connector 10 is also provided with a second cap 30 which can be removably receivable in the opening 28 of the first cap 24. The second cap 30 is also integrally connected to the first cap 24 by a second flexible part 34.

Referring to Figs. 1, 2, 3, 4 and 5, the enteral connector 10 is used for connecting at one end to an enteral feeding tube 22 or to an enteral feeding extension set tube and at the other end for connecting an enteral feeder such as an enteral-only syringe 68 or an enteral feeding extension set 70 for delivering liquid feed through the enteral connector 10 and the enteral feeding tube 22.

In the present embodiment, the enteral connector 10 is a single, unitary piece, injection molded from a phthalate-free polyvinyl chloride (PVC). The phthalate-free PVC is suitable for connecting to both silicone and polyurethane tubes. The enteral connector 10 may be composed of the same material as the feeding tube 22, or a blend of materials, or a different but compatible material. In one example, the enteral connector 10 is composed of blend of polyvinyl chloride and polyurethane elastomer. In another example, the enteral connector 10 is composed of an aromatic, polyether-based thermoplastic polyurethane or DEHP-free PVC. The enteral connector 10 may be formed from other types of suitable materials within the scope of the invention.

Referring now to Fig. 2, 4 and 5 in order to further describe the enteral connector 10, the body 12 includes a flange portion 42 which is disc shaped. The outer diameter of body 12 is largest immediately adjacent the flange portion 42. The first cap 24 has a proximal face 44 and a distal face 46. The distal face 46 of the first cap 24 abuts the flange portion 42 when the first cap 24 is received in the inlet opening 16 as illustrated in Fig. 3. The plug 36 extends from the proximal face 44 in an axial direction A to the distal face 46. The inlet port 14, the flange portion 42, the mating portion 40 and outlet port 18 are all co-axial and together form a passageway through the body 12.

The internal diameter of both the inlet port 14 and the inlet opening 16 is sized and shaped for enteral-only connection of the enteral feeder such as an enteral feeding set or enteral-only syringe 68. The external diameter of the inlet port 14 is sized and shaped to inhibit connection by a sleeve or mating part of a male connector element such as an enteral feeder or an enteral-only syringe 68 or an enteral feeding extension set 70.

As indicated above, the enteral connector 10 includes a body 12 and a first cap 24 that are joined together by a first flexible part 32. The first flexible part 32 has a thinned portion 52 of suitable length to allow the first cap 24 to be placed on a portion of the inlet port 14 and cover the inlet opening 16 and to be removed from the inlet port 14. The first flexible part 32 is connected at one end 48 to the flange portion 42 of the body 12. The other end 50 of the first flexible part 32 is connected to the external wall 26 of the first cap 24. A portion at each of the ends 48, 50 of the first flexible part 32 is slightly larger in thickness to provide reinforcement where the first flexible part 32 joins to the first cap 24 and to the body 12. A first tab 54 is connected to the external wall 26 of the first cap 24 on an opposite side of the first flexible part 32. The first tab 54 has ribs 56 which assist in holding the first tab 54 in order to cover the inlet opening 16. The first tab 54 also helps in removing the first cap 30 from the inlet opening 16.

A second flexible part 34 extends outwardly from the external wall 26 of the first cap 24 in a direction that is generally perpendicular to the axis of the first flexible part 32. The connection of second flexible part 34 is not limited to a direction that is generally perpendicular to the axis of the first flexible part 32 and can have a connection anywhere on the external wall 26 in other directions. The second cap 30 has a proximal face 144, a distal face 146 and a wall 60 extending therebetween in a direction opposite to the axial direction A from distal face 146 to the proximal face 144. The distal face 146 of the second cap 30 abuts the proximal face 44 of the first cap when the second cap is received in the opening 28.

One end 148 of the second flexible part 34 is connected to the distal face 146 of the second cap 30 and other end 150 is connected to the external wall 26 of the first cap 24. A second tab 58 is connected to the wall 60 of the second cap 30 on an opposite side of the second flexible part 34. The second tab 58 also has ribs 56 which assist in holding the second tab 58 which can be used to cover the opening 26 of the first cap 24 as illustrated in Figs. 3 and 5. The second tab 58 also helps in removing the second cap 30 from the opening 26.

The second cap 30 is sized and shaped to snugly fit into the opening 26 of the first cap 24. The wall 60 forming the outer diameter of the second cap 30 is sized and shaped approximately equal or slightly smaller to the internal diameter of the opening 26 of the first cap 24 or has a close fit ratio therewith to provide a leak-proof engagement.

Referring now to Fig. 4, in order to achieve a safe and leak-proof engagement of the first cap 24 with the inlet port 14 in particularly inlet opening 16, at least one protrusion 62 is provided at an inner surface 66 of the external wall 26. At least one depression 64 is provided on an outer wall 38 of the inlet port 14 which may releasably interconnect with the protrusion 62. The alternative embodiments of the caps and body may not include protrusion and/or depression or may contain either the protrusion or depression or a combination thereof. The depression 64 may extend along the complete periphery of the outer wall 38 of the inlet port 14 or it may be a quarter- or semi-annular depression or groove. Likewise, the protrusion 62 may extend along the complete periphery of the inner surface 66 of the external wall 26 or it may be a quarter- or semi-annular protrusion. The use of protrusion and depression are inter-changeable. Once the protrusion 62 is aligned within depression 64 i.e. the engagement of protrusion 62 and depression 64 eliminate the chances of the first cap 24 getting removed easily from the inlet port 14 when the second cap 30 is removed from the first cap 24. Thus, the combination of protrusion 62 and depression 64 provide a tight fit releasable engagement

Likewise, in order to achieve a safe and leak-proof engagement of the second cap 30 with the opening 28 of the first cap 24, at least one protrusion 162 is provided at an outer surface 168 of the wall 60. At least one depression 164 is provided on in an inner surface 166 of the plug 36 of the first cap 24 which may releasably interconnect with the protrusion 162. The alternative embodiments of the caps and body may not include protrusion and/or depression or may contain either the protrusion or depression or a combination thereof. The depression 164 may extend along the complete periphery of the inner surface 166 of the plug 36 or it may be a quarter- or semi-annular depression or groove. Likewise, the protrusion 162 may extend along the complete periphery of the outer surface 168 of the wall 60 or it may be a quarter- or semi-annular protrusion. The use of protrusion and depression are inter-changeable. Once the protrusion 162 is aligned within depression 164 i.e. the engagement of protrusion 162 and depression 164 eliminate the chances of the second cap 30 getting removed easily providing a tight fit releasable engagement.

In the alternative embodiments, it is possible to provide more than one protrusion 62 and depression 64 in the similar manner.

As illustrated in Fig. 5, an enteral feeding tube 22 is inserted into the outlet opening 20 of the enteral connector 10 and is fixed in place by use of adhesive or glue or other suitable means. The use of a feeding tube 22 is already known. In use, the feeding tube 22 can be placed in a patient and the second cap 30 can be removed from the first cap 24 and an enteral-only syringe 68 as illustrated in Fig. 7, for example, can be pushed into the opening 28 and depressed to deliver liquid feed from the syringe, through the enteral connector 10 and through the feeding tube 22 into the patient. Similarly, an enteral feeding extension set 70 as illustrated in Fig. 8 including a connector can also be conveniently connected to the inlet opening 20 by removing the first cap 24 to administer the drug or nutritional fluid to the patient.

Thus, the connector 10 (FIGS. 1 to 6) in accordance with the present embodiments of the invention advantageously can be used to ensure that insertion, interconnection and removal to and from an end portion of a feeding tube 22 or the like is facilitated without the exertion of undue force and without resulting in unwanted stretching of the end portion.

Although, the invention has been described with reference to certain specific embodiments and examples, it would be appreciated by those skilled in the art that the invention may be embodied in many forms without departing from the broader spirit and scope of the invention as set forth in the invention. Thus, variations of preferred embodiments as disclosed may become apparent to those of ordinary skill in the art upon reading the foregoing description.

CLAIMS:WE CLAIM:
1. An enteral connector (10) for use with an enteral feeding tube, syringe or extension set comprising:
a body (12) having at least one passageway allowing the medical fluid to pass therethrough, the body comprising:
an inlet port (14) having an inlet opening (16) of the passageway suitable for connection with an enteral feeder or male connector element;
an outlet port (18) having an outlet opening (20) of the passageway having a mating portion or tube connecting portion (40) for connecting to an enteral feeding tube (22);
a first cap (24) having an external wall (26) for covering the inlet port (14) being integrally connected to the body (12) by a first flexible part (32) and having a plug (40) with an opening (28), the plug being shaped and sized to fit into the inlet opening (16);
a second cap (30) removably receivable in the opening (28) being integrally connected to the first cap (24) by a second flexible part (34).
2. The enteral connector (10) as claimed in claim 1, wherein the internal diameter of external wall (26) sized approximately equal or slightly larger to the external diameter of the inlet port (14) to have a close fit ratio therewith to provide a leak proof engagement.
3. The enteral connector (10) as claimed in claim 1, wherein outer diameter of the plug (44) shaped and sized approximately equal or slightly smaller to the internal diameter of the opening (16) to have a close fit ratio therewith to provide a leak proof engagement.
4. The enteral connector (10) as claimed in claim 1, further comprising a flange portion (42) being disc shaped to be abutted by a distal face (46) of the first cap when the first cap (24) received in the inlet opening (16).
5. The enteral connector (10) as claimed in any the preceding claims, wherein the inlet port (14), the flange portion (42), the mating portion (40) and outlet port (18) are all co-axial and together form the passageway through the body (12).
6. The enteral connector (10) as claimed in claim 1, wherein the second flexible part (34) extends outwardly from the external wall (26) of the first cap (24) in a direction that is generally perpendicular to the axis of the first flexible part (32).
7. The enteral connector (10) as claimed in claim 1, wherein the second cap (30) has a proximal face (144), a distal face (146) and a wall (60) extending therebetween in a direction opposite to the axial direction (A) from the distal face (146) to the proximal face (144).
8. The enteral connector (10) as claimed in claim 7, wherein the wall (60) forming the outer diameter of the second cap (30) is shaped and sized approximately equal or slightly smaller to the internal diameter of the opening (26).
9. The enteral connector (10) as claimed in any of the preceding claims, wherein the first cap (24) provided with at least one protrusion (62) at an inner surface (66) of the external wall (26).
10. The enteral connector (10) as claimed in any of the preceding claims, the inlet port (14) provided with at least one depression (64) on an outer wall (38) thereof.
11. The enteral connector (10) as claimed in any of the preceding claims, wherein the second cap (30) provided with at least one protrusion (162) at an outer surface (168) of the wall (60).
12. The enteral connector (10) as claimed in any of the preceding claims, wherein the plug (36) of the first cap (24) provided with at least one depression (164) in an inner surface (166) thereof.