`
`(19) World Intellectual Property Organization
`International Bureau
`
`
`
`(43) International Publication Date
`9 April 2009 (09.04.2009)
`
`International Patent Classification:
`
`AOGILTE 31/00 (2006.01)
`
`International Application Number:
`PCT/US2008/01 1245
`
`International Filing Date:
`29 September 2008 (29.09.2008)
`
`(25)
`
`Filing Language:
`
`Publication Language:
`
`English
`
`English
`
`(84)
`
`(10) International Publication Number
`WO 2009/045358 Al
`
`AO,AT, AU, AZ, BA, BB, BG, BH, BR, BW,BY, BZ, CA,
`CH, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE,
`EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID,
`IL, IN,IS, JP, KE, KG, KM,KN,KP, KR, KZ, LA, LC, LK,
`LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW,
`MX, MY, MZ, NA, NG, NI, NO, NZ, OM,PG, PH,PL,PT,
`RO, RS, RU,SC, SD, SE, SG, SK, SL, SM,ST,SV, SY, TJ,
`TM,TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM,
`ZW.
`
`Designated States (unless otherwise indicated, for every
`kind of regional protection available): ARIPO (BW, GH,
`GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM,
`ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM),
`European (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI,
`FR, GB, GR, HR, HU,IE,IS, IT, LT, LU, LV, MC, MT, NL,
`NO,PL, PT, RO, SE, SI, SK, TR), OAPI (BF, BJ, CF, CG,
`CI, CM, GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG).
`
`Priority Data:
`11/906,793
`
`3 October 2007 (03.10.2007)
`
`US
`
`Applicant (for ail designated States except US): ELEC-
`TROMED,INC. [US/US]; A Corporation Of Minnesota,
`US, 502 Sixth Avenue NW, New Prague, MN 56071 (US).
`
`Inventors: HELGESON,Lonnie, J.; 502 Sixth Avenue
`NW, New Prague, S{N 56071 (US). LARSON, Michael,
`W.,; 502 Sixth Avenue NW, New Prague, MN 56071 (US).
`
`Agent: BARTZ, Richard, John; 6750 France Avenuc
`South, No. 350, Edina, MN 55435 (US).
`
`Declarations under Rule 4.17:
`
`as to applicant’s entitlement to apply for and be granted a
`patent (Rule 4.17(ii))
`as to the applicant’s entitlement to claim the priority of the
`earlier application (Rule 4.17(iii))
`
`Published:
`
`GS)
`
`(21)
`
`(22)
`
`(26)
`
`(39)
`
`(71)
`
`(72)
`
`(74)
`
`(81)
`
`
`
`2009/045358AqINITIATETUTAICA
`
`Designated States (unless otherwise indicated, for every
`kind of national protection available): AE, AG, AL, AM,
`
`with international search report
`with amended claims and statement
`
`(54) Title: PORTABLE AIR PULSATOR AND THORACIC THERAPY GARMENT
`
`
`
`la —s
`FiG.1 ™ ay
`
`(57) Abstract: A portable human bodypulsating apparatus (10) has anair pulse generator(1 1) mounted ona pedestal (29) having
`© wheels (38)to facilitate movementof the apparatus (10) on a surface. The pedestal (29) has an upright piston and cylinder assembly
`(31) operable to adjust the elevation of the air pulse generator (11). A reversible thoracic therapy garment(30) is connected with a
`WwW
`hose (61) to an air pulse generator (1 1) which can beselectively located adjacent opposite sides of a person (60) receiving therapy.
`
`
`
`WO 2009/045358
`
`PCT/US2008/011245
`
`PORTABLE AIR PULSATOR AND THORACIC THERAPY GARMENT
`
`FIELD OF THE INVENTION
`
`[0001] The invention relates to a portable medical device operable with a thoracic therapy
`
`garmentto apply repetitive compression forces to the bodyof a personto aid blood
`
`circulation, loosen and eliminate mucus from the lungs and trachea and relieve muscular and
`
`nerve tensions.
`
`BACKGROUNDOF THE INVENTION
`
`[0002] Clearance of mucusfrom therespiratory tract in healthy individuals is accomplished
`
`primarily by the body's normal mucociliary action and cough. Under normal conditions these
`
`mechanismsare very efficient. Impairment of the normal mucociliary transport system or
`
`hypersecretion of respiratory mucus results in an accumulation of mucus and debrisin 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 becomea cause of death. Abnormalrespiratory mucusclearance is a manifestation of
`
`15
`
`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.
`
`20
`
`[0003] Chest physiotherapy has hada long history of clinical efficacy andis 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 methodsof chest
`
`
`
`WO 2009/045358
`
`*PCT/US2008/011245
`
`physiotherapy to enhance mucus clearance are frequently combined for optimal efficacy and
`
`are prescriptively individualized for each patient by the attending physician.
`
`[0004] Cystic fibrosis (CF) is the most commoninherited life-threatening genetic disease
`
`among Caucasians. The genetic defect disrupts chloride transfer in and outofcells, causing
`
`the normal mucus from the exocrine glands to becomevery thick and sticky, eventually
`
`blocking ducts of the glandsin the pancreas, lungs and liver. Disruption of the pancreatic
`
`glandsprevents secretion of important digestive enzymes and causesintestinal problemsthat
`
`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
`
`10
`
`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 advancesin digestive enzyme supplementation, anti-inflammatory
`
`therapy, chest physical therapy, and antibiotics, the median life expectancy has increased to
`
`30 years with somepatients living into their 50s and beyond. CFis inherited through a
`
`15
`
`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 chancethey 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
`
`20
`
`due to respiratory insufficiency. While somepatients experience grave gastrointestinal
`
`symptoms, the majority of CF patients (90 percent) ultimately succumbto respiratory
`
`problems.
`
`[0005] Virtually all patients with CF require respiratory therapy as a daily part of their care
`
`regimen. The buildup of thick, sticky mucusin the lungs clogs airwaysandtraps bacteria,
`
`25
`
`providing an ideal environmentfor respiratory infections and chronic inflammation. This
`
`
`
`WO 2009/045358
`
`PCT/US2008/011245
`
`inflammation causes permanentscarring of the lung tissue, reducing the capacity of the lungs
`
`to absorb oxygen and,ultimately, sustain life. Respiratory therapy must be performed, even
`
`whenthepatient is feeling well, to prevent infections and maintain vital capacity.
`
`Traditionally, care providers perform Chest Physical Therapy (CPT) one to four times per
`
`wa
`
`day. CPT consists of a patient lying in one of twelve positions while a caregiver "claps" or
`
`pounds on the chest and back over eachlobe of the lung. To treat all areas of the lungin all
`
`twelve positions requires pounding for half to three-quarters of an hour along with inhalation
`
`therapy. CPT clears the mucus by shakingloose airway secretions through chest percussions
`
`and draining the loosened mucus toward the mouth. Active coughingis required to
`
`10
`
`ultimately remove the loosened mucus. CPT requires the assistance of a caregiver, often a
`
`family memberbutanurseor 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
`
`15
`
`becomestired. The requirement that a second person be available to perform the therapy
`
`severely limits the independenceof the CFpatient.
`
`{0006] 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
`
`20
`
`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
`
`homecare applications patients require easy application and low cost disposable thoracic
`
`garments connectable to portable air pressure pulsating devices that can be selectively located
`
`adjacentthe left or right side of the patients.
`
`25
`
`[0007] Artificial respiration devices for applying and relieving pressure on the chest of a
`
`
`
`WO 2009/045358
`
`PCT/US2008/011245
`
`person havebeenusedto assist in lung breathing functions, and loosening and eliminating
`
`mucusfrom 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. Patent No. 6,547,749, incorporated herein by
`
`reference, has a case accommodating an air pressure and pulse generator. A handle pivotally
`
`mountedon the case is used as a handgrip 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 havingair-
`
`10
`
`accommodating bladders that surroundthe 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. Patent 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 diaphragmsand bladdersin regular pattern or
`
`15
`
`pulses. Manually operated controls are used to adjust the pressure of the air and air pulse
`
`frequency for each patient treatment and during the teatment. The bladder worn aroundthe
`
`thorax of the CF person repeatedly compresses and releases the thorax at frequencies as high
`
`as 25 cycles per second. Each compression producesa rushof air through the lobes ofthe
`
`lungs that shears the secretions from the sides of the airways and propels them toward the
`
`20
`
`mouth where they can be removed by normal coughing. Examples of chest compression
`
`medical devices are disclosed in the following U.S. Patents.
`
`[0008] WJ. Warwick and L.G. Hansen in U.S. Patent 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 allowsair to flow into the vest and
`
`25
`
`vent air therefrom to apply pressurized pulses to the person's chest. An alternative pulse
`
`
`
`WO 2009/045358
`
`5
`
`PCT/US2008/011245
`
`pumpingsystem hasa pair of bellows connected to a crankshaft with rods operated with a de
`
`electric motor. The speed of the motoris 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 becarried by a
`
`person to different locations to provide treatment to persons in need of respiratory therapy.
`
`[0009] M. Gelfand in U.S. Patent No. 5,769,800 discloses a vest design for a
`
`cardiopulmonary resuscitation system having a pneumatic contro] unit equipped with wheels
`
`to allow the control unit to be moved along a support surface.
`
`[0010] N.P. Van Brunt and D.J. Gagne in U.S. Patent Nos. 5,769,797 and 6,036,662 disclose
`
`10
`
`an oscillatory chest compression device having an air pulse generator including a wall with
`
`an air chamber and a diaphragm mounted onthe 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
`
`15
`
`diaphragm. A blowerdelivers air to the air chamber to maintain the pressure of the air in the
`
`chamber. Controls for the motors that move the diaphragm androtate the blowerare
`
`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 systemsthat regulate the
`
`operating speeds of the motors to control the pulse frequency andair pressure in the vest.
`
`20
`
`The air pulse generator is a mobile unit having a handle and a pair of wheels.
`
`SUMMARY OF THE INVENTION
`
`[0011] 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 thoracic
`
`25
`
`garment, and a flexible hose coupling the air-pulse generator to the thoracic garmentfor
`
`
`
`WO 2009/045358
`
`PCT/US2008/011245
`
`transmitting air pressure and pressure pulses from the generator to the thoracic garment. The
`
`air-pulse generator is mounted onaportable pedestal having wheels that allow the generator
`
`to be moved to different locations to provide therapy treatments to a numberof persons. The
`
`portable pedestal allowsthe air-pulse generator to be located adjacent opposite sides of a
`
`person confined to a bed or chair. The pedestal includesa linearlift that allows the elevation
`
`or height of the air-pulse generator to be adjusted to accommodate different locations and
`
`persons. The air-pulse generator includes a housing supporting generator controls for
`
`convenient use. The housing has a top handle used to manually transport the air-pulse
`
`generator. The housingis supported on and secured to a frame assembly joinedto the top of
`
`10
`
`the pedestal. The frame assembly has parallel horizontal members connected to a platform
`
`engaging the bottom of the housingof the air-pulse generator. Upright membersjoined to the
`
`horizontal members are fastened to opposite sides of the housing of the air-pulse generator.
`
`U-shaped handles joined to and extended outwardly from the upright members provide
`
`handles to facilitate movement of the pedestal and air-pulse generator.
`
`15
`
`[0012] The thoracic therapy garmenthas an elongated flexible body havinga plurality of
`
`elongated generally parallel chambers for accommodating air. An air inlet connector joined
`
`to a lowerportion of the bodyis releasably coupledto a flexible hose joined to the air pulse
`
`outlet of the air-pulse generator. One end of the body has hook pads secured to opposite
`
`sides of the end to allow the garmentto be selectively placed around a person’s thorax in
`
`20
`
`clockwise and counterclockwise positions. The outside surface to the body has a loop texture
`
`that coacts with the loop padsto retain the garment firmly around the person’s thorax. The
`
`thoracic therapy garmentis reversible with a single air inlet connector that can be accessed
`
`from either side of a person’s bed or chair. The upper portions of the body have concave arm
`
`contours that allow the body to cover upper thorax areas.
`
`25
`
`
`
`WO 2009/045358
`
`PCT/US2008/011245
`
`DESCRIPTION OF DRAWING
`
`[0013] Figure 1 is a perspective view of a thoracic therapy garment located aroundthe thorax
`
`of a person connected with a hose to a pedestal mounted air-pulse generator located on the
`
`left side of the person;
`
`Figure 2 is a perspective view ofthe thoracic therapy garmentof Figure 1 located
`
`aroundthe thorax of a person connected with a hose to a pedestal mounted air-pulse
`
`generator located on the right side of the person;
`
`Figure 3 is a front elevational view,partly sectioned, of the thoracic therapy garment
`
`of Figure 1 located around the thorax of a person;
`
`10
`
`Figure 4 is an enlarged sectional view ofthe right side of the person of Figure 3 with
`
`the thoracic therapy garment applying pressure pulses to the person’s thorax;
`
`Figure 5 is a linear front elevational! view of the thoracic therapy garment of Figure 1;
`
`Figure 6 is a linear rear elevational view of the thoracic therapy garment of Figure 1;
`
`Figure 7 is an enlarged sectional view taken alongthe line 7-7 of Figure 5;
`
`Figure 8 is an enlarged sectional view taken along the line 8-8 of Figure 5;
`
`Figure 9 is an enlarged elevational view, partly sectioned, showing the air pulse inlet
`
`section of the thoracic therapy garment of Figure 1; and
`
`Figure 10 is an enlarged sectional view taken along the line 10-10 of Figure 5.
`
`DESCRIPTION OF INVENTION
`
`20
`
`[0014] A portable human body pulsating apparatus 10, shown in Figures 1 and 2, comprises
`
`an air-pulse generator 11 having a housing 12. A movable pedestal 29 supports generator 11
`
`and housing 12 on a surface, such as a floor. Pedestal 29 allows respiratory therapists and
`
`patient careperson to transport the entire human body pulsating apparatusto different
`
`locations accommodating a numberof personsin need of respiratory therapy and to storage
`
`25
`
`locations.
`
`
`
`WO 2009/045358
`
`PCT/US2008/011245
`
`[0015} Human bodypulsating apparatus 10 is used with a thoracic therapy garment 30 to
`
`apply repetitive pressure pulse to a person's thorax to provide secretion and mucousclearance
`
`therapy. Respiratory mucous 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 newbornswith respiratory distress syndrome
`
`have reduced mucociliary transport. Apparatus 10 provides high frequency chest wall
`
`oscillations or pulses to enhance mucus and airway clearance in a person with reduced
`mucociliary transport. High frequency pressure pulses subject to the thorax in addition to
`
`10
`
`providing respiratory therapy to a person's lungs andtrachea, also stimulates the heart and
`
`blood flow in arteries and veins in the chest cavity. Muscular and nerve tensionsare also
`relieved by the repetitive pressure pulses imparted to the front, sides, and back portions of the
`
`thorax. The lowerpart of the thoracic cage comprises the abdominal cavity which reaches
`
`upward as highas the lowertip of the sternum soas to afford considerable protection to the
`
`15
`
`large and easily injured abdominal organs, such asthe liver, spleen, stomach, and kidneys.
`
`The abdominal cavity is only subjected to very little high frequency pressure pulses.
`
`[0016] Housing 12 is a generally rectangular memberhaving a front wall 13 and side walls
`
`26 and 27 joined to a top wall 16. An arched member17 having a horizontal handle 18
`
`extended over top wall 16 is joined to opposite portions of top wall 16 whereby handle 18 can
`
`20
`
`be used to manually carry air-pulse generator 11 and facilitate mounting air-pulse generator
`
`11 on pedestal 29. A control panel 23 mounted on top wall 16 has time coated keys and
`
`frequency control keys located on opposite sides of a visual control screen. An air pressure
`
`control knob 24 is located on the left side of panel 23. The control keys, screen and air
`
`pressure control knobarein locations that are readily accessible by the respiratory therapists
`
`25
`
`and user of apparatus 10. The operating elements and functions and controls ofair-pulse
`
`
`
`WO 2009/045358
`
`od
`
`PCT/US2008/011245
`
`generator 11 are disclosed by C.N. Hansen, P.E. Cross and L.T. Helgeson in U.S. Patent
`
`Application Publication No. 2005/0235988 and incorporated herein by reference. Alternative
`
`air pulse generators are disclosed by C.N. Hansen in U.S. Patents Nos. 6,488,641 and
`
`6,547,749 incorporated herein by reference.
`
`[0016] Person care homes,assisted living facilities and clinics can accommodate a numberof
`
`personsin different roomsorlocations that require respiratory therapy or high frequency
`
`chest wall oscillations as medical treatments. The portable pulsating apparatus 10 can be
`
`manually moved to required locations and connect with a flexible hose 61 to a thoracic
`
`therapy garment 30 located around a person's thorax. As shownin Figures 1 and 2, pulsating
`
`10
`
`apparatus 10 can be selectively located adjacentthe left or right side of a person 60 who may
`
`be confined to a bed or chair.
`
`[0017] Pedestal 29 has an upright gas operated piston and cylinder assembly 31 mounted ona
`
`base 32 having outwardly extendedlegs 33, 34, 35, 36 and 37. Other types of linear
`
`expandable and contractible devices can be used to change the location of generator 11.
`
`15
`
`Caster wheels 38 are pivotally mounted on the outer ends of legs 33-37 to facilitate
`
`movementof body pulsating apparatus 10 along a support surface. One or more wheels 38
`
`are provided with releasable brakes to hold apparatus 10 is a fixed location. An example of a
`
`pedestal is disclosed in U.S. Patent No. 5,366,275. The piston and cylinder assembly 31 is
`
`linearly extendable to elevate air-pulse generator 11 to a height convenientto the respiratory
`
`20
`
`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 generator
`
`11. Generator 11 can be located in positions betweenits up and downpositions. Lever 39
`
`and gas control valve are operative associated with the lower end of piston and cylinder
`
`assembly 31.
`
`25
`
`[0018] A frame assembly 41 having parallel horizontal members 42 and 43 and a platform 44
`
`
`
`WO 2009/045358
`
`10
`
`PCT/US2008/011245
`
`mounts housing 12 on top of upright piston and cylinder assembly 31. The upper memberof
`
`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 handgrips to facilitate manual movementofthe air-pulse generator 11 and pedestal
`
`29 onafloor 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)thatfits into
`
`10
`
`receptacle 58 to provide electric power to air-pulse generator 11. A tubularair 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 and air pressure pulses to travel through hose 61 to
`
`thoracic therapy garment 30 to apply pressure pulses to a person’s body.
`
`[0019] Thoracic therapy garment 30, shownin Figure 3, is located around the person’s thorax
`
`15
`
`69 in substantial surface contact with the entire circumference of thorax 69. Thoracic therapy
`
`garment 30 functions to apply repeated high frequency compression or pressure pulses,
`
`shownby arrows 71 and 72, to the person’s lungs 66 and 67 and trachea 68. The reaction of
`
`lungs 66 and 67 andtrachea 68 to the pressure pulses causes repetitive expansion and
`
`contraction of the lung tissue resulting in secretions and mucusclearance therapy. The
`
`20
`
`thoracic cavity occupies only the upperpart of the thoracic cage which contains lungs 66 and
`
`67, heart 62, arteries 63 and 64, and rib cage 70. The high frequency pressure pulses applied
`
`to thorax 69 stimulates heart 62 and blood flow in arteries 63 and 64 and veinsin the chest
`
`cavity. Rib cage 70 also aids in the distribution of the pressure pulses to lungs 66 and 67 and
`
`trachea 68.
`
`25
`
`[0020] As shownin Figures 5 and 6, thoracic therapy garment 30 comprises an elongated
`
`
`
`WO 2009/045358
`
`VW
`
`PCT/US2008/011245
`
`generally rectangular body 73 including an end flap 74. Body 73, shown in Figures 7 and 8,
`
`has an innerair impervious flexible member76 attached to a loop-type fabric member 77.
`
`The entire outer surface of member 76 is covered with the loop-type fabric member. The
`
`loop fibers can be embeddedorfixed into member 76. Member76is a flexible plastic layer,
`
`such as air impervious urethane plastic. Other types of plastics and materials can be used for
`
`air impervious member 76. Returning to Figures 5 and 6, body 73 hasa longitudinal bottom
`
`seam or seal 78 and longitudinal middle seamsor seals 79 and 81 which form three
`
`longitudinal chambers 82, 83 and 84 for accommodating air. Seams 78, 79 and 81 are linear
`
`sonic welds. Heat seals can be used for seams 78, 79 and 81. End 86 of body 73 opposite
`
`10
`
`end 74 has longitudinal seamsor seals 87 and 88 longitudinally aligned with seams 79 and 81
`
`which provide air chambers 89, 90 and 91 for air. Seams 79 and 87 and seams 81 and 88 are
`
`spaced apart. A diagonal seam orseal 92 extends downwardly from top edge 93 of body 73
`
`to about the middle of body 73. Seam 92, as shownin Figure 9, is a divider that separates the
`
`flow of air shown by arrows 94 and 96 anddirects the flow of air into chambers 82, 83, 84,
`
`15
`
`89, 90 and 91. Anair inlet connector 97 secured to the bottom portion of member 76 and
`
`seam 78 is adapted to be releasably attached to hose 61. Air flows through connector 97 into
`
`body 73. Connector 97 is a tubular memberjoined to a flange 98 secured to body 73. Other
`
`types of hose connectors can be used to accommodate hose 61 and direct air and air pressure
`
`pulses into body 73. As shownin Figures 1 and 2, connector 97 is coupled to hose 61 when
`
`20
`
`thoracic therapy garment30 is located clockwise and counterclockwise around the person’s
`
`thorax. The same connector 97 is coupled to hose 61 when thoracic therapy garment 30 is in
`
`reversed use.
`
`[0021] Returning to Figures 5, 6 and 8, top edge 93 of body 73 has a pair of concave sections
`
`99 and 101 providing recesses or arm contoursthat increase coverage of the upper thoracic
`
`25
`
`area of the person. The side walls of body 73 below concave sections 99 and 101 have a
`
`
`
`WO 2009/045358
`
`12
`
`PCT/US2008/011245
`
`numberof small holes 102-107 for allowing a controlled flow of air from chambers82, 83
`
`and 84. As shownin Figure 8, holes 105-107 are open to opposite sides of chambers 82, 83
`
`and 84 to allow air to flow to atmosphere. Air-pulse generator 11 supplies air and air
`
`pressure pulses to chambers 82, 83 and 84 and maintains a selected air pressure in chambers
`
`82-84,
`
`[0022] As shownin Figure 10, a first pair of hook pads 108 and 109 are secured with stitches
`
`111 to opposite sides of end section 74 of body 73. Hoop pads 108 and 109, shownin
`
`Figures 5 and 6, are diagonal generally rectangular releasable fasteners. A secondpair of
`
`hook pads 112 and 113 are secured with stitches 114 to opposite sides of end section 74 of
`
`body 73. Hook pads 108, 109, 112 and 113 can be fastened to opposite sides of end section
`
`74 of body 73 with seams, such as sonic weldsor heat seals. In use, hook pads 108 and 109
`
`releasably engage the loop fabric to retain thoracic therapy garment 30 clockwise around the
`
`person’s thorax. Hook pads 112 and 113 releasably engage the loop fabric when body 73 is
`
`reversed to retain thoracic therapy garment 30 counterclockwise around the person’s thorax.
`
`15
`
`[0023] There has been shownand described an embodimentof a portable air-pulse generator
`
`connected to a thoracic therapy garment for applying high frequencypressure pulses to a
`
`person’s thorax. Changesin the structure, materials and arrangementofstructure can be
`
`made by personsskilled in the area without departing from the invention.
`
`
`
`WO 2009/045358
`
`CLAIMS
`
`13
`
`PCT/US2008/011245
`
`1.
`
`A portable human body pulsating apparatus and a thoracic therapy garment
`
`locatable around the human thorax to apply repetitive compression forces to the thoracic
`
`comprising: a generator for creating air pressure and air pressure pulses, said generator
`
`including a housing, a pedestal having an upper end, a frame assembly mounted on the upper
`
`end of the pedestal, fasteners securing the housing to the frame assembly, surface support
`
`members connected to the pedestal to facilitate movement of the body pulsating apparatus on
`
`a surface, said thoracic therapy garment including a body having a plurality of chambers for
`
`accommodatingair, an air inlet connector mounted on the body having a passage open to the
`
`chambers, and a hose connected the generator to the air inlet connector whereby air and air
`
`pressure pulses flow from the generator through the hose andair inlet connectorinto said
`
`chambers thereby applying repetitive pressure pulses to the thorax of a person having the
`
`thoracic therapy garmentlocated around the thorax of the person.
`
`2.
`
`The apparatus and thoracic therapy garment of Claim 1 wherein: said pedestal
`
`includes an upright piston and cylinder assembly operable to adjust the elevation of the
`
`generator, and a base having legs supporting the piston and cylinder assembly, said surface
`
`support members comprising wheels mounted on the legs to facilitate movement of the
`
`apparatus on a surface.
`
`3.
`
`The apparatus and thoracic therapy garment of Claim 1 including: at least one
`
`handle on the frame assembly to facilitate manual movementof the apparatus.
`
`4,
`
`The apparatus and thoracic therapy garment of Claim 1 wherein: said pedestal
`
`includes an extendable and contractible device connected to the frame assembly operable to
`
`adjust the elevation of the generator.
`
`5.
`
`The apparatus and thoracic therapy garment of Claim 1 wherein: said garment
`
`includes a body having a flexible air impervious member having opposite sides and loop
`
`
`
`WO 2009/045358
`
`14
`
`PCT/US2008/011245
`
`members joined to said opposite sides of the air impervious member, said air impervious
`
`member surroundinga plurality of chambers for accommodatingair, an air inlet connector
`
`having a passage open to said chambersto allow air and air pressure pulses to flow into said
`
`chambers, said body including an end section having opposite sides, and hook pads secured
`
`to the opposite sides of the end section of the body coacting with the loop membersto retain
`
`the body around the thorax of a person, said body being reversible whereby the hook pads on
`
`the opposite sides of the end section of the body coact with the loop membersto selectively
`
`retain the thoracic therapy garment clockwise or counterclockwise around the thorax ofa
`
`person.
`
`6.
`
`The apparatus andthoracic therapy garment of Claim 5 including: seams
`
`dividing the body into three chambersanda divider located within the body operableto direct
`
`air and air pressure pulses from theair inlet connectorinto said three chambers.
`
`7.
`
`The apparatus and thoracic therapy garment of Claim 5 wherein: said body has
`
`a longitudinal dimension and laterally spaced seams dividing the bodyinto longitudinal
`
`chambers, and a divider within the body operable to direct air and air pressure pulses from
`
`the air inlet connector into said chambers.
`
`8.
`
`The apparatus and thoracic therapy garment of Claim 1 wherein: said body
`
`includes a top section having concaverecesses providing contours for a person’s arms.
`
`9,
`
`The apparatus andthoracic therapy garment of Claim 1 wherein: said body
`
`includes a plurality of holes to allow air to flow out of said chambers.
`
`10.
`
`A thoracic therapy garmentuseable with an air pulse generator for applying
`
`pressure pulses to the thorax of a person comprising: a body havinga flexible air impervious
`
`memberhaving opposite sides and loop membersjoined to said opposite sides of the air
`
`impervious member,said air impervious membersurroundinga plurality of chambers for
`
`accommodatingair, an air inlet connector having a passage open to said chambersto allow
`
`
`
`WO 2009/045358
`
`15
`
`PCT/US2008/011245
`
`air and air pressure pulses to flow into said chambers, said body

Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ ChargeStill Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.

This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.

One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site