Surgery: kinesitherapy – Kinesitherapy – Ultrasonic
Reexamination Certificate
1999-10-18
2002-08-20
Lateef, Marvin M. (Department: 3737)
Surgery: kinesitherapy
Kinesitherapy
Ultrasonic
C607S086000
Reexamination Certificate
active
06436060
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a system for therapeutically treating bone structure using ultrasound. More particularly, the present invention relates to a system that includes a bathtub insert for use in treating bone injuries or a variety of musculoskeletal injuries and/or problems.
2. Description of the Related Art
The use of ultrasound to therapeutically treat and evaluate bone injuries is known. Impinging ultrasonic pulses having appropriate parameters, e.g., frequency, pulse repetition, and amplitude, for suitable periods of time and at a proper external location adjacent to a bone injury has been determined to accelerate the natural healing of, for example, bone breaks and fractures. For patients with reduced healing capacity, such as elderly persons with osteoporosis, ultrasonic therapy may promote healing of bone injuries that would otherwise require prosthetic replacement or leave the patient permanently disabled.
U.S. Pat. No. 4,530,360 to Duarte describes a basic non-invasive therapeutic technique and apparatus for applying ultrasonic pulses from a transducer surface placed on the skin at a location adjacent a bone injury. The applicator described in the '360 patent has a plastic tube which serves as a grip for the operator, an RF plug attached to the plastic tube for connection to an RF source, and internal cabling connected to an ultrasonic transducer. To apply the ultrasound pulses during treatment an operator must manually hold the applicator in place until the treatment is complete. As a result, the patient is, in effect, immobilized during treatment. The longer the treatment period, the more the patient and/or the assistant is inconvenienced, and certain parts of the body, such as the back, cannot be reached by the patient with such a device, thus requiring the help of an assistant. The '360 patent also describes a range of RF signals for creating the ultrasound, ultrasound power density levels, a range of duration for each ultrasonic pulse, and a range of ultrasonic pulse frequencies.
In general, an ultrasound carrier frequency between 250 kHz and 10 MHz coupled with a relatively low-frequency modulating signal (e.g. 5 Hz to 10 kHz) and low intensity acoustic signal (e.g. less than 100 milliwatts/cm
2
) aids, and will be effective for therapeutic treatment.
U.S. Pat. No. 5,211,160 to Talish et al. relates to an ultrasonic treatment system with a mounting fixture that attaches to a patient's limb using straps and a hook and loop attachment. The body application unit interfaces with the mounting fixture so that the operative surface is adjacent the skin location.
While the systems described in these patents relate to therapeutic methods and apparatus for ultrasonically treating injured bone, and describe basic mounting fixtures for use with a cast or limb for attaching the body applicator unit to the patient, they do not disclose therapeutic ultrasonic delivery systems having a device that permits placement of one or more transducers adjacent various parts of the body that are either hard-to-reach or, because of the topology of the external skin location, make it difficult to manually position and maintain a transducer adjacent thereto.
Therefore, a need exists for an apparatus which permits placement of one or more body-applicator units adjacent various parts of the body that are hard-to-reach or otherwise hard to manually position or maintain a transducer adjacent thereto.
SUMMARY OF THE INVENTION
The ultrasonic treatment apparatus of the present invention is used for preventing osteopenia, promoting bone and soft tissue growth, ingrowth, and healing of bone and soft tissue. The apparatus includes a main operating unit, including a signal generator for providing excitation signals for an ultrasonic transducer head module. At least one submergible ultrasonic treatment head module is also provided including a receiving component and an ultrasonic generation component for providing ultrasonic waves from an exposed operative surface positionable adjacent a skin location. The receiving component receives the excitation signals from the signal generator and provides input signals to the ultrasonic generation component for the generation of ultrasonic waves at the operative surface. An interface between the main operating unit and the receiving component of the ultrasonic treatment head module transmits the excitation signals from the signal generator to the receiving component. A housing configured (or configurable) at least in part to contour to a region of a human body includes at least one receptacle for holding the at least one ultrasonic treatment head module with the transducer surface adjacent a skin location when the housing is positioned adjacent the region of the human body.
The housing of the present invention encompasses an insert that is suitable for submersion in a tub, including a variety of specific configurations adapted for treatment on various regions of the torso that are prone to osteopenia or injury, such as the hip and the spine. (For the purposes of this application, the spine is defined to extend from the cervical vertebrae to the coccyx.) In its most generic embodiment, the insert is a seat-like mold that extends from the back of the thighs to the upper back, and around the hips of the user. The insert is also configured to be received within a standard residential bathtub. The insert provides for adjusting the position of the transducer surface of the ultrasonic treatment module so that it interfaces with the external skin location corresponding to the injury targeted for treatment.
The ultrasonic delivery system for therapeutic use of the present invention also includes at least one ultrasonic treatment module with a telescoping portion, the distal end of the telescoping portion defining a forward planar region. An ultrasonic generation means is housed within the at least one ultrasonic treatment module and includes an exposed transducer surface substantially parallel with the forward planar region of the telescoping portion. The system further includes a positionable insert contoured to a portion of a human body, the insert having at least one receptacle for retaining and aligning the at least one ultrasonic treatment module with the transducer surface adjacent the human body when the insert is positioned adjacent the portion of the human body it is contoured to.
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Exogen, Inc
Gray Bruce D.
Johnson Kristin L.
Kilpatrick & Stockton LLP
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