Face and airway developer appliance and method

Abstract

A facemask and accessories which overcomes the adverse effects and limitations of current designs by moving the maxilla and mandible in forward direction, which assists in correcting maxillary and mandibular skeletal and dentoalveolar deficiency and help expand the upper airway by advancing the mandible. This is accomplished by a design that is supported only by forehead and produces forces in front of maxilla and mandible. The extra-oral facebow design is characterized by providing two independent force adjustments, one above the forehead and the other one in front of the face by attachments to the upper and lower jaw bones and teeth. In particular, the two independent adjustments are provided by a fully adjustable forehead pad and bilateral adjustable bows on opposite sides of the facebow's extra-oral frame to provide protracting forces.

Claims

1. A method for treating a patient's sleep disordered breathing, the method comprising: placing a fulcrum of an appliance on a forehead of the patient, wherein the appliance comprises: an extra-oral portion comprising a lever including the fulcrum and a rigid lever arm slidingly attached to the fulcrum, wherein the rigid lever arm has a first end disposed above the fulcrum and a second end disposed below the fulcrum, wherein the extra-oral portion further includes a headstrap set attached to the rigid lever arm at a first location disposed above the fulcrum and adjacent to the first end; and an intra-oral strap assembly connected to the rigid lever arm at a second location disposed below the fulcrum and adjacent to the second end of the rigid lever arm; placing the headstrap set about a top portion of the head of the patient; attaching the intra-oral strap assembly to an intra-oral feature of the patient; and forcing the second end and the second location of the rigid lever arm away from the head by adjusting the headstrap set to pull on the first location of the rigid lever arm disposed above the fulcrum, such that the intra-oral strap assembly is placed into tension to pull on the intra-oral feature of the patient.

2. The method of claim 1, wherein said intra-oral feature is said patient's tongue.

3. The method of claim 2, wherein said intra-oral strap assembly is also attached to said patient's lower teeth.

4. The method of claim 1, wherein said intra-oral feature is said patient's lower teeth.

5. The method of claim 1, wherein said intra-oral feature is said patient's lower jaw.

6. The method of claim 1, wherein said headstrap set is attached to said lever arm by means of a top block that is slidingly engaged to said lever arm.

7. The method of claim 6, wherein a set screw is engaged to said top block to fix the position of said top block on said lever arm.

8. The method of claim 7, further including adjusting the position of said top block on said lever arm and fixing it in place with said set screw.

9. The method of claim 1, wherein said intra-oral strap assembly is connected to said lever arm by means of a bottom block.

10. The method of claim 9, wherein a set screw is engaged to said bottom block to fix the position of said bottom block on said lever arm.

11. The method of claim 1, wherein said headstrap set having a left and right side including a bow on both said left and right sides, each bow having a hook, and said head strap set further having a headstrap, and wherein said headstrap defines at least one hole for each one of said hooks, and wherein each of said hooks is engages with a said hole.

12. The method of claim 11, wherein said headstrap defines a set of holes for each one of said hooks, so that a user may select a hole to attach each said hook to, thereby constituting a further adjustment.

13. A method for treating a patient's sleep disordered breathing, the method comprising: placing a fulcrum of an appliance on a forehead of the patient, wherein the appliance comprises: an extra-oral portion comprising a type 1 lever including the fulcrum and a rigid lever arm slidingly attached to the fulcrum, wherein the rigid lever arm has a first end and a second end opposite the first end, wherein the extra-oral portion further includes a headstrap set attached to the rigid lever arm at a first location disposed above the fulcrum adjacent to the first end; and an intra-oral strap assembly connected to the rigid lever arm at a second location disposed adjacent to the second end of the rigid lever arm below the fulcrum; placing the headstrap set about a top portion of the head of the patient; attaching the intra-oral strap assembly to an intra-oral feature of the patient; and forcing the second end and the second location of the rigid lever arm away from the head by adjusting the headstrap set to pull on the first location of the rigid lever arm, such that the intra-oral strap assembly pulls on the intra-oral feature of the patient.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Exemplary embodiments are illustrated in referenced drawings. It is intended that the embodiments and figures disclosed herein are to be considered illustrative rather than restrictive.

(2) FIG. 1 is a side elevational view of a face and airway developer appliance, according to the present invention, installed onto the face of a human patient, showing the extra-oral portion of the appliance.

(3) FIG. 2 is a front elevational view of the appliance of FIG. 1, also shown installed onto the face of a human patient.

(4) FIG. 3 is a plan side view showing an alternative apparatus for correcting malocclusion and growing the lower jaw.

(5) FIG. 4a is a plan side view of a portion of the face and airway developer of FIG. 1, showing the intraoral portion of one embodiment, in its environment attached inside a patient's mouth.

(6) FIG. 4b is a bottom view of a maxillary expander with flexible loops and non-parallel expansion screws attached to the roof of the mouth by mini-implants and bonded to the top of the teeth; and having extension arms to attach to the assembly of FIG. 1 with straps.

(7) FIG. 5 is a plan side view of a portion of the face and airway developer of FIG. 1, showing the intraoral portion of an alternate embodiment, in its environment attached inside a patient's mouth.

(8) FIG. 6 is a plan side view of a portion of the face and airway developer of FIG. 1, showing the intraoral portion of another alternate embodiment designed to apply torque to an upper molar, in its environment attached inside a patient's mouth.

(9) FIG. 7a is plan side view of a portion of the face and airway developer of FIG. 1, showing the intraoral portion of yet another alternate embodiment adapted to treat sleep apnea, in its environment attached inside a patient's mouth to the lower jaw and tongue.

(10) FIG. 7b is a plan view of the appliance of FIG. 7a, with the tongue and lower jaw pulled forward to open the airway.

(11) FIGS. 8a and 8b show the appliance of FIGS. 7a and 7b, but in an environment attached inside the mouth of a patient lacking teeth.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

(12) Definition: the term teeth as used in this application encompasses implants, and any other structure that can deliver a force to the jaw bones, such as an implanted anchor for a mating element.

(13) The term child refers to patients whose facial features are still experiencing growth and encompasses adolescents who are still growing.

(14) A strap is any element capable of being placed into tension, and thereby to transfer a pulling force. A strap may be elastic or inelastic.

(15) An intra-oral feature of a patient, is the teeth, as defined above, or the jaws or tongue.

(16) Referring to FIG. 1, a face and airway developer appliance 110, includes an extra-oral assembly that consists of a lever 3 in the form of a vertical, bow-shaped metal rod, slidingly engaged to a fulcrum block 6 that is supported by a detachable fulcrum support 5. The fulcrum support 5 is supported solely by cushions 4 contacting the patient's forehead. The appliance includes a bottom block 1, slidingly supported on lever 3 in front of a patient's mouth, which in turn supports a tooth-pull bar 2, for attachment via tooth straps 16 to a patient's intra-oral features.

(17) One embodiment has a lever-pull bow 7 connected to the lever 3 by a top block 8 which pulls the top of lever 3 toward the forehead, causing bar 2 to be pushed away from the jaws. Block 8 can slide on lever 3, to permit proper moment arm force delivery to the lever 3. The bow 7 which extends laterally to the either side of patent's forehead, ends with hooks 9 for connection to a set of head straps 11 that extend on either side of the face of the patient and around the back of the patient's skull. Strap set 11 is adjusted to pull on hooks 109, and thereby pull back on lever 3.

(18) The adjustment blocks 1, 6, 8 permit customization to each patient, as they can each be slid up or down the lever 3 to adjust the force delivery from straps 11.

(19) A set screw 13, 10, 14 (FIG. 2) in block 1, 6, 8 respectively, are used to fix the vertical location of the bar 2 and bow 7 and fulcrum support 5 on the lever 3.

(20) The vertical position of the block 1 and horizontal bar 2 on the direction of the force delivery to the upper or lower jaws based on the clinical requirement for normalization of the facial structures for proper growth and airway structures for normalization of the patient's airway by advancing the mandible Referring to FIGS. 4a and 4b, device 110 further includes an intra-oral portion, including an intra-oral portion of straps 16, which are attached to anchors 15 of a maxillary anchoring assembly 23. In child patients, pulling on anchors 15 loosens the maxillary connection structures to the base of skull and causes a forward expansion of the upper jaw, which is highly desirable in patients with maxillary sagittal deficiency. By adjusting the force applied, the vertical growth of the maxilla can be encouraged, which is desirable in patients with vertical maxillary deficiency. Referring to FIG. 4b, maxillary anchoring assembly 23 includes screws 22, which are driven into the patient's palate. Screws 22 may be selectively removed on one side to provide a greater pulling force on the teeth on one side of the maxilla, than another. Side screws attached to the bone, make the maxillary bone on that side be pulled forward to take care of dental versus skeletal asymmetries. For example, if the patient's maxilla lacks bilateral symmetry, the left or the right side can be tightened to bone on the shorter side rather than on the other side, which is normal, to pull the short side more than the other. Also, if it is desired to pull more on the front of the maxilla, the frontmost screws 22 may be installed, rather than the rear screws 22. If the converse is desired the rear screws 22 may be installed, rather than the front screws. As shown in FIG. 4a, a set of straps 16 may be attached to mandible anchor 24. FIG. 5 shows a similar configuration, except for that assembly 23 is not shown, and a different form of maxillary anchor 25 is pulled by straps 16.

(21) As shown in FIG. 6, a set of straps 16 pull on a structure 112, having an extra-oral and intra-oral portion, and designed to apply a vertical torque on a pair of upper molars 21. Straps connect to hooks 18 supported by extra-oral wing 17 (an equal bow 17 present on the other side of the face), which in turn is connected to intra-oral bow 19. Bow 19 bends at its ends 20, and each end is fit into a tube 21 that is connected to a molar 122. The forward pull on straps 16, causes a downward pull at the front of bow 19, which in turn provides a clockwise rotational force on molars 122 (in the plane of FIG. 6), accompanying the generally forward force, created by the pull of straps 16 (by way of bar 2 and bow 3). In a closely related embodiment extra-oral wings 17 are placed in an intra-oral position between the cheeks and the jaws.

(22) FIGS. 7a and 7b show a system in which the straps 16 are used to pull the tongue (by way of anchor 26) and the lower jaw (by way of anchor 24) forward, for the treatment of small jaws in children or sleep apnea in children or adults. FIGS. 8a and 8b show the same system but attached in a patient without teeth.

(23) While a number of exemplary aspects and embodiments have been discussed above, those possessed of skill in the art will recognize certain modifications, permutations, additions and sub-combinations thereof. It is therefore intended that the following appended claims and claims hereafter introduced are interpreted to include all such modifications, permutations, additions and sub-combinations as are within their true spirit and scope.