In situ molded orthotic and method for its fabrication

摘要

An orthotic helmet and methods for fabrication and use thereof. The orthotic is molded in situ on a growing infant's head for the treatment of plagiocephaly, postsurgical cranial molding, or other desired treatment plans. The helmet makes contact in areas where cranial shape and volume are adequate, and no contact in areas of planned cranial growth. The helmet includes a shell, a bladder system which can be filled with a viscoelastic expandable foam, a fastener and a retaining strap. In the areas of deficient cranial volume, a volume of modeling putty equivalent to the target growth volume is placed against the cranium, manually molded until the planned target volume and form have been attained, and the helmet is molded in place over this spacer material. The spacer is then removed, and the helmet is then worn continuously until resolution of the deformity or attainment of planned form is reached.

主权项

1. An orthotic system for inducing directed growth of an irregularly-shaped associated skull of an associated user having a regularly-shaped skull portion and at least one irregularly-shaped skull portion recessed relative to the regularly-shaped skull portion, the orthotic system comprising:
a headpiece having an outer wall and an inner wall, the inner wall being shaped to receive a head of an associated user; a resilient material disposed on the inner wall of the headpiece, the resilient material having a first surface found to substantially correspond to a shape of the head of the associated user by molding the resilient material in situ between the head of the associated user and the inner wall of the headpiece, the first surface defining i) a contact wall surface area positioned to abut and limit growth of the regularly-shaped skull portion of the associated user, and ii) at least one target wall surface area positioned to define a volume between the at least one irregularly-shaped skull portion of the associated user and the at least one target wall surface area into which the growth of the skull may be directed; and, at least one spacer member comprising a manually moldable shape retaining material selectively received in the volume between the at least one irregularly-shaped skull portion of the associated user and the at least one target wall surface area, the at least one spacer member having opposite first and second sides wherein the first side has a shape corresponding to the at least one irregularly-shaped skull portion of the associated user formed by molding the material into the at least one irregularly-shaped skull portion recessed relative to the regularly-shaped skull portion, and wherein the second side has a shape corresponding to the at least one target wall surface formed by molding the second side of the material to substantially match the regularly-shaped skull portions surrounding the irregularly-shaped skull portion; wherein the resilient material comprises a molding agent having a first stage being selectively flowable in an associated bladder disposed in a space between i) the inner wall of the headpiece and ii) the head of the associated user and the second side of the at least one spacer member, and a second stage being hardened in situ on the head of the associated user, the molding agent hardening between the first and second stages thereby defining, in the second stage, the contact wall surface area and the target wall surface area.