US20150075530A1 - Ventilation interface - Google Patents
Ventilation interface Download PDFInfo
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- US20150075530A1 US20150075530A1 US14/483,960 US201414483960A US2015075530A1 US 20150075530 A1 US20150075530 A1 US 20150075530A1 US 201414483960 A US201414483960 A US 201414483960A US 2015075530 A1 US2015075530 A1 US 2015075530A1
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- nasal
- nasal pillow
- interface
- flanges
- pillow
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- 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
- A61M16/0622—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 having an underlying cushion
-
- 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
- A61M16/0611—Means for improving the adaptation of the mask to the patient with a gusset portion
-
- 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
- A61M16/0666—Nasal cannulas or tubing
-
- 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
-
- 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
- A61M16/20—Valves specially adapted to medical respiratory devices
-
- 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
- A61M2210/00—Anatomical parts of the body
- A61M2210/06—Head
- A61M2210/0618—Nose
-
- 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
- A61M2210/00—Anatomical parts of the body
- A61M2210/06—Head
- A61M2210/0625—Mouth
Abstract
A respiration assist mask having an input gas feed tube, a ventilation interface, a facial interface and nasal inserts. The gas feed tube can connect to the ventilation interface and form a seal. The ventilation interface may be joined with the facial interface to form a seal between the ventilation interface and the facial interface, as well as between the facial interface and the face of a user. Additionally, nasal inserts may be inserted into a portion of the facial interface and form a seal between the inserts and the facial interface.
Description
- This invention relates generally to the field of respiration or breathing assist masks. In particular, the invention relates to respiration or breathing assist masks utilizing both the nose and mouth.
- Obstructive sleep apnea syndrome (commonly referred to as obstructive sleep apnea, sleep apnea syndrome, and/or sleep apnea) is a medical condition that includes repeated, prolonged episodes of cessation of breathing during sleep. During a period of wakefulness, the muscles of the upper part of the throat passage of an individual keep the passage open, thereby permitting an adequate amount of oxygen to flow into the lungs. During sleep, the throat passage tends to narrow due to the relaxation of the muscles. In those individuals having a relatively normal-sized throat passage, the narrowed throat passage remains open enough to permit the adequate amount of oxygen to flow into the lungs. However, in those individuals having a relatively smaller-sized throat passage, the narrowed throat passage prohibits the adequate amount of oxygen from flowing into the lungs. Additionally, a nasal obstruction, such as a relatively large tongue, and/or certain shapes of the palate and/or the jaw of the individual, further prohibit the adequate amount of oxygen from flowing into the lungs.
- An individual having the above-discussed conditions can stop breathing for one or more prolonged periods of time (e.g. ten seconds or more). The prolonged periods of time during which breathing is stopped, or apneas, are generally followed by sudden reflexive attempts to breathe. The reflexive attempts to breathe are generally accompanied by a change from a relatively deeper stage of sleep to a relatively lighter stage of sleep. As a result, the individual suffering from obstructive sleep apnea syndrome generally experiences fragmented sleep that is not restful. The fragmented sleep results in one or more of excessive and/or inappropriate daytime drowsiness, headache, weight gain or loss, limited attention span, memory loss, poor judgment, personality changes, lethargy, inability to maintain concentration, and/or depression.
- Other medical conditions can also prevent individuals, including adults and infants, from receiving the adequate amount of oxygen into the lungs. For example, an infant who is born prematurely can have lungs that are not developed to an extent necessary to receive the adequate amount of oxygen. Further, prior to, during and/or subsequent to certain medical procedures and/or medical treatments, an individual can be unable to receive the adequate amount of oxygen. Under these circumstances, it is known to use a ventilation interface to apply a positive pressure to the throat of the individual, thereby permitting the adequate amount of oxygen to flow into the lungs. In the known ventilation interface, oxygen and/or room air containing oxygen is delivered through the mouth and/or nose of the individual. Existing types of positive pressure applied by the known ventilation interface include continuous positive airway pressure (CPAP), in which a positive pressure is maintained in the throat passage throughout a respiratory cycle, bi-level positive airway pressure (BiPAP), in which a relatively high positive pressure is maintained during inspiration and a relatively low positive pressure is maintained during expiration, and intermittent mechanical positive pressure ventilation (IPPV) in which a positive pressure is applied when apnea is sensed (I.e., the positive airway pressure is applied intermittently or non-continuously).
- One conventional ventilation interface for the application of positive pressure includes a face mask that covers both the nose and the mouth. See, for example, U.S. Pat. Nos. 4,263,212 to Mizerak and 6,123,071 to Berthon-Jones et al. Other face masks include configurations that cover only the nose or only the mouth. Standard masks have air supplied under pressure and use headgear or harnesses configured at least with what is referred to as a lip strap, thereby preventing air from escaping from the user's mouth. Such a strap is positioned level the patient's lips and wasp circumferentially around the patient's head from one side of the mask to the other. To keep the supply of positive gas pressure and to maintain the required seal that prevents the gas supply from leaking, a force must be applied to the head of the individual. As a result, the harness is generally uncomfortable to wear, particularly when sleeping. The applied pressure often results in undesirable irritation and sores caused by movement of the mask and harness during periods of both wakefulness and sleep. Further, the required seal is generally difficult to maintain when the mask and harness is moved.
- The force that the harness applied to the mask against the face also applies an undesirable pressure to the sinus area adjacent to the nose, causing the nasal sinus airways to narrow. This narrowing causes an increase in the velocity of flow through the upper anatomical airways and a decrease in the lateral pressure against the nasal mucosal wall. Additionally, if the tubing between the mask and the gas supply unit folds undesirably, this problem will be exacerbated. The above-discussed combination of increased flow velocity and decreased pressure results in the removal of moisture form the mucosal walls during inspiration and may cause an undesirable drying and a burning sensation within the nares. As a result, the individual may remove the mask to alleviate these discomforts, consequently discontinuing the beneficial application of the positive pressure. Such increased air flow velocity and decreased pressure deteriorate the laminar flow between the air input and output portions of the conventional mask.
- A common complaint of a patient regarding ventilation masks is that they cause claustrophobia. Such masks have large headgear that wrap around the entirety of the user's head and cover a significant area of the face including the periphery of both the nose and the mouth. Additionally such masks have a large amount of dead space within the mask where gas can be re-breathed by a patient, and a large area against the face of a user that must be sealed against the mask.
- In one exemplary embodiment, a respiration assist mask is disclosed. The respiration assist mask may include a ventilation interface. A cushion may be connected to the ventilation interface and the cushion may have one or more openings designed to receive one or more inputs. Additionally, the respiration assist mask may have at least one nasal pillow that may be adjustably coupled to the cushion.
- In another exemplary embodiment, a method of providing respiration assistance is disclosed. The method may include coupling at least one nasal pillow with at least one flange with a cushion having at least one flange. Additionally, the cushion may be coupled to a ventilation interface. Further, breathable gas may be provided to the ventilation interface.
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FIG. 1 shows an exploded view of an exemplary embodiment of the invention. -
FIG. 2 shows a side perspective view of an exemplary embodiment of the invention. -
FIG. 3 shows a front view of an exemplary embodiment of the invention. -
FIG. 4 shows a back view of an exemplary embodiment of the invention. -
FIG. 5 shows a top view of an exemplary embodiment of the invention. -
FIG. 6 shows a bottom view of an exemplary embodiment of the invention. -
FIG. 7 shows a right side view of an exemplary embodiment of the invention. -
FIG. 8 shows a left side view of an exemplary embodiment of the invention. -
FIG. 9 shows a top-down view of an exemplary embodiment of the invention. -
FIG. 10 shows a rotated top-down view of an exemplary embodiment of the invention. -
FIG. 11 shows a bottom-up view of an exemplary embodiment of the invention. -
FIG. 12 shows a side view of an exemplary embodiment of the invention. -
FIG. 13 shows a front view of an exemplary embodiment of the invention. -
FIG. 14 shows cut out views of membranes in another exemplary embodiment of the invention. -
FIG. 15 shows cut out view of membranes in another exemplary embodiment of the invention. -
FIG. 16 shows a top-down view of an exemplary embodiment of the invention. -
FIG. 17 shows a rotated top-down view of an exemplary embodiment of the invention. -
FIG. 18 shows a bottom-up view of an exemplary embodiment of the invention. -
FIG. 19 shows a side view of an exemplary embodiment of the invention. -
FIG. 20 shows a front view of an exemplary embodiment of the invention. -
FIG. 21 shows cut out views of membranes in another exemplary embodiment of the invention. -
FIG. 22 shows cut out view of membranes in another exemplary embodiment of the invention. -
FIG. 23 shows an exemplary view of a pair of nasal pillows -
FIG. 24 shows an exemplary rotated view of a pair of nasal pillows. -
FIG. 25 shows an exemplary rotated view of a pair of nasal pillows. -
FIG. 26 shows an exemplary perspective view of a nasal pillow. -
FIG. 27 shows an exemplary cross sectional view of a nasal pillow. -
FIG. 28 shows an exemplary rotated view of a pair of nasal pillows. -
FIG. 29 shows an exemplary top-down view of a nasal pillow. -
FIG. 30 shows an exemplary side view of a nasal pillow. -
FIG. 31 shows an exemplary bottom-up view of a nasal pillow. -
FIG. 32 shows an exemplary side view of a nasal pillow. -
FIG. 33 shows an exemplary rotated view of a nasal pillow. -
FIG. 34A shows an exemplary cross-sectional view of a pair of nasal cushions. -
FIG. 34B shows an exemplary cross-sectional view of a pair of nasal cushions. -
FIG. 35A shows an exemplary view of a cushioned interface having adjustable nasal pillows. -
FIG. 35B shows an exemplary cross-sectional view of a cushioned interface having adjustable nasal pillows -
FIG. 35C shows an exemplary cross-sectional view of a cushioned interface having adjustable nasal pillows. -
FIG. 36A shows an exemplary cross-sectional view of an adjustable nasal pillow for a ventilation interface. -
FIG. 36B shows an exemplary cross-sectional view of an adjustable nasal pillow for a ventilation interface. -
FIG. 37A shows an exemplary view of a cushion for a ventilation interface having adjustable nasal pillows. -
FIG. 37B shows an exemplary cross-sectional view of a cushion for a ventilation interface having adjustable nasal pillows. -
FIG. 37C shows an exemplary cross-sectional view of a cushion for a ventilation interface having adjustable nasal pillows. -
FIG. 38 shows an exemplary view of a cushion for a ventilation interface having adjustable nasal pillows. -
FIG. 39 shows an exemplary view of a cushion for a ventilation interface having adjustable nasal pillows. -
FIG. 40 shows an exemplary view of a cushion for a ventilation interface having adjustable nasal pillows. -
FIG. 41A shows an exemplary view of a ventilation interface having adjustable nasal pillows. -
FIG. 41B shows an exemplary perspective view of a ventilation interface having adjustable nasal pillows. -
FIG. 41C shows an exemplary cross-sectional view of a ventilation interface having adjustable nasal pillows. -
FIG. 42 shows an exemplary view of a ventilation interface having adjustable nasal pillows. -
FIG. 43A shows an exemplary view of a ventilation interface having adjustable nasal pillows. -
FIG. 43B shows an exemplary cross-sectional view of a ventilation interface having adjustable nasal pillows. -
FIG. 44A shows an exemplary view of a ventilation interface having adjustable nasal pillows. -
FIG. 44B shows an exemplary cross-sectional view of a ventilation interface having adjustable nasal pillows. -
FIG. 44C shows an exemplary cross-sectional view of a ventilation interface having adjustable nasal pillows. -
FIG. 45A shows an exemplary view of a ventilation interface having adjustable nasal pillows. -
FIG. 45B shows an exemplary cross-sectional view of a ventilation interface having adjustable nasal pillows. - Aspects of the invention are disclosed in the following description and related drawings directed to specific embodiments of the invention. Alternate embodiments may be devised without departing from the spirit or the scope of the invention. Additionally, well-known elements of exemplary embodiments of the invention will not be described in detail or will be omitted so as not to obscure the relevant details of the invention. Further, to facilitate an understanding of the description discussion of several terms used herein follows.
- The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any embodiment described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments. Likewise, the term “embodiments of the invention” does not require that all embodiments of the invention include the discussed feature, advantage or mode of operation.
- Generally referring to
FIGS. 1-8 , a ventilation interface mask is disclosed. The interface may be used for a variety of purposes, for example providing continuous positive airway pressure to a user. The ventilation interface may alleviate concerns some users have by being small than other types of ventilation masks and by eliminating portions of the mask that fit over the nose of a user. Additionally, by eliminating the portions of a mask that fit over the nose of a user, less sealing is required against the face of a user. Also, the small size of the ventilation interface reduces the amount of space on the interior of the mask, thus resulting in less gas to exhaust and a decreased amount of gas that is breathed more than once. -
FIG. 1 shows an exploded view of an exemplary embodiment of a respiration assist mask. Respiration assistmask 2 may have several separable components, such asventilation interface 4, cushioned facial interface 6, nasal inserts 8 and 9, andgas supply tube 10. In one embodiment of the invention,supply tube 10 may be connected toventilation interface 4 in order for input gas may be supplied to the device. In a further embodiment, facial interface 6 may be joined withventilation interface 4.Ventilation interface 4 may also accept nasal inserts 8 through receivingholes respiration assist mask 2 may then be positioned over the mouth of a user such that facial interface 6 forms an airtight seal over the mouth of the user. Additionally, in a further embodiment, facial interface 6 may form a seal against the upper and lower lips of the user. When respiration assistmask 2 is positioned over the mouth of a user, the user may insert nasal inserts 8 and 9 into the nares of a user. When nasal inserts 8 and 9 are inserted into the nares of a user, an airtight seal may be formed. - In another exemplary embodiment, nasal inserts 8 and 9 may be formed in a variety of shapes, for example the volcano style shown in
FIG. 1 . Additionally, any size or shape nasal insert that fits into the nares of a user and optionally provides an airtight seal may be used with respiration assistmask 2. Nasal inserts may be formed from any suitable material, for example silicone. In a further embodiment, nasal inserts 8 and 9 may be connected byconnector 16.Connector 16 may be formed out of any material and is, optionally, formed out of the same material as the nasal inserts.Connector 16 can also be separable from nasal inserts 8 and 9, or, in a different embodiment, nasal inserts 8 and 9 can be formed without a connector. Ifconnector 16 is fitted to nasal inserts 8 and 9, it may function to prevent the rotation of nasal inserts 8 and 9 when they are engaged on facial interface 6 in receivingholes connector 16 may act to retain nasal inserts 8 and 9 in a desired position. Alternatively,connector 16 may be removed to allow for rotation of nasal inserts 8 and 9 in receivingholes connector 16 is removed, two different size nasal inserts may used and attached to respiration assistmask 2 if it is needed or desired by a user. - In another embodiment shown in
FIG. 1 , nasal inserts 8 and 9 may be formed with elliptical distal ends 18 and 20, respectively. Elliptical ends 18 and 20 may be formed so as to provide comfortable and airtight seals within the nares of a user.Connector 16 may be positioned on nasal inserts 8 and 9 so as to hold nasal inserts 8 and 9 in a position which provides a comfortable and airtight seal in the nares of the user. - In yet another embodiment shown in
FIG. 1 , facial interface 6 may provide an airtight seal against the face of a user. Additionally, facial interface 6 may act as a cushion against the face of a user. Similar to the removable cushion disclosed in U.S. Pat. No. 6,595,214 (the '214 patent), which was incorporated by reference into Provisional U.S. Patent Application No. 60/634,188 to which priority is claimed, facial interface 6 may act as a removable cushion that attaches to a ventilation interface. Facial interface 6 may also act to form a seal against an upper and/or lower lip of a user. - Additionally, facial interface 6 may include
chin flap 22. When respiration assistmask 2 is placed on the face of a user,chin flap 22 may be positioned under the chin of the user. In one embodiment,chin flap 22 may provide additional sealing against the face of a user. Additionally, in another embodiment,chin flap 22 may act to provide additional comfort for a user. In a further embodiment,chin flap 22 can act to limit the movement of the lower jaw of a user. - In yet a further embodiment shown in
FIG. 1 , facial interface 6 may havemultiple membranes Membranes 24 may serve to provide additional seals against the face of a user. For example,membranes 24, and specificallymembrane 24 a, may seal against an upper and/or lower lip of a user who is wearing respiration assistmask 2. In this exemplary embodiment,membrane 24 a may be formed to be thinner thanmembrane 24 b. Thus,membrane 24 a can adhere to facial contours and fill small facial gaps as it can be a thin, flexible material. Additionally,membrane 24 b may be thicker thanmembrane 24 a to provide auxiliary sealing against the face of a user and provide structural support for the device. For example,membrane 24 a may be made of any suitable material, for example silicone, and may be approximately 0.020″ thick.Membrane 24 b may also be made of any suitable material, for example silicone, and have a thickness of approximately 0.050″. Still other parts of facial interface 6, for example 24 c, may have a thickness of approximately 0.100″. This thickness may extend around the periphery of that portion of the device. - Also,
membranes 24 may work in conjunction withchin flap 22 to provide additional sealing capabilities. As stated previously, in one embodiment,chin flap 22 may act to limit the movement of the lower jaw of a user. In a further embodiment,chin flap 22 may have some elasticity which allows a user wearing respiration assistmask 2 to move their jaw and, for example, open their mouth. In the event of this happening,membrane 24 a, which also may be elastic, may stretch upper portion of the lower jaw of the user, thus maintaining the seal between the interface and a wearer's face.Membrane 24 b, which may also be elastic, may then stretch against the bottom portion of the mouth of the user, thus maintaining an airtight seal between facial interface 6 and the face of a user. - Moreover, in a further exemplary embodiment of the invention, movement of the lower jaw of a user will not break the airtight seal of respiration assist
mask 2 against the face of a user or dislodge the nasal inserts which may be positioned against the nares of a user. In this embodiment, when the mouth of a user wearing the mask opens,chin flap 22 allows facial interface 6 to stretch. For example, if a user were to open their mouth, the lower jaw of the user would move againstchin flap 22, but remain in contact withchin flap 22 as it stretches. Thus, when facial interface 6 stretches,membranes 24 remain sealed against the moving face of the user. - In another embodiment shown in
FIG. 1 , facial interface 6 may have contoured surfaces around receivingholes flange 26 of nasal insert 8 andflange 28 of nasal insert 9. Contouredsurface 30 and contouredsurface 32 may act to hold nasal insert 8 and nasal insert 9, respectively, in a position that allows for an airtight seal to be formed between the nasal inserts and the nares of a user wearing respiration assistmask 2. Also, contoured surfaces 30 and 32 may act to provide an airtight seal between nasal inserts 8 and 9, respectively and facial interface 6. In a further embodiment, contoured surfaces 30 and 32 can act to angle nasal inserts 8 and 9, respectively, towards each other and thus orientate them to be better received into the nares of a user. - In another exemplary embodiment shown in
FIG. 1 ,auxiliary ports 34 and 36 may be positioned onventilation interface 4.Auxiliary ports 34 and 36 may be positioned on an upper portion ofinterface 4 and may project outwardly. Additionally, when they are not being otherwise utilized,auxiliary ports 34 and 36 may be capped withcoverings auxiliary ports 34 and 36 may be utilized as exhaust ports to release gas from the interior portion ofventilation interface 4.Removable coverings mask 2 and maintain the airtight seal within the device when. -
Ventilation interface 4 may also have a design such that it can accept and seal with cushioned facial interfaces of various sizes. In one exemplary embodiment, cushioned facial interface 6 may be made to have different size or shape cushions or have a different sealing area. Different size facial interfaces may maintain a similar size or shape membrane to connect withventilation interface 4, however. In other embodiments, different size facial interfaces may be made out of a material that stretches, so as to allow for an airtight seal to be formed between varying sizes of facial interface andventilation interface 4. -
FIG. 1 also showsinput gas tube 10, which may be formed in an elbow shape or any other shape which may attach toventilation interface 4. Input gas tube may be used to deliver any type of gas or aerosol and may be used in any type of respiration application, such as CPAP or BiPAP applications.Input gas tube 10 may have connection portion 42 which can be used to connectinput gas tube 10 toventilation interface 4 through the use of receivinghole 48. Connection portion 42 may be threading, allowinginput gas tube 10 to be screwed into receivinghole 48 or any other connection and sealing mechanism, such as a clip or a clasp.Input gas tube 10 may also havevalve 44 disposed on its surface.Valve 44 may be coupled with a flap, held in place byconnector 46, which is closed in an airtight seal when ventilation gas is being passed throughinput gas tube 10. However, if there is no gas being inputted throughtube 10, the flap will open, allowing outside air to enter respiration assistmask 2. - In another embodiment of the invention, the device may be worn on the face of a user with any of a variety of types of headgear. The headgear may attach to respiration assist
mask 2 through the use of headgear attachment posts 50. Attachment posts 50 may be positioned at various portions ofventilation interface 4, for example at the top and bottom of eitherside face 4. In a further embodiment, the headgear may have female connectors that allow for the headgear to be securely fastened to male attachment posts 50. In a different embodiment, the headgear may have looped ends that securely fit around attachment posts 50. Additionally, any other known type of attachments or posts may be used to securely attach headgear to respiration assistmask 2 in such as manner as to provide for the comfort of a user and allow for an airtight seal to be formed between the face of a user and respiration assistmask 2. -
FIG. 2 shows another exemplary embodiment where the components of the device are joined together. In this embodiment,gas input tube 10 may be securely connected toventilation interface 4 through any of the methods mentioned previously. Additionally,tube 10 may be secured to face 4 to provide an airtight seal between the tube and the face, but it may be rotatably engaged to the face. Thus inputgas tube 10 may be rotated so that a feed tube that may, optionally, be connected to inputgas tube 10 can be mounted in any location or position and continue to supply input gas to respiration assistmask 2. -
FIG. 2 also shows howventilation interface 4 can be connected to facial interface 6. The mating of these two devices can create an airtight seal betweenface 4 and connector 6. Additionally, any known method of connecting the two components may be utilized, such as tongue in groove, clasps, clips or the like. Connector 6 may also serve to enhance the structural rigidity of respiration assistmask 2. For example, the top portion and side portions of connector 6 may be thicker than other portions of connector 6. This can allow for stabilization of nasal inserts 8 and 9 when they are joined with connector 6. Further, this may prevent fore and aft movement as well as lateral movement of nasal inserts 8 and 9 when they are joined with connector 6, and may also act to enhance the seal between the nasal inserts 8 and 9 and connector 6. - In a further embodiment shown in
FIG. 2 , nasal inserts 8 and 9 are shown connected to facial interface 6 through the use of receivingholes - The assembled respiration assist
mask 2 shown inFIG. 2 may be joined to provide airtight seals between each of the components. Additionally, when the device is positioned on the face of a user, an airtight seal may exist between the interior portion of respiration assistmask 2 and the face of the user. - In a further embodiment of the invention,
exhaust ports 52 may be disposed on the face of respiration assistmask 2. In one exemplary embodiment, a series ofexhaust ports 52 may be formed on the surface ofventilation interface 4. Theseports 52 may be utilized to release or output carbon dioxide that is exhaled by a user wearing the mask. In an alternative embodiment, the exhaust ports may protrude fromventilation interface 4. In another embodiment, a different number of exhaust ports that may be larger or smaller may be utilized onventilation interface 4. In yet another embodiment, one or more exhaust ports have adjustable apertures or adjustable flow rates may be disposed onventilation interface 4. In still another embodiment,exhaust ports 52 may be capable of being capped or sealed from the interior or exterior ofventilation interface 4 so as to vary the flow rate of exhaust gases. In another exemplary embodiment,exhaust ports 52 may be disposed on any location ofventilation interface 4. - In a further embodiment shown in
FIGS. 3 and 4 , facial interface 6 may have an upper portion that is positioned against the upper lip of a user. For example,upper portion 6 a of facial interface 6 may rest snugly against the upper lip of a user when respiration assistmask 2 is being worn.Upper portion 6 a may act to create an airtight seal between the upper lip of a user wearing the device and connector 6. Additionally,upper portion 6 a may act as an anchor portion for respiration assistmask 2 when it is being worn by a user. Thus if a user, for example, opens their mouth and moves their lower jaw while wearing the device,upper portion 6 a of connector 6 will anchor respiration assistmask 2 on the face of the user to prevent it from being dislodged, which could potentially cause a break in the airtight seal between respiration assistmask 2 and the face of a user. Further, whenupper portion 6 a acts as an anchor, it may prevent forces onchin flap 22 caused by jaw or mouth movement of a user wearing the device from affecting the positioning and sealing of nasal inserts 8 and 9, which may be inserted into the nares of a user wearing the device. In this embodiment, stress exerted elsewhere on respiration assistmask 2 will not be translated into movement of nasal inserts 8 and 9 within the nares of a user and can prevent the dislodging of the nasal inserts from the nares. - In another embodiment of the invention shown in
FIG. 4 ,upper portion 6 a may also prevent movement of nasal inserts 8 and 9 when respiration assistmask 2 is worn or adjusted by a user. For example, if respiration assistmask 2 is worn on the face of a user through the use of headgear attached toposts 50, the user will likely need or desire to adjust the headgear so as to have comfort while ensuring the device is positioned properly. In previous devices having nasal inserts, the tightening of headgear on the head of a user would likely cause articulation and movement apart of the nasal inserts as the device onto which the nasal inserts was mounted stretched as the headgear was tightened. This articulation and movement can cause discomfort for a user and may dislodge the nasal inserts from the nares of a user. In this embodiment, however,upper portion 6 a of connector 6 acts as an anchor for respiration assistmask 2 because it is positioned against the upper lip of a wearer to create a seal. Therefore any forces acting upon respiration assistmask 2 by the use or tightening of headgear will be absorbed byupper portion 6 a of connector 6, rather than by nasal inserts 8 and 9. Thus, the comfort of a user wearing the device can be enhanced and there is a reduced possibility of nasal inserts 8 and 9 being moved within the nares of a user or dislodged, causing a break in the seal. -
FIG. 5 shows a top down view of another embodiment of the invention. In this embodiment, nasal inserts 8 and 9 are shown as being angled towards each other. In other embodiments, nasal inserts 8 and 9 may be angled or orientated differently depending on the fitting required or desired by a user. Additionally,hole 54 on nasal insert 8 and hole 56 on nasal insert 9 may be elliptical. Other sizes and shapes of the holes may be utilized depending on the application and wearer ofventilation interface 2. -
FIG. 6 shows a bottom up view of a different embodiment of the invention. This embodiment provides a bottom perspective facial interface 6 andchin flap 22. Additionally, one example of the placement of attachment posts 50 is shown.FIG. 6 also demonstrates the seal and one possible way of joining facial interface 6 andventilation interface 4 where facial interface 6 fits intoventilation interface 4 in a tongue-in-groove fashion. -
FIGS. 7 and 8 show exemplary side views of the invention. In this embodiment,chin flap 22 on facial interface 6 extends beyond other portions of facial interface 6. Additionally, interface connector may have shaped edges which can contour to the face of a user to better provide a seal against the face of the user.FIGS. 7 and 8 also showauxiliary ports 34 and 36 as being disposed inside recessed or cut out portions ofventilation interface 4. In other embodiments of the invention,auxiliary ports 34 and 36 may be disposed in an area onventilation interface 4 that is not cut out or recessed. -
FIGS. 9-22 show an exemplary embodiment of cushioned facial interface 6. In this embodiment various membranes are shown as well as the difference between membranes. For example, the facial interface shown inFIGS. 9-15 may be smaller than the facial interface shown inFIGS. 16-22 . Despite any size differences in the facial interfaces, both may be used interchangeably withventilation interface 2 and nasal inserts 8 and 9 without any alterations to those devices. Additionally, as shown inFIGS. 14-15 and 21-22,membrane 24 a is shown as an outer membrane that is thinner thaninner membrane 24 b. As discussed previously,membrane 24 a can be made of any suitable material, such as silicone. As discussed above,membrane 24 a is thin so as to be able to follow the contours of a user's face and provide a seal between facial interface 6 and the face of the user. Moreover, the thin membrane may be able to stretch in order to maintain a seal when the user's face moves, for example, such as when the user opens their mouth.Membrane 24 b is shown as being thicker thanmembrane 24 a and is also positioned insidemembrane 24 a.Membrane 24 b may also be made out of any suitable material, such as silicone, and, as discussed above, may be thicker to provide support on the inside ofmask 2.Membrane 24 b may also serve to act as a “stop.” In other words,membrane 24 b may limit the amount of movement a user may have while wearing the mask, for example, preventing the user from opening their mouth beyond a certain point. - Additionally, as shown in
FIG. 11 , the differences in the areas separating various membranes can be seen. As shown inFIGS. 11 and 18 , the distance betweenmembranes membranes 24 a-c on axis A-A can allow for increased user comfort and utility, as a seal can be made around the entire mouth of the user. Additionally, by having a seal around the entire mouth area, the structural rigidity ofmask 2 can be increased. Further, because of the increased structural rigidity, a user may be able to tightenmask 2 on their face without causing flex in the central or peripheral portions of the mask which could lead to the seal between the user's face and the facial interface being broken. This membrane structure can also allow downward pressure to be exerted on nasal inserts 8 and 9 without dislodging nasal inserts 8 and/or 9 and without significantly deforming facial interface 6 so as to cause a break in the seal between the face of the user and facial interface 6. - Referring generally to
FIGS. 23-44 , components of a ventilation interface that may be adjustable in various manners are disclosed. - An exemplary view of a pair of nasal pillows is shown in
FIG. 23 . The nasal pillows may be a connected pair or, in another exemplary embodiment, may be disposed separately. In this exemplary embodiment, a pair of nasal pillows is shown as havingopening 62 at a distal end of a nasal pillow, as well asnasal insert portion 60.Nasal insert portion 60 may flare out from opening 62 so as to provide a comfortable fit against the nares of a user. Additionally,connector 64 is shown as coupling a pair of nasal pillows.Connector 64 may be formed out of any soft or rigid material and may be attachable and detachable from one or both nasal pillows. -
FIG. 24 is another exemplary view of a pair of nasal pillows. This exemplary embodiment showsflanges Flanges example openings flange 72 and cushion 6,flange 70 and cushion 6 orflange 68 and cushion 6. Thus, the height of the nasal pillows may be varied by a user to obtain a more beneficial height. In another exemplary embodiment, any number of additional flanges may be disposed on a nasal pillow, in additional toflanges - In another exemplary embodiment shown in
FIG. 25 , a pair of nasal pillows is again shown. In this exemplary view,indented portion 74 of a nasal pillow is shown. Indented portion may act to compress when a nasal insert is inserted into the nares of a user. This compression may allow for better fitment and comfort of the nasal pillow as well as provide for an additional adjustment of height, depending on how the user insertsnasal insert portion 60. Additionally,indented portion 74 can allow for lateral and fore and aft movement of the nasal pillow. Thus, comfort may be increased and additional adjustments may be made to the fitment of the nasal pillows. -
FIG. 26 shows an exemplary view of a single nasal pillow. This nasal pillow may be separated from another nasal pillow through the removal ofconnector 64. Additionally, a single nasal pillow of a first size may be pair with a second nasal pillow having a second size, thus allowing for additional levels of adjustment to be performed by a user.FIG. 27 shows an exemplary cross sectional view of a single nasal pillow. From this view, an exemplary orientation of various flanges and grooves may be seen. For example,flanges FIG. 24 . Additionally,grooves Grooves openings grooves opening flanges -
FIG. 28 shows an exemplary rotated view of a pair of nasal inserts. In this view is can be seen thatindented portion 74 may again be compressed or expanded, depending on the fitment desired by a user. -
FIG. 29 is an exemplary top-down view of a nasal pillow. This view allows for a view ofopening 62, which may be circular, oval, substantially circular, substantially oval, or any other shape. Additionally,nasal insert portion 60 may flare out of the perimeter of opening 62, allowing for a user to insert the nasal pillow to a desired, function and comfortable depth.Nasal insert portion 60 may also act to provide a gas tight seal between a nasal pillow and the nares of a user.FIG. 31 provides an exemplary bottom-up view of a nasal pillow. From this view it is shown that the bottom portion of a nasal pillow may be of a greater area than opening 62. -
FIGS. 30 , 32 and 33 show additional exemplary embodiments of a nasal pillow. As shown inFIG. 30 ,indented portion 74 may be of a different diameter than in previous embodiments. This can allow for different degrees of adjustability, as a thinnerindented portion 74 may allow for more fore and aft movement and more lateral movement. Additionally, a thinnerindented portion 74 may allow forindented portion 74 to have a higher level of compression.FIGS. 32 and 33 show another embodiment of a nasal pillow with different sized features. In one exemplary embodiment, opening 82 can be larger or smaller than that in previous embodiments. Additionally,nasal insert portion 84 can have a lesser slope or a greater slope from opening 82, as well as different surface areas than previous embodiments. These different orientations of a nasal pillow may allow for the device to fit in the nares of various-sized nares. Additionally, it can allow for flexibility in using a first nasal pillow with a second nasal pillow, if a user has different sized nares. Additionally,indented portion 80 may also have a larger or smaller diameter than in previous embodiments. This, coupled with other larger or smaller features, may allow for a greater or lesser amount of gas flow through a ventilation interface and into the nares of a user. The gas flow provided to a user may be varied through the use of different sized nasal inserts and nasal pillows depending on the needs of that user. - In another embodiment of the invention shown in
FIG. 34 , different cushions may utilize different amount of flanges. For example, inFIG. 34 a, opening 88 is shown with a singular flange 90. Flange 90 may act to receive and seal with a nasal pillow having one or more flanges and which may or may not be adjustable in height. InFIG. 34 b,multiple flanges 94 may act with opening 92 to receive a nasal pillow having one or more flanges.Flanges 94 can be used to adjust the height of a nasal pillow having a single flange or may be used with a nasal pillow having multiple flanges to provide a greater degree of vertical adjustability. Each portion offlanges 94 may individually act to couple and seal with a nasal pillow. In a further embodiment, any number of flanges may be disposed oncushion 86 and may provide for a varying amount of adjustability of a cushion, nasal pillow or spacer. -
FIGS. 35 a-c show yet another exemplary embodiment of a ventilation interface utilizing nasal pillows that may be adjusted. Here, as shown inFIG. 35 a, nasal pillows 96 and 98 may havemultiple flanges Flanges Flanges flanges 106 and 108, respectively, ofcushion 104. Receivingflanges 106 and 108 may be disposed oncushion 104 and may include any number of flanges. Additionally, receivingflanges 106 and 108 may be disposed oncushion 104 in any manner, for example molding, adhesion or any other manner known to one having ordinary skill in the art. - In one example shown in the cutaway view of
FIG. 35 b, nasal pillow 98 is shown as being coupled withcushion 104 throughopening 112. Here nasal pillow 98 may be in a raised position fromcushion 104, as the upper flange offlange 108 is used to couple pillow 98 withcushion 104. In another exemplary embodiment shown inFIG. 35 c, nasal pillow 98 is in a lower position relative to that shown inFIG. 35 b. Here the lower flange offlange 108 may be used to couple pillow 98 withcushion 104. In further exemplary embodiments, any number of flanges may be disposed on nasal pillows 96 or 98 and any number of receivingflanges 106 and 108 may be disposed oncushion 104. Therefore, nasal pillows 96 and 98 may be vertically adjusted in a variety of manners and to any height desired by a user of the ventilation interface. - In one exemplary embodiment, shown in
FIG. 36 , one or more adjustablenasal pillows nasal pillow single assembly groove 118, as shown inFIG. 36A , ormultiple assembly grooves 120, as shown inFIG. 36B . Each nasal pillow may fit into a cushion, which may have one or more flanges for receivingassembly groove 118 orassembly grooves 120.Nasal pillows nasal insert portions indented portions nasal pillows openings - In a further exemplary embodiment shown in
FIG. 37 a-c, one manner in which nasal pillows may be attached to a cushion is shown. In the exemplary embodiment ofFIG. 37 a,nasal pillows Nasal pillows openings cushion 138.Nasal pillows flanges cushion 138. -
FIGS. 37 b and 37 c show cross-sectional, views of the exemplary embodiment ofFIG. 37 a. InFIG. 37 b,nasal pillow 134 is shown as separated fromcushion 138. Additionally,interior flanges 148 are shown insideflange 144.Interior flanges 148 may interlock and seal with flanges andgrooves 152 that are associated withopening 140.Nasal pillow 136 is shown as being joined withcushion 138.Nasal pillow 136 may useinterior flanges 150 insideflange 146 to interlock and seal with flanges andgrooves 154 ofopening 142.Nasal pillow 136 can be fitted in the lowest fitting position for this combination of flanges and grooves. However, any of a variety of different combinations of flanges and grooves may be utilized to provide varying degrees of adjustment.FIG. 35 c shows a further exemplary embodiment havingnasal pillow 134 fitted in a low position andnasal pillow 136 fitted in a raised position. Here,nasal pillow 134 may be coupled withcushion 138. In other exemplary embodiments,nasal pillow 134 may be either permanently or removably coupled withcushion 138.Nasal pillow 134 can useinterior flanges 148 insideflange 144 to interlock and seal with flanges andgrooves 152 ofopening 140.Nasal pillow 136 can join withcushion 138 in a raised position.Nasal pillow 136 may useinterior flanges 150 insideflange 146 to interlock and seal with upper flanges andgrooves 154 ofopening 142. Other exemplary embodiments may use nasal pillows of varying sizes and may provide additional flanges to allow for different adjustments to be made to the height or orientation of the nasal pillows. - In another embodiment shown in
FIG. 38 , a spacer may also then be utilized in conjunction with both a nasal pillow and a cushion. InFIG. 38 , a pair of nasal pillows, a pair of spacers and a cushion are shown.Nasal pillows spacer more flanges Flanges spacers spacers cushion using flanges spacer 166 may be separated fromnasal pillow 156 andcushion 164.Spacer 168, however, can be either permanently or removably joined with bothnasal pillow 158 andcushion 164. In this example,nasal pillow 158 usesflanges 162 to couple with theupper flanges 172 ofspacer 168. A gas tight seal may be formed betweennasal pillow 158 andspacer 168. Additionally,spacer 168 may couple withcushion 164 inopening 176.Lower flanges 172 ofspacer 168 may be used to couple with the flange disposed at the edges ofopening 176, and a gas tight seal may be provided between the two. Also, the multiple flanges may allow the spacer to fit into the pillow and the cushion at different levels. For example, if a user of a cushion desires to move a pillow away from the cushion, they may utilize a top flange or flanges of a spacer. If a user of a cushion desires to move a pillow away from the cushion, for example, they may utilize a lower flange or flanges of a spacer. In the exemplary embodiment shown inFIG. 38 , the lower portion offlange 172 is not shown as being utilized; thus a user could adjustnasal pillow 158 andspacer 168 vertically usingflange 172 ofspacer 168. -
FIG. 39 shows another exemplary embodiment of a pair of nasal pillows that are joined to a cushion using spacers. Similar to the embodiment shown inFIG. 38 ,nasal pillow 170 is shown in an exploded view and not connected to spacer 166 orcushion 164.Nasal pillow 172 may again be connected tospacer 168 andcushion 164. However, in this exemplary embodiment,nasal pillow 172 has been adjusted vertically. Here, the lower portion offlange 176 ofnasal pillow 172 can be coupled with the upper portion offlange 172 ofspacer 168, as opposed to the exemplary embodiment shown inFIG. 38 , where bothflanges 176 ofnasal pillow 172 were coupled to the twoupper flanges 172 ofspacer 168. Thus, in the exemplary embodiment shown inFIG. 39 nasal pillow 172 has been adjusted vertically when compared tonasal pillow 172 inFIG. 38 . Additionally,pillow 172 inFIG. 39 may be adjusted in any of a variety of different matters vertically. - Another exemplary embodiment of an adjustable nasal pillow is shown in
FIG. 40 . Similar toFIGS. 37 and 38 ,nasal pillow 170 is shown in an exploded view and not connected to spacer 166 orcushion 164.Nasal pillow 172 may be connected tospacer 168 andcushion 164. However, in this exemplary embodiment,nasal pillow 172 has again been adjusted vertically. Here, the lower portion offlange 176 ofnasal pillow 172 may be coupled with the upper portion offlange 172 ofspacer 168, similar to the exemplary embodiment shown inFIG. 39 . However, inFIG. 40 , the bottom-most portion offlange 172 onspacer 168 can be used to couple spacer 168 to cushion 164, usingopening 176. Thus, in the exemplary embodiment shown inFIG. 40 nasal pillow 172 has again been adjusted vertically when compared tonasal pillow 172 inFIG. 39 . Additionally,pillow 172 inFIG. 40 may also be adjusted in any of a variety of different matters vertically. - In further exemplary embodiments of FIGS. 34 and 38-40, a spacer (e.g. 166 or 168) used with a nasal pillow, such as 170 or 172, may have one or more flanges located at varying distances from each other. The flanges may be formed at different distances for different spacers, allowing for variable adjustments to be made to the pillow and cushion. In another embodiment, the spacer may be formed with one or more flanges or one or more grooves. Additionally, the cushion and pillow may also be formed with either flanges or grooves, thus allowing for the spacer to be joined in a male-female or female-male fashion with the cushion and pillow. Flanges or grooves used with any of the spacer, cushion or pillow may be formed in any shape, such as square, fully round, partially rounded or any combination thereof.
- In yet another exemplary embodiment, the spacer, such as
spacer nasal pillow 172 and then coupled withspacer 168. Additionally, any of the embodiments disclosed in this document may be used with a single pillow or one or more connected pillows, and a single spacer, one or more connected spacers, or one or more axially connected spacers. - In another exemplary embodiment shown in
FIG. 41 , a pair of nasal pillows may be joined with spacers and then coupled with a cushion for a ventilation interface. In a first view, shown inFIG. 41 a,nasal pillows flanges 196 and 198, respectively (and shown as shrouded inFIG. 41 a) to couple with spacers.Spacer 188 may couple withflange 196 ofnasal pillow 178 usingflanges 192. A similar coupling may occur betweennasal pillow 180 and spacer 190, although they are shown as already coupled in this view, thus flanges 194 are not shown inFIG. 41 a. -
FIG. 41 b shows a side perspective view of the exemplary embodiment ofFIG. 41 a. In this view, it is shown thatspacer 188 is substantially round. In another exemplary embodiment,spacer 188 may be any shape that may be coupled withnasal pillow 178 and also may be coupled with opening 196 oncushion 186. Additionally, in the view shown inFIG. 41 b,flanges 192 are shown as extending around the entire perimeter ofspacer 188. In other embodiments of the invention,flanges 192 may be disposed on only parts ofspacer 188, may be arranged in different locations, may be located at different distances from the other flanges, may be angled or may not extend around the entire perimeter of a spacer. Additionally, as shown in -
FIGS. 41 a and 41 b,cushion 186 may be configured to adhere to the contours of the face of a user.Cushion 186 may also be configured on one side to receive a ventilation interface, such as a plastic interface having a means for accepting input gas, such as CPAP or BiPAP. - Additionally, a cross-sectional view of the embodiments shown in
FIGS. 41 a and 41 b is shown inFIG. 41 c. In this view, it can be seen thatnasal pillow 180 can use multiple grooves 198 to receive the upper portion of spacer 190flange 194. Additionally, only a lower portion of spacer 190flange 194 may be used in opening 198 to couple spacer 190 to cushion 186. Further, from this exemplary embodiment,spacers 188 and 190 may be adjusted vertically oncushion 186 without disturbing the coupling ofspacers 188 and 190 tonasal pillows nasal pillows spacers 188 and 190, respectively, without disturbing the coupling ofspacers 188 and 190 withcushion 186. Also, in another exemplary embodiment,nasal pillows spacers 188 and 190, respectively, whilespacers 188 and 190 are being adjusted oncushion 186. -
FIG. 42 shows another exemplary embodiment of a ventilation interface where nasal pillows may be adjusted through the use of flanges on the nasal pillows, flanges on the cushion and through the use of spacers. Here,nasal pillows 204 and 206 may be coupled withspacers 214 and 216, respectively.Spacers 214 and 216 may also be coupled with cushion 212.Nasal pillows 204 and 206 inFIG. 42 may also be adjusted to different positions. Nasal pillow 204 may use flanges 208 on twoupper flanges 218 ofspacer 214.Spacer 214 may then be coupled to opening 226 of cushion 212 through the use of the upper portion offlange 222.Nasal pillow 206 can use the bottom portion offlanges 210 on the uppermost flange offlanges 220 of spacer 216. Spacer 216 can then be coupled to opening 228 of cushion 212 through the use of the upper portion of flange 224. In each of these embodiments, each of the nasal pillows, spacers and cushion may be adjusted independently or in conjunction with one another. For example, nasal pillow 204 could be adjusted vertically onspacer 214 without affecting the positioning ofspacer 214 onflange 222 of cushion 212. Alternatively,spacer 214 could be adjusted onflanges 218 of cushion 212 without affecting the position of nasal pillow 204 onspacer 214. In yet another alternative embodiment, the position of nasal pillow 204 onspacer 214 could be adjusted simultaneously or in conjunction with the position ofspacer 214 on cushion 212. - In another exemplary embodiment of a ventilation interface shown in
FIG. 43 , nasal pillows may be adjusted through the use of a threaded spacer. Here, as shown inFIG. 43 a,nasal pillows flanges 234 and 236, respectively.Flanges 234 and 236 may couple withspacers Spacers portions 244 and 246. This threading may either be male or female and may mate with threaded portions 252 and 254, respectively, of cushion 238. Threaded portions 252 and 254 may be either male or female, so that they may mate withspacers - In
FIG. 43 b,nasal pillow 230 is shown in a cutaway view as being separated fromspacer 240 and cushion 238.Nasal pillow 232, however, may be coupled withspacer 242 using flange 236 onpillow 232 and receivingflange 245 onspacer 242.Spacer 242 may then utilize threads 246 to be threaded intoopening 258 of cushion 238. Flanges 250 on cushion 238 may have internal threading 254 that may receive the threading of 246 ofspacer 242. In one exemplary embodiment, flanges 250 may have male threading that receives female threading ofspacer 242. Alternatively, flanges 250 may have female threading that receives male threading ofspacer 242. In yet another exemplary embodiment, cushion 238 andspacer 242 may snap together, for example with either cushion 238 orspacer 242 having a post that fits into a receiving hole or slot on the other member. In yet another exemplary embodiment, cushion 238 andspacer 242 may be joined by friction. Afterspacer 242 and cushion 238 are coupled, a user may twist eithernasal pillow 232 orspacer 242. The twisting may result in a raising or lowering of the height ofnasal pillow 232, as well as a changing of the orientation ofnasal pillow 232. In a further embodiment, both the spacers and flanges on a cushion may have threading of any length, allowing a user to adjust one or both nasal pillows to any desired height or orientation. In yet another embodiment, spacers may be coupled to a cushion through the use of friction between the spacer material and the cushion, allowing for an infinite amount of adjustment to be made to the height and orientation of one or both nasal pillows. Alternatively, any other method known to one having ordinary skill in the art may be used to couple a spacer with a cushion. -
FIG. 44 shows yet another exemplary embodiment of a ventilation interface having adjustable nasal pillows. Similar to other embodiments, as shown inFIG. 44 a,nasal pillows flanges Flanges spacers Spacers portions portions spacers FIG. 44 b, or may be partially collapsed on itself, as shown byspacer 270 inFIG. 44 c. Alternatively,spacers Spacers flanges flanges Flanges openings cushion 268. - In a further embodiment shown in
FIG. 44 b,nasal pillow 260,spacer 270 and cushion 268 are shown as separate, in a cutaway view.Nasal pillow 262, however, may useflange 266 to couple withupper flange 275 ofspacer 272.Lower flange 280 ofspacer 272 may then be coupled withflange 284 ofcushion 268, so as to allow gas to flow from a ventilation interface, throughspacer 272 and throughnasal pillow 262. In the exemplary embodiment shown inFIG. 44 b, hinge 276 ofspacer 272 is shown in an upright, elongated fashion. - In exemplary
FIG. 44 c, the orientation ofnasal pillow 262,spacer 272 and cushion 268 remains similar to that shown inFIG. 44 b.Nasal pillow 260, however, may useflange 264 to couple withupper flange 273 ofspacer 270.Lower flange 278 ofspacer 270 may then be coupled withflange 282 ofcushion 268, so as to allow gas to flow from a ventilation interface, throughspacer 270 and throughnasal pillow 260. Additionally, in the exemplary embodiment shown inFIG. 44 c, hinge 274 ofspacer 270 is shown in a collapsed fashion. Thus, the height ofnasal pillow 260 may be varied through the collapsing or elongating ofhinge 274. Additionally, the height ofnasal pillow 262 may be varied through the collapsing or elongating ofhinge 276. Each of these hinges may be collapsed or elongated in any of a variety of fashions known to a person having ordinary skill in the art and each hinge may have an infinite range of motion. - In another exemplary embodiment, the one or more nasal pillows, for example
nasal pillows nasal pillows example cushion 268. Alternatively,nasal pillows example spacers nasal pillows - In another exemplary embodiment, the spacer or spacers used in any embodiment may be any shape. For example, the spacer may be circular or oval. Additionally, the spacer may be constructed so as to be either soft or rigid. Further, the spacer may be hollow so as to allow for gas to travel through the spacer. Alternatively, the spacer may be solid and have holes or slots disposed internally so as to allow for the flow of gas from a cushion to a nasal pillow.
- Additionally, different spacers, such as
spacers - In another exemplary embodiment, any of the spacers or secondary pieces described herein, for
example spacers FIG. 44 , may be assembled and formed in any of a variety of manners. For example, a spacer may be mechanically attached to a nasal pillow or cushion, a spacer may be bonded to a nasal pillow or a cushion or a spacer may be molded into a nasal pillow or cushion. Additionally, any manner of attaching a spacer to a nasal pillow or a cushion that is known to one of ordinary skill in the art may be utilized. - In yet another embodiment, a nasal pillow in any of the above exemplary embodiments, for example
nasal pillow - In another exemplary embodiment shown in
FIGS. 45 a-b, one or more nasal inserts may be oriented in additional positions on a cushion. InFIG. 45 a, a firstnasal pillow 280 is shown as separated fromcushion 284, leavingopening 286 open andflange 288 unengaged.Nasal pillow 282 is shown as engaged to cushion 284 through the use offlange 290. Additionally, cushion 284 may have edges that seal against the face, for example the upper lip, of a user wearing the ventilation interface. InFIG. 45 b a cutaway ofnasal pillow 282 engaged withcushion 284 is shown.Nasal pillow 282 may useflanges 292 to engage withflange 290 oncushion 284. In the exemplary embodiment shown inFIG. 45 b, the lower portion offlanges 292 are used to engagenasal pillow 282 incushion 284. In alternative exemplary embodiments, any of the central orupper flanges 292 may be utilized onnasal pillow 282. Further, in the exemplary embodiment shown inFIG. 45 b,cushion 284 has a membrane 300 that may seal against the upper lip of the user, andnasal pillow 282 has a nasal insert portion 298 that may contact the bottom of a nostril. The distance between atop edge 294 of membrane 300 and abottom edge 296 of nasal insert portion 298 may be in the range of approximately 0.030″ to 2″. - Additionally, in further embodiments of the invention, one nasal pillow may be connected to another nasal pillow using a connecting member. The connecting member may be formed as part of a nasal pillow and may be made out of any material and may join the nasal pillows in any manner known to one having ordinary skill in the art. The connecting member may also be removably attached to at least one of the nasal pillows. A connecting member may be utilized with any of the embodiments described herein and may maintain its connection with each nasal pillows regardless of adjustment of the height or angle of the nasal pillows. Additionally, the nasal pillows may have thin portions that are designed to provide a place for a connecting member to securely attach.
- Any of the above embodiments may be utilized in any of a variety of respiration or respiration assist devices and are not limited to respiration assist masks. The various adjustable nasal pillows, spacers and cushions, for example, may be utilized in any of a variety of devices, including but not limited to respiration assist masks, nasal cannulas, ventilation masks, underwater breathing apparatuses, and other type of device capable of delivering breathable gas or aerosol.
- The foregoing description and accompanying drawings illustrate the principles, preferred embodiments and modes of operation of the invention. However, the invention should not be construed as being limited to the particular embodiments discussed above. Additional variations of the embodiments discussed above will be appreciated by those skilled in the art.
- Therefore, the above-described embodiments should be regarded as illustrative rather than restrictive. Accordingly, it should be appreciated that variations to those embodiments can be made by those skilled in the art without departing from the scope of the invention as defined by the following claims.
Claims (20)
1. A ventilation device, comprising:
a ventilation interface adapted to connect to a gas source supplying a gas to the ventilation interface;
a cushioned facial interface coupled with the ventilation interface, the cushioned facial interface having a gas exit configured to seal over the mouth of a user, and at least one nasal opening;
at least one removable nasal pillow with at least one receiving flange; and
the cushioned facial interface having at least three flanges proximate the at least one nasal opening, at least two of the flanges are used to receive the at least one receiving flange to couple the cushioned facial interface to the at least one removable nasal pillow.
2. The ventilation device of claim 1 , wherein the at least one nasal pillow is coupled to a second removable nasal pillow with a connecting member.
3. The ventilation device of claim 1 , wherein the cushioned facial interface has a membrane with a top edge and the at least one nasal pillow has a nasal insert portion with a bottom edge, and the distance between the top edge of the membrane and the bottom edge of the nasal insert portion that is approximately 0.030″ to 2″.
4. The ventilation device of claim 1 , wherein the cushioned facial interface has two grooves between the at least three flanges.
5. The ventilation device of claim 4 , wherein the height of the two grooves is substantially the same.
6. The ventilation device of claim 1 , wherein the at least one removable nasal pillow is a first removable nasal pillow and a second removable nasal pillow, wherein the first removable nasal pillow may couple with the cushioned facial interface at a first height and the second removable nasal pillow may couple with the cushioned facial interface at a second height.
7. A ventilation device, comprising:
a ventilation interface adapted to connect to a gas source supplying a gas to the ventilation interface;
a cushioned facial interface coupled with the ventilation interface, the cushioned facial interface having a gas exit configured to seal over the mouth of a user and having at least two receiving flanges at a receiving hole; and
at least one removable nasal pillow, the at least one removable nasal pillow having at least two flanges with at least one groove formed between the at least two flanges, wherein the at least one groove receives at least one receiving flange to couple the at least one removable pillow with the cushioned facial interface.
8. The ventilation device of claim 7 , wherein the at least one nasal pillow is coupled to a second removable nasal pillow with a connecting member.
9. The ventilation device of claim 7 , wherein the cushioned facial interface has a membrane with a top edge and the at least one nasal pillow has a nasal insert portion with a bottom edge, and the distance between the top edge of the membrane and the bottom edge of the nasal insert portion that is approximately 0.030″ to 2″.
10. The ventilation device of claim 7 , wherein the cushioned facial interface has a groove between the at least two receiving flanges.
11. The ventilation device of claim 7 , wherein the height of the at least two receiving flanges of the cushioned facial interface is substantially the same.
12. The ventilation device of claim 7 , wherein the height of the at least two flanges of the at least one removable nasal pillow is substantially the same.
13. The ventilation device of claim 7 , wherein the at least one removable nasal pillow is a first removable nasal pillow and a second removable nasal pillow, wherein the first removable nasal pillow may couple with the cushioned facial interface at a first height and the second removable nasal pillow may couple with the cushioned facial interface at a second height.
14. A ventilation device, comprising:
a ventilation interface adapted to connect to a gas source supplying a gas to the ventilation interface;
a cushioned facial interface coupled with the ventilation interface, the cushioned facial interface having a gas exit configured to seal over the mouth of a user;
at least one removable nasal pillow having at least two receiving flanges; and
the cushioned facial interface having a receiving hole with at least two flanges and one groove formed between the two flanges , wherein the groove receives at least one receiving flange to couple with the at least one removable nasal pillow.
15. The ventilation device of claim 14 , wherein the at least one nasal pillow is coupled to a second removable nasal pillow with a connecting member.
16. The ventilation device of claim 14 , wherein the cushioned facial interface has a membrane with a top edge and the at least one nasal pillow has a nasal insert portion with a bottom edge, and the distance between the top edge of the membrane and the bottom edge of the nasal insert portion that is approximately 0.030″ to 2″.
17. The ventilation device of claim 14 , wherein the at least one removable nasal pillow has a groove between the at least two receiving flanges.
18. The ventilation device of claim 14 , wherein the height of the at least two flanges of the cushioned facial interface is substantially the same.
19. The ventilation device of claim 14 , wherein the height of the at least two receiving flanges of the at least one removable nasal pillow is substantially the same.
20. The ventilation device of claim 14 , wherein the at least one removable nasal pillow is a first removable nasal pillow and a second removable nasal pillow, wherein the first removable nasal pillow may couple with the cushioned facial interface at a first height and the second removable nasal pillow may couple with the cushioned facial interface at a second height.
Priority Applications (1)
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US14/483,960 US20150075530A1 (en) | 2006-05-10 | 2014-09-11 | Ventilation interface |
Applications Claiming Priority (2)
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US11/430,902 US8887725B2 (en) | 2006-05-10 | 2006-05-10 | Ventilation interface |
US14/483,960 US20150075530A1 (en) | 2006-05-10 | 2014-09-11 | Ventilation interface |
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US11/430,902 Continuation US8887725B2 (en) | 2006-05-10 | 2006-05-10 | Ventilation interface |
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US20150075530A1 true US20150075530A1 (en) | 2015-03-19 |
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US11/430,902 Active 2029-07-05 US8887725B2 (en) | 2006-05-10 | 2006-05-10 | Ventilation interface |
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EP (1) | EP2021059A1 (en) |
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Also Published As
Publication number | Publication date |
---|---|
US8887725B2 (en) | 2014-11-18 |
EP2021059A1 (en) | 2009-02-11 |
US20070272249A1 (en) | 2007-11-29 |
WO2007130067A1 (en) | 2007-11-15 |
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