Cranial remodeling orthosis

Abstract

A cranial remodeling orthosis is shaped to extend across the top of the head with depending regions closely confining the temporal bone regions and the mastoid process regions of the cranium. The orthosis is self-suspending and preferably includes an elastic band for imparting ear-to-ear rigidity to the device.

We claim: 
     
       1. A cranial remodeling orthosis comprising a resilient band adapted to extend across the parietal bone region of the cranium and having depending regions shaped to closely confine the temporal bone regions and the mastoid process regions of the cranium with relief areas therebetween to expose the ears of a patient wearing the orthosis, said depending regions of the orthosis being adapted to provide regions of contact which fall within planes of the cranium which have circumferences which are less than the maximum occipitofrontal circumference of the cranium whereby the orthosis is held in place on the cranium. 
     
     
       2. The orthosis of claim 1, further comprising, rigidity imparting means in the form of an elastic band within that portion of the orthosis band which is adapted to extend across the parietal region of the cranium. 
     
     
       3. The orthosis of claim 2, wherein said elastic band is formed from a carbon fiber material. 
     
     
       4. The orthosis of claim 2, further characterized in that said orthosis comprises an outer layer of thermoformed plastic material and an inner liner of cushioning material and said elastic band is disposed between said outer layer and said inner liner. .Iadd. 
     
     
       5.  A method for fabricating a cranial remodeling orthosis for a patient having a condition known as brachycephalic cranial head shape abnormality, said method comprising the steps of: forming a negative impression of the head of said patient;   forming a positive impression from said negative impression;   modifying said positive impression to a desired corrected shape of said patient's head;   utilizing said modified impression to produce said orthosis;   configuring said orthosis to correct brachycephaly by constraining growth across the breadth and height of the cranium of said patient and permitting growth in the direction of the length of said cranium. .Iaddend..Iadd.   
     
     
       6.  A method in accordance with claim 5, comprising the step of: forming said orthosis to have portions shaped to closely confine the temporal bone regions and mastoid process regions of said cranium to restrict growth. .Iaddend..Iadd.7. A method in accordance with claim 6, comprising the step of:   forming said orthosis to be self-suspending on said patient's head without the use of strap devices. .Iaddend..Iadd.8. A method in accordance with claim 7, comprising the step of:   forming said orthosis to include relief areas to expose the ears of said patient. .Iaddend..Iadd.9. A method in accordance with claim 5, comprising the step of:   forming said orthosis to include relief areas to expose the ears of said patient. .Iaddend..Iadd.10. A method in accordance with claim 5, comprising the step of:   .Iadd.forming said orthosis to be self-suspending on said patient's head   
     
     
        without the use of strap devices. .Iaddend..Iadd.11.  A method in accordance with claim 10, comprising the step of: forming said orthosis from a resilient material. .Iaddend..Iadd.12. A method in accordance with claim 11, comprising the step of:   forming said orthosis of polypropylene material. .Iaddend..Iadd.13. A method in accordance with claim 5, comprising the step of:   selecting a resilient material to be included in the construction of said orthosis. .Iaddend..Iadd.14. A method in accordance with claim 13, comprising the step of:   forming said orthosis such that said orthosis has a resilient property which causes said orthosis to be urged into contact with said patient's head and holds said orthosis in place. .Iaddend..Iadd.15. A method in accordance with claim 5, comprising the steps of:   conforming a liner material to said modified impression; and   forming an outer material over said liner material to form a resilient   
     
     
        band. .Iaddend..Iadd.16.  A method in accordance with claim 15, comprising the step of: positioning one stiffening member in a predetermined position between said liner material and said outer layer material. .Iaddend..Iadd.17. A method in accordance with claim 5, comprising the steps of:   draping a liner material over said modified impression; and   vacuum thermoforming an outer layer material over said liner material to form a resilient band. .Iaddend..Iadd.18. A method in accordance with claim 17, comprising the step of:   trimming said resilient band to a desired configuration. .Iaddend..Iadd.19. A method in accordance with claim 17, comprising the step of:   positioning at least one stiffening member in a predetermined position on said liner material prior to said vacuum thermoforming. .Iaddend..Iadd.20. A method in accordance with claim 19, comprising the step of:   said stiffening member is preshaped to a desired shape. .Iaddend..Iadd.21. A method for fabricating a cranial remodeling orthosis comprising the steps of:   forming a negative impression of the head of a patient;   forming a first positive mold of said patient's head;   forming a second positive mold by modifying said first positive mold to a desired shape of said patient's head; and   forming a resilient band, said resilient band being shaped to extend across the parietal bone region of the cranium of said patient and having depending regions shaped to closely confine the temporal bone regions and   
     
     
        mastoid process regions of said cranium. .Iaddend..Iadd.22.  A method in accordance with claim 21, comprising the step of: shaping said resilient band with relief areas to expose the ears of said patient. .Iaddend..Iadd.23. A method in accordance with claim 21, comprising the step of:   adapting said resilient band to provide regions of contact with the temporal bone areas and mastoid process areas of said patient's cranium, said regions falling within planes of said cranium which have circumferences which are less than the maximum occipitofrontal circumference of said cranium. .Iaddend..Iadd.24. A method in accordance with claim 23, comprising the step of:   adapting said resilient band to draw said orthosis down to contact the top of said patient's head and thereby hold said orthosis in place.   
     
     
        .Iaddend..Iadd.25.  A method in accordance with claim 21, comprising the steps of: conforming a liner material to said second positive mold; and   forming an outer material over said liner material to form said resilient band. .Iaddend..Iadd.26. A method in accordance with claim 21, comprising the steps of:   draping a liner material over said second positive mold; and   vacuum thermoforming an outer layer material over said liner material to form said resilient band. .Iaddend..Iadd.27. A method in accordance with claim 25, comprising the step of:   positioning one stiffening member in a predetermined position between said liner material and said outer layer material. .Iaddend..Iadd.28. A method in accordance with claim 26, comprising the step of:   trimming said resilient band to a desired configuration. .Iaddend..Iadd.29. A method in accordance with claim 26, comprising the step of:   positioning at least one stiffening member in a predetermined position on said liner material prior to said vacuum thermoforming.   
     
     
        .Iaddend..Iadd.     A method in accordance with claim 29, wherein: said stiffening member is preshaped to a desired shape. .Iaddend..Iadd.31. A method for producing a cranial remodeling orthosis for a patient comprising the steps of:   providing a digitized three-dimensional image of said patient's head;   producing a cranial remodeling orthosis from said digitized image;   forming a resilient band shaped to directionally restrict growth of said patient's cranium to correct a brachycephalic cranial head shape abnormality of said patient; and   shaping said resilient band to extend across the parietal bone region of said patient's cranium and having depending regions shaped to closely confine the temporal bone regions and mastoid process regions of said patient's cranium. .Iaddend..Iadd.32. A method for producing a cranial remodeling orthosis for a patient comprising the steps of:   providing a digitized three-dimensional image of said patient's head;   producing a cranial remodeling orthosis from said digitized image;   producing a positive image of said patient's head from said digitized image;   modifying said positive image to a desired shape for the cranium of said patient;   conforming a liner material to said modified positive image;   forming an outer material over said liner material to form said orthosis; and   positioning one stiffening member in a predetermined position between said   
     
     
        liner material and said outer material. .Iaddend..Iadd.33.  A method in accordance with claim 32, comprising the step of: trimming said resilient band to a desired configuration. .Iaddend..Iadd.34. A method in accordance with claim 33, wherein:   said stiffening member is preshaped to a desired shape. .Iaddend..Iadd.35. A method in accordance with claim 32, comprising the additional step of:   positioning at least one stiffening member in a predetermined position on said liner material prior to said vacuum thermoforming. .Iaddend.