# US 2019/0314580 A1 · Adjustable dose drug delivery system

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- Number: US 2019/0314580 A1
- Document ID: US20190314580A1
- Status: Published application
- Kind: A1
- Application number: 16/346,849
- Filed: 2017-11-06
- Published: 2019-10-17
- Earliest claimed: 2016-11-07
- Assignees: Beloteca, Inc.
- Applicants: Beloteca, Inc.
- Inventors: Lawrence J. Kelly
- Web page: https://patentgrep.com/patent/US20190314580A1

## CPC

- A61M 5/31563: {interacting with a displaceable stop member}
- A61M 5/3158: {the component being manually operated or triggered by an axially moving actuator operated by user, e.g. an axially movable injection button}
- A61K 31/5513: 1,4-Benzodiazepines, e.g. diazepam {or clozapine}
- A61M 5/28: Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
- A61M 5/3135: {characterised by constructional features of the proximal end}
- A61M 5/31501: {Means for blocking or restricting the movement of the rod or piston (A61M5/5013 takes precedence)}
- A61M 5/31511: {Piston or piston-rod constructions, e.g. connection of piston with piston-rod (A61M5/5066 takes precedence)}
- A61M 5/31513: {Piston constructions to improve sealing or sliding}
- A61M 5/31535: {Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose}
- A61M 5/31551: {including axial movement of dose setting member}
- A61M 5/502: {for blocking the piston}
- A61M 2005/3126: {related to dosing}
- A61M 2205/273: preventing reuse, e.g. of disposables
- A61M 2205/582: by tactile feedback
- A61M 2210/1064: Large intestine
- A61M 2210/1067: Anus
- 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)}
- 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)

## Abstract

A drug delivery system is provided that has an adjustable dose mechanism allowing setting and locking the dose then administration of the set dose. A method for administering a medicament using the drug delivery system is also provided.

## Claims

### Claim 1

An adjustable dose drug delivery system comprising:
a plunger, a syringe body, an inner housing, a plunger sleeve, an outer housing, and a rotating collar, wherein
the plunger comprises a stopper at a distal end, a plunger flange comprising a center at a proximal end, and a plunger stem fixed to the center of the plunger flange at a proximal end;
the syringe body comprises a syringe tip at a distal end and an open proximal end comprising a syringe body flange,
wherein the plunger is slidably deposed by inserting the stopper into the open proximal end of the syringe body and pushing the plunger flange toward the syringe body distal end;
the inner housing comprises a proximal end and a distal end and encloses the syringe body and is affixed thereto,
wherein the inner housing further comprises a plurality of dosage stops spirally deposed between the inner housing proximal end and distal end;
the plunger sleeve is distal to the plunger flange, and has a circumference within a plunger flange circumference and distal thereto, and encloses, and is external to, the plunger stem, and is deposed outside the inner housing and, when pushed toward the syringe body distal end, slides along the inner housing toward the plurality of dosage stops,
wherein the plunger sleeve further comprises
a closed slot running parallel to the plunger stem, and
a dosage stop engagement mechanism that engages a dosage stop when the plunger sleeve slides along the inner housing, said engagement preventing (a) further sliding of the plunger sleeve along the inner housing and (b) further insertion of the plunger toward the syringe body distal end;
the outer housing encompasses the inner housing and comprises a proximal end overlapping and deposed outside the plunger sleeve; and
the rotating collar surrounds the plunger sleeve and the proximal end of the outer housing and is rotationally joined to the plunger sleeve by a pin inserted into the plunger sleeve closed slot, wherein
the rotating collar further comprises a window displaying dosage information present on the outer housing, and
rotating the rotating collar displays a series of specific dosages in the window and rotates the plunger sleeve to align the dosage stop engagement mechanism to a dosage stop on the inner housing corresponding to the specific dosage displayed in the window.

### Claim 2 (depends on 1)

The drug delivery system of claim 1, further comprising a locking collar surrounding the plunger sleeve and the proximal end of the outer housing adjacent to the rotating collar rotationally joined thereto, wherein
the pin is on the rotating collar or locking collar and
the rotating collar is initially separated from the locking collar by a gap, wherein closing the gap engages a locking mechanism preventing rotation of the rotating collar and plunger sleeve.

### Claim 3 (depends on 2)

The drug delivery system of claim 2, wherein the locking mechanism comprises inwardly directed tabs on the locking collar nearest to the outer housing engaging (a) slots in the rotating collar and (b) notches in the outer housing at the position of each dosage stop.

### Claim 4 (depends on 2)

The drug delivery system of claim 2, further comprising a removable insert between the rotating collar and the locking collar that prevents closing the gap.

### Claim 5 (depends on 1)

The drug delivery system of claim 1, further comprising an initial stop mechanism preventing, without rotating the rotating collar to display dosage information, (i) sliding of the plunger sleeve along the inner housing toward the plurality of stops and (ii) insertion of the plunger toward the syringe body distal end.

### Claim 6 (depends on 5)

The drug delivery system of claim 5, wherein the initial stop mechanism is (A) a protrusion on the inner housing above the dosage stops and below the plunger sleeve, and (B) open slots in the plunger sleeve extending from near the proximal end and opening at the distal end of the plunger sleeve,
where the open slots align with the protrusion when the rotating collar is rotated to display a specific dosage in the window allowing the plunger and the plunger sleeve to slide to the dosage stop corresponding to the dosage displayed.

### Claim 7 (depends on 6)

The drug delivery system of claim 6, wherein the rotating collar further comprises protrusions that are inserted into the open slots.

### Claim 8 (depends on 1)

The drug delivery system of claim 1, wherein the proximal end of the plunger sleeve is affixed to the plunger flange.

### Claim at position 9

9-10. (canceled)

### Claim 11 (depends on 1)

The drug delivery system of claim 1, further comprising detents engaging the rotating collar to reversibly stop the rotation at the dosage information displays.

### Claim 12 (depends on 11)

The drug delivery system of claim 11, wherein the detents comprise an insert in an indentation in the rotating collar, wherein the insert surrounding the proximal end of the outer housing and comprises gaps that align with shallow protrusions in the proximal end of the outer housing at a display of each dosage in the window of the rotating collar.

### Claim 13 (depends on 1)

The drug delivery system of claim 1, wherein the dosage stop engagement mechanism comprises an inwardly directed locking finger at the distal end of the plunger sleeve engaging an outwardly directed knob at the dosage stop.

### Claim 14 (depends on 23)

The drug delivery system of claim 23, wherein the dosage stop engagement mechanism further comprises an outwardly and distally directed ramp proximal to the knob, with a gap between the ramp and the knob so that the locking finger ascends the ramp and drops into the gap when the plunger sleeve moves distally along the inner housing to the dosage stop corresponding to the dosage indicated in the window, wherein engaging the mechanism at a dosage stop prevents retraction of the plunger.

### Claim 15

(canceled)

### Claim 16 (depends on 1)

The drug delivery system of claim 1, wherein the inner housing further comprises a distally deposed administration tip, suitable for administration of a medicament.

### Claim 17

(canceled)

### Claim 18 (depends on 1)

The drug delivery system of claim 1, further comprising a cap enclosing the distal portion of the outer housing.

### Claim at position 18

19-20. (canceled)

### Claim 21 (depends on 16)

The drug delivery system of claim 16, wherein the administration tip is suitable for rectal administration.

### Claim 22 (depends on 1)

The drug delivery system of claim 1, wherein the syringe body comprises diazepam.

### Claim 23

An adjustable dose drug delivery system comprising:
a plunger, a syringe body, an inner housing, a plunger sleeve, an outer housing, a rotating collar and a locking collar, wherein
the plunger comprises a stopper at a distal end, a plunger flange comprising a center at a proximal end, and a plunger stem fixed to the center of the plunger flange at the proximal end;
the syringe body is glass and comprises a syringe tip at a distal end and an open proximal end comprising a syringe body flange,
wherein the plunger is slidably deposed by inserting the stopper into the open proximal end of the syringe body and pushing the plunger flange toward the syringe body distal end;
the inner housing comprises a proximal end and a distal end and encloses the syringe body and is affixed thereto,
wherein the inner housing further comprises a plurality of dosage stops spirally deposed between the inner housing proximal end and distal end;
the plunger sleeve is distal to the plunger flange, and has a circumference within a plunger flange circumference and distal thereto, and encloses, and is external to, the plunger stem, and is deposed outside the inner housing and, when pushed toward the syringe body distal end, slides along the inner housing toward the plurality of dosage stops,
wherein the plunger sleeve further comprises
a closed slot running parallel to the plunger stem, and
a dosage stop engagement mechanism that engages a dosage stop when the plunger sleeve slides along the inner housing, said engagement preventing (a) further sliding of the plunger sleeve along the inner housing and (b) further insertion of the plunger toward the syringe body distal end,
wherein the dosage stop engagement mechanism comprises
an inwardly directed locking finger at the distal end of the plunger sleeve engaging an outwardly directed knob at the dosage stop,
and an outwardly and distally directed ramp proximal to the knob, with a gap between the ramp and the knob so that the locking finger ascends the ramp and drops into the gap when the plunger sleeve moves distally along the inner housing to the dosage stop corresponding to the dosage indicated in the window;
the outer housing encompasses the inner housing and comprises a proximal end overlapping and deposed outside the plunger sleeve;
the rotating collar surrounds the plunger sleeve and the proximal end of the outer housing and is rotationally joined to the plunger sleeve by a pin in the rotating collar inserted into the plunger sleeve closed slot, wherein
the rotating collar further comprises a window displaying dosage information present on the outer housing, and
rotating the rotating collar displays a series of specific dosages in the window and rotates the plunger sleeve to align the dosage stop engagement mechanism to a dosage stop on the inner housing corresponding to the specific dosage displayed in the window;
the locking collar surrounds the plunger sleeve and the proximal end of the outer housing adjacent to the rotating collar and rotationally joined thereto, wherein
the rotating collar is initially separated from the locking collar by a gap, wherein closing the gap engages a locking mechanism preventing rotation of the rotating collar and plunger sleeve,
wherein the locking mechanism comprises inwardly directed tabs on the locking collar nearest to the outer housing engaging notches in the outer housing at the position of each dosage stop;
the system further comprising an initial stop mechanism preventing, without rotating the rotating collar to display dosage information, (i) sliding of the plunger sleeve along the inner housing toward the plurality of stops and (ii) insertion of the plunger toward the syringe body distal end,
wherein the initial stop mechanism is (A) a protrusion on the inner housing above the dosage stops, and (B) open slots in the plunger sleeve extending from near the proximal end and opening at the distal end of the plunger sleeve,
where the open slots align with the protrusion when the rotating collar is rotated to display a specific dosage in the window allowing the plunger and the plunger sleeve to slide to the dosage stop corresponding to the dosage displayed.

### Claim 24 (depends on 1)

A method of administering a medicament to a patient, the method comprising administering the medicament using the drug delivery system of claim 1, wherein the medicament is initially inside the syringe body and a dosage of the medicament is administered through the distal end of the syringe body or outer housing.

### Claim 25 (depends on 24)

The method of claim 24, further comprising
rotating the rotating collar and plunger sleeve until a desired dosage appears in the window of the rotating collar,
applying a distal end of the system to an administration point of the patient, and
pushing the plunger and plunger sleeve until the dosage stop engagement mechanism engages the dosage stop corresponding to the desired dosage.

### Claim at position 24

26-27. (canceled)

### Claim 28 (depends on 21)

A method of administering a medicament to a patient, the method comprising administering the medicament using the drug delivery system of claim 21, wherein the medicament is initially inside the syringe body and a dosage of the medicament is administered through the distal end of the syringe body or outer housing.

### Claim at position 26

29-33. (canceled)