WO2016057847A1

WO2016057847A1 - Percussive ventilator breathing head and system and method

Info

Publication number: WO2016057847A1
Application number: PCT/US2015/054777
Authority: WO
Inventors: Loel Fenwick; Shawn GOUGHNOUR; Forrest BIRD
Original assignee: Percussionaire Corporation
Priority date: 2014-10-08
Filing date: 2015-10-08
Publication date: 2016-04-14

Abstract

A ventilator breathing head 50 and system and method having a reusable receiver body 20 that releasably engages with a single use patient breathing head 50 carrying a mass accelerator 70 to generate masses of air having kinetic energy and passing the moving masses of air to a patient's respiratory tract for oxygen/carbon dioxide exchange and ventillatory assistance. Operational conditions and measurements and data are collected by sensors 76 within the breathing head 50, the measurements and data are communicated to the receiver body 20 for visualization and interpretation by caregivers to optimize treatment.

Description

DESCRIPTION

PERCUSSIVE VENTILATOR BREATHING HEAD AND SYSTEM AND

METHOD

This Patent Cooperation Treaty patent application claims the benefit of the earlier filed US Provisional Patent Application number 62/061,592 filed by the same inventors on October 8_» 2014, and titled Improved Percussive Ventilator Breathing Head Apparatus and System. The entire contents of earlier filed US

62/061,592 is expressly incorporated herein by this reference.

TECHNICAL FIELD The present invention relates to medical care, ventilation and breathing, and more particularly, to a breathing head apparatus and system and method for percussively moving gaseous fluids into a patient's airway and lungs for gas exchange at the cellular level; for administering medicinals, ventilation and assisted breathing care to a patient; for determining operational conditions of the ventilation: and for providing real time patient feedback data for monitoring and optimizing patient care.

BACKGROUND ART AN living organisms breathe. Although the organs and structures that facilitate breathing may vary from organism to organism, the process itself is the same - transporting oxygen from the environment to ceils within tissues and the transport of carbon dioxide from the cells within tissues to the environment.

For purposes of this disclosure, the breathing process and the exchange of oxygen for carbon dioxide in the lungs Is described in terms of a human and related medical care therefore. However it is to be expressly understood this disclosure is not limited to humans and /or medical care for humans, It is expressly contemplated the inventions, processes, devices and /or techniques disclosed and /or described herein may also be used for, and useful in, the care of other organisms such as, but not limited to, pets and wildlife and also cellular tissue.

The circulatory system and the pulmonary system work cooperatively to facilitate an efficient oxygen carbon dioxide exchange. The circulatory system is dominated by the heart which is a pump having four chambers that beat in an organized sequence. Anatomically, the heart is divided into left and right sides, and upper and lower chambers. The two upper chambers are the atria and the two lower chambers are the ventricles.

The left ventricle, which is the largest chamber of the heart, pumps oxygen-rich blood to the body through the arterial system where oxygen carried by the blood is exchanged for carbon dioxide at the cellular level. This gas exchange is known as "cellular respiration" where oxygen and sugars are converted into ATP (energy) and carbon dioxide which is a waste product, The newly oxygen depleted, and carbon dioxide rich, blood returns to the heart via the venous system and enters the right atrium. As the right atrium contracts, the blood therein passes into the right ventricle. When the right ventricle contracts, the blood therein passes to the lungs via the pulmonary artery. Within the lungs, the carbon dioxide carried by the blood is exchanged for oxygen . After the oxygen /carbon dioxide exchange occurs, the oxygen-rich blood moves from the lungs back to the heart via the pulmonary vein and enters the left atrium of the heart. From the left atrium, the oxygen-rich blood passes to the left ventricle. The cycle is continuous with each heartbeat and each breath.

The pulmonary system is dominated by the lungs. When an organism breathes, air is inhaled through the nose and /or mouth. The inhaled air travels down the throat and into the trachea which divides at a lower end portion into the bronchia! tubes which allow inhaled air to pass into the lungs. Within the lungs, the bronchial tubes divide further into smaller air passages called bronchioles which divide even further and ultimately terminate at millions of tiny balloon-like air sacs called alveoli. The oxygen /carbon dioxide gas exchange occurs on the surface of the alveoli. The alveoli are the beginning point, and the termination point, of the respiratory tract. The exchange of oxygen and carbon dioxide between the alveoli and the blood occurs on the surface of the alveoli by diffusion with oxygen diffusing from the alveoli into the blood and carbon dioxide diffusing from the blood into the alveoli, Diffusion requires a concentration gradient so the concentration of oxygen in the alveoli must be kept at a higher level than the concentration of oxygen within the blood and the concentration of carbon dioxide within the alveoli must be kept at a lower level than the concentration of carbon dioxide in the blood . This is accomplished, by breathing which continuously brings air having lots of oxygen and little carbon dioxide into the lungs and the alveoli.

Breathing is an active process requiring contraction of the external intercostal muscles (located between the ribs) and the diaphragm (a sheet of muscle located between the thoracic and abdominal cavities). Contraction of external intercostal muscles causes elevation of ribs and sternum and increases the front-to- back dimension of thoracic cavity which increases the volume of the cavity and responsively lowers air pressure in lungs which causes air to move into the lungs. Simultaneously, contraction of diaphragm causes the diaphragm to move downward which increases vertical dimension of thoracic cavity and further increases the volume of the cavity which further lowers air pressure in lungs causing air to move into lungs, (See Figure 1 A). As the externa! intercostal muscles and the diaphragm contract, the lungs expand. The expansion of the lungs causes the pressure in the lungs (and alveoli) to become slightly negative relative to the environment, As a result, air moves from an area of higher pressure (the environment) to an area of lower pressure (inside the lungs and alveoli), (i.e., "breathing in").

During expiration (breathing out), the intercostal muscles and the diaphragm relax and lung volume decreases. This causes pressure in the lungs (and alveoli) to become slightly positive relative to the environment. As a result, air exits the lungs. (Figure 1 B).

The walls of alveoli are coated with a thin film of fluid that creates a molecular force called surface tension which increases as molecules come closer together, which is what happens during exhalation and the alveoli contract and become smaller. Potentially, this surface tension could cause alveoli to collapse and make inhalation (breathing in) more difficult if not impossible. The alveoli counteract surface tension by secreting pul monary surfactant. Pulmonary surfactant is a lipoprotein mixture that reduces surface tension in the thin fluid coating on the alveoli in order to facilitate the transfer of oxygen and carbon dioxide between blood and the alveoli. Insufficient pulmonary surfactant in the alveoli can contribute to atelectasis (collapse of part, or all of the lung) although, there are other causes of atelectasis, such as trauma. The pulmonary surfactant also makes the lungs an efficient location to administer medicinals to a patent because gaseous medicinals can similarly diffuse into the blood with the oxygen. The ability to ad minister medicinals through a breathing head is an aspect of the Instant invention.

Air is a mixture of gasses: primarily nitrogen, oxygen and carbon dioxide and together these gasses (along with other gasses) exert air pressure on all surfaces. That part of the pressure generated by oxygen is the "partial pressure of oxygen", while that pressure generated by carbon dioxide is the "partial pressure of carbon dioxide". A gas's partial pressure, is a measure of how much of that gas is present, (e.g., in the blood or alveoli).

The total atmospheric pressure (at sea level) is approximately 760 mm Hg and, further, sea level air comprises approximately 21 % oxygen. The partial pressure of oxygen in sea level ai r is therefore 0.21 times 760 mm Hg or 1 60 mm Hg. Within the alveoli, the partial pressure of oxygen is approximately 1 00 mm Hg, and the partial pressure of carbon dioxide is approximately 40 mm Hg. Within the alveolar capillaries (containing blood that has just returned from the tissues via the venous system) the partial pressure of oxygen is approximately 40 mm Hg, and the partial pressure of carbon dioxide is approximately 45 mm Hg, This difference in partial pressures leads to diffusion and the gas exchange. (See Figure 2.) Within the alveolar capi llaries, the diffusion of gasses occurs: oxygen diffuses from the alveoli into the blood, and carbon dioxide diffuse from the blood into the alveoli leaving the partial pressure of oxygen in the alveolar capillaries at approximately 1 00 mm Hg and the partial pressure of carbon dioxide in the alveolar capillaries at approximately 40 mm Hg.

When breathing stops, due to illness, disease or injury the oxygen carbon dioxide exchange also stops. When breathing stops life cannot continue. When natural breathing stops, ventilators can be used to administer artificial breathing to allow the oxygen carbon dioxide exchange to continue and thus life to continue.

A patient suffering chest injury or trauma including neurological injuries may not be able to expand his/her chest (contract the diaphragm and intercostal muscles), and such muscular contraction and associated skeletal movement might even exacerbate trauma and injuries and bleeding. Regardless of such injuries however, it is necessary to maintain the oxygen pressure gradient within the patient's lungs to continue the oxygen /carbon dioxide exchange to sustain life.

Most ventilators use fluid /gas pressure to inflate a patient's lungs to allow for the oxygen /carbon dioxide exchange, but such pressure ventilation techniques are known to exacerbate and even cause injuries. Percussive ventilation is a technique ch uses high frequency oscillatory ventilation to continue oxygen delivery to the alveoli.

Heretofore, ventilators have been provided that inflate and deflate a patient's lungs using fluid pressure for patients who cannot do so on their own due to disease, emergency, or injury. Unfortunately, it is well known that current ventilators do not provide immediate response data and feedback data to a caregiver for determi ning whether a patient is up-taking oxygen, nor for determining whether the exchange of oxygen and carbon dioxide is actually occurring. With known devices, a caregiver can only determine whether the ventilator is operating. There is no way the caregiver can determine whether the ventilator is actually meeting the patient's specific needs or whether the ventilator should be adjusted. This inability to determi ne if the oxygen carbon dioxide exchange is actual ly taking place can be harmful and even fatal. Further, known ventilation apparatus are generally single function devices that do nothing more than move air in and move air out. Known devices do not provide active real time feedback data to a caregiver to allow adjustments and modifications to patient treatment. Further, known devices and apparatus do not integrate advancements in treatment and monitoring information and data that may be useful in providing care and continui ng care. Further still, when the patient is in need of assisted ventilation, the patient's lungs are filled with a static volume of air which acts as "dead space", neither moving inwardiy nor outwardly. Any assistive ventilation must necessarily overcome this static nature of the air within the patient's lungs by replacing some volume of the static "bad air" with a volume "good /fresh air". One recognized drawback to known ventilation apparatus and techniques is that such apparatus and techniques only tend to facilitate an air exchange at those areas within the patient's lungs that are proximate the trachea. Known apparatus and systems and methods do not effectively exchange air in the more peripheral /deeper portions of the patient's lungs where the majority of the alveoli exist and greater gas exchange capability exists. Because these areas of the lungs remain filled with "bad air", these areas tend to become compromised which can cause further deterioration of the patient's condition. Providing an apparatus that can move fresh air into the distal and peripheral portions of a patient's lungs is an object of the present invention.

Real time patient feedback information is important in situations where a patient is being treated by someone other than a physician, for example when medical care is being provided in an isolated or remote area, and care is being administered with telemedicine. In telemedicine, an on-site caregiver is generally able to communicate with a physician or trained medical personnel through a communication media such as a satellite telephone or radio. Typically the physician or medical personnel cannot see or visual ize the patient directly and must therefore re!y on verbal information and descriptions provided by the caregiver who is on-site and who may only know basic first aid. The ability to determine the amount and concentrations of oxygen and carbon dioxide the patient is breathing and up-taking will allow the caregiver to communicate that information to a physician or trained professional to properly monitor and adjust the care as needed. Further, the ability for a non-medially trained caregiver to administer medicinals to a patient through a ventilator is a continuing need .

For example only during military operations, soldiers often experience chest injuries and lose consciousness. The majority of battlefield deaths occur within the first ten minutes of the trauma, A self-contained ventilator head that provides real time treatment feedback data may be used to maintain breathing during this time, and feedback data will allow the caregiver to alter the treatment as needed /directed before more comprehensive emergency care is available including during patient transport. Similarly, scuba divers occasionally suffer injuries that negatively impact their respiratory system and assisted ventilation is required, such as barotrauma, decompression sickness, nitrogen narcosis, or a collapsed lung. Injured divers require immediate care, often miles out at sea, and immediate patient feedback data will allow remote medical personnel to determine necessary adjustments, necessary medicinals and provide instructions to on site caregivers to make necessary adjustments to potentially save the patient's life.

The medical field is beginning to recognize instances of life-threatening barotrauma within the patient population who have received emergency mechanical pulmonary assistance. Much of the blame for such barotrauma has been focused upon pressure driven gas exchanges which occur in the pulmonary structures (lungs) of the patient. Clinical remedies for such barotrauma thus far have been to decrease the volume of delivered atr with an associated decrease in the inspiratory flow rate. In connection with such barotrauma it is believed that intra- airway abrasion is being caused by the continuous expansion and contraction of the alveoli during mechanical pressurized ventilation. This abrasive expansion and contraction can occur as frequently as 1 8,000 times per day. Such mechanically induced lung damage requires increasing oxygen concentrations in conjunction with continuous mechanical ventilation which has been shown to actually increase respiratory distress syndromes in patients receiving emergency mechanical pulmonary care. In addition, it has been found that a reduction of the volume of delivered ai r to overcome barotrauma has increased the incidence of atelectasis (alveoli collapse) and hypo-ventilation almost directly in proportion to the decrease in delivery volume.

Ventilators are available which provide volumetric diffusive respiration which resolve various of the ventilatory compromises hereinbefore described causing barotrauma. However, there are many volume/pressure ventilators presently in service which do not have such capabi lities and which represent major capital investments by hospitals and other medical facilities,

There is therefore a continuing need for a breathing head apparatus and system and method which makes it possible to utilize existing ventilators now in the field to overcome or substantially eliminate the incidence of life-threatening barotrauma in patients receiving mechanical pulmonary assistance; to move masses of oxygen rich air into the peripheral reaches of a patient's lungs using small fast moving masses of air having kinetic energy to overcome the static pressure and penetrate the dead space to reach deeper into the lungs, to provide real-time patient care feedback data and to provide a platform for administering medicinals to patients.

It is an object of the present invention to provide an interface apparatus for use with ventilators and an intrapuimonary percussive ventilator to overcome and substantially decrease the incidence of barotrauma in patients receiving mechanical pulmonary assistance and a method for managing such pul monary assistance of patients.

St is a further object of the present invention to provide a ventilator head apparatus and system and method that provides immediate patient treatment feedback and allows and facilitates medical treatment beyond ventilation only.

It is a still further object of the present invention to provide an apparatus and method for generating masses of moving air that may be shaped as desired, and directing these shaped moving masses of air deeply into a patient's respiratory tract causing inward movement of fresh oxygen rich air and outward movement of bad carbon dioxide laden air,

it is a stiil further object of the present invention to provide an apparatus and system and method for generating toroidal shaped (donut-shaped) masses of air having kinetic energy, and directing the kinetically energized moving toroidal masses of air into a patient's airway.

An even still further object of the present invention is to provide an apparatus and system and method that provides targeted generation of masses of moving air having predetermined frequencies and amplitudes to target specific conditions within a patient's lungs such as, but not limited to, breaking up mucus and excess build-ups of pulmonary surfactant. Some or all of the problems, difficulties and drawbacks identified above and other problems, difficulties, and drawbacks may be helped or solved by the inventions shown and described herein. Our invention may also be used to address other problems, difficulties, and drawbacks not set out above or which are only understood or appreciated at a later time. The future may also bring to light currently unknown or unrecognized benefits which may be appreciated, or more fully appreciated, in the future associated with the novel inventions shown and described herein.

SUMMARY

A percussive ventilator breathing head and system and method having a reusable receiver body that releasably engages with a single use patient breathing head carrying a mass accelerator to generate shaped masses of air having kinetic energy and passing the moving masses of air to a patient's respiratory tract for oxygen /carbon dioxide exchange and venti!!atory assistance. Operational conditions and measurements and data are collected by sensors within the respirator head , the measurements and data are communicated to the receiver body for visualization and interpretation by caregivers to optimize treatment.

One aspect of the instant ventilator breathing head and system and method is a percussive ventilator breathing head and system for administering percussive ventilation to a patient having an airway using a ventilator providing a gaseous fluid under continuous flow and cyclic flow, the percussive ventilator breathing head and system comprising, a unitary breathing head having an elongate main body with a first end, an opposing second end and a flow passage extending from the first end to the second end; a pressurized air inflow port defined in the main body and in communication with the flow passage and adapted to be placed in communication with the airway of the patient; an air entrainment port defined by the main body and disposed in fluid flowing communication with the flow passage and communicating in fluid delivery relative to an airway of a patient; a breath outflow port carried by the main body communicating with the flow passage and adapted to be placed in communication with the airway of the patient; a valve seat formed in the main body and circumscribing the flow passage; an ejector body slidably mounted in the flow passage of the main body and having a first end and a second end, the ejector body having its second end movable into and out of engagement with the valve seat, the ejector body further having a passageway extending therethrough from the first end to the second end; a diaphragm carried by the main body and coupled to the ejector body, the diaphragm having a retracting memory for retaining the ejector body in a retracted position with respect to the valve seat; a sensor carried by the main body in communication with the flow passage to detect operational conditions within the flow passage and for communicating the detected operational conditions to a user; a radially reduced annular lip within the flow passage adjacent the second end thereof to generate toroidal shaped masses of air exiting the flow passage for passage to the airway of the patient; the main body further having an external configuration that facilitates releasable operative engagement with a reusable receiver; the reusable receiver having a first end and an opposing second end and a seat to operatively engage with the main body of the breathing head and to receive the detected operational conditions information from the main body sensor for communication to the user, the reusable receiver further having a multi-lumen cable connector port at the first end to operatively engage with a multi-lumen cable for operatively interconnecting the reusable receiver and the main body with a ventilator; and an elongate multi lumen cable having a first end portion and an opposing second end portion, each end portion carrying a connector to operatively interconnect the multilumen cable to the reusable receiver and to the ventilator and to supply a flow of gas and medicinals from the ventilator to the reusable receiver and carried main body and to receive information from the sensor within main body for communication to a user.

A second aspect of the instant ventilator breathing head and system and method is a method for deSivering a percussive gaseous fluid to an airway of a patient, comprising providing a breathing head having a main body which has opposite first and second ends, and an internal flow passage which extends between the first and second ends, and wherein the second end of the main body is disposed in fluid delivering relation relative to a patient's airway; providing a reciprocally moveable ejector body which is matingly received within the internal flow passage of the breathing head, and biasingly urging the ejector body in a direction towards the first end of the breathing head, and wherein the ejector body has a first and second end, and further defines a fluid-flowing passageway having a variable cross- sectional dimension when the variable cross-sectional dimension is measured between the first and the second end of the ejector body, and wherein the first end of the ejector body is located near the first end of the breathing head; supplying a pressurized source of a percussive fluid to the first end of the breathing head, and directing the pressurized source of percussive fluid into the fluid-flowing passage of the reciprocally moveable ejector body, and wherein the supplied, pressurized source of the percussive fluid is effective in movably displacing the reci procal ly moveable ejector body into a spaced orientation relative to the first end of the breathing head, and wherei n the displaced ejector body further di rects the supplied , pressurized sou rce of the percussive fluid along the fluid- fSowing passage thereof, and to the second end of the breathing head so as to form a medically effective toroidal gaseous fluid mass; and del ivering the medically effective shaped gaseous mass which is exiting the second end of the breathing head to the airway of the patient,

A third aspect of the instant ventilator breathing head system and method is a method for deliveri ng a movi ng mass of air to an ai rway of a patient, comprising providi ng a breathing head having opposite first and second ends, and forming an i nternal flow passage which extends between the fi rst and second ends thereof; providi ng a mass of air to the internal flow passage; provid ing a mass accelerator, and orienting the mass accelerator so as to com municate with the internal flow passage of the breathing head , and wherein the mass accelerator imparts velocity to the mass of ai r withi n the flow passage; supplying a powering means to the mass accelerator so as to facilitate the mass accelerator's imparting velocity to the mass of ai r; and the mass of ai r havi ng velocity imparted by the mass accelerator is directed into the patient's ai rway to facilitate a medically effective oxygen /carbon dioxide exchange within the patient's lungs. A still further aspect to provide such an improved apparatus and system and method having a float transducer type sensor within the breathing head to measure inflow and outflow of gaseous fluids to calculate volume i nformation,

Other and further aspects of our invention will appear from the following specification and accompanyi ng drawings which form a part hereof. In carrying out the aspects and objects of our invention it is to be understood that its structures and features and steps are susceptible to change in design and arrangement and order with only one embodi ment bei ng ill ustrated in the accompanying drawi ngs and specified as i s required, KIIF ;i l£SCRlFTK> OF THE DRAWI GS

Preferred embodiments of the invention are described below with reference to the following accompanying drawings.

Figure 1 A is an artistic sketch of a human thoracic cavity with arrows showing the di rection of movement and volumetric changes during i nhalation .

Figu re I B i s an artistic sketch of a h uman thoracic cavity with arrows showi ng the di rection of movement and volumetric changes duri ng exhalation .

Figu re 2 is an artistic sketch of diffusion of oxygen and carbon dioxide between blood in a pulmonary capil lary and alveoli in the lungs th rough the respi ratory membrane. Figure 3 is a cross section plan view of one contemplated embodiment of a breathing head showing an arrangement of the various components therein.

Figure 4 is an isometric side view sketch of one embodiment of the reusable receiver body and one embodiment of a single use breathing head vertically aligned with the receiver body for engagement therewith.

Figure 5 is an orthographic sketch of the present invention and system configured in a manner to rest adjacent a patient's shoulder, the patient in a prone position.

Figure 6 is an orthographic sketch of a side view of the present invention and system configured into a chest resting harness for use by a patient.

Figure 7 is an artist's sketch of moving masses of air originating from and expanding outwardly from the breathing head.

Figure 7A is an artist's sketch of an orthographic side view of a toroid vortex.

Figure 7B is an artist's sketch of a cross section of the toroid vortex shown in Fig 7A with arrows showing the direction of the toroid vortex movement and the direction of air movement within the toroid vortex.

Figure 8 is an artist's isometric sketch of one embodiment of the reusable receiver body. Figure 9 is a side view of an artist's sketch of a second possible embodiment of the reusable receiver body carrying a single use breathing head shown in dashed outline.

Figure 1 0 is an orthographic cross section view of another contemplated embodiment of a breathing head showing the orientation of the various components with arrows showing the flow of air there through.

DETAILED DESCRIPTION C THE PKEPEKKRD EMBODIMENTS

The invention described herein is an improvement on and to the inventions described in US 4,060,078, US 4, 1 27, 1 23 , US 4, 1 64,21 9, US 4, 592,349 and US 6, 595,203 , US 6,581 ,600, US 4,930, 501 , US 8347883 and CA 24301 3 1 C ail issued to Forrest , Bird, MD, PhD (deceased) who is one of the co-inventors herein. The entire contents of the above identified US and foreign patents and published applications are expressly incorporated herein, in their entirety by this reference.

The readers of this document should understand that dictionaries were used in the preparation of this document.

Widely known and used in the preparation hereof are The American_{. :};He.ritac{e_.,Pjctionary_. of the English Language , 4^th Edition (© 2000), Webster's New- International Dictionary, Unabridged, (Second Edition © 1 957), Webster's ^'Third. ^'N.¾w International Dictionary- (© 1 993), The --Ox ord Eij ¾hs^'h Dictionary (Second Edition, ©1 989), and The New C&nturv Dictionary (©2001 -2005), all of which are hereby incorporated by this reference for interpretation of terms used herein and to more adequately or aptly describe various features, aspects and concepts shown or otherwise described herein using words having meanings applicable to such features, aspects and concepts.

This document is premised upon using one or more terms with one embodiment that may also apply to other embodiments for similar structures, functions, features and aspects of the inventions. Wording used in the claims is also descriptive of the inventions, and the text of both claims and abstract are incorporated by this reference into the description entirely.

The readers of this document should further understand that the embodiments described herein may rely on terminology and features used in any section or embodiment shown in this document and other terms readily apparent from the drawings and language common or proper therefore.

Our percussive ventilator breathing head and system and method generally provides a reusable receiver body 20, a breathing head 50, a respi rator drive unit 90 and a multi-lumen cable 1 00.

As shown in Figures 4 and 8 the reusable receiver body 20 has a first end portion 21 , a second end portion 22, a first side portion 23 , a second side portion 24, a top portion 25, a bottom portion 26 and defines a seat 27 in the top portion 25 extending from the first end portion 21 to the second end portion 22. in the preferred embodiment, the seat 27 is somewhat concave between the first side portion 23 and the second side portion 24 along its length. The seat 27 is configured to operatively and releasab!y mating!y receive the breathing head 50.

Support 28 structurally carried by the receiver body 20 preferably proximate the first end portion 21 provides a grasping means for the receiver body 20, In the disclosed embodiment, the support 28 is configured as a handle, but it is contemplated the support 28 may be also configured to re!easably attach proximate a patient's shoulder (Figure 5), or to a harness (Figure 6) so long as the support 28 maintains the receiver body 20 in a stable position and in an orientation suitable for patient use and medical personnel access. Positional stability can be crucial in situations where a patient may be unconscious, immobilized or otherwise unable to "hold" the receiver body 20 for use, such as a patient that has suffered a spinal injury. In a further embodiment (not shown) the support 28 is configured in the shape of a "Y" which is well known/recognized for respiratory devices in ICU (intensive care unit) settings and would thus be instantly recognizable to trained medical personnel in such settings.

The seat 27 defines plural spacedly arrayed pneumatic, electrical, magnetic and mechanical ports that communicate with mating interconnecting ports and connections carried by the breathing head 50. A pressurized air supply port 32 is defined in the seat 27 generally proximate the first end portion 21. An air entrainment port 34 is likewise defined in the seat 27 spaced apart from the pressurized air supply port 32. A breath outflow port 35 is defined in the seat 27 proximate the second end 22. At least one sensor port 36 is similarly defined in the seat 27.

Patient tube 77 pneumatically communicates with the breathing head 50 and the receiver body 20 at the second end portion 22 generally opposite the pressurized air supply port 32.

The patient tube 77 is the pneumatic passage for transfer of air, moisture, medicinals and the like to, and from, the patient. A medicinal timing cartridge 37 communicates with the breathing head 50 so that medicinals, such as, but not limited to moisture, vasoconstrictors, vasodilators, antibiotics, pain killers and the like may be supplied to a patient using the instant invention. Providing such medicinals through a patient's lungs provides for faster uptake and diffusion through the patient's body which may be imperative for medicinals such as vasodilators and vasoconstrictors. Although disclosed as communicating with the breathing head 50, it is expressly contemplated the medicinal timing cartridge 37 may also communicate with the receiver body 20. Pneumatic seals (not shown) are carried by the ports 32, 34, 35 and 36 to provide airtight seals therebetween and ensure that air, gases, moisture and /or medicinals do not escape or leak between the interconnecting components and to ensure detecting, measuring and sampling by the plurality of sensors is accurate,

A multi-lumen connector 31 is carried by the body 20 preferably proximate the support 28. The multi-lumen connector 31 releasab!y interconnects with a mating connection 1 03 carried by the multi-lumen cable 1 00 and provides multiple individual ports (not shown) for receiving power, electricity, air, moisture, medicinals, data and the like from the respiratory drive unit 90 and allowing the receiver body 20 and breathing head SO to communicate data back to the respiratory drive unit 90 and to visual displays 40, 40A which may be digital screens, or LCD screens or the like. The multi-iumen cable 1 00 provides a flexible communication and supply conduit between the respiratory drive unit 90, the receiver body 20 and the breathing head 50. One way valves (not shown) prevent contaminants, such as but not limited to bacteria and viruses from being transferred from the patient and single use breathing head 50 into the receiver body 20.

The multi-lumen cable 1 00 allows the respirator drive unit 90 to be positioned remotely from the receiver body 20 and patient and also to allow a patient to be treated by different respirator drive units 90 as the patient may be transported from location to iocation without the need to also transport the respiratory drive unit 90. The ports (not shown) defined by the multi-lumen connector 31 communicate with the pressurized air supply port 32, the patient tube 77, the air enirainment port 34, the breath outflow port 35 , the sensor port(s) 36, the medicinal timing cartridge 37 and sensor arrays 42 by means of channels (not shown), wires {not shown) and circuitry (not shown) defined within or carried within the receiver body 20 and breathing head

50. The multi-lumen connector 31 provides a port through which information (data), materials (i ncluding but not limited to air, moisture, gaseous compositions and medicinals), power, electricity and the like flow to the receiver body 20 and breathing head SO and from the receiver body 20 and breathing head 50 to assist care givers in monitoring and optimizing patient care.

In one embodiment the sensor array 42 comprises plural spacedly arrayed sensors for receiving data, and detecting operational conditions and components flowing to and from the patient such as, but not limited to, temperature, temperature differentials, temperature changes, pressure, pressure differentials, pressure changes, volume differentials, volume changes, gas velocity, moisture content, gaseous composition, cycles, rates, expiration dates on medicinal timing cartridges 37, quantities of materials within medicinal timing cartridges 37, FID identification tags 55, particulate levels and manufacturers, and the like, The sensor array 42 is carried by the receiver body 20 and cooperating sensor components are carried by the breathing head 50 so that the sensor array 42 and cooperating components interactively communicate when the breathing head 50 is operative!y engaged with the receiver body 20. In particular, but without limitation, it is contemplated the plurality of sensors (not shown) comprising the sensor array 42, which are preferably micro sensors, will detect operational conditions, components, connectors and performance, such as, but not limited to whether or not the breathing head 50 (which is a single patient use apparatus) has been previously used such as by employing radio frequency identification (RFID) tags 55, the amount of medicinal contained in (remaining in) an interconnected medicinal timing cartridge 37, maintenance schedules and whether the medicinal timing cartridge 37 is outdated /expired in which case the sensor array 42 may not allow the medicinal into the air flow passing to the patient without being intentionally (and perhaps manually) bypassed, temperature of the air passing through the breathing head 50, moisture content of the air passing through the breathing head 50, volume of air passing through the breathing head SO (during both inhale and exhale and complete respiratory cycles), pressure of the air passing through the breathing head 50, gaseous components of the air passing through the breathing head 50, in particular, but not limited to, oxygen content, nitrous oxide content, carbon dioxide content and other components of the air. Micro sensors 76 for detecting and measuring such operational conditions, components, connections, parameters and the like are preferable carried by and within the breathing head SO but may also be carried by the body 20 so that changes in components and connections and temperatures may be determined and measured. A connectivity sensor (not shown) to ensure proper connectivity between the respirator drive unit 90 and the receiver body 20 and between the receiver body 20 and the breathing head 50 which may be an LED (light emitting diode) that illuminates when there is a proper connection, and warns of an improper connection.

The multi-lumen cable 1 00 has a first end portion 1 01 and a spaced apart second end portion (not shown) with a connector 1 03 at both the first end portion 1 01 and the second end portion (not shown). The multi-lumen cable 1 00 provides a flexible generally tubular conduit between the receiver body 20 and the respirator drive unit 90 and the multiple separate lumens (not shown) defined by the multi-lumen cable 1 00 provide for individually controlled, maintained and regulated flow of air, medicinals, moisture, power, data and the like to be communicated from the respirator drive unit 90 to the receiver body 20, and to the interconnected breathing head SO and also to receive data output from the receiver body 20 and the breathing head 50. Such data may be displayed on a visual screen 40 on the receiver body 20 or a second visual disp ay screen 40A carried on the respirator drive unit 90, or perhaps even a visual display on the breathing head 50 (not shown) or transmitted to another apparatus (by means of wire, or wi reless technology) to provide real time treatment information to medical personnel observing, monitoring and treating a patient during use.

It is expressly contemplated a visual display screen 40 such as a digital screen may be carried on a side portion 23, 24 the receiver body 20 to provide basic data for use, such as pressure, volume, temperature so that this information is available to a care provider even when the receiver body 20 and breathing head 50 are interconnected with a bottle of pressurized gas (not shown) rather than a comprehensive respirator drive unit 90. Such basic information may be essential in emergency situations such as when a medic is treating an injured soldier in the field and comprehensive respirator drive units 90 are not available and yet a patient requires breathing assistance through use of the instant invention. Such basic information will allow a medic or other medical personnel to provide basic and necessary adjustments such as, but not limited to, the volume of air passing through the breathing head 50 to the patient. Such basic information may also be needed in situations where assisted breathing is being provided to a patient at a remote location and care is being directed by te!emedicine. Having such basic information visually available will ai!ow non medically trained caregivers to accurately communicate essential treatment data to medical personnel and allow trained medical personnel to direct changes /modification to treatment based upon the communicated information,

US Patent 4, 592,349 issued June 3, 1 986 to Forrest . Bird, D, PhD (deceased), one of the inventors herein discloses the original breathing head 50 which is commercially known as a Phasitron^®. The entire contents of US 4,592,349 is expressly incorporated herein by this reference.

The breathing head 50 (Figures 3 and 1 0) is generally cylindrical having a first end portion 51 , a second end portion 52, a first side portion S 3, a second side portion 54, a top portion, a bottom portion and defines a f!ow passage 57 extending therethrough from the first end portion S I to the second end portion 52. A radially reduced annuius 83 is carried within the flow passage 57 at the second end 52 so as to provide shaping of masses of air passing through the flow passage 57. In the herein disclosed embodiment, the annuius 83 causes the moving masses of air to form toroid vortexes, (donut shaped masses of air}. 7

An ejector body 70 having a first end portion 71 and a second end portion 72 and a defining a variable diameter passageway 80 extending therethrough from the first end portion

71 to the second end portion 72 is movably carried within the flow passage 57. A diaphragm 75 is carried on the first end portion 71 of the ejector body 70 and the diaphragm 75 communicates with the breathing head body 50 at the breathing head first end 51 , forming a sea! therewith. The diaphragm 75 is formed of a flexible resilient material such as, but not limited to, silicone or rubber, so as to allow the ejector body 70 to axially move, within the flow passage 57. Resiliency and retentive memory of the diaphragm 75 positionally biases the ejector body

72 a position toward the first end 51 of the breathing head 50. The second end 72 of the ejector body carries a circumferentialiy extending seal 81 , such as an "O" ring that fractionally communicates with a valve seat 74 carried within the flow passage 57 proximate the second and 52 of the breathing head 50, The valve seat 74 extends circumferentialiy about an inner surface of the flow passage 57 and provides a surface with which the circumferentialiy extending seal 81 may engage when the ejector body 70 is axially moved within the flow passage 57 toward the second end 52. The variable diameter of the passageway 80 extending through the ejector body 70 creates a venture as air passes therethrough. in a further embodiment, and more generally, a mass accelerator, which may be a diaphragm, or a piston, or a moving mass (a "puff) of gaseous fluid imparts veiocity (kinetic energy) to a mass of air causing the mass of air to move in a desired direction. Depending upon the configuration of the second end

52 of the flow passage 57, the moving mass of air may be shaped as desired , such as into a toroid vortex (a donut) (Figures 7A, 7B), to facilitate and enhance movement of the shaped mass of air more deeply into a patient's lungs. A toroid is a vortex that "rolls" outwardly upon itself from its center portion outwardly toward its periphery. (See Fig, 7B). Because the vortex is rotating, the veiocity inside the vortex is greater than the velocity of the air outside it. The velocity of the air outside the vortex is typically zero because it is standing still. Bernoulli's principle states that the faster a flow of air is moving the lower its air pressure. Since the air inside the toroidal vortex is moving and the air outside the vortex is not moving, the air pressure inside the vortex is less than the air pressure outside the vortex which holds the vortex together. Because the air on the outside of the vortex is moving backwards (opposite the direction the toroidal vortex is moving) this backwards air movement frictionally engages the still air outside the vortex, and the friction causes the toroidal vortex to continue is movement forwardly, in the direction it was originally propelled. The spinning of the air within the toroidal vortex is the energy that keeps the toroid moving for ardly - effectively down a patient's airway and deeply into the patient's lungs, penetrating the dead space and overcoming the static pressure within the patient's lungs. Further, any frictional engagement the toroid vortex may have when striking an inner surface of the patient tube 77 or an inner wall of the patient's trachea will presumably similarly provide friction allowing the toroidal vortex to continue its forward movement into the lungs. This penetrating movement of the vortex is to be distinguished from the effect of pressure ventilators that merely apply volumetric pressure to the patient airway and respiratory tract which responsive y increases air pressure within the patient's lungs due to the mechanical "pushing" of the air against the static ai r already within the patient's lungs. St is the penetration of the vortex of new air into and through the static "bad air" that provides the medically beneficial effect.

An FID tag 55 or similar identifier is carried by the breathing head SO at a position to electronically communicate with the sensor array 42 of the receiver body 20. The RFID tag 55 provides information to the receiver body 20 as to whether the breathing head SO has been previously used. As noted previously, the breathing head 50 is a single patient use apparatus because of risk of transmitting and transferring infectious diseases, viruses and bacteria from patient to patient. As such, if the RFID tag S S when presented to the receiver body 20, and processed by the receiver body 20 ind icates the breathing head 50 has been previousiy used , the system wl U not operate without providing med ical personnei with notification that the sanitary nature of the breathi ng head 50 may have been compromi sed and that a patient may be put at risk by using the previously used breathing head 50. An operator may have an option to manual ly "override." such an indication , such as when there is an emergency. The use of such an RFID tag 55 enhances the safety of the instant invention by preventing mistaken reuse of the medical care devices which might be contaminated with i nfectious bacteria, vi ruses and the l ike.

Pressu rized ai r input 58 is defi ned in the receiver body 20 proxi mate the fi rst end portion 51 for inflow of pressurized air from the respirator drive unit 90 or from a bottle of pressurized ai r (not shown) i nto the flow passage 57 and agai nst the diaphrag m 75 of the ejector body 70. The diaph ragm 75 defines a medial pressurized air passage 82 that transverses the diaphragm 75 and com municates with the passageway 80 defined by the ejector body 70. Pressurized air supply to the breathing head 50 through the pressurized ai rport 58, when impacting the diaphragm 75 causes the diaphragm 75 to distend toward the second end 52 which responsi bly causes the ci rcumferentialiy extendi ng sea! 81 to frictionally engage with the valve seat 74 providing a seal within the flow passage 57 and facilitating movement of masses of air through the passageway 80 and to the patient tube 77 for communication to the patient airway. Passage of the moving masses of air through the diametricaSly variable passageway 80 entrains an additional volume of air from the air entrainment port 66 which responsively draws a large volume of air along with the moving mass of air passing through the passageway 80. The venture created by the diametrically variable passageway 80 increases the volume of entrained air because the venture decreases air pressure within the passageway 80 due to the Bernoulli principle, discussed previously, Because a large volume of moving air is entrained (drawn along) with the moving mass of air there is little pressure carried therewith and a patient can freely exhale at any time while the breathing head 50 is functioning which provides an additional safety feature not available in known pressure ventilators. The air entrainment port 66 is defined in the breathing head 50 and pneumatically communicates with the flow passage 57. Breath outflow port 67 is defined in the breathing head SO and similarly communicates with the flow passage 57 proximate the second end portion 52. Nipple portions (not shown) each defining a channel therethrough may be carried by the breathing head 50 to facilitate operative releasable engagement with the air entrainment port 34 and the breath outflow ports 35 defined in the seat 27 of the receiver body 20, Known seals, such as "0" rings provide airtight seals between the interconnected components which are essentia! for accurate measuring and sampling during use. When the patient exhales, the exhaled air forces the ejector body 70 toward the first end SO of the breathing head 50 and out of engagement with the valve seat 74. Exhaled air passes out of the flow passage 57 through the patient breath outflow ports 67, 35.

Air heating means 69, such as, but not limited to heating turbinates or heated wires are carried within the flow passage 57 to increase the temperature of the air passing through the fiow passage 57. Power for the air heating means 69 may be provided by electrical connections carried by the receiver body 20 and communicating with the breathing head 50 from the respirator drive unit 90 or other external power source such as a battery, (not shown).

Plural sensors 76 are carried by the breathing head 50 at spacedly arrayed predetermined positions thereon and therein to communicate with the flow passage 57, the air entralnment port 66, the breath outflow port 67. the pressurized air input 58 and the air heating means 69 to take samples, to take measurements, to make comparisons and to detect operational conditions such as, but not limited to, oxygen content, nitrogen content, nitrous oxide content, carbon dioxide content, humidity, temperature, pressure, pressure differential, volume, velocity and the like. The sensors 76 detect conditions and communicate the detected conditions, using known means, (wired and wireless) to the receiver body 20 and the various interconnection ports thereon to allow the detected condition information to be communicated to the visuai display screens 40, 40A carried by the receiver body 20, the breathing head 50, and to the respirator drive unit 90, via the multi-lumen cable 1 00 or wirelessly by transmission. It is contemplated the sensors 76 may be mechanical , electrical, chemical and /or magnetic in nature /structure.

In a further embodiment, a power generating turbine 41 pneumatically communicates with the breathing head SO to generate electrical energy to power elements such as the sensors 76, the visual display screens 40, 40A and the heating means 69. Because of the need for accurate measurements within the flow passage 57, and the quantity and characteristics of the air moving therethrough during use, it is preferable that the power turbine 41 pneumatically communicates with the air entrainment port 66 so that the turbine 41 rotates as air is drawn therethrough and there over, it is expressly contemplated the powering turbine 41 may also be located within the flow passage 57, or within the receiver body 20 or in an external node (not shown), however it is desirable that the turbine not negatively impact airflow to the patient. A moisture supply (not shown) which is contemplated to include a nebulizer 78, a vaporizer (not shown), an atomizer (not shown), a medicinal supply (not shown), a medicinal timing cartridge 37 or similar structure pneumatically communicates with the flow passage 57 of the breathing head 50 preferably proximate the air entrapment port 66 for the addition of moisture and /or medicinals to the air supply provided to the patient. In the disclosed embodiment, the moisture supply (not shown) is added to the air "upstream/before" the heating means 69 to prevent the addition of moisture or medicinal to the air supply from decreasing the temperature of the air provided to the patient. A temperature probe (not shown) may be carried within the flow passage 57 proximate an air outflow port 73 which is the last position at which the temperature may be measured before passing to the patient through patient tube 77.

Similar to the FID reader carried by the receiver body 20 to determine whether or not the breathing head SO has been previously used, it is contemplated a similar RFID reader would be carried proximate the interconnection of the medicinal timing cartridge 37 to "read" and /or otherwise interpret an RFID tag 55 carried on an interconnected medicinal ti ming cartridge 37, "Timing cartridges" are medicinal containers and are known to include vasoconstrictors, vasodilators, anesthetics, pain killers, antibiotics, antihistamines and various other medicinals which may be useful in treating patients, in the event the FiD tag 55 carried by the medicinal timing cartridge 37 is detected to be expired, counterfeit, or otherwise improper a signal would be sent to the visual display screen 40, 40A to alert medical personnel to the potential problem. The RFID reader will also monitor the remaining content within the medicinal timing cartridge 37 and provide a similar alert to care givers when the medicinal timing cartridge 37 is approaching empty.

A flow meter sensor 79 communicating with the flow passage 57 will measure and provide an indication of the volume of air being provided to the patient, and being exhaled by the patient. The flow meter 79 may be a known Pitot tube assembly, and may also be an electronic sensor.

Because the instant ventilator breathing head and system and method samples and measures air flow passing to the patient, and also air flow being "breathed out" by the patient the sensor arrays 42 are continually taking samples and measurements and making comparisons throughout the respiratory cycles of the patient. The data and information gathered and coliected by the sensor arrays 42 is electrically communicated to the visual display screens 40, 40A and also communicated to the respirator drive unit 90 by means of the multi-lumen cable 1 00, and also wirelessly to known "smart devices" such as but not limited to smart phones, which may be readily available in the field during emergency use.

Having described the structure of our ventilator breathing head and system and method, its operation may be understood.

One aspect of the instant percussive ventilator breathing head and system and method is a percussive ventilator breathing head and system for administering percussive ventilation to a patient having an airway using a ventilator drive unit providing a gas under continuous flow and cyclic flow. The percussive ventilator breathing head 50 and system comprise a breathing head 50 having an elongate main body with a first end 51 , an opposing second end 52 and a flow passage 57 extending from the first end 51 to the second end 52 ; a pressurized air inflow port 58 defined in the main body 50 and in communication with the flow passage 57 and adapted to be placed in communication with the airway of the patient; an air entrainment port 66 defined by the main body 50 and disposed in fluid flowing communication with the flow passage 57 and communicating in fluid delivery relative to an airway of a patient; a breath outflow port 67 carried by the main body 50 communicating with the flow passage 57 and adapted to be placed in communication with the airway of the patient; a valve seat 74 formed in the main body and circumscribing the flow passage 57; an ejector body 70 slidably mounted in the flow passage 57 of the main body 50 and having a first end 71 and a second end 72, the ejector body 70 having its second end 72 movable into and out of engagement with the valve seat 74, the ejector body 70 further having a passageway 80 extending therethrough from the first end 71 to the second end 72; a diaphragm 75 carried by the main body 50 and coupled to the ejector body 70, the diaphragm 75 having a retracting memory for retaining the ejector body 70 in a retracted position with respect to the valve seat 74; a sensor 76 carried by the main body 50 in communication with the flow passage 57 to detect conditions within the flow passage 57 and for communicating the detected conditions to a user; a radially reduced annular lip 83 within the flow passage 57 adjacent the second end 52 thereof to generate toroidal shaped masses of air exiting the flow passage 57 for passage to the airway of the patient; the main body 50 further having an external configuration that facilitates releasabie operative engagement with a reusable receiver 20; the reusable receiver 20 having a first end 21 and an opposing second end 22 and a seat 27 to operatively engage with the main body 50 of the breathing head 50 and to receive the detected conditions information from the main body sensor 76 for communication to the user, the reusable receiver 20 further having a multi- lumen cable connector port 31 at the first end 21 to operatively engage with a multi-lumen cable 1 00 for operatively interconnecting the reusable receiver 20 and the main body 50 with the ventilator drive unit 90; and an elongate rnuSti lumen cable 100 having a first end portion 101 and an opposing second end portion 102, each end portion carrying a connector 103 to operatively interconnect the multi-lumen cable 100 to the reusable receiver 20 and to the ventilator drive unit 90 and to supply a flow of gas and medicinals from the ventilator drive unit 90 to the reusable receiver 20 and carried breathing head 50 and to receive information from the sensor 76 within breathing head 50 for communication to a user.

Having described the operation of our ventilator breathing head and system and method, the method of its use may be understood by providing a breathing head 50 having a main body which has opposite first 51 and second 52 ends, and an internal flow passage 57 which extends between the first 51 and second 52 ends, and wherein the second end 52 of the main body 50 is disposed in fluid delivering relation relative to a patient's airway; providing a reciprocally moveable ejector body 70 which is matingly received within the internal flow passage 57 of the breathing head 50, and bsasingly urging the ejector body 70 in a direction towards the first end 51 of the breathing head 50, and wherein the ejector body 70 has a first 71 and second end 72, and further defines a fluid- flowing passageway 80 having a variable cross-sectional dimension when the cross-sectional dimension is measured between the first 71 and the second end 72 of the ejector body 70, and wherein the first end 71 of the ejector body 70 is located near the first end 51 of the breathing head 50; supplying a pressurized source of a percussive fluid to the first end 51 of the breathing head 50, and directing the pressurized source of percussive fluid into the fluid-flowing passage 80 of the reciprocally moveable ejector body 70, and wherein the supplied, pressurized source of the percussive fluid is effective in movab!y displacing the reciprocally moveable ejector body 70 into a spaced orientation relative to the first end 51 of the breathing head 50, and wherein the displaced ejector body 70 further directs the supplied, pressurized source of the percussive fluid along the fluid-flowing passage 80 thereof, and to the second end 52 of the breathing head 50 so as to form a medically effective toroidal gaseous fluid mass; and delivering the medically effective shaped gaseous mass which is exiting the second end 52 of the breathing head 50 to the airway of the patient.

More generally, the method for delivering a moving mass of air to an airway of a patient comprises providing a breathing head 50 having opposite first end 51 and second end 52, and forming an internal flow passage 57 which extends between the first end 51 and second end 52 thereof; providing a mass of air to the internal flow passage 57; providing a mass accelerator 70, and orienting the mass accelerator 70 so as to communicate with the internal flow passage 57 of the breathing head 50, and wherein the mass accelerator 70 imparts velocity to the mass of air within the flow passage 57; supplying a powering means to the mass accelerator 70 so as to facilitate the mass accelerator's 70 imparting velocity to the mass of air; and the mass of air having velocity imparted by the mass accelerator 70 is directed into the patient's airway to facilitate a medically effective oxygen /carbon dioxide exchange within the patient's lungs.

Various portions and components of the instant invention, including for example, but not limited to, structural components, can be formed by one or more various manufacturing processes known to those in the art.

This disclosure and description has set out various features, functions, methods capabilities, uses and other aspects of our invention, This has been done with regard to the currently preferred embodiments thereof. Ti me and further development may change the manner in which the various aspects are implemented.

The scope of protection accorded the inventions as defined by the claims is not intended to be limited to the specific sizes, shapes, features or other aspects of the currently preferred embodiments shown and described. The claimed inventions may be implemented or embodied in other forms while still being within the concepts shown, disclosed, described and claimed herein. Also included are equivalents of the inventions which can be made without departing from the scope of concepts properly protected hereby.

Having thusly described and disclosed our PERCUSSIVE VENTILATOR BREATHING HEAD AND SYSTEM AND METHOD, we file this PCT Patent Application under the Patent Cooperation Treaty,

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Claims

CLAIMS What is claimed is:

1 . A percussive ventilator, comprising;

a breathing head having opposite first and second ends, and further defining an internal flow passage extending between the first and second ends;

a moveable ejector body having opposite ends and which is further matingly received within the internal flow passage of the breathing head, and wherein the moveable ejector body further defines a fluid- flowing passageway extending between the opposite ends thereof; and a pressurized source of percussive fluid which is coupled in fluid delivering relation relative to the first end of the breathing head, and wherein the pressurized source of percussive fluid moves the ejector body along the internal flow passageway to a position where the moveable ejector body matingly cooperates with the breathing head at a location which is near the second end thereof, and the pressurized source of the percussive fluid is released from the second end of the breathing head in the form of a medically effective toroidal shaped mass of air which is delivered to a patient's airway,

2. A percussive ventilator, comprising: a breathing head having a main body which has opposite first and second ends, and an internal flow passage which extends between the first and second ends, and wherein the second end of the main body is disposed in fluid delivering relation relative to a patient's airway;

a reciprocally moveable ejector body matingly received within the internal flow passage of the breathing head, and b asingly urged in a direction towards the first end of the breathing head, and wherein the ejector body has a first and second end, and further defines a fluid- flowing passageway having a variable cross-sectional dimension when the cross-sectional dimension is measured between the first and the second end of the ejector body, and wherein the first end of the ejector body is located near the first end of the breathing head; and a pressurized source of a percussive fluid for delivery to the first end of the breathing head, and wherein the pressurized source of percussive fluid travels into the fluid-flowing passage of the

reciprocally moveable ejector body, and is further effective in moving the reciprocally moveable ejector body into a displaced orientation relative to the first end of the breathing head, and wherein the displaced ejector body further directs the pressurized source of the percussive fluid along the fluid-flowing passage thereof, and to the second end of the breathing head, and wherein the pressurized source of the percussive fluid exits the second end of the breathing head in the form of a medically effective toroidal shaped mass of air which is delivered to the airway of the patient.

3. A percussive ventilator comprising; a breathing head having an elongated main body with a first end, an opposing, second end and, a fiow passage extending from the first end to the second end;

a pressurized air inflow port defined in the main body and located at the first end, the pressurized air inflow port disposed in fluid flowing communication with the flow passage;

an air entrainment port defined by the main body and disposed in fluid flowing communication with the fiow passage and communicating in fluid delivery relative to an airway of a patient;

a breath outflow port defined by the main body and disposed in fluid flowing communication with the flow passage and communicating in fluid delivery relative to an airway of a patient;

a valve seat defined by the main body and located within the fiow passage and near the second end thereof, and further circumscribing the flow passage;

an ejector body reciprocally mounted in the flow passage of the main body and having a first end located near the pressurized air inflow port and a second end located near the valve seat and wherein the second end of the ejector body is reciprocally movable into and out of engagement with the valve seat, and where the ejector body further defines a passageway extending therethrough from the first end to the second end;

a diaphragm carried by the first end of the main body and coupled to the first end of the ejector body, and wherein the diaphragm is movably biased in a direction retaining the ejector body in a retracted position relative to the valve seat;

a sensor carried by the main body and disposed in sensing relation relative to the flow passage so as to detect an operational condition within the flow passage and for communicating the detected operational condition to a user;

a radially reduced annular Hp within the flow passage adjacent the second end thereof to generate a medically effective toroidal shaped mass of air exiting the flow passage for delivery to the airway of the patient;

the main body further having an external configuration that facilitates reieasable operative engagement with a reusable receiver;

a reusable receiver having a first end and an opposing second end and a seat to operatively and matingly engage the main body of the unitary breathing head and to further receive the detected operational conditions information from the main body sensor for communication to the user, and wherein the reusable receiver further has a multi-lumen cable connector port at the first end thereof to operatively engage with a mu!ti-!umen cable for operatively interconnecting the reusable receiver and the main body with a ventilator; and wherein the elongated multilumen cable has a first end portion, and an opposing second end portion, and wherein each end portion carries a connector to operatively interconnect the multi-lumen cable to the reusable receiver, and to the ventilator, and to supply a flow of gas and a medicinal from the ventilator to the reusable receiver and the main body of the breathing head and to further receive information from the sensor within the breathing head for communication to a user,

4. A percussive ventilator breathing head and system for administering percussive ventilation to a patient having an airway using a ventilator providing a gas under continuous flow and cyclic flow, the percussive ventilator breathing head and system comprising:

a unitary breathing head having an elongate main body with a first end, an opposing second end and a flow passage extending from the first end to the second end;

a pressurized air inflow port defined in the main body and in communication with the flow passage and adapted to be placed in communication with the airway of the patient;

an air entrainment port defined by the main body and disposed in fluid flowing communication with the flow passage and communicating in fluid delivery relative to an airway of a patient;

a breath outflow port carried by the main body communicating with the flow passage and adapted to be placed in communication with the airway of the patient;

a valve seat formed in the main body and circumscribing the flow passage;

an ejector body slidably mounted in the flow passage of the main body and having a first end and a second end, the ejector body having its second end movable into and out of engagement with the vaive seat, the ejector body further having a passageway extending therethrough from the first end to the second end;

a diaphragm carried by the main body and coupled to the ejector body, the diaphragm having a retracting memory for retaining the ejector body in a retracted position with respect to the valve seat:

a sensor carried by the main body in communication with the flow passage to detect conditions within the flow passage and for communicating the detected conditions to a user;

a radially reduced annular hp within the flow passage adjacent the second end thereof to generate toroidai shaped masses of air exiting the flow passage for passage to the airway of the patient;

the main body further having an externa! configuration that facilitates releasabie operative engagement with a reusable receiver;

the reusable receiver having a first end and an opposing second end and a seat to operativeiy engage with the main body of the unitary breathing head and to receive the detected conditions information from the main body sensor for communication to the user, the reusable receiver further having a multi-lumen cable connector port at the first end to operativeiy engage with a muiti-lumen cabie for operativeiy interconnecting the reusable receiver and the main body with the ventilator; and

an elongate muiti lumen cable having a first end portion and an opposing second end portion, each end portion carrying a connector to operatively interconnect the multi-lumen cable to the reusable receiver and to the ventilator and to supply a flow of gas and medicinals from the ventilator to the reusable receiver and carried main body and to receive information from the sensor within main body for communication to a user,

5, The percussive ventilator of Claim 1 further comprising:

a nebulizer for supplying moisture and medicinals to the patient,

6. The percussive ventilator of Claim 1 further comprising:

a heater means communicating with the fluid passage to warm the air flowing therethrough to a desired temperature.

7. The percussive ventilator of Claim 1 further comprising:

a radio frequency identification tag (RFID) reader to communicate with RFID tags carried by medicinal containers and nebulizer containers to provide a user with information whether the medicinal container and nebulizer container is appropriate to use for patient care.

8, The percussive ventilator of Claim 1 further comprising:

a visual display screen carried by the reusable receiver and communicating with the sensor to visually display operational information to a user. S3

9. The percussive ventilator of Claim 1 wherein:

the sensor is a volume sensor to measure volumes of air being supplied to the patient airway and being received from the patient airway.

1 0. The percussive ventilator of Claim 1 wherein:

the sensor is a pressure sensor to measure the pressures of air being supplied to the patient airway and being received from the patient airway,

1 1 . The percussive ventilator of Claim 1 wherein:

the flow of air is supplied by a bottle of pressurize air.

1 2. A method for delivering a percussive gaseous fluid to an airway of a patient, comprising:

providing a breathing head having a main body which has opposite first and second ends, and an internal flow passage which extends between the first and second ends, and wherein the second end of the main body is disposed in fluid delivering relation relative to a patient's airway;

providing a reciprocally moveable ejector body which is matingly received within the internal flow passage of the breathing head, and biasingiy urging the ejector body in a direction towards the first end of the breathing head, and wherein the ejector body has a first and second end, and further defines a fluid - flowing passageway having a variable cross-sectiona! dimension when the cross-sectional dimension is measured between the first and the second end of the ejector body, and wherein the first end of the ejector body is located near the first end of the breathing head;

supplying a pressurized source of a percussive fluid to the first end of the breathing head, and directing the pressurized source of percussive fluid into the fluid-flowing passage of the reciprocally moveable ejector body, and wherein the supplied, pressurized source of the percussive fluid is effective in movably displacing the

reciprocally moveable ejector body into a spaced orientation relative to the first end of the breathing head, and wherein the displaced ejector body further directs the supplied, pressurized source of the percussive fluid along the fluid-flowing passage thereof, and to the second end of the breathing head so as to form a medically effective toroidal fluid mass; and

delivering the medically effective shaped gaseous mass which is exiting the second end of the breathing head to the airway of the patient,

1 3. A method for delivering a percussive gaseous fluid to an airway of a patient, comprising:

providing a breathing head having opposite first and second ends, and forming an internal flow passage which extends between the opposite first and second ends thereof; providing a moveable ejector body having opposite ends, and orienting the moveable ejector body within the internal flow passage of the breathing head, and wherein the moveable ejector body defines a fluid-flowing passageway between the opposite ends thereof;

supplying a source of a percussive fluid and coupling the source of the percussive fluid to the first end of the breathing head, and wherein the supplied source of the percussive fluid is effective in movably displacing the reciprocally moveable ejector body into a spaced orientation relative to the first end of the breathing head, and wherein the displaced ejector body further directs the supplied, pressurized source of the percussive fluid along the fluid-flowing passage thereof, and to the second end of the breathing head so as to form a medically effective toroidal fluid mass; and

delivering the medically effective shaped gaseous mass which is exiting the second end of the breathing head to the airway of the patient.

1 4, A method for delivering a moving mass of air to an airway of a patient, comprising:

providing a breathing head having opposite first and second ends, and forming an internal flow passage which extends between the opposite first and second ends thereof;

providing a mass of air to the internal flow passage; providing a mass accelerator, and orienting the mass accelerator so as to communicate with the internal flow passage of the breathing head, and wherein the mass accelerator imparts velocity to the mass of air within the flow passage;

supplying a powering means to the mass accelerator so as to facilitate the mass accelerator's imparting velocity to the mass of air; and

the mass of air having velocity imparted by the mass accelerator is directed into the patient's airway to facilitate a medically effective gas exchange at the alveoli within the patient's lungs,

1 5. The method for delivering a moving mass of air to a respiratory track of a patient of Claim 1 4 wherein:

the mass accelerator is a diaphragm.

1 6. The method for delivering a moving mass of air to a respiratory track of a patient of Claim 1 4 wherein:

the mass accelerator is a piston.

1 7. The method for delivering a moving mass of air to a respiratory track of a patient of Claim 1 4 wherein:

the mass accelerator is another fluid that is percussively flowing.

1 8. The method for delivering a moving mass of ai r to a respiratory track of a patient of Claim 1 4 wherein:

the mass of ai r is shaped into a configuration having medically effective affects within the patient's airway,

1 9. The method for delivering a moving mass of air to a respiratory track of a patient of Claim 1 4 wherein:

the mass of air is shaped into a toroid, 20. The method for del ivering a moving mass of air to a respiratory track of a patient of Claim 1 4 wherein:

the mass of ai r may be moved at a predetermined velocity and frequency and amplitude to target predetermined conditions within the patient's airway.