Patent ID: 12251511

DESCRIPTION OF THE SELECTED EMBODIMENTS

For the purpose of promoting an understanding of the principles of the inventions, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the inventions is thereby intended. Any alterations and further modifications in the described embodiments, and any further applications of the principles of the inventions as described herein are contemplated as would normally occur to one skilled in the art to which the inventions relate. One embodiment of the invention is shown in great detail, although it will be apparent to those skilled in the relevant art that some features that are not relevant to the present inventions may not be shown for the sake of clarity.

Referring toFIG.1, there is illustrated a schematic view of a resuscitation system20or more specifically a bag valve mask system. As illustrated, the resuscitation system is a device or kit that may include a bag22, check valve24and mask26. The resuscitation system20defines a fluid flow path from the bag20to and out of the mask26to a patient's lungs. During use air travels along the fluid flow path from the bag out of the mask and to the patient. As described in further detail below, check valve24may be a one-way valve. The mask26may be any appropriate mask used in the prior art.

The resuscitation system20may further include a reservoir28, air inlet30and valve housing32. Air inlet30may connect and provide oxygen to the bag22and reservoir28from an oxygen source34. The oxygen source34may be accessed by a separate oxygen line/tubing or by an integrated, internally route line/or tubing within the resuscitation system20. The valve housing32may include a safety release valve36upstream of check valve24and a safety release valve38downstream of check valve24. Both release valves36,38may be integrated into the valve housing32. The valve housing32may further include an air inlet40integrated into the valve housing32downstream of the check valve24. Optionally, one or more of a pressure gauge42, a PEEP valve48and a capnograph monitor46may be selectively attachable and detachable from the valve housing32. The PEEP valve, when present, is preferably downstream of said check valve24and releasing gas therethrough to ambient (atmosphere) at a pressure lower than said first predetermined pressure of said first safety release valve.

FIGS.2-3and5illustrate two side elevation views of the resuscitation system. Bag22may be in the general shape of a football or a prolate spheroid and has an inner cavity to contain oxygen and/or air. Bag22may be formed from any suitable material, for example, silicone or rubber. Bag22may include grips or grooves50to help facilitate proper use of the bag. Grips50may be formed as an integrated part of the bag22or attached as separate pieces to the bag22. In some embodiments, more than one grip50may be used to make it easier for right-hand or left-hand dominate users to grip and compress the bag22. Bag22may further include gas inlet52for passing gas into the bag22. Bag22may engage a reservoir28at gas inlet52.

In some embodiments, the reservoir28may be a bag reservoir or corrugated tubing that attaches to an independent oxygen source34. Bag22may also include a gas outlet54. Gas outlet54is an opening in the bag22allowing gas to pass through is the opening and out of the bag22to the valve housing32.

FIG.4, illustrates a cross-section view of the valve housing32and the check valve24. Check valve24may be deposed along the fluid flow path of the resuscitation system within the valve housing32. As illustrated the check valve24may be secured to the valve housing32. In some embodiments, check valve24is a one-way valve. Check valve24allows air to travel downstream from the bag22through the mask26and to the patient. Because check valve24is a one-way valve, the air expelled by the patient cannot pass upstream through the valve and into the fluid path upstream of the check valve24. This prevents the air upstream of the check valve24from being diluted or contaminated with undesirable particles such as carbon dioxide.

Referring toFIGS.2-6, valve housing30may include a gas inlet56and a gas outlet58. Both gas inlet56and gas outlet58are openings to allow the passing of gas in or out of the valve housing32. Air passes through and out of gas outlet54of bag22and through gas inlet56into the valve housing32where the air may continue to pass downstream through check valve24. After passing through the check valve24, the air continues to travel through the valve housing32and out of gas outlet58. In order to pass the air to the patient a mask26may be selectively attachable and detachable to gas outlet58. The mask26may be any suitable mask known in the art.

Valve housing32may further include an integrated pressure gauge port60. Pressure gauge port60may be located downstream of check valve24. A pressure gauge42, such as, a manometer may be selectively attached and detached from pressure gauge port60. The pressure gauge42may be used to monitor the pressure during the patient's inhalation and exhalation.

Valve housing32may further include air inlet40. Air inlet40may be located downstream or on the patient's side of valve24. Air inlet40may be a supplemental oxygen port. Air inlet40may simply allow atmospheric air to enter through the open port and into the system. In other embodiments, supplemental oxygen sources34such as an oxygen tank may be connected to the air inlet by appropriate tubing to pump oxygen into the system. The oxygen source34may be the same source or an independent source from the oxygen source used for air inlet30This advantageously allows is supplemental oxygen to be provided on the downstream side of the check valve and to the patient during ventilation and increases pressure, ensuring that the patient is receiving as much oxygen as desired.

Valve housing32can also include capnography port62to monitor the concentration of carbon dioxide (CO2) in the gases inhaled and exhaled by the patient. An air sampling tube may be connected to the capnography port to transport samples of air exhaled by the patient to be measured by a capnogram sensor/monitor46.

The pressure gauge port60, air inlet40and capnography port62may be covered by a cap64when not desired during use or during storage. This prevents unwanted entrainment of atmospheric air or contamination of the fluid path. The caps64may be easily removed to connect the various components described above.

Valve housing32may also include safety release valve36and safety release valve38. Safety release valve36may be located upstream of check valve24and safety release valve38may be located downstream of check valve24. Both safety release valves36,38are biased by a spring66and may be manufactured or adjusted to release pressure at a predetermined pressure differential between the fluid path and the ambient air. Once the pressure in the resuscitation system20exceeds the predetermined pressure differential, the safety release valve36,38is pushed open to release the pressure and maintain a safe level of pressure within the fluid path. Advantageously, this helps avoid over-pressurizing and damaging a patients lungs.

The components of the resuscitation system20may be surgically sterilized and contained within a sterile package/kit68. The components (discussed above) may all come in one kit68or they may be sold separately. For example, one kit may include the check valve24and bag22. Another kit68may include the mask26. Yet another kit68may include the bag22, valve24and mask26. A PEEP Valve48or the tubing to connect the resuscitation system20to an oxygen source34may come in the same or separate kits68. These examples are none limiting and any combination of the components discussed above may be included in the sterile packages68.

A method for providing air to a patient using the fully assembled resuscitation system will now be described. During operation, the user may place the mask over a patient who is not breathing or having difficulty breathing. The user squeezes the bag to is force air downstream of the bag from the reservoir. The air passes through out of the gas outlet of the bag and into the valve housing through the gas inlet of the valve housing. Next, the air passes through the one-way valve. While open, the one way valve blocks the exhaust valve causing all the air to go into the patients lungs. The one-way valve then closes to prevent air from traveling upstream through the valve, such as during the patient's exhalation. If desired, supplemental oxygen may be added to the system by an air inlet downstream of the one-way valve to enrich the oxygen levels provided to the patient. A safety release valve downstream of the one-way valve may open, allowing an exit for the air before the pressure reaches an unsafe level and causes barotrauma of the lungs, such as during exhalation or from the increase in pressure provided by the supplemental oxygen. During ventilation, the user may monitor a number of factors, such as pressure and carbon dioxide levels.

Glossary of Terms

While examples of the inventions are illustrated in the drawings and described herein, this disclosure is to be considered as illustrative and not restrictive in character. The present disclosure is exemplary in nature and all changes, equivalents, and modifications that come within the spirit of the inventions are included. The detailed description is included herein to discuss aspects of the examples illustrated in the drawings for the purpose of promoting an understanding of the principles of the inventions. No limitation of the scope of the inventions is thereby intended. Any alterations and further modifications in the described examples, and any further applications of the principles described herein are contemplated as would normally occur to one skilled in the art to which the inventions relate. Some examples are disclosed in detail, however some features that may not be relevant may have been left out for the sake of clarity.

Where there are references to publications, patents, and patent applications cited herein, they are understood to be incorporated by reference as if each individual publication, patent, or patent application were specifically and individually indicated to be incorporated by reference and set forth in its entirety herein.

Singular forms “a”, “an”, “the”, and the like include plural referents unless is expressly discussed otherwise. As an illustration, references to “a device” or “the device” include one or more of such devices and equivalents thereof.

Directional terms, such as “up”, “down”, “top” “bottom”, “fore”, “aft”, “lateral”, “longitudinal”, “radial”, “circumferential”, etc., are used herein solely for the convenience of the reader in order to aid in the reader's understanding of the illustrated examples. The use of these directional terms does not in any manner limit the described, illustrated, and/or claimed features to a specific direction and/or orientation.

Multiple related items illustrated in the drawings with the same part number which are differentiated by a letter for separate individual instances, may be referred to generally by a distinguishable portion of the full name, and/or by the number alone. For example, if multiple “laterally extending elements”90A,90B,90C, and90D are illustrated in the drawings, the disclosure may refer to these as “laterally extending elements90A-90D,” or as “laterally extending elements90,” or by a distinguishable portion of the full name such as “elements90”.

The language used in the disclosure are presumed to have only their plain and ordinary meaning, except as explicitly defined below. The words used in the definitions included herein are to only have their plain and ordinary meaning. Such plain and ordinary meaning is inclusive of all consistent dictionary definitions from the most recently published Webster's and Random House dictionaries. As used herein, the following definitions apply to the following terms or to common variations thereof (e.g., singular/plural forms, past/present tenses, etc.):

“About” with reference to numerical values generally refers to plus or minus 10% of the stated value. For example, if the stated value is 4.375, then use of the term “about 4.375” generally means a range between 3.9375 and 4.8125.

“Ambient” is the surrounding atmosphere and its conditions. When a concrete pressure is needed for measurement and/or comparison purposes, it is measured at sea level.

“And/or” is inclusive here, meaning “and” as well as “or”. For example, “P and/or Q” encompasses, P, Q, and P with Q; and, such “P and/or Q” may include other elements as well.

“Biological filter” generally refers to the filters known in the art that trap particles exhaled by the patient and keeps those particles from exiting into the atmosphere, including those used in face masks or filters traps.

“Check valve” as used herein means a valve that allows fluid (liquid or gas) to flow through the valve in only one direction. Types of check valves may include ball check valves, diaphragm check valves, swing check valve or titling disc check valves, flapper valve, stop-check valve, lift-check valve, in-line check valve, duckbill valve or pneumatic non-return valve.

“Downstream” as used herein means in the direction of the flow of air through the resuscitation system from the bag to the mask or toward the patient.

“Gas inlet” as used means an opening through which various gases may flow into a component or device.

“Gas outlet” as used means an opening through which various gases may flow out of a component or device.

“Multiple” as used herein is synonymous with the term “plurality” and refers to more than one, or by extension, two or more.

“Optionally” as used herein means discretionary; not required; possible, but not compulsory; left to personal choice.

“Oxygen source” as used herein the source of the oxygen being provided into the fluid flow path of the resuscitation system. For example, atmospheric air or oxygen is from an artificial source, such as an oxygen tank.

“Path” as used herein means the route of flow of air from the starting point through the resuscitation system to the patient.

“Positive End Expiratory Pressure Valve or PEEP Valve” as used herein means a valve generally used to maintain a predetermined pressure level in the lungs of a patient who is being ventilated with oxygen or air. Typical PEEP valves include a spring biased relief valve which remains closed and prevents the patient from exhaling until the pressure of the patient's exhalation gas exceeds the force of the spring after which the valve opens and the patient's exhalation gas is exhausted through an exit port on the PEEP valve and into the atmosphere.

“Pressure gauge” generally refers to an instrument for measuring the condition of a fluid (liquid or gas) that is specified by the force that fluid would exert, when at rest, on a unit area, such as pounds per square inch or newtons per square centimeter. One example of a pressure gauge is a manometer.

“Resuscitation bag” as used herein means a self-inflating bag that is compressible. A resuscitation bag may be used in a bag valve mask or resuscitation system to force air downstream of the bag to an individual who is not breathing adequately. A resuscitation bag may be operably connected to a reservoir bag and/or and oxygen source.

“Safety release valve” as used herein means a valve used to control or limit the pressure in the resuscitation system to avoid over-pressurization or barotrauma of the lungs. When a predetermined pressure differential between the resuscitation system and the ambient air is reached, the valve opens to relieve pressure within the resuscitation system. Safety release valve may be synonymous with pressure relief valve and pressure limiting valve.

“Substantially” generally refers to the degree by which a quantitative is representation may vary from a stated reference without resulting in an essential change of the basic function of the subject matter at issue. The term “substantially” is utilized herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, and/or other representation.

“Upstream” as used herein means in the direction opposite to the flow of air through the resuscitation system or, in other words, away from the patient.