|Publication number||USRE42843 E1|
|Application number||US 11/334,822|
|Publication date||Oct 18, 2011|
|Filing date||Jan 19, 2006|
|Priority date||Oct 25, 2001|
|Also published as||CA2462685A1, CN1533288A, EP1438086A2, EP1438086A4, US6679265, US7047974, US20030079749, US20040134498, WO2003035141A2, WO2003035141A3|
|Publication number||11334822, 334822, US RE42843 E1, US RE42843E1, US-E1-RE42843, USRE42843 E1, USRE42843E1|
|Inventors||Roger Strickland, Jonathan Lee, Thomas J. Wood|
|Original Assignee||Innomed Technologies, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (54), Non-Patent Citations (1), Referenced by (29), Classifications (15), Legal Events (5)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The present invention relates generally to a nasal mask or cannula and more particularly to a nasal cannula for treating a patient with a positive ventilation pressure machine for assisted ventilation.
Positive air pressure (PAP) assisted ventilation systems have been adopted for the treatment of various disorders. PAP systems are commonly used to treatment sleep apnea. Variations of PAP systems have been used to administer drugs and the like.
In operation the patient's respiration is assisted by an external pump which supplies air to the patient under a slight positive pressure. In the conventional system, air is delivered in response to preset conditions selected for each individual patient. In normal operation the patient's inspiratory phase is assisted by a pump which delivers an adequate supply of air at a slight positive pressure to a mask or cannula that is placed on the face of the patient. Full face mask systems which cover both the mouth and the nose are used. Systems which cover the mouth or nose alone are also common.
In use, when the patient exhales, the higher pressure in the mask or cannula system is used to open an exhaust valve. Thus the patient respiration is assisted on the inhalation phase by positive pressure while the expiration phase takes place at approximately atmospheric pressure.
In instances where the patient compliance is affected by the comfort of the mask it is now widely accepted that “nose only” cannula devices are preferred. Examples of current devices can be seen in U.S. Pat. No. 5,477,852 to Landis; U.S. Pat. No. 5,533,506 to Wood; U.S. Pat. No. 5,269,296 to Landis; U.S. Pat. No. 5,687,715 to Landis; U.S. Pat. No. 5,724,965 to Handke.
In contrast to prior air nasal masks, the present system includes a pair of nasal inserts which are fed bilaterally from a pair of delivery tubes which includes both a left and a right leg. If the patient occludes one leg on one side of the mask, the complimentary side is sufficient to provide all of the air required by the patient.
Air is introduced into the system through a Y-shaped adapter or coupler. The shape of the coupler cooperates with other elements to minimize noise.
A pair of bleed ports are placed in the cannula body near the patient's nose. These bleed ports reduce the amount of carbon dioxide retained by the system. The two complex ports are placed in the cannula body to reduce noise and to reduce carbon dioxide build up in the system. Example calculations show how the size, shape and location of each of these ports cooperate to reduce the inhaled carbon dioxide concentration.
An additional feature relates directly to the shape of the nasal inserts. The nasal inserts are sufficiently long and compliant that they may be inserted into the nose until they adopt a location where the cross-section of the nare and the cross-section of the insert are essentially equal. The compliance of the material used to manufacturer the device is sufficient to provide an extremely comfortable fit in the nares.
Throughout the figures of the drawing like reference numerals indicate identical structure wherein:
In operation, the positive pressure ventilation machine 24 supplies air under pressure to the nasal cannula 10 and releases exhaled air to the atmosphere. Conventional machines have a valve that is overpressure during exhalation to exhaust air. In some instances the system may also warm and humidify the delivered air. In some instances the machines are used to deliver medications.
The left delivery tube and the right delivery tube 20 should lie close to the face of the patient and the coupler 22 should be positioned in the vicinity of the neck as seen in the figure.
Nasal insert 12 and nasal insert 13 are tubes connected to and extending from the delivery tube 20 and delivery tube 21 respectively. The most distal portion of the insert 12 terminates in a flange 26. It is expected that each flange 26 will be quite soft. The flange 26 is designed to readily conform to the patient's nare. In use the patient will direct the inserts into the nose and the inserts 12 and 13 will move in the nare until the inner cross section of the nare matches the outer cross section of the flange. The anatomy of the nose will deform the shape of the insert and its flange to achieve a comfortable seal. It is expected that only one or two sizes will be required to fit a large population as most patients have similarly sized nares.
The bleed port typified by port 16 is a tube extending from the delivery tube 20 into the insert 12. Each tube has a characteristic height or length. These bleed ports serve several functions. If the bleed ports 16 and 17 are appropriately placed and sized they can reduce the accumulation of carbon dioxide. If they are properly configured, sized and located they can also be used to decrease “whistling” or other acoustic effects. One objective of the bleed ports is to decreases the amount of carbon dioxide in the cannula during inhalation to a targeted value between 0.2 to 0.7 percent. A preferred value is below approximately 0.5 percent. Applicant believes that low carbon dioxide concentrations in the system will prevent build up of carbon dioxide in the patient.
Throughout the figures and specification the following definitions obtain:
It is now recognized that simple ventilation systems which retain a large volume of exhaled gas within the air inlet track result in increased carbon dioxide concentration in the patient's blood. An increase in dissolved carbon dioxide results in the acidification of the blood and increases respiration drive and usually increases respiration rate. In the system the dead space of the device is balanced with both the size and location of the bleed port structures to prevent build-up of the concentration of carbon dioxide in the inhaled air. When the size and location of the ports is optimized, a significant reduction in carbon dioxide gas concentration is achieved.
Generally speaking if the bleed ports are to be small, they need to be located near the nasal inserts. This effect is more important if the dead space within the cannula is large. For this reason, it should be recognized that there is a relationship between dead space, bleed port location and size which can cooperate together to provide a nasal cannula with superior performance. Although it appears that the optimized ports are restrictive due to their length and size, it has also been determined that they can be shaped to minimize parasitic acoustic effects such as “whistling” which is exhibited by current generations of current nasal cannula.
A first level approximation identifies that for a given bleed port of area (BPD), the separation distance of the bleed ports is inversely related to the square of the cannula cross sectional area (X)(see
where “A” is the constant of proportionality for the expression and may be solved with reference to the given and established relationships.
It should be noted that if the ports are very far apart they need to be large to reach the carbon dioxide reduction goal, but such large bleed ports reduce the pressure in the system by such a large margin that it no longer effectively provides the positive pressure assistance.
Representative prototype devices have been fabricated with a diameter (to match cross sectional area X) of between ⅜ and ⅝ inches and other dimensions may be approximately scaled from
Various modification and additions to the invention may be made without departing from the scope of the invention.
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|U.S. Classification||128/207.18, 128/207.13, 128/207.11|
|International Classification||A62B18/02, A61M16/06, A61M16/00, A61M15/08, A62B7/00, A61M1/00, A62B18/08, A61M|
|Cooperative Classification||A61M16/0683, A61M16/0666, A61M16/0833|
|Nov 1, 2011||CC||Certificate of correction|
|Aug 28, 2015||REMI||Maintenance fee reminder mailed|
|Jan 15, 2016||FPAY||Fee payment|
Year of fee payment: 12
|Jan 15, 2016||SULP||Surcharge for late payment|
Year of fee payment: 11
|Sep 26, 2017||AS||Assignment|
Owner name: SALTER LABS, ILLINOIS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:INNOMED TECHNOLOGIES, INC.;REEL/FRAME:043700/0450
Effective date: 20170321