POSITIONING DEVICE AND METHOD FOR USE WITH A PATIENT UNDER ANESTHESIA

Abstract

An apparatus for supporting the head and neck for airway management and to facilitate the maintenance of a patent airway under anesthesia, for unconscious patients, and for any circumstance requiring a patent airway while the patient is lying on her side. The apparatus includes a head supporting surface, an adjustable neck supporting surface, and two adjustable jaw support arms to protrude the jaw forward and maintain ventilation while the patient is lying on either of his/her sides.

Claims

1: A nasal mask which can be used separately, or with an oral mask releasibly attached to the nasal mask through a closable opening on the nasal mask.

2: The nasal mask as claimed in claim 1, wherein when the oral mask is engaged with the nasal mask, the closable opening allows gases to flow bilaterally between the oral mask and the nasal mask.

3: The nasal mask as claimed in claim 1, wherein when the oral mask is combined with and engaged with the nasal mask, the combination creates a face mask which can be used for bag-mask ventilation, general anesthesia, deep sedation or respiratory treatment.

4: The nasal mask as claimed in claim 1, wherein when nasal mask is used by itself, the closable opening automatically closes whereupon the nasal mask may be used for nasal Bipap/CPAP, ventilation during intubation, general anesthesia, deep sedation, respiratory treatment, delivery of oxygen, or treatment of obstructed sleep apnea.

5: The nasal mask of claim 1, wherein the closable opening comprises a door, and the oral mask includes a connector which when engaged with the nasal mask door, pushes the door open.

6: A nasal mask, or combined nasal mask/oral mask full face mask, comprising: a nasal mask body adapted for connection with a supply of breathable gas, preferably oxygen, air, or air anesthetic gas; a cushion secured to said nasal mask body, the body and cushion forming a nose-receiving cavity, said cushion including: a nasal bridge region, a cheek region and an upper lip region; a substantially triangularly-shaped first nasal membrane formed of resilient material having a first molded inwardly curved rim to surround patient's nose; a second nasal membrane formed of resilient material, said second membrane being relatively more flexible than said first nasal membrane, said second nasal membrane having a second molded inwardly curved rim, said second molded rim being of the same general shape as said first molded rim and fixed to and extending away from said first nasal membrane so as to provide a second nasal membrane inner surface spaced a first distance from an outer surface of said first molded rim in said cheek region and said second membrane inner surface spaced a second distance from said first nasal membrane outer surface of said first molded rim in said nasal bridge region, said second distance greater than said first distance, said first and second distances measured when the mask is not in use, a portion of said second molded rim forming a face contacting seal; and wherein said seal portion is substantially coterminous with respect to said second molded rim and is resiliently deformable towards said first nasal membrane when said mask is in use.

7: The mask as claimed in claim 6 further comprising tubing for connection to a generator for the supply of gas at a pressure below, equal to, or elevated above atmospheric pressure; a gas delivery conduit having one end for coupling to said supply of gas, and its other end for coupling to an adaptor, which contains an End-Tidal CO.sub.2 port, a nebulizer port, a PEEP valve port, expiratory port and/or valve, pressure relief valve, which has an aperture which attaches to either the nasal mask, the oral mask, or the full face mask.

8: The mask as claimed in claim 6, wherein the mask is connectable to a generator for the supply of gas, wherein an amount and concentration of gas delivered is controlled by a supply source as well as the expiratory port, and/or used as a scavenger system by connecting the nasal mask and the oral mask simultaneously, where the nasal mask can be used to deliver positive pressure and the oral mask can be connected to a suctioning device to properly store and/or dispose gases.

9: The mask as claimed in claim 6, wherein the nasal mask is contoured for the patient's nasal bridge, nose, and upper lip such that when the mask and the generator gas supply are connected and worn by a patient, the mask does not interfere with the operator's access to the mouth/oral cavity, lips, cheeks, chin, jaw, and neck of the patient, and/or connected to a resuscitator bag with or without a gas supply attached to the resuscitator bag.

10: The mask as claimed in claim 6, wherein said nasal mask body includes either integrated head strap attachment points using either an anterior approach or posterior approach or separate head strap attachment points using either an anterior approach or a posterior approach when placed over the mask, which mask when combined with straps attached to a surface secure the mask to the patient's face to ensure a tight seal and to maintain the patient's head in a desired position to maintain airway patentcy.

11: The mask as claimed in claim 6 further comprising securing straps fixed to said attachment points on the mask.

12: The mask as claimed in claim 6, wherein said second nasal membrane molded rim and said first nasal membrane molded rim each have co-located notches to accommodate a bridge of a nose of a wearer.

13: The mask as claimed in claim 6, wherein said first and second molded rims are substantially saddle-shaped.

14: The mask as claimed in claim 6, wherein said second nasal membrane is shaped so that said seal portion, in use, contacts at least a bridge of a nose of a wearer.

15: The mask as claimed in claim 6, wherein said seal portion, in use, contacts facial tissue around the sides and over a bridge of the nose of the wearer, and between the base of the wearer's nose and an upper lip of the wearer.

16: The mask as claimed in claim 6, wherein said rim and said seal portion are shaped to generally match facial contours in the region of facial tissue around sides and over a bridge of a nose of the wearer, and between a base of the nose and an upper lip of the wearer.

17: A nasal mask for connection to a patient's face comprising: a mask body for connection with a supply of breathable gas; and a mouth cushion secured to said mask body, the mask body and mouth cushion forming a mouth-receiving cavity, said mouth cushion including: a mouth region, a cheek region and an upper and lower lip region; a substantially oval-shaped first mouth membrane of resilient material having a first molded inwardly curved rim to surround a patient's nose; a second mouth membrane also of resilient material, said second mouth membrane being relatively more flexible than said first mouth membrane, said second mouth membrane having a second molded inwardly curved rim, said second molded rim being of the same general shape as said first molded rim and fixed to and extending away from said first mouth membrane so as to have a second mouth membrane inner surface spaced a first distance from an outer surface of said first molded rim in said cheek region and said second mouth membrane inner surface spaced a second distance from said first mouth membrane outer surface of said first molded rim in said mouth region, said second distance greater than said first distance, said first and second distances measured when the mask is not in use, a portion of said second molded rim forming a face contacting seal; wherein said seal portion is substantially coterminous with respect to said second molded rim and is resiliently deformable towards said first mouth membrane when said mask is in use.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0219] Further features and advantages of the present invention will be seen by the following detailed description, taking in conjunction with the accompanying drawings, wherein:

[0220] FIG. 1 is a side elevational view showing a lateral positioning device in accordance with one embodiment of the present invention and illustrates a patient lying on his or her side (lateral decubitus position) in order to displace weight off his or her chest to assist in ventilation; and

[0221] FIG. 2 is the lateral device with x, y, and z views in the lateral decubitus position.

[0222] FIGS. 3A and 3B diagrammatically illustrate the apparatus and method for positioning a patient in accordance with the present invention for the supine position.

[0223] FIGS. 3A-3C are front and rear perspective views and side elevational views of yet another embodiment, the supine positioning device in accordance with the present invention;

[0224] FIGS. 4A and 4B are top perspective and side elevational views of the current embodiment shown in a lowered position;

[0225] FIGS. 5 and 6 is a side elevational view of the FIG. 4A-4B positioning device retrofitted to existing operating tables in the raised and lowered positions respectively;

[0226] FIGS. 7A and 7B are views similar to FIG. 6, of an alternative embodiment of the invention showing the head and neck independent supports mounted on the lift support;

[0227] FIG. 8 shows a traditional patient mask strap in accordance with the prior art;

[0228] FIGS. 9A and 9B show a mask strap in accordance with an embodiment of the present invention;

[0229] FIGS. 10-12 show another embodiment of mask strap in accordance with the present invention;

[0230] FIG. 13 shows a head restraint in accordance with the present invention;

[0231] FIGS. 14A-14C show a mask anchor ring in accordance with the present invention;

[0232] FIG. 14D shows a ring part of the mask and how the posterior straps attach;

[0233] FIG. 14D shows a ring part of the mask and how posterior straps will attach;

[0234] FIGS. 15A-15C illustrate use of a mask anchor ring in accordance with the present invention, and FIG. 15D illustrates a mask in which the mask anchor ring or mask anchor straps are built into the mask;

[0235] FIGS. 15E and 15F are top and bottom plan views of yet another aspect of mask in accordance with the present invention;

[0236] FIGS. 16A-16C illustrate a pneumatic head or neck rest in accordance with the present invention;

[0237] FIG. 16D illustrates a patient whose head is restrained by an anterior strap.

[0238] FIGS. 17A, 17B, 17C, and 17D and 18A and 18B show details of a pneumatic head or neck rest in accordance with the present invention;

[0239] FIG. 19 is a flow diagram in accordance with one embodiment of the present invention;

[0240] FIGS. 20A, 20B22, and 23 show one embodiment of the jaw claw and ramp subassembly in accordance with the present invention;

[0241] FIGS. 21A and 21B and 24A-24D illustrate use of the jaw claw in accordance with the present invention;

[0242] FIG. 25 is a flow diagram showing the steps for using the jaw claw in accordance with the present invention, taken in conjunction with FIG. 24 and FIG. 26;

[0243] FIGS. 27 and 28A and 28B illustrate a mandible structural model, and FIG. 28C shows a skull and mandible coordinate systems on a device in accordance with the present invention;

[0244] FIGS. 29A-29C diagrammatically illustrate a pressure sensing array in accordance with the present invention;

[0245] FIGS. 30A-30B and 31A-31C provide additional details of jaw thrust in accordance with the present invention;

[0246] FIGS. 32A-32D, 33A and 33B illustrate neck and head positioning adjustment capabilities of the device of the present invention;

[0247] FIG. 34 schematically illustrates a four-bar linkage geometry of the lift mechanism of the present invention;

[0248] FIGS. 35A-35C and 36A-36F diagrammatically illustrate the lift mechanism in accordance with the present invention;

[0249] FIG. 37 plots linkage lengths, ramp angle and head support angle in accordance with the present invention;

[0250] FIG. 38 shows a patient in a sniffing position with the jaw thrust device in accordance with the present invention;

[0251] FIG. 39 is a flow diagram of the use of the device, in order to maintain coincident neck and neck support locations at linkage axis 4 in accordance with the present invention;

[0252] FIGS. 40A-40D and 41 illustrate combined nasal and mouth ventilation masks in accordance with yet another embodiment of the present invention; and

[0253] FIGS. 42-45 and 46A-46C illustrate a preferred embodiment of the invention, installed on a conventional operating table.

DETAILED DESCRIPTION OF THE DRAWINGS

[0254] Referring to FIGS. 1 and 2 for the lateral decubitus position, an apparatus and the Steps for implementing the sniff position and jaw thrusts are described below.

[0255] Step 1: A carriage subassembly 10 is translated along the Z axis along a base subassembly rail 12 until the support surface 14, is at a comfortable height for a patient lying on his or her left side.

[0256] Step 2: A sniff subassembly, surface 16, is adjusted along the Y axis until comfortably aligned with the patient and locked in place.

[0257] Step 3: The sniff subassembly, surface 16, is adjusted along the X axis until comfortably aligned with the patient and locked in place.

[0258] Step 4: A head clamp 18 is translated along the carriage subassembly along the Z axis until the patient's head is comfortably constrained.

[0259] Step 5: A flexible band 20 is placed over the patient's forehead and attached to the back side of the sniff subassembly constraining the patient's head in rotation about the Z axis.

[0260] Step 6: The vertical adjustment arms of a left and right jaw clamp subassemblies 22, are moved along the Z axis until aligned with the patient's mandible.

[0261] Step 7: Vertical adjustment arms 24, 26 are adjusted radially about the Z axis until in line with engaging the patient's mandible.

[0262] Step 8: The left and right jaw claw subassemblies 22, 24 are rotated about the Z axis until the mandible is engaged and extended to the desired amount.

[0263] Step 9: A backboard subassembly 28 height is adjusted along the Z axis until aligned with the center of the back.

[0264] Step 10: The backboard subassembly 28 position relative to the back is adjusted along the X axis to support maintenance of the patient at a 35 sniff position angle of the head.

[0265] Step 11: A flexible band 30 is placed around the abdomen of the patient and the back surface of the back board subassembly 28 to constrain the patient in the X-Y plane.

[0266] The present invention as above described provides several distinct advantages. These include:

[0267] (1) Achieving a desired position also known as the sniffing position or chin-lift (35 of neck flexion and 15 of head extension) without the use of jaw support members that may cause stimulation, and that is comfortable for the patient while in the lateral decubitus position;

[0268] (2) Alignment of 3 axes (oropharyngeal, laryngeal, tracheal) to provide the most optimal view for intubation in the lateral decubitus;

[0269] (3) Restrain of the patient's head from moving and disengaging the patient from a desired position;

[0270] (4) Provides an easy, user friendly mechanism for the jaw thrust maneuver to be performed in a hands free fashion while the patient lies on either of his/her side;

[0271] (5) A durable device with inexpensive disposable parts that may come in contact with the patient;

[0272] (6) A device that is easily disinfected;

[0273] (7) A device that is MRI or Xray compatible; and

[0274] (8) Provides the most amount of exposure to the surgical field.

[0275] Still yet other embodiments of the invention for the supine position are shown in FIGS. 3-7. Referring next to FIGS. 3A-3C, a patient positioning device is provided which includes:

[0276] 1. An adjustable ramp 50 that fits the torso of the patient. Ramp 50 includes a base which attaches to the operating room table 54. A pivot axis 56 allows the ramp to rotate relative to the operating table 54 at the base.

[0277] 2. A lift top 58 that accommodates the neck and head of the patient, and includes a pivot axis 60 that allows the lift top to rotate relative to the ramp

[0278] 3. Linear actuators that extend or retract along the indicated axes. The linear actuators include a first linear actuator 62 that connects between base 51 attached to operating table 54 and the back of the ramp 50. Ramp 50 is hingedly attached to the base 51. One or more actuators can be used to provide the required force. Actuation results in a change in actuator length L.sub.A1. A second linear actuator 64 connects between back of the ramp 50 and the back of the lift top 58, via a hinge 55 between the ramp 50 top and the lift top 58. One or more actuators can be used to provide the required force. Actuation results in a change in actuator length L.sub.A2. A third linear actuator 66 attached to ramp 50 is used to extend and retract ramp length to meet a required patent torso length. One or more actuators can be used to provide the required force. Actuation results in a change in actuator length.

[0279] FIGS. 4A-4B show the device of FIGS. 3A-3C in a lowered position.

[0280] In yet another embodiment, the positioning device may be incorporated into an operating table, or retrofit to an existing operating table. In this later embodiment:

[0281] 1. The device can retrofit to an existing operating table 68 or be incorporated into the design of a new table as shown in FIG. 5.

[0282] 2. The ramp is raised and lowered relative to the operating table through the respective extension or contraction of linear actuator 62. The ramp pivots about the X.sub.R axis resulting in a change in .sub.R as shown in FIGS. 5 and 6.

[0283] 3. The lift top (LT) is rotated relative to the ramp about the X.sub.LT axis as shown in shown in FIG. 5 and FIG. 6 when the linear actuator 64 is extended or retracted.

[0284] 4. The extension of the linear actuator 64 can be operated independent of lift actuator 62 to result in an inclined position of the lift top about the X.sub.LT axis. The extension or retraction of linear actuator 64 can also be coordinated with the extension or retraction of linear actuator 62 to maintain the angle of the lift top relative to the operating table constant as the angle .sub.R is varied due to the change in length of linear actuator 62 as illustrated in FIG. 6 and FIG. 7 where the lift top remains parallel to the top of the operating table.

[0285] 5. The ramp length, L.sub.R, can be controlled by the extension or retraction of linear actuator 62.

[0286] 6. If desired, a jaw claw as will be described in detail hereinafter can be integrated into the lift top of the system.

[0287] Yet another embodiment, illustrated in FIGS. 7A-7B the apparatus includes a lift top 70 which interfaces with a patient's head and neck. Lift top 70 comprises two elements 72, 74 that adjust in the Z direction to interface optimally with the neck and head as shown in FIGS. 7A-7B. The neck and head adjustments are independently adjustable in the Z direction from the nominal location and comprise pneumatically driven pillows or mechanically driven pads. Another option is to have only the neck or head portions adjust and the corresponding head or neck regions be stationary pads. The nominal and extended ranges for each are illustrated.

[0288] The present invention also addresses problems encountered with the use of a face mask, including maintaining the face mask on the face of the patient during a procedure, and especially during a long term respiratory event. Also, patient movement can cause a face mask to fall off, as can incidental contact.

[0289] Referring to FIG. 8, a conventional patient mask strap 102 is illustrated. The mask strap 102 comprises one or two straps 104, 106 which are designed to be tied to the back of the patient's head. Referring to FIGS. 9A-9B, the present invention provides a mask 107 in which straps 108, 110 (FIG. 9A) or conjoined straps 111 (FIG. 9B) are placed over the mask and anchored to a base plate 112 under the patient's head. In a case where the ventilation hose has already been attached to the mask, the mask 107 may be split at one side 113 to accommodate the ventilation hose 115, and still allow the attachment of the mask to the base as illustrated in FIGS. 10 and 11.

[0290] In a situation where the oxygen hose has yet to be attached to the mask, an unseparated mask strap can be attached to the mask, then to the hose, then to the patient as illustrated in FIG. 12.

[0291] In addition to strapping a patient and mask to the base, other parts of the patients head can be attached to the base if the head needs to be constrained as illustrated in FIG. 13.

[0292] FIGS. 14A-14D illustrate yet another embodiment of our invention, in which the ventilation mask 120 is attached with a strap 122 from the front to a base such as a patient support, where the strap consists of elastomeric straps that may vary in diameter of from, e.g., 0.125 to 0.25. A mask anchor ring 124 kinematically interfaces with the mask at a plurality of interface points, preferably three, on the mask anchor ring, resulting in more evenly applied force to the mask, as shown in FIGS. 15A-15C or the mask can have the mask anchor straps (one or more on each side of the mask) built into the mask, where the mask anchor ring would not be needed (see FIG. 15D). Preferably one or more elastomeric straps 125, 127 are affixed to a mask anchor ring 124 or built into the mask (FIG. 15D, straps 125A, 127A), spaced at any number of degrees apart an imaginary circle, for example if four straps where used then they would be spaced 90 apart, where each strap would secure each of the four sides of the mask (the right side, left side, forehead side, chin side). The mask is attached over the nose only or the nose and mouth of the patient by a force, F.sub.Strap applied by the elongated straps that connect to a head support.

[0293] A single mask anchor strap 125, 127 on each side configuration is shown in FIGS. 15A-15C. Each mask anchor strap attaches posteriorly behind the head to a respective mask anchor clip 129, 131 attached to the head support with a friction connection. Alternatively, the straps may include a plurality of holes for attachment to prongs on the head support. This connection results in an essentially airtight seal between the ventilation mask and the patients face.

[0294] An advantage of the mask strap of the current invention over conventional masks is that it allows a doctor to approach a patient from in front of the patient's face, place either the nasal mask, full face mask, or combined nasal-oral mask and then attach either of the masks to the surface so that the patient's head is resting on a surface and it prevents the patient's head from moving out of the desired position. Thus, if the patient's head is already on the surface, the provider will not have to lift the patient's head in order to strap the mask to the patient's face. Also, this approach places the patient in the desired position and fixes their head and neck in this position to maintain a patent airway. The mask strap of the current invention is smaller than a conventional mask and only comprises two surfaces of which an aperture is in the center that is placed on the face mask and two arm extensions with a plurality of holes that connect to a surface. It does not contain a wide rectangular head rest that wraps around the patient's head as in the case of conventional masks. It also does not require prongs on the face mask, and thus eliminates the risk of injury to the provider and patient.

[0295] Another advantage of the present invention is that it both maintains the sniffing position by fixing the patient's head to the table and is placed in front of the patient's face. Therefore if the patient lies down the strap can be applied without having to lift the patient's head off of the table.

[0296] In another aspect of the invention there is provided either a disposable or re-usable nasal mask with an off-centered aperture for ventilation and/or one for Oxygen or a combined but detachable and either disposable or re-usable nasal mask and oral mask, which can be used either uniformly as a full 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 can be used to apply nasal non-invasive positive pressure ventilation (BiPAPBilevel Positive Airway Pressure/CPAPcontinuous positive airway pressure) to help maintain a patent airway and ventilate a patient while the anesthesiologist is attempting intubation, which will significantly prolong the time until the patient begins to desaturate. More specifically, the present invention also provides a facemask, which is capable of functioning as an improved anesthesia mask compared to the prior art masks because it uniquely combines the following advantages:

[0297] (1) the ability to deliver and evacuate gas(es) while being sealed on the patient's face,

[0298] (2) the provision of either a full face mask having a separate nasal mask or a nasal mask alone to apply nasal non-invasive positive pressure ventilation (BiPAP/CPAP) and/or oxygenation during apneic periods (time when patient is not breathing on their own), sedation cases, general anesthesia (GA), and for respiratory therapy, and it has a separate mouth mask, which when attached to the nasal mask is essentially a traditional full facemask used for oxygenation and ventilation during bag-mask ventilation, GA, and respiratory treatments, or the mouth mask can be detached in order to provide the anesthesiologists with access to the airway for intubation and fiberoptic intubation,

[0299] (3) secure the nasal mask and nasal-oral mask not only to the patient's face but also secure the patient's head and neck in position to maintain airway patency, and stabilize the mask on the patient's face without affecting its sealing capability, and

[0300] (4) detach the oral mask or use the stand alone nasal mask and attach the nasal mask and use the head rest and/or neck rest cover with the mask strap to clip onto the nasal masks from the front and secure the nasal masks to the patient's face and attach the nasal mask to a portable oxygen supply source and use the nasal mask to supply oxygen during patient transport.

[0301] (5) another advantage is that the off-center port or ports will minimize the obstruction of the anesthesiologist's glottic view during the intubation process. On-center ports will partially or completely obstruct the glottic view.

[0302] Referring to FIGS. 40A-40B, the top left picture shows a side view of the nasal mask and the bottom left picture shows a front view, which consists of three surfaces; where the first surface is the bottom surface, is open, with a soft, flexible, pneumatic, border that contours to nose bridge, side of the nose, cheeks, and upper lip in order to create seal when in contact with the patient's face. The bottom surface also has a plurality of holes on each side, which allow straps to be either attached to or detachable and used to secure the mask to the patient's face and the patient's head and/or neck in the desired position. Built into these plurality of holes are clips which allow a mask strap to attach to when the mask strap comes from behind the patient's head and attaches to these clips in front. The second surface is the top surface of the nasal mask and contains one or more openings, the first of, which can be either off-centered left or right and connects to either an anesthesia circuit, BiPAP/CPAP machine, or resuscitation bag, in order to prevent obstruction of the glottic view or it can be centered and connects to the breathing circuit to enable gas exchange. A second opening can be connected to either an End-tidal CO2 monitor or a portable oxygen supply. A third opening can be used to allow for the use of both supplemental oxygen from an oxygen supply device and used to monitor end-tidal CO2. The third surface is base surface which may or may not consist of an opening as well as a door, which when the door is opened by engagement of the mouth mask it will allow for bilateral transfer of gases and when it is closed by disengagement of the mouth mask it will prevent gases from escaping from the nasal mask.

[0303] Referring to FIGS. 40C-40D, the top right picture shows a side view of the oral mask and the bottom right picture shows a front view of the oral mask, which also consists of three surfaces; where the first surface is the bottom surface, is open, with a soft, flexible, pneumatic, border that contours to lower lips, cheeks, and upper lips in order to create seal when in contact with the patient's face. The second surface is the top surface. The third surface is the base, which consists of a connector, which when engaged with the nasal mask door, pushes the door open and allows for the bilateral flow of gases and when the connector disengages, it causes the door of the nasal mask to close shut in order to prevent leakage of gases.

[0304] FIG. 41 shows the oral mask connector within the mouth mask engaging with the nasal mask, which causes the nasal mask door to swing open and allow gases to flow into both the mouth and nose bilaterally. When the mouth mask is engaged with the nasal mask, the combination creates the traditional facemask, which can be used for bag-mask ventilation, general anesthesia, respiratory treatment, etc. When the oral mask connector disengages from the nasal mask, the nasal mask door closes, which prevents gases from escaping and now turns the traditional facemask into a nasal mask which can be used for nasal BiPAP/CPAP for sedation cases, ventilation during intubation, general anesthesia, respiratory treatments, can be attached to a portable oxygen supply source and used to deliver oxygen for patient transport, etc. FIG. 41 also shows the mask anchor, which can either surround the opening of the nasal mask or be built into the nasal mask (FIG. 41A) and attaches to a surface, which secures the nasal mask and/or the nasal-oral mask to the patient's face in order to keep a tight seal, prevent leakage of anesthetic gases, and also maintains the patient's head and neck in the desired position to ensure an open airway.

[0305] While the invention has been described for use in connection with surgery, the invention also may be used during sedation cases, especially deep sedation or patients with Obstructed Sleep Apnea (OSA) or obesity, where the upper airway of many of these patients becomes obstructed and prevents them from breathing. The oral mask of the current invention can be separated from the nasal mask and the nasal mask or just the stand alone nasal mask can be used to apply BiPAP and/or continuous positive airway pressure (CPAP) to help relieve the upper airway obstruction, maintain a patent airway, and assist in ventilation during the case. Another advantage of the current invention as opposed to existing nasal masks is in situations where a nasal mask is not sufficient to ventilate the patient. The proposed invention has the ability to reattach the oral mask and now the mask can be used for traditional bag-mask ventilation. Another advantage of the invention is the ability to apply nasal BiPAP/CPAP during semi-awake fiberoptic intubations, where being able to maintain a patient's oxygen saturation levels are also critical. Another advantage of the current nasal mask and/or nasal-oral mask is the ability to connect it to a portable oxygen supply of needed and used to transport the patient with oxygen. It can also attach to both a supplement oxygen supply source as well as a resuscitator bag simultaneously in order to provide simultaneous oxygenation and ventilation. The final advantage that the present invention has over the prior anesthesia mask art is the ability to secure not only the combined nasal mask and oral mask to the patient's face allowing for hands-free ventilation, but it also secures 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.

[0306] In yet another aspect, the present invention provides improvement over the system described in our aforesaid parent applications, by providing a simple and elegant head/neck rest that comprises a compliant adjustable head and neck rest (ie: bellows, mechanical) that is independently controllable to support a patient's head/neck to obtain an optimal sniff position by raising a patient's neck and head independently of the carriage.

[0307] Referring to FIGS. 16-18, another feature and advantage of the present invention is to provide a head/neck support 302 that may be independently controlled to support the optimum sniff position by raising a patient's head and neck independently of the ramp, whereby to improve the glottic view in real time. More particularly, in accordance with the present invention, there is provided an adjustable head/neck support mechanism that permits adjustment in the z-axis. In one embodiment the adjustable head/neck support mechanism consists of a pneumatic jack such as a compliant bellows 304 that is fixed or located on top surface of lift top 70. Alternatively, as will be described below the adjustable head/neck support may comprise a mechanical jack.

[0308] Referring again to FIGS. 16-18, pneumatic head/neck support 302 in accordance with the present invention comprises an inflatable bladder or bellows 304 comprising a plurality of rigid concentric rings 320, 322, 324, 326 joined by flexible membranes 330, 332, 334 on a rigid base 336. The bellows includes a two-way valve 338 through which air may be added or subtracted in order to inflate the bellows and increase internal pressure and bellows height. The relative (height) position of a patient's head or neck, and achievement of an optimal sniff position, may be controlled by regulating the pressure within the bellows. Thus, when air is flowed into the bellows, the head/neck bellows 304 raises, and when air flows out of the bellows, the head/neck bellows 304 lowers. A feature and advantage of the present invention is that the inflatable bellows provide a relatively low-cost highly-adjustable device that readily may be sterilized. However, the device also is sufficiently low cost that it could be used once, and then discarded. Moreover, lateral movement of the head/neck rest is significantly more constrained than if the head/neck rest were made of a purely compliant bellows for raising and or lowering the head/neck.

[0309] Referring to FIG. 19, the present invention also provides methods for positioning a patient. The methods include the steps of: providing a device according to the invention as described herein, placing the patient's head substantially on the top of the adjustable mechanism (bellows), elevating the ramp and then adjusting the mechanism so that the patient is in a sniff position.

[0310] Referring in particular to FIGS. 20A and 20B of the drawings, in another aspect, the present invention provides a device comprising:

[0311] a base 400 comprising a first side which supports the patients head and neck, a second side acting as the foundation, inner vertically adjustable support structures 406 between the first and second sides, and a detachable third inclined side or ramp 408 which supports the upper back, middle back, and shoulders of a patient and is rotatable and adjustable in the x axis;

[0312] a first support 410 positioned on the second side of the base and lockably adjustable with respect to the second side of the base in an x and y axes;

[0313] a second support 412 positioned on the second side of the base and lockably adjustable with respect to the second side of the base in the x and y axes;

[0314] a first mandible arm 414 extending from a first vertically adjusted portion of the first support 410, wherein the first vertically adjusted portion is lockable in a z axis to lockably adjust the first mandible arm with respect to the z axis, and wherein the first mandible arm 414 is positionable to be in contact with the patient's jaw; and

[0315] a second mandible arm 416 extending from a second vertically adjusted portion of the second support 412, wherein the second vertically adjusted portion is lockable in the z axis to adjust the second mandible arm 416 with respect to the z axis, and wherein the second mandible arm 416 is positionable to be in contact with the patient's jaw;

[0316] wherein the first mandible arm 414 and the second mandible arm 416 are movable such that each is positionable to be in contact with the patient's jaw and to maintain the patient in a desired position. In such case, preferably the sniffing position, aligning all 3 axes (oropharyngeal, laryngeal, tracheal), and/or in the jaw thrust maneuver, and leaving the provider hands free.

[0317] In a preferred embodiment, the base 400 is rectangular.

[0318] In one embodiment, the mandible arms 414, 416 are positionable to be in contact with the patient's jaw at three points. The most distal end of the mandible arms can pivot in three degrees in order to conform to the angle of the mandible.

[0319] The first mandible arm 414 and second mandible arm 416 each include a mandible pad 420, 422 which preferably are formed of a resiliently deformable material such as foam. In yet another embodiment, the first mandible arm 414 and second mandible arm 416 are removeably connected to the first support 410 and second support 412, respectively; and the most distal end of the first and second mandible arms 414, 416 are removeably connected to the distal end of the first and second supports 410, 412.

[0320] In yet another embodiment, the first mandible arm 414 is moveable relative to the first support 410, and the second mandible arm 416 is moveable to the second support 412.

[0321] In further embodiments, the mandible arms 414, 416 are positionable such that the mandible pads 420, 422 are in contact with the patient's jaw at one or more points.

[0322] In some embodiments, the mandible arms 414, 416 are positionable such that the mandible pads 420, 422 are in contact with the patient's jaw at three points, and in yet other embodiments the first support 410 is moveable relative to the base 400 and the second support 412 is moveable relative to the base 400.

[0323] In various embodiments the first support 410 is moveable relative to the base 400 on the X and Y axis, and the second support 412 is movable relative to the base 400 on the X and Y axis.

[0324] Referring in particular to FIGS. 21A and 21B, in one embodiment of the present invention, the mandible arms each include a curved portion 430 that consists of an adjustable and lockable mechanism 432 that attach to a respective mandible pad 420, 422, wherein the mandible pads 420, 422 are flexible, and wherein the mandible pads have a distal side configured to attach to the curved portion and a proximal side configured to contact a patient's jaw at a plurality of points, which can pivot in all angles at the distal end; and a connector portion which is configured to attach to a support.

[0325] Referring to FIGS. 22-24, in yet other embodiment, a connector portion 450, is configured to attach to a support 452 that is attached to a base 454 comprising a left side and a right side, wherein the base 454 is configured to substantially accommodate a patient's neck and head, and wherein the support 452 is moveable in three axis such that the mandible pads 420, 422 are positionable to be in contact with the patient's jaw at one or more points and to maintain a desired position.

[0326] A further embodiment to the present invention includes a detachable inclined surface 500 that may attach to the base 454, and the angle at which the inclined surface 500 is positioned can be changed, while also having the ability of extending further distance in order to maintain the same angle which assists in supporting larger patients. The inclined surface will have a back and shoulder bar 502 that rests on it which will support a patient's upper back, middle back, and shoulders. This support will enable gravity to displace weight off of patient's chest, allowing for a more patent airway.

[0327] In yet another embodiment of the present invention, there optionally is included a measuring device 530 such as a level to confirm the optimal neck flexion angle of 35. One embodiment consists of two sides, the first side 532 of which is semi cylindrical and consists of four arms 554, 556, 558, 560, each of which is located within each of the four corners, each of which makes contact with the patient's neck; the second side 562 which consists of a leveled angle.

[0328] In yet another embodiment the present invention optionally includes a leveling device 564 used to confirm the optimal head extension angle of 15. This latter embodiment consists of two sides, the first side 566 or triangular side which consists of three arms 568, 570, 572, each of which is located within each of the three corners, each of which is adjustable in the z-axis, each of which makes contact with the patient's face; and the second side 574 which consists of a 15 leveled angle.

[0329] Referring now to FIG. 25, in yet another embodiment, the present invention includes a method for positioning a patient including the steps of: placing the patient's upper back, middle back, and shoulders on an inclined surface along with the patient's neck and head substantially on the base of the device; placing the patient's head and neck in the desired position, confirming the position with a measuring device; restraining the patient's head to prevent the patient from being dislodged from the desired position; moving a first mandible arm to contact the patient's jaw; moving the second mandible arm to contact the patient's jaw; wherein the contact of the first mandible arm and the second mandible arm provides sufficient force to substantially maintain the patient's head, neck, and/or jaw in a desired position.

[0330] The invention will be further illustrated with reference to FIGS. 22-26 which illustrate the Steps for implementing the Sniff position and Jaw thrusts using the above described device as follows:

[0331] Step 1: Adjust Head Height in z with Jack Subassembly to Achieve 35 Angle by rotating handle 600 and engaging the acme screw.

[0332] Step 2: Adjust Ramp Length.

[0333] Step 3: With correct radius Head Rest in place, constrain forehead to Jack Subassembly with flexible band to achieve 15 angle.

[0334] Step 4: Attach the Jaw-Claw-Based Subassembly to the top portion of the Jack Subassembly as illustrated in FIG. 4 with the Claws separated (by rotating opposite one another along the Z axis) and tilted below the plane of the head (Rotated about the Y axis). Nominally position the left and right padded elements of the Claw below their respective mandible locations (by rotating them towards each other about the Z axis) and slide the Claw assembly along the X axis and lock the Claw assembly in position to the top of the Jack subassembly. Adjust the Left and Right Jaw Thrust Subassemblies by sliding them along the y axis along the Jaw Thrust Slide towards the patient's head and squeezing the Jaw Thrust Grip causing it to rotate about the x axis, resulting in a translation in the positive z direction until the Jaw Thrust Shelf is lightly engaged below the mandible, and locked into position.

[0335] Step 5: With the claw subassembly locked in place on the Jack Subassembly, Rotate, about the Z axis, the left and right arms of the Claw subassembly until the padded portions are engaged with their respective left and right mandible of the jaw. After the pads are securely engaged with the mandible, rotate both left and right arms of the claw about the Y direction of the Y axis until the Jaw is extended by the desired amount in the Z direction. Extend Mandible by required amount by squeezing the Left and Right Jaw Claw Grips simultaneously resulting in a rotation of the Jaw Claw and engagement with an extension of the mandible.

[0336] Lock the Left and Right Jaw Thrust Assemblies to the Jaw Thrust Slide by rotating the Jaw Thrust Lock about the x axis. This fixes the Jaw Thrust Assembly position in the x-y Plane. Proceed to engage the Left and Right Jaw thrust shelf to extend the mandible by the required amount of squeezing the Jaw Thrust Grip, causing it to rotate about the x axis, resulting in a translation in the positive z direction until the Jaw is properly extended and the Airway is open.

[0337] The foregoing steps:

[0338] (1) achieve a desired position also known as the sniffing position or chin-lift (35 of neck flexion and 15 of head extension) without the use of jaw support members that may cause stimulation and that is comfortable for the patient;

[0339] (2) Restrains the patient's head from moving and disengaging the patient from the desired position;

[0340] (3) Achieves a position in obese patients where the ear and the sternum are aligned in horizontally to achieve maximal air exchange;

[0341] (4) Provides an easy, user friendly mechanism for the jaw thrust maneuver to be performed in a hands free fashion;

[0342] (5) Displaces weight off of a patient's chest with the help of gravity by using an inclined surface;

[0343] (6) Provides a mechanism of elevating and lowering obese patients without the use of health care workers to limit work related injuries;

[0344] (7) Provides a measuring device to confirm the optimal angles of the desired position;

[0345] (8) Aligns 3 axes (oropharyngeal, laryngeal, tracheal) to provide the most optimal view for intubation; and

[0346] The present invention is believed to be first of its kind to maximize ventilation in a hands free fashion by being able to perform a jaw thrust maneuver, along with the ability to displace weight off of a patient's chest by utilizing an elevating device. The invention also is believed to be the first to utilize a measuring device (i.e.: a level) on the body in order to reassure the provider that the patients head and neck are properly aligned in the sniffing position. This invention also gives the provider the ability to first try a much lesser invasive way of maintaining a patent airway by placing the patient in the proper sniffing position without eliciting any painful stimuli. The provider can then restrain the patient's head to prevent the patient from being displaced from the desired position. If the patient's airway is not yet patent, the provider can use 2 clamps with ratchet capability, each applied to each side of the mandible to displace the jaw forward. If the patient still cannot maintain a patent airway, this invention, by placing the patient in the desired position, aligns all 3 axes in order to achieve the best possible view to intubate the patient. See FIGS. 27-31.

[0347] Yet another embodiment of the invention is shown in FIGS. 32A-32D, and 33A and 33B which show the positioning device of the present invention with a patient initially horizontal on the OR table, and raised to an inclined position. When the device is raised and lowered, it pivots about the X axis, Point 1, by an amount .sub.X1. As the device is raised or lowered, the head support, containing the independently adjustable head and neck actuators that position the head and neck for optimal intubation view, is maintained nominally parallel to the Y axis by rotating about point 4 along the X axis an amount .sub.Z4, where .sub.X4=.sub.X1. The patient is intubated while in the inclined position and then repositioned to the reclined position for the operation. The device and patient create a 4-bar linkage (FIG. 34) as defined in Table 1 below.

TABLE-US-00001 TABLE 1 Linkage Linkage Description Comment a Connects Ramp Pivot Point 1, to Patients Fixed Length, a Hip Pivot (Trochanterion), Point 2 b Connects Hip Pivot, Point 2, to Top of Neck Fixed Length, b actuator (Head/Neck Pivot location), Point 3 c Connects Head/Neck Pivot location, Point 3, Fixed Length, c to Head Support Pivot, Point 4 d Connects Head Support Pivot, Point 4, to Adjustable Ramp Pivot, Point 1 Length, d

[0348] Generalized geometry for the lifting linkage is illustrated in FIGS. 35A-37, and the associated known variables as well as equations for .sub.2 as a function of ramp angle .sub.X1, .sub.4 as a function of head support angle .sub.X4 and unknown variables .sub.3 and d are defined as follows: [0349] a, b, c, .sub.2, and .sub.4 are known [0350] 1. .sub.2=.sub.2.sub.X1 where .sub.2 is for the reclined position and .sub.X1 is the ramp pivot angle about point 1 [0351] 2. .sub.4=.sub.4+.sub.X4 where .sub.4 is for the reclined position and .sub.X4 is the head support pivot angle about point 2 [0352] 3. .sub.3=a sin [(c sin .sub.4a sin .sub.2)]/b [0353] 4. d=a cos .sub.2+b cos .sub.3c cos .sub.4

[0354] The problem is that as the ramp is raised and, or the head support is rotated about its pivot axes, one or more of the linkage lengths must change or the patient will be forced to slide along the device surface and operating table. The sliding effectively changes linkage lengths a and c, given lengths b and d are fixed. What is desired is to maintain the lengths and positions of linkage a, .sub.a and c, .sub.c fixed relative to their support surfaces as the ramp angle, .sub.X1, and head support angle, .sub.X4, are adjusted. The present invention accomplishes this requirement by changing the length of the ramp, linkage d, as a function of the initial patient geometry, ramp angle .sub.X1 and head rest angle .sub.X4.

[0355] Referring again to FIGS. 36A-36F and 37, as ramp incline is varied, .sub.X1, the head rest orientation remains parallel, in most cases horizontal to the operating table, by changing head rest angle, .sub.X4 by the opposite amount. This can be accomplished in the following manner:

a. Open loop based on known or estimated geometries of all parameters; or
b. Closed loop where the current angle
.sub.X4 is measured relative to an initial angle, .sub.X4 and driven back to that initial angel. This could be accomplished with multiple feedback sensors including but not limited to:

[0356] i. Measurement of angle relative to gravity with an inclinometer

[0357] ii. Encoder

[0358] Referring in particular to FIG. 37, as ramp incline is varied, .sub.z1, and/or head rest angle, .sub.z4 are changed to position the patient, ramp (linkage d) length is varied in order to satisfy the conditions that positions of linkage a, .sub.a and c, .sub.c fixed relative to their support surfaces. This prevents the patient from sliding along the operating table surface as the ramp and head rest angles are adjusted. This can be accomplished in the following manner:

a. Open loop based on known or estimated geometries of all parameters

[0359] i. Equations 1-4 provide the analytical solution to calculated and control length d; or

b. Closed loop where the relative positions of one or more of the following linkage termination points are measured and the length d is adjusted under closed loop control driven by sensor feedback to return the measured parameter to their original position.

[0360] i. Point 2 of linkage a's position relative to point 1

[0361] ii. Point 3 of linkage c's position relative to point 4

[0362] iii. Alternate Point 3 where the patient head meets the head rest

a. The feedback sensors monitoring relative position of the points that define the linkage length could include:

[0363] i. Position measurement sensors including but not limited to: [0364] 1. Hall effect sensors [0365] 2. Magneto-resitive sensors [0366] 3. Optical sensors [0367] a. Encoder [0368] b. Interferometric [0369] c. Position sensing detectors

[0370] ii. Stress/strain/force/torque monitoring sensors located at the point interfaces that minimize those parameters by adjusting linkage length d under closed loop control.

[0371] Referring again to FIGS. 36A-36F, in a preferred exemplary embodiment, the device includes linear actuator linkage d that adjusts the length of the ramp to accommodate the patient, Linkage g that raises the ramp about the Z axis, pivot axis 1, and linkage j that maintains the head support parallel to the X axis by counter rotating about the Z axis along Pivot Axis 4. The device and patient create a 4-bar linkage as defined in Table 1. The associated initial reclined position and relational equations for the angles and actuators d and j as a function of actuators, linkage g length, that drive ramp angle .sub.Z1 are also defined in Table 2 below.

TABLE-US-00002 TABLE 2 Patient 4-Bar Linkage & Actuator Linkages Initial Conditions when Reclined X Axis Linkage Pivot Point Definitions Distance from Neck Reclined (Initial) Associated Patient CM to Hip Pivot Location Actuator Minimum Adjustment (cm) Function Defining Equations X Axis Point Y (cm) Z (cm) 59.9 1 0.00 0.00 d Ramp Pivot Axis .sub.X1 = .sub.g .sub.g0 .sub.g0 = .sub.g .sub.g0 2 11.95 6.90 Hip Pivot 3 45.44 6.90 6.90 0 Neck Pivot & Y Neck Adjustment 4 42.90 0.00 d 38.4 21 Head Support Pivot .sub.X4 = .sub.Z1 Axis 5 Head Y Adjustment 6 9.58 3.52 g 7 26.14 0.00 g 8 44.00 3.40 j 9 65.68 1.28 j Linkage Definitions Linkage/ Linkage/ Linkage/ Opposite Opposite First Second Opposite Angle Value Angle Value Linkage Axis Axis Length cm Angle Rad Degrees Actuator? Function a 1 2 13.80 .sub.a 2.6180 150.00 .sub.a = .sub.a0 .sub.X1 b 2 3 59.99 .sub.b 0.0000 0.00 .sub.b = asin [(c sin .sub.c a sin .sub.a)]/b c 3 4 7.35 .sub.c 1.2180 69.79 .sub.c = .sub.c0 + .sub.Z4 d 1 4 45.50 .sub.d 0.0000 0.00 2301002100225G6 Determines Ramp d = a cos .sub.a + b cos .sub.b Linear Actuator Length c cos .sub.c e 1 6 10.21 .sub.e 0.2094 12.00 .sub.e = acos[(f.sup.2 + g.sup.2 e.sup.2)/2fg] f 1 7 26.14 .sub.f 2.5800 147.82 .sub.f = acos[(e.sup.2 + g.sup.2 e.sup.2)/2eg] g 6 7 16.93 .sub.g 0.3521 20.17 2331002102050G6 Determines Ramp .sub.g = acos[(e.sup.2 + f.sup.2 g.sup.2)/2ef] Linear Actuator Incline h 4 8 3.57 .sub.h 0.1512 8.66 .sub.h = acos[(i.sup.2 + j.sup.2 h.sup.2)/2ij] i 4 9 22.82 .sub.i 1.8485 105.91 .sub.i = acos[(h.sup.2 + j.sup.2 i.sup.2)/2hj] j 8 9 21.58 .sub.j 1.1419 65.43 2331002102050G6 Determines Head .sub.j0 = acos[(h.sup.2 + i.sup.2 j.sup.2)/2hi] Linear Actuator Support Incline Linkage Definitions Linkage a .sub.a0 = 150 for Small-Large Aviator a = 0.23 b based on Medium Aviator b .sub.b0 = 0 for Small-Large Aviator b = (d.sub.0 + 2.54 cm)/(1 0.23 cos (180 .sub.a0)) c .sub.c0 = acos(2.54 cm/c) c = (2.54 cm.sup.2 + (a sin(180 .sub.a0)).sup.2).sup.1/2 = (2.54 cm.sup.2 + Z.sup.2).sup.1/2 d e f g h i .sub.j = .sub.j0 + .sub.Z4 j = (h.sup.2 + i.sup.2 2hi cos .sub.j).sup.1/2 j .sub.j = .sub.j0 + .sub.Z4 j = (h.sup.2 + i.sup.2 2hi cos .sub.j).sup.1/2

[0372] An illustration in FIG. 32A-32D for a mid-sized male patient with Neck Pivot distance to Hip Pivot distance of 59.9 cm and hip pivot, axis 2, to ramp pivot, axis 2, is provided. The associated Table 3 provides angles and linkage lengths as a function of driving linkage g from a length of 16.75 cm to 22 cm. A plot of Linkage lengths d and j as well as ramp angle .sub.X1 and head support angle .sub.X4 as a function of linkage length g is provided in FIGS. 36A-36F.

TABLE-US-00003 TABLE 3 Linkage length commands for d and j as a function of linkage g Linkage g Linkage d (cm) .sub.X1 (Degrees) .sub.X1 (Rad) .sub.X4 (Degrees) .sub.X4 (Rad) (cm) .sub.a (Rad) .sub.b (Rad) .sub.c (Rad) .sub.g (Rad) Linkage j (cm) .sub.j (Rad) 16.75 1.980799995 0.0346 1.980799995 0.0346 45.27 2.6526 0.0070 1.2180 0.3175 21.70 1.1765 17.00 0.727219333 0.0127 0.727219333 0.0127 45.50 2.6053 0.0031 1.2053 0.3648 21.53 1.1292 17.25 3.168850885 0.0553 3.168850885 0.0553 45.52 2.5627 0.0134 1.1627 0.4074 21.39 1.0866 17.50 5.421111271 0.0946 5.421111271 0.0946 45.55 2.5234 0.0228 1.1234 0.4467 21.26 1.0473 17.75 7.530863273 0.1314 7.530863273 0.1314 45.59 2.4866 0.0317 1.0866 0.4836 21.13 1.0105 18.00 9.529107906 0.1663 9.529107906 0.1663 45.65 2.4517 0.0400 1.0517 0.5184 21.02 0.9756 18.25 11.43760228 0.1996 11.43760228 0.1996 45.72 2.4184 0.0479 1.0184 0.5517 20.92 0.9423 18.50 13.27230674 0.2316 13.27230674 0.2316 45.79 2.3863 0.0555 0.9864 0.5838 20.82 0.9103 18.75 15.04534012 0.2626 15.04534012 0.2626 45.88 2.3554 0.0627 0.9554 0.6147 20.72 0.8793 19.00 16.76616329 0.2926 16.76616329 0.2926 45.97 2.3254 0.0697 0.9254 0.6447 20.63 0.8493 19.25 18.44233307 0.3219 18.44233307 0.3219 46.07 2.2961 0.0765 0.8961 0.6740 20.54 0.8201 19.50 20.08000305 0.3505 20.08000305 0.3505 46.17 2.2675 0.0830 0.8676 0.7026 20.46 0.7915 19.75 21.68426774 0.3785 21.68426774 0.3785 46.29 2.2395 0.0894 0.8396 0.7306 20.38 0.7635 20.00 23.25940615 0.4060 23.25940615 0.4060 46.40 2.2120 0.0955 0.8121 0.7581 20.31 0.7360 20.25 24.80905851 0.4330 24.80905851 0.4330 46.53 2.1850 0.1015 0.7850 0.7851 20.24 0.7089 20.50 26.33635727 0.4597 26.33635727 0.4597 46.66 2.1583 0.1074 0.7584 0.8118 20.17 0.6823 20.72 27.66406041 0.4828 27.66406041 0.4828 46.78 2.1352 0.1124 0.7352 0.8349 20.11 0.6591 21.00 29.33445565 0.5120 29.33445565 0.5120 46.94 2.1060 0.1186 0.7060 0.8641 20.04 0.6300 21.25 30.80976336 0.5377 30.80976336 0.5377 47.08 2.0803 0.1240 0.6803 0.8899 19.98 0.6042 21.50 32.27183984 0.5632 32.27183984 0.5632 47.24 2.0547 0.1293 0.6548 0.9154 19.92 0.5787 21.75 33.7223866 0.5886 33.7223866 0.5886 47.40 2.0294 0.1345 0.6294 0.9407 19.86 0.5534 22.00 35.16294644 0.6137 35.16294644 0.6137 47.56 2.0043 0.1395 0.6043 0.9658 19.81 0.5282

[0373] The control steps for the device initialization and operation are outlined in FIG. 39. Optionally, if desired, a sensor may be provided for measuring the Y location of axis 3 which is the neck height adjustment. If a sensor is provided, the actuator control laws that adjust d would be appropriately modified.

[0374] An illustration of the jaw thrust parameters and associated Cartesian coordinate system are provided in FIGS. 27-29. In a jaw thrust maneuver, the mandible is moved L.sub.Thrust, due to the applied force F.sub.Thrust. In order to avoid necrosis of the muscle and epidermal tissue, the maximum allowable pressure that can be applied in a thrust is P.sub.Thrust. Given the jaw thrust is applied symmetrically on the left and right side of the mandible, the load on each side is F.sub.Thrust/2. Initial requirements for the jaw thrust maneuver are presented in Table 4.

TABLE-US-00004 TABLE 4 Jaw Thrust Maneuver Top-Level Requirements Parameter Value Comment 1 Jaw Thrust 7 mm-10 mm The most optimal protrusion of the Displacement, @ +22 about mandible is between L.sub.Thrust the Y.sub.Shull Axis 7 mm-10 mm, >10 mm does not increase patency.sup.24 2 Total Jaw 34.07 9.33 N The mean value of the highest Thrust forces to accomplish the Force, F.sub.Thrust jaw thrust maneuver.sup.26 3 Maximum <66 kPa, 4 Muscle damage occurred at high allowable hours pressure-short duration.sup.27 pressure resulting from Jaw Thrust, P.sub.Thrust

[0375] An illustration of a simplified mandible structural model is provided in FIGS. 28A-28C. For the purpose of this illustration, the mandible is assumed to be infinitely stiff with its associated coordinated system X.sub.M, Y.sub.M & Z.sub.M. The back of the skull with its associated coordinate system is tied to ground, with the assumption that it is fixed both in torsion and translation, and the mandible is constrained in all but the thrust axis. Compliance in the mandible is represented by the left and right lateral pterygoid muscle spring stiffness, K.sub.M/2, and the effective spring stiffness of the muscle and epidermal tissue below the thrust force, F.sub.Thrust/2. Note that when the patient is located on the device, the thrust force vector is applied at a nominal 70 angle about the Y.sub.AS axis as illustrated in the top right portion of FIG. 45A. The jaw thrust force, F.sub.Thrust, is transmitted over the area, A.sub.Thrust, through the muscle/epidermal tissue spring on each side of the mandible, K.sub.E&M. A.sub.Thrust is determined by the necrosis pressure limit, P.sub.Thrust, and time period that the thrust is applied. See Table 5 below.

TABLE-US-00005 TABLE 5 Biomechanically Accurate Mandible Model Requirements Parameter Value Comment 1 Mandible muscle 4.86 N/mm Based on Median thrust force of spring stiffness, K.sub.M 34 N and extension of 7 mm.sup.24,26 2 Minimum thrust >6.6 cm2 Area required with thrust force area, A.sub.Thrust of 43.4 N and maximum pressure level allowed, P.sub.Thrust of <66 kPa, 4 hours.sup.27 3 Muscle/epidermal 11 N/mm Based on Young's Modulus of tissue spring on 101.20 kPa, 3 mm thickness and each side of the A.sub.Thrust/2 Area.sup.28 mandible, K.sub.E&M

[0376] The patient is positioned on the device with the neck flexion angle at 350 and the plane of the face is 15 to the horizontal. As a result the coordinate system of the skull is rotated about the Y.sub.Skull axis and the device y axis, Y.sub.AS, by 15 as shown in FIG. 28C. As a result, the nominal jaw thrust force vector is applied at a 7 angle relative to the Y.sub.AS axis. Note the thrust angle is 22 relative to the Y.sub.Skull axis.

[0377] Referring again to FIGS. 29A-29C, a mandible base is connected to structural ground, by a six-degree-of-freedom (DOF) load cell measuring reaction forces and moments. The mandible slides along the base, constrained in all but the L*.sub.Thrust axis as shown (70 about the Y.sub.AS axis). Stiffness of the left and right lateral pterygoid muscle that provides the thrust resistance, is represented by spring stiffness K.sub.M. The simulated mandible consists of an infinitely stiff mandible bone covered by an elastomeric material shown in green (silicone rubber is the initial choice due to its similarity in mechanical properties to the skin.sup.30). With an elastic modulus of 100 kPa, the effective spring stiffness when a pressure is applied over the area A.sub.Thrust/2 with a thickness of 3 mm is K.sub.E&M (Epidermis and muscle). Jaw thrust forces are applied to the left and right side of the mandible as shown, or in shear along the sides of the mandible. A pressure sensing grid will be applied to the outer surface of the mandible in order to measure the pressure field when a jaw thrust is applied to the mandible model. Displacement of the mandible along the mandible base will be measured with a dial indicator or other distance measuring device. Details of the load cell and pressure measurement array are provided below.

[0378] Multiple jaw thrust approaches can be employed. Two approaches include the jaw thrust approach shown in FIGS. 28A-28C where a thrust moment, M.sub.Thrust, applied about the Y.sub.AS axis results in a thrust force, F.sub.Thrust/2 on the left and right side of the mandible. In this approach the hands-free jaw thrust device is detached from the device base, and jaw cups that interface with the mandible, are shown in FIGS. 29A-29C. A second approach interfaces to the side of the mandible through suction cups providing a shear thrust force. The benefit of a suction cup approach is that there is a larger area to interface on the side, as opposed to the back of the mandible, resulting in lower pressure being required to apply the thrust and reduce the possibility of skin or muscle damage. There is precedence in using vacuum to reduce bruising or other damage, as is the case in vacuum assisted delivery during pregnancy. In all cases, thrust force, due to an applied force or moment and mandible displacement will be measured and the thrust provided under closed loop control of the jaw thrust device.

[0379] The jaw thrust force provided by the device will be provided under closed loop feedback measuring P.sub.Thrust directly or indirectly, as measured either by pressure array sensors located in the Jaw Cup/Suction Cup-Mandible interface, similar to this used in the mandible model, or in a load cell measuring the applied force F.sub.Thrust or moment M.sub.Thrust. This feedback will determine the applied thrust force required for the jaw thrust maneuver.

[0380] Testing of the Mandible Model with the hands-free jaw thrust device of the present invention involved thrusting the mandible incremental distances of 5 mm-15 mm (In 1 mm steps) at angles about Y.sub.AS of 5-10. (In 10 steps). Four parameters were be simultaneously measured and recorded as a function of time during testing as illustrated in FIGS. 29A-29C. These include: [0381] 1. Thrust pressure field at the mandible interface as measured in the Mandible reference frame, P.sub.Thrust (X.sub.M, Y.sub.M, Z.sub.M). [0382] 2. Reaction forces and moments as transferred through the mandible, to the skull, to the device mechanical ground plane, F(X.sub.AS, Y.sub.AS, Z.sub.AS) and M (X.sub.AS, Y.sub.AS, Z.sub.AS). [0383] 3. Displacement of the mandible relative to the device reference frame, L. [0384] 4. Jaw thrust maneuver force, F.sub.Thrust, applied by the hands-free jaw thrust device to the mandible, as measured at the hands-free jaw thrust device, F(X.sub.JC, Y.sub.JC, Z.sub.JC) and M (X.sub.JC, Y.sub.JC, Z.sub.JC). Note these are assumed to be the similar to 2.
Table 6 provides the measurement parameters, requirements and measurement approach for testing. The last column identifies sensor solutions and provides a basis for the requirement.

TABLE-US-00006 TABLE 6 Test Measurement Parameters, Requirements & Approach Parameter Requirement Candidate Sensor/Basis of Requirement 1 Pressure Field Sensor, Reference Table, TekScan 4205 is a P.sub.Thrust (X.sub.M, Y.sub.M, Z.sub.M) @ candidate sensor Mandible Interface http://www.tekscan.com/4205-pressure- sensor 1.1 Range 0-100 kPa <66 kPa, 4 hours is the preliminary requirement.sup.27 1.2 Pressure Measurement 0.7 kPa Place holder, 1/100 of preliminary Accuracy requirement 1.3 Pressure Measurement 0.5 kPa Place holder, 1/100 of range Precision 1.4 Pressure Measurement 1.5 10.sup.3 m.sup.2/ Approximate area for rear and side of Sensor Area 6.0 10.sup.3 m.sup.2 right and left of mandible 1.5 Pressure Grid spatial <2 mm in X & Y Placeholder resolution 1.6 Pressure Array Minimum TBD Surface Radius 1.7 Pressure Measurement >10 Hz Placeholder Bandwidth 2 & 4 Reaction Force/Moment Reference Table, Candidate SRI 3702A Sensor, F (X.sub.AS, Y.sub.AS, Z.sub.AS) is a candidate sensor, and M (X.sub.AS, Y.sub.AS, Z.sub.AS) http://www.srisensor.com/pdf/m3202.pdf 2.1 Force Range 50 N-+50 N 34.07 9.33 N is expected jaw thrust force.sup.26 2.2 Moment Range 0.75 N-m to Placeholder +0.75 N-m 2.3 Force Accuracy <1 N, 1 Placeholder 2.4 Force Precision 0.05 N, 1 Placeholder 2.5 Measurement Bandwidth >10 Hz Placeholder 3 Mandible Displacement Reference Table, Candidate sensor is Sensor TBD 3.1 Length of Jaw Thrust 0.7 mm-10.0 mm Distance required to achieve airway displacement, L.sub.Thrust opening and acceptable glottic view.sup.24 3.2 Measurement Accuracy 0.01 mm, 1 3.3 Measurement Precision 0.005 mm, 1 Placeholder 3.4 Measurement Bandwidth >10 Hz Placeholder

[0385] The present invention is believed to be the first of its kind to combine several different mechanisms to maximize ventilation in a hands-free fashion. The device is also novel in that it is the only patient positioning device that can adjust head and/or neck position in real time during intubation. This is essential because the sniffing position is not the optimal intubating position for every patient, although it is for most. The invention being described has the ability to accommodate for those patients whose glottis is not in view in the sniffing position by being able to adjust the head and/or the neck until the glottis is in view.

[0386] The device is also novel because it is the only patient positioning device that secures a patient's head and neck in optimal ventilating and intubating position and can provide nasal continuous positive pressure ventilation while simultaneously attempting intubation. This helps significantly prolong the short yet critical time period between the patient's last breath and securing of the endotracheal tube.

[0387] The present invention also has an ability to perform a jaw thrust maneuver in the lateral position, along with the ability to displace weight off of a patient's chest by utilizing a lateral decubitus position, along with placing the patient in the sniffing position which aligns all 3 axes (oropharyngeal, laryngeal, tracheal). The invention also gives the provider the ability to first try a much lesser invasive way of maintaining a patent airway by placing the patient in the proper sniffing position without eliciting any painful stimuli. The provider can then restrain the patient's head to prevent the patient from being displaced from the desired position. If the patient's airway is not yet patent, the provider can adjust the mandibular arms with ratchet capability, each applied to each side of the mandible to displace the jaw forward. If the patient still cannot maintain a patent airway, the present invention, by placing the patient in the desired position, aligns all 3 axes in order to achieve the best possible view to intubate the patient.

[0388] FIGS. 42-46C illustrate another and preferred embodiment of the positioning device 1002 of the present invention installed on a conventional operating table 1004. More particularly, there is shown an alternate method of maintaining the patient's head and head support, linkages axis 3, in a collocated position as the device is raised or lowered or as the lift support is raised and lowered is to allow the hip axis 2 (X.sub.2) to be allowed to translate along the Y and Z axis as illustrated in FIGS. 46A-46C. The alternate method consists of connecting the top cushion on which the patient is lying to the slide back support and allowing the top cushion to slide relative to the anchored back support if that length is adjusted and on the roller assembly along the Y axis. Additionally, as the lift support rotates about the X axis, the head, on the head support slides along the Y axis to compensate for the change in angle and linkage length between axis 3 and 4.

[0389] FIG. 46A shows the patient lying in a supine position with the head and head support collocated at linkage axis 3. As the ramp is raised to an incline position by rotating about the X.sub.1 axis, the patient on the top cushion both slide on the device along the Y axis, FIG. 46B. The head and head support remain collocated and the hip axis 2 is allowed to move.

[0390] Referring first to FIG. 42, a foot spacer 1006 and a base spacer 1008, each having a thickness equal to the thickness of the positioning device 1002, are placed on the operating table so as to provide a level surface. Foot spacer 1006 is formed, for example, of a high density foam. Base spacer 1008 preferably includes a plurality of rollers 1010 to permit the main pad 1012 (FIG. 44) to roll back and forth as the positioning ramp is raised and lowered or extended as previously described. A foot pad 1014 is also provided, and main paid 1012 and foot pad 1014 are of the same thickness so as to approximate the height of the head and neck support 1016 of the positioning device. Referring also to FIG. 43, the main paid 1012 includes a slatted or pleated base pad 1018 which allow the support structure to bend to support the elevation of the ramp over the range of the ramp extension. The assembled unit is shown in FIG. 45. Also, if desired, additional spacer pads 1020 may be inserted between the foot pad 1014 and the main paid 1012 when the positioning device 1002 is extended, to support taller patients. See also FIGS. 46A-46C.

[0391] While the invention has been described in detail with reference to exemplary embodiments thereof, various changes can be made, and equivalents employed, without departing from the scope of the invention. By way of example, the nasal mask, oral mask, and/or full facemask can be used for nebulizer treatments. Also, the nasal mask, oral mask, and full facemask can be used to measure End-Tidal CO2 (EtCO2) or capnography. Additionally, the nasal mask, oral mask, and full facemask also consists of patent tubing which consists of two ends to be used as an gas source to transport patients, where the distal end of the tubing is connected to either a stand alone or a portable generator for the supply of gas at a pressure below, equal to, or elevated above atmospheric pressure; a gas delivery conduit coupled to said generator a portable gas supply (oxygen, anesthetic gases, air, or any other gases) and the proximal end is connected to an adaptor, which contains an End-Tidal CO2 port, a nebulizer port, a PEEP valve port, expiratory port and/or valve, pressure relief valve, which has an aperture which attaches to either the nasal mask, the oral mask, or the full face mask.

[0392] In yet other embodiments the nasal mask, oral mask, and/or full face mask can be connected to a generator for the supply of gas, where the amount and concentration of gas delivered is controlled by the supply source as well as the expiratory port.

[0393] In yet other embodiments the nasal mask, oral mask, and/or full face mask can be used as a scavenger system by connecting the nasal mask and the oral mask simultaneously, where the nasal mask can be used to deliver positive pressure and the oral mask can be connected to a suctioning device to properly store and/or dispose gases.

[0394] A feature and advantage of the present invention is that the nasal mask will contour around the nasal bridge, nose, and upper lip in such a way that it and the generator gas supply it is connected to does not interfere with the operator's access to the mouth/oral cavity, lips, cheeks, chin, jaw, and neck.

[0395] Also, the nasal mask and full face mask can be connected to a resuscitator bag with or without a gas supply attached to the resuscitator bag. Still other modifications are possible. Still other features and advantages of the present invention include: [0396] Neck and head flexion for optimizing the view as well as achieving the Sniff position can be accomplished with one or some combination of the following: [0397] a. Neck Support Lift translation along the Z axis [0398] b. Head Support Lift translation along the Z axis [0399] c. Lift Support rotation about Linkage Axis 4 (X axis) (The head support lift and neck support lift are attached to the Lift Support) [0400] d. Note one embodiment may not have the Neck Support Lift [0401] The mask anchor anterior strap may have 2 or more straps with one strap securing the chin. [0402] The mask anchor straps attach to the top surface of the head support lift, that also contains a soft gel-like doughnut to support the head, with friction wedge. [0403] The top of the head support lift with a soft doughnut-like gel that supports the head is detachable from the Lift base. This allows the top of the head support lift with the gel doughnut and mask anchor to be secured to the patient if there is the need to move the patient to a different part of the OR table without the patient positioning device. [0404] The top of the head support lift is covered with a disposable barrier. The top of this barrier has an elastic strap taped to it that can be removed and posteriorly attach to the mask that also has an oxygen port. The ventilation port serves as a CO2 exhaust port when the oxygen line is attached to the oxygen port that supplies O2 to the patient. This allows the mask to also be used as an oxygen supply mask postoperatively. [0405] The mask anchor connection that holds the anterior mask straps as well as the posterior elastic strap wedge can be integrally part of the mask, as opposed to a separate component that was shown in other embodiments.

[0406] The foregoing description of the preferred embodiments of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed, and modifications and variations are possible in light of the above teachings or may be acquired from practice of the invention. The embodiments were chosen and described in order to explain the principles of the invention and its practical application to enable one skilled in the art to utilize the invention in various embodiments as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the claims appended hereto, and their equivalents. The entirety of each of the aforementioned documents is incorporated by reference herein.