WO2008042951A2 - Inhalation devices and related methods - Google Patents

Inhalation devices and related methods Download PDF

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Publication number
WO2008042951A2
WO2008042951A2 PCT/US2007/080288 US2007080288W WO2008042951A2 WO 2008042951 A2 WO2008042951 A2 WO 2008042951A2 US 2007080288 W US2007080288 W US 2007080288W WO 2008042951 A2 WO2008042951 A2 WO 2008042951A2
Authority
WO
WIPO (PCT)
Prior art keywords
capsule
inhalation device
patient
patient interface
capable
Prior art date
Application number
PCT/US2007/080288
Other languages
French (fr)
Other versions
WO2008042951A3 (en
Inventor
Richard L. Miller
Benjamin G. Powers
Original Assignee
Manta Product Development
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US84932106P priority Critical
Priority to US60/849,321 priority
Application filed by Manta Product Development filed Critical Manta Product Development
Publication of WO2008042951A2 publication Critical patent/WO2008042951A2/en
Publication of WO2008042951A3 publication Critical patent/WO2008042951A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0028Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0001Details of inhalators; Constructional features thereof
    • A61M15/0021Mouthpieces therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0028Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • A61M15/0033Details of the piercing or cutting means
    • A61M15/0035Piercing means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0028Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • A61M15/0033Details of the piercing or cutting means
    • A61M15/0041Details of the piercing or cutting means with movable piercing or cutting means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0488Mouthpieces; Means for guiding, securing or introducing the tubes
    • A61M16/049Mouthpieces
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/08Inhaling devices inserted into the nose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/06Solids
    • A61M2202/064Powder
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/07General characteristics of the apparatus having air pumping means
    • A61M2205/071General characteristics of the apparatus having air pumping means hand operated
    • A61M2205/075Bulb type
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583Means for facilitating use, e.g. by people with impaired vision by visual feedback

Abstract

An inhalation device includes a housing, a capsule in the housing, an inhalable substance in the capsule, a patient interface connected to the housing, the patient interface adapted for use with an infant or a small child, and an air pressure source capable of providing an air stream that entrains the inhalable substance and delivers the inhalable substance through the patient interface and to a patient. The patient interface can also be used by those with compromised breathing function, such as an adult asthmatic.

Description

INHALATION DEVICES AND RELATED METHODS

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application 60/849,321, filed on October 3, 2006, and entitled "Squeeze Bulb Inhalation Device".

FIELD OF THE INVENTION

The invention relates to inhalation devices and related methods. The devices can be, for example, those useful for delivering inhalable substances in the form of a dry powder and/or a liquid.

BACKGROUND

Inhalers allow a substance, such as a drug in dry powder form, to be delivered from the inhaler to a user. In some cases, the user, such as an asthmatic, an infant or a small child, does not have sufficient lung capacity to aerosolize a powder properly. If the velocity of the air moving through the inhaler is insufficient to aerosolize the powder, too much powder can remain in the inhaler and render delivery inefficient, or the powder may come out in clumps that are not well utilized by the body. A number of different approaches have been tried to ameliorate insufficient aerosolization and clumping. These approaches include shaping the air pathway, adding valves to change the flow, and adding screens or other impediments to help aerosolize the powder.

SUMMARY OF THE INVENTION

In one aspect, the invention features an inhalation device for the delivery of one or more inhalable substances, e.g., a drug or a nutritional substance. The inhalation device includes a chamber for receiving a substance-containing capsule, a mechanism for puncturing or opening the capsule, and an active air flow supply (such as a squeeze bulb) to expel and to entrain the substance from the capsule for delivery to the patient. The active air flow supply can provide sufficient force to increase the velocity of air flow through the inhaler, thereby aerosolizing the substance (e.g., a powder) and assisting in allowing the substance to reach the patient. The inhalation device can be used for delivering substances to patients with very low breathing flow rates, such as infants or those with compromised breathing function.

In another aspect, the invention features an inhalation device, including a housing; a capsule in the housing; an inhalable substance in the capsule; a patient interface connected to the housing, the patient interface adapted for use with an infant or a small child; and an air pressure source capable of providing an air stream that entrains the inhalable substance and delivers the inhalable substance through the patient interface and to a patient.

Embodiments may include one or more of the following features. The patient interface is configured for oral delivery of the inhalable substance. The patient interface includes a flange. The flange is capable of creating a seal to a patient's face. The flange is capable of controlling the depth of insertion of an outlet opening of the patient interface into a patient's mouth. The patient interface is capable of pinching or sealing a patient's nose. The flange is capable of orienting and positioning the inhalation device relative to the patient's mouth and nose. The patient interface is configured to position an outlet opening past the front end portion of a tongue of a patient. The shape of the patient interface is configured to keep the tongue away from the outlet opening. The patient interface includes a bulb-shaped feature. The capsule is oriented in the same direction regardless of whether a patient is lying down or in an upright position during delivery of the inhalable substance. The patient interface includes a substantially 90 degree geometry. The inhalable substance includes a drug. The air pressure source includes a squeeze bulb, a syringe, or a compressed gas supply. The patient interface includes a mask, a nipple, or a nose piece. The patient interface includes a semi-rigid material or a flexible material.

The inhalation device can further include a capsule puncturing mechanism capable of translating rotary motion to linear motion through a camming action. The puncturing mechanism can puncture the capsule and enlarge a chamber containing the capsule to allow free movement of the capsule within the chamber. The camming action can be controlled by a rotatable knob. The knob can be in a first position when the capsule is puncture- free, and a second position when the capsule is punctured. The first and second positions of the knob can be indicated by visual indicia. The inhalation device can further include a mechanism capable of preventing the knob from being rotated back to the first position. The linear motion can reciprocate. In another aspect, the invention features an inhalation device, including a capsule; an inhalable substance in the capsule; and a capsule puncturing mechanism capable of translating rotary motion to linear motion through a camming action.

Embodiments may include one or more of the following features. The puncturing mechanism is capable of puncturing the capsule and enlarging a chamber containing the capsule to allow free movement of the capsule within the chamber. The camming action is controlled by a rotatable knob. The knob is capable of being in a first position when the capsule is puncture- free, and a second position when the capsule is punctured. The first and second positions of the knob are indicated by visual indicia. The visual indicia are selected from the group consisting of colored indicia, text, symbols, graphics, bumps and grooves. The inhalation device further includes a mechanism capable of preventing the knob from being rotated back to the first position. The linear motion is capable of reciprocating. The inhalation device further includes an air pressure source capable of providing an air stream capable of entraining the substance and delivering the substance through a patient interface and to a patient. The inhalable substance includes a drug.

In another aspect, the invention features a method of delivering an inhalable substance, the method includes puncturing a capsule by translating rotary motion to linear motion, the capsule containing the inhalable substance; and delivering the inhalable substance from the capsule to a patient using an active air source. Embodiments may include one or more of the following features. The method further includes enlarging a chamber containing the capsule to allow free movement of the capsule within the chamber. Translating rotary motion to linear motion is performed through a camming action. The camming action is controlled by a rotatable knob. The knob is capable of being in a first position when the capsule is puncture -free, and a second position when the capsule is punctured. The method further includes preventing the knob from being rotated back to the first position. The method further includes reciprocating the linear motion. The inhalable substance includes a drug.

In another aspect, the invention features a method of delivering an inhalable substance, the method including contacting a patient interface of an inhalation device to a patient, the patient interface interfering with or contacting the patient's nose when the inhalation device is in an improper orientation for delivering the inhalable substance; and delivering the inhalable substance to the patient using an active air source.

Embodiments may include one or more of the following features. The patient interface is adapted for use with an infant or a small child. The patient interface includes a semi-rigid material or a flexible material. The air source is capable of providing an air stream that entrains the inhalable substance and delivers the inhalable substance through the patient interface and to a patient. The patient interface is configured for oral delivery of the inhalable substance. The patient interface includes a flange, e.g., one capable of creating a seal to a patient's face. The flange is asymmetrical. The flange is oblong. The flange interferes with or contacts the patient's nose. The flange is capable of controlling the depth of insertion of an outlet opening of the patient interface into a patient's mouth. The patient interface is capable of pinching or sealing a patient's nose. The method includes positioning an outlet opening of the patient interface past the front end portion of a tongue of a patient. The shape of the patient interface is configured to keep the tongue away from the outlet opening. The patient interface includes a bulb-shaped feature. The method includes orienting an inhalable substance-containing capsule in the same direction regardless of whether a patient is lying down or in an upright position during delivery of the inhalable substance. The patient interface includes a substantially 90 degree geometry. The inhalable substance includes a drug.

The method can include puncturing an inhalable substance-containing capsule by translating rotary motion to linear motion. The method can further include enlarging a chamber containing the capsule to allow free movement of the capsule within the chamber. Translating rotary motion to linear motion can be performed through a camming action. The camming action can be controlled by a rotatable knob. The knob can be in a first position when the capsule is puncture-free, and a second position when the capsule is punctured. The method can further include preventing the knob from being rotated back to the first position. The method can further include reciprocating the linear motion.

The devices and methods described herein can be used to deliver one or more substances in solid form (e.g., a powder) and/or in fluid form (e.g., a homogeneous liquid, a slurry, a suspension). The substances can include a drug or be drug-free. The substances can be delivered through the mouth into the oral cavity and/or to the lungs. The substances (e.g., drugs (such as decongestants) and moisturizing solutions) can also be delivered through the nostrils into the nasal cavity and/or to the lungs. The substances can be delivered through both the mouth and the nostrils (for example, in embodiments where the patient interface includes a mask), and these substances can be delivered to the oral cavity, to the nasal cavity, and/or to the lungs, in any combination. Substances that are intended to be delivered into the oral cavity include, for example, nutritional compositions (such as sugars, candy, food, vitamins, and quick energy supplements in liquid and/or powder (e.g., nanoparticles) form) and non-nutritional compositions (such as flavorants (e.g., esters)). Other substances that can be delivered into the oral cavity include those used for oral hygiene and dental treatment (e.g., breath fresheners, fluoride treatments, teeth whiteners, antibacterial compositions, mouthwashes). Drugs and related compositions (such as anesthetics, therapeutic markers) can also be delivered into the oral cavity. Substances that can be delivered through the mouth and/or the nose and inhaled into the lungs include, for example, drugs (e.g., for treating asthma, bronchitis, pneumonia) and therapeutic markers (such as dyes, scanning agents, radio labeling or tagging agents, UV labeling agents, contrasts agents in liquid and/or powder (e.g., nanoparticles) form).

As used herein, an "inhalable substance" is a substance that is intended to be delivered ultimately to a nasal cavity, to an oral cavity, and/or to the lungs. When a substance is intended to be delivered ultimately to the lungs, the substance can be delivered through the nasal cavity and/or through the oral cavity. A portion of a substance intended to be delivered ultimately to the lungs may stay in the nasal cavity and/or the oral cavity and not get delivered to the lungs. Examples of inhalable substances are provided above.

An "inhalation device" is a device used to deliver an inhalable substance to a patient. The device can be operated by the patient or another person (such as a doctor, a nurse, a caretaker, or a parent). The term "active" refers to the use of one or more mechanisms and/or forces in addition to the patient's respiration. Examples of active mechanisms include air pressure devices, such as a squeeze ball, a syringe, a bellows, and a compressed air source. In comparison, use of the patient's respiration alone is considered "passive".

Other aspects, features and advantages will be apparent from the description of the following embodiments and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of an embodiment of an inhalation device.

FIG. 2 shows a cross section of the inhalation device shown in FIG. 1. FIG. 3 is an isometric view of an embodiment of an inhalation device; FIG. 3 A is an isometric view of an embodiment of a patient interface; and FIG. 3B is an isometric view of an embodiment of a patient interface.

FIG. 4 is an isometric view of the inhalation device shown in FIG. 3 with a top housing and a knob removed. FIG. 5 A is a cross-sectional view of the inhalation device shown in FIG. 3 in a first position; FIG. 5B is a cross-sectional view of the inhalation device shown in FIG. 3 in an intermediate position between the first position and a second position; and FIG. 5C is a cross- sectional view of the inhalation device shown in FIG. 3 in the second position.

DETAILED DESCRIPTION

Referring to FIGS. 1 and 2, an inhalation device 100 includes an outer housing 101 and an inner housing 102. A user can separate outer housing 101 and inner housing 102 from each other by pulling them apart to facilitate loading and unloading of a drug-containing capsule 201.

Outer housing 101 and inner housing 102 include ribs 103 and 104, respectively, for ease of gripping the housings by the user. In other embodiments, device 100 is configured as a preloaded, single-use device where outer housing 101 and inner housing 102 may not be separable by the user.

At its proximal end (e.g., relative to the person delivering the drug to a patient, such as an infant), inhalation device 100 includes a plunger 105 that serves to open capsule 201 by puncturing or other means. Plunger 105 may be depressed distally by the user to puncture capsule 201, or may be moved in other ways, such as by rotating or pulling back, to puncture capsule 201.

At its distal end, inhalation device 100 includes a patient interface 106. Patient interface

106 can take a variety of forms, such as a nipple, a standard mouthpiece, a nose piece, or a mask. Patient interface 106 can be separable from orunitarily formed with outer housing 101. As shown, inhalation device 100 includes a flange 107, which helps position patient interface 106 relative to the patient's face.

Inhalation device 100 also includes a source of moving air to help aerosolize the drug in capsule 201. As illustrated, the moving air is generated by a squeeze bulb 108 having a bulb cavity 218. When compressed by the user, squeeze bulb 108 causes an air stream to flow through device 100, and the air stream rotates capsule 201, expels the drug from the capsule, and entrains the drug into the air stream. The drug then passes through patient interface 106 and is delivered to the patient.

Inhalation device 100 includes a chamber 202 which is bounded by outer housing 101, inner housing 102 and a chamber bottom 203. Capsule 201 sits within chamber 202.

Inhalation device 100 is illustrated having two springs 204 and 205, which serve to bias the inhalation device 100 in a non -puncturing position depicted in FIGS. 1 and 2. To puncture capsule 201, the user depresses plunger 105 distally, compressing spring 205. Plunger 105 is coupled to chamber bottom 203 by spring 204, so depressing plunger 105 also moves chamber bottom 203 distally towards capsule 201. Chamber bottom 203 continues to move until an integral shoulder 206 contacts a corresponding stop 207 in inner housing 102. Movement of chamber bottom 203 causes chamber 202 to decrease in size. When shoulder 206 in chamber bottom 203 contacts stop 207 in inner housing 102, the size of chamber 202 is decreased to the point where capsule 201 is held securely for puncturing. As shown, outer housing 101 and chamber bottom 203 have spherical portions that help to align and to center capsule 201 within chamber 202 during puncturing.

Plunger 105 contains a staple 208, which has sharpened prongs to facilitate puncturing of capsule 201. Staple 208 can be a separate component that is assembled to plunger 105, or alternatively can be unitarily formed with plunger 105. The prongs of staple 208 are situated within corresponding channels 209 in chamber bottom 203. When shoulder 206 is in contact with stop 207, plunger 105 can move relative to chamber bottom 203 to compress spring 204, and to cause the prongs of staple 208 to protrude from channels 209 in chamber bottom 203, thereby puncturing capsule 201. When plunger 105 is released or withdrawn by the user, springs 204 and 205 cause plunger 105 and chamber bottom 203 to return to their non-puncturing positions depicted in FIGS. 1 and 2. When inhalation device 100 is in the non-puncturing position, the size of chamber 202 is larger than capsule 201 , and the prongs of staple 208 are recessed within channels 209 in chamber bottom 203, allowing capsule 201 to move freely in chamber 202.

Inhalation device 100 also contains a biasing pin 210, which further ensures that the prongs of staple 208 are withdrawn into holes 209 in chamber bottom 203 following puncturing of capsule 201. Biasing pin 210 is located inside of plunger 105. A dowel pin 211 passes though holes 212 in inner housing 102, slots 213 in plunger 105, and a hole 214 in biasing pin 210. Slots 213 allow relative motion between biasing pin 210 and plunger 105. Dowel pin 211 is secured by retaining rings 215. Chamber bottom 203 is coupled to plunger 105 by retaining pin 216. Retaining pin 216 passes through slots 217 in plunger 105, allowing relative motion of these two parts. When inhalation device 100 is in the non-puncturing position, biasing pin 210 is in contact with retaining pin 216 in chamber bottom 203, ensuring that chamber bottom 203 is biased to its fully forward, distal position relative to plunger 105. During puncturing of capsule 201, chamber bottom 203 can slide distally relative to plunger 105 as allowed by slots 217. If chamber bottom 203 fails to slide back proximally to its original position relative to plunger 105 by the force of spring 204 alone during withdrawal of plunger 105 following puncturing of capsule 201, biasing pin 210 will contact retaining pin 216 causing chamber bottom 203 to move back proximally to its original position, ensuring that the prongs of staple 208 are withdrawn proximally into channels 209 in chamber bottom 203. Following puncturing of capsule 201 , the drug is delivered to the patient by compression of squeeze bulb 108. Compressing squeeze bulb 108 causes air to flow out of bulb cavity 218 and through a one-way check valve 219. The air enters a cavity 220, which is bounded by outer housing 101 and inner housing 102. A mating seal geometry 221 in outer housing 101 and inner housing 102 as well as an O -ring 222 prevent air from leaking out of cavity 220. The air flows from cavity 220 through vents 223 in inner housing 102 and into chamber 202. Vents 223 are located peripherally around chamber 202. The number and/or configuration of vents 223 can be varied to provide the desired drug delivery requirements. As air flows through vents 223 into chamber 202, it causes capsule 201 to rotate about its long axis as well as to rotate and precess about chamber 202. The rotation and precession of capsule 201 cause the drug within to exit out of the holes punctured by staple 208. The drug is entrained into the air stream and exits chamber 202 through holes 224 in outer housing 101. The air with the entrained drug flows through patient interface 106 to the patient. When squeeze bulb 108 is released, a vacuum is created, causing air to flow through a one-way check valve 225 into bulb cavity 218. Check valve 219 prevents air from being drawn back through chamber 202. When bulb cavity 218 is refilled with air, squeeze bulb 108 can be compressed again. This process can be repeated until the entire drug has been delivered to the patient.

FIG. 3 shows an isometric view of an embodiment of an inhalation device 300. Inhalation device 300 includes a top housing 301 and a bottom housing 302. Top housing 301 and bottom housing 302 can be assembled to each other by ultrasonic welding, gluing, snap fits, mechanical fasteners or other attachment methods. Top housing 301 and bottom housing 302 may be attached directly to each other, or may have a flexible gasket seal between them.

Inhalation device 300 includes a knob 303 which, when rotated by the user, serves to open a drug -containing capsule (not shown) by puncturing or other means. Knob 303 is capable of being in two positions. Knob 303 can be in a first position prior to puncturing the drug- containing capsule, such as during product shipping and storage. At the time of use, knob 303 can be rotated by the user from the first position to a second position to puncture the capsule, as described more fully below. Indicating marks 304 and 305 correspond to the first and second knob positions, and provide the user with visual feedback that the capsule has been punctured and that the drug is ready for delivery. Indicating marks 304 and 305 can take a variety of forms, such as colored dots, text, symbols, molded bumps, grooves, etc.

At its distal end, inhalation device 300 includes a patient interface 306. Patient interface 306 can take a variety of forms, such as a nipple, a standard mouthpiece, a nose piece, or a mask. Patient interface 306 can be a separate part or unitarily formed with top housing 301 and/or bottom housing 302. As shown in Figure 3, patient interface 306 can be used in an oral delivery application. Patient interface 306 can be made of rigid, semi-rigid, or flexible material, or some combination thereof. Examples of rigid materials (hardness above 75 Shore D Duro meter) include engineering grade plastic injection molding materials such as polycarbonate, acetal, polystyrene and acrylonitrile butadiene styrene (ABS). Examples of semi-rigid materials (hardness approximately 55 to approximately 75 Shore D Durometer) include polypropylene and Teflon. Examples of flexible materials (hardness below 55 Shore D Durometer) include rubbers, such as silicone rubber, latex, flexible polyurethanes, and certain thermoplastic elastomers (TPE). The use of semi-rigid or flexible materials may make the patient interface 306 more comfortable in the patient's mouth, thereby reducing patient agitation and improving delivery performance. As shown, patient interface 306 includes a flange 307, which can help position patient interface 306 relative to the patient's mouth, nose and face and may provide visual indication of the proper orientation of inhalation device 300 for delivery. For example, to help orient patient interface 306 relative to the patient's nose, flange 307 is asymmetrical (e.g., oblong), with a length (parallel to the long axis of device 300) larger than a width (perpendicular to the long axis of device 300). If inhalation device 300 were to be rotated relative to the patient's mouth, flange 307 would interfere with the patient's nose to indicate that patient interface 306 is not properly oriented. In other embodiments, flange 307 includes a cut-out portion configured to match the contour of the underside of the patient's nose to provide a visual indication of the proper orientation for drug delivery. Flange 307 may also help provide a seal with the patient's mouth and face. In other embodiments, referring to FIGS. 3A and 3B, flange 307 includes feature(s) to pinch, to close or to block the patient's nose if this is wanted for drug delivery. The features can include a clip 312 (FIG. 3A) similar to clips used for swimming, or a sealing geometry 313 (FIG. 3B) such as a foam pad configured to engage with the underside of a nose. By serving as a stop, flange 307 can also prevent patient interface 306 from being pushed too far into the patient's mouth, and indicate the correct depth of insertion. As shown, patient interface 306 also includes a bulb geometry 309. Bulb geometry 309 may assist with drug delivery by helping to keep the patient's tongue away from an outlet opening 310 of patient interface 306, thereby providing unobstructed delivery. The length of patient interface 306 may also be chosen to position outlet opening 310 far enough into the oral cavity to prevent occlusion by the patient's tongue (e.g., the front end portion of the tongue), but not so far as to induce a gag reflex. Patient interface 306 can be attached to inhalation device 300 by a friction fit, by a bayonet -type mount, by a screw thread, or by other means. As shown, patient interface 306 further includes a right angle geometry 311. Right angle geometry 311 allows the orientation of the drug-containing capsule to remain consistent, such as in a horizontal orientation, regardless of whether the patient is lying on her back or positioned upright during drug delivery. Maintaining the drug-containing capsule in a consistent orientation can be beneficial for repeatable drag delivery performance. In other embodiments, patient interface 306 has geometries other than a right angle, such as straight geometry or an angle between zero and 90 degrees relative to a long axis of the inhalation device.

At its proximal end, inhalation device 300 includes a source of moving air to help aerosolize the drag. As shown, the moving air is generated by a squeeze bulb 308. When compressed by the user, squeeze bulb 308 causes air to flow through device 300, rotating the drag-containing capsule and expelling and entraining the drag into the air stream. The drag passes through patient interface 306 and is delivered to the patient. Squeeze bulb 308 may vary in size, shape, volume, and force required by the user to compress. Such variations allow inhalation device 300 to be tailored for a particular drag delivery application, patient population, or user.

Referring to FIGS. 4 and 5A, inhalation device 300 includes a capsule chamber 502 that is bounded by an upper chamber 401, a lower chamber 402, and a chamber cap 403. The drag- containing capsule 201 sits within capsule chamber 502. Some or all of the components that define capsule chamber 502 may be transparent to allow the user to observe capsule 201, e.g., to allow the user to verify that capsule 201 has been punctured, is rotating freely in capsule chamber 502, and has been completely emptied of its contents. Similarly, top housing 301 and/or bottom housing 302 may be transparent, or may contain a clear portion or window. Upper chamber 401 has peripherally located vents 404 that are in fluid communication with an air plenum 405. Vents 404 can vary in number, shape and position relative to capsule chamber 502. Varying the number, shape and position of vents 404 allows inhalation device 300 to be tailored for a particular drag delivery application, patient population, and/or air pressure source. Air plenum 405 is a cavity created by top housing 301 and bottom housing 302. Air channels 407 created by the top housing 301 and bottom housing 302 lead into air plenum 405. A one-way check valve 408 separates a valve plenum 409 from air channels 407. One-way check valve 408 opens to allow air flow from squeeze bulb 308 into air channels 407 when squeeze bulb 308 is compressed. Another one-way check valve 410 prevents air from flowing out of inhalation device 300 when squeeze bulb 308 is compressed, but allows air to flow into squeeze bulb 308 when it is released. In some embodiments, one-way check valves 408 and 410 have very low cracking pressures. One-way check valves 408 and 410 may be umbrella-type valves, duckbill- type valves, or spring load valves. One or both of one-way check valves 408 and 410 may be unitarily formed with squeeze bulb 308, either as a separate part, or as molded-in components.

Inhalation device 300 contains a capsule puncturing mechanism 411. Knob 303 is coupled to a cam 412. Cam 412 is coupled to link arms 413, which in turn are coupled to a plunger 414. In some embodiments, cam 412, link arms 413 and plunger 414 make up one part with integral flex points, such as an injection molded part with molded in hinges or flex points. Plunger 414 contains a staple 415. As shown in FIG. 5 A, lower chamber 402 rests against a shoulder 501 in upper chamber 401, and the size of capsule chamber 502 is decreased to the point where capsule 201 is held securely for puncturing. Plunger 414 and chamber cap 403 are shown having spherical portions which serve to align and to center capsule 201 within chamber

502 during puncturing.

To puncture capsule 201, the user rotates knob 303 from the first position to the second position. As knob 303 is rotated, cam 412 and link arms 413 translate this rotation to a linear motion of plunger 414. Plunger 414 contains staple 415, which has sharpened ends to facilitate puncturing of capsule 201. Staple 415 can be a separate part that is assembled to plunger 414, o r alternatively can be a unitarily-formed part of plunger 414. The prongs of staple 415 are situated within corresponding channels 503 in lower chamber 402. When knob 303 is rotated, plunger 414 begins to move relative to lower chamber 402, causing the prongs of staple 415 to protrude from channels 503 in lower chamber 402, thereby puncturing capsule 201, as shown in FIG. 5B. Staple 415 can have two prongs as shown or, in other embodiments, have a single prong or three or more prongs.

As the user continues to rotate knob 303, cam 412 and link arms 413 cause plunger 414 to move away from capsule 201. Staple 415 is withdrawn from capsule 201 and into channels

503 in lower chamber 402. As plunger 414 continues to move away from capsule 201, plunger 414 contacts shoulder 504 in lower chamber 402. The motion of plunger 414 is now coupled to lower chamber 402, so lower chamber 402 also moves away from capsule 201, thereby increasing the size of capsule chamber 502. When puncturing mechanism 411 is in the second position as shown in FIG. 5C, the size of capsule chamber 502 is larger than capsule 201, and the prongs of staple 415 are recessed within channels 503 in lower chamber 402, allowing capsule 201 to move freely within capsule chamber 502. Following puncturing of capsule 201, the drag is delivered to the patient by compression of squeeze bulb 308. Referring to FIGS. 4 and 5A, compressing squeeze bulb 308 causes air to flow out of the bulb and through one-way check valve 408. The air then travels through air channels 407 and enters air plenum 405, which is bounded by top housing 301 and bottom housing 302. Mating seal geometry 416 in top housing 301, bottom housing 302 and upper chamber 401 prevent air from leaking out of air plenum 405. The air flows from air plenum 405 through vents 404 in upper chamber 401 and into capsule chamber 502. Vents 404 are located peripherally around upper chamber 401. The number of vents 404 can be varied to provide the desired drag delivery requirements. As air flows through vents 404 into capsule chamber 502, the air causes capsule 201 to rotate about its long axis as well as to rotate and to precess about capsule chamber 502. The rotation and precession of capsule 201 causes the drag within to exit out of the holes punctured by staple 415. The drag is entrained into the air stream and exits capsule chamber 502 through holes 509 in chamber cap 403. The air with entrained drug flows through patient interface 306 to the patient. When squeeze bulb 308 is released, a vacuum is created, causing air to flow through one-way check valve 410 into bulb cavity 510. One -way check valve 408 prevents air from being drawn back through capsule chamber 502. When bulb cavity 510 is refilled with air, squeeze bulb 308 can be compressed again. This process can be repeated until the entire drag dose in capsule 201 has been delivered to the patient.

For a single-use application, inhalation device 300 can include a lockout feature to prevent knob 303 from being rotated out of the second position. The lockout feature can ensure that staple 415 remains withdrawn into channels 503 in lower chamber 402, and that capsule chamber 502 is larger than capsule 201, allowing capsule 201 to rotate freely in capsule chamber 502 and facilitating consistent drag delivery. The lockout feature can be, for example, a spring loaded catch that engages knob 303, cam 412, link arms 413 and/or plunger 414. For a multi-dose, reusable application, after the drag has been delivered from capsule

201 , the empty capsule can be removed from inhalation device 300 and replaced with a new filled capsule. As shown, upper chamber 403 is unitarily- formed or coupled to infant interface 306, which is coupled to inhalation device 300 by a friction fit with an O-ring 506. Infant interface 306 can be separated from inhalation device 300 allowing removal of capsule 201 from capsule chamber 502. Puncturing mechanism 411 can then be reset to the first position by rotating knob 303. As knob 303 is rotated from the second position to the first position, cam 412 and link arms 413 cause plunger 414 to move towards capsule chamber 502. As plunger 414 moves, it eventually contacts corresponding step 505 in lower chamber 402, coupling the motion of plunger 414 with lower chamber 402. Lower chamber 402 moves until it contacts shoulder 501 in upper chamber 401 as shown in FIG. 5B. Continued rotation of knob 303 to the first position causes plunger 414 to move away from capsule chamber 502. Spring fingers 508 prevent lower chamber 402 from being withdrawn in unison with plunger 414, as the retaining force of spring fingers 508 is greater than the force of friction between plunger 414 and lower chamber 402. As plunger 414 continues to move, staple 415 withdraws into channels 503 in lower chamber 402 until it reaches the first position as shown in FIG. 5 A. A new drug containing capsule 201 can now be placed in capsule chamber 502, and patient interface 306 reattached to inhalation device 300. Inhalation device 300 is now ready for its next use. Other embodiments are within the scope of the following claims.

Claims

WHAT IS CLAIMED IS:
1. An inhalation device, comprising: a housing; a capsule in the housing; an inhalable substance in the capsule; a patient interface connected to the housing, the patient interface adapted for use with an infant or a small child; and an air pressure source capable of providing an air stream that entrains the inhalable substance and delivers the inhalable substance through the patient interface and to a patient.
2. The inhalation device of claim 1, wherein the patient interface is configured for oral delivery of the inhalable substance.
3. The inhalation device of claim 2, wherein the patient interface comprises a flange.
4. The inhalation device of claim 3, wherein the flange is capable of creating a seal to a patient's face.
5. The inhalation device of claim 3, wherein the flange is capable of controlling the depth of insertion of an outlet opening of the patient interface into a patient's mouth.
6. The inhalation device of claim 3, wherein the patient interface is capable of pinching or sealing a patient's nose.
7. The inhalation device of claim 3, where the flange is capable of orienting and positioning the inhalation device relative to the patient's mouth and nose.
8. The inhalation device of claim 1 , wherein the patient interface is configured to position an outlet opening past the front end portion of a tongue of a patient.
9. The inhalation device of claim 1 , wherein the shape of the patient interface is configured to keep the tongue away from the outlet opening.
10. The inhalation device of claim 9, wherein the patient interface comprises a bulb- shaped feature.
11. The inhalation device of claim 1 , wherein the capsule is oriented in the same direction regardless of whether a patient is lying down or in an upright position during delivery of the inhalable substance.
12. The inhalation device of claim 11 , wherein the patient interface comprises a substantially 90 degree geometry.
13. The inhalation device of claim 1, wherein the inhalable substance comprises a drug.
14. The inhalation device of claim 1, wherein the air pressure source comprises a squeeze bulb, a syringe, or a compressed gas supply.
15. The inhalation device of claim 1, wherein the patient interface comprises a mask, a nipple, or a nose piece.
16. The inhalation device of claim 1, further comprising a capsule puncturing mechanism capable of translating rotary motion to linear motion through a camming action.
17. The inhalation device of claim 16, wherein the puncturing mechanism is capable of puncturing the capsule and enlarging a chamber containing the capsule to allow free movement of the capsule within the chamber.
18. The inhalation device of claim 16, wherein the camming action is controlled by a rotatable knob.
19. The inhalation device of claim 18, wherein the knob is capable of being in a first position when the capsule is puncture- free, and a second position when the capsule is punctured.
20. The inhalation device of claim 19, wherein first and second positions of the knob are indicated by visual indicia.
21. The inhalation device of claim 18, further comprising a mechanism capable of preventing the knob from being rotated back to the first position.
22. The inhalation device of claim 16, wherein the linear motion is capable of reciprocating.
23. The inhalation device of claim 1, wherein the patient interface comprises a semirigid material or a flexible material.
24. An inhalation device, comprising: a capsule; an inhalable substance in the capsule; and a capsule puncturing mechanism capable of translating rotary motion to linear motion through a camming action.
25. A method of delivering an inhalable substance, the method comprising: puncturing a capsule by translating rotary motion to linear motion, the capsule containing the inhalable substance; and delivering the inhalable substance from the capsule to a patient using an active air source.
PCT/US2007/080288 2006-10-03 2007-10-03 Inhalation devices and related methods WO2008042951A2 (en)

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