Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
2001-03-01
2002-11-26
Jaworski, Francis J. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
Reexamination Certificate
active
06485425
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to ultrasound transducers, and more particularly, to apparatus and method of holding and manipulating small or minute ultrasound transducers.
BACKGROUND OF THE INVENTION
Ultrasound is a ubiquitous technology capable of obtaining images, assessing functions, measuring hemodynamics, characterizing tissues, visualizing fluid flows, etc. One of the major attributes of ultrasound is its safety, adaptability, low cost, and high spatial and temporal resolution.
As less invasive surgical techniques evolve and the complexity of such procedures increases, direct alternative imaging and control of an event becomes essential. Today, ultrasound is one of the most practical energy sources that can be formulated into small usable devices capable of being manipulated within a surgical environment. Ultrasound can be used as a visual substitute within the opaque confines of body cavities and tissues. Ultrasound vision provides an immediate imaging solution to evaluate the intended result of an intervention.
As a result, ultrasound technology has evolved to be one of the most commonly employed imaging modalities in medical practice. Recent advances include the development of sophisticated multi-array devices, which are of small caliber typically attached by flexible electronics to a fully complemented ultrasound system. Until recently, the applications of small interventional ultrasound transducers have been principally confined to endoscopic applications. Endoscopic devices are rigid or semi-regid scopes, inserted through ports into body cavities (such as esophageal, rectum, vagina, etc.) or vessels. Such devices are rigid enough to be manipulated by hand or self-contained mechanisms.
However, miniaturized or small ultrasound transducer devices are still a recent advent and intend to incorporate ultrasound attributes, such as Doppler, color flow imaging, parametrics, etc. These ultrasound transducer devices are of small caliber, flexible, and incapable of having sufficient internal control. The use of very small caliber ultrasound devices within a body cavity, e.g. a surgical field, has not been previously feasible. There are at least three principal reasons for this reality. Firstly, most early ultrasound devices and transducers were too large or too rigid to accommodate manual and/or digital manipulation within the surgical field or within the appropriate body cavity. Secondly, it is very difficult to control a small or minute transducer. Thirdly, there is insufficient means of controlling the small transducers in the moist confines of a body cavity.
Currently, in a surgery involving the use of ultrasound imaging, a primary surgical physician rarely personally uses ultrasound imaging. Typically, a separate physician outside the immediate surgical environment performs the ultrasound examination. This second physician monitors changes in anatomy, physiology, and procedural outcome and communicates these observations to the primary physician. The primary physician is dependent on a disconnected, and sometimes, unpredictable or unreliable resource. It is desirable to have the primary physician use an imaging device suited for its own specific needs.
Accordingly, there is a need for means of controlling a small ultrasound device, which would allow one to easily manipulate such device in an underfluid environment, particularly in the moist confines of a body cavity. Also, there is a need for a versatile, inexpensive means of controlling such a small device.
SUMMARY OF THE INVENTION
In accordance with this invention, the above and other problems were solved by providing an apparatus and method for holding and manipulating a miniaturized ultrasound transducer.
In one embodiment of the present invention, the apparatus includes: a flexible member, a retaining member, and a control member. The miniaturized ultrasound transducer is mounted on the flexible member proximate a distal end of the flexible member. The flexible member can be a catheter or other types of thin tube carriers. The retaining member retains the flexible member proximate the distal end of the flexible member. The control member is coupled to the retaining member and is operable to move the retained flexible member and the ultrasound transducer to optimize ultrasound visualization.
Further in one embodiment, the retaining member is a clip having a C-shape. The clip retains the flexible member. The control member is a clip having a C-shape. An operator's finger is clipped onto the control member. The backsides of the C-shaped retaining member and control member are integral to each other. The operator's finger controls the movements of the flexible member and the ultrasound transducer mounted thereon.
In another embodiment of the present invention, the retaining member is a semi-rigid tube. The flexible member is inserted through and retained by the semi-regid tube, and the ultrasound transducer is exposed at an end of the semi-rigid tube. The control member includes a plurality of handles and an articulation mechanism. The articulation mechanism is connected to the handles and the flexible member, and the handles are operable to control the movements of the flexible member and the ultrasound transducer.
In another embodiment of the present invention, the retaining member is a hollow tube. The flexible member is inserted through and retained by the hollow tube, and the ultrasound transducer is exposed at an end of the hollow tube. The control member includes a multi-faceted articulated joint and a handle. The handle is connected to the multi-faceted articulated joint and is operable to control the positions of the flexible member and the ultrasound transducer.
In another embodiment of the present invention, the retaining member includes a hollow tube, a handle, a rigid shaft, and a clip. The flexible member is inserted through the hollow tube within the handle and is held in position by the clip affixed to the rigid shaft. The control member includes a trigger mechanism having a trigger and a deflecting cable or wire. The deflecting cable or wire is connected to the flexible member and the trigger. The trigger is operable to control the movements of the flexible member and ultrasound transducer.
In another embodiment of the present invention, the retaining member is a clip having a C shape. The flexible member is inserted into the clip. The control member also includes a pair of suture holes for fixing the retaining member onto a surface. The flexible member is repositionable and/or rotatable within the clip so as to move the ultrasound transducer at will.
One advantage of the present invention is that it allows one to hold and manipulate a very small ultrasound transducer, particularly within a moist surgical field.
Another advantage of the present invention is that it accommodates surgeon's needs, such as the size of a surgeon's hand, etc., and surgeon's ability to reach a specific location and function in an underfluid environment.
A further advantage of the present invention is that it empowers an operator, e.g. a surgeon, to personally and interactively assess the status and result of the operation without having a second operator to perform a separate examination and communicate the results to the operator. Accordingly, the operator is able to assess a personal status and result, thereby giving the imaging capability to the hands of an actual person who performs intervention.
These and various other advantages and features of novelty which characterize the invention are pointed out with particularity in the claims annexed hereto and form a part hereof. However, for a better understanding of the invention, its advantages, and the objects obtained by its use, reference should be made to the drawings which form a further part hereof, and to accompanying descriptive matter, in which there are illustrated and described specific examples of an apparatus in accordance with the invention.
REFERENCES:
patent: 4802487 (1989-02-01), Martin et al.
patent: 4926875
Bruce Charles J.
Seward James B.
Jaworski Francis J.
Mayo Foundation for Medical Education and Research
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