Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
1999-05-06
2001-03-20
Lateef, Marvin M. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C600S440000
Reexamination Certificate
active
06203498
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to medical devices and methods and, more particularly to a fully integrated hand held ultrasonic diagnostic instrument.
As is well known, modem ultrasonic diagnostic systems are large, complex instruments. Today's premium ultrasound systems, while mounted in carts for portability, continue to weigh several hundred pounds. In the past, ultrasound systems such as the ADR 4000 ultrasound system produced by Advanced Technology Laboratories, Inc. were smaller, desktop units about the size of a personal computer. However, such instruments lacked many of the advanced features of today's premium ultrasound systems such as color Doppler imaging and three dimensional display capabilities. As ultrasound systems have become more sophisticated they have also become bulkier.
However, with the ever increasing density of analog and digital electronics, it is now possible to foresee a time when ultrasound systems will be able to be miniaturized to a size even smaller than their much earlier ancestors. The physician is accustomed to working with a hand held ultrasonic scanhead which is about the size of an electric razor. It would be desirable, consistent with the familiar scanhead, to be able to compact the entire ultrasound system into a scanhead-sized unit. It would be further desirable for such an ultrasound instrument to retain as many of the features of today's sophisticated ultrasound systems as possible, such as speckle reduction, color Doppler and three dimensional imaging capabilities.
Ultrasonic imagining devices incorporating an entire ultrasound system into a scanhead-sized unit will be referred to hereinafter as “fully integrated” devices. In addition to a primary objective of compactness, as set forth above, such fully integrated ultrasound imaging devices would desirably possess a number of other features and characteristics which would benefit the user. For example, it would be desirable for the fully integrated device to operate free from connecting cords, cables, and other attachments, such as power cords. In particular, it would be desirable if such fully integrated devices included an on-board battery which is configured and packaged to permit easy recharging, preferably as part of a storage system where the imaging device is stowed between successive uses. Such storage systems for the device would further preferably provide for protection of the device while maintaining the device in an orientation which permits the viewing of stored images. Of course, the device should also be configured so that the image can be viewed in realtime as the device is scanned across a patient. The device should preferably include a user interface which is both convenient and reconfigurable. Thus, it would be beneficial for the device to have one or more conveniently located dedicated-function keys or buttons as well as having multi-function keys and buttons and/or a full function keyboard to permit more sophisticated and a larger variety of functions. At least some of these objectives will be met by the devices, systems, and methods of the present invention as set forth hereinafter and in the claims.
2. Description of the Background Art
Related patents and pending applications which are commonly assigned with the present application include U.S. Pat. Nos. 5,722,412 and 5,817,024; and U.S. Ser. Nos. 08/826,543 and 09/167,964, the full disclosures of which are incorporated by reference.
SUMMARY OF THE INVENTION
The present invention provides hand held ultrasound devices, systems, and methods for their use. The devices comprise an enclosure having a front, a top, and a bottom. A display, typically a liquid crystal display (LCD), is disposed in an upper section of the front of the enclosure, and an acoustic window is disposed at or near the bottom of the enclosure. An ultrasonic transducer for obtaining an ultrasonic image, typically a transducer array, is located within the enclosure near the acoustic window, and transceiver circuitry (and any other circuitry necessary for forming and controlling the image such as beamformer circuitry when a transducer array is being used) is also located within the enclosure. User controls are located on front of the enclosure below the display and above the acoustic window to permit a user to control and manipulate an image acquired by the transducer through the acoustic window and present it on the display.
In a first specific aspect of the present invention, the device is fully integrated and includes an on-board rechargeable battery. While it is possible to configure the device for powering through an external source, e.g., using a line power cord, the need to plug-in the device is inconvenient. The devices with batteries are preferably incorporated into systems comprising a recharger, preferably in the form of a tabletop base unit having a receptacle for removably receiving the ultrasonic device. Conveniently, mating electrical connectors can be provided on the bottom of the device and within the receptacle so that the hand held device will be connected to the recharging circuitry automatically when the device is placed into the base unit receptacle. By providing such continuous recharging, the imaging device will always be ready for removal and use in scanning a patient. As described in more detail below, the device may be used for realtime image viewing as it scanned across the patient. Additionally, imaging device may be viewed while placed back into the base unit where an acquired image can be displayed and manipulated using the controls on the device. When used with the base unit, the hand held device will preferably further include a handle formed in or on the top of the enclosure. The handle facilitates both removal and replacement into the base unit as well as manipulation of the device during the imaging step.
In a preferred aspect of the device, the display may be attached to the enclosure in a variety of ways. Most simply, the display will be positioned in a fixed orientation relative to the enclosure, usually being inclined in an upward manner to facilitate viewing during use and when in the base unit. In a preferred aspect, the display may be pivotally attached to the enclosure so that its viewing angle may be adjusted. Usually, the display will be moveable between a parallel orientation with the front face of the base unit to an angle of from 30° to 90° relative to the plane of the face.
The nature of the transducer circuitry will depend on the nature of the ultrasonic transducer. In the case of an array transducer, the circuitry will further include a beamformer coupled to the transceiver circuit for controlling transmission of ultrasonic waves by the individual elements of the array transducer and for delaying and combining echo signals received by said elements to form an ultrasonic beam. Usually, the transceiver circuit will include transducer element drivers responsive to said beamformer for selectively exciting said transducer elements. A multiplexor circuit, coupled to said transducer element drivers, said transducer elements, and the beamformer for alternately causing said transducer elements to be excited by said drivers and to receive echo signals for said beamformer will also be provided.
A wide variety of both dedicated and multi-function buttons, keys, switches and the like may be provided as part of the controls on the front of the enclosure. For example, the controls will usually comprise an on and off switch, and will usually further comprise an operating mode selector which permits selection of specific modes, such as B mode, Doppler, and the like. The controls will preferably further include a cursor control which permits the user to select from control options presented on the display. A particularly preferred form of cursor comprises a roller ball which is recessed in the front face of the enclosure. Recess of the roller ball protects the roller ball against both accidental movement and against damage when the unit
Bunce Steven
Pflugrath Lauren S.
Imam Ali M.
Lateef Marvin M.
SonoSite Inc.
Townsend and Townsend / and Crew LLP
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