Patent Description:
There are numerous situations where it is necessary or desirable to deliver a flow of breathing gas non-invasively to the airway of a patient, i.e., without intubating the patient or surgically inserting a tracheal tube in their esophagus. For example, it is known to ventilate a patient using a technique known as non-invasive ventilation. It is also known to deliver positive airway pressure (PAP) to treat a medical disorder, such as chronic obstructive pulmonary disease (COPD) or sleep apnea syndrome, in particular, obstructive sleep apnea (OSA). Known PAP therapies include continuous positive airway pressure (CPAP), wherein a constant positive pressure is provided to the airway of the patient in order to splint open the patient's airway, and variable airway pressure, wherein the pressure provided to the airway of the patient is varied with the patient's respiratory cycle.

COPD affects approximately <NUM> million people in the United States alone. A large percentage of these patients also have OSA, although the exact percentage is unknown. COPD and OSA tend to be treated separately, but when they occur together, there is a higher risk of additional comorbidities and nocturnal oxygen desaturations tend to be worse. This additive effect has implications for the quality of life, exacerbations, morbidity, and mortality of these patients, thus making it vitally important to pursue technologies which could help these patients.

Non-invasive ventilation and pressure support therapies involve the placement of a patient interface device including a mask component on the face of a patient. The mask component may be, without limitation, a nasal mask that covers the patient's nose, a nasal cushion having nasal prongs that are received within the patient's nares, a nasal/oral mask that covers the nose and mouth, or a full face mask that covers the patient's face. The patient interface device interfaces the ventilator or pressure support device with the airway of the patient, so that a flow of breathing gas can be delivered from a pressure/flow generating device to the airway of the patient. It is known to maintain such devices on the face of a wearer by a headgear having one or more straps adapted to fit over/around the patient's head. Because such patient interface devices are typically worn for an extended period of time, it is important for the headgear to maintain the mask component of the device in a tight enough seal against the patient's face without discomfort.

A number of known patient interface devices provide airflow to the patient through the headgear via one or more delivery conduits that wrap around portions of the patient's head as part of the headgear. That is, the headgear includes a tubing assembly with a manifold. The manifold is coupled to, and in fluid communication with, a delivery conduit. The delivery conduit is further coupled to, and in fluid communication with, the pressure/flow generating device.

PAP therapies are typically provided to the patient at night while the patient is sleeping. One study suggests that patients with hypoxemia and hypercapnia have a higher incidence of nocturnal deaths. Monitoring nocturnal desaturations could help monitor a patient's condition, and improve patient outcomes by indicating whether or not current therapies are working effectively for the patient. For example, if a patient's oxygen desaturations worsen over time, the patient may need to be put on oxygen if they are not already. Alternatively, the delivery of therapy may need to be adjusted, e.g. the patient may need oxygen increased or a different Bilevel PAP (BiPAP®) setting.

Current methods for monitoring nocturnal oxygen desaturations utilize pulse oximetry (SpO2) sensors, which are typically found in the form of a finger probe. People tend to find these probes obtrusive and uncomfortable, and they are likely to fall off during the night. Accordingly, there is room for improvement in apparatus and methods for monitoring blood oxygen saturation levels of a patient. <CIT> relates to apparatus, systems, and methods for treating obstructive sleep apnea. A CPAP system with an integrated oximeter sensor is disclosed wherein the sensor communicates with an oximeter processor that controls the blower. A nasal air flow sensor may also be incorporated that provides more data to the processor. <CIT> relates to a system for regulating a flow of oxygen to a patient where the system may include an oximeter for measuring the patient's blood oxygen level and/or heart rate; a controller for determining a desired oxygen flow rate based on the patient's blood oxygen level and/or heart rate, and generating a control signal representative of the desired oxygen flow rate.

As one aspect of the disclosure, a tubing assembly for use in providing a flow of positive pressure breathing gas to a patient is provided. The tubing assembly comprises: a manifold portion that is structured to receive the flow of positive pressure breathing gas; a number of tubular portions which each extend from the manifold portion to a distal end which is structured to be coupled to a patient interface for use in delivering the flow of positive pressure breathing gas to the patient; and a reflectance pulse oximetry sensor positioned in or on one of the number of tubular portions, wherein the sensor is structured to be disposed adjacent the patient when the tubing assembly is disposed on the head of the patient.

The sensor may be adhered to a surface of the one of the number of tubular portions.

The sensor may be coupled to the one of the number of tubular portions via over-molding.

The soft removable covering may be coupled to the one of the number of tubular portions, and the sensor may be positioned in or on the removable covering.

The sensor may be positioned with respect to the one of the number of tubular portions such that when the tubing assembly is disposed on the head of the patient the sensor is positioned on a region of the patient's face extending between a forward boundary that extends between the patient's subnasale and labiale superius and a rearward boundary that extends between the patient's temple and helical root.

The one of the number of tubular portions may comprise a skirt portion that is disposed about the sensor, and the skirt portion may be structured to shield the sensor from ambient light when the tubing assembly is disposed on the head of the patient. The skirt portion may comprise a flexible and opaque polymer. The skirt portion may include a number of protrusions each of which, when viewed in a sectional view, has an asymmetrically curved top edge that peaks toward the center of the sectional view and tapers downward toward an edge of the sectional view, and the number of protrusions may provide additional cushioning when the tubing assembly is disposed on the head of the patient. The skirt portion may include a number of protrusions each of which, when viewed in a sectional view, has a narrow stem portion arising from a surface of the skirt portion and a bulbous top edge, and the number of protrusions may provide additional cushioning when the tubing assembly is disposed on the head of the patient.

The tubing assembly may further comprise a data communication arrangement, the data communication arrangement comprising: a flexible circuit positioned in or on the same one of the number of tubular portions in or on which the sensor is positioned, the flexible circuit extending between a first end electrically connected to the sensor and an opposite second end; and one of either: an electrical connector electrically connected to the second end, the electrical connector being structured to be electrically connected to a data processor, or a wireless transmitter electrically connected to the second end, the wireless transmitter being structured to communicate wirelessly with the data processor. The flexible circuit may be structured to be disposed adjacent the patient when the tubing assembly is disposed on the head of the patient.

As another aspect of the disclosure, a mask for use in providing a flow of positive pressure breathing gas to a patient is provided. The mask comprises: a tubing assembly structured to receive the flow of positive pressure breathing gas, the tubing assembly comprising: a manifold portion structured to receive the flow of positive pressure breathing gas; and a number of tubular portions which each extend from the manifold portion to a distal end; a patient interface coupled to the distal end of each tubular portion for conveying the flow of positive pressure breathing gas to an airway of the patient; and a reflectance pulse oximetry sensor positioned in or on one of the number of tubular portions, wherein the sensor is structured to be disposed adjacent the patient when the mask is disposed on the head of the patient.

The mask may further comprise a data communication arrangement, the data communication arrangement comprising: a flexible circuit positioned in or on the same one of the number of tubular portions in or on which the sensor is positioned, the flexible circuit extending between a first end electrically connected to the sensor and an opposite second end; and one of either: an electrical connector electrically connected to the second end, the electrical connector being structured to be electrically connected to a data processor, or a wireless transmitter electrically connected to the second end, the wireless transmitter being structured to communicate wirelessly with the data processor.

As yet another aspect of the disclosure, a method for measuring a blood oxygen saturation level of a patient is provided. The method comprises: providing the patient with a mask for use in providing a flow of positive pressure breathing gas to the patient, the mask comprising: a tubing assembly structured to receive the flow of positive pressure breathing gas, the tubing assembly comprising: a manifold portion structured to receive the flow of positive pressure breathing gas; and a number of tubular portions which each extend from the manifold portion to a distal end; a patient interface coupled to the distal end of each tubular portion for conveying the flow of positive pressure breathing gas to an airway of the patient; a reflectance pulse oximetry sensor positioned in or on one of the number of tubular portions, wherein the sensor is structured to be disposed adjacent the patient when the mask is disposed on the head of the patient; and a data communication arrangement, the data communication arrangement comprising: a flexible circuit positioned in or on the same one of the number of tubular portions in or on which the sensor is positioned, the flexible circuit extending between a first end electrically connected to the sensor and an opposite second end; and one of either: an electrical connector electrically connected to the second end, the electrical connector being structured to be electrically connected to a data processor, or a wireless transmitter electrically connected to the second end, the wireless transmitter being structured to communicate wirelessly with the data processor; and detecting data about the blood oxygen saturation level of the patient with the sensor after the mask has been disposed on the head of the patient.

These and other objects, features, and characteristics of the present disclosure, as well as the methods of operation and functions of the related elements of structure and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the disclosure.

As used herein, the singular form of "a", "an", and "the" include plural references unless the context clearly dictates otherwise. As used herein, the statement that two or more parts or components are "coupled" shall mean that the parts are joined or operate together either directly or indirectly, i.e., through one or more intermediate parts or components, so long as a link occurs. As used herein, "directly coupled" means that two elements are directly in contact with each other. As used herein, "fixedly coupled" or "fixed" means that two components are coupled so as to move as one while maintaining a constant orientation relative to each other.

As used herein, the statement that two or more parts or components "engage" one another shall means that the parts exert a force against one another either directly or through one or more intermediate parts or components.

As used herein, the word "unitary" means a component is created as a single piece or unit. That is, a component that includes pieces that are created separately and then coupled together as a unit is not a "unitary" component or body. As used herein, the term "number" shall mean one or an integer greater than one (i.e., a plurality).

As used herein, a "coupling assembly" includes two or more couplings or coupling components. The components of a coupling or coupling assembly are generally not part of the same element or other component. As such the components of a "coupling assembly" may not be described at the same time in the following description.

As used herein, a "coupling" is one element of a coupling assembly. That is, a coupling assembly includes at least two components, or coupling components, that are structured to be coupled together. It is understood that the elements of a coupling assembly are compatible with each other. For example, in a coupling assembly, if one coupling element is a snap socket, the other coupling element is a snap plug.

As used herein, "correspond" indicates that two structural components are sized and shaped to be similar to each other and may be coupled with a minimum amount of friction. Thus, an opening which "corresponds" to a member is sized slightly larger than the member so that the member may pass through the opening with a minimum amount of friction. This definition is modified if the two components are said to fit "snugly" together or "snuggly correspond. " In that situation, the difference between the size of the components is even smaller whereby the amount of friction increases. If the element defining the opening and/or the component inserted into the opening is/are made from a deformable or compressible material, the opening may even be slightly smaller than the component being inserted into the opening. This definition is further modified if the two components are said to "substantially correspond. " "Substantially correspond" means that the size of the opening is very close to the size of the element inserted therein. That is, not so close as to cause substantial friction, as with a snug fit, but with more contact and friction than a "corresponding fit," i.e. a "slightly larger" fit.

A respiratory interface system <NUM> adapted to provide a regimen of respiratory therapy to a patient P according to one exemplary embodiment of the present disclosure is shown in <FIG>. Respiratory interface system <NUM> includes a pressure generating device <NUM> (shown schematically), and a delivery conduit <NUM> fluidly coupled to a mask <NUM>. Pressure generating device <NUM> is structured to generate a flow of positive pressure breathing gas and may include, without limitation, ventilators, constant pressure support devices (such as a continuous positive airway pressure device, or CPAP device), variable pressure devices (e.g., BiPAP®, Bi-Flex®, or C-Flex™ devices manufactured and distributed by Philips Respironics of Murrysville, PA), and auto-titration pressure support devices. Delivery conduit <NUM> is structured to communicate the flow of breathing gas from pressure generating device <NUM> to mask <NUM>, and mask <NUM> is structured to further communicate the flow of breathing gas received from conduit <NUM> to an airway of patient P. Delivery conduit <NUM> and mask <NUM> are often collectively referred to as a patient circuit.

Mask <NUM> includes a tubing assembly <NUM> and a patient interface <NUM> fluidly coupled to tubing assembly <NUM>. Patient interface <NUM> includes a patient sealing element <NUM> which is structured to sealingly engage about one or more of the nares and/or mouth of patient P. In one example embodiment as illustrated in <FIG>, patient sealing element <NUM> is a nasal cushion made of a soft, flexible material, such as, without limitation, silicone, an appropriately soft thermoplastic elastomer, a closed-cell foam, or any other suitable material or combination of such materials. It is to be appreciated, however, that any type of patient sealing element, such as a nasal/oral mask, a nasal pillow or a full face mask, which facilitates the delivery of the flow of breathing gas to the airway of a patient, may be used as sealing element <NUM>.

Continuing to refer to <FIG>, as well as to <FIG>, tubing assembly <NUM> includes a manifold portion <NUM> structured to receive the flow of positive pressure breathing gas from delivery conduit <NUM>, a number (two are shown in the example of <FIG>) of tubular portions <NUM> which each extend from manifold portion <NUM> to a distal end (not numbered) which is selectively coupled to patient interface <NUM>. Tubing assembly <NUM> further includes a reflectance pulse oximetry sensor <NUM> (shown schematically) coupled to one of tubular portions <NUM>. Pulse oximetry sensor <NUM> is positioned to lie immediately adjacent to the face of patient P when tubing assembly <NUM> is disposed on patient P in order to monitor the blood oxygen saturation level of patient P while patient P is receiving a treatment via mask <NUM>.

In the example shown in <FIG>, <FIG> and <FIG>, pulse oximetry sensor <NUM> is disposed (e.g., via sliding) within a pocket <NUM> which may either be formed integrally with one tubular portion <NUM> or formed separately and subsequently coupled thereto via any suitable process. Although shown being coupled to tubular portion <NUM> via pocket <NUM>, it is to be appreciated that pulse oximetry sensor <NUM> can be directly coupled to one of tubular portions <NUM> via any suitable arrangement (e.g., without limitation, adhesive, over-molding) without varying from the scope of the present disclosure, Alternatively, pulse oximetry sensor <NUM> can be coupled to a soft removable covering that is then affixed, either permanently or selectively, around one of tubular portions <NUM>. In one exemplary embodiment, pulse oximetry sensor <NUM> is coupled to a fabric covering provided with both a hook-portion and a loop-portion of a hook-and-loop fastener arrangement such that the fabric covering can be securely wrapped around one of tubular portions <NUM> and generally secured thereto via engagement of the hook and loop portions.

<FIG> further generally shows a region R of the face of patient P that has been found to yield acceptably accurate data about the blood oxygen saturation level of patient P when pulse oximetry sensor <NUM> is disposed adjacent to patient P in or near region R. Accordingly, in one exemplary embodiment of the invention, pulse oximetry sensor <NUM> is coupled to a section of one of tubular portions <NUM> that coincides with region R when tubing assembly <NUM> is disposed on the head of patient P. Region R is generally defined vertically by an upper curved line R1 that extends between the subnasale (shown generally by point A) and temple (shown generally by point B) of patient P, a lower curved line R2 that extends between the labiale superius (shown generally by point C) and helical root of the ear (shown generally by point D); and generally defined horizontally by a forward vertical line R3 that extends between the subnasale and labiale superius (points A and C) of patient P and a rearward generally vertical line R4 that extends between the temple and root of the ear (points B and D).

It is to be appreciated, however, that other regions of the head of patient P can yield reasonably accurate data about the blood oxygen saturation level of patient P when pulse oximetry sensor <NUM> is disposed adjacent to patient P in or near such regions. For example, in an alternative embodiment of the invention, pulse oximetry sensor <NUM> could be disposed adjacent to an ear of patient P.

Referring again to <FIG> and <FIG>, tubing assembly <NUM> further includes a data communication arrangement <NUM> that includes a flexible circuit <NUM> electrically connects pulse oximetry sensor <NUM> to an electrical connector <NUM>. Electrical connector <NUM> is of any suitable construction for having a cooperatively shaped connector (not numbered) coupled thereto for wired transmission of data detected by pulse oximetry sensor <NUM> to a data processor <NUM> (shown schematically) so that the data can be analyzed and further utilized depending on the particular application. For example, in one example embodiment the data gathered by pulse oximetry sensor <NUM> is utilized by pressure generating device <NUM> to vary the treatment provided to patient P. Such variance may vary from minor "tweaks" or adjustments to the parameters of the treatment being provided to major changes such as changing from a therapeutic mode to a ventilator mode if the blood oxygen level of patient P drops below a predetermined value.

<FIG> shows another example embodiment of the present disclosure similar to that shown in <FIG> except data communication arrangement <NUM>' includes a wireless transmitter <NUM>' that transmits data collected by pulse oximetry sensor <NUM> to data processor <NUM> via a wireless connection instead of a wired connection such as shown in <FIG>.

In one exemplary embodiment of the invention, flexible circuit <NUM> is positioned to lie adjacent to the face of patient P when tubing assembly <NUM> is disposed on the head of patient P. It is to be appreciated that flexible circuit <NUM> can be achieved in several ways, including but not limited to: spraying and adhering conductive material onto the surface of one of tubular portions <NUM>, or printing a flexible circuit and affixing it to one of tubular portions <NUM> via adhesion, over-molding, or any other suitable arrangement.

In order to provide for more accurate readings and/or to provide for improved patient comfort, a skirt portion <NUM> may be provided adjacent to and around pulse oximetry sensor <NUM>. Skirt portion <NUM> may be provided on (e.g., via any suitable coupling arrangement), or as an integral portion of, pocket <NUM> (such as shown in the examples illustrated in the figures) or as a separate member simply positioned around pulse oximetry sensor <NUM>. Skirt portion <NUM> structured to shield pulse oximetry sensor <NUM> from ambient light when tubing assembly <NUM> is disposed on the head of patient P. In one exemplary embodiment of the invention, skirt portion <NUM> is composed from a flexible and opaque polymer. Perspective views of different skirt portions <NUM>, <NUM>', <NUM>" formed as portions of pockets <NUM>, <NUM>' and <NUM>" are shown in <FIG>. Sectional views of the different skirt portions <NUM>, <NUM>', and <NUM>" shown in <FIG> are shown in <FIG> show skirt portion <NUM> having a surface of uniform thickness with no protrusions disposed around pulse oximetry sensor <NUM>, which is shown coupled to a printed circuit board (PCB) <NUM> (shown schematically) housed within pocket <NUM>.

<FIG> show skirt portion <NUM>' formed as a number of petal-shaped protrusions <NUM> on one surface of pocket <NUM>' around pulse oximetry sensor <NUM>. The sectional view shown in <FIG> shows the number of petal-shaped protrusions <NUM> each extend from a first coupled end 30A disposed adjacent pulse oximetry sensor <NUM> to an opposite free end 30B disposed away from pulse oximetry sensor <NUM>. Each protrusion <NUM> has an asymmetrically curved top edge 30C that peaks toward coupled end 30A and tapers downward toward free end 30B.

<FIG> show skirt portion <NUM>" which includes a thin base portion <NUM> extending upward from a surface of pocket <NUM>" around pulse oximetry sensor <NUM>, and a wider, bulbous portion <NUM> on thin base portion <NUM> opposite pocket <NUM>" that also extends around pulse oximetry sensor <NUM>.

Claim 1:
A tubing assembly (<NUM>) for use in providing a flow of positive pressure breathing gas to a patient, the tubing assembly (<NUM>) comprising:
a manifold portion (<NUM>) structured to receive the flow of positive pressure breathing gas;
a number of tubular portions (<NUM>) which each extend from the manifold portion (<NUM>) to a distal end which is structured to be coupled to a patient interface (<NUM>) for use in delivering the flow of positive pressure breathing gas to the patient;
a reflectance pulse oximetry sensor (<NUM>) positioned in or on one of the number of tubular portions (<NUM>), wherein the sensor (<NUM>) is structured to be disposed adjacent the patient when the tubing assembly (<NUM>) is disposed on the head of the patient.