CA2416853A1 - Pediatric ventilation mask and headgear system - Google Patents
Pediatric ventilation mask and headgear system Download PDFInfo
- Publication number
- CA2416853A1 CA2416853A1 CA002416853A CA2416853A CA2416853A1 CA 2416853 A1 CA2416853 A1 CA 2416853A1 CA 002416853 A CA002416853 A CA 002416853A CA 2416853 A CA2416853 A CA 2416853A CA 2416853 A1 CA2416853 A1 CA 2416853A1
- Authority
- CA
- Canada
- Prior art keywords
- mask
- shell
- headgear
- cuff
- nose
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/06—Respiratory or anaesthetic masks
- A61M16/0683—Holding devices therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/06—Respiratory or anaesthetic masks
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/06—Respiratory or anaesthetic masks
- A61M16/0605—Means for improving the adaptation of the mask to the patient
- A61M16/0616—Means for improving the adaptation of the mask to the patient with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/06—Respiratory or anaesthetic masks
- A61M16/0605—Means for improving the adaptation of the mask to the patient
- A61M16/0633—Means for improving the adaptation of the mask to the patient with forehead support
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/06—Respiratory or anaesthetic masks
- A61M16/0683—Holding devices therefor
- A61M16/0694—Chin straps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
- A61M16/0816—Joints or connectors
- A61M16/0841—Joints or connectors for sampling
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/59—Aesthetic features, e.g. distraction means to prevent fears of child patients
Abstract
A nasal or full-face mask and headgear system for improving pediatric compliance of ventilation therapy, including CPAP or BiPAP, and sized for pediatric use is provided. Each mask has a shallow concave rigid shell bearing the visage of a caricature. Unique caricatures are predetermined to represent different sizes of masks. Further, headgear is provided in keeping with the caricature theme and having additional aspects such as ears, removably attached to it. Each mask has an inner inflatable cuff to improve fit and an outer replaceable cuff to facilitate cleaning as well as fitting. The headgear is attached to the mask at three contact points using straps having key slots attached to ends of the straps and raised buttons on the mask shell. The straps are adjustable for length using Velcro TM and are not adjusted each time the system is placed onto the patient, improving positioning of the mask when the patient is asleep or resistant.
Description
1 "PEDIATRIC VENTILATION MASK AND HEADGEAR SYSTEM"
2
3 FIELD OF THE INVENTION
4 The present invention relates to apparatus used in the field of non-invasive and invasive ventilation therapies including continuous positive airway 6 pressure (CPAP) or bi-level positive air pressure (BiPAP) therapy and 7 particularly to nasal and full-face masks and headgear used to treat pediatric 8 patients.
BACKGROUND OF THE INVENTION
11 Continuous positive airway pressure (CPAP) or alternatively, 12 Bilevel Positive Airway Pressure (BiPAP) have become conventional forms of 13 non-invasive ventilation treatment for adult patients suffering from obstructive 14 sleep apnea and other nocturnal breathing disorders. Furthermore, not only has it been shown to be an effective therapy, but there is also evidence that it 16 contributes to less time in hospital, fewer medical complications and decreased 17 mortality compared to immediate intubation and ventilation.
18 Continuous positive airway pressure (CPAP) is delivered by a 19 positive airway pressure generator into a mask wom by the patient while sleeping. This effectively dilates the upper airway, preventing its collapse, thus 21 enabling the patient to assume a normal breathing pattern which results in an 22 uninterrupted sleep. For many patients this therapy dramatically improves their 23 daytime functioning and behaviour as well as their general health.
24 BiPAP delivers CPAP but also has the capability to sense when an inspiratory effort is being made by the patient and, in turn, delivers a higher 1 pressure during inspiration. When flow stops, the pressure returns to the CPAP
2 level. This positive pressure wave during inspirations unloads the diaphragm, 3 decreasing the work of breathing and has been found particularly useful in 4 patients with chronic respiratory failure due to neuromuscular weakness or dysfunction or chest wall abnormalities.
6 One study showed that the use of CPAP has resulted in a 7 reduction of intubation from 74% to 16%, major complications were decreased 8 from 48% to 16% and length of stay in hospital was reduced from 35 days to 9 days. Mortality was decreased from 29% to 9%. There is also evidence from randomized, controlled trials to show that CPAP improves oxygenation, 11 hypercapnia and reduces the rate of endotracheal intubation in pulmonary 12 edema.
13 More recently, CPAP has become a therapy of choice for pediatric 14 patents suffering from abnormal breathing during sleep resulting from among others, small upper airways, upper airway resistance syndrome, persistent 16 obstruction following surgery for adenotonsillar hypertrophy, craniofacial 17 anomalies, neuromuscular weakness, obesity, spina bifida and Down's 18 Syndrome. In many cases, standard invasive respiratory intervention such as 19 tracheostomies and intubation can be avoided. Sleep apnea has also been reported in infants considered to be at risk of death from sudden infant death 21 syndrome (SIDS) and has been seen in infants who have subsequently died of 22 SIDS.
23 Much of the information relating to compliance problems 24 associated with CPAP are reported from adult studies. Clearly, adults are better able to provide feedback to health care providers, regarding those issues which 1 prevent or limit their ability or desire to utilize the therapy. It can be extrapolated 2 however, that these issues are also present for the pediatric patient and, in many 3 cases, are made worse due to the patient's lack of understanding of the therapy 4 and fear of intervention, as well as the commercial unavailability of a wide variety of sizes or well fitting masks and headgear.
6 The major reported obstacle for most adult patients to overcome is 7 becoming accustomed to the ventilation system. Approximately 20% of patients, 8 for a variety of reasons, never team to tolerate it and a substantial proportion of 9 the others have a hard time using it regularly. The statistics for use in pediatric 90 patients can be much worse. Kribbs et al, reported in the American Journal of 11 Respiratory Diseases in 1993 that only 6% of the 35 CPAP patients studied used 12 CPAP 70% of the time for 7 hours or greater, suggesting that frequent, long 13 duration usage of nasal CPAP is a rare occurrence in obstructive sleep apnea 14 (OSA). Efforts to enhance CPAP and BiPAP use are needed especially early in treatment to reduce the significant nature of the disorder and death associated 16 with OSA and nocturnal hypoventilation. Problems such as mask fit, pressure 17 sores or redness around the nose and nasal dryness or stuffiness are common 18 reasons that patients fail to comply. Most of these problems are solvable by 19 finding a mask that fits properly.
Air leaking from around a poorly fitting nasal mask can be quite 21 uncomfortable and possibly result in suboptimal treatment. Air leaking causes 22 the generator to blow more air to achieve the prescribed pressure, thus making it 23 more uncomfortable for the patient and possibly causing more arousals during 24 sleep. In many cases, the air is directed from the poorly fitting mask directly into the patient's eyes. For this reason, it is essential that the mask fit properly, which 1 is particularly challenging in the case of children. Further, as the patient drifts off 2 to sleep, the jaw tends to relax and the mouth may open. When this happens, air 3 from the generator may escape through the mouth. A properly fitting chin strap 4 can assist in keeping the mouth closed during sleep.
Headgear is used to hold the mask in place over the nose, or over 6 the nose and mouth, in the case of a full-face mask. Typically, headgear 7 comprises a plurality of straps connected to the mask, which extend about the 8 head or to a cap fitted on the head, to stabilize the mask.
9 Pediatric patients may be introduced to CPAP from the time of birth and may continue to require treatment throughout their entire lives. Clearly nasal 11 and full-face masks designed to fit the adult face are unsuitable for these 12 patients, especially in their early years. Craniofacial abnormalities may add to 13 the difficulty in finding a mask that fits well. Further, it has been reported that 14 children wearing an improperly fitting mask during bone development can develop facial abnormalities as a result of the poorly fitting mask.
16 Nasal prongs or nasopharyngeal tubes, that may be used in a 17 hospital setting to deliver CPAP, are not available for equipment designed for the 18 home environment. As well, most manufacturers provide only one size of mask 19 for pediatric patients, if they provide a pediatric mask at all. Currently, to Applicant's knowledge there are no masks marketed as °pediatric masks" that 21 are small enough to fit premature neonatal patients satisfactorily. It appears that 22 there is little recognition that a unique range of sizes is required for the pediatric 23 population, which extends, in age, from neonate to pre-teen. Patients who have 24 syndromes that result in stunted growth may require pediatric sized masks throughout their lives.
1 Currently, masks and headgear may be sold as a pre-packaged 2 system, however, a mask from one system may be better suited with the 3 headgear from another, for a particular patient. Costs escalate if pre-packaged 4 systems are purchased, but only one of the components is usually used, due to fit or comfort considerations, in combination with a component from another 6 system. Often, a suitable component is not available at all and the therapist and 7 patient must "make do° with the closest alternative, which is often uncomfortable 8 and heavy and as a result little used.
9 One system intended specifically for pediatric use, known to Applicant, is the Resmed Infant Mask System having a nasal mask and a cap 11 (RESCAPTM). Resmed is an Australian Corporation. A single strap extends from 12 a point at the front of the cap to a tab extending from the top of the mask, 13 between the eyes, which acts as a forehead support and has a cushion designed 14 to rest against the forehead to reduce pressure sore formation. A second strap extends through the forehead support and around the patient's head to the sides 16 of the cap. Third and fourth straps extend from protruding tabs at the sides of the 17 mask to join the cap adjacent it's bottom edge. The straps are attached to the 18 mask and to the cap using VeIcroT"t.
19 A single, flexible cuff is formed about the nasal mask to accommodate and seal about the nose. While the mask is small enough to fit 21 some pediatric patients, the cuff must often be retrofit or cut to fit over individual 22 patient's noses. Once the cuff has been cut to provide a better fit for slightly 23 larger noses or abnormalities, the cut edges are likely to cause irritation at the 24 points of contact or leaks where there is insufficient sealing. Further, the cushioned forehead support continues to cause pressure sores, especially in the
BACKGROUND OF THE INVENTION
11 Continuous positive airway pressure (CPAP) or alternatively, 12 Bilevel Positive Airway Pressure (BiPAP) have become conventional forms of 13 non-invasive ventilation treatment for adult patients suffering from obstructive 14 sleep apnea and other nocturnal breathing disorders. Furthermore, not only has it been shown to be an effective therapy, but there is also evidence that it 16 contributes to less time in hospital, fewer medical complications and decreased 17 mortality compared to immediate intubation and ventilation.
18 Continuous positive airway pressure (CPAP) is delivered by a 19 positive airway pressure generator into a mask wom by the patient while sleeping. This effectively dilates the upper airway, preventing its collapse, thus 21 enabling the patient to assume a normal breathing pattern which results in an 22 uninterrupted sleep. For many patients this therapy dramatically improves their 23 daytime functioning and behaviour as well as their general health.
24 BiPAP delivers CPAP but also has the capability to sense when an inspiratory effort is being made by the patient and, in turn, delivers a higher 1 pressure during inspiration. When flow stops, the pressure returns to the CPAP
2 level. This positive pressure wave during inspirations unloads the diaphragm, 3 decreasing the work of breathing and has been found particularly useful in 4 patients with chronic respiratory failure due to neuromuscular weakness or dysfunction or chest wall abnormalities.
6 One study showed that the use of CPAP has resulted in a 7 reduction of intubation from 74% to 16%, major complications were decreased 8 from 48% to 16% and length of stay in hospital was reduced from 35 days to 9 days. Mortality was decreased from 29% to 9%. There is also evidence from randomized, controlled trials to show that CPAP improves oxygenation, 11 hypercapnia and reduces the rate of endotracheal intubation in pulmonary 12 edema.
13 More recently, CPAP has become a therapy of choice for pediatric 14 patents suffering from abnormal breathing during sleep resulting from among others, small upper airways, upper airway resistance syndrome, persistent 16 obstruction following surgery for adenotonsillar hypertrophy, craniofacial 17 anomalies, neuromuscular weakness, obesity, spina bifida and Down's 18 Syndrome. In many cases, standard invasive respiratory intervention such as 19 tracheostomies and intubation can be avoided. Sleep apnea has also been reported in infants considered to be at risk of death from sudden infant death 21 syndrome (SIDS) and has been seen in infants who have subsequently died of 22 SIDS.
23 Much of the information relating to compliance problems 24 associated with CPAP are reported from adult studies. Clearly, adults are better able to provide feedback to health care providers, regarding those issues which 1 prevent or limit their ability or desire to utilize the therapy. It can be extrapolated 2 however, that these issues are also present for the pediatric patient and, in many 3 cases, are made worse due to the patient's lack of understanding of the therapy 4 and fear of intervention, as well as the commercial unavailability of a wide variety of sizes or well fitting masks and headgear.
6 The major reported obstacle for most adult patients to overcome is 7 becoming accustomed to the ventilation system. Approximately 20% of patients, 8 for a variety of reasons, never team to tolerate it and a substantial proportion of 9 the others have a hard time using it regularly. The statistics for use in pediatric 90 patients can be much worse. Kribbs et al, reported in the American Journal of 11 Respiratory Diseases in 1993 that only 6% of the 35 CPAP patients studied used 12 CPAP 70% of the time for 7 hours or greater, suggesting that frequent, long 13 duration usage of nasal CPAP is a rare occurrence in obstructive sleep apnea 14 (OSA). Efforts to enhance CPAP and BiPAP use are needed especially early in treatment to reduce the significant nature of the disorder and death associated 16 with OSA and nocturnal hypoventilation. Problems such as mask fit, pressure 17 sores or redness around the nose and nasal dryness or stuffiness are common 18 reasons that patients fail to comply. Most of these problems are solvable by 19 finding a mask that fits properly.
Air leaking from around a poorly fitting nasal mask can be quite 21 uncomfortable and possibly result in suboptimal treatment. Air leaking causes 22 the generator to blow more air to achieve the prescribed pressure, thus making it 23 more uncomfortable for the patient and possibly causing more arousals during 24 sleep. In many cases, the air is directed from the poorly fitting mask directly into the patient's eyes. For this reason, it is essential that the mask fit properly, which 1 is particularly challenging in the case of children. Further, as the patient drifts off 2 to sleep, the jaw tends to relax and the mouth may open. When this happens, air 3 from the generator may escape through the mouth. A properly fitting chin strap 4 can assist in keeping the mouth closed during sleep.
Headgear is used to hold the mask in place over the nose, or over 6 the nose and mouth, in the case of a full-face mask. Typically, headgear 7 comprises a plurality of straps connected to the mask, which extend about the 8 head or to a cap fitted on the head, to stabilize the mask.
9 Pediatric patients may be introduced to CPAP from the time of birth and may continue to require treatment throughout their entire lives. Clearly nasal 11 and full-face masks designed to fit the adult face are unsuitable for these 12 patients, especially in their early years. Craniofacial abnormalities may add to 13 the difficulty in finding a mask that fits well. Further, it has been reported that 14 children wearing an improperly fitting mask during bone development can develop facial abnormalities as a result of the poorly fitting mask.
16 Nasal prongs or nasopharyngeal tubes, that may be used in a 17 hospital setting to deliver CPAP, are not available for equipment designed for the 18 home environment. As well, most manufacturers provide only one size of mask 19 for pediatric patients, if they provide a pediatric mask at all. Currently, to Applicant's knowledge there are no masks marketed as °pediatric masks" that 21 are small enough to fit premature neonatal patients satisfactorily. It appears that 22 there is little recognition that a unique range of sizes is required for the pediatric 23 population, which extends, in age, from neonate to pre-teen. Patients who have 24 syndromes that result in stunted growth may require pediatric sized masks throughout their lives.
1 Currently, masks and headgear may be sold as a pre-packaged 2 system, however, a mask from one system may be better suited with the 3 headgear from another, for a particular patient. Costs escalate if pre-packaged 4 systems are purchased, but only one of the components is usually used, due to fit or comfort considerations, in combination with a component from another 6 system. Often, a suitable component is not available at all and the therapist and 7 patient must "make do° with the closest alternative, which is often uncomfortable 8 and heavy and as a result little used.
9 One system intended specifically for pediatric use, known to Applicant, is the Resmed Infant Mask System having a nasal mask and a cap 11 (RESCAPTM). Resmed is an Australian Corporation. A single strap extends from 12 a point at the front of the cap to a tab extending from the top of the mask, 13 between the eyes, which acts as a forehead support and has a cushion designed 14 to rest against the forehead to reduce pressure sore formation. A second strap extends through the forehead support and around the patient's head to the sides 16 of the cap. Third and fourth straps extend from protruding tabs at the sides of the 17 mask to join the cap adjacent it's bottom edge. The straps are attached to the 18 mask and to the cap using VeIcroT"t.
19 A single, flexible cuff is formed about the nasal mask to accommodate and seal about the nose. While the mask is small enough to fit 21 some pediatric patients, the cuff must often be retrofit or cut to fit over individual 22 patient's noses. Once the cuff has been cut to provide a better fit for slightly 23 larger noses or abnormalities, the cut edges are likely to cause irritation at the 24 points of contact or leaks where there is insufficient sealing. Further, the cushioned forehead support continues to cause pressure sores, especially in the
5 1 smallest of the patients where the headgear may not fit adequately and the mask 2 moves about. The mask shell is generally triangular in shape and has a flat 3 surface into which a port is formed and tubing is attached. For many patients, the 4 flat surface of the mask shell does not permit adequate space for the nose and as a result the nose rests against the surface often resulting in pressure sores.
6 Many of the pediatric patients are non-compliant and may fall
7 asleep periodically throughout the day and night. The VeIcroTM fasteners are
8 difficult to adjust without arousing the child. More importantly, if the child has
9 fallen asleep in an awkward position, it is difficult to ensure that the mask is positioned correctly and snuggly on the face, as the length of the straps are 11 dependant on where the fasteners are fastened each and every time the mask is 12 worn.
13 Typically, patients introduced to CPAP at the toddler stage of 14 development, exhibit great resistance to use of the mask. At least in part this resistance develops because of comfort issues, including size which may 16 obstruct their vision, pressure sores as a result of contact points on the forehead 17 and cheeks, excessive weight or, in some cases, latex allergies and may further 18 include psychological reasons. Many of these patients have spent considerable 19 time in institutions, such as hospitals, and have been subjected to almost constant medical intervention of one type or another. Placing a mask on the face 21 may elicit fear of the apparatus itself or what it is perceived to be associated with 22 and particularly for those who have become tactile defiant, compliance becomes 23 a struggle that many parents and therapists are unable to resolve.
24 Often psychologists are included as an integral part of the therapy team as they attempt to improve the pediatric patient's compliance with CPAP
or 1 BiPAP therapy. In some cases, all members of a family are encouraged to also 2 wear a mask while preparing the patient and their siblings for bed so that the 3 patient views it as a "normal" process in the bedtime ritual. The mask may be 4 included among a child's toys so that they come to see it as something fun rather ~ than a medical device. Games are created around the issue of wearing the 6 mask. Often several months are spent in this process during which little or no 7 therapy is actually occurring. For some patients, the loss of time may be critical 8 to their overall health and may result in the need to proceed to more 9 conventional invasive techniques such as tracheostomy, without giving the therapy a chance.
11 One product used to improve nebulizer compliance in asthmatic 12 children is the "Bubbles The Fish" pediatric aerosol mask for use with a PARI
13 nebulizer. The mask is transparent, but made to look like a fish face so that 14 children find it fun to use, greatly improving compliance. The aerosol mask however, cannot be used to administer CPAP, as it is designed to be hand held 16 over the nose and mouth for short-term use for inhalation only, rather than 17 attached to headgear for continuous use. Size and configuration are less 18 important for this type of therapy, typically requiring only a "one size fits all"
19 mask.
The range of mask and headgear sizes required for the pediatric 21 population may represent very small incremental and visually indistinct changes 22 in dimensions. For this reason it is desirable to have a system for simple 23 recognition of the different sizes available, especially when systems are further 24 obscured when pre-packaged.
1 Clearly, there is a need for a ventilation mask and associated 2 headgear that is available to fit pediatric patients ranging from the tiniest of 3 neonates to those nearly able to wear small adult sized apparatus. Such a 4 system would be comfortable, viewed as something desirable to wear by the patient and readily identifiable as to its size for ease of fitting.
2 The mask and headgear system of the present invention alleviates the 3 problems associated with patient compliance during ventilation therapy such as 4 CPAP or BiPAP therapy. The caricatures represented on both the mask shell and on the headgear create a fun, readily accepted apparatus that is not viewed by the 6 pediatric patient as merely another intrusive medical device.
7 Further, the association of each unique caricature with a particular 8 predetermined size assists the therapist in rapid identification and fitting of the mask 9 and headgear to the patient. This is of particular advantage when a wider range of pediatric sized masks are provided for improving fit-matching and which may only 11 differ by small increments that are not readily discerned visually.
Further, proper size 12 selection improves comfort and fit with increased likelihood of compliance.
13 In a broad aspect, the invention is a system for improving compliance 14 in a pediatric population for the use of continuous positive or bi-level airway pressure masks and headgear and providing size recognition comprising: a plurality 16 of masks and headgear of predetermined known matched and serial sizes so as to 17 flt a range of pediatric patients; and a size indicator being a predetermined visage of 18 a caricature represented on each of the plurality of masks, each caricature being 19 predetermined to represent one of each of the plurality of sizes. More particularly, the size indicator is the visage of a caricature, such as an animal, on the shell of the 21 mask and related aspects such as ears, in keeping with the caricature, are attached 22 to the headgear.
23 More preferably, the invention comprises a unique mask having a 24 concave shell which is suitable for fitting over the nose or nose and mouth of a pediatric patient. The concave profile of the shell permits sufficient room for the 26 patient's nose so that it does not rest on the shell, reducing the incidence of 1 pressure sores. Further, the concave shape permits greater air movement without 2 an increase in dead space within the interior of the mask.
3 The mask provides both an outer replaceable cuff and an inner 4 inflatable cuff. The outer cuff protects the inner cuff from contact with the patient's face and can be easily removed for cleaning or replacement with a cuff having a 6 different size of opening for the nose or nose and mouth. The inner cuff can be 7 inflated to varying degrees to provide a wider range of profiles suitable for sealing 8 against individual patient's faces to provide an optimum flt within a single mask size.
9 The inner cuff when inflated, positions the shell further away from the patient's nose and cheeks allowing more room for the nose. Further, in patients such as those with 11 Down's Syndrome, in which there is relatively little, if any, nasal bridge, inflation of 12 the interior cuff aids in preventing the mask from slipping up towards the patient's 13 forehead. When deflated, the mask has a flatter profile, the shell being positioned 14 closer to the nose and cheeks, for permitting a better fit for individual patients.
The above apparatus and methodology enables the provision of a 16 mask and a system which is particularly useful in the treatment of pediatric cases.
17 Accordingly, a broad system is provided for improving compliance in a pediatric 18 population for the use of ventilation masks and headgear and providing size 19 recognition comprising: a plurality of masks and headgear of predetermined known matched and serial sizes so as to fit a range of pediatric patients wherein the mask 21 further comprises a concave shell; at least one flexible cuff attached about a 22 periphery of the shell and having an opening for receiving a patients nose or nose 23 and mouth; a port in the shell for receiving tubing for attachment to~ a ventilation 24 device; at least one exhalation port; and means for attachment to the headgear; and the headgear comprises a cap and a plurality of straps having means for attachment 26 to the mask; and a size indicator being a predetermined visage of a caricature, 1 preferably animals, represented on each of the plurality of masks, each caricature 2 being predetermined to represent one of each of the plurality of sizes.
3 Such a mask for improving compliance in a pediatric population would 4 comprise: a concave shell having an outer periphery and having a size selected from a plurality of predetermined sizes; at least one flexible cuff attached to the shell 6 about the periphery and having an opening so as to receive a patient's nose or nose 7 and mouth; at least one port in the shell for receiving tubing; at least one exhalation 8 port; and a size indicator, the indicator being indicia representing one of a plurality of 9 caricatures, each caricature predetermined to represent one of the plurality of predetermined sizes.
11 Particularly where fit is an issue, the mask comprises a concave shell 12 having an outer periphery; a flexible exterior cuff attached to the shell about the 13 periphery and having an opening so as to receive a patient's nose or nose and 14 mouth; an inflatable interior cuff attached to the shell and positioned inside the exterior cuff, the inflatable cuff further comprising a valve port extending through the 16 shell and in fluid communication with the inflatable cuff; at least one exhalation port;
17 and at least one port in the shell for receiving tubing.
2 Figure 1 is a perspective view of a nasal mask, fit over the nose of 3 a patient, and headgear of the present invention having an animal face portrayed 4 on the mask and including the optional matching ears on the headgear including an optional chin strap;
6 Figure 2 is a perspective view of a full-face mask of the present 7 invention, the mask fit over a patient's nose and mouth;
8 Figures 3a-3c are front views of a series of nasal masks, each 9 mask having a different size, the sizes represented by different caricatures;
Figures 4a and 4b are front views of a series of full-face masks, 11 each mask having a different size, the sizes represented by different caricatures;
12 Figure 5a is a back view of a nasal mask having a replaceable 13 exterior cuff and an inflatable inner cuff;
14 Figure 5b is a side view of a nasal mask according to Fig. 5a showing extension of the cuff from a profile of a mask shell having an attached 16 swivel and tubing;
17 Figure 6a is a back view of a full-face mask having a replaceable 18 exterior cuff and an inflatable inner cuff;
19 Figure 6b is a side view of a full-face mask according to Fig. 6a showing extension of the cuff from the profile of a mask shell having an attached 21 swivel and tubing;
22 Figure 7 is a partial cross-sectional view of an inflatable inner cuff 23 and a replaceable outer cuff attached to the mask shell;
24 Figure 8 is a close up side view of the raised buttons attached to the mask shell for attachment of headgear straps;
1 Figure 9a is a perspective view of a headgear of the present 2 invention, without a mask attached; and 3 Figure 9b is a close-up perspective view of the end piece and key 4 slot of a headgear strap.
2 Having reference to Fig. 1, a CPAP mask and headgear system 10 3 of one embodiment of the invention is shown. The nasal mask 20 comprises a 4 shallow concave rigid shell 21, bearing the visage bf a caricature 200, for positioning over the nose of a pediatric patient. The mask 20 is held in place 6 over the patient's nose by headgear 30, wom by the patient. The mask 20 is 7 connected to a ventilation device (not shown), such as a non-invasive CPAP
or 8 BiPAP machine or an invasive device such as a respirator, by tubing 22 9 extending from a port 23 in the mask 20 through which air pressure is administered to the patient. A swivel 24 having a right angle bend is fitted in 11 rotatable, sealed arrangement about the port 23 in the shell 21 for attaching the 12 tubing 22 to the shell 21. The swivel 24 is freely rotatable about the port 23 to 13 permit movement of the tubing 22 without displacing the mask 20 from the 14 patient's face. Further, the swivel 24 is bent at a right angle to prevent the tubing 22 from extending directly outward from the mask 20 where it may become a 16 hindrance or highly visible to the patient.
17 Similarly, Fig. 2 shows a full-face mask 40 used to cover both the 18 nose and the mouth of patients who are unable to breath solely through the 19 nose. The shell 41 of the full-face mask 40 is elongated to cover the nose and mouth and may be slightly wider at a bottom edge 42 than a nasal mask 20 used 21 for the same sized patient.
22 The shells 21, 41 are concave in shape so as to permit adequate 23 space for the patient's nose without having the nose impinge upon the shell 21.
24 Figs. 3 and 4 illustrate a representative range of nasal 20 and full-face 40 mask sizes required for fitting a pediatric population ranging in age from 1 newborn until the patient fits known adult masks. Size variations, small 20a, 2 medium 20b and large 20c, shown in Fig. 3, and small 40a and large 40b, shown 3 in Fig. 4, are often not readily discernable at a first glance and may be especially 4 difficult to identify when the systems 10 are packaged for shipping.
Accordingly, the application of a unique caricature 200 on each sized mask 20,40, to 6 reference a particular predetermined size, makes it easy to readily select the 7 size appropriate for the patient, at a glance.
8 Having reference to Figs. 5a and 5b, each nasal mask 20 further 9 comprises a first external flexible cuff 25 attached to a periphery 26 of the shell 21 for providing a seal between the shell 21 and the patient's nose and cheeks.
11 An opening 27 is formed in the cuff to permit the nose to protrude therethrough 12 into the shell 21. Preferably, the external cuff 25 is removably attached, so as to 13 permit removal for cleaning and replacement with cuffs 25 having larger or 14 smaller openings 27 to further ensure an optimum fit for the patient.
Figs. 6a and 6b show a full-face mask 40, having a similar external 16 cuff 43 attached about a periphery 44 of a full-face shell 41, however an opening 17 45 in the external cuff 43 is sized to fit over both of the patient's nose and mouth.
18 In a preferred embodiment of the invention and having reference to 19 Fig. 7, a lip 50 protrudes about the periphery 26,44 of the shell 21, 41 under which an outer compressible edge 51 of the exterior cuff 25, 43 is trapped. A
21 thickness 52 at the compressible edge 51 of the exterior cuff 25,43 is slightly 22 larger than a space 53 between the lip 50 and the shell 21,41. The cuff edge 51 23 is compressed into the space 53 and is thus retained therein. The external cuff 24 25, 43 can be readily removed by pulling the compressible edge 51 out of the space 53.
1 More preferably, as shown in Figs. 5a, 6a and 7, a second non-2 removable interior cuff 60 is formed about each shell's periphery 26, 44, 3 positioned inside the exterior cuff 25,43. The interior cuff 60 is inflatable, 4 permitting additional adjustment of the fit between the mask 20, 40 and the patient's face. A small valve port 61 extends outward from the shell 21,41 and is 6 in fluid communication with the interior cuff 60 so as to permit air to be injected, 7 typically using a syringe (not shown), into the inflatable cuff 60 until it is suitably 8 inflated to fit the patient. Similarly, the interior cuff 60 can be deflated, by 9 depressing a valve stem 62 within the valve port 61, much like an inner tube in a vehicle tire, if a flatter profile is required for fitting.
11 Advantageously, when inflated, the inflatable cuff 60 moves the 12 exterior cuff 25,43 outward into contact with the patient's face.
Therefore, it is 13 only the replaceable exterior cuff 25,43 that is subjected to facial oils, 14 medications and the like, present on the patient's face. When the exterior cuff 23, 45 requires cleaning or replacing it can simply be pulled from the lip 50 and 16 replaced.
17 As shown in Figs. 3a-3c, 4a, 4b, 5b and 6b, each shell 21,41 18 further comprises exhalation ports 70 to prevent re-breathing of C02 rich 19 exhalation air. Preferably, the exhalation ports 70 are formed in the swivel 24, directly adjacent the patient's nose. More preferably, in the case of the full-face 21 mask 40, a plurality of small perforations 71 about the periphery of the full-face 22 shell 41 act as additional exhalation ports, so as to further prevent re-breathing 23 of C02, when both the nose and mouth are covered.
24 More preferably, the exhalation ports 70 formed in the swivel 24 add to a nasal feature 201 of the caricature 200.
1 Optionally, the shells 21, 41 comprise at least one additional port 2 73 having a cap (not shown) for entrainment of additional inhalation gases, such 3 as oxygen or for measurement of parameters such as end tidal C02 for 4 monitoring excess C02 re-breathing.
Preferably, as shown in Fig. 5b, a retaining ring 80 is fit about a 6 bottom portion 81 of the swivel 24 and is axially moveable thereon. The retaining 7 ring 80 is slightly larger in diameter than the swivel 24 and is retained on the 8 swivel 24 by a flexible attachment 82. The retaining ring 80 is moved axially 9 downward over an outside of the tubing 22, when the tubing 22 is slipped over the swivel's bottom portion 81, applying compression to retain the tubing 22 on 11 the swivel 24.
12 As shown in Figs. 3 and 4, a plurality of raised buttons 90 are 13 formed at a top 28, 46 and sides 29, 47 of each shell 21,41 for attachment of the 14 headgear 30. As shown in Fig. 8, each button 90 comprises a large shaped head 91 supported on a smaller shank 92 attached to the shell 21,41.
16 Preferably, in the case of the larger full-face mask 40, more than 17 one raised button 90 is located on each side 47 of the full-face shell 41 to 18 enhance customized fitting of the system 10.
19 Having reference to Figs 1, 2, 9a and 9b, the headgear 30 is shown. The headgear 30 is used to position the nasal or full-face mask 20, 40 21 correctly over the patient's nose or nose and mouth. The headgear is available in 22 a range of sizes suitable for a pediatric population and to match the sizes of the 23 nasal and full-face masks 20, 40. The headgear 30 comprises a cap 31, which 24 extends from a peak 32 at the forehead to a neck edge 33 to cradle the back of 1 the patient's head. A plurality of straps 34 extend from the headgear 30 and are 2 attached to the raised buttons 90 on each mask sheN 21, 41.
3 Preferably, a single strap 35 extends from the peak 32 of the cap.
4 31, located at the forehead to the top 28, 46 of each mask 20, 40 and straps 36a, 36b extending outwards from each side 37, 38 of the cap 31 at the neck 6 edge 33, in opposing directions, so as to attach to the sides 29, 47 of each mask 7 20, 40.
8 Preferably, as shown in Figs. 9a and 9b, each strap 35, 36a, 36b 9 comprises an elongate body 100 attached to the cap 31 at a first end 101 and having a key slot 102 formed in a second end 103 for fitting over the raised 11 buttons 90 on each mask 20, 40 and locking into place. Each key slot 102 12 comprises a first hole 104 sized to fit the head 91 of the button 90 and a second 13 smaller hole 105 extending from the first hole 104 towards the second end 14 of the strap 100. The second hole 105 is sized so as to receive and firmly retain the shank 92 of the button 90, when the first hole 104 is placed over the head 16 of the button 90 and the strap 100 is pulled into tension to engage the shank 92 17 in the second hole 105.
18 In a preferred embodiment, as shown in Fig. 9b, a separate end 19 piece 106 having the key slot 102 formed therein is attached to the second end 103 of the strap body using a strip of hook and loop fastener 107, such as 21 VeIcroTM, so as to permit adjustment in a length of the straps 100.
22 An opening 108 is formed at a first end 109 of the end piece 106 23 for accepting the VeIcroTH' strip 107. The slot 105 is formed extending toward a 24 second end 110 of the end piece 106. The VeIcroTM strip 107 is threaded through the opening 108 and is attached to the strap 100 at a position which provides 1 optimum fit of the headgear 30 and mask 20, 40 to the patient. The length of the 2 straps 100 are therefore not adjusted each and every time the mask 20, 40 is 3 removed and replaced on the patient. The mask 20,40 is simply removed or 4 replaced on the patient's face by engaging the key slots 102 from the buttons 90 on the mask 20, 40. In this way, the headgear 30 and mask 20, 40 can be more 6 easily placed on a sleeping patient, without arousing them. Further, this assures 7 that the mask 20, 40 is positioned optimally no matter where or in what position 8 the patient has fallen asleep.
9 Optionally as shown in Figs. 1 and 9a, a chin strap 120 is attached to the headgear 30 to minimize or prevent opening of the patient's mouth during 11 therapy and thus minimize mouth leaks during use of a nasal mask 20. A
strip 12 121 of VeIcroTM is placed from side 37 to side 38 at a top 122 of the cap 31.
13 Corresponding strips of Velcro'''" 126 (only one shown) are placed on first and 14 second ends 123, 124 of the chin strap 120. When required, the chin strap's first end 123 is simply attached to the VeIcroT"' strip 121 on one side 37, 38 of the 16 cap 31, the chin strap 120 is positioned at the patients chin and the second end 17 124 is attached to the VeIcroTM strip 121 at the cap's other side 38.
18 Preferably, the chin strap 120 is formed having an oval cup-shaped 19 chin rest 125 positioned intermediate the chin strap's first and second ends 123, 124 for cradling the patient's chin. The chin rest 125 is preferably slightly padded 21 for additional comfort.
22 Having reference to Figs. 1-4 and 9a, a pair of ears 130, are 23 attached to the headgear 30 which are usually selected to be consistent with the 24 caricature 200 on the mask shell 21,41. The addition of ears 130 to the headgear 30 further improves compliance. Further, novelty is playfully added by using a 1 variety of ears, regardless of the mask selection. Preferable the ears 130 are 2 attached to the headgear 30 using small strips of Velcro'''"' 131.
4 Example 1 Having reference to Fig. 3, three nasal masks, each having a 6 predetermined size suitable for therapy over the size range of pediatric patients, 7 are shown. The mask shells are ovoid in shape and concave in profile and range 8 in size, the particular sizes being approximately; a small mask, having a height of 9 5 cm and a width of 4.5 cm at its widest portion; a medium mask having a height of 5.25 cm and a width of 5 cm at its widest portion; and a large mask having a 11 height of 5.75 cm and a width of 5 cm at its widest portion. The masks display 12 caricatures of different animal faces, each face an arbitrary yet consistent size 13 indicator representing the size of mask, for ease of identification and to improve 14 patient compliance. The small mask is a pig, the medium mask is a tiger and the large mask is a dog.
16 Similarly, as shown in Fig. 4, a full-face mask is provided in two 17 sizes, small and large. The small size is designated as an elephant and the large 18 size is designated as a zebra to improve patient compliance. The small full-face 19 mask is 8 cm in height, 3 cm in width at the top and 6.5 cm at its widest where it covers the patient's mouth and the large mask is 9 cm in height, 3 cm in width at 21 the top and 8 cm at it's widest.
22 Each shell has a lip about a periphery under which a removable 23 cuff is secured. The cuffs are available with a plurality of sizes of openings for 24 accommodating the patient's nose or nose and mouth so as to provide an optimum fit for the individual patient. The cuff sizes are represented in Table 1:
2 Table 1 - CUFF SIZES
4 Size Height Width Size Height Width Nasal Masks (cm) (cm~ Full-face masks (cm~ fcm) 6 Small 2.0 2.0 Small - standard 6.0 4.0 7 Small - wide 2.0 2.3 Large - standard 7.0 4.5 8 Medium 2.2 2.3 Large - wide 7.0 5.0 9 Medium - wide 2.2 2.5 Large 2.5 2.5 11 Large - wide 2.5 2.8 13 Preferably, the shell and cuffs and all related tubing are 14 manufactured to be latex-free. This is of particular importance to those patients, such as the spina bifida patients who are on "latex precaution° because of the 16 danger of anaphylaxis. Repeated surgery and other interventions make this 17 group of patients particularly susceptible to latex sensitivity.
18 Nasal mask sizes, in the series as shown, do not vary by more 19 than 0.5 cm in width or 0.75 cm in height. Similarly the full-face masks only vary by 1.5 cm in width and 1 cm in height. Thus, the use of animal faces to designate 21 the size ensures that the therapist is able to readily select the right size for the 22 patient without repeated trial and error sizing.
23 A further advantage of the animal face size indicators is that the 24 patient is more likely to view the mask as a fun item rather than a medical intervention, more like the pediatric oxygen device taught in US patent 5,690,096 26 to Burch. Burch's device is a plaything, fit with a plurality of oxygen ports, which 27 allow the patient to interact with the plaything while maintaining a flow of oxygen 28 when placed near the mouth and nose.
29 Headgear is provided to position the mask correctly over the patient's nose or nose and mouth during sleep. The headgear is also available in 31 a plurality of sizes, matched to the masks, to fit a range of pediatric sizes. To 1 further enhance size selection and compliance, the headgear is colored or 2 marked to match the appropriate sized mask. Preferable, the headgear is made 3 from lighfinreight breathable natural materials, such as cotton, to reduce 4 sweating.
Optionally, other aspects such as ears are added to the headgear 6 in keeping with the mask face in order to further improve compliance. For 7 example, a small pig mask would usually be accompanied by headgear in the 8 same color as the mask and having a set of pig ears attached to it. The tiger 9 headgear would be made of a fabric having a tiger stripe pattern and a pair of tiger ears attached thereto.
11 Preferably the ears are removable, such as attached using 12 VeIcroTM, to permit easy cleaning and further, easy removal, if the ears become 13 an obstruction during other intervention, or if the patient would prefer.
14 The advantages of the current pediatric mask system, which Applicant has not found in the prior art include:
16 - improved compliance by pediatric patients due to 17 psychological acceptance of the mask as a plaything;
18 improved therapeutics;
19 improved comfort; and - improved efficiency for the care professional; and 21 - a more efficient use of expensive resources.
13 Typically, patients introduced to CPAP at the toddler stage of 14 development, exhibit great resistance to use of the mask. At least in part this resistance develops because of comfort issues, including size which may 16 obstruct their vision, pressure sores as a result of contact points on the forehead 17 and cheeks, excessive weight or, in some cases, latex allergies and may further 18 include psychological reasons. Many of these patients have spent considerable 19 time in institutions, such as hospitals, and have been subjected to almost constant medical intervention of one type or another. Placing a mask on the face 21 may elicit fear of the apparatus itself or what it is perceived to be associated with 22 and particularly for those who have become tactile defiant, compliance becomes 23 a struggle that many parents and therapists are unable to resolve.
24 Often psychologists are included as an integral part of the therapy team as they attempt to improve the pediatric patient's compliance with CPAP
or 1 BiPAP therapy. In some cases, all members of a family are encouraged to also 2 wear a mask while preparing the patient and their siblings for bed so that the 3 patient views it as a "normal" process in the bedtime ritual. The mask may be 4 included among a child's toys so that they come to see it as something fun rather ~ than a medical device. Games are created around the issue of wearing the 6 mask. Often several months are spent in this process during which little or no 7 therapy is actually occurring. For some patients, the loss of time may be critical 8 to their overall health and may result in the need to proceed to more 9 conventional invasive techniques such as tracheostomy, without giving the therapy a chance.
11 One product used to improve nebulizer compliance in asthmatic 12 children is the "Bubbles The Fish" pediatric aerosol mask for use with a PARI
13 nebulizer. The mask is transparent, but made to look like a fish face so that 14 children find it fun to use, greatly improving compliance. The aerosol mask however, cannot be used to administer CPAP, as it is designed to be hand held 16 over the nose and mouth for short-term use for inhalation only, rather than 17 attached to headgear for continuous use. Size and configuration are less 18 important for this type of therapy, typically requiring only a "one size fits all"
19 mask.
The range of mask and headgear sizes required for the pediatric 21 population may represent very small incremental and visually indistinct changes 22 in dimensions. For this reason it is desirable to have a system for simple 23 recognition of the different sizes available, especially when systems are further 24 obscured when pre-packaged.
1 Clearly, there is a need for a ventilation mask and associated 2 headgear that is available to fit pediatric patients ranging from the tiniest of 3 neonates to those nearly able to wear small adult sized apparatus. Such a 4 system would be comfortable, viewed as something desirable to wear by the patient and readily identifiable as to its size for ease of fitting.
2 The mask and headgear system of the present invention alleviates the 3 problems associated with patient compliance during ventilation therapy such as 4 CPAP or BiPAP therapy. The caricatures represented on both the mask shell and on the headgear create a fun, readily accepted apparatus that is not viewed by the 6 pediatric patient as merely another intrusive medical device.
7 Further, the association of each unique caricature with a particular 8 predetermined size assists the therapist in rapid identification and fitting of the mask 9 and headgear to the patient. This is of particular advantage when a wider range of pediatric sized masks are provided for improving fit-matching and which may only 11 differ by small increments that are not readily discerned visually.
Further, proper size 12 selection improves comfort and fit with increased likelihood of compliance.
13 In a broad aspect, the invention is a system for improving compliance 14 in a pediatric population for the use of continuous positive or bi-level airway pressure masks and headgear and providing size recognition comprising: a plurality 16 of masks and headgear of predetermined known matched and serial sizes so as to 17 flt a range of pediatric patients; and a size indicator being a predetermined visage of 18 a caricature represented on each of the plurality of masks, each caricature being 19 predetermined to represent one of each of the plurality of sizes. More particularly, the size indicator is the visage of a caricature, such as an animal, on the shell of the 21 mask and related aspects such as ears, in keeping with the caricature, are attached 22 to the headgear.
23 More preferably, the invention comprises a unique mask having a 24 concave shell which is suitable for fitting over the nose or nose and mouth of a pediatric patient. The concave profile of the shell permits sufficient room for the 26 patient's nose so that it does not rest on the shell, reducing the incidence of 1 pressure sores. Further, the concave shape permits greater air movement without 2 an increase in dead space within the interior of the mask.
3 The mask provides both an outer replaceable cuff and an inner 4 inflatable cuff. The outer cuff protects the inner cuff from contact with the patient's face and can be easily removed for cleaning or replacement with a cuff having a 6 different size of opening for the nose or nose and mouth. The inner cuff can be 7 inflated to varying degrees to provide a wider range of profiles suitable for sealing 8 against individual patient's faces to provide an optimum flt within a single mask size.
9 The inner cuff when inflated, positions the shell further away from the patient's nose and cheeks allowing more room for the nose. Further, in patients such as those with 11 Down's Syndrome, in which there is relatively little, if any, nasal bridge, inflation of 12 the interior cuff aids in preventing the mask from slipping up towards the patient's 13 forehead. When deflated, the mask has a flatter profile, the shell being positioned 14 closer to the nose and cheeks, for permitting a better fit for individual patients.
The above apparatus and methodology enables the provision of a 16 mask and a system which is particularly useful in the treatment of pediatric cases.
17 Accordingly, a broad system is provided for improving compliance in a pediatric 18 population for the use of ventilation masks and headgear and providing size 19 recognition comprising: a plurality of masks and headgear of predetermined known matched and serial sizes so as to fit a range of pediatric patients wherein the mask 21 further comprises a concave shell; at least one flexible cuff attached about a 22 periphery of the shell and having an opening for receiving a patients nose or nose 23 and mouth; a port in the shell for receiving tubing for attachment to~ a ventilation 24 device; at least one exhalation port; and means for attachment to the headgear; and the headgear comprises a cap and a plurality of straps having means for attachment 26 to the mask; and a size indicator being a predetermined visage of a caricature, 1 preferably animals, represented on each of the plurality of masks, each caricature 2 being predetermined to represent one of each of the plurality of sizes.
3 Such a mask for improving compliance in a pediatric population would 4 comprise: a concave shell having an outer periphery and having a size selected from a plurality of predetermined sizes; at least one flexible cuff attached to the shell 6 about the periphery and having an opening so as to receive a patient's nose or nose 7 and mouth; at least one port in the shell for receiving tubing; at least one exhalation 8 port; and a size indicator, the indicator being indicia representing one of a plurality of 9 caricatures, each caricature predetermined to represent one of the plurality of predetermined sizes.
11 Particularly where fit is an issue, the mask comprises a concave shell 12 having an outer periphery; a flexible exterior cuff attached to the shell about the 13 periphery and having an opening so as to receive a patient's nose or nose and 14 mouth; an inflatable interior cuff attached to the shell and positioned inside the exterior cuff, the inflatable cuff further comprising a valve port extending through the 16 shell and in fluid communication with the inflatable cuff; at least one exhalation port;
17 and at least one port in the shell for receiving tubing.
2 Figure 1 is a perspective view of a nasal mask, fit over the nose of 3 a patient, and headgear of the present invention having an animal face portrayed 4 on the mask and including the optional matching ears on the headgear including an optional chin strap;
6 Figure 2 is a perspective view of a full-face mask of the present 7 invention, the mask fit over a patient's nose and mouth;
8 Figures 3a-3c are front views of a series of nasal masks, each 9 mask having a different size, the sizes represented by different caricatures;
Figures 4a and 4b are front views of a series of full-face masks, 11 each mask having a different size, the sizes represented by different caricatures;
12 Figure 5a is a back view of a nasal mask having a replaceable 13 exterior cuff and an inflatable inner cuff;
14 Figure 5b is a side view of a nasal mask according to Fig. 5a showing extension of the cuff from a profile of a mask shell having an attached 16 swivel and tubing;
17 Figure 6a is a back view of a full-face mask having a replaceable 18 exterior cuff and an inflatable inner cuff;
19 Figure 6b is a side view of a full-face mask according to Fig. 6a showing extension of the cuff from the profile of a mask shell having an attached 21 swivel and tubing;
22 Figure 7 is a partial cross-sectional view of an inflatable inner cuff 23 and a replaceable outer cuff attached to the mask shell;
24 Figure 8 is a close up side view of the raised buttons attached to the mask shell for attachment of headgear straps;
1 Figure 9a is a perspective view of a headgear of the present 2 invention, without a mask attached; and 3 Figure 9b is a close-up perspective view of the end piece and key 4 slot of a headgear strap.
2 Having reference to Fig. 1, a CPAP mask and headgear system 10 3 of one embodiment of the invention is shown. The nasal mask 20 comprises a 4 shallow concave rigid shell 21, bearing the visage bf a caricature 200, for positioning over the nose of a pediatric patient. The mask 20 is held in place 6 over the patient's nose by headgear 30, wom by the patient. The mask 20 is 7 connected to a ventilation device (not shown), such as a non-invasive CPAP
or 8 BiPAP machine or an invasive device such as a respirator, by tubing 22 9 extending from a port 23 in the mask 20 through which air pressure is administered to the patient. A swivel 24 having a right angle bend is fitted in 11 rotatable, sealed arrangement about the port 23 in the shell 21 for attaching the 12 tubing 22 to the shell 21. The swivel 24 is freely rotatable about the port 23 to 13 permit movement of the tubing 22 without displacing the mask 20 from the 14 patient's face. Further, the swivel 24 is bent at a right angle to prevent the tubing 22 from extending directly outward from the mask 20 where it may become a 16 hindrance or highly visible to the patient.
17 Similarly, Fig. 2 shows a full-face mask 40 used to cover both the 18 nose and the mouth of patients who are unable to breath solely through the 19 nose. The shell 41 of the full-face mask 40 is elongated to cover the nose and mouth and may be slightly wider at a bottom edge 42 than a nasal mask 20 used 21 for the same sized patient.
22 The shells 21, 41 are concave in shape so as to permit adequate 23 space for the patient's nose without having the nose impinge upon the shell 21.
24 Figs. 3 and 4 illustrate a representative range of nasal 20 and full-face 40 mask sizes required for fitting a pediatric population ranging in age from 1 newborn until the patient fits known adult masks. Size variations, small 20a, 2 medium 20b and large 20c, shown in Fig. 3, and small 40a and large 40b, shown 3 in Fig. 4, are often not readily discernable at a first glance and may be especially 4 difficult to identify when the systems 10 are packaged for shipping.
Accordingly, the application of a unique caricature 200 on each sized mask 20,40, to 6 reference a particular predetermined size, makes it easy to readily select the 7 size appropriate for the patient, at a glance.
8 Having reference to Figs. 5a and 5b, each nasal mask 20 further 9 comprises a first external flexible cuff 25 attached to a periphery 26 of the shell 21 for providing a seal between the shell 21 and the patient's nose and cheeks.
11 An opening 27 is formed in the cuff to permit the nose to protrude therethrough 12 into the shell 21. Preferably, the external cuff 25 is removably attached, so as to 13 permit removal for cleaning and replacement with cuffs 25 having larger or 14 smaller openings 27 to further ensure an optimum fit for the patient.
Figs. 6a and 6b show a full-face mask 40, having a similar external 16 cuff 43 attached about a periphery 44 of a full-face shell 41, however an opening 17 45 in the external cuff 43 is sized to fit over both of the patient's nose and mouth.
18 In a preferred embodiment of the invention and having reference to 19 Fig. 7, a lip 50 protrudes about the periphery 26,44 of the shell 21, 41 under which an outer compressible edge 51 of the exterior cuff 25, 43 is trapped. A
21 thickness 52 at the compressible edge 51 of the exterior cuff 25,43 is slightly 22 larger than a space 53 between the lip 50 and the shell 21,41. The cuff edge 51 23 is compressed into the space 53 and is thus retained therein. The external cuff 24 25, 43 can be readily removed by pulling the compressible edge 51 out of the space 53.
1 More preferably, as shown in Figs. 5a, 6a and 7, a second non-2 removable interior cuff 60 is formed about each shell's periphery 26, 44, 3 positioned inside the exterior cuff 25,43. The interior cuff 60 is inflatable, 4 permitting additional adjustment of the fit between the mask 20, 40 and the patient's face. A small valve port 61 extends outward from the shell 21,41 and is 6 in fluid communication with the interior cuff 60 so as to permit air to be injected, 7 typically using a syringe (not shown), into the inflatable cuff 60 until it is suitably 8 inflated to fit the patient. Similarly, the interior cuff 60 can be deflated, by 9 depressing a valve stem 62 within the valve port 61, much like an inner tube in a vehicle tire, if a flatter profile is required for fitting.
11 Advantageously, when inflated, the inflatable cuff 60 moves the 12 exterior cuff 25,43 outward into contact with the patient's face.
Therefore, it is 13 only the replaceable exterior cuff 25,43 that is subjected to facial oils, 14 medications and the like, present on the patient's face. When the exterior cuff 23, 45 requires cleaning or replacing it can simply be pulled from the lip 50 and 16 replaced.
17 As shown in Figs. 3a-3c, 4a, 4b, 5b and 6b, each shell 21,41 18 further comprises exhalation ports 70 to prevent re-breathing of C02 rich 19 exhalation air. Preferably, the exhalation ports 70 are formed in the swivel 24, directly adjacent the patient's nose. More preferably, in the case of the full-face 21 mask 40, a plurality of small perforations 71 about the periphery of the full-face 22 shell 41 act as additional exhalation ports, so as to further prevent re-breathing 23 of C02, when both the nose and mouth are covered.
24 More preferably, the exhalation ports 70 formed in the swivel 24 add to a nasal feature 201 of the caricature 200.
1 Optionally, the shells 21, 41 comprise at least one additional port 2 73 having a cap (not shown) for entrainment of additional inhalation gases, such 3 as oxygen or for measurement of parameters such as end tidal C02 for 4 monitoring excess C02 re-breathing.
Preferably, as shown in Fig. 5b, a retaining ring 80 is fit about a 6 bottom portion 81 of the swivel 24 and is axially moveable thereon. The retaining 7 ring 80 is slightly larger in diameter than the swivel 24 and is retained on the 8 swivel 24 by a flexible attachment 82. The retaining ring 80 is moved axially 9 downward over an outside of the tubing 22, when the tubing 22 is slipped over the swivel's bottom portion 81, applying compression to retain the tubing 22 on 11 the swivel 24.
12 As shown in Figs. 3 and 4, a plurality of raised buttons 90 are 13 formed at a top 28, 46 and sides 29, 47 of each shell 21,41 for attachment of the 14 headgear 30. As shown in Fig. 8, each button 90 comprises a large shaped head 91 supported on a smaller shank 92 attached to the shell 21,41.
16 Preferably, in the case of the larger full-face mask 40, more than 17 one raised button 90 is located on each side 47 of the full-face shell 41 to 18 enhance customized fitting of the system 10.
19 Having reference to Figs 1, 2, 9a and 9b, the headgear 30 is shown. The headgear 30 is used to position the nasal or full-face mask 20, 40 21 correctly over the patient's nose or nose and mouth. The headgear is available in 22 a range of sizes suitable for a pediatric population and to match the sizes of the 23 nasal and full-face masks 20, 40. The headgear 30 comprises a cap 31, which 24 extends from a peak 32 at the forehead to a neck edge 33 to cradle the back of 1 the patient's head. A plurality of straps 34 extend from the headgear 30 and are 2 attached to the raised buttons 90 on each mask sheN 21, 41.
3 Preferably, a single strap 35 extends from the peak 32 of the cap.
4 31, located at the forehead to the top 28, 46 of each mask 20, 40 and straps 36a, 36b extending outwards from each side 37, 38 of the cap 31 at the neck 6 edge 33, in opposing directions, so as to attach to the sides 29, 47 of each mask 7 20, 40.
8 Preferably, as shown in Figs. 9a and 9b, each strap 35, 36a, 36b 9 comprises an elongate body 100 attached to the cap 31 at a first end 101 and having a key slot 102 formed in a second end 103 for fitting over the raised 11 buttons 90 on each mask 20, 40 and locking into place. Each key slot 102 12 comprises a first hole 104 sized to fit the head 91 of the button 90 and a second 13 smaller hole 105 extending from the first hole 104 towards the second end 14 of the strap 100. The second hole 105 is sized so as to receive and firmly retain the shank 92 of the button 90, when the first hole 104 is placed over the head 16 of the button 90 and the strap 100 is pulled into tension to engage the shank 92 17 in the second hole 105.
18 In a preferred embodiment, as shown in Fig. 9b, a separate end 19 piece 106 having the key slot 102 formed therein is attached to the second end 103 of the strap body using a strip of hook and loop fastener 107, such as 21 VeIcroTM, so as to permit adjustment in a length of the straps 100.
22 An opening 108 is formed at a first end 109 of the end piece 106 23 for accepting the VeIcroTH' strip 107. The slot 105 is formed extending toward a 24 second end 110 of the end piece 106. The VeIcroTM strip 107 is threaded through the opening 108 and is attached to the strap 100 at a position which provides 1 optimum fit of the headgear 30 and mask 20, 40 to the patient. The length of the 2 straps 100 are therefore not adjusted each and every time the mask 20, 40 is 3 removed and replaced on the patient. The mask 20,40 is simply removed or 4 replaced on the patient's face by engaging the key slots 102 from the buttons 90 on the mask 20, 40. In this way, the headgear 30 and mask 20, 40 can be more 6 easily placed on a sleeping patient, without arousing them. Further, this assures 7 that the mask 20, 40 is positioned optimally no matter where or in what position 8 the patient has fallen asleep.
9 Optionally as shown in Figs. 1 and 9a, a chin strap 120 is attached to the headgear 30 to minimize or prevent opening of the patient's mouth during 11 therapy and thus minimize mouth leaks during use of a nasal mask 20. A
strip 12 121 of VeIcroTM is placed from side 37 to side 38 at a top 122 of the cap 31.
13 Corresponding strips of Velcro'''" 126 (only one shown) are placed on first and 14 second ends 123, 124 of the chin strap 120. When required, the chin strap's first end 123 is simply attached to the VeIcroT"' strip 121 on one side 37, 38 of the 16 cap 31, the chin strap 120 is positioned at the patients chin and the second end 17 124 is attached to the VeIcroTM strip 121 at the cap's other side 38.
18 Preferably, the chin strap 120 is formed having an oval cup-shaped 19 chin rest 125 positioned intermediate the chin strap's first and second ends 123, 124 for cradling the patient's chin. The chin rest 125 is preferably slightly padded 21 for additional comfort.
22 Having reference to Figs. 1-4 and 9a, a pair of ears 130, are 23 attached to the headgear 30 which are usually selected to be consistent with the 24 caricature 200 on the mask shell 21,41. The addition of ears 130 to the headgear 30 further improves compliance. Further, novelty is playfully added by using a 1 variety of ears, regardless of the mask selection. Preferable the ears 130 are 2 attached to the headgear 30 using small strips of Velcro'''"' 131.
4 Example 1 Having reference to Fig. 3, three nasal masks, each having a 6 predetermined size suitable for therapy over the size range of pediatric patients, 7 are shown. The mask shells are ovoid in shape and concave in profile and range 8 in size, the particular sizes being approximately; a small mask, having a height of 9 5 cm and a width of 4.5 cm at its widest portion; a medium mask having a height of 5.25 cm and a width of 5 cm at its widest portion; and a large mask having a 11 height of 5.75 cm and a width of 5 cm at its widest portion. The masks display 12 caricatures of different animal faces, each face an arbitrary yet consistent size 13 indicator representing the size of mask, for ease of identification and to improve 14 patient compliance. The small mask is a pig, the medium mask is a tiger and the large mask is a dog.
16 Similarly, as shown in Fig. 4, a full-face mask is provided in two 17 sizes, small and large. The small size is designated as an elephant and the large 18 size is designated as a zebra to improve patient compliance. The small full-face 19 mask is 8 cm in height, 3 cm in width at the top and 6.5 cm at its widest where it covers the patient's mouth and the large mask is 9 cm in height, 3 cm in width at 21 the top and 8 cm at it's widest.
22 Each shell has a lip about a periphery under which a removable 23 cuff is secured. The cuffs are available with a plurality of sizes of openings for 24 accommodating the patient's nose or nose and mouth so as to provide an optimum fit for the individual patient. The cuff sizes are represented in Table 1:
2 Table 1 - CUFF SIZES
4 Size Height Width Size Height Width Nasal Masks (cm) (cm~ Full-face masks (cm~ fcm) 6 Small 2.0 2.0 Small - standard 6.0 4.0 7 Small - wide 2.0 2.3 Large - standard 7.0 4.5 8 Medium 2.2 2.3 Large - wide 7.0 5.0 9 Medium - wide 2.2 2.5 Large 2.5 2.5 11 Large - wide 2.5 2.8 13 Preferably, the shell and cuffs and all related tubing are 14 manufactured to be latex-free. This is of particular importance to those patients, such as the spina bifida patients who are on "latex precaution° because of the 16 danger of anaphylaxis. Repeated surgery and other interventions make this 17 group of patients particularly susceptible to latex sensitivity.
18 Nasal mask sizes, in the series as shown, do not vary by more 19 than 0.5 cm in width or 0.75 cm in height. Similarly the full-face masks only vary by 1.5 cm in width and 1 cm in height. Thus, the use of animal faces to designate 21 the size ensures that the therapist is able to readily select the right size for the 22 patient without repeated trial and error sizing.
23 A further advantage of the animal face size indicators is that the 24 patient is more likely to view the mask as a fun item rather than a medical intervention, more like the pediatric oxygen device taught in US patent 5,690,096 26 to Burch. Burch's device is a plaything, fit with a plurality of oxygen ports, which 27 allow the patient to interact with the plaything while maintaining a flow of oxygen 28 when placed near the mouth and nose.
29 Headgear is provided to position the mask correctly over the patient's nose or nose and mouth during sleep. The headgear is also available in 31 a plurality of sizes, matched to the masks, to fit a range of pediatric sizes. To 1 further enhance size selection and compliance, the headgear is colored or 2 marked to match the appropriate sized mask. Preferable, the headgear is made 3 from lighfinreight breathable natural materials, such as cotton, to reduce 4 sweating.
Optionally, other aspects such as ears are added to the headgear 6 in keeping with the mask face in order to further improve compliance. For 7 example, a small pig mask would usually be accompanied by headgear in the 8 same color as the mask and having a set of pig ears attached to it. The tiger 9 headgear would be made of a fabric having a tiger stripe pattern and a pair of tiger ears attached thereto.
11 Preferably the ears are removable, such as attached using 12 VeIcroTM, to permit easy cleaning and further, easy removal, if the ears become 13 an obstruction during other intervention, or if the patient would prefer.
14 The advantages of the current pediatric mask system, which Applicant has not found in the prior art include:
16 - improved compliance by pediatric patients due to 17 psychological acceptance of the mask as a plaything;
18 improved therapeutics;
19 improved comfort; and - improved efficiency for the care professional; and 21 - a more efficient use of expensive resources.
Claims (33)
EXCLUSIVE PROPERTY OR PRIVILDGE IS CLAIMED ARE DEFINED AS
FOLLOWS:
1. A system for improving compliance in a pediatric population for the use of ventilation masks and headgear and providing size recognition comprising:
a plurality of masks and headgear of predetermined known matched and serial sizes so as to fit a range of pediatric patients; and a size indicator being a predetermined visage of a caricature represented on each of the plurality of masks, each caricature being predetermined to represent one of each of the plurality of sizes.
a plurality of masks and headgear of predetermined known matched and serial sizes so as to fit a range of pediatric patients; and a size indicator being a predetermined visage of a caricature represented on each of the plurality of masks, each caricature being predetermined to represent one of each of the plurality of sizes.
2. The system as described in claim 1 wherein each mask further comprises:
a concave shell having at least one flexible cuff attached about a periphery of the shell and having an opening for receiving a patients nose or nose and mouth;
a port in the shell for receiving a tubing for attachment to a ventilation device;
at least one exhalation port; and means for attachment to a headgear.
a concave shell having at least one flexible cuff attached about a periphery of the shell and having an opening for receiving a patients nose or nose and mouth;
a port in the shell for receiving a tubing for attachment to a ventilation device;
at least one exhalation port; and means for attachment to a headgear.
3. The system as described in claim 1 wherein the shell further comprises at least one other port having a removable cap.
4. The system as described in claim 1 wherein the headgear comprises:
a cap; and a plurality of straps, each strap being attached to the headgear at a first end and having means for attachment to the mask at a second end.
a cap; and a plurality of straps, each strap being attached to the headgear at a first end and having means for attachment to the mask at a second end.
5. The system as described in claim 4 wherein the means of attachment of the headgear straps to the mask comprise:
a plurality of raised buttons located at the periphery of the mask shell; and a shaped slot formed in the second end of each strap for retaining the button.
a plurality of raised buttons located at the periphery of the mask shell; and a shaped slot formed in the second end of each strap for retaining the button.
6. The system as described in claim 5 further comprising:
a first headgear strap is attached from a peak in the cap over the bridge of the nose to a top of the mask shell so as to not impair vision; and second and third headgear straps extending outwards in opposing directions from a neck edge of the cap to attach to buttons on a first and second side of the mask shell.
a first headgear strap is attached from a peak in the cap over the bridge of the nose to a top of the mask shell so as to not impair vision; and second and third headgear straps extending outwards in opposing directions from a neck edge of the cap to attach to buttons on a first and second side of the mask shell.
7. The system as described in claim 3 wherein the headgear further comprises a chin strap so as to prevent mouth leaks.
8. The system as described in claim 1 wherein the caricature on the mask is an animal face.
9. The system as described in claim 4 further comprising a matching aspect, further identifying the caricature, attached to the headgear.
10. The system as described in claim 4 further comprising ears attached to the headgear.
11. The system as described in claim 10 wherein the ears match the caricature.
12. The system as described in claim 9 wherein the matching aspect is ears.
13. The system as described in claim 8 wherein there are two exhalation ports, the exhalation ports forming part of a nasal feature of the animal face.
14. A system for improving compliance in a pediatric population for the use of ventilation masks and headgear and providing size recognition comprising:
a plurality of masks and headgear of predetermined known matched and serial sizes so as to fit a range of pediatric patients wherein:
the mask further comprises a concave shell; at least one flexible cuff attached about a periphery of the shell and having an opening for receiving a patients nose or nose and mouth; a port in the shell for receiving tubing for attachment to a ventilation device; at least one exhalation port; and means for attachment to the headgear; and the headgear comprises a cap and a plurality of straps having means for attachment to the mask; and a size indicator being a predetermined visage of a caricature represented on each of the plurality of masks, each caricature being predetermined to represent one of each of the plurality of sizes.
a plurality of masks and headgear of predetermined known matched and serial sizes so as to fit a range of pediatric patients wherein:
the mask further comprises a concave shell; at least one flexible cuff attached about a periphery of the shell and having an opening for receiving a patients nose or nose and mouth; a port in the shell for receiving tubing for attachment to a ventilation device; at least one exhalation port; and means for attachment to the headgear; and the headgear comprises a cap and a plurality of straps having means for attachment to the mask; and a size indicator being a predetermined visage of a caricature represented on each of the plurality of masks, each caricature being predetermined to represent one of each of the plurality of sizes.
15. The system as described in claim 14 wherein the mask shell further comprises at least one other port having a removable cap.
16. The system as described in claim 14 wherein the means of attachment of the headgear straps to the mask comprise:
a plurality of raised buttons located at the periphery of the mask shell; and a shaped slot formed in the second end of each strap for retaining the button.
a plurality of raised buttons located at the periphery of the mask shell; and a shaped slot formed in the second end of each strap for retaining the button.
17. The system as described in claim 14 further comprising:
a first headgear strap is attached from a peak in the cap over the bridge of the nose to a top of the mask shell so as to not impair vision; and second and third headgear straps extending outwards in opposing directions from a neck edge of the cap to attach to buttons on a first and second side of the mask shell.
a first headgear strap is attached from a peak in the cap over the bridge of the nose to a top of the mask shell so as to not impair vision; and second and third headgear straps extending outwards in opposing directions from a neck edge of the cap to attach to buttons on a first and second side of the mask shell.
18. The system as described in claim 14 wherein the headgear further comprises a chin strap so as to minimize mouth leaks.
19. The system as described in claim 14 wherein the caricature on the mask is an animal face.
20. The system as described in claim 14 further comprising a matching aspect, further identifying the caricature, attached to the headgear.
21. The system as described in claim 20 wherein the matching aspect is a set of ears.
22. The system as described in claim 19 wherein there are two exhalation ports, the exhalation ports forming part of a nasal feature of the animal face.
23. A mask for improving compliance in a pediatric population and providing size recognition for use with ventilation therapy, the mask comprising:
a concave shell having an outer periphery and having a size selected from a plurality of predetermined sizes;
at least one flexible cuff attached to the shell about the periphery and having an opening so as to receive a patient's nose or nose and mouth;
at least one port in the shell for receiving tubing;
at least one exhalation port; and a size indicator, the indicator being indicia representing one of a plurality of caricatures, each caricature predetermined to represent one of the plurality of predetermined sizes.
a concave shell having an outer periphery and having a size selected from a plurality of predetermined sizes;
at least one flexible cuff attached to the shell about the periphery and having an opening so as to receive a patient's nose or nose and mouth;
at least one port in the shell for receiving tubing;
at least one exhalation port; and a size indicator, the indicator being indicia representing one of a plurality of caricatures, each caricature predetermined to represent one of the plurality of predetermined sizes.
24. The mask as described in claim 23 wherein the caricature is an animal face.
25. The mask as described in claim 23 further comprising a second inflatable cuff attached within the periphery of the shell and within the flexible cuff.
26. The mask as described in claim 23 wherein the at least one flexible cuff is removable and replaceable.
27. The mask as described in claim 23 further comprising at least one additional port having a cap so as to administer additional inhalation gases or monitor exhalation gases.
28. The mask as described in claim 23 further comprising a compression slip ring to retain the tubing to the shell.
29. The mask as described in claim 23 wherein the shell is transparent.
30. The mask as described in claim 24 wherein there are two exhalation ports, the exhalation ports forming part of a nasal feature of the animal face.
31. A mask for use with ventilation therapy, the mask comprising:
a concave shell having an outer periphery;
a flexible exterior cuff attached to the shell about the periphery and having an opening so as to receive a patient's nose or nose and mouth;
an inflatable interior cuff attached to the shell and positioned inside the exterior cuff, the inflatable cuff further comprising a valve port extending through the shell and in fluid communication with the inflatable cuff;
at least one exhalation port; and at least one port in the shell for receiving tubing.
a concave shell having an outer periphery;
a flexible exterior cuff attached to the shell about the periphery and having an opening so as to receive a patient's nose or nose and mouth;
an inflatable interior cuff attached to the shell and positioned inside the exterior cuff, the inflatable cuff further comprising a valve port extending through the shell and in fluid communication with the inflatable cuff;
at least one exhalation port; and at least one port in the shell for receiving tubing.
32. The mask as described in claim 31 having a removable exterior cuff, the mask further comprising:
a lip formed about the periphery of the shell for forming a space between the shell and the lip; and an exterior cuff having a flexible compressible edge, the edge sized slightly larger than the space so as to be fit in the space when compressed and retained therein.
a lip formed about the periphery of the shell for forming a space between the shell and the lip; and an exterior cuff having a flexible compressible edge, the edge sized slightly larger than the space so as to be fit in the space when compressed and retained therein.
33. The mask as described in claim 31 further comprising at least one additional port having a cap so as to administer additional inhalation gases or monitor exhalation gases.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US10/066,562 US6860268B2 (en) | 2002-02-06 | 2002-02-06 | Pediatric ventilation mask and headgear system |
| US10/066562 | 2002-02-06 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2416853A1 true CA2416853A1 (en) | 2003-08-06 |
Family
ID=27658688
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002416853A Abandoned CA2416853A1 (en) | 2002-02-06 | 2003-01-21 | Pediatric ventilation mask and headgear system |
Country Status (2)
| Country | Link |
|---|---|
| US (1) | US6860268B2 (en) |
| CA (1) | CA2416853A1 (en) |
Families Citing this family (94)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6540154B1 (en) * | 1991-04-24 | 2003-04-01 | Aerogen, Inc. | Systems and methods for controlling fluid feed to an aerosol generator |
| US5758637A (en) | 1995-08-31 | 1998-06-02 | Aerogen, Inc. | Liquid dispensing apparatus and methods |
| US6235177B1 (en) * | 1999-09-09 | 2001-05-22 | Aerogen, Inc. | Method for the construction of an aperture plate for dispensing liquid droplets |
| US6948491B2 (en) * | 2001-03-20 | 2005-09-27 | Aerogen, Inc. | Convertible fluid feed system with comformable reservoir and methods |
| US7600511B2 (en) * | 2001-11-01 | 2009-10-13 | Novartis Pharma Ag | Apparatus and methods for delivery of medicament to a respiratory system |
| MXPA02010884A (en) * | 2000-05-05 | 2003-03-27 | Aerogen Ireland Ltd | Apparatus and methods for the delivery of medicaments to the respiratory system. |
| US7971588B2 (en) | 2000-05-05 | 2011-07-05 | Novartis Ag | Methods and systems for operating an aerosol generator |
| US8336545B2 (en) | 2000-05-05 | 2012-12-25 | Novartis Pharma Ag | Methods and systems for operating an aerosol generator |
| DE10035946C2 (en) * | 2000-07-21 | 2002-06-27 | Map Gmbh | Bracket for a breathing mask |
| US6732944B2 (en) * | 2001-05-02 | 2004-05-11 | Aerogen, Inc. | Base isolated nebulizing device and methods |
| US7677467B2 (en) | 2002-01-07 | 2010-03-16 | Novartis Pharma Ag | Methods and devices for aerosolizing medicament |
| US20050205089A1 (en) * | 2002-01-07 | 2005-09-22 | Aerogen, Inc. | Methods and devices for aerosolizing medicament |
| CA2472644C (en) | 2002-01-07 | 2013-11-05 | Aerogen, Inc. | Devices and methods for nebulizing fluids for inhalation |
| US6779524B2 (en) * | 2002-01-10 | 2004-08-24 | Steffi A. Strawder | Moldable scented face mask |
| ES2603067T3 (en) | 2002-01-15 | 2017-02-23 | Novartis Ag | Methods and systems for operating an aerosol generator |
| US8997742B2 (en) | 2002-04-23 | 2015-04-07 | Resmed Limited | Ergonomic and adjustable respiratory mask assembly with cushion |
| US7743767B2 (en) | 2002-04-23 | 2010-06-29 | Resmed Limited | Ergonomic and adjustable respiratory mask assembly with frame |
| AUPS192602A0 (en) * | 2002-04-23 | 2002-05-30 | Resmed Limited | Nasal mask |
| US8042542B2 (en) * | 2002-04-23 | 2011-10-25 | Resmed Limited | Respiratory mask assembly with magnetic coupling to headgear assembly |
| US20070044792A1 (en) * | 2005-08-30 | 2007-03-01 | Aerogen, Inc. | Aerosol generators with enhanced corrosion resistance |
| EP1509259B1 (en) * | 2002-05-20 | 2016-04-20 | Novartis AG | Apparatus for providing aerosol for medical treatment and methods |
| EP1603619B1 (en) | 2003-02-21 | 2019-04-10 | ResMed Limited | Nasal assembly |
| US8181650B2 (en) * | 2003-05-15 | 2012-05-22 | Robert Fayette Andrew Nelson | Multitask medical treatment respiratory apparatus |
| FR2854808B1 (en) * | 2003-05-16 | 2005-11-11 | Robert Schegerin | REMOVABLE INNER MASK FILTER FOR RAPID SETTING FOR AIRCRAFT DRIVERS |
| US8616195B2 (en) | 2003-07-18 | 2013-12-31 | Novartis Ag | Nebuliser for the production of aerosolized medication |
| DE10338169A1 (en) * | 2003-08-20 | 2005-03-10 | Weinmann G Geraete Med | Ventilation mask with hood |
| FR2859383A1 (en) * | 2003-09-09 | 2005-03-11 | Taema | Harness and mask assembly for treating sleep apnoea has inflatable elements on both mask surround and harness straps that fit over head |
| US7255107B1 (en) * | 2003-10-14 | 2007-08-14 | Gomez Roy C | Nasal mask assembly for nasal delivery |
| US7004163B2 (en) * | 2003-12-29 | 2006-02-28 | Ramses Nashed | Gas delivery, evacuation and respiratory monitoring system and method |
| US8336549B2 (en) * | 2003-12-29 | 2012-12-25 | Ramses Nashed | Disposable anesthesia face mask |
| US6889689B1 (en) * | 2004-01-06 | 2005-05-10 | Deborah W. Neuman | Bubble CPAP cap for neonates |
| US7178525B2 (en) | 2004-02-06 | 2007-02-20 | Ric Investments, Llc | Patient interface assembly supported under the mandible |
| US7946291B2 (en) * | 2004-04-20 | 2011-05-24 | Novartis Ag | Ventilation systems and methods employing aerosol generators |
| US7290541B2 (en) * | 2004-04-20 | 2007-11-06 | Aerogen, Inc. | Aerosol delivery apparatus and method for pressure-assisted breathing systems |
| US7267121B2 (en) * | 2004-04-20 | 2007-09-11 | Aerogen, Inc. | Aerosol delivery apparatus and method for pressure-assisted breathing systems |
| DE102004029034B3 (en) * | 2004-06-09 | 2005-05-12 | Eberhard-Karls-Universität Tübingen | Cap for securing respiration device to head of newborn infant provided with chin strap and opening between opposing side sections of cap closed by fastenings |
| US7243652B2 (en) * | 2004-08-23 | 2007-07-17 | Hsiner Co., Ltd. | Respirator mask |
| US8042539B2 (en) | 2004-12-10 | 2011-10-25 | Respcare, Inc. | Hybrid ventilation mask with nasal interface and method for configuring such a mask |
| US8757150B2 (en) | 2004-12-17 | 2014-06-24 | Ric Investments, Llc | Condensation reduction and management systems in a gas flow delivery system |
| DE202006021258U1 (en) | 2005-01-12 | 2014-05-05 | Resmed Limited | Upholstery for patient interface |
| US20060174891A1 (en) * | 2005-02-10 | 2006-08-10 | Ammann Shari R | Neonatal breathing device and method |
| US20060186585A1 (en) * | 2005-02-22 | 2006-08-24 | Afshin Sadri | Systems, methods and apparatus for non-disruptive and non-destructive inspection of metallurgical furnaces and similar vessels |
| JP5064383B2 (en) | 2005-05-25 | 2012-10-31 | エアロジェン，インコーポレイテッド | Vibration system and method |
| US7513255B2 (en) * | 2005-06-03 | 2009-04-07 | Ric Investments, Llc | Patient interface device with universal headgear mounting member |
| US7762254B2 (en) * | 2005-08-02 | 2010-07-27 | Ric Investments, Llc | Mask mounting mechanism |
| US8245711B2 (en) | 2005-08-15 | 2012-08-21 | Ric Investments, Llc | Patient interface with adjustable cushion |
| WO2007045023A1 (en) * | 2005-10-19 | 2007-04-26 | Resmed Ltd | Nasal mask assembly |
| US20070107723A1 (en) * | 2005-11-15 | 2007-05-17 | Maraha Berg | Pediatric tracheostomy mask |
| US7878200B2 (en) * | 2006-02-13 | 2011-02-01 | Carefusion 2200, Inc. | Infant headgear for supporting a patient airway interface device |
| US7500480B2 (en) | 2006-06-16 | 2009-03-10 | Koninklijke Philips Electronics N.V. | Chin pivot patient interface device |
| CN101516427B (en) * | 2006-07-28 | 2012-08-08 | 雷斯梅德有限公司 | Delivery of respiratory therapy |
| US20080110463A1 (en) * | 2006-11-14 | 2008-05-15 | Julius Hajgato | Nebulizer mask for delivery of aerosolized and nebulized medications |
| US20080168996A1 (en) * | 2006-12-29 | 2008-07-17 | Christla Willis | Animasks kid's dust masks animasks aka Child friendly filter masks |
| US9486597B2 (en) * | 2007-01-30 | 2016-11-08 | Ric Investments, Llc | Aerosol delivery mask |
| US8826909B2 (en) * | 2007-06-01 | 2014-09-09 | Ramses Nashed | Respiratory face mask and headstrap assembly |
| US20090014006A1 (en) * | 2007-07-10 | 2009-01-15 | Levin Eric M | Novelty mask cover |
| US8757157B2 (en) | 2007-08-02 | 2014-06-24 | Resmed Limited | Mask for delivery of respiratory therapy to a patient |
| US8573217B2 (en) * | 2007-11-14 | 2013-11-05 | Ric Investments, Llc | Face mask |
| US20110030123A1 (en) * | 2009-08-05 | 2011-02-10 | Paul Palmeiri | Mask |
| CN105771053B (en) * | 2009-11-20 | 2020-03-13 | 瑞思迈私人有限公司 | Mask system |
| US20110209708A1 (en) * | 2010-02-26 | 2011-09-01 | New York University | Ventilation Interface Device |
| US8851078B2 (en) * | 2010-03-05 | 2014-10-07 | Resmed Limited | Chin strap |
| FR2958549B1 (en) * | 2010-04-13 | 2013-04-12 | Georges Boussignac | APPARATUS FOR RESPIRATORY ASSISTANCE. |
| NZ728600A (en) * | 2010-09-30 | 2018-10-26 | ResMed Pty Ltd | Patient interface systems |
| EP3928820B1 (en) | 2010-10-08 | 2023-12-20 | ResMed Pty Ltd | Headgear with first and second adjustment device |
| EP3556416B1 (en) * | 2010-10-18 | 2023-11-29 | Fisher & Paykel Healthcare Limited | A nasal cannula, conduit and securement system |
| JP6195914B2 (en) * | 2012-06-07 | 2017-09-13 | コーニンクレッカ フィリップス エヌ ヴェＫｏｎｉｎｋｌｉｊｋｅ Ｐｈｉｌｉｐｓ Ｎ．Ｖ． | Full face mask for children |
| AU2013326190B2 (en) * | 2012-10-02 | 2018-02-08 | Koninklijke Philips N.V. | Customizable cushion utilizing fitted plug inserts |
| NZ631169A (en) * | 2013-03-15 | 2017-04-28 | Resmed Ltd | Method and apparatus for controlling pressurized gas delivered to a patient |
| WO2014155270A1 (en) * | 2013-03-26 | 2014-10-02 | Koninklijke Philips N.V. | Faceplate and faceplate sizing method |
| US20150119742A1 (en) * | 2013-10-30 | 2015-04-30 | Rutgers, The State University Of New Jersey | Nasal oxygen mask and breathing circuit assembly |
| USD737027S1 (en) * | 2014-01-13 | 2015-08-25 | Crystal Nicely | Hat |
| MX2016015858A (en) | 2014-06-04 | 2017-06-28 | Revolutionary Medical Devices Inc | Combined nasal and mouth ventilation mask. |
| CN111921054B (en) | 2014-08-20 | 2023-09-08 | 革新医疗器械有限公司 | Ventilation mask |
| USD825740S1 (en) | 2014-12-12 | 2018-08-14 | Revolutionary Medical Devices | Surgical mask |
| USD777905S1 (en) | 2015-04-21 | 2017-01-31 | Parker-Hannifin Corporation | Nasal mask |
| WO2016201358A1 (en) | 2015-06-11 | 2016-12-15 | Revolutionary Medical Devices, Inc. | Ventilation mask |
| EP4000671B1 (en) * | 2015-07-24 | 2023-09-20 | Fisher & Paykel Healthcare Limited | Headgear assembly |
| US20180361097A1 (en) * | 2015-12-22 | 2018-12-20 | Koninklijke Philips N.V. | Interface device having user selected indicia formed therein |
| USD780907S1 (en) * | 2016-02-12 | 2017-03-07 | Kimberly Bouie | Nebulizer mask |
| US10576228B2 (en) | 2016-06-15 | 2020-03-03 | Accutron, Inc. | Inhalation apparatus |
| BR112019004967A8 (en) | 2016-09-14 | 2023-03-21 | Revolutionary Medical Devices Inc | VENTILATION MASK |
| WO2018085035A1 (en) * | 2016-11-01 | 2018-05-11 | Michael Carney | Breathing device |
| USD848606S1 (en) | 2016-11-07 | 2019-05-14 | Revolutionary Medical Devices, Inc. | Surgical mask |
| CA176664S (en) * | 2017-03-09 | 2018-04-03 | Vectura Delivery Devices Ltd | Facemask |
| USD867578S1 (en) | 2017-06-23 | 2019-11-19 | Accutron, Inc. | Inhalation apparatus |
| WO2019002455A1 (en) | 2017-06-30 | 2019-01-03 | Koninklijke Philips N.V. | Method and apparatus for selecting a mask using augmented face sketches |
| USD898188S1 (en) | 2017-11-17 | 2020-10-06 | Revolutionary Medical Devices, Inc. | Surgical mask |
| USD862685S1 (en) * | 2018-01-12 | 2019-10-08 | Michael Carney | Anesthesia character mask for children |
| USD862684S1 (en) * | 2018-01-12 | 2019-10-08 | Michael Carney | Anesthesia character mask for children |
| USD936825S1 (en) | 2018-03-09 | 2021-11-23 | Hu-Friedy Mfg Co., Llc | Capnography fitting |
| US11116929B2 (en) * | 2018-03-12 | 2021-09-14 | 3B Medical, Inc. | Pediatric CPAP mask |
| US11602649B2 (en) * | 2020-10-19 | 2023-03-14 | Dania Altagracia Pellerano | Nose mask |
| US11872346B1 (en) * | 2023-05-26 | 2024-01-16 | Dcstar Inc | Breathing mask with a foam pad |
Family Cites Families (36)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| USD293613S (en) | 1985-11-18 | 1988-01-05 | Anesthesia Respiratory Technology, Inc. | Anesthesia and respiratory face mask |
| GB8603558D0 (en) * | 1986-02-13 | 1986-03-19 | Lifeline Ltd | Face mask |
| CA1302009C (en) | 1988-07-08 | 1992-06-02 | Brian H. Harrison | Universal head harness |
| US4989596A (en) * | 1989-02-14 | 1991-02-05 | Macris Allen G | Face chamber |
| USD323908S (en) | 1989-11-09 | 1992-02-11 | Smith Industries Medical Systems, Inc. | Face mask |
| US5243971A (en) | 1990-05-21 | 1993-09-14 | The University Of Sydney | Nasal mask for CPAP having ballooning/moulding seal with wearer's nose and facial contours |
| US5121745A (en) | 1990-07-23 | 1992-06-16 | Israel Michael B | Self-inflatable rescue mask |
| US5542128A (en) | 1993-04-20 | 1996-08-06 | Lomas; Christiane | Headwear for supporting a breathing apparatus |
| US5441046A (en) | 1993-09-29 | 1995-08-15 | Respironics, Inc. | Quick release mechanism for nasal and/or oral gas delivery mask |
| US5570689A (en) | 1993-09-30 | 1996-11-05 | Respironics, Inc. | Respiratory mask having a vertically adjustable spacer element that limits seal deformation on a wearer's face |
| USD362061S (en) | 1994-01-21 | 1995-09-05 | Respironics, Inc. | Respiratory mask body |
| US5505207A (en) | 1994-01-28 | 1996-04-09 | Critikon, Inc. | Character distinguishing sized blood pressure cuff system |
| US5429126A (en) | 1994-03-30 | 1995-07-04 | Bracken; Mary R. | Respiratory mask headset attachment |
| US5647357A (en) | 1995-09-08 | 1997-07-15 | Respironics, Inc. | Respiratory mask facial seal |
| US5813423A (en) | 1995-11-01 | 1998-09-29 | Kirchgeorg; John | Inhalator and/or resuscitator mask adaptable for use with an adult and child |
| US6405725B1 (en) * | 1996-02-26 | 2002-06-18 | Evergreen Medical, Inc. | Method and apparatus for ventilation/oxygenation during guided insertion of an endotracheal tube |
| US5690096A (en) | 1996-03-14 | 1997-11-25 | Burch; John M. | Pediatric oxygenation device |
| US5657752A (en) | 1996-03-28 | 1997-08-19 | Airways Associates | Nasal positive airway pressure mask and method |
| AUPO126596A0 (en) | 1996-07-26 | 1996-08-22 | Resmed Limited | A nasal mask and mask cushion therefor |
| US6035852A (en) | 1996-08-30 | 2000-03-14 | Hoftman; Moshe | Inflated cuff anesthesia/respirator mask with improved nasal/maxilla bone adaptation |
| US6192886B1 (en) | 1996-10-17 | 2001-02-27 | Hans Rudolph, Inc. | Nasal mask |
| US6019101A (en) | 1996-10-31 | 2000-02-01 | Sleepnet Corporation | Nasal air mask |
| US5921239A (en) * | 1997-01-07 | 1999-07-13 | Sunrise Medical Hhg Inc. | Face mask for patient breathing |
| US5746201A (en) | 1997-01-23 | 1998-05-05 | Nellcor Puritan-Bennett | CPAP nose mask |
| US5853002A (en) | 1997-03-14 | 1998-12-29 | Kawasaki; Mary Kelly | Pediatric nebulizer enhancer |
| US6119694A (en) | 1997-07-24 | 2000-09-19 | Respironics Georgia, Inc. | Nasal mask and headgear |
| DE19735359A1 (en) | 1997-08-14 | 1998-01-29 | Konrad Kleehaupt | Breathing mask |
| US6192876B1 (en) * | 1997-12-12 | 2001-02-27 | Astra Aktiebolag | Inhalation apparatus and method |
| US6119693A (en) | 1998-01-16 | 2000-09-19 | Resmed Limited | Forehead support for facial mask |
| USD420128S (en) | 1998-11-12 | 2000-02-01 | Vital Signs Inc. | CPAP face mask |
| US6615832B1 (en) * | 1999-06-22 | 2003-09-09 | Bragel International, Inc. | Wear article with detachable interface assembly |
| USD448473S1 (en) | 1999-08-10 | 2001-09-25 | Respironics, Inc. | Nasal mask |
| USD441860S1 (en) | 1999-08-10 | 2001-05-08 | Respironics, Inc. | Forehead pad for a nasal mask |
| US6095647A (en) | 1999-09-13 | 2000-08-01 | Health & Technology, Inc. | Ophthalmoscope attachment |
| US20010032648A1 (en) | 2000-03-03 | 2001-10-25 | Bernadette Jestrabek-Hart | Exhaust airway for nasal continuous positive airway pressure mask |
| TWM256710U (en) * | 2000-08-11 | 2005-02-11 | Jia-Ching Ye | Hair hoop or hair ribbon structure with costume mask |
-
2002
- 2002-02-06 US US10/066,562 patent/US6860268B2/en not_active Expired - Fee Related
-
2003
- 2003-01-21 CA CA002416853A patent/CA2416853A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| US20030145859A1 (en) | 2003-08-07 |
| US6860268B2 (en) | 2005-03-01 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US6860268B2 (en) | Pediatric ventilation mask and headgear system | |
| US11793965B2 (en) | Adjustable headgear tubing for a patient interface | |
| JP6797066B2 (en) | Nose mask system | |
| WO2017124155A1 (en) | Adjustable headgear tubing for a patient interface | |
| CN111511431A (en) | Catheter hub connector for a patient interface | |
| CN214860277U (en) | Patient interface and CPAP system comprising same | |
| US10391273B2 (en) | Sleep apnea device to positively block exhaling and method of use | |
| CN111918688B (en) | Connector assembly | |
| CN215916038U (en) | Oronasal patient interface | |
| US20230241342A1 (en) | Adjustable headgear tubing for a patient interface | |
| WO2016122716A1 (en) | Improved sleep apnea device to positively block exhaling and method of use | |
| Bach et al. | The management of neuromuscular ventilatory failure | |
| JP7427079B2 (en) | Therapy system for breathing-related disorders, patient interface and headgear used therein | |
| TWI751691B (en) | A patient interface system for treatment of respiratory disorders | |
| US20240100282A1 (en) | Therapy system for respiratory-related disorders, and patient interface and headgear for use in same | |
| CA3210467A1 (en) | Full-face patient interface | |
| CA2416410C (en) | Ventilation interface for sleep apnea therapy | |
| NZ744240B2 (en) | Adjustable headgear tubing for a patient interface |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |