# US 2013/0152926 A1 · Dry powder inhalers that inhibit agglomeration, related devices and methods

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- Number: US 2013/0152926 A1
- Document ID: US20130152926A1
- Status: Published application
- Kind: A1
- Application number: 13/734,323
- Filed: 2013-01-04
- Published: 2013-06-20
- Earliest claimed: 2004-09-13
- Assignees: Oriel Therapeutics, Inc.
- Inventors: Michael King; Jeffrey Alan Warden; Patrick D. Lopath; Richard D. LaRoche
- Web page: https://patentgrep.com/patent/US20130152926A1

## CPC

- A61M 15/0091: {mechanically breath-triggered}
- A61M 15/001: {using ultrasonic means}
- A61M 15/008: {Electronic counters}
- A61M 15/0086: {Inhalation chambers}
- B01F 25/43161: {composed of consecutive sections of flat pieces of material}
- B01F 25/431974: {Support members, e.g. tubular collars, with projecting baffles fitted inside the mixing tube or adjacent to the inner wall}
- A61M 15/0081: {Locking means}
- A61M 15/0083: {Timers}
- A61M 2202/064: Powder
- A61M 2205/3569: sublocal, e.g. between console and disposable
- A61M 2205/3584: using modem, internet or Bluetooth®
- A61M 2205/3592: using telemetric means, e.g. radio or optical transmission
- A61M 2206/14: Static flow deviators in tubes disturbing laminar flow in tubes, e.g. archimedes screws
- B01F 25/431971: {Mounted on the wall}
- Y10T 29/49826: Assembling or joining
- 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)}
- B01F: MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING (mixing paints B44D3/06)
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

Inhalers with fins that deagglomerate dry powder using inspiratory effort of a user of an inhaler. The inhaler fins, at least in steady state conditions, are configured to generate dry powder and airflow patterns having turbulence with flow vortices, some of which may have a vortex having an axis of rotation that extends in an inspiratory flow direction while others may have a vortex that is substantially orthogonal to the inspiratory flow direction in an inspiratory airflow path, as an amount of dry powder travels through the inhaler to thereby deagglomerate the dry powder without trapping undue amounts of the dry powder during inhalation.

## Claims

### Claim 1

A method of deagglomerating dry powder in a dry powder inhaler, comprising:
generating a dry powder and air flow pattern having flow vortices using at least one fin that extends across at least a portion of an inspiratory flow path, wherein the at least one fin generates a plurality of point induced flow vortices at a common axial location so that some of the vortices have an opposite rotation relative to others about a respective axis of rotation that extends axially in the inspiratory flow direction of dry powder and air flow to thereby facilitate deagglomeration of the dry powder without trapping undue amounts of the dry powder in the inhaler.

### Claim 2 (depends on 1)

A method according to claim 1, wherein the generating step employs a plurality of spaced apart statically configured fins that reside in the inspiratory airflow path, each having at least one point and least two edge portions that meet to define the at least one point, the fins creating point and edge induced flow vortices in the dry powder and air airflow pattern, wherein the point induced flow vortices have a corresponding respective axis of rotation that extends in the inspiratory flow direction, wherein the edge induced flow vortices are shedding vortices that have a corresponding respective axis of rotation that is substantially perpendicular to the inspiratory flow direction, and wherein the airflow path has a deagglomerating portion that encloses the fins, the deagglomerating portion having a cross-sectional area that is about 200 mm2 or less.

### Claim 3 (depends on 1)

A method according to claim 1, wherein the at least one fin comprises a plurality of fins that extend from a boundary surface across a subportion of a cross sectional width of the inspiratory flow path, the fins configured to define at least one point and two edges that reside in the inspiratory flow path.

### Claim 4 (depends on 3)

A method according to claim 3, wherein, when viewed from the end in cross-section, fins extend from circumferentially spaced locations and converge to occupy at least a major portion of the cross-sectional surface area of an interior cavity associated with the inspiratory airflow path.

### Claim 5 (depends on 3)

A method according to claim 3, wherein the fins are arranged in at least two offset fin arrays.

### Claim 6 (depends on 3)

A method according to claim 3, wherein the fins are arranged in at least two aligned fin arrays.

### Claim 7 (depends on 3)

A method according to claim 3, wherein the fins are sized using proportions defined according to the mathematical ratio of 1.618, where A is to B as B is to C with “C” being a total cross sectional surface area of the inspiratory flow path at a first location defined by where the first plurality of fins axially terminate in a downstream direction of the flow path, “A” being the surface area of a plurality of fins at the first location, and “B” being the remaining area of the cross sectional surface area of the flow path.

### Claim 8

An inhaler comprising:
an inhaler body with an inspiratory flow path therein; and
at least one fin residing in the inspiratory flow path, the at least one fin comprising at least two edges that converge to define a point, the at least one turbulence promoter being configured to generate a plurality of point-induced and edge-induced flow vortices of air and dry powder in response to inspiratory effort by a user, whereby some of the flow vortices have an axis of rotation that extends in an inspiratory flow direction and some of the flow vortices have an axis of rotation that is substantially orthogonal to the inspiratory flow direction.

### Claim 9 (depends on 8)

An inhaler according to claim 8, wherein the at least one fin comprises a plurality of axially spaced apart fins, each statically residing in the inspiratory flow path and configured to extend from a boundary surface across a sub-portion of a width of the inspiratory airflow path thereat.

### Claim 10 (depends on 8)

An inhaler according to claim 8, wherein the at least one fin is a plurality of fins, each fin having a body portion that inclines inwardly at an acute angle in a primary direction of flow from a bounding surface, the fins configured to define at least one point and two edges that reside in the inspiratory flow path that generate flow vortices.

### Claim 11 (depends on 10)

An inhaler according to claim 10, wherein the fins are arranged as at least two offset fin arrays.

### Claim 12 (depends on 10)

An inhaler according to claim 10, wherein the fins are arranged as at least two aligned fin arrays.

### Claim 13 (depends on 10)

An inhaler according to claim 10, wherein at least a first plurality of the fins are sized using a mathematical ratio of 1.618 where A is to B as B is to C with “C” being a total cross sectional surface area of the inspiratory flow path at a first location defined by where the first plurality of fins axially terminate in a downstream direction of the flow path, “A” being the surface area of a plurality of fins at the first location, and “B” being the remaining area of the cross sectional surface area of the flow path.

### Claim 14 (depends on 13)

An inhaler according to claim 13, wherein the first plurality of fins are three circumferentially spaced apart fins that incline from the bounding surface at about 45 degrees.

### Claim 15 (depends on 8)

An inhaler according to claim 8, wherein the fins are held by a cylindrical insert with an outer wall that abuts an inner wall of the inhaler, wherein the fins comprise a plurality of circumferentially spaced apart fins and a plurality of longitudinally spaced apart fins, wherein the fins have an outermost portion attached to the cylindrical insert outer wall and an opposing innermost portion, and wherein the fins angle inward so that the innermost end portion resides closer to a mouthpiece of the inhaler.

### Claim 16 (depends on 8)

An inhaler according to claim 8, wherein the fins comprise a plurality of circumferentially spaced apart fins and a plurality of longitudinally spaced apart fins, wherein the fins have an outermost portion and an opposing innermost portion, and wherein the fins angle inward from a bounding wall toward a mouthpiece of the inhaler so that the innermost end portion resides closer to a mouthpiece of the inhaler.

### Claim 17 (depends on 10)

An inhaler according to claim 10, wherein at least some of the fins are generally triangularly shaped to have two long edges that converge to an innermost point that resides in the inspiratory airflow path.

### Claim 18 (depends on 10)

An inhaler according to claim 10, wherein the fins are substantially triangular with at least one point extending in the inspiratory airflow path.

### Claim 19 (depends on 8)

An inhaler according to claim 8, wherein the at least one fin comprises a substantially conical or concave body portion with apertures, the body portion having a larger upstream portion and a smaller downstream portion in the direction of flow.

### Claim 20

A method of fabricating a dry powder inhaler, comprising:
providing an insert having at least one fin extending angularly inward from a bounding surface; and
placing the insert into an inspiratory airflow path of an inhaler.

### Claim 21

An inhaler insert, comprising an insert sized and configured for insertion into a dry powder inhaler inspiratory flow path, the insert having a plurality of spaced apart fins ramped from a bounding surface toward an axial centerline of an inhaler inspiratory flow path.