Image analysis – Applications – Biomedical applications
Reexamination Certificate
1998-07-15
2001-05-22
Patel, Jay (Department: 2723)
Image analysis
Applications
Biomedical applications
C033S512000, C382S154000
Reexamination Certificate
active
06236743
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a three dimensional digitizing system, to be used primarily for the determination of the precise shape of a three dimensional body, such as a patient's body part that is in need of an effective, precision fitted, support socket for a clinical support device such as an orthotic brace and/or a prosthetic limb, and can be used conveniently and effectively with bodies that cannot be fitted, readily moved or re-positioned into a cast/mold or specialized laser/photographic scanner type device.
Further, the present invention relates to a method of precisely defining the shape and contour of a portion of a three dimensional body, such as for the formation of a support socket of a clinical support device in a manner which provides for minimal trial and error, and is comfortable and convenient to implement in a variety of situations and orientations.
2. Description of the Related Art
In a variety of specialized industries, there is a need to identify and define the precise shape and configuration of all or a portion of a three dimensional body. That three dimensional body may include an artifact, structure or part to be duplicated or mated with, a human body part to be reproduced or supported, or any other physical object to be identified with precision. Presently, the most common way of determining and utilizing the desired shape and contour requires the making of a mold of the body in question. For example, plastic or wax molds or impressions are frequently used with inanimate or easily manipulable objects. Resent technology has, however, permitted the use of laser scanning or other mechanical devices to receive the body to be scanned, and thereby use laser refraction and reflectivity to map out the precise shape and contour of the three dimensional body. While such molding or laser scanning techniques have proven generally effective with many three dimensional bodies and in many applications, there are still a number of attendant drawbacks associated with their use.
Specifically, one primary disadvantage associated with known scanning systems involves the scanning environment. In particular, conventional laser or ultrasound digitizing systems require the body to be analyzed to be located within a precision environment that is part of the device itself. Moreover, the orientation and position of the body must be constantly maintained for an extended period of time. While these procedures may be acceptable with smaller bodies, when larger or animate bodies are the subject of digitizing, it can become very difficult and costly to bring the body to the digitizer and fit the body into the necessary pre-defined parameters of the digitizer.
An alternative to the confined operating environments of such laser or ultra sound digitizers involves point by point digitizing. These systems typically employ a pointer or other device to plot certain predefined and necessary points on a body to be digitized. From these points, the remaining structure can be extrapolated by a computer system and a rough image is generated. Unfortunately, however, such systems are very time consuming to utilize, requiring many individual points to be independently plotted if an accurate image is to be generated, and even if a number of points are plotted, minor variations between the plotted points are generally not accounted for in an accurate manner. Furthermore, such systems require complete stability of the position and orientation of the body being digitized in order to maintain proper reference.
Accordingly, there is a need for a digitizing system that is portable, does not require an elaborate and predefined environment in order to precisely digitize any shape or sized body in an accurate manner. Further, such a device should actually take into account the contours of the body, not relying on computerized extrapolation to define an approximation of the shape of the body.
By way of example, an important and prevalent application of the need for precision identification of the shape and configuration of a three dimensional body relates to the prosthetic and orthotic fields of medicine wherein precise, customized clinical support devices, such as prosthetic limbs or orthotic braces, must often be constructed to correspond to unique and very specific shapes. In these applications, as in the various other related and unrelated applications, the desire to determine the precise shape of all or part of a three-dimensional body, such as the human body part to be supported, is quite necessary and often quite critical to the formation of an effective mold, model, or mating part, such as the support socket of the clinical support device. For example, in the case of a prosthetic limb, the support socket is generally adapted to be fitted over the terminal portion of a patient's limb in order to act as a replacement for the missing limb. As such, a precise fit is necessary because a substantial amount of constant pressure is going to be exerted on the terminal end of the limb as the clinical support device is utilized. Specifically, most portions of the human body are not capable of withstanding constant focused pressure thereon for extended periods of time. This factor therefore necessitates that in the definition and formation of the support socket of the clinical support device, the pressure that will be exerted from the support device to the patient be spread out as much as possible, thereby preventing any concentrated or focused pressure on any one portion of the terminal end of the limb.
Currently in the prosthetic/orthotic field of art, it is substantially difficult to use known devices and methods to define the necessary configuration without substantial time and effort being put into initial molding and various revised moldings of the support socket of the clinical support device.
This factor alone has made the conventional art relating to the formation of clinical support devices very specialized, with the practitioners often being highly skilled craftsmen with extensive years of training and experience. Specifically, because prior art systems and methods of defining the support socket are so imprecise, the extensive training and experience is necessary in order for the practitioner to get a feel for their patients' needs merely by viewing the patient and analyzing a conventional plaster type mold or photographically scanned image, and to recognize what the results of minor changes or modifications to the mold will be after viewing the pressure points which result after trial of an initial molded support socket. As is evident, such trial and error molding is not only time consuming and inconvenient for the patient, but can also become quite expensive due to the labor intensive nature of the work and the need to have a highly skilled practitioner. Accordingly, there is a need in the art to provide a system and method that can substantially facilitate the formation of a clinical support device while also increasing the precision of the form of an initially constructed support socket.
Continuing further with the example of the field of art relating to the formation of clinical support devices, there are presently three existing methods of shape capture that are utilized to define the support socket of a clinical support device. The first, most commonly used method simply involves the formation/molding of a plaster cast to capture the shape of the applicable body part. Once the plaster cast is taken, it is removed from the patient and filled with plaster to form a positive mold. The practitioner will then call upon their experience and/or best guess to guide them in adding or removing plaster by hand in order to modify the shape taken during casting and thereby create a final shape. As such, the final shape is truly a combination of the molded shape and the practitioner's skill and experience in determining where certain modifications should be made. A final plaster shape is then made and draped in some manner with h
Malloy & Malloy P.A.
Patel Jay
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