# US 10,765,602 B1 · Medication delivery systems and methods

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- Number: US 10,765,602 B1
- Document ID: US10765602B1
- Status: Granted
- Kind: B1
- Application number: 16/578,498
- Filed: 2019-09-23
- Published: 2020-10-01
- Granted: 2020-09-08
- Earliest claimed: 2019-03-29
- Assignees: Eli Lilly and Company
- Applicants: Eli Lilly and Company
- Inventors: Jaime Ray Arnett; Andrew Thomas Snow
- Web page: https://patentgrep.com/patent/US10765602B1

## CPC

- A61J 1/1425: {Snap-fit type}
- B05B 11/0027: {Means for neutralising the actuation of the sprayer (pump locking means B05B11/1059); Means for preventing access to the sprayer actuation means}
- A61K 9/14: Particulate form, e.g. powders, {Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles (microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51)}
- A61M 15/0026: {Hinged caps}
- A61M 15/08: Inhaling devices inserted into the nose
- B05B 11/062: {designed for spraying particulate material}
- C07K 14/605: Glucagons
- G09B 23/28: for medicine
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- A61K 38/28: Insulins
- A61M 11/00: Sprayers or atomisers specially adapted for therapeutic purposes (in general B05B; {aerosol containers B65D83/14})
- A61M 2202/064: Powder
- A61M 2210/0618: Nose
- 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
- B05B: SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES (spray-mixers with nozzles B01F25/72; processes for applying liquids or other fluent materials to surfaces by spraying B05D)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- 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)}
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- G09B: EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS (devices for psychotechnics or for testing reaction times A61B5/16; games, sports, amusements A63; projectors, projector screens G03B)

## Abstract

The present disclosure relates to a medication delivery system including a medication administration device, a medication within the medication administration device, a container defining a cavity receiving the medication administration device, and a cap attached to the container and sealing the medication administration device within the cavity. The medication administration device includes an actuator extending from a body and operable to expel the medication by depressing the actuator into the body. The cap includes hold down members positioned to bear against the body of the medication administration device to prevent movement of the medication administration device toward the cap beyond a predetermined distance. The medication administration device is thereby prevented, inter alia, from prematurely discharging the medication during storage and transport.

## Claims

### Claim 1

A medication delivery system comprising:
a medication administration device comprising a body having a discharge end defining a medication discharge port and an opposed actuator end, the medication administration device including a medication reservoir, the medication administration device further including an actuator for ejecting a medication from the reservoir through the discharge port,
the actuator extending out of the actuator end of the body,
the actuator being linearly moveable from an extended position to a depressed position, the discharge port being sealed when the actuator is in the extended position and the discharge port being open when the actuator is in the depressed position, the actuator being operable to discharge the medication from the reservoir upon axial movement of the actuator from the extended position to the depressed position;
said medication received within the reservoir of the medication administration device;
a container having an axially extending side wall and a closed bottom wall defining a cavity having an access opening defined by an end wall portion, the medication administration device being received within the cavity with the discharge end adjacent the closed bottom wall of the container, and a desiccant disposed within the cavity, the desiccant having an annular shape to define an opening to receive the medication discharge port of the medication administration device, in which the container includes a continuous interior shoulder disposed radially inward from an interior surface of the axially extending side wall, the continuous interior shoulder axially spaced from the closed bottom wall at a distance to securely retain the desiccant between the continuous interior shoulder and the closed bottom wall, in which the desiccant includes an annular notch defined along a radially outer surface of the desiccant, the annular notch configured to receive the continuous interior shoulder when the desiccant is disposed within the container; and
a cap coupled to the container, and movable relative to the container between an open position and a closed position, the cap in the closed position is sealably engaged with the container to enclose the medication administration device within the cavity,
the cap defining one or more hold down members, wherein, when the cap is in the closed position, the one or more hold down members extends axially from the cap in a direction toward the closed bottom wall and is sized to allow at most a predetermined amount of axial movement of the medication administration device in the direction away from the closed bottom wall, wherein the one or more hold down members is contactable with a non-actuator portion of the medication administration device.

### Claim 2 (depends on 1)

The medication delivery system of claim 1 in which the one or more hold down members is a rigid structure.

### Claim 3 (depends on 2)

The medication delivery system of claim 2 in which the body of the medication administration device includes a radially extending circumferential surface surrounding the actuator and facing away from the closed bottom wall, wherein, when the cap is in the closed position, the one or more hold down members is positioned radially outside the actuator to be contactable against the circumferential surface.

### Claim 4 (depends on 3)

The medication delivery system of claim 3 in which the cap having a cup shaped body comprising a cap side wall and defining a recess configured to receive a portion of the actuator, wherein the one or more hold down axial members extends out beyond the recess.

### Claim 5 (depends on 4)

The medication delivery system of claim 4 in which an interior surface of the cap side wall and an interior surface of the one or more hold down members define a continuous surface.

### Claim 6 (depends on 4)

The medication delivery system of claim 4 wherein the one or more hold down members comprises a pair of hold down axial projections extending from the cup shaped body of the cap at radially opposite sides of the cap.

### Claim 7 (depends on 4)

The medication delivery system of claim 4 wherein the cap includes an outer rim disposed around the cup shaped body, a circumferential flange depending axially from a bottom wall facing surface of the outer rim, the one or more hold down members disposed spaced radially inward relative to the flange, and extending axially beyond the flange.

### Claim 8 (depends on 2)

The medication delivery system of claim 2 in which the cap is coupled to the container by a hinged connection.

### Claim 9 (depends on 8)

The medication delivery system of claim 8 in which the hinged connection is a living hinge.

### Claim 10 (depends on 8)

The medication delivery system of claim 8 in which the one or more hold members includes two hold down members, the two hold down members disposed circumferentially away from one another, the hinged connection disposed circumferentially between the two hold down members.

### Claim 11 (depends on 8)

The medication delivery system of claim 8 in which the one or more hold members includes a single hold down member.

### Claim 12 (depends on 3)

The medication delivery system of claim 3 in which the cap includes an outer rim extending radially from the cup shaped body, and a circumferential flange depending axially from a bottom wall facing surface of the outer rim, and the container and the cap comprise a latch member to secure the cap to the container in the closed position, the latch member including a latch extending axially from the outer rim of the cap, wherein said flange extends axially beyond the latch.

### Claim 13 (depends on 12)

The medication delivery system of claim 12 in which the one or more hold down members of the cap comprises two hold down members, the two hold down members disposed circumferentially away from one another, the hinged connection disposed circumferentially between the two hold down members, and the latch disposed circumferentially between the two hold down members radially opposite to the hinged connection.

### Claim 14

A medication delivery system comprising:
a medication administration device comprising a body having a discharge end defining a medication discharge port and an opposed actuator end, a medication reservoir containing a medication, and an actuator for ejecting the medication from the reservoir through the discharge port, the actuator extending out of the actuator end of the body, the actuator being linearly moveable from an extended position to a depressed position, the discharge port being sealed when the actuator is in the extended position and the discharge port being open when the actuator is in the depressed position, the actuator being operable to discharge said medication from the reservoir upon axial movement of the actuator from the extended position to the depressed position; and
a container comprising an axially extending side wall and a closed bottom wall defining a cavity having an access opening defined by an end wall portion, the medication administration device being received within the cavity with the discharge end adjacent the bottom wall of the container, a cap hingedly coupled to the container, the cap movable relative to the container between an open position and a closed position, the cap in the closed position is sealably engaged with the container to enclose the medication administration device within the cavity, and a desiccant disposed within the cavity, the desiccant having an annular shape to define an opening to receive the medication discharge port of the medication administration device, wherein the body of the medication administration device includes a radially extending circumferential surface surrounding the actuator and facing away from the closed bottom wall,
in which the container includes a continuous interior shoulder disposed radially inward from an interior surface of the axially extending side wall of the container, the continuous interior shoulder axially spaced from the closed bottom wall at a distance to securely retain the desiccant between the continuous interior shoulder and the closed bottom wall, in which the desiccant includes an annular notch defined along a radially outer surface of the desiccant, the annular notch configured to receive the continuous interior shoulder when the desiccant is disposed within the container,
wherein the cap defines a pair of hold down members, wherein, when the cap is in the closed position, the hold down members extend axially from the cap in a direction toward the closed bottom wall and sized to allow at most a predetermined amount of axial movement of the medication administration device in the direction away from the closed bottom wall, wherein each of the hold down members has a contact end surface contactable with the circumferential surface of said medication administration device, radially outside the actuator of the medication administration device, wherein the hold down members are configured to allow each of the contact end surfaces to maintain its relative axial position and radial position relative to the cap and the circumferential surface of said device.

### Claim 15 (depends on 14)

The medication delivery system of claim 14 in which the medication administration device is an air dispersion device.

### Claim 16 (depends on 15)

The medication delivery system of claim 15 in which the medication is an intranasal delivery powder.

### Claim 17 (depends on 16)

The medication delivery system of claim 16 in which the powder is glucagon.

### Claim 18

A method for providing a medication delivery system containing a glucagon composition, the method comprising:
positioning a medication administration device within a container,
the medication administration device comprising a body having a discharge end defining a medication discharge port and an opposed actuator end, the medication administration device including a medication reservoir containing a glucagon medication, the medication administration device further including an actuator for ejecting said glucagon medication from the reservoir through the discharge port, the actuator extending out of the actuator end of the body, the actuator being linearly moveable from an extended position to a depressed position, the discharge port being sealed when the actuator is in the extended position and the discharge port being open when the actuator is in the depressed position, the actuator being operable to discharge the glucagon medication from the reservoir upon axial movement of the actuator from the extended position to the depressed position;
the container having a side wall and a closed bottom wall defining a cavity having an access opening defined by an end wall portion, the cavity receiving the medication administration device within the cavity with the discharge end adjacent the closed bottom wall of the container, and a desiccant disposed within the cavity, the desiccant having an annular shape to define an opening to receive the medication discharge port of the medication administration device, in which the container includes a continuous interior shoulder disposed radially inward from an interior surface of the side wall, the continuous interior shoulder axially spaced from the closed bottom wall at a distance to securely retain the desiccant between the continuous interior shoulder and the closed bottom wall, in which the desiccant includes an annular notch defined along a radially outer surface of the desiccant, the annular notch configured to receive the continuous interior shoulder when the desiccant is disposed within the container; and
sealing a cap to the container to provide a hermetic seal enclosing the medication administration device within the cavity, the cap defining one or more hold down members positioned and configured to interfere with movement of the medication administration device to allow at most a predetermined amount of movement of the medication administration device in the direction away from the closed bottom wall without the actuator contacting an axial end surface of the cap.

### Claim 19

A medication container and cap assembly for containing a medication administration device, the medication administration device comprising a body having a discharge end defining a medication discharge port and an opposed actuator end, the medication administration device including a medication reservoir containing a medication, the medication administration device further including an actuator for ejecting the medication from the reservoir through the discharge port, the actuator extending out of the actuator end of the body, the actuator being linearly moveable from an extended position to a depressed position, the discharge port being sealed when the actuator is in the extended position and the discharge port being open when the actuator is in the depressed position, the actuator being operable to discharge the medication from the reservoir upon axial movement of the actuator from the extended position to the depressed position, the assembly comprising:
a container having a side wall and a closed bottom wall defining a cavity having an access opening defined by an end wall portion, the cavity being sized and configured to receive the medication administration device, the medication administration device being receivable within the cavity with the discharge end adjacent the closed bottom wall of the container, and a desiccant disposed within the cavity, the desiccant having an annular shape to define an opening to receive the medication discharge port of the medication administration device, in which the container includes a continuous interior shoulder disposed radially inward from an interior surface of the side wall, the continuous interior shoulder axially spaced from the closed bottom wall at a distance to securely retain the desiccant between the continuous interior shoulder and the closed bottom wall, in which the desiccant includes an annular notch defined along a radially outer surface of the desiccant, the annular notch configured to receive the continuous interior shoulder when the desiccant is disposed within the container; and
a cap coupled to the container by a hinged connection, and configured to mate with the container when in a closed position and provide a hermetic seal to enclose the medication administration device inserted within the cavity, the cap defining a pair of hold down members positioned and configured to interfere with movement of the medication administration device to allow at most a predetermined amount of movement of the medication administration device in the direction away from the closed bottom wall, the hold down members disposed circumferentially away from one another, the hinge connection disposed circumferentially between the two hold down members.

### Claim 20 (depends on 19)

The assembly of claim 19 in which the container side wall is sized to allow an end portion of the actuator to extend out beyond the container side wall, the cap having a cup shaped body defining a recess configured to receive the end portion of the actuator, each of the hold down members extending from the cup shaped body, wherein an interior surface of the cup shaped body that faces the recess and an interior surface of the hold down members define a continuously smooth surface.

### Claim 21 (depends on 1)

The medication delivery system of claim 1 in which the medication administration device is an air dispersion device.

### Claim 22 (depends on 21)

The medication delivery system of claim 21 in which the medication is an intranasal delivery powder.

### Claim 23 (depends on 22)

The medication delivery system of claim 22 in which the powder is glucagon.