Source: https://patents.google.com/patent/US9629975B1/en
Timestamp: 2019-04-19 21:33:35+00:00

Document:
2016-10-17 Assigned to REVOLUTIONARY MEDICAL DEVICES, INC. reassignment REVOLUTIONARY MEDICAL DEVICES, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: PEDRO, Michael J., KANE, DAVID M., REDFORD, Ryan G.
2018-04-18 Assigned to BANK OF AMERICA, N.A., AS COLLATERAL AGENT reassignment BANK OF AMERICA, N.A., AS COLLATERAL AGENT FIRST LIEN SECURITY AGREEMENT Assignors: REVOLUTIONARY MEDICAL DEVICES, INC.
2018-04-18 Assigned to WILMINGTON TRUST, NATIONAL ASSOCIATION, AS COLLATERAL AGENT reassignment WILMINGTON TRUST, NATIONAL ASSOCIATION, AS COLLATERAL AGENT SECOND LIEN SECURITY AGREEMENT Assignors: REVOLUTIONARY MEDICAL DEVICES, INC.
A method for ventilating a patient in which nasal mask having an exhalation scoop formed of a flexible or resiliently deformable material, fixed adjacent a lower portion of mask, is positioned to overlie an upper lip of a patient. When needed, the exhalation scoop is folded back on itself to provide access to the patient's mouth.
This application claims priority from U.S. Provisional Application Ser. No. 62/394,405, filed Sep. 14, 2016.
The present invention relates to improvements in anesthesia masks and ventilation masks.
During surgery a patient usually is placed under anesthesia. The most common delivery system consists of canisters containing anesthesia gases and oxygen, a system of regulating the gas flow and the patient's breathing, and a device ensuring the potency of the patient's airway for breathing, oxygenation and the delivery of the anesthetic gas mixture. A ventilation mask is used to provide oxygen to the patient either during emergency and/or elective airway management, which includes but is not limited to: before a patient is anesthetized for surgery while the patient is sedated during the surgery or procedure; while the patient is recovering from anesthesia; after the patient has recovered from anesthesia; and during any event where a patient requires supplemental oxygen. However, conventional ventilation masks are less then ideal.
Moreover, situations may arise during surgery that require rapid intubation of a patient. Full face masks, i.e. masks covering both the nose and mouth of a patient are problematic in emergency situations since a mask must be removed to uncover the mouth of a patient for intubation. However, removing the mask also removes oxygen support.
In our co-pending PCT Application Serial Nos. PCT/US2014/44934, PCT/US2015/034277 and PCT/US2015/044341 (hereinafter the '934, '277 and '341 PCT applications), we provide improved ventilation/anesthesia masks that overcome the aforesaid and other problems with the prior art by providing, in one aspect, a combination mask comprising a nasal portion or mask and an oral portion or mask defining respectively a nasal chamber and an oral chamber, detachably connected to one another wherein the nasal mask may be used separately or connected to the oral mask as a combination nasal/oral mask. We also provide a nasal mask with one or more ports, and various strap systems for holding the mask on a patient's face. We also provide a nasal only mask with one or more sensors for sensing end-tidal CO2 or other gases, and for scavenging gases. See our co-pending PCT Application Serial No. PCT/US16/037070 (hereafter the '070 PCT application). Such combination nasal/oral masks and nasal only masks are available commercially from Revolutionary Medical Devices, Inc. of Tucson, Ariz., under the trademark SuperNO2VA®.
The present invention provides improvements in nasal masks such as described in our aforesaid PCT applications, by providing an exhalation scoop adjacent the bottom of the nasal mask to overlay at least in part the upper lip of a patient, when the mask is worn. The exhalation scoop may be formed of a flexible, preferably resiliently deformable material, and fixed to the exterior of the mask by mechanical clips or the like, or an adhesive. Alternatively, the exhalation scoop may be formed with a lip to fit in a matching groove in the outer surface of the nasal mask, or formed integrally with the mask. The exhalation scoop is flexible so as to permit a surgeon to compress or push the exhalation scoop out of the way to permit access to the patient's mouth, while the nasal mask remains on the patient. Alternatively, the exhalation scoop may be folded back on itself leaving access to the patient's mouth, while the nasal mask remains on the patient.
In one aspect the invention provides a nasal mask having exhalation scoop formed of a the flexible or resiliently deformable material, fixed adjacent a lower portion of mask, adapted to overlie an upper lip of a patient when the mask is worn.
In another aspect the exhalation scoop is adapted to be pressed out of the way to permit access to the mouth of a patient.
In still another aspect the exhalation scoop is adapted to be folded back on itself to permit access to the mouth of a patient.
In yet another aspect, the mask includes an end-tidal CO2 port for sampling exhaled CO2 expelled from a mouth and/or nose of a patient.
In still yet another aspect the mask includes a ventilation port adapted to attach to an anesthesia machine, ventilation machine, hyperinflation bag or other ventilation or gas accessory.
In a still further aspect the mask further includes an oxygen port adapted for connection to an oxygen source for supplying oxygen to an interior of the mask.
In another aspect, the mask has tabs or eyelets for attaching one or more mask straps.
In yet another aspect the exhalation scoop is fixed to the mask or formed integrally with the mask.
The present invention also provides a method for ventilating a patient, comprising providing a nasal mask having exhalation scoop formed of a the flexible or resiliently deformable material, fixed adjacent a lower portion of mask, and adapted to overlie an upper lip of a patient when the mask is worn, and when needed, moving the exhalation scoop out of the way to provide access to the patient's mouth.
In one aspect of the method the exhalation scoop is pressed out of the way to permit access to the mouth of a patient.
In another aspect of the method the exhalation scoop is folded back on itself to permit access to the mouth of a patient.
In still yet another aspect the method includes providing a nasal mask with a exhalation scoop as described above, and monitoring end-tidal CO2 port by sampling exhaled CO2 expelled from a mouth and/or nose of a patient using an end-tidal CO2 monitor.
In still yet another aspect, the mask is attached to an anesthesia machine, ventilation machine, hyperinflation bag or other ventilation or gas accessory, or to an oxygen source for supplying oxygen to an interior of the mask.
FIG. 4 is a view similar to FIG. 2, showing a nasal mask with an exhalation scoop folded out of the way to provide oral access.
As used herein “nasal mask” preferably comprises a nasal mask similar to the nasal mask such as described in our aforesaid '934, '277, '341, and '070 PCT Applications including in particular a SuperNO2VA® nasal mask available commercially from Revolutionary Medical Devices, Inc. of Tucson, Ariz.
FIGS. 1A-1D are front, rear, top and perspective views of a nasal mask 10 similar to the nasal mask described in our aforesaid PCT Application No. PCT/US16/37070, having a exhalation scoop 12 fixed to lower portion 14 of the mask. Exhalation scoop 12 is formed of a flexible, preferably resiliently deformable material. Exhalation scoop 12 may be formed of the same material forming the nasal membrane 15, and preferably has a Shore A Hardness durometer of 2-10, more preferably 3-7, most preferably 5.
Referring also to FIG. 2, the mask 10 also includes a gas sampling device (shown in phantom at 16) has suction attached to an end-tidal (“ET”) CO2 port 18 and adapted for drawing gas samples from both the oral and nasal exhalations of the patient. One opening 20 of the EtCO2 manifold is behind the exhalation scoop 12 to overlie the upper lip of a patient, when the mask is worn by a patient, on the exterior of the nasal mask 10, where a negative pressure (pressure less than atmospheric pressure) is created by a gas sampling device 16. A second opening 22 of the manifold is below the nares on the interior of the nasal mask where a negative pressure is also created by the gas sampling device 16. When the patient exhales, oral and nasal exhalation are collected through openings 20, 22 and proceed through the manifold and exit the EtCO2 port that is connected to the gas sampling device 16 that provided the negative pressure. Concentration levels of the gas, such as CO2 are then measured by gas sampling device 16.
The nasal mask interior chamber is pressurized through a ventilation port 23 by an anesthesia machine or another ventilation device (shown in phantom at 24). Flow from the patient's nose is drawn to the negative pressure of the opening of the manifold interior of the nasal chamber. The patient's mouth is at atmospheric pressure and the flow of the oral exhalation is channeled by the exhalation scoop where it is drawn by the negative pressure presented by gas sampling system through the manifold opening. Samples of both the nasal and oral exhalation flow through a manifold, and exit the EtCO2 port 18 to the gas sampling device 16. The mask 10 also includes an oxygen port 25 for supplying oxygen from an oxygen source (shown in phantom at 27) to a patient.
One benefit of the flexible exhalation scoop design is that if the surgeon requires access to the patients mouth to employ a device such as an intubation tube or endoscope 26, the exhalation scoop 12 can be flexed or pushed by the device in the nominal “y” direction, providing access to the patient's mouth as shown in FIG. 3.
Another benefit of one flexible exhalation scoop 12 design is that if the surgeon requires access to the patient's mouth, that there exists a bi-stable condition where the scoop 12 overlies the upper lip and/or mouth of the patient, as shown in FIG. 2, or the scoop 12 can be folded over itself about the nominal—“X” axis and remain stable with the scoop 12 no longer covering the mouth as shown in FIG. 4. This allows access to the patient's mouth as shown, and nasal Et CO2 can still be collected. Once the endoscope 26 or other device is removed from the patient's mouth, should the clinician decide to continue collecting oral Et CO2 samples, the flexible exhalation scoop 12 can be unfolded about the “X” axis, again covering the patient's mouth as in FIG. 2.
Completing the nasal mask are tabs\or eyelets 30 for attaching one or more head straps (not shown).
providing a nasal mask having an exhalation scoop formed of a flexible or resiliently deformable material, fixed adjacent a lower portion of the mask, and adapted to overlie an upper lip of the patient when the mask is worn, and when needed, folding the exhalation scoop back on itself to provide access to the patient's mouth.
2. The method of claim 1, further including monitoring end-tidal CO2 by sampling exhaled CO2 expelled from the mouth and/or nose of the patient via an end-tidal CO2 port.
3. The method of claim 1, further including attaching the mask to an anesthesia machine, ventilation machine, hyperinvation bag or a ventilation or gas accessory.
4. The method of claim 1, further including attaching the mask to an oxygen source for supplying oxygen to an interior of the mask.
5. The method of claim 1, wherein the exhalation scoop is formed of a flexible or resiliently deformable material having a Shore A Hardness durometer selected from 2-10.
6. The method of claim 1, wherein the exhalation scoop is formed of a flexible or resiliently deformable material having a Shore A Hardness durometer of about 5.
7. The method of claim 1, wherein the exhalation scoop is formed of a flexible or resiliently deformable material having a Shore A Hardness durometer of 3-7.
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