USRE36583E - Cranial remodeling orthosis - Google Patents
Cranial remodeling orthosis Download PDFInfo
- Publication number
- USRE36583E USRE36583E US08/876,682 US87668297A USRE36583E US RE36583 E USRE36583 E US RE36583E US 87668297 A US87668297 A US 87668297A US RE36583 E USRE36583 E US RE36583E
- Authority
- US
- United States
- Prior art keywords
- orthosis
- iadd
- iaddend
- patient
- accordance
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
- 238000007634 remodeling Methods 0.000 title claims abstract description 12
- 210000001595 mastoid Anatomy 0.000 claims abstract description 9
- 210000003582 temporal bone Anatomy 0.000 claims abstract description 9
- 239000000463 material Substances 0.000 claims description 38
- 238000000034 method Methods 0.000 claims description 32
- 230000005856 abnormality Effects 0.000 claims description 14
- 210000005069 ears Anatomy 0.000 claims description 7
- 238000003856 thermoforming Methods 0.000 claims description 6
- 206010053682 Brachycephaly Diseases 0.000 claims description 4
- 208000009283 Craniosynostoses Diseases 0.000 claims description 4
- 210000003455 parietal bone Anatomy 0.000 claims description 4
- 239000004743 Polypropylene Substances 0.000 claims description 3
- 239000004033 plastic Substances 0.000 claims description 3
- 229920003023 plastic Polymers 0.000 claims description 3
- -1 polypropylene Polymers 0.000 claims description 3
- 229920001155 polypropylene Polymers 0.000 claims description 3
- 229920000049 Carbon (fiber) Polymers 0.000 claims description 2
- 239000004917 carbon fiber Substances 0.000 claims description 2
- 238000010276 construction Methods 0.000 claims description 2
- VNWKTOKETHGBQD-UHFFFAOYSA-N methane Chemical compound C VNWKTOKETHGBQD-UHFFFAOYSA-N 0.000 claims description 2
- 238000009966 trimming Methods 0.000 claims 3
- 238000004519 manufacturing process Methods 0.000 claims 2
- 239000012858 resilient material Substances 0.000 claims 2
- 238000007493 shaping process Methods 0.000 claims 2
- 230000001936 parietal effect Effects 0.000 claims 1
- 208000009782 Plagiocephaly Diseases 0.000 description 2
- 206010068737 Facial asymmetry Diseases 0.000 description 1
- 229920005830 Polyurethane Foam Polymers 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- OSGAYBCDTDRGGQ-UHFFFAOYSA-L calcium sulfate Inorganic materials [Ca+2].[O-]S([O-])(=O)=O OSGAYBCDTDRGGQ-UHFFFAOYSA-L 0.000 description 1
- ZOMBKNNSYQHRCA-UHFFFAOYSA-J calcium sulfate hemihydrate Chemical compound O.[Ca+2].[Ca+2].[O-]S([O-])(=O)=O.[O-]S([O-])(=O)=O ZOMBKNNSYQHRCA-UHFFFAOYSA-J 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 239000002537 cosmetic Substances 0.000 description 1
- 239000006261 foam material Substances 0.000 description 1
- 210000002454 frontal bone Anatomy 0.000 description 1
- 239000011507 gypsum plaster Substances 0.000 description 1
- 239000011496 polyurethane foam Substances 0.000 description 1
- 210000003625 skull Anatomy 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
- A61F5/01—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces
- A61F5/04—Devices for stretching or reducing fractured limbs; Devices for distractions; Splints
- A61F5/05—Devices for stretching or reducing fractured limbs; Devices for distractions; Splints for immobilising
- A61F5/058—Splints
- A61F5/05883—Splints for the neck or head
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
- A61F5/01—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces
- A61F5/04—Devices for stretching or reducing fractured limbs; Devices for distractions; Splints
- A61F5/05—Devices for stretching or reducing fractured limbs; Devices for distractions; Splints for immobilising
- A61F5/058—Splints
- A61F5/05883—Splints for the neck or head
- A61F5/05891—Splints for the neck or head for the head, e.g. jaws, nose
Definitions
- This invention is concerned with correcting brachycephalic cranial abnormalities in humans.
- abnormalities may be afflicted with cranial abnormalities, known as plagiocephaly, which also contribute to facial asymmetry.
- Such abnormalities are correctable, particularly if treatment is undertaken at an early age, preferably when the subject is less than six months old. The subject can thus be spared the indignity of going through life with a cosmetic disability.
- the band orthosis of the '229 patent is effective for treatment of a variety of cranial abnormalities.
- This abnormality is known as brachycephalic cranial head shape abnormality.
- the brachycephalic head shape expresses itself as occipital flattening of the cranium with resultant biparietal breadth and/or height abnormalities usually accompanied by bi-temporal and frontal breadth abnormalities.
- the supernormal brachycephalic head shape is one in which the maximum cranial breadth departs from established anthropometric norms in being disproportionately large in relation to the maximum cranial length.
- the orthosis of this invention acts to correct brachycephaly by constraining growth across the breadth and height of the cranium while encouraging an increase in the maximum cranial length.
- the orthosis is configured to extend across the top of a 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.
- FIG. 1 is a perspective view of an orthosis constructed in accordance with this invention
- FIG. 2 is a view of the top of an infant's head, illustrating the abnormality known as brachycephaly;
- FIG. 3 is a top view of the orthosis with a portion broken away to show its construction
- FIG. 4 is a sectional view from the side of the orthosis, taken as indicated, by line 4--4 in FIG. 3:
- FIG. 5 is a sectional view of the orthosis taken as indicated by line 5--5 in FIG. 3;
- FIG. 6 is a perspective view of an elastic band employed in the orthosis.
- the numeral 11 is employed to indicate, generally, the orthosis of this invention.
- This orthosis is employed to correct the cranial abnormality known as "brachycephaly" which is illustrated in FIG. 2.
- the abnormality is manifested as a cranial condition in which the breadth "B" of the cranium is disproportionately large in relation to the length "L” of the cranium.
- the orthosis 11 is employed to remodel the cranium by allowing growth of the cranium length to the dot and dash configuration shown while constraining growth of the cranium in breadth.
- FIGS. 3-5 The preferred configuration for the orthosis is illustrated in FIGS. 3-5. It comprises a central, or upper, region 12 which is shaped to extend over the top and closely conform to the configuration of the top of the cranium. For most subjects, this region 12 of the orthosis will cover an anterior region of the parietal bone and possibly a posterior region of the frontal bone. Depending upon the size of the cranium of the subject, this upper region 12 of the orthosis will have a front to back width of approximately four (4) to five (5) inches (10.16 to 12.7 cm.).
- depending regions 13 and 14 Integrally associated with the central region 12 of the orthosis are depending regions 13 and 14 on each side of the orthosis.
- Depending regions 13 are shaped to closely confine temporal bone regions of the cranium adjacent and forward of the ears of the subject.
- Depending regions 14 are shaped to closely confine mastoid process regions of the cranium to the rear and beneath the ears of the subject. Cut out regions 15 between depending regions 13 and 14 uncover the ears of the subject for his or her comfort.
- the orthosis 11 be configured to be self-suspending, i.e., remain in stabilized position on the cranium of the subject without the aid of a chin strap.
- the latter aid which is often required with helmet-type orthosis, is deemed undesirable because it can interfere with eating and possibly deform the subject's jaw bone.
- Self-suspension of the orthosis 11 of this invention is achieved as a result of the close confinement of the temporal bone and mastoid process regions of the cranium by the depending regions 12 and 13 of the orthosis.
- the regions of contact formed by orthosis regions 12 and 13 fall within planes of the cranium which have circumferences which are less than the maximum occipitofrontal circumference of the subject's cranium.
- the inherent resiliency of the orthosis draws the orthosis down with the central region 12 in contact with the top of the subject's head and holds the orthosis in place.
- Orthosis 11 is constructed with an outer layer 16 of plastic material and an inner liner 17 of compressible foam material.
- sheet plastic of co-polymer polypropylene material approximately 3/16" (4.76 mm) thick is suitable for forming the outer layer 16. This material is light in weight, possesses considerable strength, yet is resilient and is thermoformable to almost any desired shape.
- the preferred material for the liner 17 is sheet polyurethane foam having a thickness of approximately 3/8" (10 mm).
- the inherent stiffness and resiliency of the outer layer 16 of polypropylene will be sufficient to hold the orthosis in place and effectively restrain growth across the breadth and height of the cranium.
- the ear-to-ear stiffness of the orthosis can be enhanced by incorporating stiffening means therein, preferably in the form of an arcuate elastic band 18 positioned in the upper region 12 of the orthosis.
- stiffening means preferably in the form of an arcuate elastic band 18 positioned in the upper region 12 of the orthosis.
- a carbon fiber material is preferred for the band 18 inasmuch as this material offers significant strength with very little weight. For the comfort of the subject, it is desirable to keep the weight of the orthosis as low as possible.
- the orthosis 11 must be constructed to afford some flexibility to permit the opposite depending regions 13 and 14 to be spread apart to install and remove the orthosis from the subject's head.
- the orthosis of this invention should be individualized for each subject. This means that each orthosis should be fabricated from an impression of the head of the subject of be treated.
- the technique for fabricating an orthosis 11 involves forming a positive model of the subject's skull.
- This model can be constructed from a plaster of Paris negative mold of the head or from a digitized laser image of the head.
- the positive model is modified to the configuration desired for the remodeled cranium and then employed to shape the orthosis.
- the latter step involves draping the liner material 17 over the model and then vacuum thermoforming the outer layer material 16 over the model.
- the model is removed from this structure and the structure is trimmed to the configuration illustrated in the drawing and described above.
- the elastic band 18 is to be employed, it is pre-shaped to the desired configuration and placed over the liner material 17 before the outer layer material 16 is thermoformed. This encases the band 18 between outer layer 16 and liner 17.
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- Health & Medical Sciences (AREA)
- Otolaryngology (AREA)
- Biomedical Technology (AREA)
- Nursing (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Engineering & Computer Science (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pulmonology (AREA)
- Orthopedics, Nursing, And Contraception (AREA)
Abstract
Description
Claims (12)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/876,682 USRE36583E (en) | 1993-03-05 | 1997-06-16 | Cranial remodeling orthosis |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/026,774 US5308312A (en) | 1993-03-05 | 1993-03-05 | Cranial remodeling orthosis |
| US46759495A | 1995-06-06 | 1995-06-06 | |
| US08/876,682 USRE36583E (en) | 1993-03-05 | 1997-06-16 | Cranial remodeling orthosis |
Related Parent Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| US08/026,774 Reissue US5308312A (en) | 1993-03-05 | 1993-03-05 | Cranial remodeling orthosis |
| US46759495A Continuation | 1993-03-05 | 1995-06-06 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| USRE36583E true USRE36583E (en) | 2000-02-22 |
Family
ID=26701643
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| US08/876,682 Expired - Lifetime USRE36583E (en) | 1993-03-05 | 1997-06-16 | Cranial remodeling orthosis |
Country Status (1)
| Country | Link |
|---|---|
| US (1) | USRE36583E (en) |
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6423019B1 (en) * | 1997-02-20 | 2002-07-23 | Cleveland Clinic Foundation | Cranial remodeling headpiece |
| US20020192508A1 (en) * | 1995-04-10 | 2002-12-19 | Norton David P. | Method of fabricating improved buffer architecture for biaxially textured structures |
| US20030145384A1 (en) * | 2002-02-06 | 2003-08-07 | Stelnicki Eric Jason | Infant sleep guard system and method |
| US6939316B2 (en) | 2003-07-14 | 2005-09-06 | Infa-Safe, Inc. | Cranial orthosis for preventing positional plagiocephaly in infants |
| US20060042013A1 (en) * | 2004-08-31 | 2006-03-02 | Children's Hospital Boston | Head positioning device |
| US20070027826A1 (en) * | 2004-01-07 | 2007-02-01 | Cranial Technologies, Inc. | Method and apparatus for producing three dimensional shapes |
| US7563237B1 (en) | 2005-06-13 | 2009-07-21 | James David Murphy | Cranial correction orthoses |
| US20110113533A1 (en) * | 2009-11-19 | 2011-05-19 | Manuel Guillen | Sports/swimming head protection device |
| US20110132379A1 (en) * | 2008-01-18 | 2011-06-09 | Young Joon Lee | Head-Shape Remodelling Instrument |
| US9402760B2 (en) | 2010-08-18 | 2016-08-02 | Christopher Burnside Gordon | In situ molded orthotic and method for its fabrication |
Citations (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US1569181A (en) * | 1922-02-10 | 1926-01-12 | Thomas J Hartman | Football helmet |
| US1576987A (en) * | 1925-04-08 | 1926-03-16 | Spalding & Bros Ag | Headgear |
| US2758304A (en) * | 1954-03-15 | 1956-08-14 | Mcgowan Hugh | Football helmet |
| US3364499A (en) * | 1965-10-22 | 1968-01-23 | Chester S. Kwoka | Protective helmet |
| US3577562A (en) * | 1969-10-01 | 1971-05-04 | Mike C Holt | Athletes{3 {0 protective helmet particularly football |
| SU659134A1 (en) * | 1976-06-24 | 1979-04-30 | Предприятие П/Я А-3611 | Helmet |
| US4352352A (en) * | 1980-05-13 | 1982-10-05 | Franz Janovsky | Head gear manipulator for invalids |
| FR2509585A1 (en) * | 1981-07-15 | 1983-01-21 | Petzl Paul | Safety helmet with outer shell and inner cap - has straps joined in star shape by central supple membrane |
| US4377009A (en) * | 1979-09-17 | 1983-03-22 | Huey Douglas | Head protector |
| US4645198A (en) * | 1985-08-05 | 1987-02-24 | Levenston Frederick M | Neck exercising device |
| US4722056A (en) * | 1986-02-18 | 1988-01-26 | Trustees Of Dartmouth College | Reference display systems for superimposing a tomagraphic image onto the focal plane of an operating microscope |
| US4742464A (en) * | 1983-04-14 | 1988-05-03 | Francois Duret | Method of making a prosthesis, especially a dental prosthesis |
| US4776324A (en) * | 1987-04-17 | 1988-10-11 | The Children's Orthopedic Hospital And Medical Center | Therapeutic and protective infant helmets |
| US4821200A (en) * | 1986-04-14 | 1989-04-11 | Jonkopings Lans Landsting | Method and apparatus for manufacturing a modified, three-dimensional reproduction of a soft, deformable object |
| US5094229A (en) * | 1991-02-11 | 1992-03-10 | Pomatto Jeanne K | Cranial remodeling orthosis |
| US5119516A (en) * | 1988-11-21 | 1992-06-09 | Bell Sports, Inc. | Reinforced expanded plastic helmet construction |
| US5177815A (en) * | 1990-04-09 | 1993-01-12 | Andujar Edward M | Protective headgear |
-
1997
- 1997-06-16 US US08/876,682 patent/USRE36583E/en not_active Expired - Lifetime
Patent Citations (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US1569181A (en) * | 1922-02-10 | 1926-01-12 | Thomas J Hartman | Football helmet |
| US1576987A (en) * | 1925-04-08 | 1926-03-16 | Spalding & Bros Ag | Headgear |
| US2758304A (en) * | 1954-03-15 | 1956-08-14 | Mcgowan Hugh | Football helmet |
| US3364499A (en) * | 1965-10-22 | 1968-01-23 | Chester S. Kwoka | Protective helmet |
| US3577562A (en) * | 1969-10-01 | 1971-05-04 | Mike C Holt | Athletes{3 {0 protective helmet particularly football |
| SU659134A1 (en) * | 1976-06-24 | 1979-04-30 | Предприятие П/Я А-3611 | Helmet |
| US4377009A (en) * | 1979-09-17 | 1983-03-22 | Huey Douglas | Head protector |
| US4352352A (en) * | 1980-05-13 | 1982-10-05 | Franz Janovsky | Head gear manipulator for invalids |
| FR2509585A1 (en) * | 1981-07-15 | 1983-01-21 | Petzl Paul | Safety helmet with outer shell and inner cap - has straps joined in star shape by central supple membrane |
| US4742464A (en) * | 1983-04-14 | 1988-05-03 | Francois Duret | Method of making a prosthesis, especially a dental prosthesis |
| US4645198A (en) * | 1985-08-05 | 1987-02-24 | Levenston Frederick M | Neck exercising device |
| US4722056A (en) * | 1986-02-18 | 1988-01-26 | Trustees Of Dartmouth College | Reference display systems for superimposing a tomagraphic image onto the focal plane of an operating microscope |
| US4821200A (en) * | 1986-04-14 | 1989-04-11 | Jonkopings Lans Landsting | Method and apparatus for manufacturing a modified, three-dimensional reproduction of a soft, deformable object |
| US4776324A (en) * | 1987-04-17 | 1988-10-11 | The Children's Orthopedic Hospital And Medical Center | Therapeutic and protective infant helmets |
| US5119516A (en) * | 1988-11-21 | 1992-06-09 | Bell Sports, Inc. | Reinforced expanded plastic helmet construction |
| US5177815A (en) * | 1990-04-09 | 1993-01-12 | Andujar Edward M | Protective headgear |
| US5094229A (en) * | 1991-02-11 | 1992-03-10 | Pomatto Jeanne K | Cranial remodeling orthosis |
Cited By (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20020192508A1 (en) * | 1995-04-10 | 2002-12-19 | Norton David P. | Method of fabricating improved buffer architecture for biaxially textured structures |
| US6423019B1 (en) * | 1997-02-20 | 2002-07-23 | Cleveland Clinic Foundation | Cranial remodeling headpiece |
| US20030145384A1 (en) * | 2002-02-06 | 2003-08-07 | Stelnicki Eric Jason | Infant sleep guard system and method |
| US20040181878A1 (en) * | 2002-02-06 | 2004-09-23 | Stelnicki Eric Jason | Infant head guard and method of use |
| US6954954B2 (en) | 2002-02-06 | 2005-10-18 | Pediatric Medical Solutions, Llc | Infant sleep guard system and method |
| US6939316B2 (en) | 2003-07-14 | 2005-09-06 | Infa-Safe, Inc. | Cranial orthosis for preventing positional plagiocephaly in infants |
| US7542950B2 (en) * | 2004-01-07 | 2009-06-02 | Cranial Technologies, Inc. | Method and apparatus for producing three dimensional shapes |
| US20070027826A1 (en) * | 2004-01-07 | 2007-02-01 | Cranial Technologies, Inc. | Method and apparatus for producing three dimensional shapes |
| WO2006026764A1 (en) | 2004-08-31 | 2006-03-09 | Childrens Hospital Boston | Head positioning device |
| US20060042013A1 (en) * | 2004-08-31 | 2006-03-02 | Children's Hospital Boston | Head positioning device |
| US7563237B1 (en) | 2005-06-13 | 2009-07-21 | James David Murphy | Cranial correction orthoses |
| US20110132379A1 (en) * | 2008-01-18 | 2011-06-09 | Young Joon Lee | Head-Shape Remodelling Instrument |
| US20110113533A1 (en) * | 2009-11-19 | 2011-05-19 | Manuel Guillen | Sports/swimming head protection device |
| US9402760B2 (en) | 2010-08-18 | 2016-08-02 | Christopher Burnside Gordon | In situ molded orthotic and method for its fabrication |
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Legal Events
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|---|---|---|---|
| FEPP | Fee payment procedure |
Free format text: PETITION RELATED TO MAINTENANCE FEES FILED (ORIGINAL EVENT CODE: PMFP); ENTITY STATUS OF PATENT OWNER: SMALL ENTITY |
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| PRDP | Patent reinstated due to the acceptance of a late maintenance fee |
Effective date: 20040916 |
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| AS | Assignment |
Owner name: CRANIAL TECHNOLOGIES, INC, ARIZONA Free format text: NUNC PRO TUNC ASSIGNMENT;ASSIGNOR:POMATTO-HERTZ, JEANNE K.;REEL/FRAME:027425/0837 Effective date: 20111221 |