1. Field of the Invention
This invention relates generally to storing transducers used in ultrasonic imaging systems and, in particular, to the storage and maintenance of endocavity transducers, such as transesophageal echo (TEE) transducers.
2. Description of the Related Art
Ultrasonic imaging systems are used to observe the internal organs of a patient. The ultrasonic range is described essentially by its lower limit: 20 kHz, roughly the highest frequency a human can hear, although medical ultrasound imaging systems tend to use frequencies in the 2 to 15 MHz range. The systems emit ultrasonic pulses which, if not absorbed, echo (i.e., reflect), refract, or are scattered by structures in the body. Most of the received signal is from scattering, which is caused by many small inhomogeneities (much smaller than a wavelength) making a small part of the wave energy disperse in all directions. The signals are received and are translated into images by the ultrasound system.
A typical ultrasound system 100 is shown in
The component which is placed on (or in) the patient in order to transmit and receive the ultrasonic waves which image the region of interest in the patient is called a “transducer”. In
Ultrasonic transducers take a variety of shapes and sizes, and each one is designed for one or more particular imaging applications. In general, transducers fit in one of two categories: those used externally (placed on the skin of the patient) and those used internally (placed inside the patient). External ultrasonic transducers, such as those used to perform imaging of a fetus during pregnancy, are familiar to most of the public. Internal ultrasonic transducers are less well-known, and include endocavity transducers (such as endorectal and endovaginal transducers) and intraoperative transducers (which are used during surgery to visualize internal structures).
One type of endocavity transducer is a transesophageal echo (TEE) transducer, such as the TEE transducer 200 shown in
A TEE transducer 200, with its probe 210 inserted inside a patient, can be seen in
In
Although TEE transducer 200 in
Because, as graphically depicted by TEE transducer 200 in
Exemplary transducer cleaning and maintenance operations are described in SONOS 7500/5500 TRANSDUCER REFERENCE GUIDE, Edition 7, published in December 2002 by Philips Electronics (Part No. M2424-99300-07; hereinafter referred to as “GUIDE”), hereby incorporated by reference. For example, as described therein, an endocavity transducer must be thoroughly washed, preferably with an enzymatic cleaner, and disinfected, preferably with a glutaraldehyde-based disinfectant, after each examination. After disinfecting the transducer for a period of time, it is thoroughly rinsed with sterile water and checked for any residual organic material. If any is found, the process is repeated (for full description, see, e.g., pages 2-14-2-15, GUIDE).
Although endocavity transducers could be stored like the external transducers 150 in
As an example of the storage problems for endocavity transducers, consider a TEE transducer, such as the one described in reference to
However, these designated cleaning/disinfecting areas may be situated a considerable distance away from the location or locations where the ultrasonic transducers will be used to examine patients. For instance, in a typical mid-size hospital, the cleaning and disinfection area may be located in the basement, whereas the operating room (OR), intensive care unit (ICU), echo lab, radiology suites, or other places where endocavity ultrasound examinations are performed, may be located on the first, second, or third floor. Thus, in such a hospital, endocavity transducers will have to be transported to and from the examination area and the cleaning/disinfecting area, either with or without the rest of the ultrasound system. This naturally requires that the locations of the transducers be tracked, as well as their present disinfecting status, to ensure that each ultrasound system will have an appropriately matched disinfected transducer when an examination is about to be performed. Besides the extra work involved in such transportation and tracking, there is the risk of contamination whenever the transducers are moved from one place to another.
In addition to these problems, there may be particular storage or maintenance needs for particular transducers. For instance, the flexible shaft 230 of a TEE transducer 200 must not be bent or coiled into a circle of less than a certain diameter (typically around one foot) in order to avoid damaging the steering mechanism or shaft 230 itself. Furthermore, the distal end of the TEE transducer should be protected by a tip protector in order to prevent damage to the transducer array 342.
Therefore, there is a need for a system and apparatus for the proper maintenance and storage of endocavity transducers used by ultrasound systems. Furthermore, it should be noted that, although the problems discussed above were brought up in the context of endocavity transducers in general, and in the context of TEE transducers in particular, the problems for which the present invention is a solution may be suffered by any ultrasonic transducer which belongs in the “critical” device category (devices which contact blood, compromise tissue, or are used in a sterile field) and/or “semi-critical” device category (devices which may come into contact with mucous membranes but do not penetrate a body surface).
One object of the present invention is to provide a receptacle appropriate for the storage, maintenance, and transportation of ultrasonic transducers used in critical or semi-critical environments.
Another object of the present invention is to provide an ultrasonic transducer receptacle which can be securably attached and detached from an ultrasound imaging system.
Yet another object of the present invention is to provide an ultrasonic transducer receptacle in which portions of the ultrasonic transducer only come into contact with a disposable liner.
Still another object of the present invention is to provide an ultrasonic transducer receptacle which has a visual means by which the present status, in terms of usage and/or cleaning/disinfecting, may be determined.
A further object of the present invention is to provide an ultrasonic transducer receptacle which is integrated into the physical structure of the ultrasound imaging system.
These and other objects are met by the present invention, a receptacle appropriate for the storage, maintenance, and transportation of ultrasonic transducers used in critical or semi-critical environments. In one aspect, the receptacle is embodied in a tray capable of being detachably secured to an ultrasound system, in which at least a portion of the ultrasonic transducer may be placed while being transported. In another aspect, the receptacle is embodied in a case which has a form-fitting cavity for holding the ultrasonic transducer, a movable or removable cover for sealing the transducer inside the case, and a handle to be used when the case is being transported.
A liner may be used to line the interior of the receptacle, thereby keeping the surfaces of the transducer separate from the interior surfaces of the receptacle. The liner may be disposable, semi-permanent, or permanent (depending on its ability to be cleaned and/or disinfected).
The movable/removable cover on the case may be transparent so that the operator can quickly determine the condition of the transducer contained within. Furthermore, a status indicator may be attached to the receptacle in order to provide the operator with information concerning the transducer.
Other objects and features of the present invention will become apparent from the following detailed description considered in conjunction with the accompanying drawings. It is to be understood, however, that the drawings are designed solely for purposes of illustration and not as a definition of the limits of the invention, for which reference should be made to the appended claims. It should be further understood that the drawings are not necessarily drawn to scale and that, unless otherwise indicated, they are merely intended to conceptually illustrate the structures and procedures described herein.
In the drawings:
In general, the present invention is directed to a receptacle in which an ultrasonic transducer may be stored and transported, and which also provides appropriate sanitary safeguards for ultrasonic transducers used in critical or semi-critical environments. Two presently preferred embodiments are described herein: a tray which has a cavity for holding at least a portion of the ultrasonic transducer, and which is capable of being detachably secured to the ultrasound system, according to a first preferred embodiment; and a case which has a form-fitting cavity for holding the ultrasonic transducer, and which has a handle and a movable or removable cover, through or by which the operator may determine the current status of the ultrasonic transducer. These presently preferred embodiments, the tray and the case, are only two examples within the wide variety of embodiments possible in accordance with the present invention. In other words, the scope of the present invention includes embodiments which share one or more features of both the presently preferred embodiments, and embodiments which share one or more features with only one of the presently preferred embodiments.
In the first presently preferred embodiment, the inventive receptacle takes the form of tray 500, as shown in
As can be seen in
Tray 500 is constructed of a material which is capable of being cleaned, disinfected, and/or sterilized (thereby making tray 500 reusable). However, in other embodiments of the present invention, it is possible for the receptacle to be constructed from a material which is disposable, i.e., an embodiment where the receptacle itself is disposable or semi-permanent. Tray 500 preferably weighs less than a maximum of about 10 pounds when empty.
Tray 500 is removably attached to pedestal 410. In
In
The tray embodiment shown in
Preferably, the entire transducer 200 is placed in tray 500 for transport to the cleaning/disinfecting area, where all the component parts of transducer 200 are appropriately cleaned and disinfected. When tray 500 is holding the entire transducer, probe handle 240 is held in portion 520 across from where probe 210 is clipped, and flexible shaft 230 juts out from tray 500. Specifically, shaft 340 runs out from probe 210 at trap lip 532 and re-enters tray 500 so that the portion entering probe handle 240 rests on at tray lip 534. Of course, other embodiments may wish to avoid having any portion of the transducer hanging out of tray 500. The remaining portions of transducer 200, connector cable 250 and connector plug 260 (not shown in
In order to clarify the cleaning/disinfecting status of the transducer 200 lying in tray 500, a status indicator may be used to indicate whether it is currently ready to be used, whether it has just been used, or whether it has been in storage, and for how long (as it may require another cycle of cleaning/disinfecting before use). Systems of status identification according to the present invention will be described in greater detail in reference to the second preferred embodiment, described below with reference to
In the first preferred embodiment of the present invention, as shown in
In the second presently preferred embodiment, the inventive receptacle takes the form of a case 600, as shown in
Preferably, the cover of case 600 is substantially transparent so that the operator may easily observe the transducer contained therein in order to determine general status and/or level of contamination of the transducer. In addition, a status indicator may be incorporated into the cover or into another part of case 600. The status indicator would provide information to anyone viewing the outside of case 600 as to the transducer stored within. Such information may include, for example, the state of disinfection and/or cleaning, the appropriate routing for the transducer, the owner of the transducer, the safety test status of the transducer, the repair status of the transducer, or any other information of importance concerning the transducer.
The status indicator may be implemented, for example, by lettering, symbols, and/or color codes on a designated rewritable surface located on the transparent cover. As another example, a system of status indication could be used in which removable labels (with lettering, symbols, and/or color codes) are placed on, and removed from, the cover after specified acts, events, or periods of time. The status indicator could also be implemented by mechanical means (such as movable tabs in slots) or electronic means (such as an LED or LCD display with appropriate controls) attached to the cover of case 600. Other embodiments of the present invention may locate the status indicator on a different surface of case 600, or may implement the status indicator by another means.
The interior 620 of case 600 has a form-fitting cavity for the transducer. The form-fitting cavity would be similar in shape to the cavity shown in the prior art case of
While there have shown and described and pointed out fundamental novel features of the invention as applied to two preferred embodiments thereof, it will be understood that various omissions and substitutions and changes in the form and details of the devices illustrated, and in their operation, may be made by those skilled in the art without departing from the spirit of the invention. For example, it is expressly intended that all combinations of those elements and/or method steps which perform substantially the same function in substantially the same way to achieve the same results are within the scope of the invention. Moreover, it should be recognized that structures and/or elements and/or method steps shown and/or described in connection with any disclosed form or embodiment of the invention may be incorporated in any other disclosed or described or suggested form or embodiment as a general matter of design choice. It is the intention, therefore, to be limited only as indicated by the scope of the claims appended hereto.
Applicants claim the benefit of Provisional Application Ser. No. 60/529,122, filed DEC. 12, 2003.
Number | Date | Country | |
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60529122 | Dec 2003 | US |