Intra-oral ice pack

A sealed envelope or enclosure, shaped to fit a portion of the internal anatomy of the human mouth at a surgical site, said enclosure containing a non-toxic liquid or gel material capable of freezing to a semi-solid or solid state. The envelope may also contain a binder such as a sponge material or gauze impregnated with the liquid or gel material. The enclosure is placed in the mouth, to provide both pressure and cold, to reduce bleeding, swelling and pain after oral surgery or trauma.

BACKGROUND OF THE INVENTION
 The invention comprises a reusable or disposable intra-oral ice pack for
 the reduction of swelling and the relief of pain resulting from dental
 surgery or trauma to the human mouth, palate, lips, cheeks or gums. It is
 made to fit any oral site such as the lingual, buccal, labial, palatal,
 gingival or mucosal areas of the mouth. The intra-oral ice pack is shaped
 to fit firmly against a portion of the upper or lower oral cavity for use
 during post-operative oral surgery or following trauma to the mouth.
 The usual method of reducing swelling in the mouth area is the application
 of an ice pack, having water or some other liquid or semi-solid substance
 as its temperature storage medium, externally to the face, in the area
 adjacent the mouth, cheek or jaw. The patient is usually given an ice pack
 with instructions to hold the pack on the face with one or two hands
 following surgery. It is a major problem for the patient to comply because
 it interferes with the patient's use of his hands for other needed
 purposes.
 The use of ice packs is common for the effective treatment of bleeding,
 pain and swelling in maxillofacial and oral surgery as well as traumatic
 injury. The application of ice to the affected area in the first hours
 after surgery or injury reduces swelling at the site, thereby reducing
 pain. Bleeding is also substantially minimized as local blood vessels are
 constricted by the application of cold locally to the affected site. To
 reduce swelling in the mouth, the current practice is to apply an ice pack
 externally to the face in the mouth, cheek or jaw region.
 One type of internal cold pack has been suggested in U.S. Pat. No.
 4,983,122 to Mitnick, however his device is a U-shaped mouthpiece, with
 thermal bags adapted to be attached where desired, and suffers from being
 too large and uncomfortable for the patient and not capable of reaching
 certain affected areas. In addition, his added bags are susceptible of
 coming loose from the base to which they are attached, which can be
 dangerous for the patient. In addition, Mitnick does not use or disclose a
 binder, which makes his device less flexible and thus uncomfortable for
 the patient.
 Cold packs are generally comprised of a flexible envelope or enclosure
 enclosing water or a chemical gel which serves as a temperature storage
 medium. The enclosure is usually made of a thermoplastic film such as
 polyethylene or polypropylene containing a liquid or gel which has a low
 freezing point. Preferably, the gel maintains its gel-like consistency
 over a wide range of temperatures and is non-toxic. The envelope or ice
 pack containing the ingredients specified is put into a freezer or other
 chilling device for a short period of time to reach the desired
 consistency and temperature.
 OBJECTS OF THE INVENTION
 Accordingly, several objects and advantages of the invention are as
 follows:
 It is an object of this invention to provide a removable, disposable ice
 pack for the reduction of swelling and the treatment of pain following
 dental or oral surgery, trauma to the human mouth, palate, or gums.
 It is another object of this invention to provide an ice pack which may be
 applied to the internal portions of the upper or lower oral cavities of
 the human mouth to reduce swelling and pain.
 It is a further object of the invention to provide an ice pack which is
 shaped to fit and be retained in various portions of the mouth.
 It is yet a further object of the invention to provide an ice pack for oral
 use which provides sterile cold directly and more efficiently to the site
 of the surgery.
 Still a further object of the invention is to provide an intra-oral ice
 pack which also applies pressure on the surgical site which acts as a
 surgical dressing to minimize bleeding.
 Another object of the invention is to provide an intra oral ice pack which
 frees the patient's hands allowing him or her to conduct other normal
 activities.
 Still another object of the invention is to provide an intra-oral ice pack
 which is non-toxic, sterile and reusable, if desired.
 Further objects and advantages will become apparent from a consideration of
 the following description and drawings.

DETAILED DESCRIPTION OF THE INVENTION
 Referring now to FIGS. 1 and 2 there is shown the upper teeth 10, upper lip
 12, nose 14 and hard palate 16 of a patient. An intra-oral ice pack 18 is
 shaped to fit the area of the hard palate 16. Ice pack 18 may be shaped to
 fit any particular area of the mouth so that it will press firmly against
 an area within the mouth that requires the application of cold to stop
 bleeding and reduce swelling as well as reducing pain associated with oral
 surgery or trauma. In the case of the upper palate 16, the intra-oral ice
 pack 18 is dome shaped (convex) so that it fits well against upper palate
 16 and so that the outer edge 19 of intra-oral ice pack 18 fits firmly
 against the palatal tissue adjacent all of the upper teeth 10. The firm
 fit produces pressure against the treated area, a well as cold, both of
 which reduce bleeding and pain.
 FIG. 3, which is a cross-section of FIG. 1, shows that intra-oral ice pack
 18 comprises an outer envelope 20, containing a binder 22 which is
 impregnated with a liquid 24. Liquid 24 surrounds binder 22 as well as
 impregnating it. The intra-oral ice pack is also effective without the
 binder 22, however the binder 22 will allow the ice pack to be more
 flexible.
 Envelope 20 is made from a convenient non-toxic material such as a
 transparent thermoplastic film such as polyethylene, polypropylene,
 polyethylene terephthalate or similar materials which are flexible, tear
 resistant and puncture resistant. Binder 22 can be made of any convenient
 material which is non-toxic and which can absorb a liquid so that it is
 impregnated with the liquid. Liquid 24 fills envelope 20 fully both
 impregnating binder 22 and surrounding it with excess liquid to
 substantially fill envelope 20. Binder 22 can be a sponge, cotton or
 typical medical gauze folded in several thicknesses or any other non-toxic
 material that will absorb the liquid and remain somewhat flexible when
 frozen at standard freezer temperatures, which range from about minus 10
 degrees F. to about 20 degrees F.
 Liquid 24 is a non-toxic temperature storage medium having a somewhat gel
 type consistency when at room temperature, and semi-rigid to rigid
 consistency after removal from long-term freezer storage. The liquid
 generally comprises water with a freezing point depressant such as salt,
 glycerine or propylene glycol, with a thickening agent such as a starch,
 cellulosic, or a proprietary gelling agent such as a carbomer, for
 example, Carbopol.RTM. manufactured by BF Goodrich Co.
 Antimicrobial additives may be added to minimize the potential for
 bacterial or mold growth such as a combination of parabens, which are
 recognized in the Food Chemical Codex as accepted food additives when used
 at proper concentrations. Other antimicrobial agents such as Dowicil.RTM.
 products produced by Dow Chemical Company may also be used.
 When placed in a standard freezer for at least 2 hours, an intra-oral ice
 pack using 2+2 gauze impregnated with the above formula in a polyethylene
 envelope will become flexibly ice cold and be ready for use. Since it is
 somewhat flexible it will mold to the exact shape of the affected site to
 deliver more cold to the site. It can thus be made to fit any oral site
 such as the lingual, buccal, labial, palatal, gingival or mucosal tissues
 of the mouth. As can be seen, it must be manufactured in specific shapes
 to fit the contour of each section of the mouth where it is to be used.
 Although it is flexible in its cold state, which helps in achieving good
 contact with the affected area, it is not flexible enough to fit every
 portion of the mouth. The shape of the inta-oral ice pack must be very
 diferent for the buccal area of the mouth as opposed to the palatal area.
 An external insulation layer 64 (as shown in FIG. 9) may be affixed to the
 outside of envelope 20, such as on dome portion 21 of ice-pack 18, to
 protect upper palate 16 from the effects of the cold. This would be done
 if it is desired to have the cold concentrated only on the teeth 10 and
 the gum tissue adjacent teeth 10 and not on upper palate 16 itself. On the
 other hand, if it was desired to concentrate the cold on the upper palate
 and not on the teeth or the gum tissue of the teeth, an outside insulation
 layer would be affixed along the edge 19 of ice pack 18.
 FIGS. 4 and 5 show another embodiment of the invention for the lower teeth
 26 and lower palate 28, with the tongue 30 pulled back. The intra-oral ice
 pack 32 comprises an outer envelope 34, an inner binder 36 and fluid 38,
 impregnating binder 36 and filling envelope 34. The ice pack is shaped to
 fit the lingual or lower teeth area, and provide cold treatment to the
 lower palate 28 and/or inner surface of the lower teeth 26 and gums 27.
 The lower palate inta-oral ice pack is substantially oval shaped with a
 flat side 25 adjacent teeth 26 and gums 27, supporting teeth 26.
 An external insulation layer (as shown in FIG. 9) may be affixed to the
 outside of envelope 20, such as on the lower side of ice-pack 32, to
 protect lower palate 28 from the effects of the cold. Again, this would be
 done if it is desired to have the cold concentrated only on the lower
 teeth 26 and the gum tissue 27 adjacent teeth 26 and not on lower palate
 28 itself. On the other hand, if it was desired to concentrate the cold on
 lower palate 28 and not on teeth 26 or gum tissue 27 of teeth 26, an
 external insulation layer would be affixed along the flat surface 25 of
 ice pack 32.
 FIGS. 6 and 7 depict another embodiment showing the front labial portion of
 the human mouth, upper lip 38, the lower lip 40, the upper front teeth 42
 and the lower front teeth 44. The intra-oral ice pack 45 comprises
 envelope 46, inner binder 48 and liquid 50. This embodiment is adapted to
 treat the inner portion of the lips 38 and 40 and/or the upper and lower
 teeth 42 and 44 as well as the gums adjacent those teeth. As can be seen,
 the ice pack 45 is shaped to fit the front area of the mouth and teeth and
 is narrow and elongated so as to fit under both upper and lower lips 38
 and 40. An external insulation layer may be affixed covering the front or
 outer surface of ice pack 45 so as to protect the inside of lips 38 and 40
 from the cold, and thus the cold surface will only contact teeth 42 and 44
 and the gums supporting the teeth, if that is the surface to be treated.
 The external insulation could, if desired, be affixed to the rear surface
 of ice pack 45, protecting teeth 42 and 44 and the gums supporting the
 teeth, in the event the inside of the lips are to be treated with cold.
 FIGS. 8 and 10 depict another embodiment of an inta-oral ice pack 52
 adapted for use in the buccal portion or sides of the mouth adjacent the
 side lower teeth 54 and lower lip 56. Again, the ice pack comprises an
 outer envelope 58, binder 60 and liquid 62. The ice pack is substantially
 rectangular as it is again shaped to fit the area involved.
 As described, the external surface or side of the ice pack not facing the
 surgical or affected site can be insulated to maintain the cold on the
 affected site for longer periods of time. This can be done by affixing a
 protective cover 64, such as a piece of gauze, tape, cotton or other
 protective, non-conductive, insulating material on the external surface of
 the ice pack 58 facing the non-affected, non-treated portion of the mouth.
 A string 67, such as a piece of dental floss or thread, can be attached to
 the intra-oral ice pack as a safety measure so that the patient will not
 swallow it. One end of the thread or dental floss is attached to the
 intra-oral ice pack and the other hangs free. The string is long enough to
 hang out of the mouth as a safety precaution against swallowing the ice
 pack.
 The intra-oral ice pack can be stored at room temperature in the dental
 office or it can be stored in the freezer. It can be disposable after one
 use or be reusable by the patient by refreezing it. The outer surfaces of
 the ice pack can be rounded with no sharp edges and any areas desired may
 be insulated from the cold with external protective insulation. The entire
 ice pack which is in contact with the affected area can be covered by one
 or two layers of gauze, cotton or other material to reduce the effect of
 the cold if the patient cannot tolerate it and, in addition, to absorb
 moisture or blood. This cover can be a disposable sheath which can be
 placed over the ice pack and removed after each use.
 The intra-oral ice pack can be used following oral surgery, peridontal
 surgery, implant surgery, maxiofacial surgery, or plastic surgery as well
 as trauma to the lip, nose, cheek, teeth and gums. It has a number of
 advantages in that cold is applied directly and more efficiently to the
 affected site and pressure directly on the affected site acts as a
 surgical dressing which helps to minimize bleeding. In addition, patient
 compliance with its use is much higher than existing extra-oral ice packs
 because there is no conflict with the patient's normal routines because
 both of the patient's hands are free. Further, it is non-toxic,
 non-irritating, sterile and reusable if desired.
 The intra-oral icepack can be easily cold sterilized prior to use by
 standard cold sterilization, such as dipping in a 1% to 10% chlorhexidine
 solution or in a 1% to 10% iodine solution.