Body pulsating method and apparatus

A vest for a human body has an air core coupled to a pulsator operable to subject the vest to pulses of air which applies and releases high frequency pressure forces to the body. The pulsator has two diaphragms connected to a brushless electric dc motor with rotary to reciprocating linear motion transmitting mechanisms comprising scotch yokes having anti-lash assemblies operable to generate air pulses in an air pulsing chamber. The diaphragms also increase the pressure in a manifold chamber. A check valve connects the manifold chamber with a pulsing chamber to allow pressurized air to flow from the manifold chamber into the pulsing chamber. An air flow control valve in communication with the manifold chamber is used to adjust the pressure of the air in the manifold and pulsing chambers. A programmable motor controller adjusts the duration of operation and speed of the motor to vary the operational time and frequency of the air pulses.

FIELD OF THE INVENTION

The invention is directed to a medical device and method to apply repetitive compression forces to the body of a person to aid blood circulation, loosening and elimination of mucus from the lungs of a person and relieve muscular and nerve tensions.

BACKGROUND OF THE INVENTION

Clearance of mucus from the respiratory tract in healthy individuals is accomplished primarily by the body's normal mucociliary action and cough. Under normal conditions these mechanisms are very efficient. Impairment of the normal mucociliary transport system or hypersecretion of respiratory mucus results in an accumulation of mucus and debris in the lungs and can cause severe medical complications such as hypoxemia, hypercapnia, chronic bronchitis and pneumonia. These complications can result in a diminished quality of life or even become a cause of death. Abnormal respiratory mucus clearance is a manifestation of many medical conditions such as pertussis, cystic fibrosis, atelectasis, bronchiectasis, cavitating lung disease, vitamin A deficiency, chronic obstructive pulmonary disease, asthma, and immotile cilia syndrome. Exposure to cigarette smoke, air pollutants and viral infections also adversely affect mucociliary function. Post surgical patients, paralyzed persons, and newborns with respiratory distress syndrome also exhibit reduced mucociliary transport.

Chest physiotherapy has had a long history of clinical efficacy and is typically a part of standard medical regimens to enhance respiratory mucus transport. Chest physiotherapy can include mechanical manipulation of the chest, postural drainage with vibration, directed cough, active cycle of breathing and autogenic drainage. External manipulation of the chest and respiratory behavioral training are accepted practices as defined by the American Association for Respiratory Care Guidelines, 1991. The various methods of chest physiotherapy to enhance mucus clearance are frequently combined for optimal efficacy and are prescriptively individualized for each patient by the attending physician.

Cystic fibrosis (CF) is the most common inherited life-threatening genetic disease among Caucasians. The genetic defect disrupts chloride transfer in and out of cells, causing the normal mucus from the exocrine glands to become very thick and sticky, eventually blocking ducts of the glands in the pancreas, lungs and liver. Disruption of the pancreatic glands prevents secretion of important digestive enzymes and causes intestinal problems that can lead to malnutrition. In addition, the thick mucus accumulates in the lung's respiratory tracts, causing chronic infections, scarring, and decreased vital capacity. Normal coughing is not sufficient to dislodge these mucus deposits. CF usually appears during the first 10 years of life, often in infancy. Until recently, children with CF were not expected to live into their teens. However, with advances in digestive enzyme supplementation, anti-inflammatory therapy, chest physical therapy, and antibiotics, the median life expectancy has increased to 30 years with some patients living into their 50's and beyond. CF is inherited through a recessive gene, meaning that if both parents carry the gene, there is a 25 percent chance that an offspring will have the disease, a 50 percent chance they will be a carrier and a 25 percent chance they will be genetically unaffected. Some individuals who inherit mutated genes from both parents do not develop the disease. The normal progression of CF includes gastrointestinal problems, failure to thrive, repeated and multiple lung infections, and death due to respiratory insufficiency. While some patients experience grave gastrointestinal symptoms, the majority of CF patients (90 percent) ultimately succumb to respiratory problems.

A demanding daily regimen is required to maintain the CF patient's health, even when the patient is not experiencing acute problems. A CF patient's CF daily treatments may include:Respiratory therapy to loosen and mobilize mucus;Inhalation therapy with anti-inflammatory drugs, bronchodilators and antibiotics for infections;Oral and intravenous antibiotics to control infection;Doses of Pulmozyme to thin respiratory mucus;20 to 30 pancreatic enzyme pills taken with every meal to aid digestion;a low-fat, high-protein diet;Vitamins and nutritional supplements; andExercise.
A lung transplant may be the only hope for patients with end stage cystic fibrosis.

Virtually all patients with CF require respiratory therapy as a daily part of their care regimen. The buildup of thick, sticky mucus in the lungs clogs airways and traps bacteria, providing an ideal environment for respiratory infections and chronic inflammation. This inflammation causes permanent scarring of the lung tissue, reducing the capacity of the lungs to absorb oxygen and, ultimately, sustain life. Respiratory therapy must be performed, even when the patient is feeling well, to prevent infections and maintain vital capacity. Traditionally, care providers perform Chest Physical Therapy (CPT) one to four times per day. CPT consists of a patient lying in one of twelve positions while a caregiver “claps” or pounds on the chest and back over each lobe of the lung. To treat all areas of the lung in all twelve positions requires pounding for half to three-quarters of an hour along with inhalation therapy. CPT clears the mucus by shaking loose airway secretions through chest percussions and draining the loosened mucus toward the mouth. Active coughing is required to ultimately remove the loosened mucus. CPT requires the assistance of a caregiver, often a family member but a nurse or respiratory therapist if one is not available. It is a physically exhausting process for both the CF patient and the caregiver. Patient and caregiver non-compliance with prescribed protocols is a well-recognized problem that renders this method ineffective. CPT effectiveness is also highly technique sensitive and degrades as the giver becomes tired. The requirement that a second person be available to perform the therapy severely limits the independence of the CF patient.

Artificial respiration devices for applying and relieving pressure on the chest of a person have been used to assist in lung breathing functions, and loosening and eliminating mucus from the lungs of CF persons. Subjecting the person's chest and lungs to pressure pulses or vibrations decreases the viscosity of lung and air passage mucus, thereby enhancing fluid mobility and removal from the lungs. These devices use vests having air-accommodating bladders that surround the chests of persons. Mechanical mechanisms, such as solenoid or motor-operated air valves, bellows and pistons are disclosed in the prior art to supply air under pressure to diaphragms and bladders in regular pattern or pulses. Manually operated controls are used to adjust the pressure of the air and air pulse frequency for each patient treatment and during the treatment. The bladder worn around the thorax of the CF person repeatedly compresses and releases the thorax at frequencies as high as 25 cycles per second. Each compression produces a rush of air through the lobes of the lungs that shears the secretions from the sides of the airways and propels them toward the mouth where they can be removed by normal coughing. External chest manipulation with high frequency chest wall oscillation was reported in 1966. Beck G JChronic Bronchial Asthma and Emphysema. Rehabilitation and Use of Thoracic Vibrocompression, Geriatrics(1966); 21: 139-158.

G. A. Williams in U.S. Pat. No. 1,898,652 discloses an air pulsator for stimulating blood circulation and treatment of tissues and muscles beneath the skin. A reciprocating piston is used to generate air pressure pulses which are transferred through a hose to an applicator having a flexible diaphragm. The pulsating air generated by the moving piston imparts relatively rapid movement to the diaphragm which subjects the person's body to pulsing forces.

J. D. Ackerman et al in U.S. Pat. No. 2,588,192 disclose an artificial respiration apparatus having a chest vest supplied with air under pressure with an air pump. Solenoid-operated valves control the flow of air into and out of the vest in a controlled manner to pulsate the vest, thereby subjecting the person's chest to repeated pressure pulses.

J. H. Emerson in U.S. Pat. No. 2,918,917 discloses an apparatus for exercising and massaging the airway and associated organs and loosening and removing mucus therefrom. A blower driven with a motor creates air pressure for a device that fits over a person's nose and mouth. A diaphragm reciprocated with an electric motor pulses the air flowing to the device and the person's airway. The speed of the motor is controlled to regulate the number of vibrations per minute.

R. F. Gray in U.S. Pat. No. 3,078,842 discloses a bladder for cyclically applying an external pressure to the chest of a person. A pressure alternator applies air pressure to the bladder. A pulse generator applies air pressure to the bladder to apply pressure pulses to the chest of the person.

R. S. Dillion in U.S. Pat. No. 4,590,925 uses an inflatable enclosure to cover a portion of a person's extremity, such as an arm or leg. The enclosure is connected to a fluid control and pulse monitor operable to selectively apply and remove pressure on the person's extremity.

W. J Warwick and L. G. Hansen in U.S. Pat. Nos. 4,838,263 and 5,056,505 disclose a chest compression apparatus having a chest vest surrounding a person's chest. A motor-driven rotary valve allows air to flow into the vest and vent air therefrom to apply pressurized pulses to the person's chest. An alternative pulse pumping system has a pair of bellows connected to a crankshaft with rods operated with a dc electric motor. The speed of the motor is regulated with a controller to control the frequency of the pressure pulses applied to the vest. The patient controls the pressure of the air in the vest by opening and closing the end of an air vent tube.

C. N. Hansen in U.S. Pat. Nos. 5,453,081 and 5,569,170 discloses an air pulsating apparatus for supplying pulses of air to an enclosed receiver, such as a vest located around a person's chest. The apparatus has a casing with an internal chamber containing a diaphragm. An electric operated device connected to the diaphragm is operated with a pulse generator to vibrate the diaphragm to pulse the air in the chamber. A hose connects the chamber with the vest to transfer air and air pulses to the vest which applies pressure pulses to the person's chest.

N. P. Van Brunt and D. J Gagne in U.S. Pat. Nos. 5,769,797 and 6,036,662 disclose an oscillatory chest compression device having a wall with an air chamber and a diaphragm mounted on the wall and exposed to the air chamber. A rod pivotally connected to the diaphragm and rotatably connected to a crankshaft transmits force to the diaphragm during rotation of the crankshaft. An electric motor drives the crankshaft at selected controlled speeds to regulate the frequency of the air pulses generated by the moving diaphragm. An air flow generator, shown as a blower, delivers air to the air chamber to maintain the pressure of the air in the chamber. Controls for the motors that move the diaphragm and rotate the blower are responsive to the air pressure pulses and pressure of the air in the air chamber. These controls have air pulse and air pressure responsive feedback systems that regulate the operating speeds of the motors to control the pulse frequency and air pressure in the vest.

C. N. Hansen in U.S. Pat. No. 6,488,641 discloses a pulsator operable to generate repetitive air pressure pulses used to apply pressure pulses to a human body. The pulsator has a scotch yoke motion transmitting mechanism for reciprocating diaphragms to generate repetitive air pressure pulses. A manually adjusted analog control coupled to a brush electric motor is used to control the speed of the motor and reciprocating frequency of the diaphragms. The control must be manually adjusted for each use and different users of the pulsator according to a prescribed or desired treatment. Manual adjustments of the speed of the motor to change the frequency of the pressure pulses can be made during use of the pulsator.

C. N. Hansen in U.S. Pat. No. 6,547,749 discloses a pulsator having two diaphragms connected to scotch yokes which transmits rotary motion of a brush dc electric motor to reciprocating motions of the diaphragm to generate air pressure and air pulses. The scotch yokes are subject to surface wear due to prolonged strains and friction resulting in vibrations and noise. A first manually operated control is used to select the frequency of the air pulses by controlling the speed of the motor. A second manually operated control is used to adjust the pressure of the air generated by the pulsator. These controls must be manually adjusted for each use and during use of the pulsator according to a prescribed or described treatment. The controls have manually turned knobs to adjust the pulse frequency and air pressure generated by the pulsator. The user must remember the frequency and previous air pressure or have written instructions for these settings for consistent treatment.

SUMMARY OF THE INVENTION

The invention is a medical device used to deliver high-frequency chest wall oscillations to promote airway clearance and improve bronchial drainage in humans. The primary components of the device include an air-pulse generator, an air inflatable vest, and a flexible hose coupling the generator to the vest for transmitting air pressure and pressure pulses from the generator to the vest. The vest includes an air core or bladder connected with the hose to the generator. Air pressure pulses subjected to the air core create repetitive high frequency pressure pulses that are transmitted to the thorax of a person wearing the vest whereby high frequency chest wall oscillations enhance mucus clearance in the person's respiratory system. The air pressure pulses are established with movable diaphragms located between air pumping chambers and an air pulsing chamber. Scotch yoke motion transmitting mechanisms change rotatory motion from a brushless dc electric motor to reciprocating movements of the diaphragms. The reciprocating diaphragms pump air to increase air pressure and pulse the air by increasing and decreasing air pressure in a chamber in communication with the hose. Each scotch yoke motion transmitting mechanism includes a yoke secured directly to a diaphragm, a shuttle slidably mounted on the yoke and an eccentric on a shaft rotatably mounted in the shuttle. An anti-lash assembly has a lash plate biased against the shuttle to compensate for manufacturing tolerances, thermal growth, and wear of the shuttle and yoke, to reduce stress and impact forces and inhibit vibrations and noise. The anti-lash assembly has a lash plate biased with springs into continuous engagement with the shuttle. A guide pin mounted on the yoke maintains the lash plate aligned with the shuttle. The power supply for the brushless dc motor includes a digital frequency control component that also controls the time or duration of operation of the device. The control component has memory microchips that store time and frequency data for ease and reliable use. A control panel has a screen having manual display coupled to time and frequency keys which are manually operated to change the time and frequency programs or change manual time and frequency operation of the device. The air pressure in the vest is regulated with an adjustable air flow restrictor that limits the flow of air into an air pumping chamber thereby controlling the pressure of the air in the air pumping chamber, air pulsating chamber and bladder of the vest.

The preferred embodiment of the body pulsating apparatus has a case with walls surrounding an air pulsing chamber. An elongated hose carries air and air pulses to an air core in a vest located about the upper body of a person. The case has an internal wall that separates the air pulsing chamber from an air manifold chamber. One or more one-way valves mounted on the internal wall allow air to flow from the air manifold chamber into the air pulsing chamber and prevent reverse flow of air back from the air pulsing chamber into the air manifold chamber. The case has top and bottom openings covered with diaphragms attached with flexible peripheral members to the case to enclose the air pulsing chamber. Located within the air pulsing chamber is a pair of linear reciprocating motion transmitting mechanisms for linearly moving the diaphragms in straight line opposite directions to pulse the air in the air pulsing chamber. The motion transmitting mechanisms are scotch yokes which provide the diaphragms with straight line harmonic motions. An electric brushless dc motor rotates a common shaft having a pair of eccentrics that laterally moves shuttles with respect to the yokes, and reciprocates yokes with respect to the yoke guides. The yokes are fixed directly to the diaphragms. Each scotch yoke includes an anti-lash assembly to compensate for wear of the shuttle and yoke, allow for thermal growth and relaxed manufacturing tolerances, and prevent movement of the shuttle normal to its lateral movements relative to the yoke to reduce stress and impact forces on the shuttle and inhibits vibrations and noise. The anti-lash assembly has a flat lash plate located in surface engagement with the top surface of the shuttle. A pair of compression coil springs mounted on the yoke bias the lash plate against the shuttle. A cylindrical guide pin fixed to the yoke extends into a hole in the lash plate to maintain the lash plate aligned with the shuttle and allow the lash plate to compensate for wear of the shuttle, yoke and lash plate. The operating speed of the motor is controlled with a motor controller wired to a screen and time and frequency adjusting keys. The controller is programmable to change the speed of the motor which is proportional to air pulse frequency in the air pulsing chamber. Covers located over the diaphragms attached to the casing have air pumping chambers in communication with the manifold chamber. The inward reciprocating movements of the diaphragms draws air through an air flow control into air manifold chamber and pumping chambers and the outward reciprocating movement of the diaphragms then compresses the air in the air manifold chamber and pumping chambers. The pressure of the air in the air manifold chamber is regulated with a manually adjustable air flow control valve. Restricting the flow of air into the manifold chamber reduces the pressure of the air in the air manifold chamber. When the pressure of the air in the air manifold chamber exceeds the air pressure in the air pulsing chamber, the one-way valve opens to allow air to flow into the air pulsing chamber. The reciprocating movements of the diaphragms pulse the pressurized air at a frequency determined by the speed of the electric brushless dc motor that drives the scotch yokes.

DESCRIPTION OF PREFERRED EMBODIMENT

The body pulsating apparatus, indicated generally at10inFIG. 1, has a vest11and an air pressure and pulse generator12operable to apply repetitive pressure pulses to the vest located about a human body to provide secretion and mucus clearance therapy. Respiratory mucus clearance is applicable to many medical conditions, such as pertussis, cystic fibrosis, atelectasis, bronchiectasis, cavitating lung disease, vitamin A deficiency, chronic obstructive pulmonary disease, asthma, and immobile cilia syndrome. Post surgical patients, paralyzed persons, and newborns with respiratory distress syndrome have reduced mucociliary transport. Apparatus10provides high frequency chest wall oscillations or pulses to enhance mucus and airway clearance in a person13with reduced mucociliary transport.

Vest11located around the person's upper body or thorax14is supported on the person's shoulders16and17. As shown inFIG. 2, vest11expanded into substantial surface contact with the exterior of upper body14functions to apply repeated compression or pressure pulses, shown by arrows18to body14. The reaction of body14to the pressure pulses causes repetitive expansion of the body when the pressure pulses are in the low pressure phase of the pressure cycle. The pressure pulses subjected to lungs19and21and trachea22provide secretions and mucus clearance therapy. The thoracic cavity occupies only the upper part of the thoracic cage and contains right and left lungs19and21, heart23, arteries24and26, and rib cage27. The repeated pressure pulses applied to thorax14stimulates heart23and blood flow in arteries24and26and veins in the chest cavity. Muscular and nerve tensions are also relieved by the repetitive pressure pulses imparted to the front, sides, and back portions of thorax14. The lower part of the thoracic cage comprises the abdominal cavity29which reaches upward as high as the lower tip of the sternum so as to afford considerable protection to the large and easily injured abdominal organs, such as the liver, spleen, stomach, and kidneys. The two cavities are separated by a dome-shaped diaphragm28. Rib cage27has twelve ribs on each side of the trunk. The ribs consist of a series of thin, curved, rather elastic bones which articulate posteriorly with the thoracic vertebrae. The spaces between successive ribs are bridged by intercostal muscles. The rib cage29aids in the distribution of the pressure pulses to the lungs19and21and trachea22.

Vest11has an outside cover31comprising a non-elastic material, such as a nylon fabric. Other types of materials can be used for cover31. Cover31is secured to a flexible inside liner32located adjacent and around body14. Liner32is a flexible fabric, such as a porous cotton fabric, that allows air to flow through the fabric toward body14. A closure device33, shown as a zipper, secures the bottom of liner32to an upwardly directed end portion34of cover31. An air core or bladder36having internal chamber37and a manifold passage38is located between cover31and liner32. A plurality of air passages39between passage38and chamber37allow air to flow upwardly into chamber37. An elongated coil spring41in the lower portion of air core36inside manifold passage38maintains the manifold passage38open. Other types of structures that maintain manifold passage38open and allow air to flow through passage38can be used in the lower portion of air core36. The end portion33of non-elastic cover31and coil spring41substantially reduces the inward pressure of the vest on the abdominal cavity29and organs therein and reduces stress on the digestive system. Air core36has a plurality of vertically aligned air flow control apertures42that restrict the flow of air from air core chamber37into the space between cover31and liner32. The air flowing through porous liner32ventilates and cools body14surrounded by vest11.

Returning toFIG. 1, vest11has a pair of upright shoulder straps43and44laterally separated with a concave upper back edge. Upright front chest portions46and47are separated from straps43and44with concave curved upper edges which allow vest11to fit under the person's arms. Releasable fasteners, such as loop pads48and49, secured to the outer surfaces of chest portions46and47cooperate with hook pads (not shown) secured to the insides of shoulder straps43and44to releasably connect shoulder straps43and44to chest portions46and47. Shoulder straps43and44extend forwardly over shoulders16and17and downwardly over chest portions46and47. The hook and loop pads are releasable VELCRO fasteners that connect shoulder straps43and44to chest portions46and47and hold chest portions46and47adjacent the front of body14.

Vest11has a first lateral end flap51extended outwardly at the left side of the vest. A rectangular loop pad52secured to the outside of the end flap51cooperates with hook pads on a second lateral end flap53on the right side of vest11to hold vest11around body14. The hook and loop pads are VELCRO fasteners that allow vest11to be tightly wrapped around body14.

As shown inFIG. 1, a releasable retainer54connected to the vest end flaps hold the flaps51and53in over lapped positions and prevents the releasable hook and loop fasteners52from disengaging during the application of repetitive pulse to the body14on the person13. Retainer54comprises an elongated strap56secured at one end thereof to chest portion53. Opposite ends of strap56have hook and loop releasable fasteners57that allow strap56to be fastened into a D-ring. A pair of D-rings58and59attached to chest portion46are aligned with strap56. Strap56is looped through D-ring58and connected with fasteners57to hold the vest end flaps51and53and vest11around the body14of the person. The free end of strap56can be quickly pulled to release fasteners57and disengage retainer54. C. N. Hansen and L. J. Helgeson in U.S. Pat. No. 6,676,614 disclose a vest operable to subject a person's thorax to pressure pulses.

In use, vest11is placed about the person's body14, as shown inFIG. 1, and held in place with shoulder straps43and44. Releasable fasteners48and49secure straps43and44to chest portions46and47. The vertical location of vest11on body14is adjusted by changing the connection relationship of straps43and44on releasable fasteners48and49. The circumferential location of vest11is maintained in a light fit around the person's body13with releasable fasteners52. Retainer54maintains fasteners52in engagement with each other and prevents disengagement during the pulsating of vest11. Strap56of retainer54is looped through one of the D-rings58,59and attached together with hook and loop fasteners57. Air pulsator12is then connected with hose61to tube62at and end of to apply repetitive pressure pulses to body14of person13.

Air pressure and pulse generator12is mounted in a case62having an open top and a cover63hinged to case62operable to close case62. A handle64pivotally mounted on case62is used as a hand grip to facilitate transport of generator12. Case62and cover63have overall dimensions that allow the case to be an aircraft carryon item.

Air pressure and pulse generator12has a top member66mounted on case62enclosing the operating elements of the generator. Top member66is not readily removable from case62to prohibit unauthorized adjustments and repairs of the operating components of the air pressure and pulse generator12. Top member67supports a main electric power switch67and a front panel68having time control keys69, an information display screen70, frequency control keys71and an air pressure manual control knob72. Time control keys69are electronic switches comprising an upper + key and a lower − key to selectively program an increase or decrease of a treatment cycle between 0 to 30 minutes. The selected time period is registered on screen70. Screen70is an electronic viewing display device, such as a liquid crystal display or a light-emitting organic material display. Frequency control keys71are electronic switches comprising an upper + key and a lower − key to selectively program an increase or decrease of the pulse frequency between 5 and 25 cycles per second or Hz. As shown inFIG. 1, time control key69, information display screen70, frequency control key71and air pressure control knob72are located on front panel68for user friendly convenience and use. The adjustment of the air pressure in air core36is controlled by manually turning knob72. The average air pressure in air core36is controlled between atmosphere pressure and one psi, as shown inFIG. 4by pressure scale73with numbers 10 to 100. The oscillating pressure pulses cycle above and below the selected average pressure.

As shown inFIGS. 5,6,7and11, air pressure and air pulse generator12has a combined air pulsator and pump unit78operable to create air pressure pulses, shown by arrows79, which are transported by hose61to air core36. Unit78has a rectangular case81having upright side walls82and83joined to end walls84and85. An internal wall86extended between and joined to side walls82and83separates an air pulsing chamber87from a manifold or vestibule chamber88. Manifold chamber88is between end wall85and inside wall86. The top and bottom of casing81is open. A pair of diaphragms89and91mounted on casing81close the casing openings to enclose the air pulsing chamber87located between diaphragms89and91. A first pan-shaped cover92secured to the top of case81with fasteners93is located outwardly of diaphragm89. The space between cover92and diaphragm89is a first pumping chamber94in fluid communication with manifold chamber88to allow air to flow into and out of chamber94. A second pan-shaped cover96secured to the bottom of case81with fasteners97is located outwardly from diaphragm91. The space between cover96and diaphragm91is a second air pumping chamber98in fluid communication with the manifold chamber88to allow air to flow between chambers88and98. Air flows from pumping chambers94and98into manifold chamber88and from manifold chamber88into pulsing chamber87through a one-way valve or check valve99, shown by arrow100inFIG. 14. Valve99when closed, as shown inFIG. 8, prevents the flow of air from pulsing chamber87back to manifold chamber88. Valve99, shown inFIG. 8, has a cylindrical housing101mounted on wall86. Housing101has a passage102open to chambers87and88accommodating a valving member or disk103movable between open and closed positions. A transverse pin104mounted on housing101retains disk103in passage102and provides a fulcrum for disk103to allow disk103to pivot to its open position. One or more one-way valves mounted on wall86can be used to permit air to flow from manifold chamber into pulsating chamber87and block reverse flow of air from pulsating chamber87back to manifold chamber88.

Diaphragm89has a rectangular rigid metal plate106joined to a peripheral flexible flange107of rubber or plastic. The inner portion of flange107is bifurcated and bonded to opposite sides of plate106. The outer portion of flange107is clamped with fasteners93between cover92and casing81. As shown inFIGS. 8,9,14and15, flange107has an opening108allowing air to flow between first pumping chamber94and manifold chamber88. Flexible flange107has a flexible convolution fold section109comprising upward and downward directed ribs that allow linear lateral movement of plate106without stretching and stressing the flexible material of flange107. Diaphragm91has a rigid metal plate11located on the bottom side of chamber87and parallel to plate106. A flexible flange112joined to plate106is clamped with fasteners97between casing81and cover96. Flange112has an opening113allowing air to flow between manifold chamber88and second pumping chamber98. A middle section of flange112around plate111has a flexible convolution fold section that allows linear lateral movement of plate111without stretching and stressing the flexible material of flange112.

Diaphragms89and91are linearly moved in opposite lateral directions with linear motion transmission assemblies indicated generally at116and117driven with a variable speed brushless dc electric motor118. A belt and pulley power transmission119driveably connects motor118to motion transmission assemblies116and117. As shown inFIGS. 11 and 13, motion transmission assembly116has a cross member121secured with fasteners122and123to casing side walls82and83. Member121has a pair of parallel upright guide surfaces124and126. A yoke127having opposite sides located in sliding engagement with guide surfaces124and126is secured to plate106with a pair of bolts128and129. Bolts128and129extended through holes131and132in plate107prevent relative movement, including pivotal movement, between yoke127and plate106. Yoke127has only linear reciprocating movement which prevents rocking and angular movement of diaphragm89during reciprocation thereof. As seen inFIG. 13, yoke127has a lateral opening or window133accommodating a slide block or shuttle134. Shuttle134has a bore accommodating an eccentric136mounted on a shaft137. Eccentric136is surrounded with a roller bearing138located in the bore of shuttle134. Yoke127, shuttle134, eccentric136and shaft137are known as a scotch yoke power transmission assembly.

As shown inFIGS. 16 to 18, bolts128and129secure the top of yoke127to diaphragm plate106. An anti-lash assembly200bears against the flat top surface209of shuttle134to maintain the bottom surface205of shuttle134in sliding surface contact with flat surface210of yoke127. Anti-lash assembly200compensates for manufacturing tolerances, thermal growth, and wear of shuttle surfaces205and209and adjacent yoke surfaces and maintains surfaces205,210and208,209in sliding contact to reduce stress and impact forces and inhibits vibrations and noise. A lash plate201has flat surface208located in sliding contact with shuttle flat surface209. Plate201is a steel member having a central cylindrical hole202accommodating a cylindrical guide pin203. Hole202can extend through plate201. Pin203is press fitted or secured into a cylindrical bore204in the top of yoke127. The lower end of pin203has a slip fit in hole202to allow lash plate201to move down to maintain surface engagement with the top surface209of shuttle134. Opposite ends206and207of lash plate201are maintained spaced from adjacent inside walls of yoke127with pin203. A pair of coil compression springs211and212bias lash plate201into continuous surface contact with the surface209of shuttle134. Springs211and212located in cylindrical bores213and214in the top of yoke127extend downwardly into cylindrical recess216and217in lash plate201. Other types of biasing members, such as elastic rubber or plastic cores, can be used for continuously biasing lash plate201down against shuttle134.

A second scotch yoke power transmission assembly operatively connected to plate111of diaphragm91comprises a yoke139secured with a pair of bolts140and141to plate111. Bolts140and141prevent relative movement, including pivotal movement, of yoke139relative to plate111whereby diaphragm91has only linear reciprocating movements. Yoke139has outside upright sides located in sliding engagement with upright guide surfaces142and143of a second cross member144which restricts movement of yoke139to reciprocating linear movement. Returning toFIG. 11, fasteners146and147secure cross member144to casing side walls82and83. Second cross member144is located adjacent first cross member121and rotatably accommodates the outer end of shaft137, as shown inFIGS. 8,14and15. Yoke139has an opening or window148slidably accommodating a slide block or shuttle149having a cylindrical bore for a roller bearing152and eccentric151secured to shaft137. Eccentric151is located diametrically opposite eccentric136, as shown inFIG. 14, so as to provide rotational balance to the scotch yoke power transmission assemblies.

An anti-lash assembly218, shown inFIGS. 8,12,14and15, biases a lash plate into continuous surface engagement with shuttle149of the scotch yoke secured to diaphragm plate111with bolts140and141. Anti-lash assembly218has the same structures and functions as anti-lash assembly shown inFIGS. 16 to 18.

Returning toFIG. 11, belt and pulley power transmission119has a small drive pulley153connected to drive shaft154of motor118. A first endless belt156located about pulley153and a large pulley157secured to a jack shaft158transmits power to shaft137with a small pulley162on jack shaft158and an endless belt163coupling pulley162to a large pulley164secured to shaft137. The small and large pulleys153,157and162,164provide power transmission119with speed reduction operation of shaft137. As shown inFIGS. 6,8and11, motion transmission assemblies116and117, and belt and pulley power transmission119are located in pulsing chamber87and are surrounded by casing81and diaphragms89and91. The isolation of the motion transmission assemblies116and117in chamber87reduces noise and protects these assemblies and belt and pulley power transmission119from external environmental contaminates.

As shown inFIG. 5, a brushless electric dc motor118mounted on a side of air pulsator and pump unit78is wired to a programmable power supply165for controlling the time of operation of the unit and the frequency of the generated air pulses. Power supply166is adapted to be connected to either 110 volt 60 cycle or 220 volt 50 cycle power sources. A manually operated switch67connects the power source to a circuit board166operable to supply dc power to a digital controller170wired to motor118and control panel keys69,71,74,75and76and screen70. Controller170has programmable electronics including dynamic random access memory micro chips for controlling the operating time and speed of motor118. Plus and minus time keys69are used to set the operation time of pulsator12between 0 and 30 minutes in 30 second intervals. Plus and minus frequency keys71are used to set the frequency of the air pulses by regulating the operating speed of motor118to adjust the pulse frequency between 5 and 25 pulses per second or Hz intervals. Manual and programmable data is displayed on screen70as hereinafter described.

The pressure of the air in manifold chamber88is controlled with a variable orifice proportional free-flow valve167operable to restrict or choke the flow of air into and out of manifold chamber88. Valve167has a body168having a passage169. An air flow restrictor171, shown as a threaded member, mounted on body168and extended into passage169regulates the flow of air through passage169into a tube172. Other types of air flow restrictors, such as a rotatable grooved ball or a movable disk, can be used to regulate air flow through valve167. The remote end of tube172is connected to an elbow173mounted on casing wall85. Elbow173has a passage174open to manifold chamber88to allow air to flow into manifold chamber88. A passage175in body168allows a limited amount of air to flow into passage174into manifold88. Passage175is a fixed air flow passage in body168that allows air to by-pass air flow restrictor171in user controlled variable air flow passage169so that the minimum treatment will not go down to zero. A cylindrical porous member176mounted on body168filters and allows air to flow into and out of passage169and attenuates noise of air flowing through passage169. Knob72is mechanically connected to restrictor171whereby rotation of knob72changes the restriction size of the air flow passage169and the rate of flow of air through passage169. The rate of air flow through passage169controls the volume of air that flows into and out of manifold chamber88. The volume of air in manifold chamber88and pumping chambers94and98is proportional to the pressure of the air in manifold chamber88generated by linear lateral movements of diaphragms89and91, shown by arrows177and178inFIG. 6. The adjustment of valve167regulates the pressure of the air in manifold chamber88, shown at183inFIG. 7. The air pressure in manifold chamber88follows a sine wave due to the harmonic linear reciprocating motion of diaphragms89and91. The pressure of the air in pulsing chamber87, shown at184, has a sine wave opposite the sine wave of air pressure183. When the air pressure in manifold chamber88exceeds the air pressure in pulsing chamber87, air flows from manifold chamber88, through one-way valve99into pulsing chamber87and from pulsing chamber into the air chamber37of air core36.

As shown inFIGS. 5 and 6, an air flow control member181having a longitudinal passage182is mounted on the air inlet side of elbow173. Member181modulates the air flow into and out of manifold chamber88to compensate for variations in air flow in tube172, valve167and porous member176.

In use, vest11is placed about the person's upper body or chest14, as shown inFIGS. 1 and 2. Shoulder straps43and44connected to loop pads48and49vertically support vest11on person13. The circumferential portion of vest11around body14is maintained in a comfortable snug fit with releasable connectors52and54. Air pressure and pulse generator12is connected to the air core36within vest11with flexible tube61. The remote end of tube61is connected to the air inlet end60of air manifold passage38of air core36. Person13or the care person sets knob72to select the air pressure within air core36. Manual operation of the air pressure and pulse generator12is selectively controlled by the user or another person. Power switch67is turned ON to power up the generator. As shown inFIG. 19, the WELCOME screen70will display WELCOME for 5 seconds and then automatically advance to HOME screen70displaying PROGRAMS 1-3 and MANUAL modes of operation. If no inputs are received the screen falls to the MANUAL screen which displays 10 minutes and 10 Hz. The user may press the switch associated with the word “MANUAL” on the display to advance to the MANUAL screen without waiting. Time operation can be reset in 30 second increments through a range from 30 seconds to 30 minutes with the use of the plus or minus keys69. Frequency is set in 1 Hz increments through the range from 5 to 20 Hz with the use of plus or minus keys71. Increment rate of time and frequency changes begin at a slow scroll rate of 0.5 seconds per increment for the first 5 increments and then a fast scroll rate of 0.25 seconds per increment. Actuation of the START key74begins running the generator and stores the time and frequency settings for later reset uses. Actuation of the HOME key76returns to HOME screen.

During the running of generator12the MANUAL screen displays the count down time in one second increments as shown inFIG. 20. Time cannot be reset while the generator12is running. Frequency can be reset in 1 Hz increments through the range from 5 to 20 Hz whether running or paused. The MANUAL screen70also displays the message TO STOP PRESS PAUSE while the generator is running. Pressing PAUSE key stops running the generator12and freezes the time display with the time remaining shown. The MANUAL screen displays PAUSED and remaining time and set Hz as shown inFIG. 21. Actuation of the START key74resumes running the generator12at the displayed time and frequency settings. After timing out to 00:00, generator12shuts off, sounds two beeps, and displays 00:00 for 5 seconds before re-displaying the last settings that were utilized and stored as described herein.

The program mode of air pressure and pulse generator12allows a user or caregiver to set three separate protocols, PROGRAMS 1, 2 or 3, that can be used each time a treatment is performed. This allows multiple users to save individual prescriptions or one user to set three different treatment protocols. Presetting treatment protocols prescribed by a physician into generator12permanently saves treatment settings which allows simple one-touch user control of treatments. Young children will not be able to skip portions of treatment. Older persons will not need to be attentive to the protocol thereby allowing other tasks, such as reading or computer work. Referring toFIG. 22, there is shown the sequence to set PROGRAM 1. When switch67is turned ON screen70will display WELCOME for 5 seconds and then change to HOME screen for 10 seconds. If no input is received or MANUAL display lower right key71is touched, screen70falls to MANUAL screen. Pressing the time or frequency key next to PROGRAM 1, PROGRAM 2, or PROGRAM 3 during the 10 second input period flows control to INITIAL PROGRAM screen. Upon arriving at this screen, the top line will display the selected program number, shown as PROGRAM 1. This program number, for example PROGRAM 1, will remain until the user has chosen whether to execute or reset the program. SET key75is then pressed to begin presetting the prescribed protocol. START key74is pressed to execute a previously existing program. HOME key76is actuated to return to the HOME screen.

The time and frequency data can be changed when SET key75is actuated. The program for treatment sequences begins with line A which is highlighted reverse video across the entire line A. Time keys69are used to reset in 30 second increments through the range from 00:00 to 30:00 minutes. Frequency keys76are used to set the frequency in 1 Hz increments through the range from 5 to 25 Hz. Pressing SET key69stores the displayed values for time and frequency for line A and scrolls to line B. If the user does not want to change time or frequency of line B, pressing SET key75will scroll to line C. The time and frequency values for lines B, C, D, E. or F can be changed with the use of time key69and frequency key71. Pressing SET key75from the last line reverts to line A and looping through all the lines until START key74or HOME key76is pressed. Pressing START key74at any time begins running generator12. PROGRAM 2 and PROGRAM 3 are changed according to the method described with respect to PROGRAM 1.

FIGS. 23 to 26diagram the user interface for a different program, identified as PROGRAM 3. The HOME screen is used to activate PROGRAM 3. The HOME screen is used to activate PROGRAM 3. The SET control75is used to program the treatment sequences, beginning with line A. The line that is active for changing values is displayed with highlighting reverse video across the entire line as shown inFIG. 23. Time can be re-set in 30 second increments through the range from 00:00 to 30:00 minutes with time control keys69. Frequency is set in 1 Hz increments through the range from 5 to 20 Hz with frequency control keys71. The increment rate of time and frequency changes begins at a slow scroll rate of 0.5 seconds per increment for the first five increments and then a fast scroll rate of 0.25 seconds per increment. Pressing START at any time begins running generator12. Pressing SET stores the displayed values for time and frequency for the displayed line and scrolls to the next line. If the user does not want to change time or frequency, pressing SET will scroll to the next line. Pressing SET from the last line reverts to line A and loops A through F until START or HOME is pressed. Pressing HOME at any time returns to HOME screen shown inFIG. 19. Pressing START begins to execute the displayed program. The execution of the program will immediately scroll past any lines whose time entry is 00:00. Time and frequency values cannot be changed at any time in the execution mode whether running or paused. The remaining time value is displayed while running and continuously counting down. The user can press PAUSE any time that generator12is running, causing generator12to stop and display the word PAUSED, as shown inFIG. 26, in place of the line letter. The remaining time is displayed while paused. When generator12is running, HOME is an inactive button. Generator12stops and beeps twice when the timer runs down to 00:00. When generator12stops the message TREATMENT COMPLETE displays on screen70. The display then scrolls up to the WELCOME screen shown inFIG. 22. Generator12is ready for new START, SET or HOME instructions.

The user or caregiver can test the operations of generator12regarding accumulated run time, test with vest, test without vest and motor temperature limits. The accumulated run time is displayed on screen70by pressing and hold SET key75during any display of the HOME screen. The accumulated run time is displayed in 4-digit hours as long as SET key75is pressed. Pressing and holding HOME key76before and during power-up causes the system to wake-up in the test operations mode, initially in the test with vest screen. START key74is pressed to begin the test. Air pressure knob72is set on 50. If the specified air pressure is achieved the system has passed the test. When the specified air pressure is not reached the second test without the vest is conducted. The vest end of hose61is plugged and the pressure adjusted to 10. The test begins by pushing START key75. If the specified pressure is reached the vest needs service. In the event that the specified pressure is not reached, the system needs service. HOME key76is pressed to skip the test. Motor118is prevented from starting while any motor operating temperature limit is outside the allowable limits of motor too hot or motor too cold. The motor operating temperature limits are factory set with the low temperature limit of 50 degrees F. and the high temperature limit of 200 degrees F. The motor operating temperature limits can be factory adjusted to other low and high temperatures.

An alternative mode of operation of generator12has a random program in addition to the manual and programmed modes of operation described herein. The random program has a frequency between 5 and 25 Hz without a definite pattern during a set time period. The controller170has memory electronic components that randomly alter the speed of motor118thereby changing the frequency of the air pulses and pressure pulses subjected to a person's body. The changes in pressure pulses mitigate wearisome uniformity and monotony.

As shown inFIGS. 6,8,11,14and15, motor118through power transmission119rotates shaft137and turns eccentrics136and151about the axis of shaft137. Eccentrics136and151laterally move slide blocks or shuttles134and149relative to yokes127and139and linearly reciprocate yokes127and139. Diaphragms89and91directed secured with bolts128,129,140and141to yokes127and139are linearly moved outwardly, shown by arrows186and187inFIGS. 12,13and15, and inwardly, shown by arrows117and178inFIGS. 6 and 15. The anti-lash assemblies200and218associated with the scotch yoke motion transmission mechanisms eliminate vertical movements of shuttles134,149relative to yokes127,139to inhibit vibrations and noise. As shown inFIG. 15, when diaphragms89and91are linearly moved inwardly toward each other air flows from manifold chamber88into pumping chamber94and98. A restricted amount of air flows through valve167and air flow control member181into manifold chamber88. Knob72is adjusted to control air flow through valve167thereby control the amount and pressure of air in manifold chamber88. Inward movement of diaphragms89and91increase the pressure of air in pulsing chamber87closing one-way valve99and transferring air under pressure through hose61to air core36. Air core36expands inwardly to retain flexible liner32of vest11in firm engagement with the chest and back of person13. Linear inward and outward movements of diaphragms89and91generate air pressure pulses in chamber87and air core36which applies repetitive forces, shown by arrows18, to the chest and back of person13to simultaneously apply high frequency oscillation therapy to all lobes of the lungs and airway passages to enhance removal of mucus, secretions, and like materials therefrom.

As shown inFIGS. 12 to 14, outward linear movements of diaphragms89and91force air out of pumping chambers into manifold chamber88thereby increasing the pressure of the air in manifold chamber88. When the pressure of the air in manifold chamber88exceeds the pressure of the air in pumping chamber87, one-way valve99opens to allow air to flow from manifold chamber88into pulsing chamber87, shown by arrow100inFIG. 14, thereby increasing the pressure of the air in pulsing chamber87and air core36. One-way valve99closes in response to a drop in air pressure in manifold chamber88and prevents back flow of air from pulsing chamber87into manifold chamber88. The size of passage182limits the amount of air that can flow into manifold chamber88thereby preventing excess pressure of air in manifold chamber88in the event that valve167becomes inoperative. Hole175in valve body168allows a limited amount of air to flow into and out of manifold chamber88to maintain a minimum pressure of air in pulsing chamber87and air core36in the event that valve167is closed.

Diaphragms89and91when linearly moved in opposite directions by the linear motion transmission assemblies116and117repetitively perform the dual functions of establishing air pressure and pulsing the air in pulsing chamber87and air core36. The frequency of air pulses is controlled between 5 and 25 cycles per second by varying the speed of brushless dc motor118. Control panel keys71used by person13or the caregiver to program the speed of motor118to change the pulse frequency of the air pulses in pulsing chamber87and air core36. Duration of operation of pulsator12is programmed with time keys69. The valve167restricts the flow of air into and out of manifold chamber88to regulate the pressure of the air in manifold chamber88which is transferred through check valve99to pulsing chamber87responsive to the linear movements of diaphragms89and91.

Hose61directs air under pressure and air pulses to air manifold passage38in the bottom of air core36. An elongated coiled spring41within air core36maintains passage38open to allow air to flow through openings39upwardly into air chamber37. The air pulsing in chamber37applies inwardly and upwardly directed pulsing forces to the person's rib cage27which transfers the pulsing forces to the lungs and airway passages. The outer cover31of vest11being non-elastic material limits outward expansion of air core36. Outer cover31extended around the lower portion of air core36containing coil spring36limits inward pressure of air core36on the person's abdomen. The frequency of the pulses range from 5 to 25 cycles per second. The pulse forces loosen mucus and secretions from the lungs and airway passages toward the mouth where they can be removed by normal coughing. Air core36has a plurality of small openings or holes42which allow limited amounts of air to flow out of chamber37into vest11. The air ventilates and cools the upper body14surrounded by vest11and deflates air core36when air pressure and pulse generator12is turned OFF.

The body pulsating apparatus and method has been described as applicable to persons having cystic fibrosis. The body pulsating apparatus and method is applicable to bronchiectasis persons, post-surgical atelectasis, and stage neuromuscular disease, ventilator dependent patients experiencing frequent pneumonias, and persons with reduced mobility or poor tolerance of Trendelenburg positioning. Person with secretion clearance problems arising from a broad range of diseases and conditions are candidates for therapy using the body pulsating apparatus and method of the invention.

The present disclosure is a preferred embodiment of the body pulsating apparatus and method. It is understood that the body pulsating apparatus is not to be limited to the specific materials, constructions, arrangements and method of operation shown and described. It is understood that changes in parts, materials, arrangement and locations of structures may be made without departing from the invention.