Abstract:
The present invention is a device for pre-surgical treatment of cleft lip and cleft palate. The device is extraoral thus reducing the risk associated with existing devices and technologies that are intraoral, such as, for example utilizing a Nasoalveolar Molding (NAM) appliance. The adjustable extraoral nasal molding appliance of the present invention consists of an adjustable and securable head fastener, a front connector with a forehead rest pad, a rod support having an aperture through which a rod is slidably connected, a fastener for locking a rod in a set position, the rod, a spring and at least one nasal bulb. Different shaped springs can be attached for treating unilateral as well as bilateral cleft lip and palate patients. Different nasal bulbs can be attached for treating unilateral as well as bilateral cleft lip and palate patients.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This non-provisional patent application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/916,624 filed on Dec. 16, 2013 which is expressly incorporated herein in its entirety by reference thereto. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to devices and appliances used to treat cleft lip and palate prior to corrective surgery. The present invention relates to orthodontics and orthopedics for lip and palate closure. The present invention relates further to head fastening devices. The present invention also relates to appliances and equipment that are supported from head straps and hats. 
     BACKGROUND OF THE INVENTION 
     Orofacial clefts are among the most common congenital anomalies with prevalence of about one out of every seven hundred births in the United States. Throughout their lives, children who have an orofacial cleft need several surgical procedures and complex medical treatments requiring various medical and dental specialists. 
     Studies support the use of pre-surgical infant orthopedic treatment, such as a Nasoalveolar Molding (NAM) appliance, to create a more aesthetic result after primary lip closure in patients with cleft lip and palate deformities. Studies have also shown improved nasal symmetry with the use of a nasal molding appliance following primary closure of the lip. In the neonate, temporary plasticity of the alar cartilages exists due to higher levels of hyaluronic acid circulating in the infant which allows for orthopedic changes. NAM appliance works to stretch and contour the alar tissue and the columella while bringing the palatal shelves into closer approximation. 
     The modern school of pre-surgical orthopedic treatment of the cleft lip and palate patient started in the 1950&#39;s where series of intraoral plates were used to mold the alveolar segments together. In 1993, nasal bulb attachments were utilized in conjunction with the plate to mold the lip, nose and the alveolus in neonates prior to lip repair. 
     The method of fabrication of the NAM appliance starts with an initial impression of the infant&#39;s palate. The materials commonly used for the impression of the palate are: alginate, polyvinyl siloxane, aluwax, and compound materials. Patients are evaluated for potential airway complications. Stock or customized trays are used to load the impression material. The infant is positioned upright and the tray/impression material is placed in the infant&#39;s mouth until the material is set. The tray is removed and the patient&#39;s mouth is suctioned and inspected to make sure no material remains in the oral or nasal cavity. The impression is poured up with stone and the plate is fabricated using an acrylic material. The tray is then tried in the patient and lined using a softer denture reline material for better comfort and fit. The nasal stent is fabricated chairside using stainless steel orthodontic wire with a helical design. An acrylic nasal bulb in the shape of a ball is fashioned and the stent is imbedded using acrylic to the fabricated plate. The plate with the nasal stent is inserted and the upper lip is taped using tape to act as a prolabial band. The bulb is positioned inside the nasal passage such that pressure is applied against the alar tissue and the columella causing growth and reducing the cleft. Due to the position of the spring and it being supported from the NAM appliance in the infant&#39;s mouth the resulting force applied is primarily medial (toward the centerline of the face) superior (upward) and anterior (away from the face). 
     The patient is seen in the office or hospital setting on two separate visits for the fabrication of the appliance and the appliance is adjusted every 1-2 weeks until the patient is determined to be ready for primary lip closure surgery. The average time of lip closure in infants can range from 4-6 months. 
     The custom fabrication of the NAM appliance, doctor time, and weekly appointments for NAM adjustments, make the procedure time consuming, technique sensitive, and expensive. Trained clinicians are also difficult to find. The primary professionals, typically pediatric dentists or orthodontists, who perform pre-surgical infant orthopedics on neonates with cleft lip and palate are usually associated with large hospitals or dental schools and universities. Due to the very time consuming nature of the current NAM fabrication process, potential airway complications, and numerous appointments, there is a need for a more universal appliance that can be adjustable and can be utilized in any medical provider&#39;s office or setting with minimal training. 
     Therefore, it is an object of the present invention to provide an improvement over existing intraoral nasal molding devices/appliances. It is the object of the invention to provide an extraoral device/appliance that can be more easily fitted and adjusted, is more convenient and comfortable, and provides safer and better treatment. It is an object of the present invention to provide an adjustable extraoral appliance that can be fitted to the infant and adjusted without the need for an impression of the maxilla resulting in less risk than NAM devices. There is a need for a device that can be provided to parents with less consumption of doctor time than existing technologies (less office visits)—an easier to size/fit device. There is a need for a less costly and resource consuming device. There is a need for a universal, adjustable, extraoral nasal molding appliance that can be utilized in many rural areas and underserved countries where access to healthcare, and qualified medical and dental professionals are limited. There is also a need for a better performing appliance capable of applying greater forces in the desired directions/vectors. 
     SUMMARY OF THE INVENTION 
     The adjustable extraoral nasal molding appliance of the present invention consists of an adjustable and securable head fastener, a front connector with a forehead rest pad, a rod support having an aperture through which a rod is slidably connected, a fastener for locking the slidable rod in a set position, a rod, a spring and a nasal bulb. Different shaped and sized springs can be attached. Different shaped and sized nasal bulbs can be attached for molding of unilateral as well as bilateral cleft lip and palate. The device is safer than NAM devices for pre-surgical treatment and closure of cleft lip and palate because it is completely extraoral. 
     While the invention will be described in connection with certain embodiments, it will be understood that the invention is not limited to those embodiments. To the contrary, the invention includes all alternatives, modifications and equivalents as may be included within the spirit and scope of the present invention. 
     The head fastener includes an easy to secure head band adjustable in size preferably using hook and loop material. Alternatively, buttons or other fastening devices can be used to adjust the size of the band. The head fastener includes a front connector that gets positioned near the middle of the infant&#39;s forehead when the head fastener is secured on the head. The inside of the head fastener preferably includes a pad or other component, such as, for example, gel strips, to reduce discomfort during use. 
     In the preferred embodiment, a rod support is fixedly attached to the outside of the front support. The rod support includes an aperture through its length such that a rod can slide up and down with respect to the fastener, rod support, and/or the front support. This slidability allows for the placement and adjustment of the bulb in the nasal passage and the forces exerted on the infant using the device. Alternatively, the rod support may be removably attached to the front support with a screw or other removable fastening structure. In such an embodiment, the rod may be fixedly attached to the rod support. Alternatively, the position of rod support may be adjustable on the front support. 
     In the preferred embodiment the rod support does not allow the rod to rotate with respect to the rod support although such an embodiment with the ability to rotate and lock in a desired rotational position is included within the scope of the invention. 
     With the rod attached to the rod support, the front support and rod is positioned in the middle of the infant&#39;s face with the rod between the eyes for the least obstruction of the infant&#39;s vision. The first end of the rod is inserted into the aperture in the rod support and locked into position at the desired height using a fastener such as a set screw or the like. 
     The second end of the rod includes a spring and a bulb. The first end of the spring may be fixedly attached or removably attached to the second end of the rod. The connection between the second end of the rod and the first end of the spring may provide for height adjustment of the bulb. In one embodiment of the invention, a connector may be provided between the second end of the rod and the first end of the spring. The connector can be configured for a single spring and bulb or for two springs and bulbs for bilateral cleft lip and palate treatment. 
     The spring when strained, provides a resistive force needed for pressure (force) on the alar tissue and columella in the desired direction(s) to help reshape nasal tissues and the lip which in turn will reshape the maxilla through growth. The spring is preferably a two or three coil steel wire that can be stretched, bent and/or reshaped to provide a variable distance for activation of the bulb(s) on the infant initially and during the course of the treatment period. In one embodiment, alternatively, during treatment, the spring can be removed and replaced with a different spring. The second end of the spring is attached to the bulb, preferably near the bottom/underside of the bulb (eg. middle of convex side of a kidney shaped bulb) to try to prevent the metal spring from directly contacting the facial tissue/skin. 
     The bulb(s) may be configured in a variety of shapes and sizes and can be constructed from a variety of materials. Preferably the bulb is kidney shaped to help prevent direct contact of the spring with the facial tissue/skin and for application of forces at the preferred locations. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the general description of the invention given above and the detailed description of an embodiment given below, serve to explain the principles of the present invention. Similar components of the devices are similarly numbered for simplicity. 
         FIG. 1  is a perspective view of one embodiment of the device according to the present invention with an adjustable and securable head fastener, a front connector with a forehead rest pad, a hinged rod support having an aperture through which a rod is slidably connected, a fastener for locking a slidable rod in a set position, a rod, a rod connector, a double helical spring and a nasal bulb. 
         FIG. 2  is an enlarged and exploded perspective view taken at arrow  2  in  FIG. 1  showing part of the rod, a removable lockable rod connector, a removable double helical spring and a removable nasal bulb. 
         FIG. 3  is a sectional view of the rod shown in  FIGS. 1 and 2  taken as section line  3 - 3  in  FIG. 2 . 
         FIG. 4  is a sectional view of an alternative rod configuration. 
         FIG. 5  is a sectional view of an alternative rod configuration with a flat side. 
         FIG. 6  is a perspective view of an alternative embodiment of the invention shown worn on the head of an infant. The head fastener includes an addition strap over the top of the head from the front to the back of the head strap. The rod support is not hinged in this embodiment. Axes X-X, Y-Y, and Z-Z are shown originating at the spring. 
         FIG. 7  is a partial perspective view of a partial view of an alternative embodiment of the invention for a bilateral cleft lip and palate showing a bilateral adaptor for connection to two springs and bulbs. 
         FIG. 8  is a front perspective view of another embodiment of the device according to the present invention shown on the head of an infant with the bulb in position in the nasal passage. The device shown includes an adjustable and securable head fastener, a front connector with a forehead rest pad, a rod support having an aperture through which a rod is slidably connected, a fastener for locking a slidable rod in a set position, a rod, a triple helical spring and a nasal bulb. 
         FIG. 9  is an enlarged, partial and cut perspective view of the bottom of the rod, the spring, the bulb and face of the infant shown in  FIG. 8 . The bulb is shown in a desired location inside and outside the nasal passage. The desired component forces (F) on the nasal tissue and lip are shown on the X, Y, and Z axes. 
         FIG. 10  is a front perspective view of another embodiment of the device according to the present invention shown on the head of an infant with bilateral cleft lip and palate with a U-shaped bulb in position within both nasal passages. The device shown includes an adjustable and securable head fastener, a front connector with a forehead rest pad, a rod support having an aperture through which a rod is slidably connected, a fastener for locking a slidable rod in a set position, a rod, a rod connector, a double helical spring and a bilateral nasal bulb. 
         FIG. 11  is an enlarged, partial perspective view of the bottom of the device shown in  FIG. 10 . 
         FIG. 12  is an enlarged, partial perspective view of the bottom of the rod, the rod connector, the spring, the bulb and nose/face of the infant shown in  FIG. 10 . The bulb is shown inside and outside the nasal passage. The desired component forces (F) on the nasal tissue are shown on the Y and Z axes. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring to the Figures, the invention consists of a fastener  110  for securing the appliance/device to the head  111  of an infant, preferably around the circumference of the head  111 . The fastener  110  is adjustable in size and it is also removable. For example, an elastic head band can be used as a fastener. More preferably, the fastener  110  comprises a non-elastic, adjustable band  115  that more securely attaches to the head  111  of the infant. A non-elastic fabric band  115  with a fastening means, e.g., buttons, hook and loop material (Velcro)  116 , etc., can be used. As shown in the Figures, the band  115  may loop through a slot  117  in a front connector  118  which includes a pad  119 . Other fasteners can include hats that cover the head of the infant, a fabric band that circumscribes the head of the infant with one or more straps connecting portions of the band on opposite sides of the head and transversing over the top of the head as shown in  FIGS. 6 ,  8 , and  10 , as well as other fastening devices that may attach to the forehead of the infant without any structure around the entire head, such as, for example, a fastener  110  with adhesive or a pad that fastens to the forehead of the infant using adhesive or using tape. 
     Preferably, the fastener  110  comprises a comfort pad (forehead/glabella rest)  119  where the front of the fastener contacts the forehead of the infant. Preferably, pad  119  is positioned on the inside portion of a front connector  118  such that when the device is worn, the front connector  118  is located near the middle of the forehead of the infant. It is understood that additional pads  119  can be included on the fastener  110  or front connector  118  and/or additional connectors  118  may be positioned at other parts of the device, such as, for example, at the sides and/or the back of the head of the infant. In the preferred embodiment, the fastener  110  includes a front connector  118 . 
     According to one embodiment of the invention, the fastener  110  includes a rod support  120  fixedly attached to the front connector  118 . Most preferably, the rod support  120 , is fixedly attached to the outside portion of the front connector  118  as viewed when the device is worn as shown in the figures, although the rod support  120  could be located on the inside of the rod support  118 . 
     In the embodiment shown in  FIGS. 1-3 , the rod support  120  is attached to the front connector  118  in a hinged manner such that the rod support  120  can rotate about axis R-R. In such an embodiment it is desirable to be able to lock the hinge in a certain position, such as, for example, a stop mechanism or pin, or gear, etc. Most preferably, the rod support  120  does not rotate with respect to the front connector  118  and is fixedly attached without any hinge mechanism such as shown in  FIGS. 6-12 . 
     As shown in  FIG. 1 , rod support  120  comprises an aperture  122  though its length. The aperture  122  allows for a slidable connection with a rod  130  which can be secured at a desired height using a locking device, such as, for example, as shown in  FIGS. 1-2 , the set screw  124  with a threaded hole  125  in the rod support  120 . With rod  130  placed in the aperture  122 , the rod  130  can slide up and down with respect to the rod support  120  along the length of the rod in the Y-Y axis. Other locking devices for the rod  130  are included in the scope of the invention including pins, clamps and the like. Where the locking device is a set screw  124 , the rod  130  preferably comprises at least one flat surface for connection to the end of the set screw  124 . Rod  130  may also include indentations (not shown) along its length where the end of the set screw  124  can connect. As shown in  FIGS. 3 ,  4 , and  5 , the rod  130  can be a variety of cross sectional shapes including rectangular, mostly circular, as well as triangular, pentagonal and other geometric shapes. Rod  130  can be a solid rod or more preferably to help reduce the weight of the device, rod  130  can be hollow. Rod  130  can be made of metal or other materials, e.g., plastic, with rigidity and strength. Rod  130  is preferably linear/straight along its length but can also be non-linear for improved ergonomics, comfort and/or infant visibility. 
     The slidability of the rod  130  in the Y-Y axis allows for ease of installation of the device on the infant. It is understood, however, that rod  130  need not be slidably attached to the rod support  120 . Alternatively, the device can include a plurality of rods of various lengths and the rod  130  of desired length for a particular infant can be selected through trial and error and fastened to the rod support  120  using, for example, a screw, pin or other fastener. 
     In yet a further embodiment, the rod  130  may be fixedly attached to the rod support  120  which is removably attachable to the front connector  118 . In such an embodiment, the desired length for the rod support  120  and the rod  130  can be selected from a plurality of different lengths that are prefabricated. 
     At the lower end of rod  130  is at least one spring  150  and at least one bulb  160  attached to the at least one spring  150 . The spring  150  can be fixedly attached to the rod  130  or removably attached to the rod  130 . For example, the end of spring  150  may insert into a hole (not shown) in the end of rod  130 . Alternatively, the end of spring  150  comprises a screw  152  (such as for example as shown in  FIG. 2 ) that threads into a receiving threaded hole (not shown in figures) in the end of rod  130 . In the embodiments shown in  FIGS. 1 ,  2 ,  6 ,  7 , and  10 - 12 , a connector  140  enables easier removal of the spring  150  and bulb  160  from rod  130 , although the inclusion of the connector  140  is not necessary as shown in the embodiment in  FIGS. 8 and 9 . The connector  140  shown in the figures, with a bilateral adapter  145  as shown in  FIG. 7 , provides for easy modification of the device for a bilateral treatment with two springs  150  and two bulbs  160 . In an embodiment comprising a threaded opening in the bottom of rod  130 , the bilateral adapter  145  can thread directly into the bottom of the rod  130  without use of a connector  140 . Connector  140  can be configured in a sleeve type configuration to slide over the exterior of the second end of rod  130  as shown in  FIG. 2 . In such a configuration, the connector  140  can be attached to the rod using a set screw  124  with or without a corresponding hole  125  and/or holes/indentations  125  in rod  130 . The bottom of connector  140  includes a receiving threaded hole  143  for attachment to the spring  150 . Connector  140  provides another way to adjust the height of the device and the bulb(s)  160  with respect to the infant when the device is worn. 
     The spring  150  at the end of the rod  130 , when strained, provides a resistive force needed to help apply pressure on the alar tissue and columella in the desired direction(s) and thus help reshape the tissue and lip which in turn will reshape the maxilla through growth. The use of a spring  150  and the ability to reshape the spring  150  and/or easily modify its configuration provides flexibility in all three axes X, Y, and Z (in all directions). A triple helical coil spring  150 , as shown in  FIGS. 8 and 9 , is most preferred to provide the desired spring force and for ease with modification of the spring  150  configuration. The three coil spring  150  provides a high degree of flexibility for modification of the location of the bulb. The spring  150  coils can be stretched/modified to provide a great distance for activation of the bulb(s) on the infant initially and during the course of the treatment period. Other spring configurations, including double helical coils (also shown in the figures), single helical coils, zig-zag configurations, and other geometries are also possible and included in the scope of the invention. Use of two springs  150  is also possible for a bilateral case. 
     Bulb(s)  160  may be configured in a variety of shapes and sizes and can be constructed from a variety of materials. For example, bulb  160  can be kidney shaped as shown in  FIGS. 1-9 . A kidney shaped bulb is advantageous over a round bulb for activation/contact on the alar tissue and the outside of the nose/lip. This prevents the spring from contacting the skin and it increases the surface area contact between the bulb and the tissue/skin. 
     For a bilateral case where forces are desired in each nostril of the infant, as shown in  FIGS. 10-12 , the device can be used with one spring  150  connected to a bilateral bulb or the device can include two springs  150  with two separate unilateral bulbs  160  as shown in  FIG. 7 . 
     The bulb may be made of an acrylic material or another material that does not cause irritation when placed inside the nose, such as, for example plastic or silicone, or a combination thereof. 
     In the embodiment shown in the figures, the bulb  160  is shown non-removable from the end of spring  150 . The end of the spring may compression fit inside an opening in the bulb  160 . Alternatively, and more preferred, the end of spring  150  is configured without a straight pointed shape such that the bulb, prior to drying or curing, such as with a heated acrylic bulb when formed on the end of the spring  150 , becomes fixed to the end of the spring  150 . For example, the end of the spring  150  could be configured with a hook, bend, elbow, coil, etc. 
     Alternatively, the bulb  160  could be removable with, for example, a threaded opening for attachment onto threads on the end of the spring  150 . 
     For purposes of explaining how the device is used, the device is fitted onto the head of the infant with the front connector  118  positioned at the middle of the infant&#39;s forehead. The size of the fastener  110  is adjusted to fit snugly on the infant. A rod  130 , spring  150  and bulb  160  are assembled for the desired length and for the patient&#39;s particular case. The first end of the rod  130  (opposite the bulb  160 ) is inserted into the aperture  122  in the rod support  120  until the bulb  160  is in the desired position inside the nasal passage of the infant. The location of the bulb (height, angle, position medially, etc.) and/or the spring configuration/shape is adjusted to achieve the desired pressure on the tissue/skin of the infant. 
     During treatment of the infant over the course of 4-6 months, when using the device according to the invention, the position of the bulb requires adjustment in at least one direction, most commonly superiorly along the Y-Y axis but also medially and anteriorly in the X-X and Z-Z axes. Such adjustments can be accomplished by modifying the shape of the metal spring  150 , by removing and replacing the metal spring  150  with a different shaped spring, by adjusting the height of the rod  130  on the rod support  120 , by removing and replacing the rod  130  with a rod having a different length, by repositioning the fastener  110  and/or front connector  118  a little higher on the forehead of the infant, by removing and replacing the bulb  160  with a bulb of different shape and configuration, and/or by adjusting the height of the connector  140  at the bottom of the rod  130 . Any one or more of these adjustment methods and structures are included in the scope of the invention. At least 5-7 mm of height adjustment in the Y-Y axis is desired and possible using the present invention.