NZ705165B2

NZ705165B2 - A ventilator comprising a blower and a valve assembly

Info

Publication number: NZ705165B2
Application number: NZ705165A
Authority: NZ
Inventors: Philippe Auguste Chalvignac; David Creusot; Timothy Tsunfai Fu; Dion Charles Chewe Martin; Quangang Yang; Timothy Tsun Fai Fu
Original assignee: Resmed Motor Technologies Inc
Priority date: 2009-08-11
Filing date: 2010-08-11
Publication date: 2021-01-28

Abstract

Disclosed is a ventilator system (10) for delivery of respiratory therapy to a patient. The system (10) includes housing with a first opening that acts as an inspiration inlet for airflow to the patient for inspiration and acts as an expiration outlet for expired air from the patient during expiration. The housing also has a second opening that acts as an inspiration outlet for airflow to the patient for inspiration and acts as an expiration inlet for expired air from the patient during expiration. A blower receives air from the first opening and provides pressurized air to the second opening. The ventilator system (10) further includes a passive valve assembly structured to allow air to flow through the blower along a flow path from the first opening to the second opening, and from the second opening to the first opening. The blower is positioned between the first opening and the second opening. on. The housing also has a second opening that acts as an inspiration outlet for airflow to the patient for inspiration and acts as an expiration inlet for expired air from the patient during expiration. A blower receives air from the first opening and provides pressurized air to the second opening. The ventilator system (10) further includes a passive valve assembly structured to allow air to flow through the blower along a flow path from the first opening to the second opening, and from the second opening to the first opening. The blower is positioned between the first opening and the second opening.

Description

A VENTILATOR COMPRISING A BLOWER AND A VALVE LY CROSS-REFERENCE TO APPLICATION This application claims the benefit of U.S. Provisional Application Nos. ,043, filed August 11, 2009, 61/261,527, filed November 16, 2009, 61/272,188, filed August 28, 2009, and 61/272,919, filed November 19, 2009, each of which is incorporated herein by reference in its ty.

FIELD OF THE INVENTION The present invention relates to a blower for generating a pressure differential (e.g., air at positive or negative (vacuum) pressure). In an embodiment, the blower may be used in a ventilator system. In an embodiment, the blower may be used in a positive airway re (PAP) device used for the delivery of respiratory therapy to a patient. Examples of such therapies are Assist/Control Ventilation, Intermittent Mandatory Ventilation, Pressure Support Ventilation, uous Positive Airway Pressure (CPAP) ent. These may be delivered via a non-invasive patient interface or invasive patient interface. The therapy is used for treatment of various respiratory conditions including respiratory failure, respiratory insufficiency, or Sleep Disordered Breathing (SDB). However, the blower may be used in other ations (e.g., vacuum applications (medical or otherwise)).

BACKGROUND OF THE INVENTION A need has developed in the art for blower designs that are quieter, more compact and less expensive. The present invention provides alternative ements of blowers that consider this need.

An example of prior art in this field is described in U.S. Patent Application Publication No. US 2005/0036887 (Nadjafizadeh et al.).

SUMMARY OF THE INVENTION [0004A] red aspects of the ion are set forth in the appended claims.

Particular embodiments are described below in non-limiting terms.

An embodiment of the invention relates to a small, portable ventilator system located al to the patient, and thus allows ation and expiration through the system.

WO 17763 2010/001031 Another embodiment of the invention relates to a ventilator ing an efficient powerful miniature motor ed with an efficient low-inertia impeller and small blower.

Another embodiment of the invention relates to a ventilator located proximal to the patient. The proximal location of the ator allows the use of a short breathing circuit which provides minimal circuit resistance to enhance compliance, requires low deadspace within the ventilator, allows the use of a separate battery and user interface from the ventilator, and allows more accurate flow and volume sensing as sensors are closer to the patient.

Another embodiment of the invention relates to a blower ured to efficiently manage heat ed by the motor. For example, the blower may include a nonelectrically conductive sleeve close to a central segment of the motor. This arrangement avoids electrically conductive material close to the central segment of the motor to reduce eddy t induced inductive losses, a consequence of a high-performance miniature motor embodiment. In another example, heat conductive elements (e.g., aluminum stator, aluminum flow sensor) coupled to the motor are maximized to act as heat sinks.

Another ment of the invention relates to a ventilator including a valve arrangement at the proximal or patient side opening of the blower ured to control the dual direction of air flow through the ventilator, and thus minimize rebreathed volumes.

Another embodiment of the invention relates to a ventilator including a single flow element and single flow sensor that measures flow in both directions and acts as a heat sink for the motor. Proximal use of such a ator results in the flow sensor being d to moist exhalant from the t, which increases the risk of potential errors for flow measurement. As the flow sensor according to an embodiment of the invention acts as heat sink for the motor, the motor will warm the flow sensor and prevent condensation. Thus, there is no requirement for a separate heater to heat the flow sensor.

Another embodiment of the invention relates to a ventilator structured to stabilize pressure and flow around the flow sensor to enhance flow g. For example, the ventilator may include a plenum chamber around the impeller that provides a uniform pressure source for the stator to minimize offset and impulse noise in the flow sensing. Also, the ventilator may provide a downstream chamber to allow flow recirculation through the 2010/001031 stator without affecting the flow sensing as flow is fully developed before flow hits the flow sensor.

Another embodiment of the invention relates to a ventilator having low source impedance by maximizing the cross-sectional area of the flow path (e.g., stator angles, impeller vane ry) while balancing this with l deadspace within the ventilator since the patient breathes entirely h the ventilator.

Another embodiment of the invention relates to a ventilator including a battery pack arrangement where both the ventilator and the battery pack include a micro-controller or microprocessor to allow the transfer of ventilator settings and patient details between the modules to make it easy to transfer patients onto a new ventilator or replace the battery.

Another embodiment of the invention relates to a modular system having separate modules for ventilator, handset (controller/user interface), oxygen enhancement, extension y, heat moisture exchange filter (HMEF), mucous trap, and/or harness or vest. r embodiment of the invention relates to a ventilator for a patient including a blower structured to provide a source of rized air. The blower includes a housing having a proximal opening or al end (e.g., t side opening or g proximal to the patient) and a distal opening or distal end (e.g., ambient side opening or opening distal from the patient), a stator component provided to the housing, an er positioned between the proximal opening of the housing and the stator ent, and a motor adapted to drive the impeller.

The ventilator may include one or more of the following aspects. For example, the ventilator may include a valve assembly provided to the proximal opening of the blower and structured to allow air to flow through the blower along a flow path in both directions. The valve assembly is structured to allow air to flow into the blower via the proximal opening during an inhalation phase of the patient's breathing cycle and allow air to exit the blower via the proximal opening during an exhalation phase of the patient's breathing cycle. The stator component may include a ity of air directing grooves along its exterior surface, the leading edge of the air directing grooves extending tangentially outwards from the outer tips of the impeller blades and configured to collect the air exiting the impeller blades and direct it from a generally tangential ion to a generally radial direction by dividing the air from the impeller and directing the air along a curved path towards the distal opening so that airflow becomes substantially laminar. The ventilator may include a flow element provided to the motor along the flow path structured to measure flow in both directions and conduct heat from the motor. The housing and stator component may cooperate to define a plenum chamber around the impeller. The ventilator may include a r downstream from the plenum chamber to allow flow recirculation through the stator component without passing through the flow element. The ventilator may e a non-electrically conductive sleeve surrounding the central segment of the motor along the flow path. The flow element and the stator component may be constructed of heat conductive material to conduct heat from the motor. The flow element and the stator component may be constructed of um. The ventilator may include a mucous trap provided to the distal opening of the blower. The mucous trap provides a capture plate adapted to capture any particulate matter d by the patient.

The ventilator may include a heat moisture exchange filter provided to the distal opening of the blower. The heat re exchange filter includes a filter and/or pad to condition air inhaled by the patient and/or protect the ventilator from particulate matter expired by the patient. The cross-sectional area of the flow path may be maximized and ed with minimal deadspace within the ventilator to provide low source impedance. The ator may include a battery powered control unit separate from the ator. The ventilator and control unit may both include a micro-controller configured to record patient data and allow transfer of ventilator settings and t details. The ventilator may be adapted for use at a location proximal to the patient. The ator may be incorporated into a headworn system. The ventilator may be d to be mounted to a structure including a wall, bed, bed head, hair, table or chair, and connected via tubing to a patient interface. The ventilator may be adapted to fit into a support structure incorporated into clothing. The clothing may be a shirt, T-shirt, or pajamas.

The ventilator blower may be built into a patient interface unit. The ator may be supported by a shoulder-type harness. The ventilator may be supported by a pendant-type arrangement. The ventilator may be supported by a strap or band around a part of the user's body. The strap or band may be a chest band. The strap or band may be an arm band. The flow element may include an inner core and a plurality of vanes extending from the inner core. The flow t may include 40-60 vanes. The inner core of the flow element may include a split configuration structured to allow the flow element to be fit around the motor and to expand and contract with changes in heat from the motor. 2010/001031 Another embodiment of the invention relates to a modular ventilator system including a ventilator module and one or more of the following individually eable modules: a control module to remotely l the ventilator module; an extension battery module for the control ; an oxygen enhancement module provided to the ator module; a mucous trap module ed to a distal opening of the ventilator module; a heat moisture exchange filter module provided to a distal opening of the ventilator module; and/or a strap module including one or more straps to stabilize the ator module and/or the control module. The control module may include an internal rometer and allow a pulse er and/or a CO2 monitor to be connected thereto.

One embodiment of the invention relates to a blower including a housing ing a proximal opening and a distal opening that are co-axially aligned, a stator component provided to the housing, an impeller positioned between the proximal opening of the housing and the stator component, and a motor d to drive the impeller. The impeller includes a plurality of impeller blades. The stator component includes a plurality of air directing grooves along its exterior surface. The leading edge of the air directing grooves extend tangentially outwards from the outer tips of the er blades and are configured to collect the air exiting the impeller blades and direct it from a generally tangential direction to a generally radial ion by dividing the air from the impeller and directing the air along a curved path towards the distal opening so that airflow becomes substantially laminar.

Other aspects, features, and advantages of this invention will become apparent from the following detailed description when taken in conjunction with the accompanying drawings, which are a part of this disclosure and which illustrate, by way of example, principles of this invention.

BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings facilitate an understanding of the various embodiments of this invention. In such gs: Fig. 1 is a perspective view of a blower according to an embodiment of the present invention; 2010/001031 Fig. 2 is an exploded View of the blower of Fig. 1; Fig. 3 is a perspective View of the stator component and impeller of the blower of Fig. 1; Fig. 4 is a perspective View of a blower according to r embodiment of the present invention; Fig. 5 is an exploded view of the blower of Fig. 4; Fig. 6 is an exploded view of the stator component, motor, and er of the blower of Fig. 4; Fig. 7 is a top View of an impeller according to an embodiment ofthe present invention; Fig. 8 is a bottom View of the impeller of Fig. 7; Fig. 9 is a perspective view of a blower according to another embodiment of the present invention; Fig. 10 is a side View of the blower of Fig. 9; Fig. 11 is a top view of the blower of Fig. 9; Fig. 12 is a cross-sectional view through line 12-12 of Fig. 10; Fig. 13 is a side view of the stator component of the blower of Fig. 9; Fig. 14 is a bottom view of the stator component of Fig. 13; Fig. 15 is a perspective View of the blower of Fig. 9 attached to tubing; Fig. 16 is a side view of a blower including a passive air valve assembly according to an embodiment of the present invention; Fig. 17 is a cross-sectional View of the blower of Fig. 16; Fig. 18 is an enlarged cross-sectional view of the blower of Fig. 16; Fig. 19 is a perspective view of a CPAP version of a blower according to an embodiment of the t ion; Fig. 20 is a side view of the blower of Fig. 19; Fig. 21 is a cross-sectional View of the blower of Fig. 19; Fig. 22 is a perspective view of a CPAP version of a blower according to an embodiment ofthe present invention; Fig. 23 is a cross—sectional view of the blower of Fig. 22; Fig. 24 is a m illustrating pressure versus ﬂow for various RPM for a blower according to an embodiment ofthe present invention; Fig. 25 is a perspective view of a ventilator system according to an embodiment ofthe invention; Fig. 26 is another ctive View of the ventilator system of Fig. 25; Figs. 27—31 are side, front, rear, bottom, and top Views of the ventilator system of Fig. 25; Fig. 32 is a sectional View of the ventilator system of Fig. 25; Fig. 33 is another cross-sectional View of the ventilator system of Fig. 25; Fig. 34 is an exploded view of the ventilator system of Fig. 25; Fig. 35 is a perspective View of a blower of the ator system ing to an embodiment ofthe invention; Figs. 36-39 are rear, side, bottom, and top views of the blower of Fig. 35; Fig. 40 is a cross-sectional View of the blower of Fig. 35; Fig. 41 is a perspective view of a top housing part of the blower according to an embodiment ofthe invention; Figs. 42-44 are side, top, and bottom views of the top housing part of Fig. 41; Fig. 45 is a perspective View of a bottom housing part of the blower ing to an embodiment ofthe invention; Figs. 46-50 are left side, right side, rear, top, and bottom Views of the bottom housing part of Fig. 45; Fig. 51 is a perspective view of a ﬁrst part of the stator component of the blower according to an embodiment of the invention; Figs. 52-54 are side, top, and bottom views of the ﬁrst part of Fig. 51; Fig. 55 is a perspective View of a second part of the stator component of the blower according to an embodiment of the invention; Figs. 56-58 are top, bottom, and side views of the second part of Fig. 55; Fig. 59 is a cross-sectional view of the second part of Fig. 55; Fig. 60 is a perspective view of an impeller of the blower according to an embodiment of the invention; Figs. 61-63 are side, top, and bottom views of the impeller of Fig. 60; Fig. 64 is a perspective view of a sleeve of the blower according to an embodiment ofthe ion; Figs. 65—67 are side, top, and bottom views of the sleeve of Fig. 64; Fig. 68 is a perspective View of a ﬂow element of the blower according to an embodiment ofthe invention; Fig. 69 and 70 are side and bottom views ofthe ﬂow t of Fig. 68; Fig. 71 is a perspective View of a valve assembly according to an embodiment of the invention; Figs. 72-74 are side, top, and bottom views ofthe ﬁlter/valve assembly of Fig.

Fig. 75 is a cross-sectional view of the ﬁlter/valve ly of Fig. 71; Fig. 76 is an exploded View of the ﬁlter/valve assembly of Fig. 71; Fig. 77 is a perspective View of a ﬁlter cover of the ﬁlter/valve assembly according to an embodiment ofthe invention; Figs. 78-80 are side, top, and bottom views of the ﬁlter cover of Fig. 77; Fig. 81 is a perspective View of an air ﬂow diverter/manifold of the ﬁlter/valve ly according to an embodiment of the invention; Figs. 82—84 are side, top, and bottom views ofthe air ﬂow diverter/manifold of Fig. 8 1 ; Fig. 85 is a perspective view of an air ﬂow diverter cap of the ﬁlter/valve assembly according to an embodiment ofthe invention; Figs. 86—88 are side, top, and bottom views of the air ﬂow diverter cap of Fig.

Fig. 89 is a perspective view of an air inlet membrane valve of the ﬁlter/valve assembly according to an embodiment ofthe invention; Figs. 90-92 are side, top, and bottom views ofthe air inlet membrane valve of Fig. 89; Fig. 93 is a perspective View of an air outlet membrane valve of the ﬁlter/valve assembly according to an embodiment ofthe invention; Fig. 94-96 are side, top, and bottom views of the air outlet membrane valve of Fig. 93; Fig. 97 is an ed View of a mucous trap according to an embodiment of the invention; Fig. 98 is a perspective View of an outer case of the mucous trap according to an embodiment of the invention; Figs. 99-101 are top, bottom, and side views of the outer case of Fig. 98; Fig. 102 is a cross-sectional view of the outer case of Fig. 98; Fig. 103 is a perspective view of an inner case of the mucous trap according to an embodiment ofthe invention; Figs. 7 are top, , front, and side views of inner case of Fig. 103; Fig. 108 is a cross-sectional View of the inner case of Fig. 103; Fig. 109 is a cross-sectional view of the ventilator system of Fig. 25 showing air ﬂow during inspiration; Fig. 110 is a cross-sectional view of the ventilator system of Fig. 25 showing air ﬂow during expiration; Fig. 111 is a cross-sectional View of a heat moisture exchange ﬁlter (HMEF) ing to an embodiment ofthe invention; Fig. 112 is a cross-sectional view of the HMEF of Fig. 111 provided to a ventilator system; Fig. 113 is an exploded view ofthe HlVIEF of Fig. 111; Fig. 114 is an exploded cross-sectional view of the HMEF of Fig. 111; Fig. 115 another exploded view ofthe HMEF of Fig. 111; Fig. 116 is a perspective View of an outer casing of the HMEF ing to an embodiment of the invention; Figs. 9 are bottom, top, and side views of the outer casing of Fig. 116; Fig. 120 is a cross-sectional View of the outer casing of Fig. 116; Fig. 121 is a perspective view of an inner casing of the HMEF according to an embodiment of the invention; Figs. 122—124 are top, bottom, and side views of the inner casing of Fig. 121; Fig. 125 is a cross-sectional View of the inner casing of Fig. 121; Figs. 126 and 127 are perspective and side Views of a HMEF according to another embodiment; Fig. 128 is a perspective View of a remote for the ventilator system according to an ment of the invention; Figs. 129-132 are front, top, left side, and right side views of the remote of Fig. 128; Fig. 133 is a perspective View of a ventilator system with a mucous trap according to an embodiment ofthe invention; Fig. 134 is a perspective View of a ventilator system with a HMEF according to an embodiment of the invention; ' Fig. 135-1 is a perspective View of a remote or handset for the ventilator system according to an embodiment ofthe ion; Fig. 135-2 is a ctive View of an optional extension battery for the handset of Fig. 135-1; Fig. 135-3 is a perspective view of the handset of Fig. 135-1 coupled to the ion battery of Fig. 135-2; ] Fig. 136 is a top view of the handset of Fig. 135-1; Fig. 137 is a perspective View of a docking station or dock according to an embodiment of the invention, the dock in a ﬁrst position; Fig. 138 is a perspective View of the t of Fig. 135-1 within the dock of Fig. 137; Fig. 139 is a perspective View of the dock of Fig. 137 in an extended second Fig. 140 is a perspective view of the handset and ion battery of Fig. 135- 3 within the dock of Fig. 139; Fig. 141 shows a ventilator adapted for tracheotomy ventilation, a handset, a handset harness, and a stabilizing strap according to an embodiment of the invention; Fig. 142 shows a ventilator adapted for tracheotomy ation, a handset with extension battery, and a handset harness according to an embodiment of the invention; Fig. 143 shows a ator adapted for tracheotomy ventilation, a handset, a handset harness, a stabilizing strap, and an oxygen conservation accessory according to an embodiment ofthe invention; Figs. 144-1 to 144-3 show a headwom ventilator system according to an embodiment ofthe invention; Fig. 145 shows a headwom ator system according to an embodiment of the invention; Fig. 146-1 to 146-4 show a headwom ventilator system according to an embodiment ofthe ion; ] Fig. 147 shows a headwom ator system according to an embodiment of the invention; ' Fig. 148 shows a headwom ventilator system according to an embodiment of the invention; Fig. 149 shows a headwom ator system according to an embodiment of the invention; Fig. 150 shows a headwom ventilator system according to an embodiment of the invention; ] Figs. 151-1 to 151-3 show a headwom ventilator system according to an embodiment ofthe invention; Fig. 152-1 and 152-2 show a headwom ventilator system according to an embodiment of the invention; Fig. 153 shows a headwom ventilator system according to an embodiment of the invention; Fig. 154 shows a headwom ventilator system according to an ment of the invention; Fig. 155 shows a headwom ventilator system according to an embodiment of the invention; ] Fig. 156 shows a headwom ventilator system according to an embodiment of the ion; Fig. 157 shows a headwom ventilator system according to an embodiment of the invention; Fig. 158 shows a headwom ventilator system according to an embodiment of the invention; WO 17763 Fig. 159 shows a patient interface with a built-in blower according to an embodiment ofthe invention; Figs. 160-1 and 160-2 show a patient interface with a built-in blower according to an embodiment of the invention; Figs. 161-1 and 161-2 show a patient interface with a built-in blower according to an embodiment ofthe invention; Figs. 162-1 and 162-2 show a patient interface with a built-in blower according to an embodiment ofthe invention; Figs. 163-1 and 163-2 show a patient interface with a built-in blower ing to an embodiment ofthe invention; Figs. 164-1 to 164-3 shows a patient interface with a built-in blower according to an embodiment of the invention; Fig. 165 shows a patient interface with a in blower according to an embodiment ofthe invention; Fig. 166 shows a patient interface with a built-in blower according to an embodiment ofthe invention; Fig. 167 shows a patient interface with a built-in blower ing to an embodiment ofthe invention; Figs. 168-1 and 168-2 show a patient interface with a built-in blower according to an embodiment ofthe invention; Fig. 169 shows a t interface with a built-in blower according to an embodiment ofthe invention; ] Fig. 170 shows a t interface with a built-in blower according to an ment ofthe invention; Fig. 171 shows a patient interface with a built—in blower according to an embodiment ofthe invention; Fig. 172 shows a patient interface with a built—in blower according to an embodiment of the ion; Fig. 173 shows a patient ace with a built-in blower according to an embodiment ofthe invention; - Fig. 174 shows a patient interface with a in blower according to an embodiment of the invention; Fig. 175 shows a patient interface with a in blower according to an embodiment ofthe invention; Fig. 176 shows a patient ace with a in blower according to an ment ofthe inventiOn; Fig. 177 shows a portable ventilator according to an embodiment ofthe invention; Fig. 178 shows a portable ventilator according to an embodiment ofthe invention; ] Fig. 179 shows a portable ventilator according to an embodiment ofthe invention; Figs. 180-1 and 180-2 show a portable ventilator according to an embodiment ofthe invention; Figs. 181-1 to 181-4 show a portable ventilator according to an embodiment of the invention; Fig. 182 shows up tubing according to an embodiment ofthe invention; Fig. 183 shows a portable ventilator according to an embodiment ofthe invention; Fig. 184 shows a portable ventilator according to an embodiment ofthe invention; Fig. 185 shows a portable ventilator according to an embodiment ofthe invention; Fig. 186 shows a portable ventilator according to an embodiment ofthe invention; Figs. 187-1 and 187-2 show a wearable ventilator according to an ment of the invention; Figs. 188-1 to 188-4 show a wearable ventilator according to an ment ofthe invention; Figs. 189-1 to 189-3 shows a wearable ventilator ing to an embodiment ofthe invention; Fig. 190 shows a wearable ventilator according to an embodiment ofthe invention; Fig. 191 shows a wearable ventilator according to an embodiment ofthe invention; Figs. 192-1 and 192-2 show a wearable ator according to an embodiment ofthe invention; ] Fig. 193 shows a wearable ventilator according to an embodiment of the ion; Fig. 194 shows a wearable ventilator according to an embodiment of the invention; Fig. 195 shows a wearable ventilator according to an embodiment of the ion; Fig. 196 shows a wearable ventilator according to an embodiment of the invention; Fig. 197 shows a wearable ventilator according to an embodiment of the ion; and Figs. 198-1 and 198-2 show a wearable ventilator according to an embodiment of the invention.

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS The following description is provided in on to l embodiments which may share common characteristics and features. It is to be understood that one or more features of any one ment may be combinable with one or more features ofthe other embodiments. In addition, any single feature or ation of features in any of the embodiments may constitute additional embodiments.

In this speciﬁcation, the word "comprising" is to be understood in its "open" sense, that is, in the sense of "including", and thus not limited to its "closed" sense, that is the sense of "consisting only of". A corresponding meaning is to be attributed to the corresponding words "comprise", "comprised" and "comprises" where they appear.

Aspects ofthe invention will be described herein in its application to invasive and non—invasive patient tions via patient interfaces and to positive airway pressure (PAP) devices, but it is to be tood that the aspects of the invention may have application to other ﬁelds of application where blowers are used such as ventilators, e.g., in both positive re and negative pressure applications.

In this speciﬁcation, the words "air pump" and "blower" may be used hangeably. The term "air" may be taken to include breathable gases, for example air with supplemental oxygen or heliox. It is also acknowledged that the blowers described herein may be ed to pump ﬂuids other than air.

] Also, each blower embodiment below is described as including a single stage design. r, it should be appreciated that aspects of the invention may be applied to multiple stage designs, e.g., two, three, four, or more stages. 1. Blower Figs. 1-6 illustrate a single stage blower 10 according to an embodiment of the t invention. As described below, the blower provides an arrangement that is compact, efﬁcient, relatively quiet, low cost, low complexity, and provides laminar ﬂow. In an embodiment, the blower may be ured to provide pressurized air in the range of 2—30 cmHZO, and may be structured to provide pressurized air greater than 60 cmHzO.

As illustrated, the blower 10 includes a housing 20 with ﬁrst and second housing parts 22, 24, a stator ent 30 including air directing grooves 35, a motor 40 positioned within the stator component 30 and adapted to drive a rotatable shaﬁ or rotor 50, and an impeller 60 provided on one side of the stator component 30 and coupled to an end portion of the rotor 50. As illustrated, the blower provides a relatively simple, stacked assembly.

As best shown in Fig. 5, the ﬁrst and second housing parts 22, 24 may be coupled to one another by one or more fasteners 26 (e.g., screws). In addition, the ﬁrst and second housing parts 22, 24 may e a joint (e.g., alignment pin 28(1) and receiving hole 28(2) arrangement as shown in Fig. 5) to facilitate alignment and connection. Fig. 2 shows an alternative joint for coupling the housing parts, e.g., annular protrusion 29 adapted to be received in annular groove.

The blower 10 has a proximal opening or proximal end 23 (e.g., patient side g or opening al to the patient) provided by the ﬁrst housing part 22 at one end and a distal opening or distal end 25 (e.g., ambient side opening or opening distal ﬁ'om the patient) provided by the second housing part 24 at the other end. The blower 10 is operable to draw a supply of gas into the housing 20 through the proximal opening 23 and provide a pressurized ﬂow of gas at the distal opening 25.

The blower 10 has axial symmetry with both the proximal opening 23 and distal opening 25 co-axially aligned with an axis A of the blower (e.g., see Fig. 1). In use, gas enters the blower axially at one end and leaves the blower axially at the other end. Such arrangement may provide relatively low noise in use, e.g., due to axial symmetry and/or low volute turbulence. ary ments of such s are disclosed in W0 2007/134405 A1, which is incorporated herein by nce in its entirety.

] In the illustrated embodiment, as shown in Fig. 4, the blower may be relatively compact and have a diameter D of about 60-70 mm, e.g., 63 mm, and a height H of about 35- 45 mm, e.g., 38.5 mm. However, other suitable sizes are possible. 1.1 Stator Component As shown in Figs. 2, 3, 5, and 6, the stator component 30 includes ﬁrst and second parts 32, 34 that are coupled to one another, e.g., by one or more fasteners 33 as shown in Fig. 6. In addition, the ﬁrst and second housing parts 32, 34 may e a joint (e.g., alignment pin 31(1) and ing hole 31(2) arrangement as shown in Fig. 6) to facilitate alignment and connection. The ﬁrst and second parts 32, 34 cooperate to deﬁne a hollow interior adapted to support and maintain the motor 40 and rotor 50 in an operative position. In on, the ﬁrst and second parts 32, 34 cooperate to deﬁne a generally "turnip"—shaped or (e.g., lly bulbous shape) with a plurality of air directing grooves 35 that extend along the exterior surface of the parts.

As illustrated, the air directing grooves or volutes 35 are conﬁgured and arranged to collect and divide air from the impeller 60 and direct the air along a curved path towards the outlet 25 so that the airﬂow becomes laminar and minimizes volute turbulence along the length of the grooves. The leading edge ofthe air directing grooves 35 extend tangentially outwards from the outer tips of the impeller blades to prevent blade pass tonal noise being produced when the impeller blades pass the stator vanes. The leading edge ofthe stator vanes are conﬁgured to t the air exiting the impeller blades and direct it from a generally tangential direction to a lly radial direction. Speciﬁcally, an inlet portion (1) of each groove extends generally tangentially from the outer perimeter or rim ofthe impeller 60 so that air exiting the impeller 60 can enter the groove. Preferably, the entry angle ofthe air entering the grooves is approximately between 5-10% away from the plane of rotation of the impeller. As illustrated, the inlet portion 35(1) extends from the rim of the er 60 to the maximum radial extent outer perimeter ofthe stator component. The groove curves rds from the inlet portion 35(1) (e.g., at about 80-90°) into the outlet n 35(2) of the groove which extends towards the cone-shaped base 36 of the stator ent. As illustrated, the outlet portion 35(2) deﬁnes a laminar ﬂow path that is positioned out of the line of sight of the impeller 60, i.e., outlet portion extends along lower side of the stator component. The grooves 35 all smoothly converge or rejoin at the generally haped base 36 to form an axial exit. The converging paths of the grooves create acoustic destruction for low noise.

In addition, the depth of each groove 35 increases or deepens as it extends from the inlet portion 35(1) towards the outlet portion 35(2), i.e., groove turns into more of a "tunnel" at the outlet portion. However, at the point where the air leaves the groove 35 and passes towards the outlet 25, the depth of the groove may be diminished by a ramp that angles the air path towards the outlet. Preferably, the depth of the groove is between 0-4 mm in this embodiment.

In the illustrated embodiment, nine air directing grooves 35 are provided to the stator component 30. However, it should be appreciated that more or less grooves are le, e.g., 3, 4, 5, or more s.

In an embodiment, the blower provides a rising fan performance curve, e.g., which may be varied by changing the area provided by the grooves.

Preferably, the stator component may be constructed of a polymeric material or polycarbonate. Additionally, it may be preferred to uct the portion of the stator component ting the motor out of aluminum. This aluminum portion of the stator component may ﬁinction as an additional heat sink for the motor. 1.2 Motor The motor 40 es a magnet provided to rotor 50 and a stator assembly 45 to cause spinning movement ofthe rotor 50 via the magnet. The stator assembly 45 includes a stator core on which stator windings 47 are wound. In an embodiment, the stator core is in the form of a solid e ring. However, the stator core may have a different arrangement, e.g., stack of sheet metal laminations. In an embodiment, the stator assembly may include a toroidal wound motor architecture (sensorless), e.g., based on common transformer windings.

] In Fig. 6, the stator assembly 45 includes six windings 47 on the stator core, which provides a symmetric arrangement. However, the stator assembly may include ative winding arrangements, e.g., 3 gs. Also, as illustrated, dividers 48 may be optionally provided n the windings 47.

As rated, exterior surfaces of the stator assembly 45 may be supported and retained by the ﬁrst and second parts 32, 34 of the stator component 30, i.e., stator assembly encased or enclosed between the ﬁrst and second parts.

Also, the ﬁrst and second parts 32, 34 of the stator component 30 are structured to retain bearings 51(1), 51(2) that rotatably t the rotor 50. For e, the ﬁrst part 32 may include a recess for supporting one bearing 51(1) and the second part 34 may e a recess for supporting the other bearing 51(2). The ﬁrst and second parts 32, 34 may be structured to support bearings of the same or mixed bearing sizes.

In addition, the ﬁrst part 32 provides an opening 37 along its axis that allows the end portion of the rotor 50 to pass hrough for engagement with the impeller 60. 1.3 Impeller In the illustrated embodiment, as best shown in Figs. 7 and 8, the impeller 60 includes a plurality of continuously curved or straight blades 62 sandwiched between a pair of disk-like shrouds 64, 66. The shrouds may help to reduce tonal noise in use. The lower shroud 66 incorporates the hub or bushing that is adapted to receive the rotor 50. Also, the impeller includes a tapered conﬁguration wherein the blades taper towards the outer edge.

Further details of impellers are disclosed in A1, which is incorporated herein by reference in its entirety.

The shrouding of the impeller may also preferably at least partially cover the blades. This may have the beneﬁt ofpreventing the blades from contacting the inner wall of the housing and breaking, e.g., if the blower suffers a shock while in operation.

As best shown in Fig. 8, the impeller es 14 blades 62. In this arrangement, the ratio of impeller blades 62 to grooves 35 in the stator component 30 (i.e., 14:9) includes no common divisible number, which helps to avoid blade pass frequencies and tonal noises. However, it should be appreciated that more or less blades are possible. The blades are angled in a backwards direction relative to the direction of the ﬂow to assist in reducing noise. 1.4 Fluid Flow Path Air enters the blower 10 at the proximal opening 23 and passes into the impeller 60 where it is accelerated tangentially and directed ly outward. Air then ﬂows into the air directing grooves 35 which direct the air rdly along the stator component . Air from the grooves 35 then converges at the base 36 ofthe stator component and is directed towards the distal opening 25. Due to the air directing grooves 35, ﬂow at the outlet is substantially laminar which leads to relatively low conducted noise. In addition, the motor 40 g the impeller 60 is ed within the stator component 30 which leads to vely low conducted noise.

Additionally, the air ﬂow path may be aged to ﬂow over the body of the motor to carry away heat produced from the motor. 2.0 "Mini" Blower Figs. 9-15 illustrate a blower 210 according to another embodiment ofthe t invention. In this embodiment, the blower 210 is relatively small with d1 about 22 mm (i.e., for connection to cuff of air delivery tubing), d2 about 22-25 mm (e.g., 24 mm), d3 about 80-100 mm, e.g., 82 mm, and d4 about 40-45 mm, e.g., 43 mm. However, other le sizes are possible.

As illustrated, the blower 210 includes a housing 220 (e.g., constructed of a polymeric material such as PEEK) with ﬁrst and second housing parts 222, 224, a stator component 230 (e.g., constructed of a polymeric material such as PEEK) including air directing grooves 235, a motor 240 supported by the stator component 230 and adapted to drive a rotatable shaﬁ or rotor 250, and an impeller 260 (e.g., constructed of a ric material such as PEEK) provided on one side ofthe stator component 230 and coupled to an end portion of the rotor 250. The impeller 260 has a small clearance above the stator component 230 and is adapted to rotate counterclockwise in use.

The blower 210 has axial symmetry with both the proximal opening 223 and distal g 225 aligned with an axis A of the blower (e.g., see Fig. 12). In an embodiment, a ﬁlter may be connected to the proximal opening 223. Also, in an embodiment, the distal opening 225 may be connected to a moisture trap to prevent water or ﬂuid from entering the housing.

In the illustrated embodiment, the outlet 225 is provided by an outlet tube 227 which allows ventilator tubing to be connected to the housing. Fig. 15 illustrates a PAP device 217 with the outlet tube 227 connected to ventilator tubing 215. A patient interface (not shown) is coupled to the other end of the tubing 215. The patient interface can be in the form of a nasal mask, a ﬁill face mask, a nasal cannula, nasal prongs, nasal s, or the like, which in turn may be ted on the patients head via headgear. The headgear may support the blower 210.

In an ment, the blower 210 may be structured to provide pressurized air greater than 60 cmHzO at ﬂow rates of up to 215 L/min. 2.1 Stator Component As shown in Figs. 12-14, the stator component 230 includes ﬁrst and second parts 232, 234 that are coupled to one another. The ﬁrst and second parts 232, 234 may be coupled to one r by one or more fasteners (e.g., screws) or by an adhesive (e.g., glue)).

In addition, the ﬁrst and second parts may provide a joint (e.g., second part includes recess 231(1) to receive ﬁrst part, and ﬁrst part includes one or alignment pins 231(2) to engage within hollow interior of second part) to tate alignment and connection.

The ﬁrst and second parts 232, 234 cooperate to deﬁne a hollow interior and are adapted to support the motor 240 and rotor 250 in an ive position. In addition, the ﬁrst and second parts 232, 234 ate to deﬁne a plurality of air directing grooves 235 (e.g., nine air directing grooves) including an inlet portion 235(1) and outlet portion 235(2) as described above.

The stator component 230 may be attached to the housing 220 by one or more fasteners, e.g., three ng screws. However, the stator component may be attached to the housing in other suitable manners. Alternatively, the stator component may not be attached to the housing but ed by a friction ﬁt. The hollow interior of the stator component 230 aids in the g process and reduces the weight of the stator component. The hollow interior of the stator component 230 may be ﬁlled and sealed from the air path to reduce the deadspace within the ventilator.

In an alternative embodiment as shown in Figs. 17-18, instead of using fasteners to couple the ﬁrst and second parts 232, 234 to one another, fasteners may be replaced with an O—ring 276 adapted to be ed into a gap 277 between the ﬁrst and second parts 232, 234 ofthe stator ent. In this example, each part 232, 234 may include a respective groove or ring-shaped recess 277(1), 277(2) that cooperate to deﬁne the gap 277 adapted to receive the O-ring 276. The O-ring 276 may be adapted to sit within the respective recesses and resist forces pulling apart the ﬁrst and second parts 232, 234. onally, the O-ring has advantages including easier assembly during cture (e.g., fewer fasteners), vibration isolation, and shock resistance, and may also additionally reduce noise generated by high speed vibration during use. 2.2 Motor The motor 240 is in the form of a brushless DC motor structured to cause ng movement ofthe rotor 250. In an embodiment, the motor may be a 13 mm diameter motor with 30 watt power consumption and up to 80,000 rpm. However, different size motors such as a larger motor is le, e.g., 16 mm diameter motor. Also, the motor may be sterilisable and sealed. The sealing feature may prevent or limit corrosion of the motor caused by exposure to high relative humidities or bodily ﬂuids.

As illustrated, the ﬁrst part 232 of the stator component 230 es a recess 238 to receive the end of the motor 250 and an opening 237 to allow the rotor 250 to pass therethrough for engagement with the impeller 260. The motor 240 is attached to the ﬁrst part 232 of the stator component 230 by one or more mounting screws 239, e.g., three mounting screws.

The second part 234 ofthe stator component 230 includes an opening 255 that allows the lower end ofthe motor 240 to pass therethrough. The opening of the second part 234 may also help to support and retain the motor, e.g., friction ﬁt.

The base of the motor 240 includes one or more power connection points 249 (e.g., three power connection points) for connecting power wiring. As illustrated, a cone or bullet shaped piece 270 is supported by the second housing part 224 and is conﬁgured and positioned to cover or protect the connection points 249 so they are separate from the air path, i.e., wiring and power connection points are shielded or enclosed by the cone-shaped piece.

A printed t board assembly (PCBA) 272 is mounted to the g to control the motor. The PCBA may contain one or more sensors to enhance control, e.g., Hall sensors, thermal sensors.

] In an embodiment, the motor may be connected to le ic heat sinks, and/or the- air path may be encouraged to ﬂow over the motor to aid in heat exchange.

Additionally, the motor may be encapsulated in a thin jacket to reduce motor noise. In an embodiment, the jacket may be constructed of a soft polymer or silicone. 2.3 Flow and Pressure Sensors A ﬂow sensor 290 and a pressure sensor 296 may be provided along the air ﬂow path. As shown in Fig. 12, the ﬂow sensor 290 includes inlet tubes 292(1) and outlet tubes 292(2) in ﬂuid ication with the air ﬂow path that allow air to enter and exit the sensor. Flow straighteners 280 are provided to the housing adjacent the outlet of the stator component 230 and upstream of the ﬂow sensor 290 (e.g., see Fig. 12). The ﬂow straighteners 280 are conﬁgured and arranged to hten the air ﬂow exiting the stator component 230 to prevent tangential air ﬂow across the ﬂow sensor inlet tubes 292(1), which provides a more accurate ﬂow estimate from the ﬂow .

The pressure sensor 296 includes a e ne 298 in ﬂuid communication with the air ﬂow path, wherein displacement of the ﬂexible membrane provides an indication ofpressure of the air in the air ﬂow path.

A second PCBA 274 is mounted to the housing (on an opposite side to the ﬁrst PCBA 272) to control and receive data from the ﬂow sensor 290 and pressure sensor 296. 2.4 Fluid Flow Path Air enters the blower 210 at the proximal opening 223 and passes into the impeller 260 where it is accelerated tangentially and directed radially outward. Air then ﬂows into the air directing grooves 235 of the stator component 230 which direct the air along the stator component 230. Air from the s 235 then exits the stator component 230 and passes along a channel deﬁned between the second housing part 224 and the lower end ofthe motor 240 towards the distal opening 225. Due to the air directing s 235 and the ﬂow straighteners 280, ﬂow at the distal opening 225 is substantially laminar which leads to relatively low conducted noise. The air directing grooves 35, 235, 535 have a substantially constant cross-sectional area so that the resistance for airﬂow in both directions is reduced. In particular, expiratory impedance is d by having a uniform cross-sectional area for the ﬂuid ﬂow path. 3. Ventilator ] In an embodiment, the blower may be used as a ator blower. When the blower is used as a ventilator blower, the proximal opening of the blower may be connected to a passive air valve assembly. Alternatively, the valve assembly may be provided (e.g., integrally ) to the outﬂow or outlet of the blower. The valve assembly can minimize deadspace when the device is employed as a ventilator.

Figs. 16-18 illustrate a blower 210 including a passive air valve assembly 201 ing to an embodiment ofthe present invention. The blower 210 includes a g 220 with ﬁrst and second g parts 222, 224 deﬁning a proximal opening 223 and distal opening 225, a stator component 230 including air directing grooves 235, a motor 240 supported by the stator component 230 and adapted to drive a rotatable shaﬁ or rotor 250, and an impeller 260, as described above. The ﬁrst and second parts 232, 234 of the stator component are coupled using an O-ring 276 as described above.

In the illustrated embodiment, the valve assembly 201 is provided to the proximal opening 223 ofthe blower 210. The valve assembly 201 includes a housing 202 adapted to support a ﬁrst valve 203 and a second valve 205. The ﬁrst valve 203 is in communication with atmosphere and positioned and ed to allow. air to ﬂow into the blower via the proximal opening 223 during an inhalation phase of the patient’s breathing cycle (as indicated by the arrows I). The second valve 205 is in communication with atmosphere and positioned and arranged to allow air to exit the blower via the proximal opening 223 during an exhalation phase ofthe patient’s breathing cycle (as indicated by the arrows E).

] The housing 202 includes ﬁrst and second housing parts 202(1), 202(2) (e.g., coupled to one another by a clip structure) and an intermediate housing part 202(3) that retains the valves 203, 205 within the g. As illustrated, the intermediate housing part 202(3) cooperates with the ﬁrst and second housing parts to sandwich an edge of the valve 203. The valve 205 includes a hub 205(1) that is secured within an opening provided to the intermediate housing part 202(3).

The second g part 202(2) includes openings 206 to allow communication with atmosphere via valve 203, and the ﬁrst housing part 202(1) and the housing part 202(3) include respective openings 207, 208 to allow communication with atmosphere via valve 205. 3.1 Mobile or Portable Ventilator System ] Another aspect ofthe present invention relates to a small, portable ventilator adapted for use at a location proximal to the t. In one ment, the ventilator may be used for non—invasive ventilation that is delivered to a patient via a mask or nasal prongs.

In an alternative embodiment, the ventilator may be used for invasive ventilation via connection to a tracheotomy tube or endotracheal tube. Some exemplary advantages of having a proximal ventilator include ng the length of the tubing required to r the ation to the patient (i.e., allows the use of a short breathing circuit which provides minimal circuit resistance to enhance compliance), and a smaller, lighter device that may enhance mobility for a patient. In one embodiment, the ventilator may be conﬁgured as a wearable system as described in greater detail below.

In one ment, the ventilator is placed close to the patient and used with a non-vented patient interface device such as a non-vented mask, non-vented mouthpiece, tracheotomy tube or endotracheal tube. Thus, the patient es in and out through the ventilator. Consequently, a ace within the device that is compatible with the tidal volume ofthe patient should be achieved. The deadspace is minimized by the internal dimensions ofthe blower and ly by the passive valve assembly incorporated into the ventilator inlet. In such a non-vented proximal system, the heat ted from the motor needs to be managed within the limitations ofthe motor’s speciﬁcation. A ventilator commonly includes two sets each of a ﬂow element and a ﬂow sensor to measure atory and expiratory ﬂow respectively to monitor and/or l ventilation. A non-vented ventilator in such close proximity to the patient allows direct monitoring of bidirectional respiratory ﬂow, but may suffer condensation on the ﬂow element caused by the patient’s exhaled gas, and so may affect the cy of ﬂow/volume measurements. The ventilator is a highly ergonomic ambulatory ventilator with excellent electro-pneumatic efﬁciency, promoting battery life or allowing a small battery pack. Advantageously, the patient is not required to be tethered to a bulky unit Via bulky hoses. An associated advantage is that the ventilator is not required to overcome the resistive losses of a long breathing circuit, nor correct volume measurements for the ance of long breathing systems. The ventilator can sit directly at the end of the cannula, potentially eath clothing, with only a thin ﬂexible ical cable to the handset (battery and user ace). Disconnection hazard is d, because the patient can be moved together with the ventilator rather than separately.

In an alternative embodiment the ventilator may used with a vented patient interface, either invasive for example with a tracheotomy having a vent, or non-invasive for example using a vented mask, vented mouthpiece, vented nasal prongs, etc. In this conﬁguration, the ator may be located proximal or distal from the patient as desired because in a system with a proximal vent, where the patient’s exhalate is ﬂushed from the circuit, the circuit length and deadspace of the ventilator does not impose additional deadspace. To adequately ﬂush exhalate from the circuit, a minimum vent ﬂow is required, achieved by a m PEEP and the vent’s dimensions. Thus, the passive exhalation valve relevant to the non-vented embodiment would not be necessary in a dedicated vented implementation. Furthermore, heat management ofthe motor is simpliﬁed in a vented system due to the presence of a bias ﬂow and no condensation forms on the ﬂow t as minimal expired air is ﬂowing over the ﬂow element. It may be preferable to avoid passing the heat to the gas and thence to the patient. Accordingly, it may be decided to pass the heat to ambient.

In such a vented ventilator arrangement, the small size, weight and battery operating time of the ventilator according to an embodiment of the invention would se the ility of the device. It allows for a compact ambulatory device, say belt mounted or holster mounted, applicable to rehabilitation or as an emergency respirator. Alternatively the ventilator may be mounted on the head or on the body and used with a short breathing tube as bed in more detail later.

Also, for non-invasive, the ventilator may be used with a non-vented mask, since a passive exhalation valve is provided to the ventilator. Moreover, the ator may also be designed for use with an external or third party tory valve under the ventilator’s control, such as an intersurgical valve or a proximal solenoid valve if a non-vented mask is used such as that bed in co-owned pending PCT application no. , ﬁled June 9, 2010. In such a case, the passive exhalation valve may not be necessary but an inlet ﬁlter may still be advantageous.

Overall Ventilator System Figs. 25-110 illustrate a ventilator system 500 according to an embodiment of the t invention.' As illustrated, the ventilator system 500 includes a blower 510, a ﬁlter/valve assembly 501 provided to the proximal opening ofthe blower, and a mucous trap 575 provided to the distal opening of the blower. The mucous trap is an optional component and may be replaced with a standard 15/22 mm conical connector, or a heat re exchange ﬁlter (HMEF), for example, as bed below.

Blower The blower 510 includes a housing 520, a stator component 530 including air directing grooves 535, a motor 540 adapted to drive a rotatable shaﬂ or rotor 550, and a low inertia centriﬁlgal impeller 560. A printed circuit board assembly (PCBA) 572 is mounted to the housing to l the motor. The PCBA 572 may be encapsulated or d by a cap 573. In addition, a casing 512 including ﬁrst and second parts 512(1), 512(2) may be provided to enclose the blower.

As best shown in Figs. 32-50, the g 520 includes a ﬁrst or top housing part 522 (e.g., see Figs. 41-44) deﬁning a proximal opening or proximal end 523 (e.g., patient side opening or opening proximal to the patient) and a second or bottom housing part 524 (e.g., see Figs. 45-50) deﬁning a distal opening or distal end 525 (e.g., ambient side opening or opening distal from the t). It should be appreciated that the proximal opening acts as an inlet for airﬂow to the patient for inspiration and acts as an outlet for expired air from the patient during expiration. Likewise, the distal opening acts as an outlet for airﬂow to the patient for inspiration and acts as an inlet for expired air from the patient during expiration.

As shown in Figs. 36 and 48, the bottom housing support 524 es one or more openings 527 that allow sensors of the PCBA 572 to communicate with the air ﬂow path within the blower. The bottom housing part 524 also includes multiple heat sinks or ﬁns 526 to assist with ng heat.

In the illustrated embodiment, the ﬁrst and second housing parts 522, 524 may be coupled to one another by a bayonet type connection (see Figs. 41-44), e.g., protrusions 522(1) provided on ﬁrst housing part 522 d to slidably engage within respective slots 524(1) provided on the second housing part 524. However, it should be appreciated that the ﬁrst and second g parts may be secured to one another in other suitable manners, e.g., fasteners, etc.

As best shown in Figs. 32-34 and 51—59, the stator component 530 es a ﬁrst part 532 (e.g., see Figs. 51-54) and a second part 534 (e.g., see Figs. 55-59) that are coupled to one another. The ﬁrst part 532 (e.g., constructed of a heat conducting material such as aluminum) provides a tube or motor ﬂange 533 d to support the motor 540 in an operative position. The ﬁrst part 532 includes an opening 537 to allow the rotor 550 to pass therethrough for engagement with the impeller 560. The second part 534 (e.g., constructed of a heat conducting material such as aluminum) deﬁnes the plurality of air directing s or channels 535 as described above to direct air from a centriﬁlgal ﬂow to an axial ﬂow. The stator ent may act as a heat conductive element or heat sink to dissipate heat from the motor. A rubber component 536 is provided within the stator component to assist with heat dissipation.

A non-electrically conducting motor sleeve 545 (e.g., constructed of plastic) is provided to the motor 540 below the stator component along a central segment ofthe motor.

The sleeve 545 ts inductive losses from the motor 540.

A ﬂow t 555 (e.g., constructed of a heat conducting material such as aluminum) is provided in the air ﬂow path between the motor 540 and the bottom housing part 524. The ﬂow element 555 acts a ﬂow sensor and includes a plurality of vanes 555(1) (e.g., 20-60 vanes, e.g., 40 vanes) that measures ﬂow in both directions and provides a heat conducting function for the motor, i.e., acts as a heat sink for the motor (e.g., see Figs. 68-70).

The housing 520 and stator component 530 cooperate to deﬁne a plenum chamber 528 (e.g., see Figs. 32 and 33) for air ﬂow from the impeller 560. Also, the housing 520 and sleeve 545 cooperate to deﬁne a downstream r 529 (e.g., see Figs. 32 and 33) to allow ﬂow recirculation h the stator component without affecting the ﬂow sensor, i.e., downstream chamber allows ﬂow to p fully r and reduce turbulence before the ﬂow element. Furthermore, having a plenum chamber 528 for the air ﬂow from the impeller reduces the occurrence of blade pass tonal noise as the impeller blades 562, particularly the tips of the impeller blades, are shielded from the stator vanes 535. Thus, there is no line of sight between the tips of the impeller blades 562 and the stator vanes 535.

] As shown in Figs. 32-34, a gasket 521 (e.g., constructed of silicon) may be ed between the ﬁrst and second housing parts 522, 524, e.g., for sealing, vibration isolation, shock resistance, reduce noise. In addition, as shown in Figs. 32—34, an o-ring 541(1) may be provided between the ﬁrst housing part 522 and the ﬁlter/valve assembly 501 and an o-ring 541(2) may be provided between the ﬁrst and second parts 532, 534 ofthe stator component 530 and the sleeve 545, e.g., for sealing, vibration isolation, shock resistance, reduce noise. The o-ring 541(2) seals the internal volume of the stator component to prevent airﬂow into the stator component and thus reduce the ace volume.

Filter/Valve Assembly As best shown in Figs. 32, 33, and 71—96, the ﬁlter/valve assembly 501 includes a ﬁlter cover 502 (e.g., see 77-80) deﬁning an air inlet 502(1) and an ary port 502(2) (e.g., for auxiliary oxygen), an air ﬂow diverter/manifold 504 (6g, see Figs. 81-84) deﬁning air inlets 504(1) and expired air outlets 504(2) and outlet channels 504(3), an air ﬂow diverter cap 506 (e.g., see Figs. 85-88), an air inlet membrane valve or inhale valve membrane 507 (e.g., see Figs. 89-92) to l airﬂow into the blower proximal opening for inspiration and airﬂow out of the blower for expiration, an inlet valve ring 508, an air outlet membrane valve or exhale valve membrane 509 (e.g., see Figs. 93-96) to allow air to be expired, and a ﬁlter 503 to ﬁlter the inlet airﬂow.

In the illustrated embodiment, the ﬁlter/vale assembly may be coupled to the blower by a t type connection, e.g., protrusions 504(4) provided on base ofthe air ﬂow diverter/manifold 504 (e.g., see Fig. 74 and 84) adapted to slidably engage within respective slots 522(2) provided on the top of the ﬁrst housing part 522 (e.g., see Fig. 41). r, it should be appreciated that the ﬁlter/valve assembly and the blower may be secured to one another in other le manners.

The air ﬂow diverter cap 506 es structure 506(1) to maintain positioning of the outlet valve 509, e.g., see Fig, 75. Also, the air ﬂow diverter cap 506 cooperates with the ﬁlter cover 502 to support the ﬁlter 503 adjacent the inlet of the ﬁlter cover. In addition, the air ﬂow diverter cap 506 provides openings 506(2) (e.g., see Fig. 87) that communicate with air inlets 504(1) for inlet air ﬂow therethrough. Operation ofthe ﬁlter/valve assembly 501 is described in more detail below.

Mucous Trap As best shown in Figs. 32, 33, and 97-108, the mucous trap 575 may be ed, e.g., to protect the ﬂow element 555. The mucous trap 575 es an outer case 576, an inner case 578, a seal ring 577 between the outer and inner cases, and a port seal 579.

The outer case 576 provides a tube 576(1) for connecting tubing communicated with the patient, e.g., via a mask. The tube acts as an outlet for airﬂow to the patient for ation and acts as an inlet for expired air from the patient during expiration. The inner case 578 provides a capture section or capture plate 578(1) in the middle of the ﬂow path, e.g., to capture any particulate matter expired by the t. The outer and inner cases 576, 578 be coupled to one another via a snap-ﬁt, e.g., inner case includes snap-ﬁt tabs adapted to interlock with recesses provided to the outer case.

Fig. 133 is a perspective view of a ventilator system 500 with an integrated mucous trap 575 . Operation ofthe mucous trap is described in more detail below.

Heat Moisture Exchange Filter (HMEF) In an embodiment, a heat. moisture exchange ﬁlter 580 (HMEF) may be provided to the ator (e.g., in lieu of the mucous trap or of a standard conical connector) to provide a level of humidiﬁcation and protection for the patient’s airway, e.g., conditioning the d air and/or protect the ventilator from exhaled particulates. The HIVIEF may be a replaceable accessory, but includes an integrated and ed appearance with respect to the ventilator. For example, Fig. 134 is a perspective View of a ventilator system with an integrated HMEF 580.

As shown in Figs. 112-125, the HMEF 580 es an outer casing 582, an inner casing 584, a ﬁlter pad or ﬁlter media 586, a heat and moisture exchange pad 588 (e.g., foam sponge), and a port seal 589 (e.g., constructed of silicone). The outer casing 582 provides a tube 582(1) for connecting tubing communicated with the patient, e.g., via a mask.

The tube acts as an outlet for airﬂow to the patient for inspiration and acts as an inlet for expired air from the patient during expiration. An ultrasonic weld line 584(1) is provided to the inner casing 584 to attach the inner and outer casings. The inner and outer casings cooperate to deﬁne an internal re port 585 for measuring pressure on the patient side of the ﬁlter media 586. The internal pressure port 585 uses the ﬁlter media 586 to protect the pressure sensor from bacteria, etc.

In an alternative embodiment, an off-the-shelfHMEF may be used with the . For example, Figs. 126 and 127 show an olf—the-shelfHMEF 580-1 (e.g., ECO MAXI heat moisture exchange ﬁlter) that possibly could be used with the ventilator.

In r alternative embodiment, the same functionality of the HIVIEF could be orated into the patient ace (e.g., mask, tube) as opposed to a unit inline with the ventilator as described above.

Wearable System As noted above, the ventilator may be conﬁgured as a wearable system. The wearable ventilator may be embodied as a single unit, with power storage and control interface built in, or may be embodied as a divided unit where the o-pneumatic transducer (or blower/ﬁlter/sensing assembly) is as small and as proximal as is practicable, and ents that are able to be segregated from electro-pneumatic transducer (such as the t power and/or control components) are conveniently located elsewhere (such as on (e.g., vest, belt, etc.), or near the patient (e.g., wheelchair, seat, pillow, bed, bedside, or operated by carer). The power/control unit may include a battery to power the device and a user interface to allow the adjustment of the parameters for therapy. It can also accommodate the ventilator alarm.

Fig. 135-1 and 136 show a remote or handset 590 (e.g., power/control unit) for the ventilator according to an embodiment ofthe invention. The handset 590 may include an optional extension battery 599 that is releasably connected to the handset (e.g., see Figs. 135- 2 and 135-3).

As illustrated, the handset 590 includes a housing 591 (e.g., constructed of PC/ABS), a bumper strip 592 (e.g., constructed of TPU) that provides a seal between housing parts of the housing, a ne keypad 593, a display screen 594 (e.g., color LCD screen), a ventilator connection 595 for attaching the electrical cable icated with the ventilator, a remote alarm connector 596, a communications connection 597, an alarm buzzer 598, and an SD card reader 587.

In the rated embodiment, the keypad 593 includes a start/stop ventilation button , a menu selection button 593(2), an up/increase button , a down/decrease button 593(4), an idate/accept button 593(5), a manual breath button 593(6), an audio pause button , alarm indicators 593(8), and a DC input connected indicator 593(9).

However, it should be appreciated that such keypad arrangement is only exemplary and other suitable buttons and button arrangements may be provided to the keypad.

Fig. 137 shows a docking station or dock 565 according to an embodiment of the invention. The dock 565 deﬁnes a cradle 566 to support the handset 590 and contacts for charging the handset. The dock includes DC charging contacts 567(1), remote alarm contacts , a remote alarm connection 567(3), and a power indicator 567(4). Fig. 138 shows the handset 590 in a docked position within the dock 565.

As best shown in Fig. 139, the cradle 566 includes a le cradle member 566(1) that allows the size of the cradle to be enlarged to accommodate the handset 590 with an extension battery 599. Fig. 139 shows the dock with the cradle member 566(1) moved to an extended position. Fig. 140 shows the handset 590 with extension battery 599 in a docked position within the enlarged cradle.

Figs. 141 to 143 show various arrangements ofthe portable ator 500 and handset 590 in use as a wearable . For example, Fig. 141 shows a ventilator 500 adapted for tracheotomy ventilation, a neck strap 568(1) for supporting the ventilator near the patient’s chest, a stabilizing strap 568(2) for stabilizing the ventilator near the patient’s chest, and a handset 590 supported on the patient’s waist by a handset harness and strap 568(3).

The stabilizing strap 568(2) may be optional, e.g., Fig. 142 shows the ventilator supported by the neck strap 568(1) without a stabilizing strap. Also, Fig. 142 shows the handset harness and strap 568(3) supporting a handset 590 with an ion battery 599. Fig. 143 shows an arrangement similar to Fig. 141, with an oxygen conservation accessory 569 provided to the ator.

Figs. 128-132 show another embodiment of a battery operated remote 590-1 for controlling the ator.

Operation Operation and additional aspects of the ventilator are described in more detail with speciﬁc reference to Figs. 32, 33, 109, and 110.

The ventilator may optionally include the ﬁlter/valve assembly 501 having an air inlet 502(1) that allows air to be drawn in from the atmosphere into the system. The air is ably passed through the ﬁlter 503 to remove any particulate matter. However the ﬁlter/valve assembly may not be required if there was no concerns about ﬁltering the air, or with mufﬂing noise, or with oxygen enrichment, then the blower could simply communicate with atmosphere. ally, the ﬁlter 503 may be an anti-bacterial (AB) ﬁlter. In the illustrated ment, the AB ﬁlter is provided on the proximal side to: (1) protect the ventilator and the ambient environment from pathogens, (2) protect the ﬂow meter from secretions, and/or (3) act as a heat moisture exchange (HME).

] The ﬁlter/valve ly 501 includes 2 one-way valves (i.e., air inlet valve 507 and air outlet valve 509) red "back-to-back" to separate inhaled ﬂow from exhaled ﬂow. The air inlet valve 507 is in the form of a ﬁrst membrane including an annular portion 507(1) that lifts up due to the resulted vacuum around the blower proximal opening 2010/001031 during inspiration. This opens the air inlet valve 507 and allows air to ﬂow into the blower proximal opening 523 during inspiration (e.g., see Fig. 109). The air inlet valve 507 has a central aperture that allows air to ﬂow therethrough. The air outlet valve 509 is in the form of a second membrane and air will not exit through the air outlet valve during inspiration because ofthe vacuum created here. The air outlet valve 509 is closed during inspiration in order to prevent air being drawn into the blower through the expired air outlets or outlet ls 504(3) directly. Two exemplary reasons for not drawing air through the expired air outlets include: (1) air at the outlets has relatively rich C02, and (2) air drawn from the expired air outlets will not pass the ﬁlter.

During expiration, the air ﬂows back through the ventilator to the air outlet valve 509. The air inlet valve 507 remains closed around the perimeter of the blower proximal opening sealing the inlet ﬂow path from the d air, and the air outlet valve 509 is pushed upwards to allow the expired air to exit out the expired air outlet ls 504(3) (e.g., see Fig. 110). There may be one or more expired air outlet ls 504(3) provided to the valve assembly, e.g., two expired air outlets as illustrated. Thus, the exhaled air is separated from the inhaled air in the ﬁlter/valve assembly. It is noted that the impeller and rotor are still running during expiration to maintain a positive end expiratory pressure (PEEP) or prevent stall.

Air enters the blower proximal g 523 and ﬂows into the impeller 560.

In the illustrated embodiment, the impeller has 11 vanes 562 (e.g., see Fig. 63). The number of impeller blades is preferably a prime number to reduce tonal noise. Also, the number of impeller blades may be selected to provide ent pneumatic performance as well as sufﬁcient expiratory resistance, provide relatively low inertia, and/or prOvide a strong structure that results in low deformation during high speed revolution. However, it is noted that the impeller may e a different number of blades such as 9 or 13 depending upon the blower requirements. The number of er blades may be balanced against the ﬂow impedance and the ncy, where too many blades. may increase the ﬂow impedance and too few blades may reduce the ncy. The impeller may be a mixed ﬂow, low inertia impeller that is attached to the rotor of the motor. The impeller has an alternating shroud arrangement as described in co-pending US. application no. 12/083,350, which is incorporated herein by reference in its entirety. The blades of the impeller may be curved backwards in relation to the rotation of the impeller. This facilitates a reduction in acoustic noise. Backward curving impeller blades also facilitates a decreasing pressure ﬂow curve which may be advantages for volume-control ventilation as it ers ﬁner resolution for controlling the ﬂow throughout the inspiratory cycle. r, for embodiments focused on pressure-target ventilation or for vasive ventilation (where higher inspiratory ﬂow rates are helpful), then radial or forward-facing blades may be preferable.

The motor 540 is a powerful, relatively quiet, miniature and efficient motor, such as a Maxon EC13 motor (30 W or 50 W). It may be preferred that the motor be ﬁilly sealed and autoclavable to allow sterilization of the system. A narrow diameter facilitates the low deadspace ofthe non-vented embodiment. However, the minimal dimensions of the motor, particularly around the motor windings, permits the motor’s magnetic ﬂux to interact with any closely-adjacent conductive structures, and in doing so reducing the s efficiency. Also, the pneumatic work done by the motor inherently es heat, even with such an efﬁcient motor, which for a small motor with small surface area may need speciﬁc design treatments to target thermal management of the motor. In an embodiment, the motor couples thermally conductive parts of high surface area to the motor in the interest of heat management, but speciﬁcally avoids electrically conductive parts around that section of the motor producing strong magnetic ﬂux to avoid loss ofmotor efﬁciency. Speciﬁcally, the ﬂow meter and the stator and the base ofthe housing may all be thermally conductive elements coupled tely with the motor body, while the region between the ﬂow meter and stator may be electrically non—conductive.

] The impeller 560 rotates and s the airﬂow tangentially outwards from the er. The air from the impeller enters the plenum chamber 528 that surrounds the impeller. The plenum r is a constant volume chamber having a constant diameter.

The plenum chamber allows a uniform or stable pressure to be produced, especially at low ﬂow rates. The plenum chamber acts as a reservoir or a buffer for ﬂow exiting the impeller.

The volume that the plenum chamber provides suppresses the offset and s noise in ﬂow measurement at low ﬂow, especially at zero ﬂow. This stable pressure s or minimizes the pressure variation around the circumference of the stator inlet, which if uncontrolled can promote offset error in the ﬂow sensing: this pressure variation can induce zed ﬂow from say a high-pressure zone, through a t ofthe ﬂow element, then circulating back through r segment ofﬂow element to a low pressure zone around the circumference of the stator inlet. The plenum chamber also discourages pressure impulses being developed, that can lead to impulse noise in the ﬂow sensing. Having the plenum chamber radial outwards from the impeller and the stator vanes or air directing s 535 starting from this plenum chamber also reduces blade pass tonal noise as the tips of the impeller blades are shielded from the stator vanes.

From the plenum chamber 528, the air ﬂow is directed h the stator component 530 including part 534 with air ing s 535. The stator component includes a plurality of channels or air directing grooves 535 that assist in directing the airﬂow from a generally tangential direction to a generally axial direction and encouraging a laminar ﬂow. In an exemplary embodiment, the part 534 ofthe stator component has a cross- sectional area of about 170-180 mm2, d substantially equally between 13 channels of the part. However, the cross-sectional area and number of channels may be varied depending upon the patient use and size of the system. For example, a ventilation system for pediatrics may have a smaller cross-sectional area, e.g., less than 170 m2. The number of channels may be selected to: include a prime , avoid coupling with the impeller, and/or balance between the deadspace and resistance. The cross-sectional area is substantially maintained h the channels to reduce turbulence despite variation in width and depth of the vanes.

The stator vanes 538 (e.g., see Fig. 58) that deﬁne the channels 535 are wider closer to impeller with a shallower depth and proceed down with a ng width and expanding depth. A substantially constant cross-section assists in maximizing laminar ﬂow through the channels. The substantially constant cross-section also reduces tory nce for the exhaled . The shapes ofthe channels assist with the moldability of the stator part.

The channels in the stator are separated from each other, e.g., such that air does not ﬂow between channels in use. The stator channels have an upper curved proﬁled with an angle at the tip, e.g., about 20-40°, e.g., about 30°. However, the stator channels may have other suitable tip angles. The tip angle may be selected with the consideration of ﬂow and rotating speed the blower is likely to have when in normal use, the resistance, and/or moldability, for example. The stator component 530 is assembled within the blower housing 520 via a drop in assembly and is ched between the top and bottom housing parts 522, 524. The blower housing parts may be molded from thermally conductive polycarbonate (e.g., Coolpoly E4501).

In an embodiment, the stator component ismolded from a heat ting material such as aluminum. The aluminum s in dissipating heat from the motor as it acts as a heat sink. It is noted that different size stators with a different number ofvanes may be used depending upon the desired tidal volume required. r, as mentioned above, it may be desired to limit the deadspace within the blower to maintain a d tidal volume for the patient.

Due to the both the inspiratory and expiratory ﬂow passing through the blower, the cross-sectional area of the blower, i.e. ace volume, should be balanced against the desire to minimize any imposed respiratory resistance on the t. Thus, the system is optimized to reduce the impedance for the expiratory ﬂow through the system while also minimizing the deadspace .

Below the stator component 530 is a downstream chamber 529 that provides a volume between the end ofthe stator component 530 and the ﬂow t 555. This downstream chamber helps to reduce ﬂow turbulence and allows airﬂow recirculation through the stator without aﬁ'ecting the ﬂow g h the ﬂow element 555 at zero ﬂow or a very low ﬂow, ﬁirther diminishing the ulation effect discussed for the plenum chamber above. This ensures that the air ﬂowing through the ﬂow element is more stable and more uniform to ensure a smooth ﬂow signal is obtained. The downstream chamber also helps to remove the ﬂow measurement offset at zero and very low ﬂow.

The non—electrically conductive sleeve 545 (e.g., formed from a non- electrically conductive material such as a plastic) surrounds the motor 540 within the downstream chamber 529. The sleeve surrounds the central portions of the motor and is d to prevent or substantially reduce the formation of eddy currents that lead to inductive losses in the motor and reduced motor efﬁciency, e.g., sleeve has a proﬁle following the stator component to create a smooth ﬂow transition. The sleeve also assists in maintaining the correct alignment ofthe stator component. The o-ring 541(2) between the top ofthe sleeve 545 and the bottom of the stator component 530 seals the internal space within the stator reducing the deadspace volume. A heat-conductive elastomer component or rubber component 536 is also located within the stator component to assist with dissipating heat from the motor. The rubber component has a mentary shape to the stator component.

The ﬂow element 555 is located below the downstream chamber 529. The sleeve 545 also provides a stop for the locating of the ﬂow element 555. The ﬂow element (e.g., constructed from a heat conducting material such as aluminum) provides an onal heatsink for the motor 540, assisting in dissipating heat from the motor. This advantageously also warms the ﬂow element minimizing condensation on the ﬂow element which may ely effect ﬂow measurement. The ﬂow element is a circular component adapted to ﬁt around the end ofthe motor. As best shown in Figs. 68-70, the ﬂow element includes 20-60 vanes, e.g., 40 vanes. The number of vanes is designed to ensure good resolution at low ﬂow while also accommodating the measurement ofmaximum ﬂows as dictated by the alternate applications of the ator. In the embodiment that combines both vented and non-vented ' applications the ﬂow element can measure a vely high maximum ﬂow, for example in. The ﬂow element 555 has a split inner core 556 (from which the vanes 555(1) extend as best shown in Figs. 68 and 70) with split 556(1) to allow the ﬂow element to be a spring-ﬁt around the bottom ofthe motor and to expand and contract with the changes in heat of the motor. In an exemplary embodiment, the ﬂow element may be ell ﬂow sensor X202705.

] After the ﬂow element 555, the air ﬂow path proceeds through the system to the outlet ﬂow tube to the patient. The cross-sectional area in the ﬂow path is maintained substantially constant to reduce the generation of the turbulence through the ﬂow path.

Turbulence can lead to undesirable noise or losses in the system. It may be advantageous to include a mucous trap 575 (e.g., as described above with respect to Figs. 32, 33, and 97-108) proximal to the ventilator to catch any expired particulate matter expired by the t, for example mucous. A capture plate 578(1) is located within the central region of the outlet ﬂow tube to the patient. It is the capture plate that catches any particulate matter expired.

During inspiration, the airﬂow travels through the mucous trap and around the capture plate to the outlet ﬂow tube 576(2) to the patient. During expiration, the air entering the outlet ﬂow tube hits the capture plate 578(1) which catches any d particulate , the air can then ﬂow around the capture plate and back through the ventilator to the ﬁlter/valve assembly 501 as sed above. Alternatively to the mucous trap 575, a ﬁlter element may be used, to provide anti-bacterial or anti-viral ﬁltration, and/or act as a heat/moisture exchanger which can be ofphysiological beneﬁcial by conditioning the inhaled air, and/or protect the ventilator from exhaled particulates. For example, the HMEF 580 as discussed above may be provided to the ventilator in lieu of the mucous trap.

The chamber space provided by the ﬁlter/valve assembly 501 acts as a type of mufﬂer to assist in reducing ted noise from travelling back through the system.

The ﬁlter/valve assembly 501 also includes port 502(2) to allow oxygen to be attached to the inlet to enable the supply of oxygen enriched air to the t. The oxygen is directed into the inlet ﬂow path area of the ﬁlter/valve assembly. In one embodiment, the volume ofthe chamber at the air inlet of the ﬁlter/valve assembly.may be increased to provide an oxygen reservoir that will be ﬁlled by the oxygen supply during expiration to allow a boost ofoxygen to be supplied upon the switch to inspiration.

] Optionally, the ﬁlter/valve assembly may provide attachments for 3rd party ﬁlters, as a user preference or for special-purpose ﬁltration (e.g., smoke, dust, contaminants, toxins, toxic gas absorption).

It may be advantageous for the ator to know which inlet accessory is in use, for example to calculate an estimated Fi02 (i.e., fraction of inspired oxygen). Means may be provided to detect which ofthe inlet accessories in use, either as user-input to the controller (menu), or automatic detection. Automatic detection may be achieved by a variety of established means, e.g., embedded magnets with hall-sensor detection, optical reﬂectors, microswitch and mechanical key, inductance loop, etc.

] The ated power/control ly (e.g., handset 590 as discussed above) provides several es. For example, the ated power/control assembly may act as a renewable power source. If the power/control assembly is removable, it can be ed quickly with another power/control assembly with a fresh battery . The assembly includes a mechanism where the ventilation conﬁguration is stored within the electro- pneumatic transducer assembly, sy of a local microcontroller and sensor unit within the transducer. An alarm may be included in the electro-pneumatic ucer ly, instead of or in addition to the power/control unit. The segregated power/control assembly may also act as a mobile programming unit, in that the ventilation conﬁguration is duplicated within the power/control handset, so the choice exists r to accept the conﬁguration of the W0 2011/017763 electro-pneumatic transducer, or the conﬁguration ofthe power/control unit. This allows rapid "pasting" of settings to a new patient or a new ventilator, for instance as may be of value in an institutional setting such as a hospital, or as may be of value in allong a dependent patient to carry a redundant o-pneumatic transducer assembly in case of mechanical failure, with rapid changeover.

] The power/control assembly, whether integrated with the electro-pneumatic transducer or whether segregated, also includes features of use in an ambulatory device. It possesses in internal accelerometer (can be single or multiple-axis), and allows peripheral sensors to also be connected such as a pulse oximeter or C02 monitor (trans—cutaneous or end-tidal). Together or in isolation this can allow: accelerometer monitoring of rehabilitation parameters, such as pedometer estimation of six—minute walk distance, which can improve clinical management patients during of ventilator-assisted exercise programs; accelerometer monitoring ofpatient falls, which may optionally utilize the ventilator’s alarm function in drawing attention to the patient fall; accelerometer ion all of the ventilator, allowing blower ion to be suspended (for self-protective reasons) in anticipation of an impending impact; accelerometer detection of e ambient vibration, which may interfere with the ator’s y to correctly sense patient breathing activity (trigger/cycle): if ambient vibration is detected, a mandatory ation regime may be instituted until the external inﬂuence has been removed; accelerometer detection of increased patient activity, which alone or in concert with oximeter—sensed heart-rate or oxygen saturation, may be used to alter ventilation parameters in anticipation of increased ventilatory demand; accelerometer-driven user input for changing ventilation parameters: in certain nments, such as e glare, noise, motion, etc, traditional medical device user interfaces such as electronic displays and button navigation may be challenged: an accelerometer interface allows a sensed rhythm and vigor of motion (acceleration) to be used to drive parameters such as breath rate and amplitude; separate means of conﬁrming the user’s intention may be required, to separate t or incidental movement from an instructional movement; a sensed C02 driven tion of ation: in ﬁeld ventilators, used by emergency personnel or even users without any medical training, simplicity of operation is key, and automation is one way of maximizing simplicity: allowing the ator to perform limited automation of control, for instance closed loop adjustment of tidal volume to maintain C02 target, is one potential approach: and/or an oxirneter combined with adjustable oxygen ﬂow allows the user to adjust oxygen guided by blood oxygen saturation.

'In emergency ventilation, it may be advantageous to offer an estimate of fraction of‘inspired oxygen. Oxygen sensing cells provide this directly, but are large. An aspect of the invention includes a ated FiOz, based on the supplemental oxygen ﬂow rate r user-input or sensed with a ﬂow meter) and knowledge ofthe delivered tidal volume and the internal ions ofthe ventilator.

For al transport ventilators, operation within an MRI environment is advantageous. Most ators possess ferrous or magnetic ents, which may limit the proximity ofthe ventilator to the magnet bore. However a small, efficient micromotor ventilator platform with minimal ferrous components may permit closer proximity than ional es. It may be advantageous to for such a ventilator to monitor ambient magnetic ﬁeld strength, so that an alarm may be raised if it is being used with an excessive magnetic ﬁeld. An aspect ofthe invention may optionally e a magnetic ﬁeld strength sensor, such as a Hall-effect sensor, to sense ambient ﬁeld th and provide appropriate feedback to the user.

The power and control unit for an embodiment of the ventilator is formed as a separate unit to the pneumatic components described above. The control unit may be ed as a handset (e.g., handset 590 as discussed above). The control unit may comprise a power unit such as a battery unit or the power or battery unit may be made as separate unit that is d to attach to the control unit. The control unit and the ventilator unit both include a controller capable of recording the patient data. In this manner, different control units may be interchanged with different ventilator units and the exchange of patient details may be exchanged from the ventilator to a new handset or vice versa. Thus, in an embodiment where the power or battery unit is incorporated within the control unit, then when the battery gets low a new charged control unit may be connected to the ventilator and the patient and therapy details exchanged from the ventilator to the new control unit to proceed with therapy. Alternatively, if a patient is moved from one location to another and the ventilator unit is to be exchanged then the control unit may send the patient and therapy data to the new ventilator to in the appropriate treatment.

WO 17763 The control unit also comprises the user interface system to allow the setting, input and adjustment ofpatient details and therapy parameters. The beneﬁt ofhaving a separate control unit from the proximally located ventilator unit is an increase in usability in adjusting parameters. It allows the user to see the user interface more easily than if it was attached to the proximal ventilator unit. Furthermore, the clinician or nurse may be able to adjust the parameters while the user is being mobilized rather than having to stand in front of the user.

In an alternative embodiment the ventilator unit may comprise a simple user interface and/or battery to allow the simple adjustments of the ventilator.

Alternative Arrangements In an alternative embodiment ofthe invention, a ventilator system may include a headworn system. In this embodiment, the blower may be mounted on the patient’s head (e.g., on the crown ofthe patient’s head or on the front portion of a patient’s head).

In an embodiment, the elbow and external tubing may be removed as the tubing may run through the headgear.

In an embodiment, the blower may be mounted on a foam cushion to t or limit transmission of vibration and noise. The foam cushion may include multiple layers offoam ofdifferential sses or ies.

The blower may be mounted at an angle normal to the patient’s (e.g., in an orientationsuch as ear to ear). Alternatively, the blower may be aligned in direction n the rear of the head and the patient’s nose.

The blower may be d on a front n ofa patient’s head between the crown and the forehead, preferably closer to the patient’s forehead.

In an embodiment, the headgear may include an air channel with no or d turns in the air path and a 90° turn may be avoided.

Additionally, one or more headgear straps (e.g., constructed of fabric) may be adapted to function as a vent for the . ' ] Figs. 144-1 to 158 show headwom ventilator systems according to alternative embodiments ofthe present invention. As rated, the blower may rest on the top and/or side of the patient’s head in use.

In Fig. 144-1 to 144—3, the patient ace or mask includes a ﬂame 1020, a cushion 1030 provided to the ﬂame and adapted to form a seal with the patient nose and mouth, and headgear 1040 to support the mask in position on the patient’s head. The headgear 1040 includes side straps 1041, 1043 and an over—the-head strap 1042 that passes between the patient’s eyes towards the top of the patient’s head. As illustrated, the headgear 1040 supports a blower 1050 in position on the crown ofthe t’s head. The over-the- head strap 1042 forms a duct to communicate pressurized air ﬂom the blower to the breathing chamber deﬁned by the cushion. In addition, the headgear includes multi layer foam and/or dampening material 1049 to support the blower 1050 and limit vibration/noise. In an embodiment, the mask may e one or more s as described in PCT Application , ﬁled February 27, 2009, which is incorporated herein by reference in its entirety.

Frame 20 is ed such that it connects with cushion 30 adjacent its perimeter or outer most edge. This is so that the appearance of the mask is less obtrusive as the visual impact of the mask will be reduced. It also enables a clear line of sight to the patient’s nares and/or mouth when viewed ﬂom the ﬂont. A short tube 1023 is coupled with the cushion 1030 to r the pressurized air ﬂom the blower 1050 via the headgear ﬂexible tubing 1042 to the cushion 1030. The short tube 1023 may be integrally moulded with the cushion 103 0. The short tube 1023 may be made ﬂom a sealing material such as silicone.

Frame 1020 may include headgear connection portions 1021 for interfacing with ar straps 1041. As shown in Fig. 144-1, headgear straps 1041 may be connected to the ﬂame using clips 1045. Alternative connection means are possible, such as hooks or slots for receiving headgear straps, push ﬁt, hook and loop connections, magnets, or any other connecting means. Headgear may also be provided with a cuff or interfacing means that is able to be push ﬁt or ise connect with the ﬂame. As shown in Fig. 144-1, over-the- head strap 1042 is ed with a cuff 1055, the cuff being ed, glued, ultrasonically welded, radio ﬂequency welded, or connected by any other means, to the end or connecting portion of over-the-head strap 1042. This interfacing means then ts to the ﬂame.

Flexible tubing may be molded within the over—the-head strap 1042 and interfacing means to connect with the mask. The ﬂexible tubing may alternatively be molded with the mask, for example as one part with the cushion, and inserted within the cuff 1055 and over-the-head strap 1042.

Over-the—head strap 1042 may be constructed of more than one layer of material. Preferably, the outer most layer 1047 may be a fabric, textile or other soﬁ material for providing t when in contact with the patient’s skin. An inner layer 1048 may be ‘foam, gel, 3D woven fabric, or any other dampening material to absorb noise from the air delivery tube. Another inner layer may be a polymer sheet or ﬁlm 1046 (e.g., Fig. 146—2-3) to seal the inner portion of the duct so as to t air leakage. The polymer sheet may be polyurethane, polyvinyl or another suitable r. Alternatively, the inner n may be sealed using silicone ng or a separately attachable duct 1052 (Fig. 1462). In a further alternative, a d foam may be inserted within the outer layer. Preferably, the portion of the over-the-head strap contacting the user’s face may include additional layers or thicker regions of the ing layer so as to absorb more vibration and noise.

At the blower connecting end ofthe over-the-head strap 1042, a second cuff or connecting means 1053 may be provided to connect the blower outlet to the ar 1040.

The second cuff 1053 may be formed from a polymer material. The polymer may be a thermoplastic elastomer, thermoplastic urethane, polyester, polypropylene or any other suitable material. The cuffmay be glued or integrally formed with the over-the-head strap 1 042.

The blower mounting n 1054 ofthe headgear may include a cradle or positioning means to capture the blower, stabilise it in position, and ably absorb noise and vibration. The blower mounting portion 1054 of the headgear may e additional layers of dampening materials 1049 such as foam, silicone, gel, 3D textiles or any other suitable dampening materials.

The blower may have an air intake or inlet portion 1052 positioned parallel to the top portion of the patient’s head (as shown in Fig. 144-1). Alternatively, the inlet may be positioned normal or perpendicular to the top portion of the patient’s head.

Fig. 145 shows a mask similar to the mask of Fig. 144-1. In contrast, the patient interface of Fig. 145 includes a nasal n 1130 and the frame 1120 includes an alternative conﬁguration for attaching lower headgear straps 1141.

Lower ar connectors 1121 may be slots or loops to receive loops of headgear straps 1141. Preferably, slots may be connected to arms or wings that may move the connection point ofthe headgear to the frame away from the patient’s line of sight.

In Figs. 146-1 to 146-4, the patient interface includes a nasal prong or pillow arrangement 1230 d to form a seal with the patient’s nares. The headgear 1240 includes side straps 1244 that form ducts to communicate pressurized air from the blower to the nasal prong arrangement. In an embodiment, the headgear and/or mask may include one or more aspects as described in A1, U.S. Patent Application Publication 2009/0044808 A1, or US. Patent 7,318,437, each of which is incorporated herein by reference in its entirety. ] n 1230 may include a plug or vent clip 1231 to seal the cushion. In order to cture the pillows on cushion 1230, the core may be d through the aperture shown in Fig. 146-3. Alternatively, the plug may include vent holes if using a vented system to provide venting to the mask arrangement. Alternatively a plug may be solid for use in a non-vented system. Fig 146-3 shows the cushion 1230 with the ﬂoating core and the aperture from which the core has been removed as indicated by the arrow.

] Headgear straps 1244 may be attachable to the cushion 1230. Headgear straps 1244 may be ducted or hollowed to enable the passage of gas through the straps. The cushion connecting ends ofthe ar straps 1244 may include cuffs or connecting means to enable removal of the n from the headgear. The cuffs may be molded, glued, radio frequency welded, ultrasonically welded or otherwise attached to the cushion connecting ends of the headgear straps 1244.

The headgear may include more than one layer as shown in Figs. 146—2-1 to 146-2—3. The outer most layer 1047 will preferably include a soft, comfortable material such as fabric, foam, frosted polymers or any other suitable material. Preferably, an inner layer 1048 may comprise a dampening material such as foam, gel, silicone, 3D textiles or any other suitable material. Preferably, the headgear straps 1244 may be constructed using ultrasonic welding or thermoforming or a combination thereof. An inner most n 1046 of the headgear straps 1244 may include a sealed, ducted portion for transmitting gases from the blower to the cushion. This may be constructed from an extruded silicone tube, a helical tube, or a polyurethane tube.

The top portion ofthe ar may include a transition portion or connecting portion 1245 for joining the headgear straps 1244 to the blower (e.g., see Fig. 146-4).

Transition portion may include a generally W-shaped portion as shown in Fig. 146-4, wherein there are two outer ns for connecting with the side straps or ducts within headgear straps, and a central connecting portion for connecting with the blower. This transition portion may be integrally formed with the ar, for example by thermoforming, ultrasonic g, gluing or any other connecting means. In an ative embodiment, the transition portion may be positioned within or on the headgear without permanent ﬁxation.

The transition n may be made of any sealed material, such as silicone, TPE, TPU, polypropylene, polycarbonate, or any other suitable material. Preferably, transition n may sealingly engage with headgear ducts and the blower. The transition portion and headgear ducts may sealingly engage by interference ﬁt. atively, they may be formed in one piece. The transition portion and blower may sealingly engage by interference ﬁt, such as push ﬁt.

Figs. 147-158 show ative conﬁgurations for communicating pressurized air from the blower to the mask, alternative frame conﬁgurations for ing headgear, alternative headgear arrangements, and/or alternative cushion or sealing arrangements.

Fig. 147 shows a blower 1350 mounted on the top or at the apex ofthe patient’s head that is held in position by a headgear 1340. The headgear may include a securing portion for maintaining the blower in position on the headgear. The securing portion may include a formed region that holds the blower in ssion to maintain it in position.

Alternatively, the securing portion may include a sock, clip, wrap or any other structure to maintain the blower in position. The headgear may further include a channel or hollow region to pass a tube from the blower outlet to the mask 1320. The channel or hollow region may extend along the length ofthe tube or a n thereof. The channel may maintain the heat within the tube and make the system appear more streamlined. The channel may further dampen or prevent the ﬂow of noise from the blower to the mask. The mask may e a cushion and a frame. The mask may further include lower headgear connection points. The lower headgear connection points may include clips, loops or other headgear connection mechanism.

Fig. 148 further demonstrates an arrangement for mask and blower system, where there are two blowers 1350 mounted at the top or apex region of the t’s head.

Each blower may t to a tube, where the tube then ts to the mask system 1320.

Preferably, the tubes connecting the blowers and the mask are positioned under or encapsulated within the headgear straps. The embodiment shows two blowers, however it is possible for more than two blowers to be positioned on the headgear.

Fig. 149 shows an alternative arrangement to the embodiment shown in Fig. 148. Fig. 148 shows a ﬁlll face mask or mask that seals around at least the nose and mouth of a t. The embodiment shown in Fig. 149 shows a mask 1320 that seals around a nose region of a patient. In addition, the mask includes a ﬂame, where the frame may be a skeleton ﬂame or a ﬂame that surrounds the perimeter of the mask without shrouding or covering the central portion of the mask. This may make it easier to see the patient’s nares when the system is in use. Such an arrangement may be beneﬁcial in a clinical setting where a view to the patient’s nares is desirable. In on, the ﬂame includes outriggers or slender extensions ﬂom the ﬂame to the headgear connecting portions to reduce the visual bulk ofthe mask and also to enable greater ﬂexibility at the headgear connecting portions. Such ﬂexibility may be desirable to enable greater sealing engagement of the mask with the patient.

Fig. 150 shows a full-face mask 1320 according to a further ment of the present ion. The blower 1350 is positioned at the top or apex of the patient’s head.

The intake of the blower housing is rd facing, that is, facing in a horizontal direction away ﬂom the patient’s face. It may also be possible for the intake of the blower housing to be positioned in alternative orientations such as directly vertical. The ar 1340 may include a l or hollow region for oning of a tube, the tube being attached to the outlet of the blower g and the mask. The headgear channel may terminate at a cuff or connecting region, where the mask ﬂame having an opposition cuff or connection region for engagement with the headgear channel. The connection may be a mechanical connection such as a snap ﬁt or taper lock. Alternatively the connection may be a permanent chemical connection or may be molded in one piece. The ﬂame may be of a skeleton or perimeter arrangement similar to that shown in Fig. 149.

Figs. 151-1 to 151-3 show an alternative arrangement ofthe present invention, where the patient interface 1320 is a pillows or prongs type mask. The patient interface is ﬂuidly connected or a part of a tube arrangement 1340, where the tubes are routed or positioned on each ofthe patient’s cheeks and between the t’s eyes and ears. The tubes terminate or connect to a blower or blower housing 1350, positioned at the top or apex ofthe patient’s head. The ar may encapsulate or ise surround the tubes as shown in Fig. 151-3. The headgear may be formed with the tubes or may be retrospectively ﬁt or placed around the tubes. As shown in Fig. 151—2 the tubes may be radio frequency welded within a thermoformed fabric, for example.

Figs. 152-1 and 152-2 show an alternative pillows or prongs type mask 1320, where the tube is routed directly vertical or upwards of the patient’s head. That is, the tube is positioned in use between the patient’s eyes. The mask may connect to the headgear 1340 on its lateral sides by push ﬁt tabs, hook and loop, or any other engagement mechanism.

Preferably, for vented s the mask may have an oriﬁce for venting on its lower portion, directly opposite the position or ment points of the prongs or pillows. This may be to facilitate manufacture by allowing the core to be removed from the pillow or prong mask as described above in relation to Fig. 146.

Fig. 153 shows a ﬁirther embodiment of the present invention. This embodiment includes many attributes of the system described in Fig. 150. The on or minimized frame 1320 in this embodiment has a top portion that is generally upsidedown T— shaped. The upper stem ofthe T-shaped portion loops or wraps around the tube 1325. Lower headgear connectors are positioned on the lower portion of the minimized frame.

Fig. 154 shows an alternative embodiment ofthe present invention. The mask 1320 may have side connectors to a tube or tubes, where the tubes are directed or positioned along the t’s cheeks and between the patient’s eyes and ears. The tubes terminate or t at the blower 1350, and connect to the rear or inferior side of the blower or blower housing. The rear or inferior side of the blower is lly opposite the side of the blower facing the same direction as the face of the patient. This may enhance the stability of the system by cupping or embracing the rear of the patient’s head in use.

Fig. 155 shows a further alternative ment ofthe t ion. The mask 1320 may have a tube connecting portion at the top or apex of the mask. The tube may bifurcate at the general forehead region of the patient. There may be a webbing or mesh at the junction or separation point of the tube to prevent the bifurcated tube from splaying to far outward. The bifurcated tubes may then enter or connect to the outlet of the blower or blower housing 1350.

Fig. 156 shows a further alternative embodiment of the present invention. The mask 1320 is a full face mask having an alternative conﬁguration for attaching lower headgear straps.

Fig. 157 shows an ative patient interface 1320, being a nasal cradle. The nasal cradle may have a tube connecting portion at the front of the nasal cradle cushion that delivers the pressurized air from the blower 1350 directly into the front of the nasal cushion.

A tube is routed directly vertical or upwards of the patient’s head from tube ting portion to the blower positioned on the patient’s head. That is, the tube is positioned in use between the patient’s eyes. Headgear side straps 1340 support the positioning of the nasal cradle on the patient’s nares.

Fig. 158 shows an alternative patient interface 1320, being a nasal . The nasal cradle may include a single oriﬁce to deliver breathable gas to both nares of the patient, with the outer walls ng an outer region of the nose of the t.

As noted above, mounting the blower on the patient’s head (e.g., on the patient’s crown) may allow vibration noise to be transmitted directly to the skull of the patient. Also, the headgear straps may transmit noise to the patient’s skull in use. Thus, blower support ures may be used to le or isolate the blower from the patient’s skull so as to dampen vibrations in use.

Preferably, the blower may not radiate heat to a level that the t cannot tolerate or is dangerous. Preferably, the blower may not produce temperatures over 60°C.

Preferably, the blower may not produce temperatures over 30°C.

Another aspect of the invention relates to a ventilator system in which the blower is built into or incorporated into the patient ace or mask. In an embodiment, the blower may be d into two or more smaller blowers. Miniature blowers such as the small 8W blowers manufactured by Maxon having a diameter of imately 8 mm and a length of approximately 30 mm may be utilized or other commercially available miniature blowers. In one embodiment, the stator and air path features such as volute or plenum chamber may be build into the internals ofthe mask. 2010/001031 Figs. 159-176 show masks with a built in blower according to alternative embodiments of the present ion.

In Fig. 159, the patient interface or mask includes a nasal prong or pillow ement 1330 adapted to form a seal with the patient’s nares. First and second blowers 1350(1), 1350(2) are provided to respective ends of the nasal prong arrangement to e rized air to the nasal prong arrangement. The mask may be attached to the patient’s face by a combination of hook and loop (e.g., Velcro) tabs and adhesive. In an embodiment, one blower may be used.

Blowers 1350(1) and 1350(2) may be encapsulated by a dampening means.

For example, dampening means may include a mufﬂer, such as a silicone casing, a foam and/or fabric layer or any other suitable material.

Tab portions may be connected to the nasal prong arrangement 1330 for removably attaching it to an adhesive facial pad. Tab portions may include integrally molded hooks to engage with loops ed on the adhesive facial pad. In an embodiment, attachment means may be provided as disclosed in pending US. application no. 12/478,537 ﬁled June 4, 2009, which is incorporated herein by reference in its entirety.

Mufﬂing and/or ﬁltering materials may be provided to the air inlet portions of the blowers 1350(1) and 1350(2). For example, foam pads may be attached or otherwise formed with blowers at their inlet portion.

In Figs. 160-1 and 160-2, the patient interface or mask includes a nasal prong or pillow arrangement 1430 adapted to form a seal with the patient’s nares. First and second blowers 1450(1), 1450(2) are provided in-line with respective nasal prongs to provide pressurized air.

Nasal prongs may be provided with barbs or interference means to engage with an inner p0rtion of a patient’s naris.

The blower may be positioned such that the outlet directs airﬂow directly into a nasal prong, and the inlet receives air through an aperture in the n. The inlet may be adjacent or near a ﬁlter and/or muﬁler 1451 so as to reduce noise and e the patient with clean air. The ﬁlter and/or mufﬂer may comprise a ﬁlter al, foam, fabric, mesh or any other suitable material and any ation thereof. 2010/001031 Headgear straps 1440 may be connected to a cushion for securing the patient interface to the patient. The headgear straps may be connected at the rear of the patient’s head by a slidably engaging portion. The headgear straps may connect to the blowers and se wiring to supply power to the blowers. Power is provided to the blower via a wire to a l unit that includes a power supply unit. The control unit may also comprise a user interface to allow the setting ofparameters to control the blowers.

In Figs. 161-1 and 161-2, the patient interface includes a nasal n 1530 and ﬁrst and second blowers 1550(1), 1550(2) provided to respective ends ofthe nasal cushion to provide pressurized air to the nasal cushion. The silicone cushion provides ducting to icate rized air from the blowers to the nasal cushion.

' The cushion 1530 may be a therrnoforrned textile, e.g., see Fig. 161-2 including fabric portion 1530(1) and silicone sealing n and ducts 1530(2). The e could be woven or non-woven. The cushion may include a foam and/or fabric layer. The therrnoforrned textile may e a sealing surface, such that is non-air permeable or at least minimally ble. This may be achieved by silicone spraying, molding or ise attaching a non-permeable or minimally permeable material to one or more portions ofthe fabric. Alternatively, the cushioning portion may be removably attached to the sealing surface. The sealing surface may include a patient contacting portion, a frame or support portion for maintaining the cushion away from the user’s nose, and a ducted portion for attaching to air delivery tubes.

Headgear straps 1540 may be formed by ultrasonic welding and/or thermoforming. Headgear straps may be made from a fabric and foam composite. Headgear straps may alternatively be a fabric. Headgear straps may include reinforcing ns.

Headgear straps may ﬂirther include additional baﬁling or muffling portions 1541 to reduce noise from the blower and/or n. For e, mufﬂing portions are shown in Fig. 161- 1 positioned near or proximal to the patient’s ears, to prevent excessive noise travelling to the patient’s ears.

In Figs. 162-1 and 162-2, the patient interface includes a frame 1620, a nasal cushion 1630 provided to the frame, and a blower 1650 provided to the front of the frame and icated with the breathing chamber deﬁned by the cushion. In an embodiment, the headgear and/or patient interface may include one or more aspects as described in W0 2009/052560 A1, US. Patent Application Publication 2009/0044808 A1, US. Patent No. 7,318,437, or PCT Application No. , ﬁled February 27, 2009, each of which is incorporated herein by reference in its entirety.

] Headgear 1640 shown in Fig. 162-1 and 162-2 may include a cable or wiring system that is molded into the headgear strap. For example, the wiring 1640(1) may be encapsulated within a foam and/or fabric strap 1640(2) as shown in Fig. 162-2, wherein the foam and/or fabric may be formed by thermoforming and/or ultrasonic welding. The foam may be used to support the wires in position, insulate the cables and in the wires in an unobtrusive manner. The wiring is shown in the form of a ribbon cable, although other forms of wiring may be utilized.

In Fig. 163-1 and 163-2, the t interface includes a frame 1720 (including a forehead support), a full-face cushion 1730 provided to the frame, and a blower 1750 provided to the front of the ﬂame and communicated with the breathing r deﬁned by the cushion. A mesh vent 1751 is mounted on either side of the blower. The mesh vent would allow air to ﬂow into the blower as indicated by the arrows in Fig. 163—2. The mesh vent would act as a ﬁrst ﬁlter to ﬁlter the incoming air.

The frame 1720 includes an aperture or ring for engaging with a blower 1750.

The blower may clip or otherwise engage with the frame.

A second ﬁlter 1752, such as a HEPA ﬁlter, may be ﬁtted to an inner portion ofthe mask near or proximal to the outlet of the blower to ﬁlter the air being delivered to or expired from the t as indicated on Fig. 163-2. It may also assist in dampening the noise.

In Figs. 164-1 to 164-3, the patient interface includes a nasal cushion 1830, headgear 1840 to support the cushion in position on the patient’s head, and a blower 1850 supported by the headgear. The nasal cushion may be constructed of a ant material such as silicone, gel, or foam. The blower may be overmolded or otherwise encapsulated in a housing, where the g may be made from a c, metal, or other material that is able to maintain its shape. The housing may also function as a mufﬂer to reduce noise. In an embodiment, the cushion may include one or more aspects as described in Australian Application 2524, ﬁled June 2, 2009, which is incorporated herein by reference in its entirety.

Headgear 1840 for supporting the mask 1830 may include a channel or other ment means for a power supply cable to connect the motor to a power supply. The channel may be contained within the headgear. The l may protect the wiring, prevent lement or strangulation of the patient and give the system a streamlined appearance.

The headgear 1840 may be thermoforrned or otherwise shaped.

A mufﬂer or ﬁlter 1851 may also be ﬁtted adjacent the mask 1830 and blower 1850, as a foam or fabric molded or attached to the headgear as shown in Fig. 164-3.

Alternatively, the muffler or ﬁlter may be a non-woven material. The mufﬂer or ﬁlter may ﬁlter exhaled gases and/or reduce the noise from the mask and . In a further alternative, the muﬁler or ﬁlter may be integrally formed or apart of the ar.

Figs. 165-176 show alternative frame conﬁgurations for attaching headgear, ative headgear arrangements, alternative cushion or sealing arrangements, and/or alternative ventilator conﬁgurations. For example, in Figs. 165 and 166, the patient ace 2530 includes a dual blower (i.e., ﬁrst and second s 2550(1), 2550(2)) supported by the mask frame. In Fig. 167 a mask 2530 wherein the blower is built into the mask is shown. In Figs. 168-1 and 16802, snap-on pillows or nasal prongs 2530 may be provided to the blower 2550. In Figs. 169 and 170, the patient interface 2530 may provide a foam intake. In Figs. 171—176, the blower 2550 is provided to the ﬁ'ont ofthe mask 2530 and the mask includes a streamline design.

For example, Fig. 165 shows a pair of blowers or blower gs 2550(1), 2550(2) mounted on to the mask or patient interface. The inlets of the blowers are oned horizontally outwards in the medial-lateral direction. A similar conﬁguration is demonstrated in Fig. 166.

Figs. 168-1 and 168-2 depict a blower outlet being connected directly to a patient interface 2530. The patient interface 2530 shown is a pillows or prong arrangement.

Alternative patient interfaces may be used, for example nasal cradles, nasal, full face or oro- nasal masks.

Another aspect of the invention relates to a portable ventilator that may be attached to a bed, wheelchair, table, chair, etc. Figs. 177-186 show portable ators according to alternative embodiments of the present invention.

As shown in Fig. 177, the portable ventilator 1950 may be adapted to be mounted by the patient’s bedside or wall. The bedside embodiment may e a detachable blower mounted on a docking station 1970 or nightstand. The able ventilator may include batteries, such as lithium ion batteries, for powering the device when not connected to the main/AC power. The night stand may be ﬁtted with an overhead tube 1960 (ﬂexible tube, ﬁxed shape tube, or combination thereof) adapted to connect to tubing associated with the mask. The overhead tube may be made from a metal such as stainless steel, or r such as thermoplastics or silicone, or combination f. The overhead tube may be able to rotate on the stand or bend in selected regions such as the top horizontal bar. The overhead tube includes a series of lights or LED’s at the cuff or connection region with the mask tube which can be activated by touch or by a change in the system (such as detachment). Also the overhead tube can provide a soft light for the patient to see at night. The light may assist the patient when detaching or reattaching a ﬂexible mask tube to the overhead tube. The color of the light may be associated with an tion reason. The cuﬂ' or connection region of the overhead tube may include a magnet that may attract a magnet or ferrous material at the end or connection region ofthe mask tube. This may aid attachment ofthe mask tube to the overhead tube.

In Fig. 178, the ator is d to be mounted to the wall or bedhead. An overhead tube 2060 may extend from the ventilator and adapted to connect to tubing associated with the patient interface. A mufﬂer and/or ﬁlter may be ed to the blower to ﬁlter gases being delivered to the patient and/or reduce the noise of the system. Similar to the ment in Fig. 177, the overhead tube may be ed to the bed, bed head, wall or any other region proximal to the patient. The overhead tube may connect to a case 2050, where the case 2050 receives a power supply for the ventilator system. The power supply may be a battery or mains power supply. The case 2050 may be constructed of a polymer such as thermoplastic elastomer, thermoplastic urethane, or may be constructed from a metal such as aluminum. The case 2050 may have a wire or other means of carrying the power supply to the blower attached to the end of the overhead tube. The case may also include a microprocessor and user interface to allow the control and setting ofparameters for the ventilator system.

In Figs. 179 and 185, the portable ventilator 2650 may be attachable to a blower dock 2655 which may be structured to retain, charge, and/or download diagnostics from the blower.

In Figs. 180-1 and 180-2, the bloWer 2650 is in the form of a ventilator pouch.

The pouch may be deﬂatable when not in use for portability.

In Figs. 181-1 to 181-4, the portable ventilator 2650 may be provided to a base 2656 adapted to charge the ator by induction charging.

] - Fig. 182 shows embodiments of an overhead tube 2657 which may include light-up tubing.

Figs. 183, 184, and 186 show alternative casings 2658 for enclosing or protecting a portable ventilator. For example, Fig. 183 shows a fabric or foam/fabric type case 2658, Fig. 184 shows a ne type case 2658, and Fig. 186 shows an aluminum alloy type case 2658.

] A battery pack may be provided with the mask and ventilator system. The battery pack may be worn on the body ofthe patient. Alternatively, the battery may be provided with a cord such that it may be positioned away from the patient, for example on a bed side table. The y may be ﬂexible such that if it is worn on the body of the patient it may bend and conform to the l shape of the patient. The battery may have a wire or cable connecting it to the motor. The cable may have a quick release or force release portion, such that if a force is applied to the cable, the cable will disconnect the battery from the motor. This may be beneﬁcial to avoid strangulation ofthe patient, or quick removal of the power from the motor.

Another aspect of the invention s to a ventilator adapted to be wearable or carried by the patient and not mask or head mounted.

Figs. 187-1 to 198-2 show wearable ventilator according to alternative embodiments ofthe present invention.

In Fig. 187-1 and 187—2, the ventilator 2150 is supported by a shoulder-type harness 2180 which supports the ventilator nt the patient’s chest.

In Figs. 188-1 to 188-4, the ventilator 2150 is ted by a pendant-type arrangement. Figs. 188-2 and 188-3 show alternative conﬁgurations for inlets and outlets of the ventilator.

In Figs. 189-1 to 189-3, 190, 195, and 196, the ventilator 2150 is supported by an article of ng, such as a shirt (e.g., T-shirt), pajamas, etc., wherein the clothing includes a blower support structure such as a pocket for example along the front of the shirt.

In Figs. 191 and 197, the ator 2150 is supported by a shirt (e.g., T-shirt) including a blower support structure (e.g., pocket) along the shoulder of the shirt. In Fig. 196 the ventilator 2150 is shown used with a tracheotomy tube for providing invasive ventilation support.

Figs. 192-1 to 194 show ventilator 2150 supported by a strap or band arrangement 2160. In Figs. 192-1 and 192-2, the strap wraps around the patient’s chest. In Fig. 193, the strap wraps around the patient’s neck, e.g., collar style. In Fig. 194, the strap wraps around the patient’s arm.

In Figs. 198-1 and 198-2, the ventilator 2150 is supported by a soft casing adapted to wrap around the patient’s neck. The casing may include pockets for supporting tubing 2166. In Figs. 192-1 and 196, the ventilator is shown as an invasive system using a tracheotomy tube.

It should be appreciated that s of the ventilator system, e.g., blower, may include alternative ements. For example, U.S. provisional application nos. 61/272,188, ﬁled August 28, 2009, and 61/272,919, ﬁled November 19, 2009 (each of which is incorporated herein by reference in its entirety) disclose alternative blower arrangements and CPAP systems including one or more s that may be incorporated into the ventilator system. That is, the blower arrangements and CPAP systems described in U.S. provisional application nos. 61/272,188, ﬁled August 28, 2009, and 61/272,9l9, ﬁled er 19, 2009, may be adapted for use as a ventilator system. 4. CPAP Applications In an embodiment, the blower may be useful in relation to applications for uous positive air pressure (CPAP) ﬂow generators.

In such CPAP applications, the blower may be reduced in size e the output ﬂow rate and/or pressures needed are vely lower, e.g., not as high as ventilators.

Figs. 19-23 illustrate a CPAP version of a blower 310 according to an embodiment of the present invention. As rated, the blower includes a housing 320 with ﬁrst and second housing parts 322, 324 deﬁning a al opening 323 and distal g 325, a stator component 330 including air directing grooves 335, a motor 340 supported by the stator component 330 and d to drive a rotatable shaﬁ or rotor 350, and an impeller 360, as described above. The ﬁrst and second parts 332, 334 ofthe stator. component are coupled using an O-ring 376 as described above.

The embodiment illustrated in Fig. 22 may also include wiring 404 for connecting power and/or l to the blower 310. The embodiment illustrated in Fig. 23 also includes PCBA 402, which may be used to control a ﬂow sensor and pressure sensor, as explained above in conjunction with Fig. 12. PCBA 402 may be coupled to the housing 320 using screws, glue or plastic retaining snaps (not shown) molded into the housing 320, or by other coupling.

In an example, the motor may rotate at speeds of approximately up to 40,000 rpm and generate pressures up to 14 cmH20. In an example, the impeller may have a diameter d6 between 20-40 mm (e.g., 30 mm) and the housing may have an outside maximum width d7 of 30-50 mm (e.g., 37 mm) and an e maximum height h1 of 30-50 mm (e.g., 43 mm). In an example, the motor may have a diameter d5 of about 10-15 mm (e.g., 12 mm) and a length of about 20-30 mm (e.g., 26 mm). However, other suitable sizes are possible. The blower may weigh less than 500 gms, and more speciﬁcally may weigh between 50—200 grns.

] Fig. 24 illustrates pressure versus ﬂow curves for various RPM illustrating characteristics of the blower according to embodiments ofthe invention. As illustrated, the pressure versus ﬂow is relatively constant over a range ofmotor speeds, (e.g., 30,000 rpm to 40,000 rpm), which aids a t being able to breathe back h the blower if there is no or a limited amount oftubing connected to the blower. This will limit or eliminate the need for a vent in a mask or patient ace attached to the tubing as part of a PAP device. Chart 1-1 below sets forth fan curve data for pressure versus ﬂow rate at various RPM, as illustrated in Fig. 24.

————- Chart 1-1 The embodiments described in this speciﬁcation are preferably adapted to be used in travel applications and in ions where minimal size and bulk of the blower is preferred.

While the invention has been described in connection with what are presently considered to be the most practical and preferred embodiments, it is to be understood that the invention is not to be limited to the disclosed embodiments, but on the contrary, is ed to cover various modiﬁcations and equivalent arrangements included within the spirit and scope ofthe invention. Also, the various ments described above may be implemented in conjunction with other embodiments, e.g., aspects of one embodiment may be combined with aspects of r embodiment to realize yet other ments. Further, each independent feature or component of any given assembly may constitute an additional embodiment. In addition, while the invention has ular application to patients who suﬁ‘er from OSA, it is to be appreciated that patients who suffer ﬁ‘om other illnesses (e.g., congestive heart failure, diabetes, morbid obesity, stroke, ric surgery, etc.) can derive beneﬁt from the above teachings. Moreover, the above teachings have applicability with patients and non-patients alike in non-medical applications.

James & Wells Ref: 505325DIV/99

Claims

WHAT IS CLAIMED IS:

1. A ventilator system for delivery of atory y to a patient comprising: a housing; a first opening in the housing configured to act as an ation inlet for airflow to the t for inspiration and act as an expiration outlet for d air from the patient during expiration; a second opening in the housing ured to act as an inspiration outlet for airflow to the patient for inspiration and act as an expiration inlet for expired air from the patient during expiration, a blower structured to receive air from the first opening and provide pressurized air to the second opening; the ventilator system further comprising a passive valve assembly structured to allow air to flow through the blower along a flow path from the first opening to the second opening during inspiration, and the expired air to flow through the blower along the flow path from the second g to the first opening during expiration, wherein the valve assembly includes at least one inspired air inlet and at least one expired air outlet, and wherein the valve assembly is configured to separate air traveling through the at least one inspired air inlet into the first g during inspiration from the expired air traveling from the first opening through the at least one expired air outlet during expiration; and n the blower is positioned between the first opening and the second opening.

2. The ventilator system of claim 1, wherein the housing includes: a first or top housing part comprising a printed circuit board assembly (PCBA) mounted thereto, the printed circuit board assembly comprising one or more sensors; and a second or bottom housing part; and wherein the bottom housing part includes one or more openings that allow sensors of the PCBA to communicate with the flow path within the blower.

3. The ventilator system of either claim 1 or claim 2 n the first opening and the second opening are provided at opposing ends of the housing.

4. The ventilator system of any one of claims 1 to 3 wherein the valve assembly is configured to: open the at least one inspired air inlet during inspiration; close the at least one expired air outlet during inspiration; close the at least one inspired air inlet during expiration; and open the at least one expired air outlet during expiration.

5. The ventilator system of claim 4 wherein the valve ly includes an inlet valve configured to open and close the at least one inspired air inlet, and an outlet valve configured to open and close the at least one expired air outlet.

6. The ventilator system of claim 5 wherein the outlet valve es a first membrane configured to move between a first position closing the at least one expired air outlet during inspiration and a second position opening the at least one expired air outlet during expiration, and wherein the inlet valve es a second membrane configured to move between a third position opening the at least one inspired air inlet during inspiration and a fourth on closing the at least one inspired air inlet during expiration.

7. The ventilator system of any one of the preceding claims wherein the valve assembly is provided proximal to the first opening.

8. The ventilator system of claim 7 wherein the valve assembly includes a filter configured to filter air before the air enters the first opening.

9. The ventilator system of any one of the preceding claims wherein a heat moisture exchange filter is provided to the ventilator system to provide a level of humidification and protection for the patient’s airway.

10. The ventilator system of claim 9 wherein the heat moisture exchange filter is ed proximal to the second opening.

11. The ventilator system of any one of claims 1 to 8 wherein a mucous trap is provided proximal to the second opening.

12. The ventilator system of claim 11 wherein the mucous trap comprises a capture plate for e of d particulate matter.

13. The ventilator system of claim 11 wherein the mucous trap comprises: an outer case; an inner case; a seal ring between the outer and inner cases; and a port seal.

14. The ventilator system of claim 13, wherein the mucous trap outer case provides a tube for connecting tubing communicated with the patient.

15. The ventilator system of claim 14, n the tube provides: an outlet for airflow to the patient for inspiration; and acts as an inlet for expired air from the patient during tion.

16. The ventilator system of either claim 14 or claim 15, wherein the inner case provides a capture section or capture plate for capture of expired particulate matter. WO 17763