Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
1999-09-21
2001-07-17
Jaworski, Francis J. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C600S459000
Reexamination Certificate
active
06261231
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to the field of ultrasound imaging and, more specifically, to an apparatus and a method for holding an ultrasound probe to enable a clinician hands-free imaging capabilities.
BACKGROUND OF THE INVENTION
Ultrasound/contrast imaging is commonly performed by a clinician using a hand held probe which is positioned adjacent to a patient. However, the effective use of a hand held probe is limited by frame-to-frame variability in the images produced, occupational health hazards, and the inability to monitor an organ of interest during exercise induced stress. These limitations can seriously and deleteriously affect the utility of the ultrasound/contrast imaging technique.
Frame-to-frame variability in the images arises from movement of the probe between successive images. To minimize distortions resulting from frame-to-frame variability, the probe must be maintained in a steady orientation relative to the patient. For example, when imaging a patient's heart, 5 to 10 cardiac cycles are typically needed for contrast myocardial perfusion to occur before the next ultrasound wave is emitted. Since a cardiac cycle is typically about 1 second in duration, a clinician must be able to steadily hold a probe for 5 to 10 seconds between successive ultrasonic emissions. Movement of the probe during that time period will result in frame-to-frame variability between images and cardiac views obtained.
Additionally, holding the probe in a steady orientation for long periods of time can lead to occupational health hazards (e.g. ergonomic injuries). Mercer et al., J. Am. Soc. of Echocardiography, pp. 363-366 (May 1997), reported studies relating to the occupational health hazards due to long term use of hand held probes. The hazards include muscle strain and injury from standing over the patient, carpel tunnel syndrome resulting from wrist strain, stress and burnout due to long days of repetitious probe holding, and an increased likelihood of disease transmission between the patient and sonographer.
Further, it is impractical to use a hand held probe to monitor the organ of interest while the patient is undergoing exercise-induced stress. As a result, ultrasound imaging with stress exercise is traditionally performed only before and after the stress is performed. However, it would be beneficial to monitor ultrasound images while the patient is actually undergoing exercise-induced stress.
In light of the foregoing, it would be beneficial to provide an apparatus and a method for hands-free use of an ultrasonic probe to monitor an organ of interest. The apparatus and method should enable the orientation of the probe to be adjusted relative to the patient in order to produce optimal images of the organ of interest. However, once the position of the probe has been adjusted, the apparatus and method should enable the probe to be maintained in that position throughout the ultrasound procedure, in order to minimize the effects of frame-to-frame variability in the images. Further, the apparatus and method should reduce the incidence of occupational health hazards associated with the long term use of hand held probes and enable images of the organ of interest to be produced while the patient is undergoing exercise-induced stress. Additionally, the apparatus and method should be adaptable to work in cooperation with the known hand held ultrasonic probes.
SUMMARY OF THE INVENTION
The problems associated with the use of hand held ultrasonic probes are overcome to a large degree by the present invention. The present invention relates to an apparatus and a method for producing ultrasound images of an object of interest without the need for a clinician to hold and maintain an ultrasonic probe adjacent to the patient near the organ of interest.
The present invention relates to a probe holder for holding a probe comprising a body portion having a longitudinal bore. A membrane holder, defining an opening, is positioned over a first end of the body portion. The size and shape of the membrane holder may be selected to allow for subcostal views or to cover more surface area of the patient without repositioning the probe holder. The membrane holder comprises a longitudinal groove and a ring positioned within the longitudinal groove for holding a membrane to cover the opening. Additionally, a membrane fixture may be positioned within the opening of the membrane holder for securing the membrane to the membrane holder.
A receptacle for receiving the probe is provided. The receptacle has a longitudinal passage and is rotatably positioned within the longitudinal bore of the body portion at or near a second end of the body portion. The membrane, the membrane holder, the body portion, the receptacle, and the probe define a sealed chamber for containing a contacting medium.
In one particular embodiment, the probe holder further comprises an upper membrane, having an opening, positioned over the longitudinal bore of the body portion at the first end of the body portion. A sealing member is provided for securing a perimeter of the opening in the upper membrane to an outer surface of the probe. In this embodiment, the membrane, the membrane holder, the body portion, the upper membrane, and the probe define the sealed chamber for containing the contacting medium.
The receptacle may further comprise a probe securing means positioned within the longitudinal passage of the receptacle for retaining the probe within the receptacle with a window of the probe directed generally toward the opening in the membrane holder. In one embodiment, the probe securing means comprises a rubber tube. Alternatively, the probe securing means comprises a locking cuff, such as an inflatable locking cuff. In yet another embodiment, the probe securing means comprises a multipodal locking devices.
An annular lip may be provided which is formed along an inner surface of the body portion and concentric with the longitudinal bore of the body portion. The annular lip contacts an outer surface of the receptacle and is shaped to provide smooth rotation of the receptacle within the body portion, thereby facilitating manipulation of the probe to obtain optimum ultrasound images of an object of interest.
The probe holder may further comprise a locking means operatively connected to the body portion for maintaining the receptacle in a selected orientation. In one embodiment, the locking means comprises a locking cap positioned over the second end of the body portion, a pressing ring positioned between the locking cap and an outer surface of the receptacle, and an insert positioned between the pressing ring and the outer surface of the receptacle. The locking cap is movable between a first position wherein the receptacle is rotatable within the body portion and a second position wherein the locking cap exerts pressure on the insert through the pressing ring to maintain the receptacle in a selected orientation.
The probe holder is secured to a patient or other subject by a belt, harness, or holster. A coupling means is operatively connected to the belt, harness, or holster for securing the body portion of the probe holder to the belt, harness, or holster with the membrane in contact with the subject.
The present invention also relates to a method for holding a probe adjacent to a subject. The probe is positioned within a probe holder in accordance with the present invention. A contacting medium is then inserted within the sealed chamber of the probe holder. The probe and probe holder are then secured to the subject adjacent to the object of interest. The orientation of the probe is adjusted by rotating the receptacle of the probe holder within the longitudinal channel of the body portion until the resulting ultrasound image of the object of interest is optimized. If desired, the position of the probe is then locked by actuating the locking cap.
REFERENCES:
patent: 4316271 (1982-02-01), Evert
patent: 4483344 (1984-11-01), Atkov et al.
patent: 4722346 (1988-02-01), Chen
patent: 4796632 (1989-01-01), Boyd et al.
paten
Damphousse David J.
Kagan Mikhail
Dolan Peter L.
DuPont Pharmaceuticals Company
Jaworski Francis J.
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