Patent Description:
Oral surgery involves many procedures which include those performed on upper airways, tonsillectomy, adenoidectomy, palate surgery, tongue surgery, other transoral surgery, and certain dental procedures.

Upper airway surgery such as adenoidectomy and tonsillectomy are very commonly performed procedures on both children from 6months old up to adults. Over the last <NUM> years there has been an increasing trend to use "hot" instruments such as diathermy (mono-polar electro-cautery), coblation (bipolar electro-cautery) and LASER to dissect or remove tissue to minimize blood loss compared to old fashion scalpel techniques. The use of "hot instruments is now the standard and universal method. These instruments have a handle held by the surgeon, a shaft through which the current flows and a tip through which the electricity is applied to the tissue. The shaft has a thin layer of insulation.

There are two significant problems which are occasioned by the use of hot instruments such as a diathermy. The first is the risk of burning soft tissue causing patient trauma and scarring. The second is the emission of toxic gases and other noxious agents such as viruses. The risks to patients and theatre staff arising from the use of these "hot" instruments can be summarised as follows:
Burns to the corners of the mouth. This is a potentially devastating cosmetic and functional injury and can occur from heat transmitted through the shaft of the instrument. Faulty insulation in the shaft can lead to a direct electrical burn. Electricity passing/arcing to another instrument held against the corner of the mouth, can occur in the mouth (such as the metal sucker held by an assistant nurse).

Ignition of built up anaesthetic gases/ oxygen in the mouth can also cause a flash fire.

The shaft of a diathermy can become hot enough from transmitted heat during prolonged use in a procedure enough to burn soft tissues. There have been many reported cases of faulty insulation allowing electricity to emit from the shaft. During oral surgery using a diathermy, burning tissue causes an emission of a large plume of smoke which can potentially contain and carry viruses such as CJD, HPV, HIV etc as well as toxins which are the equivalent of smoking a packet of cigarettes per hour of exposure. Although the known dissection instrument has now changed to a "hot" dissector, the rest of the instruments and techniques have not changed or adapted from the time of "cold steel" dissection.

During oral surgery, a patient's mouth is held open for access to the surgical site. According to known methodology, a patient's mouth is held open by a Boyle-Davis gag. This holds the mouth open wide along a Y axis but offers little protection for the facial and mouth tissues and particularly for the corners of the mouth. The instruments are passed into the mouth with the shaft of the instrument lying against the corners of the mouth as the mouth is a confined space. Currently the corners of the mouth are not adequately protected during surgery. Some make-shift protection is offered by use of gauze squares folded up and draped about the corners of the mouth. Since this affords inadequate protection, the patient's tissue can be burnt away. Mouth burns during tonsillectomy is known in the medical literature. Burns around the lips and mouth - primarily from the use of a cauterizing device-are an underreported complication of tonsillectomy and can result in long-term problems, according to a study reported in the Archives of Otolaryngology and Head and Neck Surgery. Removal of the tonsils (along with the nearby adenoid glands) "remains one of the most commonly performed surgical procedures in the United States", (Dr. Park, of The University of Utah School of Medicine, Salt Lake City). While most patients do very well, a number of complications can occur, included bleeding, pain, and voice changes. In one study, a team conducted a review of children and teens who sustained a mouth burn during a tonsillectomy at Primary Children's Medical Center (PCMC) in Salt Lake City between January <NUM> and December <NUM>. In addition, they conducted an online national survey of pediatric ear, nose, and throat doctors. Of the <NUM>,<NUM> surgeries performed at PCMC, <NUM> patients sustained mouth burns, including one that required reconstructive surgery. Of <NUM> surveys sent to physicians, <NUM> were completed. A total of <NUM> respondents reported having a patient develop a burn around the mouth. Roughly <NUM> percent of the burns were severe, necessitating additional treatment. Most of the burns occurred when the tonsils were removed with devices used to cauterize the area. However, a few cases occurred even when a scalpel was the main instrument for removal and cautery was simply used to control bleeding. The most common cause of injury was a defective cautery device tip. The surgeon's experience level, by contrast, had no impact on the risk of a mouth burn. The authors concluded that "because tonsillectomy remains one of the most frequently performed procedures, measures to avoid this complication exist and should be considered for every case.

Permanent right corner of mouth and upper lip burn scars from tonsillectomy diathermy burn is a known risk of oral surgery, but there is little available to ensure that burns are prevented.

Currently gas emissions from burning tissue are arrested by a vacuum sucker which is held in the mouth by an assistant such as a theatre nurse. The sucker receives and evacuates the smoke that fills the mouth and obscures the surgeons view of the operating field. The surgeon's face (only covered by a thin mask) is very close to the patient's mouth. The nurse is also very close, so that both readily inhale smoke that emits during the procedure.

There are practical disadvantages arising from the use of the known equipment. For instance there is a need for nurse to stand for the duration of the surgery holding a sucker in the patient's mouth. This is laborious and tedious. It is also potentially dangerous as the sucker being waved in the mouth can damage teeth and other tissue. The sucker also obstructs the surgeon's view especially when operating in small mouths of infants. As uncuffed anaesthetic tubes are usually used for children, anaesthetic gases can leak into the mouth which, if not suctioned clear can be breathed in by and affect the surgeon and theatre personnel.

Accordingly, there is a long felt want to provide an insulation barrier to protect soft tissues from heat and burns during oral or dental surgeries. There is also a long felt want to provide an improved method of gas evacuation when soft tissues are burned during oral surgery. <CIT> discloses a dental prop, throat dam and retractor. <CIT> discloses a dental appliance. <CIT> discloses an instrument carrier for positioning a dental instrument. <CIT> discloses a dental retractor and saliva ejector.

Outlined broadly below are embodiments and features of the invention to enable the invention to be better understood, and in order that the present contribution to and improvement over the current the art may be better appreciated. There are, of course, additional features of the invention that will be described hereinafter and which will form the subject matter of the claims.

In this respect, before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways in various anatomical sites including in veterinary applications. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting. As such, those skilled in the art will appreciate that the conception, upon which this disclosure is based, may readily be utilized as a basis for the designing of other variations on the tool assembly, structures, methods and systems for carrying out the purposes of the present invention.

It is therefore an object of the present invention to provide a new and improved tool which removes the practical disadvantages encountered in oral surgery.

With the aforesaid prior art problems and disadvantages of current methodologies, the present invention provides improvement in devices used in oral surgery and more particularly provide a disposable soft tissue protector which protects such structures as corners of the mouth during surgery. More particularly the invention provides a device which protects oral tissues from burns and other potential damage which may be occasioned during oral surgery. More particularly the present invention provides a disposable guard which protects the soft tissues of a patient during surgery of the oral cavity and is capable of receiving and evacuating gasses created by hot instruments.

The present invention pertains to a protection device for use in oral surgery for providing a physical barrier between surgical instrumentation and a patient's soft tissue as claimed in claim <NUM>. Advantageous aspects of the invention are defined in the dependent claims <NUM>-<NUM>.

Preferably the body of the device is manufactured from materials selected from plastics, metals or a combination of the two. The device may be manufactured from other materials which are preferably pliable or plastic, electrically insulating and thermally inert. In this regard the device is capable of self locating and remaining connected to the mouth of a patient, protecting such areas as the corner of the mouth and lips. The design geometry can be varied to suit different anatomical sizes enabling staff to select a size suitable for a particular patient. Typically a surgeon will place a return portion over the lip margins and crimp it against the mouth using its inbuilt plasticity. According to one embodiment, a kit of protection devices can be provided allowing a surgeon to select a suitable size for a particular patient anatomy.

Preferably, the body of the device is manufactured from materials selected from plastics, metals or a combination of the two. The device is preferably manufactured from materials which are pliable and plastic, electrically insulating and thermally inert. The device is capable of self locating and remaining connected to the mouth of a patient, protecting such areas as the corner of the mouth and lips. The shape of the device can be varied to suit different anatomical sizes enabling staff to select a size suitable for a particular patient. The device has inbuilt plasticity to enable a surgeon to crimp the device over at least a portion of lip margins. According to one embodiment, the device is manufactured from a rigid material or combination of materials which are non pliable and pre set to accommodate a particular patient's mouth.

According to the preferred embodiment, the device minimises risks of tissue burning and gas ingestion in oral surgeries by: <NUM>. protecting the side of the mouth from thermal/electrical injury; and <NUM>. providing continuous suction to clear the mouth of smoke plume and gases to ensure a clear view, minimize the emission of smoke to the surgeon and staff and to negate the need for an oral sucker and a nurse to hold it.

These together with other objects of the invention, along with the various features of novelty which characterize the invention, are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and the specific objects attained by its uses, reference should be had to the accompanying drawings and descriptive matter in which there is illustrated preferred embodiments of the invention.

The present invention provides an alternative to the known prior art and the shortcomings identified. The foregoing and other objects and advantages will appear from the description to follow. In the description reference is made to the accompanying representations, which forms a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. These embodiments will be described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that other embodiments may be utilized and that structural changes may be made without departing from the scope of the invention as defined by the claims. In the accompanying illustrations, like reference characters designate the same or similar parts throughout the several views. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.

The invention will be better understood and objects other than those set forth above will become apparent when consideration is given to the following detailed description thereof. Such description makes reference to the annexed drawings wherein:.

The present invention will now be described in more detail according to a preferred embodiment but non limiting embodiment and with reference to the accompanying illustrations. The examples referred to herein are illustrative and are not to be regarded as limiting the scope of the invention. While various embodiments of the invention have been described herein, it will be appreciated that these are capable of modification, and therefore the disclosures herein are not to be construed as limiting of the precise details set forth, but to avail such changes and alterations as fall within the purview of the description.

<FIG> shows a perspective view of a mouth protecting device <NUM> according to a preferred embodiment. Protector <NUM> comprises a body <NUM> having a first end <NUM> and second end <NUM>. Second end <NUM> locates inside the mouth of a patient ( not shown) and first end <NUM> locates outside the mouth of a patient with return portion <NUM> defining a recess <NUM> which accommodates and wraps around the lips of the patient. Return portion <NUM> according to one embodiment, resiliently deformable and/or pliable and allows a surgeon to adjust to accommodate the patient's lip. Body <NUM> includes a planar region <NUM> which, when device <NUM> is in use, lies against the outside of the patient's cheek and provides protection while the mouth is held open during surgery, a physical barrier between surgical instrumentation such as a hot diathermy and the cheek and to some extent the buccal region.

Protector <NUM> includes tubes <NUM> and <NUM> adapted to respective edge regions <NUM> and <NUM> of body <NUM>. These may be integrally formed with body <NUM> or alternatively connected to body <NUM> depending upon particular design requirements and selected materials of construction. Tubes <NUM> and <NUM> are joined to a vacuum line which evacuates gases from the surgical field ( see <FIG>). Tube <NUM> has a first end <NUM> which when device <NUM> is in use locates inside a mouth of a patient and a second end <NUM> which terminates outside the mouth. Likewise tube <NUM> has a first end <NUM> which, when device <NUM> is in use, locates inside a mouth of a patient and a second end <NUM> which terminates outside the mouth. According to one embodiment, tubes <NUM> and <NUM> each include respective through passages <NUM> and <NUM> which provide a suction paths to evacuate the toxic gases which accumulate at the site of the oral surgery. Ends <NUM> and <NUM> engage a gas discharge tube ( see <FIG>).

<FIG> shows with corresponding numbering a rear perspective view of the protector <NUM> of <FIG>. <FIG> shows with corresponding numbering a side perspective view of the protector of <FIG>.

<FIG> shows a side elevation view of the protector of <FIG>. <FIG> shows a front elevation view of the protector of <FIG>. <FIG> shows a top elevation view of the protector of <FIG>.

<FIG> shows a plan view of an open mouth <NUM> of a patient with a first protection device <NUM> and opposing second device <NUM> respectively engaging lip regions <NUM> and <NUM>. Protector <NUM> comprises a body <NUM> having a first end <NUM> and second end <NUM>. Second end <NUM> locates inside the mouth <NUM> and receives lip region <NUM> in recess <NUM> defined by radiused return <NUM>. Likewise protector <NUM> comprises a body <NUM> having a first end <NUM> and second end <NUM>. Second end <NUM> locates inside the mouth <NUM> and receives lip region <NUM> in recess <NUM> defined by radiused return <NUM>. Return portions <NUM> and <NUM> are pliable and allow a surgeon to adjust to accommodate the patient's lip regions <NUM> and <NUM> respectively. According to one embodiment, return portions <NUM> and <NUM> are pliable and resiliently deformable. Body <NUM> of device <NUM> and body <NUM> of lie against and protect cheeks <NUM> and <NUM> respectively and provide a physical barrier to unwanted instrument contact with the patient.

Protection device <NUM> includes tubes <NUM> and <NUM> adapted to respective edge regions of body <NUM>. Tubes <NUM> and <NUM> are joined to a vacuum line <NUM> which evacuates gases away from the surgical field to a collection unit or other known collector. Likewise, protection device <NUM> includes tubes <NUM> and <NUM> adapted to respective edge regions of body <NUM>. Tubes <NUM> and <NUM> are joined to a vacuum line <NUM> which also evacuates gases away from the surgical field to a collection unit or other known collector. Although the arrangement in <FIG> employs bilateral opposing like devices, it will be appreciated by persons skilled in the art that the following combinations can also be employed: one device with gas evacuation tubes, two devices but only one with gas evacuation tubes.

<FIG> shows with corresponding numbering, the protection devices <NUM> and <NUM> of <FIG> each connected to respective vacuum discharge lines <NUM> and <NUM> which both terminate in a single line <NUM> en route to the gas collection apparatus (not shown).

<FIG> shows a perspective enlarged view of a smaller version of a protective device <NUM> according to one embodiment connected to a vacuum tube <NUM>. Protector <NUM> comprises a body <NUM> including a planar region <NUM> and tubes <NUM> and <NUM> preferably integrally formed with body <NUM>. Tubes <NUM> and <NUM> are joined to vacuum line <NUM> which evacuates gases from the surgical field ( see <FIG>).

<FIG> shows a more elongated version of a protective device <NUM> according to another embodiment. Protector <NUM> comprises an elongated body <NUM> including a planar region <NUM> having significantly increased surface area and elongated evacuation tubes <NUM> and <NUM>. Tubes <NUM> and76 are joined to vacuum line <NUM> which evacuates gases from the surgical field.

The vacuum tubes preferably enter the mouth to a depth as far as possible. The mid tube lengths of the vacuum tubes are preferably around <NUM> long and are press fit into a Y shaped joiner. Preferably the width of the lip protector moulding and tube would be in the region of <NUM> - <NUM> but other sizes are contemplated to accommodate different sized patient anatomies.

According to one embodiment, the device is constructed flat with built in capacity for bending into shape by a user. The pliability may be introduced using an internal membrane in the body. In a further embodiment, the protection device comprises a moulded silicone body which is contoured to slide over a patient's lip and clamp lightly on walls of the cheek. The clamping force can be adjusted by the surgeon when locating the device on the patient's mouth. Incorporated in the moulded silicone are tubes which have a first end which locates in the mouth when the device is in situ and a second end extending outside the mouth. Each tube has a through passage which spans between the first and second ends. The tubes have an inside diameter within the range of <NUM>-<NUM> and an outside diameter within the range of <NUM>-<NUM>. A preferred tube size is <NUM> inside diameter and <NUM> outside diameter. Preferably the tubes are clear and either bonded to guide channels or moulded integral with the body of the device.

According to a preferred embodiment the device is malleable and easily applied for self - retention in a corner-of-the-mouth. Preferably, during surgery there is provided one on each side of the patient's mouth. Preferably one or both of the devices include integral suction tubes incorporated into the body of the device with the tubes being connected to known standard suction tubing. The protection device preferably has a length within the range <NUM> - <NUM> but alternative sizes are contemplated. Materials of construction are selected from smooth, heat resistant, non reflective, semi-firm material, plastic/silastic or a coated thin malleable metal with a heat/electricity insulating coating. Selecting a malleable material allows the device to engage the lip region of the mouth and with sufficient clamping elasticity in the material to stay in place during surgery. This eliminates the need to use inefficient wet gauze squares which are currently in use and sit on the corners of the mouth.

Preferably the device is single use and disposable although materials capable of sterilization are contemplated. Although the embodiments shown incorporate two lateral suction tubes, alternative embodiments are contemplated, such as but not limited to, use of one suction tube, location of a tube or tubes intermediate the edges or a tube which can be attached as required to the protection device. As the suction is of a smoke plume, rather than fluid, the suction tubes/canulas do not need to be wide bore. The radii of curvature of the tubes and angles of repose are adapted to suit particular mouth geometry as required and to facilitate passage of gases. The suction tubing would preferably be around <NUM> long with an end able to be attached to standard suction tubing. In a further embodiment, the suction tube includes a form of double adaptor so that theatre wall suction tubing can be used for both this device and a standard gas sucker. Typically the devices are provided in a sterile, disposable kit including those with and without suction tubes and adaptors as required. The device described herein improves patient safety and is convenient for staff application.

Claim 1:
A protection device (<NUM>) for use in oral surgery for providing a physical barrier between surgical instrumentation and a patient's soft tissue,
the device comprising :
a device body (<NUM>) having :
- a first end (<NUM>) which, during use, locates outside a patient's mouth and a second end (<NUM>) which, during use, locates inside the mouth of the patient;
- a planar region arranged to oppose an adjacent inside surface of the mouth and an integrally connected cheek engagement portion formed from the same material, each having common side edges;
- a substantially U-shaped return portion (<NUM>) through which the device body (<NUM>) transitions from the planar region inside the mouth to the cheek engagement portion outside the mouth,
the return portion (<NUM>) defining a recess (<NUM>) configured to accommodate and wrap about the lips of the patient;
wherein the return portion (<NUM>) is pliable enabling the device (<NUM>) to accommodate an anatomical shape of the patient's mouth and to be crimped over at least a portion of the patient's lip margins, the device body (<NUM>) including tubes (<NUM>,<NUM>) each one having a first end (<NUM>,<NUM>) configured to locate outside the mouth and a second end (<NUM>,<NUM>) configured to locate inside the mouth and each having a through passage extending from the second end (<NUM>, <NUM>) to the first end (<NUM>, <NUM>).