Abstract:
An intra-oral cavity device for preventing contact between upper and lower teeth of an anesthetized patient. The device includes an elongate pillow that when gripped between the teeth of a patient, prevents contact between the teeth and/or gums and thereby prevents damage to the teeth and/or gums. The pillow may be made of a fibrous, porous and/or absorbent material. The device is adapted for single use and thus disposal after use by a patient. A method of the use of performing surgery using such a device is also provided.

Description:
BACKGROUND OF INVENTION  
         [0001]    Many surgical procedures are performed while the patient is anesthetized. While under the influence of the anesthesia, the surgical patient oftentimes will incur damage to their teeth. Typically, the damage is done while the patient is going under or waking up. During surgery, the patient is oftentimes given muscle relaxers which reduces hard biting and grinding reducing the risk of tooth damage during this portion of the surgical procedure. Teeth can break from hard biting or damage can be due to grinding of the teeth which can produce chipped teeth and even broken teeth. Additionally, during some surgical procedures, the anesthetized patient will have an endotracheal tube or an LMA (laryngeal mask airway) inserted between the teeth and partially down the throat for providing air and/or other gases to the lungs. This tube can exacerbate surgical problems of the surgical patient by the patient biting down which can crimp the hose thereby limiting or preventing flow of gas therethrough possibly causing pulmonary edema, hypoxia, hypercabia or perhaps cause damage to the front teeth. As few as two missed breaths can injure the patient, including causing pulmonary edema. If teeth are damaged they need to be repaired which adds to the expense of the surgical procedure. It is not uncommon for the surgeon to pay for dental work rather than turn a claim over to their insurance carrier because of the potential increase in insurance premiums.  
           [0002]    While devices are known for placing between a patient&#39;s teeth to prevent tooth damage, they have drawbacks. For example, mouth guards such as those worn by athletes need to be formed to shape prior to use. They are also placed between all of the teeth preventing access for a gas tube as is sometimes required for surgery. Further, such guards tend to be expensive and require effort by the hospital staff and patient to make ready to use. Other tooth guards are known and are made out of either plastic or other elastomeric material, therefore, for all practical purposes are non-porous and are also relatively thin in the area between the teeth. Because they are thin, the teeth are not spaced far enough apart to provide access for the gas tube. If such polymeric or plastic guards are made thicker, then the weight and expense likewise increase and are non porous or absorbent. Further, plastic or elastomeric guards, even though resilient, have little deformation under load and if the teeth are opened slightly, then there is no more tooth force on the guard to retain it in place between the teeth. Elastic and polymeric materials can, when deformed in one direction, apply relatively high resulting forces in other than the direction of compressive biting force which could cause unwanted lateral forces on the teeth. Elastomeric and polymeric protectors may also be cut by some teeth in use risking severing a portion that could injure the patient.  
           [0003]    It is also recommended to monitor certain physiological aspects of a patient during surgery, e.g., the patient&#39;s temperature. Also, some patients will expectorate fluids, such as bile or stomach contents into the oral cavity potentially causing problems. Temperature sensors such as those carried by esophageal stethoscopes are used to monitor a patient&#39;s temperature by contacting the soft tissue in the oral cavity with the sensor which is connected to a monitor showing and/or recording the sensed temperature. Temperature monitoring is important to keep the patient from getting too cold or too hot.  
           [0004]    There is thus a need for an improved surgical device to protect teeth and/or gums from damage during the surgical procedure.  
         SUMMARY OF INVENTION  
         [0005]    The present invention involves the provision of a surgical device for use intra-orally to guard teeth and/or gums from damage when the surgical patient is anesthetized. The device includes a pillow comprising a porous, absorbent and/or fibrous material having one transverse dimension adequate to hold the teeth spaced apart sufficient under biting load to allow the use of a gas tube inserted between the front teeth. The length of the pillow can be such as to allow a portion to be placed between the teeth from the rear of the teeth toward the front of the teeth having sufficient length left over to be extra-oral to provide for grasping for insertion and removal and to allow a member of the surgical team to monitor the location of the pillow during surgery. Means is provided to maintain the pillow as a monolithic structure preventing portions of the pillow from separating during the surgical procedure. A tab may be provided for positioning extra-orally to assist in removal and may be secured as by taping to the patient to help secure the pillow in place.  
           [0006]    The present invention also allows for the provision of, in a surgical patient, a pillow positioned in an oral cavity. A portion of the pillow is positioned between teeth in the oral cavity while being adapted to also have an extra-oral portion projecting from the oral cavity. The portion between the teeth and/or gums holds the teeth and/or gums spaced apart. The pillow is elongate and comprises absorbent, fibrous and/or porous material and has a relaxed transverse dimension adequate to allow for it to be retained in place during movement of the teeth and/or gums during the surgical procedure and to keep the teeth and/or gums separate when biting force is applied thereto. Means is associated with the pillow and maintains the pillow as a monolithic structure both inside and outside of the oral cavity.  
           [0007]    The invention is also directed to the provision of a method of treating a surgical patient by preparing a patient for surgery with the patient having an oral cavity. At least one pillow is placed in the oral cavity whereby a portion of the pillow may be extra-oral and at least a portion of the pillow is intra-oral. The pillow is elongate and comprises absorbent, fibrous and/or porous material. A portion of the intra-oral portion of the pillow is positioned between molars and/or molar gum area to maintain the teeth and/or gums in the oral cavity spaced apart during at least a portion of the surgery. Surgery is performed on the patient with the pillow being retained between the teeth and/or gums of the patient by the patient. After surgery, the pillow is removed from the oral cavity and disposed of. 
       
    
    
     BRIEF DESCRIPTION OF DRAWINGS  
       [0008]    [0008]FIG. 1 is a perspective view of an intra-oral cavity surgical device shown in place in a surgical patient with the patient being shown.  
         [0009]    [0009]FIG. 2 is an enlarged perspective view of an oral cavity with a pair of the surgical devices in place.  
         [0010]    [0010]FIG. 3 is a perspective view of the intra-oral surgical device with portions broken away to show internal details.  
         [0011]    [0011]FIG. 4 is a fragmentary perspective view of an alternate embodiment of the present invention.  
         [0012]    [0012]FIG. 5 is a fragmentary perspective view of a second alternate embodiment of the present invention. 
     
    
       [0013]    Like numbers throughout the various figures designate like or similar parts.  
       DETAILED DESCRIPTION  
       [0014]    As illustrated in FIGS. 1 and 2, a surgical patient, such as a human, has an oral cavity  5  in which is placed one or more cushion devices. During surgical procedures, a tube  7 , e.g., an endotracheal tube or LMA, may be inserted into the oral cavity to provide gas for the surgical patient or for other purposes. Gas is supplied from a source  8  of gas such as a pressurized tank or a pump. The oral cavity  5  includes teeth projecting from gums  10  with the teeth including front teeth designated generally  11  and molars designated generally  12 . The teeth  11  and  12  are in both the upper (maxilla) and lower (mandible) jaws  14  and  15  respectively. It is to be noted that some patients may not have teeth or only a few teeth or false teeth and therefore, as used herein and in the claims, between the gums means between the upper and lower teeth, where and if present, and/or gums unless otherwise indicated. Even though a portion of the device  3  may be between teeth, it is also between the gums. False teeth are usually removed from a patient prior to being anesthetized.  
         [0015]    As best seen in FIGS. 1 and 2, an intra-oral device  3  that includes a pillow  21  that is shown in detail in FIG. 3, is positioned between the upper and lower-jaws  14  and  15  on at least one side of the mouth or one on each side of the mouth, to be retained between the upper and lower gums along the side gums and if the patient has teeth, between the upper and lower rear teeth  12 .  
         [0016]    As seen in FIG. 3, an intra-oral cavity cushion device  3  is provided. The device  3  includes a pillow  21 , a finger tab  24  and means designated generally  26  for maintaining the pillow as a monolithic structure during storage, use and removal. In the form of the invention shown in FIG. 3, the pillow  21  is comprised of a fibrous and/or porous (formed by interstitial spaces between the fibers and threads) material such as absorbent cotton. The fibrous material may be woven, knit or felt which is absorbent and porous and may be of natural fiber or synthetic fiber or a combination thereof. In a preferred embodiment, the material can be a cotton gauze  22  (a woven material) rolled into an elongate roll. The tightness of the roll will determine the firmness and compressibility of the pillow  21 . It is preferred that under the anticipated force of biting by the patient, that when compressed, the pillow have a transverse dimension of at least about ¼ inch and preferably between the gums in the range of between about ¼ inch and about ½ inch to provide adequate space between the front teeth and/or gums  11  for the tube  7  to prevent its being occluded. Preferably, the gauze is a woven gauze as is well known in the art and can be clean and/or sterile as delivered to the surgeon for use. It has been found that a pillow  21  having a transverse dimension, which for example, in a round cross section execution is the diameter of the pillow  21  with a diameter being at least about ⅜ inch and preferably in the range of between about ⅜ inch and about 1 inch (in a relaxed or unloaded condition) to provide sufficient support to hold the teeth spaced adequately for positioning the tube  7  between the front teeth. The pillow  21  has two portions which will vary in length depending on the patient&#39;s teeth and/or gum size. An intra-oral portion is designated by the bracket  29  and an extra-oral portion is designated by the bracket  30 . In a preferred embodiment, the length of the pillow  21  designated L in FIG. 3 is in the range of between about 1½ inches and about 3½ inches. Typically, the intra-oral portion  29  has a length in the range of between about 1½ inches and 2½ inches with the remainder, if any, of the length of the pillow  21  being the extra-oral portion, i.e., that portion that may project from the patient&#39;s mouth during use. The size of the oral cavity, gums and/or teeth of the patient and/or how far in the pillow needs to be inserted will determine how much of the pillow is intra-oral and how much is extra-oral. In some cases, the entire length of the pillow may be intra-oral.  
         [0017]    In the form of invention shown in FIG. 3, the pillow  21  comprises a fibrous woven gauze. The pillow can be advantageously produced by forming the gauze  22  into a roll. This can be accomplished by rolling five three by three inch squares of gauze, each having four layers of material. The exterior layer can be an unfolded layer of gauze  32  having two layers wrapped tightly around the inner layers of gauze. Such an execution is particularly advantageous when making the pillow  21  by hand. In mass production, other forms and arrangements of fibrous material may be used. For example, the inner layers of material may be random fibers or random pieces of woven, knit or felt like material wrapped inside an outer layer which forms a continuous sheet of material enclosing the inner material.  
         [0018]    A finger tab  24  is provided to assist in handling of the pillow  21  by the surgeon or other personnel working in the operating room, for example, the anesthesiologist. The finger tab  24  is preferably flexible to help prevent injury to the patient and to provide a means of securing the intra-oral device to the patient. A preferred finger tab  24  is an elongate ribbon of adhesive backed fabric having one end projecting from an end of the pillow  21  and a portion of the length thereof positioned between contacting surfaces of the material forming the pillow  21 . The tab  24 , for example, can be a synthetic or natural fiber material, can have a width in the range of between about ¼ inch and about ½ inch, and is clean and/or sterile when used by medical personnel. The tab may also be polymeric. The tab  24  in a preferred embodiment has the exposed end thereof folded over where two adhesive backed face portions  31  engage one another such that the tab is substantially free of adhesive on at least two exterior surfaces, i.e., the adhesive is not generally exposed. The other end  34  has exposed adhesive that adheres the tab  24  to the pillow  21 , for example, by adhesively being secured to a layer of a sheet of the fabric comprising the pillow  21 , either one of the interior sheets or the exterior sheet.  
         [0019]    Means  26  is provided to retain the pillow  21  as a monolithic structure with a sheet exterior. In the case of the structure illustrated in FIG. 3, the means  26  includes a retainer  33  that prevents the exterior sheet and interior material from unrolling or separating. The retainer  33  includes an adhesive tape such as Tegaderm which can encircle the pillow  21  around a substantial part thereof and is secured to the exterior fabric sheet or encircle the entirety of the pillow&#39;s outer periphery and be secured to itself and the exterior fabric sheet. It also may extend along substantially the entire length of the pillow. The retainer  33  preferably bridges the exposed end  35  of the exterior fabric sheet of the pillow  21  and is adhesively secured to the pillow material on both sides of the end  35  to prevent unrolling. The tape comprising the illustrated retainer preferably has an adhesive coating that is water resistant to prevent the adhesive from becoming unattached from the pillow  21  or itself when moisture from the oral cavity is exposed thereto or from the pillow if wetted prior to use. The tape should be flexible and be cut and tear resistant and may be polymeric. Adhesive tape is particularly advantageous because it will not cause any physical damage to the patient and is readily flexible to conform to the shape of the pillow when it is either stored or deformed during use. A shrinkable polymeric tube or elastic band can be used as an alternate to or in combination with an adhesive tape retainer  33 .  
         [0020]    [0020]FIG. 4 shows a first alternative embodiment of the present invention and comprises a pillow designated generally  51 . In this alternate form of invention, the pillow  51  is comprised of a tubular covering or sock  53  which can be made of a sheet of woven, knit or felt fabric made of fibrous material such as natural, synthetic or a combination of fibers like cotton, polyester or the like. The cover  53  may be formed with a seam or seamless in its elongate or longitudinal dimension and has normally closed ends  55 , only one being shown in FIG. 5. The cover  53  has an interior  57  that can be filled with fibrous, porous and/or absorbent material  58  such as natural or synthetic fibers like cotton or polyester, a sponge-like material such as cellulosic or elastomeric sponge. The fibrous material may be random fibers compressed in the covering  53  or rolled sheet material. As shown, one end  55  has a selectively sealable opening  59  that can be expanded or contracted by use of a drawstring  61 . The material  58  may be inserted through the opening  59  and then by pulling of the drawstring  61 , the opening  59  can be closed to prevent loss of the material  58 . The drawstring  61  can also serve as a finger tab like the tab  24 . The dimensions and compressibility of the device  51  can be the same as the dimensions and compressibility of the device  21 . Further, the drawstring  61  serves the same function as the tape  33  providing means for preventing the material  58  from separating from the pillow and retaining the pillow as a monolithic structure.  
         [0021]    [0021]FIG. 5 shows a second alternative embodiment of the present invention. In this embodiment, the pillow designated generally  71  is made of a foam or sponge-like material either cellulosic or elastomeric with interstitial voids. The pillow  71  has the same dimensions and characteristics as those described for the pillows  21  and  51 . The pillow  71  may include a tube such as the tube  53  shown in FIG. 4 or may have the exterior of the foam material exposed for contact with the patient. The pillow  71  may be made by rolling the foam or sponge material  72  in a spiral or other suitable pattern like the pillow  21 . Also, the pillow  71  is a monolithic structure and may be made by forming the pillow such as by cutting or molding, not requiring any additional rolling or the like. A tab  24  may be provided by adhesively securing it to the pillow  71 . Alternatively, a slot or opening  75  may be cut or otherwise formed in the pillow  71  with the tab  24  having a portion thereof inserted into the slot  75  and being adhesively secured to the pillow  71 . If the pillow  71  is made by rolling foam or sponge material in a spiral pattern or other pattern (as shown), then the tab  24  may extend through the opening  75  and be secured between surfaces of the foam comprising the pillow  71  as the tab  24  is secured in the pillow  21 . In the event the pillow is made by rolling foam material, means  26  such as that used for the pillow  21  may be utilized to retain the pillow  71  as a monolithic structure during storage and use.  
         [0022]    In use, any of the three disclosed embodiments or other embodiments of the present invention are used during a surgical procedure where the patient is anesthetized by having a sheet of fabric such that the exterior and interior material will remain as part of the intra-oral device and the device will remain as an integral structure. Further, the use of a retainer as described also helps prevent the dislodging of fibers from either the interior or exterior of the device as well as reducing the shearing of any material from the device if it is of a foam or sponge-like structure. Prior to being anesthetized, the size of the oral cavity will be estimated to determine the appropriate size of device and pillow. Prior to inserting the device into the oral cavity and between the gums, the pillow may be wetted with water, but is preferred that the pillow be able to absorb water in an amount of at least about ¼ of its relaxed volume. The mouth of the patient is opened and the device is installed. Only one may be used or alternatively, one between each side of the mouth leaving, if desired, an extra-oral portion and the tab positioned extra-orally. By wetting the device, the device can be conformed to a shape with the wetness helping the device retain that shape to facilitate insertion of the device in the appropriate location in the mouth. Further, wetting can help reduce mouth dryness during the surgical procedure. If desired, the finger tab  24  may be secured to the patient, for example, by taping it to the cheek which will help prevent dislodgment of a pillow  21  from the mouth and to help retain it in place. Alternately, the tab  24  may be provided with an adhesive surface allowing the tab to be directly secured to the patient. In such an execution, the adhesive surface may be covered with a removable member such as those used on bandages to allow for convenient storage and handling. After insertion of one or two devices  3  into the oral cavity, the surgical procedure is performed once the patient is adequately anesthetized. After being anesthetized, an LMA or an endotracheal tube may be inserted into the oral cavity as is known in the art and preferably is inserted prior to insertion of the device  3 . After the surgical procedure is completed, the patient is allowed to wake up while retaining the device(s)  3  in place between the gums. Two of the devices may be secured together with their respective tabs or with a common tab. After the patient has adequately awakened, the device may be removed from the oral cavity. In the event the tab is secured to the patient, it is separated from the patient prior to removal of the device. The device  3  may then be disposed of in an appropriate manner.  
         [0023]    [0023]FIG. 5 shows an additional embodiment of the present invention. This embodiment may be utilized in any of the embodiments of the invention. One or more sensors  81  are carried by the pillow  71  and are operable to sense a condition or change in condition in the oral cavity such as the patient&#39;s temperature. Also, on occasion, a patient will expectorate bile or stomach contents which can eventually get into the lungs causing damage due to acidity thereof. The sensor  81  can be connected to an apparatus such as a monitor  83  which would sound an alarm or provide some other visual or audio signal indicative of the fluid coming into the mouth. The presence of such fluid can be indicated by a change in pH, a change in the moisture content of the pillow or by sensing for certain gases in the oral cavity. In a preferred embodiment, the sensor  81  would sense for a change in acidity and a signal from the monitor  83  would be provided to surgical personnel to indicate the presence of such fluid allowing the personnel to remove or otherwise handle the expectorated fluid. The sensor  81  may also be operable to sense for moisture, e.g., by a change in conductance. The sensor  81  may also be operable to sense a patient&#39;s temperature. Such a temperature sensor can be a thermocouple, which can be shielded for safety. The sensor  81  could also sense a plurality of such conditions. The shielding of the sensor  81  can be a resilient cover, such as a soft plastic, to protect the teeth and oral cavity tissue from damage and the shield can be positioned to contact tissue in the oral cavity. The sensor  81  can also be shielded by being imbedded inside the pillow. The sensor  81  can extend through the pillow  71  from end-to-end extending from the ends if desired. If shielding is not desired, the sensor  81  may be affixed to the exterior of the pillow as desired. Shielding may be partial or total.  
         [0024]    The use of the described pillow permits easy temporary mounting of the sensor to the pillow as well as easy adjustment of the position of the sensor.  
         [0025]    As is evident from the foregoing description, certain aspects of the present invention are not limited by the particular details of the examples illustrated herein and it is therefore contemplated that other modifications and applications, or equivalents thereof, will occur to those skilled in the art. It is accordingly intended that the claims shall cover all such modifications and applications that do not depart from the spirit and scope of the present invention.  
         [0026]    Other aspects, objects and advantages of the present invention can be obtained from a study of the drawings, the disclosure and the appended claims.