Cranial position orientation detection method and apparatus for pediatric patients

Abstract

A force distribution apparatus and method are presented. Various embodiments of the disclosed apparatus include a plurality of layers configured and oriented to be deployed on a subject in a manner that disperses forces and lowers peak pressures experienced by the subject when resting on a surface, which tends to minimize risks of deformation and local ischemia. An innovative combination of novel construction methods, material selections, and sensors produce an apparatus that possesses an inherent three-dimensional shape despite being built from essentially flat components, while also retaining an ability to effectively distribute forces and reduce pressures. Further embodiments of the disclosed apparatus are adapted to detect and monitor motion and position of the subject, providing retrospective or real-time data for caregivers.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation-in-part of U.S. application Ser. No. 14 / 504,404, filed Oct. 1, 2014, which claims priority to and the benefit of U.S. Provisional Application Ser. No. 62 / 012,795, filed Jun. 16, 2014, entitled “Pressure Distribution for Neonates at Risk of Cranial Molding”, to U.S. Provisional Application Ser. No. 61 / 885,486, filed Oct. 1, 2013, entitled “Bonnet For Preventing & Treating Neonatal Cranial Molding & Skin Breakdown,” and to U.S. Provisional Application Ser. No. 61 / 947,203 filed Mar. 3, 2014, entitled “Pressure Distribution for Neonates at Risk of Cranial Molding,” the contents of each of which are incorporated herein in their entireties by this reference. This application also references U.S. Non-Provisional application Ser. No. 13 / 642,034, filed Apr. 21, 2011, entitled “Neonatal Cranial Support Bonnet”, which claims priority to provisional application U.S. Provisional Application Ser. No. 61 / 327,647, filed...

AI Technical Summary

Benefits of technology

[0015]When affixed to the head of the infant, the force-distributing cranial support is configured to reduce compressive forces on soft, flexible cranial plates that define a cranial cavity. The force-distributing cranial support cradles the head, further promoting the proper development of the infant's head, reducing the incidence or preventing the development of plagiocephaly, brachycephaly, and dolichocephaly (referred to collectively as, “positional cranial molding” or, simply, “cranial molding”), as well as other forms of skeletal deformation. Such reduction of the development of cranial molding is also thought to aid in the prevention and treatment of other related disorders and diseases in neonatal subjects—most notably by permitting the normal growth of brain tissue within the cranial cavity, perhaps positively affecting cognitive development.

[0016]Though not the primary object of the present invention, due to the surprising ability to distribute pressures with minimal encumbrance around the subject, embodiments of the invention are also able to reduce skin interface pressures and, hence, can also be used secondarily to prevent diseases and disorders caused by prolonged or excessive skin interface pressures. The distribution of pressure may also reduce skin interface pressures on areas of the soft tissue where compressive forces are otherwise concentrated and, hence, tend to cause partial or complete capillary collapse. Such capillary collapse may lead to pressure ulcers, pressure sores, skin breakdown, decubitus ulcers, or other pathophysiologic conditions. The force-distributing apparatus may thus be prophylactically affixed to the human in a manner to distribute pressure in an at-risk area to prevent such pathophysiology.

[0017]Beyond prevention, in the event that initial cranial molding or skin breakdown is observed, preferred methods of the invention prompt caregivers to interventionally secure the force-distributing cranial support in a corresponding position on the subject's head, both to help in treatment of the deformation or skin breakdown, as well as to prevent further harm. The treatment aspects are enabled by the ability of the force-distributing cranial support to distribute external cranial forces and to distribute and reduce skin interface pressures on the areas of the subject's head where compressive forces are otherwise concentrated and, hence, tend to cause partial or complete capillary collapse. By distributing and reducing as much, the force-distributing cranial support thereby helps treat and allow natural healing of tissue that has already partially deteriorated due to pressure points.

[0019]The materials and dimensions of the force-distributing assembly of the force-distributing cranial support are such that when the head of the infant who is lying in a supine repose on a surface is so enveloped, the force-distributing assembly distributes the force applied at a contact point on the surface over a larger area and thus disperses the pressure associated with the weight of the infant's head. Further, the head strap portion is dimensioned and oriented to secure the occipital cup portion against the posterior aspect of the infant's head. The occipital cup portion and the head strap portion comprise a readily cleanable, hypoallergenic, biocompatible, and non-irritating material that is selectively coated with a grip-providing material. Preferably the grip-providing material is oriented on a side of the force-distributing cranial support that contacts the infant's head. In other embodiments of the invention, the force-distributing cranial support also includes a padded layer within, oriented essentially adjacent to the force-distributing assembly, both the force-distributing assembly and the padded layer assuming the concavity of the occipital cup portion.

Problems solved by technology

Such cranial deformation, unfortunately, may not merely be a cosmetic condition.

Evidence suggests that children with deformational plagiocephaly have an increased risk for developmental impairment or developmental delay, perhaps because brain parenchyma shifts to conform to positional skull deformities.

In spite of the long history and steady increase in the incidence of cranial molding, optimal solutions have not been presented.

It is known that some orthotics are used in an attempt to ameliorate such conditions, yet the cranial molding rate remains high, and many other challenges and obstacles encountered with the prior art remain unresolved.

For instance, in animal models, it has been shown that sleep deprivation results in a sharp decline in the number of new neurons being developed.

Insufficient sleep has been shown to sensitize neonatal and pediatric patients to experience pain during periods of wakefulness and that fear and anxiety have a negative impact on sleep.

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