None.
The invention relates to a medical device operable with a thoracic therapy garment and method to apply repetitive compression forces to the body of a person to aid blood circulation, loosen and eliminate mucus from the lungs and trachea and relieve muscular and nerve tensions.
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, immotile cilia syndrome and neuromuscular conditions. 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. 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 50s 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 persons experience grave gastrointestinal symptoms, the majority of CF persons (90 percent) ultimately succumb to respiratory problems.
Virtually all persons with cystic fibrosis (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 person 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 person 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 person 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 person.
Persons confined to beds and chairs having adverse respiratory conditions, such as CF and airway clearance therapy, are treated with pressure pulsating devices that subject the person's thorax with high frequency pressure pulses to assist the lung breathing functions and blood circulation. The pressure pulsating devices are operatively coupled to thoracic therapy garments adapted to be worn around the person's upper body. In hospital, medical clinic, and home care applications, persons require easy application and low cost disposable thoracic garments connectable to portable air pressure pulsating devices that can be selectively located adjacent the left or right side of the persons.
Artificial pressure pulsating devices for applying and relieving pressure on the thorax 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. An example of a body pulsating method and device disclosed by C. N. Hansen in U.S. Pat. No. 6,547,749, incorporated herein by reference, has a case accommodating an air pressure and pulse generator. A handle pivotally mounted on the case is used as a hand grip to facilitate transport of the generator. The case including the generator must be carried by a person to different locations to provide treatment to individuals in need of respiratory therapy. These devices use vests having air-accommodating bladders that surround the chests of persons. An example of a vest used with a body pulsating device is disclosed by C. N. Hansen and L. J. Helgeson in U.S. Pat. No. 6,676,614. The vest is used with an air pressure and pulse generator. 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 a regular pattern or pulses. Manually operated controls are used to adjust the pressure of the air and air pulse frequency for each person 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. Examples of chest compression medical devices are disclosed in the following U.S. Patents.
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 located in a housing located on a table 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. The apparatus must be carried by a person to different locations to provide treatment to persons in need of respiratory therapy.
M. Gelfand in U.S. Pat. No. 5,769,800 discloses a vest design for a cardiopulmonary resuscitation system having a pneumatic control unit equipped with wheels to allow the control unit to be moved along a support surface.
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 an air pulse generator including 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. A blower delivers air to the air chamber to maintain a positive pressure above atmospheric 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. The air pulse generator is a mobile unit having a handle and a pair of wheels.
C. N. Hansen in U.S. Pat. No. 6,547,749 also discloses a body pulsating apparatus having diaphragms operatively connected to a dc motor to generate air pressure pulses directed to a vest that subjects a person's body to high frequency pressure forces. A first manual control operates to control the speed of the motor to regulate the frequency of the air pressure pulses. A second manual control operates an air flow control valve to adjust the pressure of the air directed to the vest thereby regulating the vest pressure on the person's body. An increase or decrease of the speed of the motor changes the frequency of the air pressure pulses and the vest pressure on the person's body. The second manual control must be used by the person or caregiver to adjust the vest pressure to maintain a selected vest pressure.
C. N. Hansen, P. C. Cross and L. H. Helgeson in U.S. Pat. No. 7,537,575 discloses a method and apparatus for applying pressure and high frequency pressure pulses to the upper body of a person. A first user programmable memory controls the time of operation of a motor that operates the apparatus to control the duration of the supply of air under pressure and air pressure pulses to a vest located around the upper body of the person. A second user programmable memory controls the speed of the motor to regulate the frequency of the air pressure pulses directed to the vest. A manual operated air flow control valve adjusts the pressure of air directed to the vest thereby regulating the vest pressure on the person's upper body. An increase or decrease of the speed of the motor changes the frequency of the air pressure pulses and changes the vest pressure on the person's upper body. The manually operated air flow control valve must be used by the person or caregiver to maintain a selected vest pressure. The vest pressure is not programmed to maintain a selected vest air pressure.
N. P. Van Brunt and M. A. Weber in U.S. Pat. No. 7,121,808 discloses a high frequency air pulse generator having an air pulse module with an electric motor. The module includes first and second diaphragm assemblies driven with a crankshaft operatively connected to the electric motor. The air pulse module oscillates the air in a sinusoidal waveform pattern within the air chamber assembly at a selected frequency. A steady state air pressure is established in the air chamber with a blower driven with a separate electric motor. A control board carries electronic circuitry for controlling the operation of the air pulse module. Heat dissipating structure is used to maximize the release of heat from the heat generated by the electronic circuitry and electric motors.
The invention is a medical device and method to deliver high-frequency thoracic wall oscillations to promote airway clearance and improve bronchial drainage in humans. The primary components of the device include an air pulse generator with user programmable time, frequency and pressure controls, an air inflatable thoracic garment, and a flexible hose coupling the air pulse generator to the thoracic garment for transmitting air pressure and pressure pulses from the air pulse generator to the thoracic garment. The air pulse generator has an air displacer assembly that provides consistent and positive air displacement, air pressure and air flow to the thoracic garment. The air displacer assembly has two rigid one-piece members or displacers that angularly move relative to each other to draw air from an air flow control valve and discharge air pressure pulses at selected frequencies to the thoracic garment. An alternative air displacer assembly has one rigid one-piece displacer that angularly moves to draw air from an air flow control valve and discharge air pressure pulses at selected frequencies to the thoracic garment to subject the thoracic wall of a person to high-frequency oscillations. Diaphragms and elastic members are not used in the air displacer assembly. A power drive system including separate power transmission assemblies having eccentric crankshafts angularly move the rigid displacers in opposite directions. These eccentric crankshafts of the power transmission assemblies are driven by a variable speed electric motor regulated with a programmable controller. The air pulse generator is shown mounted on a portable pedestal having wheels that allow the generator to be moved to different locations to provide therapy treatments to a number of persons. The portable pedestal allows the air pulse generator to be located adjacent opposite sides of a person confined to a bed or chair. The pedestal includes a linear lift that allows the elevation or height of the air pulse generator to be adjusted to accommodate different locations and persons. The thoracic therapy garment has an elongated flexible bladder or air core having one or a plurality of elongated generally parallel chambers for accommodating air. An air inlet connector joined to a lower portion of the air core is releasably coupled to a flexible hose joined to the air pulse outlet of the air pulse generator. The thoracic therapy garment may be reversible with a single air inlet connector that can be accessed from either side of a person's bed or chair. The air pulse generator includes a housing supporting air pulse generator controls for convenient use. The air pulse generator controls include a control panel having user interactive controls for activating an electronic memory program to regulate the time or duration of operation of the air pulse generator, the frequency of the air pulses and the pressure of the air pulses directed to the therapy garment. The pressure of the air established by the air pulse-generator is coordinated with the frequency of the air pulses whereby the air pressure is substantially maintained at a selected pressure when the pulse frequency is changed.
A human body pulsing apparatus 10 for applying high frequency pressure pulses to the thoracic wall 69 of a person 60, shown in
Human body pulsing apparatus 10 is a device used with a thoracic therapy garment 30 to apply pressure and repetitive high frequencies pressure pulses to a person's thorax 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. Air pulse generator 11 through hose 61 provides high frequency chest wall oscillations or pulses to a person's thorax enhance mucus and airway clearance in a person with reduced mucociliary transport. High frequency pressure pulses subjected to the thorax in addition to providing respiratory therapy to a person's lungs and trachea.
As shown in
Private care homes, assisted living facilities and clinics can accommodate a number of persons in different rooms or locations that require respiratory therapy or high frequency chest wall oscillations as medical treatments. Air pulse generator 11 can be manually moved to required locations and connected with a flexible hose 61 to a thoracic therapy garment 30 located around a person's thorax. Air pulse generator 11 can be selectively located adjacent the left or right side of a person 60 who may be confined to a bed or chair.
Pedestal 29 has an upright gas operated piston and cylinder assembly 31 mounted on a base 32 having outwardly extended legs 33, 34, 45, 36 and 37. Other types of linear expandable and contractible devices can be used to change the location of generator 11. Caster wheels 38 are pivotally mounted on the outer ends of the legs to facilitate movement of body pulsating apparatus 10 along a support surface. One or more wheels 38 are provided with releasable brakes to hold apparatus 10 in a fixed location. An example of a pedestal is disclosed by L. J. Helgeson and Michael W. Larson in U.S. Pat. No. 7,713,219, incorporated herein by reference. Piston and cylinder assembly 31 is linearly extendable to elevate air pulse generator 11 to a height convenient to the respiratory therapist or user. A gas control valve having a foot operated ring lever 39 is used to regulate the linear extension of piston and cylinder assembly 31 and resultant elevation of pulse generator 11. Air pulse generator 11 can be located in positions between its first (closed) and second (open) positions. Lever 39 and gas control valve are operatively associated with the lower end of piston and cylinder assembly 31.
A frame assembly 41 having parallel horizontal members 42 and 43 and a platform 44 mounts housing 12 of air pulse generator 11 on top of upright piston and cylinder assembly 31. The upper member of piston and cylinder assembly 31 is secured to the middle of platform 44. The opposite ends 46 of platform 44 are turned down over horizontal members 42 and 43 and secured thereto with fasteners 48. Upright inverted U-shaped arms 51 and 52 joined to opposite ends of horizontal members 42 and 43 are located adjacent opposite side walls 26 and 27 of housing 12. U-shaped handles 56 and 57 are joined to and extend outwardly from arms 51 and 52 provide hand grips to facilitate manual movement of the air pulse generator 11 and pedestal 29 on a floor or carpet. An electrical female receptacle 58 mounted on side wall 27 faces the area surrounded by arm 51 so that arm 51 protects the male plug (not shown) that fits into receptacle 58 to provide electric power to air pulse generator 11. A tubular air outlet sleeve is mounted on side wall 26 of housing 12. Hose 61 leading to thoracic therapy garment 30 telescopes into the sleeve to allow air, air pressure and air pulses to travel through hose 61 to thoracic therapy garment 30 to apply pressure and pulses to a person's body.
Thoracic therapy garment 30, shown in
As shown in
Screen 24 of control panel 23 may have three user interactive controls 109, 110 and 111. Control 109 is a time or duration of operation of motor 101. For example, the time can be selected from 0 to 30 minutes. Control 110 is a motor speed regulator to control the air pulse frequency for example between 5 and 20 cycles per second or Hz. A change of the air pulse frequency results in either an increase or decrease of the air pressure in garment 30. The pressure of the air in garment 30 is selected with the use of average or bias air pressure control 111. The changes of the time, frequency and pressure may be manually altered by applying finger pressure along the controls 109, 110 and 111. Control panel may include a start symbol 112 operable to connect air pulse generator 11 to an external electric power source. Set and home symbols 113 and 114 may be used to embed the selected time, frequency, and pressure in the memory data of controller 106. A cable 116 wires controller 106 with control panel 23. One or more cables 117 wire control panel 23 to controller 106 whereby the time, frequency and pressure signals generated by slider controls 109, 110 and 111 are transmitted to controller 106. Other types of panels and devices, including tactile switches in the form of resistive or capacitive technologies and dials can be used to provide user input to controller 106.
The air pressure in garment 30 is regulated with a first member shown as a proportional air flow control valve 118 having a variable orifice operable to restrict or choke the flow of air into and out of air pulse generator 11. Valve 118 has a body 119 having a first passage 121 to allow air to flow through body 119. An air flow control member or restrictor 122 having an end extended into the first passage regulates the flow of air through passage 121 into tube 131. Body 119 has a second air bypass passage 123 that allows a limited amount of air to flow into tube 131. The air in passage 123 bypasses air flow restrictor 122 whereby a minimum amount of air flows into air pulse generator 11 so that the minimum therapy treatment will not go down to zero. A filter 124 connected to the air inlet end of body 119 filters and allows ambient air to flow into and out of valve 118. Air flow restrictor 122 is regulated with a second member shown as a stepper motor 126. Stepper motor 126 has natural set index points called steps that remain fixed when there is no electric power applied to motor 126. Stepper motor 126 is wired with a cable 127 to controller 106 which controls the operation of motor 126. An example of a stepper motor controlled metering valve is disclosed by G. Sing and A. J. Horne in U.S. Patent Application Publication No. US 2010/0288364. The stepper motor control is described by L. J. Helgeson and M. W. Larson in U.S. Provisional Patent Application Ser. No. 61/573,238, incorporated herein by reference. Other types of air flow meters having electronic controls, such as a solenoid control valve, a rotatable grooved ball valve or a movable disk valve, can be used to regulate the air flow to air pulse generator 11. An orifice member 128 has a longitudinal passage 129 located in tube 131. Orifice member 128 limits the maximum air flow into and out of air pulse generator 11 to prevent excessive air pressure in garment 30.
As shown in
A second housing 144 joined to adjacent interior wall 134 accommodates a cover 146 enclosing a manifold chamber 148, shown in
As shown in
As shown in
As shown in
Power transmission assembly 189 is operatively associated with displacer 152 and arm 178 to angularly move displacer 152 toward and away from displacer 153 to draw air into pumping chamber 137 and compress and pulse air in pulsing chamber 177. Power transmission assembly 189 includes a crankshaft having a shaft 191 with one end rotatably mounted on end wall 136 with a bearing 192. The opposite end of shaft 191 is rotatably mounted on interior wall 134 with a bearing 193. Other structures can be used to rotatably mount shaft 191 on housing walls 134 and 136. Crankshaft includes a crank pin 194 offset from the axis of rotation of shaft 191. A first pair of cylindrical roller members 196 rotatable mounted on crank pin 194 engage a first pad 197 retained in a recess in middle section 162 of displacer 152. A second pair of cylindrical roller members 198 rotatably mounted on crank pin 194 engage a second pad 199 retained in a recess in middle section 162 of displacer 152. Roller members 196 and 198 are axially spaced on opposite sides of arm 178. As seen in
Second air displacer 153 has the same structure as first air displacer 152. Axles or pins 203 pivotally mount the rear section of displacer 153. The axial axis of pins 203 is parallel to the axial axis of pins 154 and 156. The entire outer peripheral edges of displacer 153 has a seal 204 located in engagement with curved surfaces 206 and 207 of housing 100 as shown in
As shown in
In use, as shown in
As shown in
A modification of the air pulse generator 300, shown in
A power drive system 323 driven with an electric motor 324 rotates crankshafts 314 and 320 whereby the crankshafts concurrently angularly move displacers 304 and 306. Power drive system 323 has a first power train assembly 326 driving a second power train assembly 327 that rotates crankshafts 314 and 320. First power train assembly 326 has a drive timing pulley 328 mounted on motor drive shaft 329 engageable with an endless tooth belt 331 located around a driven timing pulley 332. Pulley 332 is secured to a shaft 333 retained in a bearing 334 mounted on a fixed support 336. Support 336 is attached to housing 307 with fasteners 337 and 338. Second power train assembly 327 has a drive timing pulley 339 mounted on shaft 333. A bearing 334 holds shaft 333 on support 336. Belt 341 extended around timing pulleys 339, 342 and 343 rotates pulleys 342 and 343 mounted on crankshafts 314 and 320 thereby rotating crankshafts 314 and 320 and angularly moving displacers 304 and 306 relative to each other. The movement of displacers 304 and 306 draws air into manifold chamber 308 and through openings 309 and 311 into pumping chambers 312 and 313. When the air pressure in pumping chambers 312 and 313 is greater than the air pressure in pulsing chamber 315, the air flows through the check valves from pumping chambers 312 and 313 into pulsing chamber 315. When the displacers 304 and 306 move toward each other, air pressure and air pulses are forced into hose 61 and carried by hose 61 to the air core 35 of garment 30. The air pressure and air pulses in air core 35 of garment 30 subjects the thoracic wall of the person with repetitive forces.
The body pulsing apparatus and method has been described as applicable to persons having cystic fibrosis. The body pulsing 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 position. 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 body pulsating apparatus and method disclosed herein has one or more angularly movable air displacers and programmed controls for the time, frequency and pressure operation of the air pulse generator and method. It is understood that the body pulsating apparatus and method is not limited to specific materials, construction, arrangements and method of operation as shown and described. Changes in parts, size of parts, materials, arrangement and locations of structures may be made by persons skilled in the art without departing from the invention.
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