Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
1998-10-13
2001-01-09
Jaworski, Francis J. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C604S272000, C600S143000
Reexamination Certificate
active
06171249
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a medical device and, more specifically, to an ultrasound device.
2. Prior Art
With the advent of laparoscopic surgery, ultrasound imaging can be used to image beneath the surface of organs. Implementation is achieved by the introduction of an ultrasound imaging probe through a cannula.
FIG. 1A
shows the end of one such probe
10
with a distal transducer array
12
on the end of its shaft
14
. The array
12
is positioned at tissue
16
to be imaged. Images are generated by the transducer array located at the end of a shaft, and are transmitted via a signal cable through the shaft and handle. Images are reconstructed by computer connect by cable to the probe handle and displayed on a CRT screen. A typical ultrasound image
15
corresponding to
FIG. 1A
is shown in FIG.
1
B. It is desirable to have a flexible tip to the shaft such that the transducer array can be bent relative to the axis of the shaft. A skilled surgeon can maneuver the probe tip to the organ/area of interest.
In conjunction with ultrasound imaging, there is also a need to obtain biopsy samples of suspicious areas. The use of ultrasound allows the surgeon to guide the biopsy procedure. This procedure, generically called ultrasound guided biopsy is depicted in FIG.
2
A. The surgeon positions the probe
10
and, using the ultrasound image
15
shown in
FIG. 2B
that is viewed on a display, guides the biopsy needle
18
to the suspect area B. The advantage of this method is the accuracy by which a laparoscopic surgeon can obtain biopsy samples.
In laparoscopic surgery, as illustrated in
FIG. 2A
, both probes and needle are introduced via separate cannulas. The workload on the surgeon to execute a biopsy is high as he must coordinate the location of two objects (probe and needle) while looking at a real time ultrasound image and a video image. U.S. Pat. No. 5,437,283 describes a laparascopic ultrasound probe with integrated biopsy capabilities. The probe can function as an image only probe and, with an attachment, as a biopsy probe.
FIG. 3A
schematically shows the ultrasound probe
20
and biopsy device
22
of U.S. Pat. No. 5,437,283. The biopsy device
22
generally comprises a needle
24
, a guide
25
and a gun
27
. By virtue of the attachment, the biopsy needle
24
, made of conventional stainless steel, is constrained to follow a sampling trajectory that always passes within of the ultrasound image (See FIG.
3
C). This approach greatly reduces the workload of the physician performing laparoscopic ultrasound guided biopsy.
The use of laparoscopic ultrasound probes with deflectable tips exposes the shortcomings of U.S. Pat. No. 5,437,283. Probes with the attachment
22
will need a larger cannula in the patient. The biopsy needle
24
is constrained to be parallel with the rigid shaft
26
. Deflectable tips
28
can only be two-way deflectable (not four-way deflectable) because deflection on the perpendicular lateral direction from that illustrated in
FIG. 2A
will cause the image to be out of the trajectory plane of the biopsy needle. It is obvious that the bending neck
30
can only deflect in one direction, away from the path of the needle
24
, otherwise the tip
28
would block the path of the needle. Because the tip
28
can only be deflected away from the path of the needle
24
in one direction, this limits the flexibility of the probe. Another problem is that, at the extremes of deflection, the image of the trajectory is small. Furthermore, it is not possible to preprogram the trajectory of the needle's path because the angle which the biopsy needle enters the ultrasound image will be a function of the deflection angle of the neck
30
and tip
28
. Thus the target line for the biopsy needle cannot be determined in advance. It can only be estimated from the deflection angle.
SUMMARY OF THE INVENTION
In accordance with one embodiment of the present invention an endoscope is provided comprising a shaft, an ultrasound device, a working channel, and a biopsy needle. The shaft has a bending neck. The ultrasound device is located at a distal end of the bending neck. The working channel extends through the shaft and bending neck and has an opening proximate the ultrasound device. The biopsy needle is located in the working channel. The needle is comprised of superelastic material and is extendible and retractable out the working channel opening proximate the ultrasound device.
In accordance with another embodiment of the present invention a medical needle assembly is provided having a front end with an aperture. The needle assembly has a first member forming the front end which is comprised of a shape memory alloy with superelastic properties allowing the first member to resiliently deform with a strain of at least 6 percent.
In accordance with another embodiment of the present invention a medical system is provided having an ultrasound probe, a display, and means for displaying a combined image on the display. The ultrasound probe has means for extending a needle from the probe. The display is connected to the probe. The means for displaying a combined image on the display can display an ultrasound image from the probe and a computer generated image of an expected path of the needle relative to the ultrasound image if the needle were to be extended from the probe.
REFERENCES:
patent: 4346717 (1982-08-01), Haerten
patent: 4763662 (1988-08-01), Yokoi
patent: 5158086 (1992-10-01), Brown et al.
patent: 5398690 (1995-03-01), Batten et al.
patent: 5437283 (1995-08-01), Ranalletta et al.
patent: 5601588 (1997-02-01), Tonomura et al.
patent: 5634466 (1997-06-01), Gruner
patent: 5873828 (1999-02-01), Fujio et al.
Chin Milton
Konstorum Gregory S.
Circon Corporation
Jaworski Francis J.
Perman & Green LLP
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