Patent Application
20170173290
During surgery a patient usually is placed under anesthesia and the most common delivery system consists of canisters containing anesthesia gases and oxygen, a system of regulating 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 an anesthetic gas mixture. A mask is used to provide oxygen to the patient either before the patient is anesthetized, while the patient is anesthetized, or if the patient is sedated during the surgery or procedure. However, one of the drawbacks of mask ventilation is that it requires constant contact between the provider's hands and the patient's face to hold the mask in place and keep the patient in the sniffing position in order to ensure that oxygen and anesthetic gases do not leak out into the air and that the patient's airway remains patent. If the provider does not maintain the patient in the sniffing position, a dangerous complication known as upper airway obstruction may occur. The reason the provider needs to perform continuous mask holding and maneuvering is due to the human anatomy and physiology. When muscles of the jaw, tongue and upper airway relax due to sedatives and/or muscle relaxants given to the patient for sedation and/or anesthesia, wherein, the jaw of the patient drops and the tongue obstructs the airway resulting in snoring (partial obstruction) or apnea (complete inability for oxygen to pass via the upper airway into the lungs), the upper airway (mouth, pharynx, larynx) may become partially obstructed and possibly completely closed. Another problem exists when a provider fails to administer enough anesthesia or sedative or the anesthesia or sedative begins to wear off and the patient begins to move. This can cause the patient's airway to obstruct as well since the patient's head and neck position are no longer in the sniffing position. Patient movement during surgery also can be dangerous because it can cause the surgeon to make a mistake, particularly in eye, ear, nose, neck, head, and throat surgery.
Notwithstanding the aforesaid potential problems, the use of facemasks, whether nasal masks, which only cover the nose, or facemasks, which cover both the nose and mouth, to apply inhalational agents, such as oxygen or volatile anesthetic gases, is essentially universal in the medical field. However, up until now, nasal masks and facemasks have been used separately as either nasal masks alone or facemasks alone. A significant clinical need has emerged, where combining a nasal mask with a mouth mask into one could have a substantial impact on patient safety during both endotracheal intubation and monitored anesthesia care cases involving sedation. For example, current standard of care recommends pre-oxygenating (delivering 100% oxygen via facemask) a patient for several minutes prior to endotracheal intubation in order to fill the patient's lungs with oxygen. Also, pre-oxygenating a patient significantly lengthens the time (2-8 minutes) that patient begins to desaturate (blood-oxygen levels begin to fall to critically low levels). Exemplary of gas inhalation masks used in administering general anesthesia (GA) to a patient is that disclosed in U.S. Pat. No. 5,975,079 (Hellings et al). As indicated by this patent, an acceptable anesthesia mask should be disposable, made of transparent material, have a strap or straps to hold the mask in place, when desired, be of sufficient size to cover the patient's nose and mouth, and have a pneumatic sealing cushion, not only to promote patient comfort, but to prevent exposing the medical staff to anesthesia or other applied gas or gases. See also U.S. Pat. No. 8,336,549 B2 in which there is discussed a disposable anesthesia face mask comprising a shell member having an annular flange and a donut shaped pneumatic sealing cushion attached to the shell member annular flange. The shell member and its flange are “pear-shaped” defining a nasal portion of first transverse extent, a mouth portion of second transverse extent, and an under-the-chin engagement portion of third transverse extent, where the second transverse extent is greater than the first transverse extent and the third transverse extent is greater than the second transverse extent.
Other prior art anesthesia masks and CPAP masks are described in U.S. Pat. No. 5,738,094; US 2014/0083425; US 2003/0024533; U.S. Pat. No. 6,779,524; US 2014/0076311; U.S. Pat. No. 8,001,968, U.S. Pat. No. 6,112,746; U.S. Pat. No. 8,528,558; U.S. Pat. No. 7,178,524; U.S. Pat. Nos. 7,036,508; 5,560,354; US 2015/0059759; and U.S. Pat. No. 5,243,971
Furthermore, mask straps and harnesses are commonly used to hold masks on a patient. However, a common problem in the majority of cases today with the use of currently available mask straps and/or the head harness is that they still require the provider to hold and maneuver the mask continuously during the surgery because there is no way of fixing patient's head and neck to a surface. U.S. Pat. No. 6,981,503 B1 (hands-free anesthesia mask) proposes a way of attaching a head strap to the face; however, it does not provide a means of restricting head and neck movement. Many times when the patient is relaxed with sedation and anesthesia the head falls forward, causing collapse of the airway. One way to solve this problem is to fix the patients face mask or head to a base surface which will prevent it from falling forward. Also, to avoid partial and/or complete obstruction the provider can perform a maneuver called the “jaw thrust” maneuver. The “jaw thrust” maneuver” is done with one hand moving the jaw up and forward to move the tongue so that the airway is opened. The “jaw thrust” is performed while holding a mask over the patient's mouth and nose to deliver oxygen. In order to ventilate the patient while performing a “jaw thrust” the provider is required to hold the mask over the patient's face almost constantly and prevents the ability to perform other tasks during the surgery. This has led to a significant loss of popularity of the mask anesthetics and the increased use of other airway devices, which are more invasive and have greater potential side effects and complications. Also, a problem exists that when a mask is adjusted on a patient when in a sniff position, when the patient's head is moved to a more natural or “vertical” position, e.g., post operation, the mask becomes loose on the patient's head. See also U.S. Pat. No. 6,439,231; U.S. Pat. No. 6,003,511; U.S. Pat. No. 5,983,896; U.S. Pat. No. 5,778,872; U.S. Pat. No. 4,265,235; U.S. Pat. No. 5,404,873; U.S. Pat. No. 3,856,051; U.S. Pat. No. 3,556,097; U.S. Pat. No. 4,007,737; U.S. Pat. No. 4,188,946; U.S. Pat. No. 4,265,235; U.S. Pat. No. 4,463,755; U.S. Pat. No. 4,232,667; U.S. Pat. No. 4,596,246; U.S. Pat. No. 5,121,746; U.S. Pat. No. 5,284,160; U.S. Pat. No. 5,778,872; and U.S. Pat. No. 6,129,082; U.S. 2003/0183232 A1; U.S. Pat. No. 3,815,596; U.S. Pat. No. 5,462,050; U.S. Pat. No. 6,035,852; U.S. Pat. No. 6,412,488; U.S. Pat. No. 6,736,139; U.S. Pat. No. 6,792,943; U.S. Pat. No. 6,981,503; U.S. Pat. No. 7,753,051 U.S. Pat. No. 6,981,503 B1; U.S. Pat. No. 7,753,051; U.S. 2009/0178680; U.S. Pat. No. 4,905,712; U.S. Pat. No. 3,889,668; U.S. Pat. No. 3,897,777; US 2007/0295335.
In our co-pending PCT Application Serial No. PCT/US14/44934, we provide an improved mask strap system for an anesthesia mask that allows hands-free patient ventilation while maintaining the patient in the sniffing position and preventing head and neck movement. We also provide an anesthesia strap system for maintaining an anesthesia face mask on the head of the user, that prevents movement of the patient's head and neck, and can be placed in front of the patient's face. Therefore if the patient is already lying down, sedated, or anesthetized, the provider will not have to lift the patient's head off the table. We also provide an anesthesia mask anchor ring system including a plurality of elastomeric cords connecting the mask anchoring to a support.
The present invention provides improvements over the foregoing and other prior art, and helps to solve the problem of patient's desaturating by maintaining ventilation even during intubation. The present invention in one aspect provides a gas ventilation mask comprising an anesthesia nasal mask and a mouth or oral mask defining respectively a nasal chamber and an oral chamber, detachably connected to one another so that the nasal mask may be used either separately as a nasal mask, or together with the mouth mask as a combination nasal-mouth mask.
In another aspect of the invention, the mask is characterized by one or more of the following features:
(a) wherein the nasal and oral chambers are connected to one another through a self-closing valve or passage, preferably a septum or duck valve or passage;
(b) further including at least one ventilation or oxygen port communicating with the nasal chamber, wherein at least one of the ventilation or oxygen port preferably is offset to a side of the nasal chamber;
(c) comprising both a ventilation port and an oxygen port communicating with the nasal chamber, wherein at least one of the ventilation port and/or the oxygen port preferably is offset to a side of the nasal chamber, and further comprising a removable stopper or cap for at least one of the ports;
(d) wherein the mask is formed at least in part of a transparent material to permit visualization of condensation or aspiration;
(e) further comprising a multi-lobed, preferably Y-shaped seal that interfaces with the patient's face and the oral and/or nasal ventilation chambers of the mask;
(f) further comprising a J-shaped seal, connected to the oral chamber that seals the oral chamber and nasal chamber interface when the two chambers are engaged, preventing gas from escaping through that interface;
(g) further comprising a multi-lobed, preferably Y-shaped seal on the nasal chamber that over-laps the J-shaped seal of the oral chamber, preventing gas from escaping that interface when both chambers are pressured;
(h) further comprising a mask strap anchor pair that has one closed side for accommodating a strap attached and an open side, or two open sides, wherein the open side or sides allows a care provider to attach the strap to a patient, wherein the open side or sides preferable are oriented up so that when strap tension force is applied, the force is resisted by a bottom portion of the strap anchor in order that the strap does not slide off the anchor; and
(i) further comprising grip indents on the left and right surfaces of the oral chamber for gripping by a care provider in placing the mask onto a patient's face.
In another aspect of the invention, the mask comprises a nasal cushion including a nasal bridge region, a cheek region, and an upper lip region, and a mouth cushion including a lower lip region, a cheek region, and an upper lip region; a first nasal membrane or seal comprising a substantially triangularly shaped frame of resiliently deformable material having a first molded inwardly curved rim of the first nasal membrane or seal; a second nasal membrane or seal of resiliently deformable material, the second nasal membrane or seal being thinner, as thin, or thicker than the first nasal membrane or seal, the second nasal membrane or seal having a second molded inwardly curved rim, the second nasal membrane or seal curved rim spaced a first distance from the first nasal membrane or seal curved rim in the cheek region and the second nasal membrane or seal curved rim spaced a second distance from the first nasal membrane or seal curved rim in the nasal bridge region, the second distance being greater than the first distance. The first and second distances being measured when the mask is not in use. A portion of the second membrane or seal curved rim forms a face contacting seal. A first mouth membrane or seal comprises a substantially oval shaped frame of resiliently deformable material having a first molded inwardly curved rim of the first mouth membrane or seal; a second mouth membrane or seal of resiliently deformable material, being thinner, as thin, or thicker than the first mouth membrane or seal, has a second molded inwardly curved rim. The second mouth membrane or seal curved rim is spaced a third distance from the first mouth membrane or seal curved rim in the cheek region and the second mouth membrane or seal curved rim is spaced a fourth distance from the first mouth membrane or seal curved rim in the mouth region. The fourth distance is greater than the third distance, the third and fourth distances being measured when the mask is not in use, a portion of the second membrane or seal curved rim forming a face contacting seal.
In still yet another aspect of the invention, the mask as above described is characterized by one or more of the following features:
(a) wherein the second molded rim and the first molded rim have a co-located notch to accommodate the bridge of a wearer's nose; wherein the first nasal membrane or seal molded rim and the second nasal membrane or seal molded rim preferably are substantially saddle-shaped, wherein the second nasal membrane or seal preferably is shaped so that the seal portion, in use, contacts at least the wearer's nose; and, wherein the seal portion, in use, preferably contacts the wearer's facial tissue around the sides and over the bridge of the wearer's nose, and between the base of the wearer's nose and the top wearer's lip;
(b) wherein the second rim and seal portion are shaped to generally match facial contours of the wearer in the region of facial tissue around the sides and over the bridge of the wearer's nose, and between the base of the wearer's nose and the wearer's upper lip;
(c) wherein the first and second nasal membranes or seals comprise single molded pieces;
(d) wherein the first molded inwardly curved rim of the first nasal membrane or seal is as thick, less thick, or thicker than the second nasal membrane or seal; and
(e) wherein the second molded inwardly curved rim of the second nasal membrane or seal is as thick, less thick, or thicker than the first nasal membrane or seal.
In a still further aspect of the invention the mask includes a mask body for connection with a supply of breathable gas; and a nasal cushion secured to the mask body, the mask body and the cushion forming a nose-receiving cavity. The cushion includes: a nasal bridge region, a cheek region and an upper lip region; and a substantially triangularly-shaped first nasal membrane or seal of resiliently deformable material is provided having a first molded inwardly curved rim to surround wearer's nose. A second nasal membrane or seal also formed of resiliently deformable material is provided. The second membrane or seal is relatively more flexible than the first nasal membrane or seal. The second nasal membrane or seal has a second molded inwardly curved rim, the second molded rim being of the same general shape as the first molded rim and being fixed to and extending away from the first nasal membrane or seal so as to have a second nasal membrane or seal inner surface spaced a first distance from an outer surface of the first molded rim in the wearer's cheek region. The second membrane or seal inner surface is spaced a second distance from the first nasal membrane or seal outer surface of the first molded rim in the nasal bridge region. The second distance is greater than the first distance, when the first and second distances are measured when the mask is not in use. A portion of the second molded rim forms a face contacting seal, wherein the portion preferably is substantially coterminous with respect to said second molded rim and is resiliently deformable towards said first nasal membrane or seal.
In another aspect of the invention, the mask is characterized by one or more of the following features:
(a) the second membrane or seal molded rim and the first nasal membrane or seal molded rim preferably each have a co-located notch to accommodate the bridge of a wearer's nose. The first and second molded rims preferably are substantially saddle-shaped. The second nasal membrane or seal preferably is shaped so that the seal portion, in use, contacts at least the wearer's nose. And, wherein the seal portion, in use, contacts the wearer's facial tissue around the sides and over the bridge of the wearer's nose, and between the base of the wearer's nose and the wearer's upper lip of the wearer; and
(b) wherein the rim and the seal portion are shaped to generally match facial contours in the region of facial tissue around the sides and over the bridge of the wearer's nose, and between the base of the nose and the upper lip of the wearer.
The present invention also provides a nasal CPAP treatment apparatus and a oral/nasal full face mask comprising: a generator, ventilator or O2 source for the supply of gas at a pressure elevated above atmospheric pressure; a gas delivery conduit coupled to the generator; and a nasal mask or a full face mask that comprises a nasal cushion including a nasal bridge region, a cheek region, and an upper lip region, and a mouth cushion including a lower lip region, a cheek region, and an upper lip region; a first nasal membrane or seal comprising a substantially triangularly shaped frame of resilient material having a first molded inwardly curved rim of the first nasal membrane or seal; a second nasal membrane or seal of resilient material, said second nasal membrane or seal being thinner, as thin, or thicker than the first nasal membrane or seal. The second nasal membrane or seal has a second molded inwardly curved rim, the second nasal membrane or seal curved rim being spaced a first distance from the first nasal membrane or seal curved rim in the cheek region and the second nasal membrane or seal curved rim being spaced a second distance from the first nasal membrane or seal curved rim in the nasal bridge region. The second distance is greater than the first distance, the first and second distances being measured when the mask is not in use. A portion of the second membrane or seal curved rim forms a face contacting seal. A first mouth membrane or seal comprises a substantially oval shaped frame of resiliently deformable material having a first molded inwardly curved rim of the first mouth membrane or seal; a second mouth membrane or seal of resilient material, the second mouth membrane or seal being thinner, as thin, or thicker than the first mouth membrane or seal, the second mouth membrane or seal having a second molded inwardly curved rim. The second mouth membrane or seal curved rim is spaced a third distance from the first mouth membrane or seal curved rim in the cheek region and the second mouth membrane or seal curved rim being spaced a fourth distance from the first mouth membrane or seal curved rim in the mouth region. The fourth distance is greater than the third distance, the third and fourth distances being measured when the mask is not in use, a portion of the second membrane or seal curved rim forming a face contacting seal.
In another aspect of the invention, the CPAP as above described is characterized by one or more of the following features:
(a) wherein the first and second molded rims preferably each have a co-located notch to accommodate the bridge of a wearer's nose. The first and second molded rims preferably are substantially saddle-shaped. The second nasal membrane or seal preferably is shaped so that the seal portion, in use, contacts at least the wearer's nose. The seal portion, in use, contacts the facial tissue around the sides and over the bridge of the nose, and facial tissue around the sides and over the bridge of the nose, between the base of the nose and the upper lip and between the base of the nose and the upper lip of the wearer;
(b) wherein the second molded rim and the seal portion are shaped to generally match facial contours in the region of facial tissue around the sides and over the bridge of the wearer's nose, between the base of the wearer's nose and the wearer's upper lip and between the base of the wearer's nose and the wearer's upper lip of the wearer. The second molded rim and the first molded rim preferably have a co-locating rim to accommodate the lips of a wearer's mouth. The first mouth membrane or seal molded rim and the second mouth membrane or seal molded rim preferably are substantially oval shaped. The second mouth membrane or seal preferably is shaped so that the seal portion, in use, contacts at least a wearer's upper and lower lip, and also preferably contacts the facial tissue around the sides and over the upper and lower lips of the mouth of the wearer. The second rim and seal portion preferably are shaped to generally match facial contours in the region of facial tissue around the sides and over the upper and lower lip of the mouth of the wearer. The first and second mouth membranes or seals preferably comprise one molded pieces, wherein the first molded inwardly curved rim of the first mouth membrane or seal preferably is as thick, less thick, or thicker than the second mouth membrane or seal, and wherein the second molded inwardly curved rim of the second mouth membrane or seal preferably is as thick, less thick, or thicker than the first mouth membrane or seal.
The present invention also provides a mask for connection to a wearer's face comprising: a mask body for connection to a supply of breathable gas; and a mouth cushion secured to said mask body. The mask body and cushion form a mouth-receiving cavity. The cushion includes: a mouth region, a cheek region and an upper and lower lip region. A substantially oval-shaped first mouth membrane or seal of resilient material has a first molded inwardly curved rim to surround the wearer's mouth; a second mouth membrane or seal also formed of resiliently deformable material, the second mouth membrane or seal being relatively more flexible than the first mouth membrane or seal. The second mouth membrane or seal has a second molded inwardly curved rim, the second molded rim being of the same general shape as the first molded rim and fixed to and extending away from the first mouth membrane or seal so as to have a second mouth membrane or seal inner surface spaced a first distance from an outer surface of the first molded rim in the cheek region. The second mouth membrane or seal inner surface is spaced a second distance from the first mouth membrane or seal outer surface of the first molded rim in the mouth region. A portion of the second molded rim forms a face contacting seal. The seal portion is substantially coterminous with respect to the second molded rim and is resiliently deformable towards the first mouth membrane or seal in use of the mask.
In another aspect of the invention, the aforesaid mask is characterized by one or more of the following features:
(a) the second membrane or seal molded rim and the first mouth membrane or seal molded rim preferably each have a co-located rim to accommodate the wearer's mouth. The first and second molded rims preferably are substantially oval-shaped. The second mouth membrane or seal preferably is shaped so that the seal portion, in use, contacts at least the wearer's mouth. The seal portion, in use, preferably contacts the facial tissue around the sides and over the wearer's mouth, and between the wearer's upper and wearer's lower lip, wherein said rim and said seal portion preferably are shaped to generally match facial contours in the region of facial tissue around the sides and the wearer's mouth, and between the wearer's upper and wearer's lower lip.
(b)(1) Optionally, the mask has a ventilator circuit port, projecting from a side of the nasal chamber as a straight port nominally located in an X-Y plane located on a left side of the patient projecting in a negative X direction or essentially parallel to the X axis, wherein the angle of the port relative to the X axis preferably projects at an angle that varies from plus 90 degrees to negative 90 degrees.
(b)(2) Optionally, the mask has a ventilator circuit port projecting from a side of the nasal chamber as a straight port nominally located in an X-Y plane located on the right side of the patient projecting in the positive X direction or essentially parallel to the X axis, wherein the angle of the port relative to the X axis preferably projects at an angle that varies from plus 90 degrees to negative 90 degrees.
(b)(3) Optionally, the mask has a straight ventilator circuit port that is at an angle nominally located in the X-Y plane, wherein the ventilator circuit port preferably projects to an angle out of that plan by plus 90 degrees to negative 90 degrees.
(b)(4) Optionally, the mask has an alternate ventilator circuit port, projecting from a top of the nasal chamber in the negative Y direction as an elbowed port nominally located in the X-Y plane, wherein an open end of the elbow that connects with the ventilator points to a right side of the patient projecting in a positive X direction or essentially parallel to the X axis, wherein the angle of the elbowed port relative to the X axis preferably projects at an angle that varies from plus 90 degrees to negative 90 degrees.
(b)(5) Optionally, the mask has an alternate ventilator circuit port, projecting from a top of the nasal chamber in the negative Y direction as an elbowed port nominally located in the X-Y plane, wherein an open end of the elbow that connects with the ventilator points to a left side of the patient projecting in a negative X direction or essentially parallel to the X axis, wherein the angle of the elbowed port relative to the X axis preferably projects at an angle that varies from plus 90 degrees to negative 90 degrees, wherein the angle of the elbow portion of the alternate ventilator circuit port, preferably also projects at an angle out of the plane by plus 90 degrees to negative 90 degrees.
(b)(6) Optionally, the mask has an oxygen port projecting from a side of the nasal chamber as a straight port nominally located in an X-Y plane located on a left side of the patient projecting in the negative X direction that can be parallel to the X axis, wherein the angle of the port relative to the X axis preferably projects at an angle that varies from plus 90 degrees to negative 90 degrees.
(b)(7) Optionally, the mask has an oxygen port projecting from the side of the nasal chamber as a straight port nominally located in an X-Y plane located on a right side of the patient projecting in the positive X direction that can be parallel to the X axis, wherein the angle of the port relative to the X axis preferably projects at an angle that varies from plus 90 degrees to negative 90 degrees.
(b)(8) Optionally, the mask has an oxygen port, projecting from a top of the nasal chamber in a negative Y direction as an elbowed port nominally located in an X-Y plane, wherein the open end of the elbow that connects with the ventilator points to a right side of the patient projecting in the positive X direction that can be parallel to the X axis, wherein the angle of the elbowed port relative to the X axis preferably projects at an angle that varies from plus 90 degrees to negative 90 degrees.
(b)(9) Optionally, the mask has an oxygen port projecting from a top of the nasal chamber in a negative Y direction as an elbowed port nominally located in an X-Y plane, wherein the open end of the elbow that connects with the ventilator points to a left side of the patient projecting in the negative X direction that can be parallel to the X axis, wherein the angle of the elbowed port relative to the X axis preferably projects at an angle that varies from plus 90 degrees to negative 90 degrees.
(b)(10) Optionally, the mask has an alternate ventilator circuit port projecting from a front of the nasal chamber in the positive Z direction as an elbowed port, wherein an open end of the elbow that connects with the ventilator is pointing to a left side of the patient projecting in a negative X direction or essentially parallel to the X axis, nominally in the X-Y plane, wherein the angle of the elbowed port relative to the X axis preferably projects at an angle that varies from plus 180 degrees to negative 180 degrees, or wherein the angle of the elbow portion of the alternate ventilator circuit port, that is nominally located in the X-Y plane also preferably projects at an angle out of that plane by plus 90 degrees to negative 90 degrees.
(b)(11) Optionally, the mask has an oxygen port, projecting from a front of the nasal chamber in a positive Z direction as an elbowed port, wherein an open end of the elbow that connects with the ventilator points to s left side of the patient projecting in a negative X direction or essentially parallel to the X axis, nominally in the X-Y plane, wherein the angle of the elbowed port relative to the X axis preferably projects at an angle that varies from plus 180 degrees to negative 180 degrees, or wherein the angle of the oxygen port elbow portion that is nominally located in the X-Y plane preferably also projects to an angle out of that plane by plus 90 degrees to negative 90 degrees.
(b)(12) Optionally, the mask has a ventilator circuit port projecting from a side of the Nasal Chamber as a straight port nominally located in a Y plane located in a center side of the patient projecting in the negative y direction.
(b)(13) Optionally, the mask has an oxygen port projecting from a side of the nasal chamber as a straight port nominally located in a X-Y plane located on a left side of the patient projecting in the negative X direction or essentially parallel to the X axis, wherein the angle of the port relative to the X axis projects at an angle that varies from plus 90 degrees to negative 90 degrees.
(b)(14) Optionally, the mask has an alternate ventilator circuit port projecting from a front of the nasal chamber in a positive Z direction as an elbowed port, wherein the elbow has an ability to swivel 360 degrees about the Z axis of the straight port connected to the nasal chamber, wherein the swivel elbow preferably is nominally a 90 degree elbow.
(b)(15) Optionally, the mask has a straight ventilator port connected to the nasal chamber in any location.
(b)(16) Optionally, wherein the nasal chamber of the mask is configured with one or more ventilator circuit ports and zero or one or more oxygen ports.
(b)(17) Optionally, wherein nasal chamber of the mask is designed to operate under a positive gauge pressure relative to the ambient atmosphere at a pressure less than or equal to 90 cm of water.
(b)(18) Optionally, wherein the nasal and oral chambers of the mask, when connected, are designed to operate under a positive gauge pressure relative to the ambient atmosphere at a pressure less than or equal to 90 cm of water.
(b)(19) Optionally, the nasal chamber is designed to operate under a negative gauge pressure relative to the ambient atmosphere at a pressure greater than or equal to negative 10 pounds of force per square inch.
(b)(20) Optionally, the nasal and oral chambers, when connected, are designed to operate under a negative gauge pressure relative to the ambient atmosphere at a pressure greater than or equal to 10 pounds of force per square inch.
In yet another embodiment of the invention there is provided a nasal mask comprising a ventilation port, an O2 port and a cap or plug interchangeable between the ventilation port and the O2 port.
The present invention in yet another aspect provides improvements in devices for holding a mask in position on a patient, and in another aspect for holding a patient's head in position. More particularly, in one aspect of the invention, there is provided a mask anchor for holding a face mask on a patient, comprising a head bonnet for engaging a back of a patient's head, a posterior head strap that originates from behind the patient's head, in contact with the patient's head and attaches either directly or indirectly to the mask when the mask is on the patient's face, wherein the strap can be tightened to create a seal to allow for positive pressure ventilation or left loose and for providing supplement oxygen.
In another embodiment the mask anchor may include one or more straps for attachment to a base/surface, for securing the mask to the patient's face and also for securing the patient's head to the base/surface and for stabilizing the patient's head in position.
In another embodiment, the mask anchor comprises three straps, a first side strap, a second side strap and a third side strap approximately evenly spaced from and joined to the first strap and the second strap, and positioned posteriorly.
In one embodiment the posterior head strap is attached directly to the mask, or the first and second straps are attached directly to the mask.
In yet another embodiment, the posterior head strap is attached to an anchor ring which in turn is placed on the mask, or the first and second side straps attach to a mask anchor ring which is placed over the mask.
The present invention also provides a mask strap system including an expandable strap portion, having the ability to extend up to twice its length or more when the patient is in a sniff position, so as to maintain tension on the mask when the patient is placed in a natural or “vertical” position.
In one embodiment the anesthesia mask strap system comprises an expandable strap portion having the ability to extend; second and third non-expandable strap sections fixed to ends of the expandable strap section; and an adhesion section or device for fixing a length of the strap system when the second and third non-expandable strap sections are pulled to tension the expandable strap section. Preferably, the expandable strap section has the ability to extend up to twice its length, or more, and is formed of a resiliently expandable elastic material.
In yet another aspect of the mask strap system, the second and third non-expandable strap sections are fixed by adhesion to themselves. In such aspect the adhesion comprises hook and loop fasteners, or a mechanical clasp, such as a gripper, a suspender-type no-slip clasp, a button and buttonhole, or a tab and belt hole.
In another and preferred aspect of the mask strap system, the strap system length is fixed by folding the second and third non-expandable strap sections back on themselves.
In still yet another embodiment of the mask strap system, the second and third non-expandable strap sections are fixed to a patient head support or a table supporting the patient.
The present invention also provides an anesthesia mask having a strap system as above described.
The present invention also provides an anesthesia mask comprising an anesthesia nasal mask and a mouth mask defining respectively a nasal chamber and an oral chamber, detachably connected to one another so that the nasal mask may be used either separately as a nasal mask, or the nasal mask and the mouth mask used together as a combination nasal-mouth mask. The anesthesia mask preferably has two sets of retention straps, each comprising a first expandable strap portion having the ability to extend and second and third non-expandable portions fixed to ends of the first expandable strap portions, respectively and an adhesive section or device for fixing a length of the strap system when the second and third non-expandable strap sections are pulled to tension the expandable strap section, attached respectively to the nasal chamber and the oral chamber. In a preferred embodiment, the adhesion section comprises hook and loop fasteners.
With the current invention, the combined nasal mask and oral mask, can be used together as a facemask to ventilate a patient either prior to endotracheal intubation or during general anesthesia (GA), or the mouth mask can be separated from the nasal mask and the nasal mask used to apply continuous positive airway pressure (CPAP) to help maintain a patent airway and ventilate a patient while the anesthesiologist attempts intubation, which will significantly prolong the time until the patient begins to desaturate. The current invention also is useful during sedation cases, especially for deep sedation or for patients with Obstructed Sleep Apnea (OSA) or obesity, where the upper airway of many of these patients becomes obstructed and prevents or impedes breathing. The mouth mask of the current invention also can be separated from the nasal mask and the nasal mask can be used to apply continuous positive airway pressure (CPAP) to help relieve the upper airway obstruction, maintain a patent airway, and assist in ventilation during the case. The combined nasal and mouth mask of the current invention also is useful in situations where a nasal mask is not sufficient to ventilate the patient. With the mask of the present invention one can reattach the mouth mask and the mask used for traditional bag-mask ventilation. The mask of the present invention also permits a health care provider to apply nasal CPAP during semi-awake fiberoptic intubations, where being able to maintain a patient's oxygen saturation levels may be critical, or to apply PEEP to mechanically ventilated patients. Yet another feature and advantage of the mask of the present invention over the prior anesthesia mask art is the ability to secure not only the combined nasal mask and mouth mask to the patient's face allowing for hands-free ventilation, but also to secure the patient's head and neck in place by attaching to a surface and maintaining the patient in a position that ensures a patent airway, which is critical for oxygenation and ventilation.
Further features and advantages of the present invention will be seen from the following detailed description, taken in conjunction with the accompanying drawings, wherein like numerals depict like parts, and wherein:
As used herein, unless otherwise stated, the mask of the present invention advantageously may be used for delivering anesthesia, for positive pressure ventilation, CPAP, administration of supplemental oxygen, or PEEP (positive and expiratory pressure) in connection with a variety of pressurized gas sources including ventilation circuits, AMBU bags, oxygen canisters, etc.
Also, as used herein, the term “nasal mask” and “nasal chamber”, and “oral mask” and “oral chamber”, respectively, may be used interchangeably.
Major elements of mask 10 in accordance with the present invention are illustrated
The nasal chamber 12 and oral chamber 14 of the mask are mated and connected to one another through a nasal/oral port 17 which includes a septum or duck valve 16 (
A nominal, e.g., 15 mm diameter OD ventilator port 28 in the nasal chamber 12 interfaces with an anesthesia ventilation circuit or bag-mask (not shown). A preferred orientation of the ventilator port 28 is on the left side of the mask although alternate positions could be off center or on the right side of the mask as illustrated in
A second port 30 for introduction of oxygen is provided in nasal chamber 12, and includes a cap 32 which seals the oxygen port 30 during ventilation of the patient. Cap 32 is removed during patient transport and an oxygen supply line (not shown) is connected to the oxygen port 30, and typically past operation. The connection can be either a “Christmas Tree” type, as the preferred style, or a luer lock connection. The preferred location of oxygen port 30 is on the left side of the patient. An alternate configuration could be on the right side.
When the nasal chamber 12 and oral chamber 14 are connected, the septum valve 16, is opened by the septum valve proboscis 18. This opening allows gas flow between the nasal chamber 12 and the oral chamber 14. As noted supra, a septum or duck valve is the preferred configuration, although other valves that are open when the two chambers are connected are possible. When the two chambers are separated, the proboscis 18 is removed, the duck valve 16 closes, sealing the nasal chamber 12 and prevents flow of gas out of the nasal chamber due to ventilator pressure inside the chamber. One or more septum or duck valves can interface between the nasal chamber 12 and the oral chamber 14, although, two are a preferred configuration. Alternatively, simple caps or plugs may be used in place of the septum or duck valve(s) to seal the nasal chamber. Note that in an alternate configuration the separate oxygen port 30 may be eliminated, and the oxygen supply line could interface directly with nasal portion of the nasal/oral port 17. A snap cap interface 34 exists on the outside of oxygen port 30. During nasal ventilation, a snap cap 36 is placed over oral port 30, sealing the nasal chamber 12. When the nasal chamber 12 and oral chamber 14 are connected, the tapered nasal/oral proboscis 18 engages with the nasal/oral port 17, creating a seal to the exterior, while allowing gas flow between the nasal chamber 12 and oral chamber 14. Note that in an alternate configuration, the duck valve or septum port could be located on the oral chamber 14 and the hollow proboscis located on the nasal chamber 12.
Anchor straps 38, 40 are located on the left and right sides of the nasal chamber 12. Anchor straps 38, 40 secure the mask to a patient's head or to a patient head support device as described in our PCT application number PCT/US14/44934, or in our co-pending U.S. Application Ser. No. 62/118,301, filed Feb. 19, 2015, the contents of which are incorporated herein by reference.
Soft interface rings 38, 39, which may be, e.g. a gel filled or air filled ring, or ring formed of a low durometer material such as foam, silicone, a low durometer thermoplastic elastomer, a low durometer thermoplastic urethane, are connected to the nasal chamber 12 and oral chamber 14, and interface the nasal chamber 12 and the oral chamber 14, respectively to the patient's face over the nose and mouth, providing near-air-tight seals, as will be described in detail.
When the nasal chamber 12 solely is being used for ventilation of a patient, the nasal/oral port is sealed it so that positive ventilation pressure can be achieved.
Use of the nasal/oral mask of the present invention will now be described. When the nasal chamber 12 and oral chamber 14 of the mask are connected as shown in
When the nasal chamber 12 and oral chamber 14 of the mask are separated as shown in
Ventilation port 28 as shown is designed to nominally fit on the inner diameter of a ventilation circuit (not shown). Alternate configurations are possible where the ventilation port 28 fits the outer diameter of the ventilation circuit. In use, ventilation port 28 is connected to a anesthesia circuit, while the oxygen port 30 is connected an O2 supply. The ventilation port 28 may be located to the top or to one side of the mask (preferably to the left side of the mask). In the
In another embodiment, shown in
In still yet another embodiment ventilation port 70 may project from the top of the nasal chamber 12 in the negative Y direction as an elbowed port nominally located in the X-Y plane. In such embodiment, the open end of the elbow that connects with the ventilator points to the left side of the patient projecting in the negative X direction that can be parallel to the X axis. Additionally the angle of the elbowed port relative to the X axis can project at an angle that varies from plus 90 degrees to negative 90 degrees.
The angle of the elbow portion of the alternate ventilation port, 70 that is nominally located in the X-Y plane also can project to an angle out of that plane by plus 90 degrees to negative 90 degrees.
Oxygen port 30 may project from the side of the left nasal chamber as a straight port nominally located in the X-Y plane located on the left side of the patient projecting in the negative X direction that can be parallel to the X axis. The angle of oxygen port 30 relative to the X axis can project at an angle that varies from plus 90 degrees to negative 90 degrees. Oxygen port 30 may project from the side of the nasal chamber 12 as a straight port nominally located in the X-Y plane located on the right side of the patient projecting in the positive X direction that can be parallel to the X axis. Additionally the angle of the oxygen port 30 relative to the X axis can project at an angle that varies from plus 90 degrees to negative 90 degrees. Oxygen port 30 also may project from the top of the nasal chamber 12 in the negative Y direction as an elbowed port nominally located in the X-Y plane. The open end of the elbow that connects with the ventilator points to the right side of the patient projecting in the positive X direction that can be parallel to the X axis. Additionally the angle of the elbowed port relative to the X axis can project at an angle that varies from plus 90 degrees to negative 90 degrees.
Oxygen port 30 also may project from the top of the nasal chamber in the negative Y direction as an elbowed port nominally located in the X-Y plane as shown in phantom in
Yet another alternative is shown in
Alternatively, the ventilation port 28 may project from the side of the nasal chamber as a straight port nominally located in the Y plane located in the front of the nasal chamber 12 projecting in the negative y direction, and the oxygen port 30 project from the side left of the nasal chamber as a straight port nominally located in the X-Y plane located on the left side of the patient projecting in the negative X direction that can be parallel to the X axis. Additionally the angle of the ventilation and oxygen ports relative to the X axis can project at an angle that varies from plus 90 degrees to negative 90 degrees.
Referring again to
Views of the nasal and oral chambers and corresponding seals are shown in
In the illustrated embodiment, the nasal chamber is intended to seal, in part to the oral chamber. Alternatively, as will be described below, the nasal chamber and the oral chamber may be sealed directly and independently to the patient's face, in which case a Y-shaped seal is the preferred seal for both chambers. The seals are intended to keep gases within the chambers when pressurization is provided via the ventilation port. In this embodiment are two types of seals 102, 104 in the mask, a multi-lobed, preferably Y-shaped seal 102 (Y describes the seal cross-section) which is the interface between the oral chamber 108 and nasal chamber 106 to the face of the patient, and a J-shaped seal 104 (J describes the seal cross-section) which is the interface between the region where the oral and nasal chambers 108, 106 connect. In both cases, the intent of the seal is to prevent gas from leaving the chamber through those interfaces when the chambers are pressurized relative to the ambient environment.
Details of the force and pressure interaction of the multi-lobed, preferably Y-shaped seal with the patient's face are illustrated in
K
seal×δSeal=2×FTension
An additional benefit of the multi-lobed, preferably Y-shaped seal design is that when a differential pressure, PVentilation, is applied to the interior of the chamber as illustrated in
Details of the J-shaped seal 102 (J describes the seal cross section) are illustrated in
K
JSeal×δJSeal=FJSeal
As will be appreciated, the multi-lobed, preferably Y-shaped seal and the J-shaped seal provide numerous advantages. For one the multi-lobed, preferably Y-shaped seal prevents gas leaving the pressurized portion of the oral and/or nasal chamber of the mask. Also, the multi lobe, preferably Y-shaped seal, when pressurized, the interior leg of the Y is pressed against the patient's face, further sealing the mask. And the J-Seal seals the oral chamber and nasal chamber interface when the two chambers are engaged, preventing gas from escaping through that interface. Further, the J-Seal, when pressurized, the interior hook of the J is pressed against the patient's face, further sealing the mask. Moreover, the multi-lobed preferably Y-shaped seal on the nasal chamber over-laps the J-shaped seal of the oral chamber, preventing gas from escaping that interface when both chambers are pressurized.
With the mask of the present invention duckbill valves are closed when the oral and nasal chambers are separated, and open when engaged by the proboscis of the oral chamber, allowing gas flow between the oral and nasal chambers.
Finally, grip indents are provided on the left and right surfaces of the oral chamber allowing easier gripping by the anesthesiologist in placing the mask onto a patient's face.
More particularly a full face ventilation mask consisting of an oral chamber and a nasal chamber is illustrated in
The oral chamber portion of the mask is shown in
The nasal chamber portion of the mask shown in
One or more self-closing valves, preferably in the form of duckbill valves are integral to the nasal chamber as shown in
When the nasal and oral chambers are engaged as illustrated in
The embodiment shown in
The mask of the present invention has numerous advantages over prior art masks. These include:
Referring to
W(Y)=W1−(W1−W2)/L×Y Equation 1
A(Y)=W(Y)×D (per groove) Equation 2
For this arrangement rate of flow out of the ventilation port can be controlled by the amount the cap plug is inserted into the ventilation port as shown in
Referring to
The mask clips 230, 232 have several functions. First they allow for a third attachment for the distal arm extensions 228 of the head strap to prevent the distal arm extensions 228 from coming undone. A second function is to prevent a patient's head from moving side to side by securing the patient's head to the head support surface 234. When the distal arm extensions 228 of the head strap attach to the mask clips 232, it secures the patient's head to the surface 234.
A third function of the mask anchor clip 232 is to prevent the patient's head and/or neck from moving away from the head support 234 or head support pillow 236 when the head and/or neck angles of the patient are adjusted. The distal end of the mask arm extension 240 (
In another embodiment the mask anchor head strap attaches to the mask anchor ring 242, which can be placed over an aperture 244 of a mask and surrounds the aperture 244 of a mask, rather than attach directly to the clips built into the mask (
The mask ring has an advantage in that it can be used with different size masks. Also, if desired, two or more straps may be placed on each side of the mask.
Referring now to
An outer and top view of the strap, along with its major elements, are illustrated in
A first non-expandable strap section 312 is positioned on the left side of the patient with a hook surface on the strap outer side, away from the patient's neck, and is attached to the expandable strap on the outer or inner side of the expandable strap. A second non-expandable strap section 314 is positioned on the right side of the patient with a hook surface on the strap outer side, away from the patient's neck, and is attached to the expandable strap on the outer or inner side of the expandable strap. A first hook and loop adhesion patch 316 is positioned on the left side of the patient with loop surface on the strap outer side, away from the patient's neck that is attached to the expandable strap on the outer most surface. A second hook and loop adhesion patch 318 is positioned on the right side of the patient with loop surface on the strap outer side, away from the patient's neck that is attached to the expandable strap on the outermost surface. Alternatively, the loop and hook surfaces could be reversed on the nonexpendable strap sections and adhesion patch accordingly. Alternatively, the non-expandable strap sections and the expandable strap section may be fixed to one another by an adhesive or mechanically such as by buttons, staples, stitching, snaps, etc.
In use the mask 324 is placed over patient's nose and the strap is drawn around the back of the neck as shown in
Referring to
Referring to
Various changes may be made in the above invention without departing from the spirit and scope thereof. Referring to
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US15/34277 | 6/4/2015 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62007802 | Jun 2014 | US | |
| 62056293 | Sep 2014 | US | |
| 62060417 | Oct 2014 | US | |
| 62061045 | Oct 2014 | US | |
| 62065504 | Oct 2014 | US | |
| 62091370 | Dec 2014 | US | |
| 62118301 | Feb 2015 | US | |
| 62149313 | Apr 2015 | US | |
| 62161086 | May 2015 | US | |
| 62161093 | May 2015 | US |
