Surgery – Respiratory method or device – Means for supplying respiratory gas under positive pressure
Reexamination Certificate
2000-05-22
2002-04-16
Dawson, Glenn K. (Department: 3761)
Surgery
Respiratory method or device
Means for supplying respiratory gas under positive pressure
C128S200240
Reexamination Certificate
active
06371112
ABSTRACT:
FIELD AND BACKGROUND OF THE INVENTION
The present invention relates to a self contained constant pressure applied proximally (CPAP) device and to a system and method which prevent collapse of the upper airway. More particularly, the present invention relates to the use thereof for treatment of breathing disorders including, but not limited to, obstructive sleep apnea (OSA), apnea of infancy (AOI) and sudden infant death syndrome (SIDS).
OSA is a syndrome with significant morbidity and mortality (C. Guilleminault and M. Partinen (eds.) (1990) “Obstructive Sleep Apnea Syndrome: Clinical; Research and Treatment”. Raven Press, New York, N.Y., USA, pp xv-xvii). OSA is caused by repeated collapse of soft tissues forming the walls of the upper airway in the sub-glottal region during sleep (C. Guilleminault and M. Partinen, Ibid.). Opening of this portion of the airway depends upon the balance between negative pressure, which is at least −7 or −10 cm H
2
O in normal quiet breathing (Levitzki MG (eds)(1986) “Pulmonary Physiology” McGraw—Hill Book Company, New York, N.Y., USA pp 37-40) outside the cavity caused by muscular action during breathing (e.g. action of the diaphragm and muscles surrounding the rib cage) and muscle tone in the upper airway itself (C. E. Sullivan et al., in C. Guilleminault and M. Partinen, Ibid., pp 49-69; S. T. Kuna et al. (1991) JAMA 266:1384-1389; J. E. Remmers et al., (1978) J. Appl. Physiol. 44:931-938; and D. J. Tangel et al. (1991) J. Appl. Physiol. 70:2574-2581). This repeated collapse of the upper airway causes a decrease in blood oxygen saturation which leads to sleep disturbances, fatigue and a general feeling of malaise in affected patients.
OSA is a common disorder with an estimated 2% of women and 4% of men being affected to a degree that treatment is advisable. This means that an estimated 12 to 18 million patients are affected in the USA. Since only about 7 to 18% of the population has been tested for this disorder, these estimates should be viewed as minimum estimates (C. Guilleminault in C. Guilleminault and E. Largesi (eds.) (1983) Raven Press, New York, N.Y., USA, pp 107-125; M. Partinen et al. (1988) Chest 94: 1200-1204; J. JE et al. (1988) Chest 94:9-14; National Commission on Sleep Disorders Research (1995) “Wake Up America: A National Sleep Alert” U.S. Government Printing Office, Washington, D.C., USA, pp 2-10; T. Young et al. (1997) Sleep 20:705-706).
Currently accepted treatment for OSA typically includes continuous positive airway pressure (CPAP). CPAP, as currently practiced, involves connection of a pressurized air delivering device to the mouth or nose of the patient. This device typically is connected to a pressurized air source in the form of a compressor or tank with a regulator. These pressurized air supplies are expensive, large, and noisy.
Delivery of a constant flow of a breathable gas mixture through the device maintains a constant positive pressure in the upper airway. This constantly applied pressure prevents the collapse of the airway described hereinabove(C. E. Sullivan et al. (1981) Lancet 1:862-865; M. H. Sanders et al. (1983) Chest 83:144-145). CPAP is effective in treating OSA by preventing collapse of the airway and associated tiredness, fatigue, diminished intellectual function, and snoring and can even lengthen patient life expectancy (J. Hender et al. (1995) Eur. Respir. J. 8:222-229; H. Minemura et al. (1998) Intern. Med. 37: 1009-1013; C. Jenkinson et al. (1999) Lancet 353: 2100-2105).
In order to keep the pressure in the airway constant during inhalation and exhalation, a pressure valve is sometimes incorporated into the pressurized air delivering device. One such valve is taught by U.S. Pat. No. 4,298,023 for a spring loaded exhalation valve. Teachings of this patent specifically relate to treatment regimens which include a flow of gas delivered to the airway from a pressurized air supply.
However, patient compliance with CPAP treatment regimens is typically poor despite the proven efficacy of the treatment. Research suggests that 60 to 70% compliance is the norm and that the average patient use of CPAP is limited to 5 hours per night (N. P. Kribbs et al. (1993) Am. Rev. Respir. Dis. 147:887-895; H. Rauscher et al. (1993) Chest 103:1675-1680). In addition, many patients never begin treatment at all owing to the high cost of CPAP equipment.
Infants are typically obligatory nasal breathers (Shannon DC In: Disorders of the Respiratory Tract In Children- SIDS and Apnea in infancy Kendig & Chemick eds (1990) W. B. Saunders Company, Philadelphia, Pa., USA pp 939-952.). Any change in airflows in the upper airways increase vulnerability to inadequate ventilation because: (1). the hypopharynx is shallow; (2) the tongue and epiglottis are more cephaled and (3) the mandible is more mobile (Tonkin S.(1975) Pediatrics 55:650-654). Normal infants typically have difficulty responding to nasal occlusion. Studies show that 44% of 6 week old infants struggled but failed to establish an oral airway when the nostrils were pinched for 25 seconds (Swift PGF et al (1973) Arch Dis Child 48:947-950). The physiologic basis for the failure to maintain adequate oral ventilation during occlusion in both normal and at risk infants is unknown. This mechanism has been suggested as a cause of AOI which can lead to SIDS (Anderson R B et al (1971) Biol Neonate 18:395-398.
There is thus a widely recognized need for, and it would be highly advantageous to have, a device, system and method which prevent collapse of the upper airway devoid of the above limitation.
SUMMARY OF THE INVENTION
According to one aspect of the present invention there is provided a self contained CPAP device. The device comprises; (a) a mouthpiece insertable in a mouth of a patient; (b) a breathing tube connecting between an outside environment and an interior of the mouth, the breathing tube containing at least one bi-directional pressure sensitive valve therein; (c) at least one inflatable body, the inflatable body functioning to adjust an internal cross sectional area of the breathing tube during a process of respiration, the inflatable body further serving to regulate an air pressure within the mouth during the process of respiration; and (d) a mask, the mask being in fluid communication with the inflatable body and being designed and constructed to cover a nose of the patient, such that exhaled air is routed thereto.
According to another aspect of the present invention there is provided a system for prophylactic treatment of a breathing disorder, the system comprising a self contained CPAP device, the device being designed and constructed to: (a) maintain sufficient pressure in an upper airway of a patient such that collapse thereof is prevented; and (b) function independently of any item selected from the group consisting of a pump, a compressor, a pressurized gas cylinder and an electro-hydrolytic oxygen source.
According to yet another aspect of the present invention there is provided an improved method of preventing a breathing disorder by means of CPAP, the method comprising the steps of: (a) inserting a mouthpiece in a mouth of a patient; (b) allowing inhaled air to flow through at least one bidirectional pressure sensitive valve contained within a breathing tube connecting between an outside environment and an interior of the mouth; (c) adjusting an internal cross sectional area of the breathing tube during a process of respiration by means of at least one inflatable body, the at least one inflatable body serving to regulate an air pressure within the mouth during the process of respiration and (d) covering a nose of the patient with a mask, the mask being in fluid communication with the at least one inflatable body and being designed and constructed to receive exhaled air therefrom and route the exhaled air to the nose of the patient.
According to further features in preferred embodiments of the invention described below, the at least one inflatable body comprises: (i) at least one elastic balloon; (ii) at least one first additional unidirectiona
Dawson Glenn K.
Friedman Mark M.
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