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 Title: |
US5269296:
Nasal continuous positive airway pressure apparatus and method
[ Derwent Title ]
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| Country: |
US United States of America
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| Inventor: |
Landis, Robert M.; New York, NY 10016
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| Assignee: |
None
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| Published / Filed: |
1993-12-14
/ 1993-02-17
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| Application Number: |
US1993000019993
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| IPC Code: |
Advanced:
A61M 16/06;
IPC-7:
A61M 15/08;
A62B 7/00;
A62B 9/04;
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| ECLA Code: |
A61M16/06S; A61M16/06L;
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| U.S. Class: |
Current:
128/207.18;
128/204.18;
128/207.17;
128/912;
128/DIG.026;
604/094.01;
D24/164;
Original:
128/207.18;
128/204.18;
128/207.17;
128/912;
128/DIG.26;
604/094;
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| Field of Search: |
128/DIG. 26,911,912,207.15,207.16,207.17,207.18,204.11,204.12,204.18,200.24,200.26,201.22,203.21
604/094
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| Priority Number: |
| 1991-10-29 |
US1991000784371 |
| 1993-02-17 |
US1993000019993 |
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| Abstract: |
A nasal continuous positive airway pressure apparatus includes a pair of cannula each having an inflatable cuff to position the cannulae within the nares of a patient. The cannulae are connected to a source of positive air pressure to provide continuous positive nasal airway pressure. The cuffs may be inflated by providing cuff apertures in the cannula so that the positive airway pressure during inhalation and exhalation maintain the cuffs inflated and the cannulae positioned within the nares during treatment. Alternatively, the cuffs may be separately inflated. The apparatus includes an inflatable air strap harness to position and hold the nasal cannulae device relative to the patient's head. The inflatable air strap harness is soft and flexible and comfortable for the patient to wear. The air strap is inflated and secured, such as with a hook and loop belt, surrounding the patient's head with the cannulae inserted into the patient's nares. The cuffs are inflated and air pressure applied to the conduit to administer treatment. The air strap is inflated by the same air pressure being applied to the patient's airway or is inflated by a separate source such as a hand pump.
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| Primary / Asst. Examiners: |
Millin, V.; Passaniti, Sebastiano
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| INPADOC Legal Status: |
Show legal status actions
Family Legal Status Report
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| Parent Case: |
This is a continuation of copending application Ser. No. 07/784,371, filed on Oct. 29, 1991 now abandoned.
The present invention relates to a method and apparatus for treating sleep apnea. More specifically, the present invention provides a nasal continuous positive airway pressure device which is reliable and comfortable to wear and therefore more acceptable to the patient.
BACKGROUND OF THE INVENTION
Obstructive sleep apnea is a condition in which the patient's airway passage is blocked and no air can pass to the lungs. During a customary sleep period a person suffering from sleep apnea can experience so called apneatic events, that is, periods when the patient's airway becomes blocked, often for ten seconds or more, until the patient rouses and starts breathing normally again. Those suffering from sleep apnea may experience hundreds of apneaic events each night causing a deficiency of restful sleep and, due to a depleted oxygen levels, possible long term health problems such as heart ailments.
Continuous positive airway pressure (CPAP) and, more specifically, nasal continuous positive airway pressure (nCPAP) has been shown to be an effective treatment for sleep apnea. See "The Effect of Nightly Nasal CPAP treatment on Underlying Obstructive Sleep Apnea and Pharyngeal Size", N. A. Collop, A. J. Block and D. Hellard, Chest 1991; 99:855-860; and "Nasal Continuous Positive Airway Pressure Facilitates Respiratory Muscle Function During Sleep in Severe Chronic Obstructive Pulmonary Disease", B. J. Petrof, R. J. Kimoff, R. D. Levy, M. G. Cosoi, and S. B. Gottfried, Am. Rev. Respir. Dis. 1991; 143:928-935. This treatment involves applying a constant gas pressure, typically a mixture of air supplemented with moisture vapor or oxygen, through the nasal passages to prevent negative pressure conditions within the passage which can lead to obstruction, thereby allowing continuous air flow through he upper air passageway. nCPAP treatment typically involves placing a mask over the nose of the patient by means of a harness or other headgear and providing a source of positive low pressure air connected to the mask. Conventional nasal masks are considered uncomfortable, cumbersome and noisy (due to air leaks) and in many cases are a formidable obstacle to patient acceptance of nCPAP therapy.
U.S. Pat. No. 4,782,832 issued to Trimble, et al. proposes an alternative device for nCPAP treatment intended to overcome the deficiencies of conventional mask devices. The Trimble structure has become the accepted apparatus for nCPAP treatment. Trimble discloses a nasal puff adapted to be worn adjacent the nose of a wearer-patient. The nasal device includes a relatively small plenum chamber including structure defining an inlet adapted for coupling with a source of gas, and a pair of spaced apart, separate gas outlets in communication with the inlet. Typically, the plenum chamber is in the form of a generally Y-shaped hollow body with the gas outlets located i the branches of the body. The nasal puff further includes a pair of gas delivery elements each having a gas flow passageway therethrough and respectively operatively coupled with a corresponding gas outlet for conveying gas from the outlet through and out the passageway. Each of the gas delivery elements is configured for insertion into a respective naris of a patient, and for this purpose the outer wall of the elements are generally frustoconically shaped so as to sealingly engage the naris-defining surfaces of the nose. Adjustability of the naris elements is provided by rotatably mounting the elements to the plenum housing and by mounting the elements in slots permitting selective lateral positioning of the elements with respect to each other. Flexible bellows-type corrugated sections can be provided in each of the elements and or in appropriate positions in the plenum housing so as to add further ranges of flexibility and adjustable. The nares elements are fabricated from relatively soft, deformable, shape-retaining synthetic resin material permitting manual deformation and alteration of the effective shape and position of the elements. Trimble discloses a harness to be worn on a patient's head with a flexible mask-retaining straps extending from the main harness strap to each side of the nasal puff. The harness assembly includes an elongated gas-conveying tube which is adapted for coupling with the inlet of the nasal puff and extends upwardly along the length of the bridge of the patient's nose and across the patient's forehead, terminating at the top of the patient's forehead. The tube is longitudinally bifurcated to divide the overall tube and present a pair of elongated, juxtaposed passageways, one of which is connected to a source of pressurized air and the other to a discharge tube for purging patient-generated CO2 during exhalation.
The Trimble nasal puff and harness assembly is the accepted apparatus for treatment of sleep apnea using nCPAP therapy. While the Trimble device is a improvement over prior mask structure, some patients continue to object to the Trimble structure as uncomfortable to wear. Studies show that a small but significant number of patients fail or are unable to continue nCPAP treatment, at least some due to the inconvenience or discomfort of wearing the presently available apparatus. See "The Effect of Positive Reinforcement on Hourly Compliance in Nasal Continuous Positive Airway Pressure Users with Obstructive Sleep Apnea", E. C. Fletcher and R. A. Luckett, Am. Rev. Respir. Dis. 1991; 143:936-941; "Maxillofacial Surgery and Nasal CPAP", R. W. Riley, N. B. Powell, C. Guilleminault, Chest 1990; 98:1421-1425; and "Surgical Treatment of Obstructive Sleep Apnea--is Mandibular Surgery an Advance?", Chest 1990; 98:1315-1316.
Notwithstanding general concensus that nasal continuous positive airway pressure is an effective treatment for sleep apnea, a substantial number of patients either cannot tolerate treatment or choose to forego treatment. It is believed a substantial number of such patients could benefit from a harness and nares delivery structure which is more convenient to use and comfortable to wear, thereby resulting in increased treatment compliance.
SUMMARY OF THE INVENTION
In accordance with the present invention, an improved nCPAP system and apparatus is provided. One aspect of the invention includes at least one cannular configured and dimensioned to be loosely inserted into a patient's naris. The cannula includes an inflatable cuff with means for inflating the cuff to engage the interior walls of the nose defining the naris in order to hold the cannula in place within the naris. A source of pressurized gas, preferably air, is connected by a hose conduit to the cannula to provide nCPAP treatment.
In a preferred embodiment of the invention two cannulae with inflatable cuffs are provided; one for each naris. A resilient cannula connector also is provided for selectively positioning the cannulae with respect to each other and relative to the patient's nares. The means for inflating the inflatable cuffs may be a separate source of gas or fluid pressure connected to the cuffs, and may be connected to the cuffs through a separate inflation tube led inside or outside of the cannula. In this configuration inflation pressure may be provided by any suitable means, such as a hand activated pump. Of course, a pressure release valve must also be provided to release the inflation pressure to permit deflation of the inflatable cuffs. More preferable, cuff inflation is attained by providing cuff apertures in the side walls of the cannulae to permit communication between the lumen of the cannulae and the inflatable cuffs. The cuff apertures are configured and dimensioned to allow sufficient air pressure from each cannula lumen to enter the associated inflatable cuff to inflate the cuff and maintain the cuff in an inflated state during nCPAP treatment. Because constant pressure is provided to the cannula lumen during nCPAP treatment, such pressure must be overcome during exhalation by the patient, ensuring sufficient constant pressure within the cannula lumen to maintain the cuffs in the inflated state during both inhalation and exhalation.
The device in accordance with the preferred embodiment of the invention further includes a conduit for supplying constant gas pressure to the cannulae. The conduit preferably is made of a soft flexible material so as to minimize patient discomfort. The conduit preferable includes one or more vent apertures, such as vent holes, configured and dimensioned to relieve pressure during exhalation. The vent holes are sufficiently small in area so that the presence of the vent holes does not significantly detract from supply of pressurized gas to the cannula, yet the vent holes relieve the combined pressure of exhaled air and pressurized gas by allowing exhaled gas to exit the conduit through the vent holes. The nCPAP device may be held in place solely by the inflatable cuffs and/or by a supplemental harness for positioning the nCPAP device and conduit. A standard positioning harness may suffice, but a further aspect of the invention provides an improved harness which is more comfortable to wear and, therefore, acceptable to the patient.
The harness in accordance with the preferred embodiment of the invention is an air strap harness in which inflatable members surround and conform to the contour of the patient's head so as to maintain a constant position of the nCPAP device in a comfortable manner. The air strap includes an air hose connector attached to a primary air hose, with the air hose connector adapted to engage a source of pressurized gas used for nCPAP treatment. The primary hose branches into right and left harness segments at a Y connection, and each segment further includes a base air hose, a vertical extension hose extending substantially perpendicularly to the base air hose from a point distal to the Y connector, and an arched buttress connector hose extending from the base air hose proximal to the Y connector to a point on the vertical extension hose distal to the connection between the base air hose and the vertical extension hose. The buttress segments help provide a defined shape of the inflatable harness and ensure proper positioning of the nasal delivery device. The nCPAP device is mounted at the end of one of the vertical hose segments, and a posterior base connector hose connects the ends of the right and left base air hose segments distal to the Y connector. Securement means are provided for connecting the ends of the vertical hose segments distal to the base air hoses in order to the hold the harness around the patient's head. Preferably, all hoses of the right and left harness segments and the posterior base connector hose are made of soft inflatable plastic which inflate upon application of air pressure to the air hose connector. Advantageously, the inflatable harness itself constitutes the air conduit to the nCPAP device providing constant air pressure to the cannulae. In an alternative embodiment a separate conduit may be disposed within the harness to carry pressurized air to the cannulae. The inflatable harness is more comfortable to the user and, with the improved nCPAP device, constitutes a system which is more acceptable to the patient, resulting in greater treatment compliance. In a further alternative embodiment the inflatable harness assembly is independent of the nCPAP device and air supply and is separately inflatable, with the nCPAP delivery device secured to the harness for proper positioning.
In use, the posterior base connector hose is positioned behind the patient's neck at the base of the head with the Y connection disposed above the patient's head and the right and left harness segments to either side of the head. The nCPAP delivery device is adjusted and positioned with the cannulae in the nares, and the right and left harness segments are connected using the securement means. Typically, the vertical hose segments are disposed adjacent the cheeks of the patient and the arched buttress hose segments extend behind each ear and join the respective base air hoses. Upon activation of the air pressure source the hoses inflate to comfortably cushion the patient and provide support to the nCPAP delivery device. The securement means can be adjusted to suit patient comfort.
As used herein, the terms, "inflation" and "inflated" refer to distension of the cannula cuff to fill out the cuff without stretching the material thereof.
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| Family: |
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First Claim:
Show all 19 claims |
What is claimed is:
1. A nasal airway pressure device comprising:
- a pair of naris cannulae made of a substantially rigid material, each said cannulae configurated and dimensioned for insertion into the naris of a patient and having a lumen;
- a pair of inflatable cuffs, each said cuff surrounding at least a portion of one of said cannulae, each said cuff configured and dimensioned to inflate and come into contact with the interior, naris defining walls of a patient's nose so as to maintain the position of a portion of said cannulae within a naris of a patient and establish a substantially air-tight seal between said cannular portion and the naris, a second portion of said cannulae configurated and dimensioned to extend out of the naris;
- at least one aperture providing gaseous communication between said cannulae lumen and said inflatable cuff for inflating said inflatable cuffs;
- a conduit in communication with said lumen at said second cannular portion for supplying positive gas pressure to said lumen, said positive gas pressure inflating said cuffs through said aperture during inhalation by the patient so that said cuffs engage the interior walls of the patient's naris in order to maintain the position of said cannulae in the naris and establish a substantially air-tight seal between said cannulae and the naris, said cuffs being inflated during exhalation of the patient by exhaled gas expelled through said cannulae in communication with said aperture, said conduit including at least one vent hole for relieving excess pressure during exhalation.
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| Background / Summary: |
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| Drawing Descriptions: |
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| Description: |
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| Forward References: |
Show 124 U.S. patent(s) that reference this one
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| Foreign References: |
None
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| Other References: |
"The Effect of Positive Reinforcement on Hourly Compliance in Nasal Continuous Positive Airway Pressure Users with Obstructive Sleep Apnea", E. C. Fletcher, and R. A. Luckett, Am. Rev. Respir. Dis. 1991; 143-941.
"Maxillofacial Surgery and Nasal CPAP" R. W. Riley, N. B. Powell, C. Guilleminault, Chest. 1990; 98:1421-1425.
(5 pages)
Cited by 4 patents
"Surgical Treatment of Obstructive Sleep Apnea-is Mandibular Surgery an Advance?" Chest, 1990; 98:1315-1316.
(2 pages)
"The Effect of Nightly Nasal CPAP Treatment on Underlying Obstructive Sleep Apnea and Pharyngeal Size" N. A. Collop, A. J. Block and D. Hellard, Chest. 1991;99:855-860.
(6 pages)
Cited by 4 patents
[ISI abstract]
"Nasal Continuous Positive Airway Pressure Facilitates Respiratory Muscle Function During Sleep in Severe Chronic Obstructive Pulmonary Disease" B. J. Petrof, R. J. Kimoff, R. D. Levy, M. G. Cosoi and S. G. Gottfried, Am. Rev. Respir. Dis. 1991, 143:928-935.
(8 pages)
Cited by 4 patents
[ISI abstract]
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