Surgery: splint – brace – or bandage – Orthopedic bandage – Splint or brace
Reexamination Certificate
2002-03-01
2003-12-02
Lucchesi, Nicholas D. (Department: 3764)
Surgery: splint, brace, or bandage
Orthopedic bandage
Splint or brace
C602S017000, C602S018000
Reexamination Certificate
active
06656143
ABSTRACT:
SPECIFICATION
This invention relates to a vacuum fixation bag and method of use thereof The. invention as described relates to a sterile vacuum fixation bag for use in stabilizing the head during medical and surgical procedures where the head must remain immobilized for prolonged periods of time. The device provides for semi-rigid fixation of the head within the setting of medical imaging studies including but not limited to computed tomography (CT), magnetic resonance imaging (MRI) studies, nuclear medicine studies and positron emission tomography (PET). The invention described is also suited for use during invasive procedures that require head fixation such as neurosurgical procedures, ophthalmologic procedures, cranio-facial surgery and other procedures involving the head and face that require head immobilization. The invention is designed for placement inside of standard imaging systems such as the head coil of an MRI scanner or the head platform of a CT scanner. The invention is suitable for head stabilization during cranio-facial procedures, neurosurgical procedures, opthomolgical procedures and any type of procedure requiring head immobilization by attachment to the operating or procedure table.
The current practice of medical imaging relies upon the acquisition of multiple images during the routine sequence of imaging a single subject. Often the acquisition of the serial images is compromised by patients moving their head during the imaging acquisition period. It is estimated that 30% of medical imaging, specifically, magnetic resonance imaging studies, need to be repeated due to head motion artifact. Additionally, newer imaging modalities rely on the reproducible location of sequential images to provide localizing information during studies such as functional MR imaging. The movement of subjects during such studies invalidates the data obtained and necessitates the reimaging of said individuals. The invention submitted addresses this problem by providing a non-invasive sterile device for semi-rigid head fixation during medical imaging procedures. The device is a single use, sterile vacuum fixation bag specifically designed to address the problem of patient movement during medical imaging. The invention is designed to fix the subject's head within the medical imaging device and provide semi-rigid fixation during the imaging procedure to reduce the need to repeat the imaging due to patient head movement.
The invention submitted also provides for semi rigid head fixation during medical procedures that require head fixation. The indications for usage would include any procedure where head immobilization is sought to either facilitate the procedure or protect the patient's head during the procedure. Current indications would include but not be limited to any type of craniofacial procedure including neurosurgical, ophthalmologic, otolaryngology, radiologic, dental or plastic surgery procedure where head stabilization is desired. The invention submitted provides for semi-rigid fixation by application to the subject's head and attachment of the device to the operating or procedure table. The invention is non-invasive and provides head fixation during procedures that require head immobilization.
The invention submitted is a single use, sterile vacuum fixation device for stabilization of the head during medical imaging or surgical procedures. The invention is a vacuum fixation device comprised of an airtight plastic bag which contains Styrofoam beads and a closable port for insertion and withdrawal of air. The unique configuration of the bag allows for semi rigid fixation of the head by providing contact along the under surface of the mandible, the lateral portion of the head bilaterally to contact the peri-auricular surfaces and a forehead portion configured for contacting the subject's forehead. The invention is also provided in a form that allows for access to the cranial vault for cranial procedures. Once fitted to the subject, air is evacuated from the bag via the closable port bringing the Styrofoam beads into close proximity to one another developing the semi rigid mold which provides the basis for the semi-rigid fixation. The device is then fixed to either the medical imaging device or the procedure table to secure the subjects head.
The vacuum fixation bag is made by methods well known in the art. The bag is made of a plastic material, such as any flexible plastic that is suitable for external use in a medical device. The foam beads can be made of any suitable multicellular expanded synthetic resinous material, such as Styrofoam. The closable stem is likewise made of flexible plastic which is melded to the bag to provide a passage for air into and out of the bag. The closable stem has a stopper at its distal end which can be opened to release air or inserted to prevent air from entering the system.
CROSS-REFERENCE TO RELATED APPLICATIONS
U.S. Patents
3,745,998
July 1973
Rose, et al.
4,885,811
December 1989
Hayes, et al.
6,079,056
June 2000
Fogelberg, et al.
3,397,688
December 1965
Gottfried, et al.
5,569,175
October 1996
Chitwood, et al.
5,454,781
October 1995
Chitwood, et al.
The application describes a head immobilization device that has a unique geometric configuration that addresses several issues unique to this patent application. Firstly, the device is configured to allow for semi-rigid fixation of the head using polymer beads contained within thin plastic sheeting. Rose, et al (U.S. Pat. No. 3,745,998) discuss vacuum immobilization and note “numerous evacuated envelopes have been proposed for use as rigidified immobilization devices” [Section 14, line 48]. Rose continues in their application to define more specifically the nature of the elastic materials and the filler; however in contrast to the current application, Rose only provides for very simple designs which are useful only during immobilization of a single extremity or of the body as a whole. The issues involved in immobilization of the head are not addressed in any fashion and the invention as described would not provide for adequate immobilization of the head. Adequate immobilization of the head requires specific points of contact to limit motion in flexion, extension, rotation, and lateral movement. Thus, while the general use of a vacuum immobilization device is presented by Rose, et al. the utility of this device for immobilization of the head is not feasible and not inferred in their application. The submitted invention provides a unique geometric design exclusively provided for immobilization of the head utilizing a well known technique which incorporates vacuum fixation.
Secondly, it is provided that Chitwood, et al. (U.S. Pat. No. 5,454,781) provides for a device used to provide cervical traction. The device only provides contact with the subject's neck area and a forehead strap is provided to further restrain the subject. The device provides for cervical traction/stretch and is not designed for immobilization. This device, as described, fails to provide fixation of the head in such a fashion as to prevent movement. The subject would be able to move their head in several directions since the device only provides fixation about the neck and forehead. Lateral movement of the head is not addressed nor is flexion/extension. Chitwood, et al. provides a continuation of U.S. Pat. No. 5,441,479 in their U.S. Pat. No. 5,569,175. U.S. Pat. No. 5,569,175 was also provided as evidence of prior art. Chitwood, et al again describe a continuation of their earlier work now providing a platform for attaching the cervical traction device. Again, this invention in not designed for head immobilization and to the contrary, is designed for “rotation of the platform about any one of or all of an x-axis, a y-axis, and a z-axis” [Section 2, line 10-11]. Chitwood, et al. fail to describe a device that is intended for head immobilization and to the contrary describe a device that promotes movement of the head while producing traction of the neck. The current invention submitte
Hamilton Lalita M.
Lucchesi Nicholas D.
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