Surgery: kinesitherapy – Kinesitherapy – Ultrasonic
Reexamination Certificate
1999-10-18
2001-11-27
Lateef, Marvin M. (Department: 3737)
Surgery: kinesitherapy
Kinesitherapy
Ultrasonic
C310S316020, C310S348000, C607S051000
Reexamination Certificate
active
06322527
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to an apparatus for therapeutically treating injuries using ultrasound. More particularly, the present invention relates to an apparatus which utilizes a portable signal generator and transducer for 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 (“Duarte”) describes a basic therapeutic technique and apparatus for applying ultrasonic pulses from an ultrasonic applicator placed on the skin at a location adjacent a bone injury. Duarte gives a range of R-F signals for creating the ultrasound, ultrasound power density levels, a range of duration for each ultrasonic pulse, and a range of ultrasonic pulse frequencies. The length of daily treatment is also described. The applicator described in the '360 patent has a plastic tube which serves as a grip for the operator, an R-F plug attached to the plastic tube for connection to an R-F 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 is inconvenienced.
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 in the wound-healing method and apparatus described above.
U.S. Pat. Nos. 5,003,965 and 5,186,162 both to Talish and Lifshey (“Talish '965” and “Talish '162”, respectively) describe an ultrasonic delivery system where the R-F generator and transducer are both part of a modular applicator unit that is placed at the skin location. The signals controlling the duration of ultrasonic pulses and the pulse repetition frequency are generated apart from the applicator unit. Talish '965 and Talish '162 also describe fixture apparatus for attaching the applicator unit so that the operative surface is adjacent the skin location. In Talish '965 and Talish '162, the skin is surrounded by a cast, while in U.S. Pat. No. 5,211,160 to Talish and Lifshey (“Talish '160”) fixture apparatus is described for mounting on uncovered body parts (i.e.,, without a cast or other medical wrapping). Talish '160 also describes various improvements to the applicator unit.
Duarte, Talish '965, Talish '162, and Talish '160, are all incorporated into this application by reference.
While the systems described in these patents relate to therapeutic methods and apparatus for ultrasonically treating injured bone, they do not disclose a self-contained signal. generator and transducer which permits maximum patient mobility during treatment. Therefore, a need exists for apparatus which optimizes patient mobility during therapeutic ultrasonic treatment.
SUMMARY OF THE INVENTION
The ultrasonic treatment apparatus of the present invention is used for therapeutically treating injuries using ultrasound. The apparatus includes an ultrasonic treatment composite having a signal generator which provides excitation signals for an ultrasonic transducer within the composite. The portable composite is constructed to be worn by the patient adjacent the treatment site, and provides treatment timer control circuitry. The composite may have a power interface for an external power supply, and a control interface, which appropriately activates the composite components in order to provide daily ultrasonic treatment. (Alternatively, the composite may have an integral power supply.) In operation, the composite is positioned with the transducer adjacent the external skin location corresponding to the injury and excited for a predetermined period of time.
Thus, the present invention may include a therapeutic ultrasonic composite comprising a transducer and an integrated circuit unit positioned adjacent the transducer. The therapeutic ultrasonic composite also includes signal generation circuitry, housed on the integrated circuit unit, for generating a driving signal for the transducer, and a driving interface between the signal generation circuitry and the transducer. In operation, driving signals generated by the signal generation circuitry are transmitted to the transducer by the interface, thereby driving the transducer for the creation of therapeutic ultrasound.
Preferably, the composite has a integrated circuit unit (“ICU”) that is positioned adjacent a transducer, the ICU supporting the signal generator circuitry for providing excitation signals to the transducer. A control interface on the ICU can support a data link between the signal generator circuitry and external treatment control circuitry. When the data link is made across the control interface, the external treatment control circuitry provides appropriate control information to the signal generator circuitry, thus activating the therapeutic ultrasound treatment for a period of time.
In a preferred embodiment of the present invention, the ICU is a separate silicon based chip that is mounted to the non-operative surface (back surface) of a ceramic piezo-electric transducer wafer. The ICU has external leads that interface with receptors on the transducer, thus providing an electronic link so that driving signals created by the signal generator circuitry on the chip may drive the transducer. In an alternative preferred embodiment, the ICU is incorporated into the back side of the ceramic transducer wafer, which provides the substrate for the signal generator circuitry. In such an alternative embodiment, the electronic link between the signal generator circuitry and the transducer would be internal to the ceramic wafer.
Thus, an alternative preferred embodiment of the present invention includes a therapeutic ultrasonic composite comprising a transducer formed by a portion of a piezo-electric substrate, the transducer having an operative surface for the emission of therapeutic ultrasound. An integrated circuit is formed in a portion of the piezoelectric substrate, the integrated circuit having signal generation circuitry for generating a driving signal for the transducer. A driving interface is formed within the substrate between the signal generation circuitry and the transducer and, in operation, driving signals generated by the signal generation circuitry are transmitted to the transducer by the interface, thereby driving the transducer for the creation of therapeutic ultrasound at the operative surface.
The present invention also includes a system for providing therapeutic ultrasonic therapy comprising an ultrasonic treatment composite having an integrated circuit containing signal generation circuitry positioned adjacent and interfacing electronically with a transducer. The signal generation circuitry is configured to provide driving signals to the transducer via the interface for the generation of therapeutic ultrasound. An external treatment control circuitry separate from the composite is provided, and configured to generate control signals for the integrated circuit. A control interface between the external treatment control circuitry and the integrated circuit is included for transmitting the control signals generated
Exogen Inc.
Gray Bruce D.
Kilpatrick & Stockton LLP
Lateef Marvin M.
Mantis Mercader Eleni
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