Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
1998-04-02
2001-04-10
Lateef, Marvin M. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C600S411000, C600S439000, C600S461000, C606S130000
Reexamination Certificate
active
06216029
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to apparatus for performing needle biopsy, aspiration or injection by computer-aided controlled movement of a medical needle as it penetrates the body guided by an ultrasound or other imaging device.
BACKGROUND INFORMATION
Recently ultrasound diagnosis and therapy have become widely used, and many surgical procedures have been replaced by gentler and less time consuming invasive needle therapy to the benefit of the patient. Inter alia, ultrasonic imaging of maternal and fetal tissues has greatly facilitated prenatal diagnosis and treatment, and ultrasound imaging devices greatly assist the physician in properly positioning a biopsy needle to perform amniocentesis, cordocentesis and trans-abdominal chorionic sampling.
There are many different biopsy techniques and needles, and the needle depends on the type of patient and the target organ. The method most widely used today is the “free hand” technique, whereby the transducer is placed at a certain distance from the entry site of the needle and the needle is manipulated with one hand. This technique requires considerable skill and frequently repeated punctures, unless the target is relatively large or located superficially. For these reasons and because manipulation of the needle as guided by an ultrasound image generally requires both hands of the physician, much effort has been made to design and provide automatic devices for guiding the needle as directed by the ultrasound beam.
Early developed devices include a needle attached to an ultrasound transducer housing, the needle being spaced from and articulated with respect to the transducer. Such devices help the physician to manually direct the needle onto the desired biopsy location and to insert it to the required depth. Such devices are, for instance, described in U.S. Pat. No. 4,899,756, issued to Sonec, and U.S. Pat. No. 4,911,173, issued to Terwillinger. While all of these devices provided some movement of the needle guide and needle relative to the transducer, the physician is nevertheless significantly hampered in positioning the needle prior to and during insertion, as well as in re-positioning the transducer once the needle is inserted into the body.
Other commonly used devices include a transducer and a coaxial needle guide for manually positioning and inserting a needle. While these devices allow rapid and convenient guided biopsy, they have several significant drawbacks: 1) The transducer must be placed directly over the lesion, thereby requiring its sterilization or its draping by a sterile covering. 2) The physician is forced to hold the transducer in one hand while using the other for sterilizing and anesthetizing the biopsy site. 3) After inserting the needle, the transducer must be held by an assistant or must be removed while the needle is maneuvered. 4) Multiple passes may necessitate re-positioning of the transducer and re-insertion of the needle. 5) The existing needle guides may make it difficult to enter some superficial lesions. 6) Most transducers are flat, straight and relatively large, making some costal and subcostal approaches difficult.
A completely automatic apparatus for computer controlled stereotactic brain surgery is described in U.S. Pat. No. 5,078,140, issued to Kwoh. This apparatus suffers from the drawback that the needle or needle guide is integrally connected to the apparatus, thereby not permitting the physician to choose the most suitable trajectory of the needle towards the target. In addition, the apparatus is highly complicated, expensive and has to be calibrated for every operation.
Another device is an ultrasound directed needle guide, developed by the present Applicant, and disclosed in Israel Patent Application 107,523. It includes an ultrasound transducer and a needle, guide which holds a syringe and needle. Both the transducer and the needle guide are each attached to a universally movable arm such that each may be placed on a patient's body in any desired position. The arms are vertically movable along a vertical post and are provided with direction sensors configured to signal the position of the attached instruments to computer means. The transducer transmits the image of the target to an imaging device which in turn transmits the information to the computer means which is programmed to indicate the angular direction of the needle guide onto the target and to direct the physician to place the needle in the correct position and direction on the patient's body.
SUMMARY OF THE INVENTION
The present invention seeks, inter alia, to improve the articulated arm system disclosed in applicant's above mentioned Israel Patent Application 107,523. The present invention does away with the articulated arm and provides an improved “free-hand” technique for using the transducer and needle. The transducer is used to project on a computer screen an image of a body portion to be treated, thereby permitting a physician to obtain on the screen the preferred needle trajectory as well as the actual position of the needle guide, inserted needle and needle tip. The physician may then correct the actual trajectory in accordance with the displayed information.
Optionally, the target in the body portion to be treated may be selected and marked by the physician, such as with a cursor or other selection device. In case the needle point does not lie in the plane of the target image, the physician either changes the position of the needle or rotates the imaging source or detector so as to obtain the coinciding plane on the display screen.
Unlike the prior art, the present invention provides a system for multiple, daily use by any physician who does not need to be specially skilled in the art.
In the present invention, the image may be produced by any known imaging apparatus, such as ultrasound, computerized tomography (CT) or X-ray, which will permit positioning of the ultrasound transducer or other imaging detector at a distance from the actual entry site, thereby permitting the physician to place the needle in an optimal position.
It is noted that throughout the specification and claims the term “needle” encompasses any invasive device or tool and the term “needle guide” encompasses any device for holding and guiding a needle (or invasive device or tool) as well as a needle (or invasive device or tool) with an integrated electronic system. The term “orientation” encompasses spatial position information with respect to six degrees of freedom, such as in a Cartesian system, position along any of three mutually perpendicular axes and angular rotation about any of the axes. The terms “orientation” and “position” are used interchangeably.
The present invention may use a variety of apparatus for sensing the orientation of the transducer and needle. One preferred embodiment of apparatus for defining the position of the ultrasound transducer with wireless transmission includes mounting three small battery-operated infrared ultrasonic transponders on the ultrasound transducer in triangular alignment, each transponder having a different triggering code. A position sensing device is provided with three spaced-apart infrared ultrasonic transceivers which emit coded infrared signals to the respective transponder on the transducer and which receive ultrasonic responses from the respective transponder. The received signals provide triangulation information for the controller to calculate the exact position of the transducer in three-dimensional space.
A position sensing unit for the needle may work in a similar manner. The position sensing unit is provided with at least two transceivers configured to transmit wireless coded infrared signals to at least two transponders mounted on the needle or needle guide which issue coded signals back to the transceivers for calculating the needle position and direction, and to transmit the data to the computing device for display on the screen.
In another embodiment, both the transducer and the needle are provided with transmitters which continuously emit signal
Kenyon & Kenyon
Lateef Marvin M.
Shaw Shawna J
Ultraguide Ltd.
LandOfFree
Free-hand aiming of a needle guide does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Free-hand aiming of a needle guide, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Free-hand aiming of a needle guide will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2437082