Patent Description:
Patients having lung related diseases are unable to ventilate their lungs properly and may also suffer mucus clearance issues. This may happen when the normal lung defense system is damaged by lung related diseases.

Many patients with neuromuscular weakness, spinal cord injury, as well as many other disorders associated with inability to control the full inhalation and explosive exhalation require mechanical assistance to cough or to remove their lung secretions.

Generally, patients who have neuromuscular issues such as ineffective glottis closure, impaired diaphragm movement or weak respiratory muscles need mechanical assisted cough devices, i.e. Mechanical Insufflation/Exsufflation (M-IE). One of the well-known treatment modalities to treat these kind of patients is Mechanical insufflation and exsufflation device, which is well documented in prior art. For example, M-IE devices mimic/simulate the cough function, typically, for those patients who have a peak airflow lesser than <NUM> liters per minute, by providing a positive pressure air and suddenly creating a negative pressure inside the lung, which in turn brings the mucus along the upper airways. M-IE devices may also find their application in patients who have upper airway clearance issues after surgery, for example.

In general, the existing secretion clearance devices provide an internal gas source as either internal blowers, turbines or some form of pumps.

Out of the aforesaid devices, dual limb ventilation devices provide a patient circuit which has a dedicated limb for inspiratory gases or the gases going towards the lung and expiratory gases coming out of the lung. Such devices provide an internal positive pressure source while the expiration phase from the lung or external load is passive i.e. flow is generated by recoil of elastic lung and chest wall.

International application <CIT> discloses a mechanical in-exsufflation device, comprising a patient interface unit configured to permit a negative pressure airflow therethrough and a positive pressure airflow from a medical mechanical ventilator; a suction unit for generating airflow under negative pressure that flows through the patient interface unit; a first valve for selectively blocking airflow from a medical mechanical ventilator to the patient interface unit; and a second valve separate from the first valve for selectively blocking airflow from the patient interface unit to the suction unit.

Further, a device known and used in the prior art for performing mechanical inexsufflation is the "CoughAssist®" from the JH Emerson Company of Cambridge, MA. The CoughAssist® device uses a turbine to perform insufflation of the lungs by blowing air into a patient at a defined pressure for a predetermined period of time through a tube connected to the patient's endotracheal tube, tracheostomy tube or facemask. After the predetermined period of time, a valve mechanism within the CoughAssist® device rapidly switches the direction of airflow within the length of tubing, resulting in rapid exsufflation of the patient's lungs. The exsufflation flow continues until the valve mechanism disconnects the tubing from the turbine, terminating the exsufflation flow. There is then a pause period, during which no airflow occurs and airway pressure is equal to zero (atmospheric pressure), until the next insufflation cycle commences. This pause period is necessary to avoid hyperventilation of the patient, and usually lasts about one to three seconds. The cycle is repeated several times to complete the secretion removal treatment. Further, the CoughAssist® device and other such available devices are unable to generate a range of oscillations in combination with the insufflation/exsufflation cycles.

<CIT> discloses a valve which comprises a housing in which a movable valve element having first and second valve members is disposed. A plurality of ports are disposed in the housing, and first and second seal portions are connected to the housing. The first and second seal portions each have a sealed configuration in which first and second pairs of ports are sealed from one another with the first and second valve members respectively. At least one of the first seal portion and the first valve member is deformable such that, when only the first seal portion is in the sealed configuration with the first valve member, deformation allows the second seal portion to be brought into the sealed configuration with the second valve member, and/or at least one the second seal portion and the second valve member is deformable such that, when only the second seal portion is in the sealed configuration with the second valve member, deformation allows the first seal portion to be brought into the sealed configuration with the first valve member.

<CIT> refers to a manual inexsufflator including a standard mechanical ventilator, a medical suction unit, and a piston-like sliding valve mechanism which connects a patient ventilation interface with either the ventilator or the suction unit. By sliding the valve mechanism in and out the user selectively connects the patient to either the ventilator, for purposes of insufflation, or the suction unit, for purposes of exsufflation. The ventilator may generate expiratory positive airway pressure between inexsufflation cycles.

<CIT> discloses to an MIE (mechanical insufflator/exsufflator) apparatus having a blower, a direction valve, an oscillator, and a mask hose connector. The blower is connected to the direction valve, which is connected to the oscillator, which is connected to the hose connector. During insufflation, a direction valve connects exhaust of a blower to an oscillator, causing positive pressure at the hose connector. During exsufflation, the direction valve connects the blower intake to the oscillator, causing negative pressure at the hose connector. The oscillator is a butterfly valve with a <NUM>° rotating disc. During insufflation, the disc is fixed to steadily modulate the airflow. During exsufflation, the oscillator is inactive or in flutter mode. When inactive, the disc is fixed to allow maximum air flow. In flutter mode, the disc continuously rotates so that the air flow rapidly alternates between maximum and minimum.

<CIT> discloses an apparatus for insufflating the airways of a patient with radiopaque powder, said apparatus comprising a container defining a chamber adapted to hold a pile of said powder, in insufflating circuit comprising an inlet line communicating with said chamber and also communicating with the atmosphere, said insufflating circuit also comprising an outlet line communicating with and leading from said chamber said outlet line being adapted to be sucked upon by the patient and constituting a means by which the patient may provide intermittant negative pressure in said chamber whereby, when the patient inhales, a stream of air is drawn into said chamber from said inlet line and flows through said chamber and into said outlet line for delivery into the airways of the patient, a cloud generating circuit comprising a pressure pump having inlet and outlet conduits, said outlet conduit being connected to the discharge side of said pump and being positioned with its discharge end located adjacent and directed toward said pile of powder whereby operation of said pump causes air to impinge against said pile and creates a cloud of powder within said chamber for entrainment in said air stream, and said inlet conduit being connected to the suction side of said pump and communicating with said chamber to keep the chamber substantially at atmospheric pressure and thereby prevent air and powder from being forced into said outlet line as a result of operation of said pump.

<CIT> relates to a treatment device and method of use, and in particular to a treatment device adapted to assist the clearance of bronchial secretions in persons whose cough function is impaired. The invention provides a treatment device having a pump with a negative pressure inlet side and a positive pressure outlet side. The device has a breathing tube for connection to a patient, and a pressure sensor adapted to determine the pressure within the breathing tube. A valve selectively connects the breathing tube to the inlet side or the outlet side of the pump whereby to provide cycles of positive and negative pressure within the breathing tube. A controller is provided to control the valve. An indicator alerts the patient to an operational status of the device so that the patient can breathe in time with the device and in particular can seek to cough at the same time as the pressure within the breathing tube is rapidly reduced.

Hence, there is a need for a respiratory system which overcomes the aforementioned and other related challenges.

Subject-matter referred as embodiments and/or disclosures which are not covered by the appended claims are not part of the invention.

It is an object of the present subject matter to provide a multitude of functions to clear patient's airway clearance.

It is another object of the present subject matter to provide a positive pressure generating source.

It is yet another object of the present subject matter to provide a negative pressure generating source.

It is yet another object of the present subject matter to provide a primary valve to allow or block positive and negative airflow to a patient through an interfacing assembly.

It is yet another object of the present subject matter to provide a two-opening rotary valve in fluid connection with the first pressure generating source and the second pressure generating source.

It is yet another object of the present subject matter to provide a three-opening rotary valve in fluid connection with the first pressure generating source and the second pressure generating source.

It is yet another object of the present subject matter to provide a voice coil based valve in fluid connection with the first pressure generating source and the second pressure generating source.

It is yet another object of the present subject matter to provide mechanical insufflation/exsufflation.

The respiratory system comprises a patient interface unit configured to permit either a negative pressure airflow or a positive pressure airflow to a patient interface, a negative pressure generating source for generating negative pressure airflow that flows through the patient interface unit, a positive pressure generating source for generating positive pressure airflow that flows through the patient interface unit and a first valve fluidly connected to said pressure generating sources for selectively blocking and/or unblocking airflow from either of the said pressure generating sources.

In the present invention, said first valve is a rotary valve. The first valve, at a first position, is configured to block negative pressurized airflow at patient interface and allows the positive pressurized airflow to enter the patient interface. The first valve, at a second position, is configured to block the positive pressurized airflow at patient interface and allows the negative pressurized airflow to enter the patient interface. The first valve at a third position, with a variable displacement from said third position configured to impart oscillations on top of positive pressure airflow. The first valve at a fourth position, with a variable displacement from said fourth position configured to impart oscillations on top of negative pressure airflow.

The pressure generating sources are connected to the patient interface unit by a tubing, wherein the tubing is a Y shaped tubing. The first valve comprises at least two or more openings of equal or varying sizes. The positive pressure generating source overlaps with either of the said openings to allow positive air flow at the patient interface. The negative pressure generating source overlaps with either of the said openings to allow negative air flow at the patient interface. The first valve is placed inside the respiratory system. The respiratory system further comprises a control unit to control operation of the said system. The control system is configured to generate insufflation and exsufflation waveforms by only operating the said first valve. The control system is further configured to generate oscillations on top of insufflation and exsufflation cycles, one at a time, by only operating the said first valve. The pressure generating sources are one or more of blowers, compressors.

In an embodiment, the first valve is a linear motion valve, wherein the first valve comprises a voice coil having a first plunger and a second plunger. The ends of first and second plungers include a first strip and a second strip respectively. The first strip and the second strip are configured to block the pressure generating sources.

The first valve at a fourth position, with a variable displacement from said fourth position configured to impart oscillations on top of negative pressure airflow. The first valve at a first position is configured to block negative pressurized airflow at patient interface and allows the positive pressurized airflow to enter the patient interface. The first valve at a second position is configured to block the positive pressurized airflow at patient interface and allows the negative pressurized airflow to enter the patient interface. The first valve at a third position, with a variable displacement from said third position configured to impart oscillations on top of positive pressure airflow. The first valve at a fourth position, with a variable displacement from said fourth position configured to impart oscillations on top of negative pressure airflow.

A method of operating the respiratory system (not claimed) according to the present application comprises
generating positive pressure airflow/insufflation from a positive pressure generating source to the patient's interface/lung through a first valve, the first valve being in first orientation, wherein first position of the first valve selectively prevents negative pressurized airflow at the patient interface/lung, and allows the positive pressure airflow to enter patient interface/lung. Further, generating a negative pressure airflow/exsufflation by using negative pressure generating source <NUM> along patient interface/lung by using said first valve's second position, wherein second position of the valve selectively prevents positive pressure airflow from entering patient's interface/lung and allows the negative pressure airflow to enter patient interface/lung. Furthermore, the method comprises generating oscillation, either on top of said positive pressure airflow or on top of negative pressure airflow, by back and forth switching of the first valve from third position to fourth position. The step of switching the first valve from first position to second position is based on pre-determined time or pressure or volume parameters. The step of switching the first valve from second position to first position is based on pre-determined time or pressure or volume parameters. The positive pressurized flow ranges from <NUM> to <NUM> cmh20 as per the set parameters. The negative pressurized flow ranges from -<NUM> to - <NUM> cmh20 as per the set parameters. The steps of changing the position of the valve, which are optionally automated, is electromechanical in nature. The steps of generating pressurized airflows at the patient interface comprise a defined sequence: positive pressure airflow, followed by positive pressured airflow of higher value, and ends with negative pressure airflow. The step of generating pressurized airflows at the patient interface comprises of a series of said sequence ranging from <NUM> to <NUM>.

A respiratory system comprises a patient interface unit configured to permit either negative pressure airflow or positive pressure airflow to a patient interface. A negative pressure generating source is provided for generating negative pressure airflow that flows through the patient interface unit. A positive pressure generating source is provided for generating positive pressure airflow that flows through the patient interface unit. A first valve structure fluidly connected to said pressure generating source's airflow paths for selectively blocking and unblocking airflow from either of the said pressure generating sources. A second valve structure fluidly connected to a positive pressure airflow path and/or to a negative pressure airflow path to generate oscillations to said pressurized airflows. The first valve at first position blocks the negative pressure airflow at patient interface and allows the positive pressure airflow to enter the patient interface. The first valve at second position blocks the positive pressure airflow at patient interface and allows the negative pressure airflow to enter the patient interface. The first valve at third orientation with a variable displacement from said third orientation can impart oscillations on top of positive pressure airflow. The first valve at fourth orientation with a variable displacement from said fourth position can impart oscillations on top of negative pressure airflow. The second valve at first position with a variable displacement from said first position can impart oscillations on top of either of pressurized airflow path, depending on the location of the second valve. The second valve structure operationally can change its position from one location to other, either inside the positive pressure path or inside the negative pressure path to generate oscillations on respective pressured airflows.

In an embodiment, the valves are rotary valves. The first position of valve can be a position where the valve can allow complete positive pressurize airflow to pass through it and block the negative pressure airflow from entering the patient interface. The second position of the valve can be a position where the valve can allow negative pressure airflow to pass through it and block the positive pressure airflow from entering the patient interface. The third position of the valve can be any position where the valve can allow complete or partial positive pressure airflow to pass through it and block the negative pressure airflow from entering the patient interface. The fourth position can be any position where the valve can block both positive pressure airflow and negative pressure airflow from patient interface. The fifth position of the valve can be any position where the valve can allow complete or partial negative pressure airflow to pass through it and block the positive pressure airflow from entering the patient interface. The sixth position can be any position where the valve can block both positive pressure airflow and negative pressure airflow from entering the patient interface. The first valve comprises at least two or more openings of equal or varying sizes. The first valve is placed in between the patient interface and second valve. The respiratory system further comprises a
control unit to control the operation of the said system. The control system is configured to generate insufflation and exsufflation waveforms by only operating the said first valve.

In an embodiment, the valve is linear valve. The linear motion valve can be made from voice coil. The control system is configured to generate oscillations on top of insufflation and exsufflation cycles, one at time, by only operating the said first valve. The control system is configured to generate oscillations on top of insufflation and exsufflation cycles, both at the same time, by using said two valves. The pressure generating sources are connected to the patient interface unit by a tube. In an embodiment, the tube is a Y-shaped tube.

A method of operating the respiratory system according to the present application comprises: generating pressurized positive airflow/insufflation from a positive pressure generating source to the patient interface/lungs through a first valve, valve being in first position/orientation, wherein first position of the first valve selectively prevents entering negative pressure airflow from entering patient interface/lung. Further, generating a negative pressurized air flow/exsufflation by using negative pressure generating source at patient interface/lung by using said first valve's second position, wherein second position of the valve selectively prevents positive pressure airflow from entering patient lung. Furthermore, generating the oscillation either on top of said positive pressure airflow or on top of said negative pressure airflow by back and forth switching of the first valve from third position to fourth position and simultaneously generating the additional oscillation either of said pressured airflow by back and forth switching of the second valve from one position to other position. The step of switching the first valve from first position to second position is based on pre-determined time or pressure or volume parameters. The step of switching the first valve from second position to first position is based on pre-determined time or pressure or volume parameters. The step of switching the first valve from third position to fourth position and vice-versa is based on pre-determined frequency and oscillation amplitude requirements. The step of switching the first valve from fifth position to sixth position and vice-versa is based on pre-determined frequency and oscillation amplitude requirements. The step of switching the second valve from first position to any other position and vice-versa occurs based on pre-determined frequency and oscillation amplitude requirements. The positive pressurized flow ranges from <NUM> to <NUM> cmh20 as per the set parameters. The negative pressurized flow ranges from -<NUM> to - <NUM> cmh20 as per the set parameters. The steps of changing the position of the valve, which are optionally automated, is electromechanical in nature. The steps of generating pressurized flows at the patient interface comprise a defined sequence: positive pressurized flow, followed by positive pressurized airflow of higher value, and end with negative pressurized flow. The defined sequence comprises of a series of said sequence ranging from <NUM> to <NUM>. The pressure generating sources are one or more of blowers, compressors. The steps of generating oscillation comprises of generating an oscillation of frequency <NUM> to <NUM> and amplitude of <NUM> cmh20 to <NUM> cmh20. The second valve structure, operationally, can change its position from one location to other, either inside the positive pressure path or inside the negative pressure path to generate oscillations on respective pressured airflows.

A further understanding of the present subject matter can be obtained by reference to various embodiments set forth in the illustrations of the accompanying drawings. The drawings are not intended to limit the scope of the present subject matter, which is set forth with particularity in the claims as appended or as subsequently amended, but merely to clarify and exemplify the subject matter.

For a fuller understanding of the nature and object of the present subject matter, reference is made to the accompanying drawings, wherein:.

The following presents a detailed description of various embodiments of the present subject matter with reference to the accompanying drawings.

As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless expressly stated otherwise. It will be further understood that the terms "includes", "comprises", "including" and/or "comprising" when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. Furthermore, "connected" or "coupled" as used herein may include operatively connected or coupled. As used herein, the term "and/or" includes any and all combinations and arrangements of one or more of the associated listed items.

The embodiments of the present subject matter are described in detail with reference to the accompanying drawings. However, the present subject matter is not limited to these embodiments which are only provided to explain more clearly the present subject matter to the ordinarily skilled in the art of the present disclosure. In the accompanying drawings, like reference numerals are used to indicate like components.

Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains.

The detailed description set forth below in connection with the appended drawings is intended as a description of the several presently contemplated embodiments of a respiratory system. The respiratory system is capable of providing multiple therapies for respiratory system, more specifically, for airway clearance. The apparatus can be configured to deliver various airway clearance therapies through hardware/mechanical, software and patient circuit configurations. This description is not intended to represent the only form in which the disclosed subject matter may be developed or utilized. The description sets forth the functions and features in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions may be accomplished by different embodiments that are also intended to be encompassed within the scope of the present disclosure. It is further understood that the use of relational terms such as first and second and the like are used solely to distinguish one from another entity without necessarily requiring or implying any actual such relationship or order between such entities.

The respiratory system comprises two independent pressure generating sources, a valve to switch between insufflation/positive pressure flow and exsufflation/negative pressure flow, and to generate oscillations on top of either of these cycles. In other words, the valve can be used to generate oscillations along with switching between the insufflation/positive pressure flow and exsufflation/negative pressure flow.

In order to generate secondary oscillations on top on insufflation and exsufflation oscillation cycles, the respiratory system can optionally employ a secondary valve either on a fluidic path of a positive pressure generating source or on a fluidic path of a negative flow generating source. A patient interface unit acts as a fluidic conduit between the pressure generating sources and the patient. A control unit which forms a part of the system is configured to generate required pressurized flow and oscillations as per the user settings. The aforesaid valves can be manipulated into a plurality of orientations/positions, which are aligned and/or adjusted with respect to the respective pressure generating sources as per the therapy requirements.

<FIG> illustrates a schematic diagram of a respiratory system <NUM> one embodiment of the present disclosure. The respiratory system <NUM> comprises a plurality of components including but not limiting to a first pressure generating source <NUM>, a second pressure generating source <NUM> and an interfacing assembly <NUM>. The first pressure generating source <NUM> and the second pressure generating source <NUM> are configured to generate flow and pressure. The aforesaid pressure generating sources can be chosen from blowers, turbines, pumps, and the like. However, it is evident to a person of ordinary skills in the art that the type of patient interface tube and the pressure generating sources used does not limit the scope of present disclosure. The interfacing assembly <NUM> acts as a fluidic conduit between the aforesaid pressure/flow generators and the patient. The respiratory system <NUM> further includes a primary valve <NUM> and a control unit. The primary valve <NUM> is configured to switch between insufflation/positive pressure flow and exsufflation/negative pressure flow, and to generate oscillations in combination with the aforesaid insufflation and exsufflation cycles. A control unit is configured to control the aforesaid pressure generating sources and the primary valve <NUM> to generate a pressurized flow and oscillation as per the requirement of the user/patient. Further, the respiratory system <NUM> includes a secondary valve <NUM> to generate oscillations along with either insufflation or exsufflation. The secondary valve <NUM> can be positioned in a positive air flow path <NUM> between the primary valve <NUM> and the first pressure generating source <NUM> to generate secondary oscillations during the negative pressure exsufflation cycle. It is to be noted that with said configuration, primary valve <NUM> can perform dual role, one is to switch between insufflation and exsufflation cycles and other is to generate primary exsufflation oscillations. Alternately, the secondary valve <NUM> can be positioned in a negative air flow path <NUM> between the primary valve <NUM> and the second pressure generating source <NUM> to generate secondary oscillations during the insufflation cycle. Note that with this configuration, the primary valve can perform dual role, one is to switch between insufflation and exsufflation cycles and other is to generate primary insufflation oscillations.

In an embodiment, the respiratory system <NUM> includes a rotary valve comprising a plurality of opening fluidly connected to the first pressure generating source <NUM> and the negative pressure generating source. <FIG> is a schematic diagram illustrating a respiratory system <NUM> comprising a rotary valve with a plurality of openings. Further, the respiratory system <NUM> includes a Y-shaped tube <NUM> for connecting the pressure generating sources <NUM>, <NUM> to the interfacing assembly <NUM>. However, it is evident to a person skilled in the art that any other appropriate tube known in the art can also be used in place of the Y-shaped tube.

In an embodiment, the primary valve is a two opening rotary valve <NUM>' comprising a thin disc having two openings fluidly connected to the first pressure generating source <NUM> and the second pressure generating source <NUM> to selectively allow flow of air from either pressure generating sources. The two opening rotary valve is operated by a single motor with its shaft attached to the center <NUM> of said valve. <FIG>, <FIG>, <FIG>, <FIG> illustrate a plurality of rotary positions of a two opening rotary valve <NUM>' with respect to the positive and the negative pressure generating sources in accordance with an embodiment of the present subject matter. The two opening rotary valve <NUM>' is positioned between the pressure generating sources <NUM>, <NUM> and the interfacing assembly <NUM> to selectively allow pressurized air from the respective pressure generating sources to the interfacing assembly <NUM>. The two opening rotary valve includes a first opening <NUM> and a second opening <NUM> which can be in fluid connection with the positive and negative pressure generating sources respectively. The first opening <NUM> can be circular in shape and the second opening <NUM> can be either rectangular or elliptical in shape. However, the shape of first and second opening <NUM> is only illustrative and not limiting the present subject matter. Further, the size of the first and second opening <NUM> can be either same or different. The center <NUM> of the two-opening rotary valve is connected to a shaft (not shown) which enables the rotation of said valve. <FIG> illustrates the two opening rotary valve, wherein the interfacing assembly <NUM> is fluidly disconnected from the first and second pressure generating source. The `first pressure generating source' of the present invention is also referred as the 'positive pressure generating source' and the 'second pressure generating source' is also referred as the 'negative pressure generating source' for the purpose of the present detailed description.

<FIG> illustrates a first position of the two opening rotary valve, wherein the interfacing assembly <NUM> is fluidly connected to the positive pressure generating source <NUM> through the second opening <NUM> and disconnected from the negative pressure generating source <NUM>. In other words, only the negative pressure generating source <NUM> is completely blocked and the positive pressure generating source <NUM> completely overlaps with the second opening <NUM>. Such an orientation is configured to generate only positive air flow or insufflation at the interfacing assembly <NUM>.

<FIG> illustrates a second position of the two opening rotary valve, wherein the interfacing assembly <NUM> is fluidly connected to the negative pressure generating source <NUM> through the second opening <NUM> and disconnected from the positive pressure generating source <NUM>. In other words, only the positive pressure generating source <NUM> is completely blocked and the negative pressure generating source <NUM> completely overlaps with the second opening <NUM>. Such an orientation is configured to generate only negative air flow or exsufflation at the interfacing assembly <NUM>.

<FIG> illustrates a third position of the two opening rotary valve. This orientation allows partial positive pressurized flow from the positive pressure generating source <NUM> to the interfacing assembly <NUM>. The negative pressure generating source <NUM> is fluidly disconnected from the interfacing assembly <NUM>. The fourth position allows a variable displacement from said fourth position and is configured to impart oscillations on top of positive pressure airflow. However, it is evident to a person skilled in the art that the position shown in <FIG> is for illustration purpose only and in broader terms, such position refers to slight overlap of second opening <NUM> with the positive pressure generating source <NUM>. Said overlap range can be any value between <NUM> % and <NUM>%, the first opening <NUM> is fluidly disconnected from both the pressure generating sources. The two opening rotary valve in said orientation allows the positive pressure generating source <NUM> to undergo a variable displacement to impart oscillations through the positive pressure air flow.

<FIG> illustrates a fourth position of the two opening rotary valve. This orientation allows partial negative pressurized flow from negative pressure generating source <NUM> to the interfacing assembly <NUM>. The positive pressure generating source <NUM> is fluidly disconnected from the interfacing assembly <NUM>. However, it is evident to a person skilled in the art that the position shown in <FIG> is for illustration purpose only and in broader terms, such position refers to slight overlap of second opening <NUM> with the negative pressure generating source <NUM>. Said overlap can be any value between <NUM> % and <NUM>%, the first opening <NUM> is fluidly disconnected from both the pressure generating sources. The two opening rotary valve in said orientation allows the negative pressure generating source <NUM> to undergo a variable displacement to impart oscillations through the negative pressure air flow.

<FIG> illustrates a fifth position of the two opening rotary valve. In this position, the second opening <NUM> completely overlaps with the positive pressure generating source <NUM> and allows complete positive pressurized flow to the interfacing assembly <NUM>. The negative pressure generating source <NUM> partially overlaps with the first opening <NUM> and allows partial negative pressurized flow from negative pressure generating source <NUM> to the interfacing assembly <NUM>. However, it is evident to a person skilled in the art that the position shown in <FIG> is for illustration purpose only and in broader terms, the sixth position refers only to the second opening <NUM> completely fluidly connected to the positive pressure generating source <NUM> allowing positive pressurized flow to the interfacing assembly <NUM>, and the first opening <NUM> fluidly partially overlaps with the negative pressure generating source <NUM>. The two opening rotary valve in said orientation allows the negative pressure generating source <NUM> to undergo a variable displacement to impart oscillations through the negative pressure air flow. Further, said two opening rotary valve in said position also allows complete positive pressurized air flow or insufflation at the interfacing assembly <NUM>.

<FIG> illustrates a sixth position of the two opening rotary valve. In this position, the second opening <NUM> completely overlaps the negative pressure generating source <NUM> and allows complete positive pressurized flow to the interfacing assembly <NUM>. The positive pressure generating assembly partially overlaps with the first opening and allows partial positive pressurized flow from positive pressure generating source <NUM> to the interfacing assembly <NUM>. However, it is evident to a person skilled in the art that the position shown in <FIG> is for illustration purpose only and in broader terms, the seventh position refers only to the second opening completely fluidly connected to the negative pressure generating source <NUM> allowing negative pressurized flow to the interfacing assembly <NUM>, and the first opening <NUM> fluidly partially overlaps with the positive pressure generating source <NUM>. The two opening rotary valve in said orientation allows the positive pressure generating source <NUM> to undergo a variable displacement to impart oscillations through the positive pressure air flow. Further, said two opening rotary valve in said position also allows complete negative pressurized air flow or exsufflation at the interfacing assembly <NUM>.

The respiratory system <NUM> described is capable of providing a multitude of therapies for respiratory patients. In operation, the control unit is configured to switch the two opening rotary valve between the first position (<FIG>) and the second position (<FIG>) which results in mechanical insufflation therapy. Further, alternate switching between completely blocked position (<FIG>) and third position (<FIG>) results in a oscillation of positively pressurized flow and alternating switching between completely blocked position (<FIG>) and fourth position (<FIG>) results in a oscillation of negatively pressurized flow. Amplitude of these oscillations is determined by how far the second opening and first opening <NUM> fluidly occlude the respective pressure generating sources. Furthermore, alternate switching between the first position (<FIG>) and the fifth position (<FIG>) results in oscillation through negatively pressured flow and alternate switching between second position (<FIG>) and sixth position (<FIG>) results in oscillation through positively pressured flow. The invention doesn't limit other possible combination of valves and orientations to generate secondary oscillations on top of primary oscillations described. It is to be noted that with the help of the additional secondary valve <NUM>, secondary oscillations can be achieved on either on insufflation cycles or exsufflation cycles.

In an embodiment, the primary valve is a three-opening rotary valve <NUM>" comprising a thin disc having three openings fluidly connected to the first pressure generating source <NUM> and the second pressure generating source <NUM> to selectively allow flow of air from either pressure generating sources. The disc is enclosed in a housing (not shown) with inlet and outlet ports corresponding to the negative and positive pressure generating sources. The three opening rotary valve is operated by a single stepper motor with its shaft attached to the center <NUM> of said valve. <FIG>, <FIG>, <FIG> and <FIG> illustrate a plurality of rotary positions of a three opening rotary valve with respect to the positive and negative pressure generating sources in accordance with an embodiment of the present subject matter. The three opening rotary valve is positioned between the pressure generating sources and the interfacing assembly <NUM> to selectively allow pressurized air from the respective pressure generating sources to the interfacing assembly <NUM>. The three opening rotary valve includes a first opening <NUM>, a second opening <NUM> and a third opening <NUM> which can be in fluid connection with the positive and negative pressure generating sources. The first opening <NUM> and the second opening <NUM> can be circular in shape whereas the third opening <NUM> can be either rectangular or elliptical with straight sides. However, shape of the first, second and third opening <NUM> is only illustrative and not limiting the present subject matter. Further, the size of the first, second and third opening <NUM> can be either same or different. The center of the three opening rotary valve is connected with a shaft which enables the rotation of said valve. The first opening <NUM> is dedicated for negative pressure source. Upon rotation of the three opening rotary valve, the first opening <NUM> rotates simultaneously with the second opening <NUM> on opposing side to close the negative pressure generating source <NUM> while the positive pressure generating source <NUM> is made open due to the rotary motion of the disc. The second opening <NUM> when operated in conjunction with the first opening <NUM> in opposing side, opens and closes the positive pressure source in opposing phase to the first opening <NUM>. Further, the third opening can oscillate the negative pressure generating source <NUM> from closed position while the second opening <NUM> keeps the positive pressure generating source <NUM> open due to its elongated shape. <FIG> illustrates a first position of the three opening rotary valve, wherein only positive pressure generating source <NUM> is open and overlaps completely with the second opening <NUM>. The three opening rotary valve in said orientation allows insufflation through the respiratory system <NUM>.

<FIG> illustrates a second position of the three opening rotary valve. In this position, only negative pressure generating source <NUM> is open and overlaps completely with the first opening <NUM>. The three opening rotary valve in said orientation allows exsufflation through the respiratory system <NUM>. This position can also be oscillated for both positive and negative source at high frequency. Further, <FIG> illustrates a third position of the three opening rotary valve wherein the third opening <NUM> completely overlaps with the positive pressure generating source <NUM> and the second opening <NUM> partially overlaps with the negative pressure generating source <NUM>. Thus, the negative pressure generating source <NUM> oscillates and the positive pressure generating source <NUM> is completely open for insufflation. The invention doesn't limit other possible combination of valves and orientations to generate secondary oscillations on top of primary oscillations described. It is to be noted that with the help of additional secondary valve <NUM>, secondary oscillations can be achieved on either on insufflation cycles or exsufflation cycles.

In an embodiment, the primary valve used to manipulate pressurized airflow is a voice coil based valve/voice coil valve. <FIG>, <FIG>, <FIG> illustrate a plurality of positions of voice coil plungers of a voice coil valve <NUM>"' with respect to the positive and negative pressure generating sources in accordance with an embodiment of the present subject matter. The voice coil valve <NUM>"' can be used for mechanical insufflation and exsufflation process in combination with the pressure generating sources. The voice coil valve includes a voice coil <NUM> with a first plunger <NUM> corresponding to the positive pressure generating source <NUM> and a second plunger <NUM> corresponding to the negative pressure generating source <NUM>. The first and second plungers <NUM>, <NUM> extend on both sides of the voice coil <NUM> and are supported by leaf springs. Each of the ends of the first and second plungers <NUM>, <NUM> includes a first strip <NUM> and a second strip <NUM> respectively. The first strip <NUM> is capable of covering the opening of positive pressure generating source <NUM> and the second strip <NUM> is capable of covering the opening of negative pressure generating source <NUM>. The voice coil valve <NUM>"' further includes a first air tight housing <NUM> for axial movement of the first plunger <NUM> and a second air tight housing <NUM> for axial movement of the second plunger <NUM>. Further, the first and second housing include two inlet ports and two outlet ports corresponding to the positive pressure generating source <NUM> and the negative pressure generating source <NUM> respectively. <FIG> illustrates a first position of the voice coil valve with respect to the positive pressure generating source <NUM> and the negative pressure generating source <NUM>. In this position, the first strip <NUM> does not cover the positive pressure generating source <NUM> and allows positive pressure air flow to the interfacing assembly <NUM>. The second strip <NUM> completely covers the negative pressure generating source <NUM> and thus, the negative pressure airflow is fluidly disconnected from the interfacing assembly <NUM>. It is to be noted that the voice coil construction is for illustration purpose only. Other variations are possible to extend or lessen the dimension of the plungers and other structures described here to get the similar waveforms at the patient interface.

<FIG> illustrates a second position of the voice coil valve with respect to the positive pressure generating source <NUM> and the negative pressure generating source <NUM>. In this position, the first strip <NUM> completely covers the positive pressure generating source <NUM> and the positive pressure air flow is disconnected from the interfacing assembly <NUM>. The second strip <NUM> does not cover the negative pressure generating source <NUM> and thus allows negative pressure airflow to the interfacing assembly <NUM>.

Further, <FIG> illustrates a third position of the voice coil valve with respect to the positive pressure generating source <NUM> and the negative pressure generating source <NUM>. In this position, the first strip <NUM> partially covers the positive pressure generating source <NUM> and allows positive pressure airflow to the interfacing assembly <NUM>. The second strip <NUM> completely covers the negative pressure generating source <NUM> and negative airflow is fluidly disconnected from the interfacing assembly <NUM>. Alternate back and forth operation between the first position (<FIG>) and the third position (<FIG>) results in oscillation of positive pressure generating source/positive pressure airflow.

<FIG> illustrates a fourth position of the voice coil valve with respect to the positive pressure generating source <NUM> and the negative pressure generating source <NUM>. In this position, the first strip <NUM> completely covers the first pressure generating source <NUM> and the positive pressure airflow is fluidly disconnected from the interfacing assembly <NUM>. The second strip <NUM> partially covers the negative pressure generating source <NUM> and fluidly, partially, allows negative pressure airflow to the interfacing assembly <NUM>. Alternate back and forth operation between the second position (<FIG>) and fourth position (<FIG>) results in oscillation of negative pressure generating source/negative pressure flow.

<FIG> illustrates a fifth position of the voice coil valve with respect to the positive pressure generating source <NUM> and the negative pressure generating source <NUM>. In this position, the first strip <NUM> does not cover the first pressure generating source <NUM> and the positive pressure airflow is fluidly completely connected to the interfacing assembly <NUM>. The second strip <NUM> partially covers the negative pressure generating source <NUM> and fluidly, partially, allows negative pressure airflow to the interfacing assembly <NUM>. Alternate back and forth operation between the first position (<FIG>) and fifth position (<FIG>) results in oscillation of negative pressure flow while the respiratory system <NUM> is in insufflation phase.

<FIG> illustrates a sixth position of the voice coil valve with respect to the positive pressure generating source <NUM> and the negative pressure generating source <NUM>. In this position, the first strip <NUM> partially covers the first pressure generating source <NUM> and the positive pressure airflow is fluidly, partially, allows positive pressure airflow to the interfacing assembly <NUM>. The second strip <NUM> does not cover the negative pressure generating source <NUM> and negative pressure airflow is fluidly completely connected to the interfacing assembly <NUM>. Alternate back and forth operation between the second position (<FIG>) and sixth position (<FIG>) results in oscillation of positive pressure flow while device is in exsufflation phase.

In an embodiment, the respiratory system <NUM> further comprises a manifold/air router structure. The manifold/air router structure can be hollow cuboidal type, circular type, Y-shaped, cylindrical type or any other suitable manifold/air router structure type known in the art. However, it is evident to a person of ordinary skills in the art that the type of manifold/air router structure used does not limit the scope of the present disclosure. The primary valve <NUM> structure is in fluid connection with the interfacing assembly <NUM> through the manifold/air router structure. As with the rotary valve structure, the invention doesn't limit other possible combination of valves and orientations to generate secondary oscillations on top of primary oscillations described. It is to be noted that with the help of additional secondary valve <NUM>, secondary oscillations can be achieved on either on insufflation cycles or exsufflation cycles.

As described hereinabove, the respiratory system <NUM> of the present subject matter provides a unique opportunity to address the present challenges. The respiratory system <NUM> can deliver multitude of functions to assist patient with neuromuscular issues to manage their secretion.

Claim 1:
A respiratory system (<NUM>) comprising: a patient interface unit configured to permit either a negative pressure airflow or a positive pressure airflow to a patient; a negative pressure generating source (<NUM>) for generating negative pressure airflow that flows through the patient interface unit; a positive pressure generating source (<NUM>) for generating positive pressure airflow that flows through the patient interface unit; and a first valve fluidly (<NUM>) connected to said pressure generating sources for selectively blocking and/or unblocking airflow from either of the said pressure generating sources, wherein said first valve at a first position, is configured to block the negative pressure airflow at a patient interface and allows the positive pressure airflow to enter the patient interface, said first valve at a second position, configured to block the positive pressure airflow at the patient interface and allows the negative pressure airflow to enter the patient interface, said first valve at a third position, with a variable displacement from said third position configured to impart oscillations on top of the positive pressure airflow, said first valve at a fourth position, with a variable displacement from said fourth position configured to impart oscillations on top of the negative pressure airflow wherein said pressure generating sources are connected to the patient interface unit by a Y-shaped tube, and wherein the first valve is a rotary valve comprising a thin disc having at least two or more openings of equal or varying sizes.