US3888252A

US3888252A - Powder inhaler

Info

Publication number: US3888252A
Application number: US435937A
Authority: US
Inventors: Anthony J Side; Bernard Mcdonald
Original assignee: Individual
Current assignee: Individual
Priority date: 1974-01-23
Filing date: 1974-01-23
Publication date: 1975-06-10
Anticipated expiration: 1992-06-10

Abstract

A device for inhaling medicinal powders or the like is described. The device is a tube containing a desiccator through which a person inflates a balloon. Means are provided for maintaining the balloon in an inflated state. The tube is then assembled to a mouthpiece with a capsule retainer in the air stream between the balloon and the mouthpiece. A medicinal capsule in the retainer is perforated as the device is assembled so that powder is free to flow therefrom. Air flow causes the capsule retainer to rotate and draws powder into the air stream for inhalation by a person. In another embodiment powder may sift into the air stream without rotation of the capsule holder.

Description

Side et al.

1 1 POWDER INHALER [76] Inventors: Anthony J. Side, Goring-on-Thames,

Oxfordshire, England; Bernard McDonald, 18212 Pacific Coast Hwy., Malibu, Calif. 90265 [22] Filed: Jan. 23, 1974 [21] Appl. N0.: 435,937

[52] U.S. Cl 128/266; 128/208 [51] Int. Cl A6lm 15/06 [58] Field of Search 128/265, 266, 208, 187; 222/193, 107, 95, 389

[56] References Cited UNlTED STATES PATENTS 1,628,843 5/1927 Horton 128/266 1,929,154 10/1933 Sundock 128/265 1,934,793 11/1933 Grain et a1... 128/266 2,533,065 12/1950 Taplin et a1 128/266 X 2,946,332 7/1960 Sacks 128/266 2,966,282 12/1960 Geisler 222/107 X 3,155,573 11/1964 Fowler 128/266 X 3,518,992 7/1970 Altouyan et al. 128/208 June 10, 1975 Primary ExaminerAldrich F. Medbery Attorney, Agent, or Firm-Christie, Parker & Hale 57] ABSTRACT A device for inhaling medicinal powders or the like is described. The device is a tube containing a desiccator through which a person inflates a balloon. Means are provided for maintaining the balloon in an inflated state. The tube is then assembled to a mouthpiece with a capsule retainer in the air stream between the balloon and the mouthpiece. A medicinal capsule in the retainer is perforated as the device is assembled so that powder is free to flow therefrom. Air flow causes the capsule retainer to rotate and draws powder into the air stream for inhalation by a person. In another embodiment powder may sift into the air stream without rotation of the capsule holder.

10 Claims, 8 Drawing Figures POWDER INHALER BACKGROUND For a number of years various bronchodilators have been used for affording temporary relief from acute bronchial spasms. Such spasms are often encountered in chronic obstructive pulmonary diseases, such as bronchial asthma, bronchitis, emphysema, and the like. Such drugs have been administered by injection. ingestion. inhalation or suppository, depending upon the drug and the desired duration of effect. None of these drugs have prevented asthmatic spasms. At best, they afford temporary relief and terminate an acute attack.

A drug with a new mode of action has been recently introduced. Sodium chromoglycate apparently behaves as a prophylactic agent and entirely prevents onset of bronchial attacks. This drug is packaged in conventional gelatin capsules in the form ofa very fine dust or powder. This powder is non-packing and flows freely from small perforations in the gelatin capsule.

To use the powdered drug the patient inhales the dust to allow the medication to act directly on the bronchial tissue. thereby having a maximum action on the bronchus with minimal effect on the rest of the body. At least two devices have been developed for permitting a patient to inhale the material from a capsule conveniently at any location. One of these devices permits the powder to sift into an air stream which is inhaled by the patient. much in the manner that a person smokes a pipe; inhaling the powder and then exhaling with the device removed from his mouth. In another such device, the gelatin capsule is perforated at one end in a capsule receiver mounted within the device. The capsule receiver has turbine blades which cause it to spin as the person inhales air through the device. Powder thus comes out of the capsule and is entrained in the air stream for inhalation by the patient.

On occasion these devices fail to deliver all or part of the medication needed by the patient. As a result, the daily dosage prescribed by the physician may not be controllable in all circumstances. One difficulty with the present devices is that they require the patient to inhale with a considerable degree of force in order to entrain powder within the air stream. Unfortunately. an asthmatic may not be able to do this sufficiently forcibly', otherwise, he would not require the drug in the first place.

Generally. the ability of persons to forcibly inhale is less than their ability to forcibly exhale. In bronchial asthma the ability to forcibly blow out is impaired as well as the ability to inhale. However. the expiratory force still substantially surpasses the inspiralory capability of the patient.

It is, therefore. desirable to provide a means for inhaling powdered medication or the like without requiring a great forcible inhalation by the person requiring the medication. Preferably, the inhalation force is augmcntcd by temporarily storing some of the exhalation force to aid in inhaling. If desired. manual means may be employed for augmenting the inhalation l'orcc.

BRIEF SUMMARY ()I" I'Hli lNVl-IN'IION There is, thcrclorc. provided in practice olthis invention according to a presently preferred embodiment a powder inhaler having a mouthpiece and an inflatable elastic balloon connected thereto. Means are provided for temporarily closing the balloon in an inflated state (ill and for interconnecting the mouthpiece and balloon for introducing a powder into a gas stream flowing from the balloon to the mouthpiece.

Preferably a desiccant is provided for eliminating breath moisture in an embodiment wherein the balloon is inflated by exhalation. Further, a gelatin capsule or the like may be used for dispensing the powder in a turbine arrangement for assuring thorough powder distribution.

DRAWINGS These and other features and advantages of the present invention will be appreciated as the same becomes better understood by reference to the following de tailed description of presently preferred embodiments when considered in connection with the accompanying drawings wherein:

FIG. 1 illustrates an exploded and partially cutaway side view ofa powder inhaler constructed according to principles of this invention;

FIG. 2 illustrates a longitudinal cross-section of a capsule retainer for the powder inhaler of FIG. I.

FIGS. 3, 4 and 5 are transverse cross-sections through the capsule retainer as indicated in FIG. 2;

FIG. 6 is a fragmentary detail of means for temporarily sealing a balloon;

FIG. 7 illustrates in longitudinal cross-section another embodiment of powder inhaler; and

FIG. 8 is a transverse cross-section through the pow dcr inhaler of FIG. 7.

DESCRIPTION FIG. I illustrates in exploded view a powder inhaler constructed according to the principles of this invention with some portions cut away to better illustrate the interior.

As illustrated in this embodiment. the powder inhaler has a mouthpiece II ofthe same general configuration as a smokers pipe. At the end of the mouthpiece. opposite that portion which would go into a patient's mouth, there is a cylindrical bore 12 ending in an internal shoulder I3. Radially extending spokes 14 within the mouthpiece support an axial spindle l6. The end of the spindle has a sharp point I7 to serve as a hearing.

A hollow blow pipe I8 has an outside diameter that fits snugly in the bore I2 so that the end I) of the blow pipe abuts the shoulder I3 when assembled to the mouthpiece. A cylindrical bore 21 within the blow pipe loosely receives a capsule retainer 22. An inwardly directed ridge or ring 23 is provided at one end of the bore 2| in the blow pipe. and when fully assembled this ridge loosely fits into a peripheral groove 24 near one end of the capsule retainer.

The balance of the interior of the blow pipe I8 contains a desiccant 26 for removing entrained water and reducing moisture content of breath. The desiccant 26 is illustrated schematically in FIG. I as a helical porous member within the bore of the blow pipe. The desiccant can actually take many forms suitable for reducing moisture without greatly inhibiting the flow of air thcrcthrough. For example. the desiccant can be as simple as porous paper that is readily wcttcd by water. or it can include additional non-toxic hygroscopic materials for reducing the moisture content of breath. Porous plastic members can also be used with or without additional desiccating chemicals. Fvcn metal members may be used with sufficient mass and surface area for condensing a substantial portion of the water in a persons breath. Many suitable desiccant arrangements will be apparent to one skilled in the art.

The end of the blow pipe 18 fits into a short plastic mounting tube 27. The plastic mounting tube 27 has a flattened center portion 28 for temporarily limiting air flow as hereinafter described in greater detail. An ordinary inflatable normally flaccid rubber balloon 29 or similar elastically resilient air storage reservoir in connected to the end of the mounting tube 27. lt will be ap parent that if desired the tube 27 can be made integral with the blow pipe instead of being provided as a separate element.

Although the illustrated arrangement permits interchange and replacement of components, the capsule retainer 22 is illustrated in greater detail in the longitudinal cross-section of FIG. 2 and the transverse crosssections of FIGS. 3, 4 and 5. The capsule retainer is generally circular in cross-section except for a pair of opposed raised portions 31 running along a portion of the length. The outside diameter of the capsule retainer fits through the ring 23 in the extrance to the blow pipe. The raised portions 31 are, however, sufficiently far apart to engage the ring as the retainer is pressed into position. The walls of the capsule retainer are sufficiently flexible that the protruding portions 31 are pressed towards each other as they pass the ring 23.

Within the raised protrusions 31 are a plurality of short spikes 32 extending inwardly towards the center of the capsule retainer. In FIGS. 2 and 4 a typical capsule 33 is illustrated in phantom in the position it would occupy when assembly in the powder inhaler. The points of the spikes 32 in their undeflected position as illustrated in FIGS. 2 and 4 define the sides of a cylindrical locus within which the capsule is positioned. When the retainer 22 is pressed into the blow pipe the protrusions 31 are pressed inwardly by the ring 23 and the spikes 32 perforate the walls of the gelatin capsule. When the capsule retainer is completely within the blow pipe the protrusions 31 spring back to their original position, withdrawing some or all of the spikes from the holes thus made in the gelatin capsule. Powder within the capsule is then free to flow from the holes made by the spikes. It will be noted that holes in the capsule are made at multiple points along its length. This helps discharge all of the powder by permitting some air flow through the capsule and low pressure regions adjacent it.

The end of the capsule tits in a shallow axial depres sion 34 within the capsule retainer. The depression is in the end of an axial sleeve 36 which is positioned within the powder inhaler by three radiating spokes 37. The interior of the sleeve 36 terminates in a conical portion 38 which, when assembled, mates with the point 17 on the spindle 16 of the mouthpiece. The spindle and conical end thus form a point bearing which permits rapid rotation of the capsule retainer,

At the end ofthe powder inhaler are a plurality of inwardly directed radial turbine blades 39. The turbine blades do not extend to the center of the capsule retainer but provide sufficient clearance that a capsule can be freely inserted into the retainer. The spokes 37 are preferably also skewed relative to the axis of the inhaler for imparting rotation thereto. The spokes and the blades react to the flow of air through the powder inhaler for rapidly spinning the capsule retainer. Such rapid spinning helps discharge powder from the capsule and enhances entrainment in the flowing air stream. A fine screen 41 is provided at the downstream end of the capsule retainer for minimizing the chance of inhalation of a foreign object, such as a fragment of the gelatin capsule. if desired, such a screen may be positioned in the mouthpiece instead of in the capsule retainer.

FIG. 6 illustrates in fragmentary detail a portion of the flat region 28 between the blow pipe and balloon. An internal ridge 42 is formed on one wall of the flat portion. An enlargement 43 is formed along the length of the ridge remote from the wall 44 of the flat portion. On the opposite wall 46 of the flat portion, there are a pair of raised, spaced apart ridges 47 defining a space therebetween complementary to the ridge 42 and enlargement 43 on the opposite wall. When the walls 44 and 46 are pressed towards each other, the opposed ridges 42 and 47 interengage, forming a reasonable gas seal. Such a technique is employed for sealing various plastic containers and, although not completely airtight, very little flow occurs through such a seal.

When it is desired to open such a seal, the side edges of the flat portion 28 are pinched towards each other causing the two walls to bow away from each other, disengaging the ridges. Air pressure, if any, within the tube 27 increases the tendancy of the walls to bow away from each other and open the seal. Such a seal provides a convenient and inexpensive way of temporarily sealing the balloon 29. All one needs to do to close the seal is pinch the two walls of the flat portion 28 towards each other. To open the seal the edges of the walls are pinched towards each other.

To use the powder inhaler, one first opens the seal and blows through the blow pipe 18 to inflate the balloon 29. As will be apparent temporary sealing may be provided by simply pinching the neck of the balloon until sufficient inflation has been obtained, at which time it is preferred to close the somewhat more permanent seal formed by the flat portion 28 of the tube. Any moisture in the person's breath is removed by the desiccant 26 as the balloon is inflated. All entrained moisture and much of the condensible moisture is removed so that substantially dry air which will not cause caking of the medicinal powder inflates the elastic balloon.

The patient then inserts a capsule 33 in the capsule retainer 22, and the retainer is pressed into the bore 21 of the blow pipe 18. The downstream end 48 of the powder inhaler is made somewhat larger than the bore so that the patient cannot inadvertently insert the capsule retainer in the wrong direction. As the capsule retainer is pressed through the ring 23, the protrusions 31 on the side walls deflect and cause the spikes 32 to perforate the gelatin capsule. The retainer is pressed into the point that the groove 24 aligns with the ring 23 so that the blow pipe does not inhibit free rotation of the retainer.

The mouthpiece 1] is then assembled to the blow pipe, bringing the internal shoulder 13 into engagement with the end 19 of the blow pipe. The point 17 on the spindle 16 engages the conical end 38 of the sleeve 36 and provides a rotational bearing for the retainer. The patient then inhales through the mouthpiece while at the same time releasing some or all of the air from the inflated balloon 29. This air temporarily stored in the elastic inflated balloon 29 augments the force ofinhalation so that a greater air flow is obtained than by inhalation alone. This augmented air flow assures complete emptying of the rotating capsule and excellent entrainment of the medicinal powder in the air stream. If for some reason some of the powder is retained, the mounting tube 27 can be removed from the blow pipe 18 and the balloon reinflated for additional inhalation. In this case the desiccant 26 removes moisture from air as it leaves the balloon.

After the powder inhaler has been used, the desiccant material may be removed and discarded. If desired, the desiccant material can be dried in place by means of gentle heating so that it can be re-used many times. The capsule retainer is inexpensive enough that it can be discarded after each usage along with the blow pipe and its contained desiccant. If desired, however, the capsule retainer can be pulled out of the blow pipe, washed, dried and re-used. The gelatin capsules can be shaken out or dissolved in warm water.

FIG. 7 illustrates in longitudinal cross-section another embodiment of powder inhaler constructed according to principles of this invention. As illustrated in this embodiment there is a mouthpiece 51 through which the patient may inhale a medicinal powder as hereinabove described. The mouthpiece 51 has a cylincrical end 52 for receiving the end of a blow pipe 53. The blow pipe is packed with a desiccant 54. The desiccant in this embodiment is in the form of a packing of porous material with air flow passages therethrough for assuring a large contact area between breath and the desiccant for thorough drying without greatly increasing resistance to air flow. The desiccant material is preferably disposable so that it can be removed from the blow pipe and discarded when loaded with water, thereby permitting re-use of the blow pipe.

An ordinary rubber balloon 56 is mounted on the opposite end of the blow pipe. A conventional quarter turn valve 57 is provided between the desiccant material and the balloon for temporarily sealing the balloon in its inflated state. A hand operated rubber inflation bulb S8 is connected to the blow pipe by way of a side tube 59. A pair of check valves 61 and 62 are connected to the rubber inflation bulb so that air is drawn in and pumped into the balloon in a conventional manner when the valve 57 is closed.

Thus. the patient is given the alternative of inflating the balloon by blowing through the blow pipe 53 as hereinabove described, or, if the patient has difficulty exhaling with sufficient force to inflate the balloon to a sufficient extent. the rubber squeeze bulb 58 can be used for inflation. Ordinarily when the squeeze bulb is used there is no need to provide a desiccant prior to air entering the balloon. It will also be recognized that the alternative arrangement for temporarily sealing the balloon and for inflating the balloon can be incorporated in the embodiment of FIG. I if desired. Other permutations of the illustrated embodiments will also be apparent.

A capsule retainer 63 is mounted in the upper transverse portion of the mouthpiece 5i, much in the manner ofa smokers pipe. The capsule retainer has a lower conical portion 64 open at its bottom end. A plurality of sharp cutting blades 66 are formed inside the conical retainer so that when a gelatin capsule 67 is pressed into the retainer. the blades cut it open and permit powder contained therein to sift out. A screen 68 is provided across the bottom of the capsule retainer to prevent particles of the capsule from sifting down into the air stream. Thorough emptying of the capsule and passage of powder through the screen can be obtained with no more than gentle tapping of the powder inhaler. A cover 69 is connected to the retainer by a flexible strap 71. Pressing the cap in place in the retainer assures that the capsule completely engages the blades 66 to assure opening of the capsule.

The powder inhaler illustrated in FIG. 7 is used in much the same manner as hereinabove described. The patient first inflates the rubber balloon 56, either by blowing through the blow pipe or by pumping it up with the bulb 58. The valve 57 is kept closed after inflation for temporarily storing air under pressure in the balloon. The mouthpiece 51 is then connected to the blow pipe 53. A capsule is inserted in the capsule retainer 63 and the cover 69 is pressed down tearing the capsule open and permitting the powder to sift out into the lower portion of the mouthpiece. The patient can then inhale while opening the valve 57 for drawing powder into the bronchial passages. It will be noted that the powder sifts into a lower portion 72 of the mouthpiece that is not in a direct line with the mouthpiece portion that the patient holds in his mouth. This enhances turbulence of air in the mouthpiece and further assures entrainment and mixing of powder into the air stream through the powder inhaler. It will also be noted that the two check valves 61 and 62 connected to the bulb 58 permit the patient to inhale through this passage even after the balloon is deflated.

In the embodiment illustrated in FIG. 7, the powder capsule retainer 63 can readily be re-used since it is out of the air stream and the gelatin capsule can be picked out before the next usage. The desiccant material in the blow pipe can be replaced between usages if the balloon is inflated with the person's breath. The entire device is made of plastics which can be rinsed off if required. Preferably, the plastic is thoroughly dried with an ordinary hair dryer or the like to assure that no moisture causes packing or caking of the medicinal powder.

Although limited embodiments of powder inhaler constructed according to the principles of this invention, have been described and illustrated herein, many modifications and variations will be apparent to one skilled in the art. Thus, for example, other means may be employed for temporarily sealing the balloon in its inflated state. Similarly, other means for opening capsules and permitting the powder contents to enter the path of air flow will be apparent to those skilled in the art. It is therefore to be understood that within the scope of the appended claims, the invention may be practiced otherwise than as specifically described.

What is claimed is:

1. A medicinal powder dispensing device for supplying powder to an air stream to be inhaled comprising:

a mouthpiece having an air flow passage therethrough;

a means for providing an air stream including an inflatable normally flaccid elastic balloon;

means connected to the balloon for manually inflating the balloon;

means for temporarily closing the balloon in an inflated state; disconnectable air passage means interconnecting the balloon and mouthpiece for controlling the passage of air from the balloon to the mouthpiece; and

means for introducing powder into the air stream between the balloon and the mouthpiece.

2. A powder inhaler as defined in claim 1 further comprising:

means for opening a gelatin capsule within the powder inhaler for releasing powder therefrom into an air stream between the balloon and the mouthpiece.

3. A powder inhaler as defined in claim 2 wherein the means for opening a capsule comprises:

a capsule retainer;

a means for mounting the capsule retainer for rotation within the air flow path through the powder inhaler; and

means for rotating the capsule retainer in response to air flow through the powder inhaler 4. A powder inhaler as defined in claim 2 wherein the means for opening comprises:

a capsule retainer;

means for mounting the capsule retainer outside the direct flow path of air between the balloon and mouthpiece. said capsule retainer including cutting members for cutting a capsule inserted in the capsule retainer and a powder flow channel between the capsule retainer and the air flow path between the balloon and the mouthpiece.

5. A powder inhaler as defined in claim 1 wherein the means for introducing comprises:

a side passage out of the air path between the balloon and the mouthpiece; a capsule retainer selectively insertable in the side passage; a cover for the capsule retainer; means for opening a gelatin capsule within the capsule retainer when the cover is applied; and an opening between the capsule retainer and the air path for passage of powder from a capsule into the air path. 6. A powder inhaler as defined in claim I further comprising:

cam means for perforating a gelatin capsule in response to assembly of the powder inhaler. 7. A powder inhaler as defined in claim 6 wherein the cam means includes a plurality of perforation members 8 for opening the capsule in a plurality of locations along its length for enhancing powder distribution 8. A powder inhaler as defined in claim 1 wherein the means for manually inflating the balloon comprises a tube connected to the balloon for directing breath into the balloon. and a desiccant in the tube for removing breath moisture.

9. A powder inhaler as defined in claim 1 wherein the means for manually inflating the balloon comprises a hand operated squeeze bulb connected to the balloon and a pair of check val es connected to the bulb for drawing air into the bulb and pumping air into the balloon.

10. A powder inhaler comprising:

a mouthpiece having an air flow passage therethrough:

an inflatable elastic balloon;

means for temporarily closing the balloon in an inflated state:

disconnectable air passage means interconnecting the balloon and mouthpiece for passage of air from the balloon to the mouthpiece;

means for introducing a powder into an air stream between the balloon and the mouthpiece; and

means for opening a gelatin capsule within the powder inhaler for releasing powder therefrom into an air stream between the balloon and the mouthpiece comprising:

a capsule retainer;

a means for mounting the capsule retainer for rotation within the air flow path through the powder inhaler;

means for rotating the capsule retainer in response to air flow through the powder inhaler:

a plurality of capsule perforating spikes arrayed adjacent a capsule receiving region in the capsule retainer; and

an elastically deflectable mounting for the spikes for pressing the spikes towards the capsule receiving location in response to assembly of the powder inhaler.

Claims

1. A medicinal powder dispensing device for supplying powder to an air stream to be inhaled comprising: a mouthpiece having an air flow passage therethrough; a means for providing an air stream including an inflatable normally flaccid elastic balloon; means connected to the balloon for manually inflating the balloon; means for temporarily closing the balloon in an inflated state; disconnectable air passage means interconnecting the balloon and mouthpiece for controlling the passage of air from the balloon to the mouthpiece; and means for introducing powder into the air stream between the balloon and the mouthpiece.

2. A powder inhaler as defined in claim 1 further comprising: means for opening a gelatin capsule within the powder inhaler for releasing powder therefrom into an air stream between the balloon and the mouthpiece.

3. A powder inhaler as defined in claim 2 wherein the means for opening a capsule comprises: a capsule retainer; a means for mounting the capsule retainer for rotation within the air flow path through the powder inhaler; and means for rotating the capsule retainer in response to air flow through the powder inhaler.

4. A powder inhaler as defined in claim 2 wherein the means for opening comprises: a capsule retainer; means for mounting the capsule retainer outside the direct flow path of air between the balloon and mouthpiece, said capsule retainer including cutting members for cutting a capsule inserted in the capsule retainer and a powder flow channel between the capsule retainer and the air flow path between the balloon and the mouthpiece.

5. A powder inhaler as defined in claim 1 wherein the means for introducing comprises: a side passage out of the air path between the balloon and the mouthpiece; a capsule retainer selectively insertable in the side passage; a cover for the capsule retainer; means for opening a gelatin capsule within the capsule retainer when the cover is applied; and an opening between the capsule retainer and the air path for passage of powder from a capsule into the air path.

6. A powder inhaler as defined in claim 1 further comprising: cam means for perforating a gelatin capsule in response to assembly of the powder inhaler.

7. A powder inhaler as defined in claim 6 wherein the cam means includes a plurality of perforation members for opening the capsule in a plurality of locations along its length for enhancing powdEr distribution.

8. A powder inhaler as defined in claim 1 wherein the means for manually inflating the balloon comprises a tube connected to the balloon for directing breath into the balloon, and a desiccant in the tube for removing breath moisture.

9. A powder inhaler as defined in claim 1 wherein the means for manually inflating the balloon comprises a hand operated squeeze bulb connected to the balloon and a pair of check valves connected to the bulb for drawing air into the bulb and pumping air into the balloon.

10. A powder inhaler comprising: a mouthpiece having an air flow passage therethrough; an inflatable elastic balloon; means for temporarily closing the balloon in an inflated state; disconnectable air passage means interconnecting the balloon and mouthpiece for passage of air from the balloon to the mouthpiece; means for introducing a powder into an air stream between the balloon and the mouthpiece; and means for opening a gelatin capsule within the powder inhaler for releasing powder therefrom into an air stream between the balloon and the mouthpiece comprising: a capsule retainer; a means for mounting the capsule retainer for rotation within the air flow path through the powder inhaler; means for rotating the capsule retainer in response to air flow through the powder inhaler; a plurality of capsule perforating spikes arrayed adjacent a capsule receiving region in the capsule retainer; and an elastically deflectable mounting for the spikes for pressing the spikes towards the capsule receiving location in response to assembly of the powder inhaler.