# US 10,307,337 B2 · Oral administration coupler for back-of-mouth delivery

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- Number: US 10,307,337 B2
- Document ID: US10307337B2
- Status: Granted
- Kind: B2
- Application number: 15/815,713
- Filed: 2017-11-17
- Published: 2018-03-15
- Granted: 2019-06-04
- Earliest claimed: 2015-03-24
- Assignees: Neomed, Inc.
- Applicants: Neomed, Inc.
- Inventors: Benjamin Martin Davis; Mark M. Costello; Mariann Cary; Adrian McDermott
- Web page: https://patentgrep.com/patent/US10307337B2

## CPC

- A61J 7/0053: {Syringes, pipettes or oral dispensers}
- A61J 11/0035: {having particular shape or structure}
- A61J 15/0011: {Feeding-tubes for delivery of nourishment to the mouth; Mouth pieces therefor (breast-nipple shields A61J13/00; mouth pieces for drinking straws A47G21/185; straws to take medicine A61J7/0038, mouthpieces for tracheal tubes A61M16/0488)}
- A61L 29/041: {obtained by reactions only involving carbon-to-carbon unsaturated bonds}
- A61L 29/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
- A61M 5/142: Pressure infusion, e.g. using pumps
- A61M 39/10: Tube connectors or tube couplings
- A61J 15/0076: {Feeding pumps (A61M1/00, A61M5/142, A61M25/1018 take precedence)}
- A61M 39/1033: {Swivel nut connectors, e.g. threaded connectors or bayonet-connectors}
- A61M 2005/3139: {Finger grips not integrally formed with the syringe barrel, e.g. using adapter with finger grips}
- A61M 2202/0482: Enteral feeding product
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

An improved oral administration coupler for delivery of fluids such as medications and nutritional fluids. Example oral administration couplers have a first end with an applicator for oral delivery to an infant, and a second end with a coupling compatible with an enteral fluid delivery syringe. A fluid delivery conduit extends in fluid communication from the first end to the second end, to deliver fluid from the syringe to the infant. In some example embodiments, the coupler is configured for back-of-mouth delivery, and can comprise a generally elongate and at least partially flexible tube or straw.

## Claims

### Claim 1

An oral administration coupler for delivering fluids from a syringe to a child or infant, the syringe comprising a female connector, the oral administration coupler comprising:
a coupling comprising an ENFit compatible coupling end and an applicator coupling end, and a conduit extending therebetween; and
a straw comprising a first end coupled to the applicator coupling end and a second end generally oppositely extending therefrom,
wherein the ENFit compatible coupling comprises an outer circumferential collar having threads defined on an internal portion thereof, and a transfer port generally axially extending relative to the collar and comprising the conduit extending therethrough, and wherein at least one vent is formed within a portion of the collar and generally defined between the collar and the transfer port.

### Claim 2 (depends on 1)

The oral administration coupler of claim 1, wherein the ENFit compatible coupling is configured for removable engagement with the female connector of the syringe.

### Claim 3 (depends on 1)

The oral administration coupler of claim 1, further comprising a flange extending outwardly from the collar and being positioned between the ends of the coupling.

### Claim 4 (depends on 3)

The oral administration coupler of claim 3, wherein the flange is generally circular in shape, and wherein a smoothly radiused transitional surface is provided from the generally elongate member to an outer peripheral portion of the flange.

### Claim 5 (depends on 3)

The oral administration coupler of claim 3, wherein the flange is generally non-circular in shape and comprises a plurality of openings.

### Claim 6 (depends on 1)

The oral administration coupler of claim 1, wherein the female connector of the syringe further comprises a lumen extension tip axially extending therein and comprises a lumen therein and in communication with an internal chamber of the syringe, and wherein when the female connector is engaged with the ENFit compatible coupling end of the coupling, the lumen extension tip fully extends within a conduit of the transfer port.

### Claim 7 (depends on 6)

The oral administration coupler of claim 6, wherein a volume defined within the conduit of the coupler is substantially reduced by the conduit of the transfer port being occupied by the lumen extension tip of the female connector.

### Claim 8 (depends on 7)

The oral administration coupler of claim 7, wherein the volume defined within the conduit is generally no more than about 0.01 mL.

### Claim 9 (depends on 1)

The oral administration coupler of claim 1, wherein a length of between about 20 millimeters to about 80 millimeters is defined between the ENFit compatible coupling end and the second end of the straw.

### Claim 10 (depends on 1)

The oral administration coupler of claim 1, wherein the straw comprises polyvinyl chloride.

### Claim 11 (depends on 1)

The oral administration coupler of claim 1, wherein the straw comprises polyurethane.

### Claim 12 (depends on 1)

The oral administration coupler of claim 1, wherein the straw comprises silicone.

### Claim 13 (depends on 1)

The oral administration coupler of claim 1, wherein the straw comprises an outer diameter of between about 2-6 millimeters and an inner diameter of between about 0.3-2 millimeters.

### Claim 14 (depends on 13)

The oral administration coupler of claim 13, wherein the straw comprises an outer diameter of about 4 millimeters and an inner diameter of about 0.56 millimeters.

### Claim 15 (depends on 1)

The oral administration coupler of claim 1, wherein the second end of the straw comprises a rounded surface to mitigate the risk of trauma during oral delivery.

### Claim 16 (depends on 1)

The oral administration coupler of claim 1, wherein at least one connecting member couples the collar to the transfer port.

### Claim 17

An oral administration coupler for back-of-mouth delivery comprising:
a central fluid transfer member comprising a first end and a generally opposite second end, the first end comprising a syringe coupling and the second end comprising a tube extending therefrom in a direction generally opposite the first end, the syringe coupling comprising an outer circumferential collar having threads defined on an internal portion thereof, a transfer port generally axially extending relative to the collar of the syringe coupling, and at least one vent formed within a portion of the collar and generally defined between the collar and the transfer port; and
a lumen defined within the central fluid transfer member and extending from the first end to the second end through the entirety of the transfer port and the tube, wherein the central fluid transfer member defines a length between the first and second ends sufficient to deliver fluid from the central fluid transfer member to a back of a child's mouth from a fluid delivery device at least partially external of the child's mouth.

### Claim 18 (depends on 17)

The oral administration coupler of claim 17, wherein the coupling is configured for removable engagement with a syringe having a threaded tip.

### Claim 19 (depends on 17)

The oral administration coupler of claim 17, wherein a length of between about 15 millimeters to about 60 millimeters is defined between the first and second ends of the central fluid transfer member.

### Claim 20 (depends on 17)

The oral administration coupler of claim 17, wherein an end portion of the tube is substantially tapered or rounded such that trauma to a patient's mouth is mitigated.

### Claim 21 (depends on 17)

The oral administration coupler of claim 17, wherein the syringe coupling of the first end is an ISO 80369-3 formatted coupling.

### Claim 22 (depends on 17)

The oral administration coupler of claim 17, wherein the tube comprises polyvinyl chloride.

### Claim 23 (depends on 17)

The oral administration coupler of claim 17, wherein the tube comprises polyurethane.

### Claim 24 (depends on 17)

The oral administration coupler of claim 17, wherein the tube comprises silicone.

### Claim 25 (depends on 17)

The oral administration coupler of claim 17, wherein the tube comprises between about a 4 Fr to about a 12 Fr feeding tube.

### Claim 26 (depends on 17)

The oral administration coupler of claim 17, wherein the tube comprises an outer diameter of about 4 millimeters and an inner diameter of about 0.56 millimeters.

### Claim 27 (depends on 21)

The oral administration coupler of claim 21, wherein the ISO 80369-3 formatted coupling is configured for coupling engagement with a female connector a syringe, wherein the syringe further comprises a lumen extension tip axially extending therein and comprises a lumen therein and in communication with an internal chamber of the syringe, and wherein when the female connector is engaged with the ISO 80369-3 formatted coupling, the lumen extension tip fully extends within a conduit of the transfer port.

### Claim 28

An oral administration coupler for delivering fluids from a syringe to a child or infant, the syringe comprising a female connector, the oral administration coupler comprising a conduit extending from a first end to a second end, the first end comprising an elongate applicator for oral insertion to deliver fluids to the child or infant, and the second end comprising a coupling for removable engagement with the female connector of the syringe, the coupling comprising an outer circumferential collar having threads defined on an internal portion thereof and a transfer port generally axially extending relative to the collar and comprising the conduit extending therethrough, and wherein at least one vent is formed within a portion of the collar and generally defined between the collar and the transfer port.

### Claim 29 (depends on 28)

The oral administration coupler of claim 28, further comprising a clamp for temporarily closing or sealing the elongate applicator.

### Claim 30 (depends on 28)

The oral administration coupler of claim 28, further comprising a plunger movably mounted within a barrel of the syringe, the plunger comprising an elongate tube extending therefrom for insertion within the conduit of the oral administration coupler so as to reduce a volume defined by the conduit of the oral administration coupler such that dosing inaccuracies are improved.

### Claim 31 (depends on 28)

The oral administration coupler of claim 28, wherein the elongate applicator comprises one or more markings or graduations for assisting in the measurement of a dosage quantity.

### Claim 32 (depends on 28)

The oral administration coupler of claim 28, wherein the elongate applicator comprises an outer tube and an inner tube, wherein the outer tube comprises an inner diameter and an outer diameter and the inner tube comprises an inner diameter and an outer diameter, wherein the outer diameter of the inner tube is generally dimensionally similar to the inner diameter of the outer tube.

### Claim 33 (depends on 28)

The oral administration coupler of claim 28, further comprising a radial channel formed along a portion of the outer circumferential collar, and a flange is connectable with the radial channel.

### Claim 34 (depends on 28)

The oral administration coupler of claim 28, further comprising a cover or cap connectable to an end of the elongate applicator for providing closure to the conduit.

### Claim 35

An oral administration coupler for delivering fluids from a syringe to a child or infant, the syringe comprising a female connector, the oral administration coupler comprising:
a coupling comprising a syringe coupling end and an applicator coupling end, and a conduit extending therebetween; and
a straw comprising a first end coupled to the applicator coupling end and a second end generally oppositely extending therefrom,
wherein the syringe coupling end comprises an outer circumferential collar having threads defined on an internal portion thereof, and a transfer port generally axially extending relative to the collar and comprising the conduit extending therethrough, and wherein at least one vent is formed within a portion of the collar and generally defined between the collar and the transfer port.
