Data processing: structural design – modeling – simulation – and em – Simulating nonelectrical device or system
Reexamination Certificate
1998-08-12
2001-02-20
Teska, Kevin J. (Department: 2763)
Data processing: structural design, modeling, simulation, and em
Simulating nonelectrical device or system
C703S001000, C128S922000, C434S262000, C434S267000, C434S270000
Reexamination Certificate
active
06192329
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates generally to assessing the risk of injury to a child by a product, and more particularly to using computer and physical anatomical models of young children in conjunction with computer and physical models of a product to determine the risk of injury to a child from that product.
For young children, particularly those younger than 4 years old, placing objects of all kinds in their mouths or other body orifices is normal developmental behavior. However, this behavior carries risk of injury and, in the case of foreign bodies that become impacted in the airway, death by asphyxiation.
A study of choking in young children examined the characteristics of objects that had caused serious aerodigestive tract (airway, cricopharyngeal, or esophageal) injury, as indicated by the need for operative removal, or death due to choking as reported to the Consumer Product Safety Commission (CPSC). The results confirmed previous reports in the medical literature that the risk of injury or death posed by a food, toy or toy part, or another object depends upon its size, shape, and consistency.
The study used a computer-simulated Small Parts Test Fixture (SPTF) to analyze the characteristics of 101 rigid, three-dimensional objects that caused young children to choke to death. According to Part 1501 of the Federal Hazardous Substances Act, an object intended for use by small children will be approved for interstate commerce if it does not fit within the SPTF, a rigid cylindrical device designed to simulate the young child's airway. Of the 101 objects that had caused children's deaths, fourteen (14) passed the SPTF test. Thus, fourteen objects that did not fit completely within the SPTF had caused children's deaths. These results indicate that a more accurate means to assess risk is needed.
The assessment of risk posed by various objects for causing impaction injury or death can be improved in two ways. First, “research tools” used to assess the risk of impaction should more closely model the irregular shapes of the body cavities being studied. Second, because a child's anatomy changes with development, models should be developed of various body cavities for children of different ages.
SUMMARY OF THE INVENTION
Systems and methods consistent with the present invention use anatomically accurate, age-indexed models of children's body cavities to assess the hazards of impaction with various toys or toy parts. In particular, modern computer-aided design (CAD) techniques are used to develop several models of the oral cavities and airways, nasal passages and sinuses, and external auditory canals of young children of various ages. In addition, physical models corresponding to the computer simulated models are used to assess the hazards of impaction with toys and toy parts in oral cavities and airways, nasal passages and sinuses, and external auditory canals of young children of various ages.
A method consistent with the present invention for forming a physical model of a head for assessing injury risks includes the steps of obtaining digital images of an external head, skull, and at least one cavity of a human head, generating stereo lithographic solids for the digital images of the external head, skull and at least one cavity, creating molds of the external head, skull and at least one cavity using the corresponding stereo lithographic solids, casting moldable material into the mold of the at least one cavity, attaching together the molds of the external head, skull and at least one cavity, pouring a hardener into the mold of the external head, and removing the moldable material in the mold of the at least one cavity to create an opening in the at least one cavity after the moldable material has cured.
Both the foregoing general description and the following detailed description provide examples and explanations only. They do not restrict the claimed invention.
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J. S. Reilly et al., “Prevention And Management Of Aerodigestive Foreign Body Injuries In Childhood”,Pediatric Otolaryngology, vol. 43, No. 6, Dec. 1996, pp. 1403-1411.
F. L. Rimell et al., “Characteristics Of Objects That Cause Choking In Children”,Original Contributions, vol. 274, No. 22, Dec. 13, 1995, pp. 1763-1766.
D.Stool, G. Rider & J. Welling, ‘Human Factors project: Development of computer models of anatomy as an aid to risk management’, received by publisher Dec. 17, 1996, Int. Jrnl of Pediatric Otorhinolaryngology vol. 43 pp. 217-227.
Rider Eugene
Stool Daniel K.
Finnegan Henderson Farabow Garrett & Dunner L.L.P.
Knox Lonnie A.
Risk Analysis & Management
Teska Kevin J.
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