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Description  |
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BACKGROUND OF THE INVENTION
This invention generally relates to the use of ultrasound transducers in
conjunction with a needle, biopsy instrument, catheter or etc. in medical
procedures, and more particularly may relate to the use of ultrasound
transducers and scanners as an aid to physicians, such as, obstetricians
when performing amniocentesis procedures, in a sterile clinical setting.
In recent years, there has been a ground swell of intense concern among
medical and public health professionals relating to the spread of the
acquired immune deficiency syndrome, commonly known as AIDS. Fervent
debates rage on among top medical researchers about how the AIDS virus may
be transmitted, but most prominent medical scholars agree that one way the
AIDS virus may be transmitted is by the direct exchange that occurs in a
blood to blood exchange. One possible direct exchange occurs when an
unaffected person is the recipient of blood from a donor having AIDS, such
as in a transfusion. However, this high volume of blood exchange is not
necessary for transmission to occur. In fact, it is believed that the AIDS
virus can be transmitted to another, when a needle which has been exposed
to the virus is used by an unaffected person. For this reason, it is
commonly believed that drug users, who share needles for drug injections,
are in a high AIDS risk category. Similarly, pregnant women undergoing
amniocentesis, with the aid of ultrasound transducers and their associated
needle guides, both of which are used again and again on numerous women,
are at an elevated risk because of the increased exposure of the needle to
the previously used transducer and needle guide.
One needle guide which has enjoyed much use in the past is described in
U.S. Pat. No. 4,497,325 to Victor J. Wedel, which is hereby incorporated
herein by this reference. Another type of needle guide which has found
increased use recently is similar to the Instrument Guide manufactured by
Advanced Technology Industries of Bothell, Washington. This device is
attached to an ultrasound transducer which is enclosed in a protective
sterile sheath.
While these needle guides, or variations of them, have been used in the
past they do have serious drawbacks when viewed in the light of the AIDS
threat. Because of the high product cost, both of the guides are typically
reused numerous times on various patients from a broad spectrum of
backgrounds. This reuse necessitates sterilization procedures for the
guides before each new use. Because of the relatively complicated design
of these guides, it is often difficult and time consuming to completely
sterilize them.
Consequently, a need exists for improved needle guides which reduce the
risk of disease transmissions while concomitantly increase the ease in
sterilization procedures for ultrasound transducers and related equipment.
SUMMARY OF THE INVENTION
It is an object of the present invention to reduce the risk of transmission
of disease during the use of ultrasound transducers in conjunction with
needle guides and needles.
It is a feature of the present invention to use a monolithic needle guide
in conjunction with an ultrasound transducer and an associated mounting
bracket.
It is an advantage of the present invention to increase the ease of the
sterilization procedures for the transducer and associated equipment by
utilizing all disposable parts which come into contact with the patient
and the needle.
It is another object of the present invention to provide a stable guide
during needle insertion.
It is another feature of the present invention to include a relatively
small external needle guide, having a relatively small surface area in
contact with the patient.
It is another advantage of the present invention to allow the physician's
hands to firmly grasp the transducer and attached needle guide while still
permitting, the much desired, actual physical contact between the
physician and the patient.
It is a further object of the present invention to allow quick release of
the needle guide from the transducer.
It is a further feature of the present invention to employ a needle guide,
of a somewhat resilient material, having a notch therein for engaging a
mounting bracket.
It is a further advantage of the present invention to facilitate quick
release of the needle guide from the transducer while not requiring
complete removal of the transducer.
The present invention provides a monolithic disposable needle guide for
ultrasound transducers designed to satisfy the aforementioned needs,
provide the previously propounded objects, include the above-described
features and produced the earlier articulated advantages. The invention is
"sterilization-less" and "broadbased-less" in the sense that the entire
needle guide is not subjected to repeated sterilization procedures in
order to reduce the risk of disease transmission from one patient to
another and the needle guide does not have a broad base at the interface
with the patient. Instead, a single monolithic and disposable needle guide
having a small "footprint" is used with a transducer and a mounting
bracket.
Accordingly, the present invention utilizes an ultrasound transducer in
combination with a mounting bracket thereon and a single quick release
monolithic disposable need guide.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective and schematic view of the needle guide and mounting
bracket of the present invention together with a needle, ultrasound
transducer, and associated sterile sheath in a representative environment.
FIG. 2 is an exploded perspective view of the mounting bracket and needle
guide of the present invention.
FIG. 3 is a perspective view of the mounting bracket of the present
invention in an opened position.
FIG. 4 is a perspective view of the needle guide of the present invention
in an opened position.
DETAILED DESCRIPTION
In the following detailed description, and drawings, it is understood that
like reference numerals refer to like objects throughout.
Now, referring to FIG. 1 there is shown, an ultrasound transducer 10, with
a mounting bracket, generally designed 100, thereon both of which are
disposed within a semi-transparent sheath 12. The needle guide, generally
designated 200, is shown attached to the bracket 100 with the sheath 12
interposed therebetween, and is further shown having a needle 14 extending
therethrough into a representative patient 16. Dashed lines 18 represent
the needle 14 under the surface of the skin of the patient 16. The needle
14 may be substituted with a biopsy instrument, catheter or other medical
instrument.
The ultrasound transducer 10, is well known and use in the art, but
substitution of an alternative imaging device is contemplated. Similarly,
the semitransparent sheath 12 is well known and is used in the art, but
anything irrespective of its optical characteristics which serves to
isolate the transducer 10 and the bracket 100 from the patient 16, the
needle 14 and the needle guide 200 may be substituted.
The configuration of the transducer 10, the needle guide 200, the needle 14
and the patient 16 are such that, a physician can firmly grasp the
transducer 10 and needle guide with one hand while still maintaining
contact with the patient 16, and manipulate the needle 14 with the other
hand. This maintained physician to patient contact is often desired by
both doctors and patients alike.
Now referring to FIG. 2, there is shown the mounting bracket 100 together
with the needle guide 200. The bracket 100 comprises a first semi-circular
and concave member 102 and a second semi-circular and concave member 104.
The members 102, and 104 are preferably made of aluminum/lexan plastic.
Members 102 and 104 are connected; at a hinge end 106 and 108,
respectively, by a hinge 110, and at a latch end 112 and 114, respectively
by a latch 116.
Member 104 has a top side 118 and a bottom side 120. A top notch 122, and a
bottom notch 124 are present in member 104 at its top side 118 and bottom
side 120 respectively. Notches 122, and 124 are for receiving guide 200,
with the sheath 12 (FIG. 1) interposed there between.
Guide 200 has a notched side 202 and a smooth side 204. Sides 202 and 204
have a smooth side top end 206, notched side top end 208, a smooth side
210, a notched side notch 212, a smooth side bottom end 214 and a notched
side bottom end 216.
Notches 210 and 212 are present so that guide 200 may engage with bracket
100 and are formed with recesses 218, 220, 222, and 224 in order to
facilitate a quick release.
Sides 202 and 204 are joined together at a common edge 226, to create a
hinged link arrangement which enables the sides 202 and 204 to be
separated for needle installation and removal.
Now referring to FIG. 3, there is shown the mounting bracket generally
designated 100, in an open position.
Now referring to FIG. 4, there is shown the needle guide 200, in an opened
position. There is also shown a grooved notched surface 228 and a
nongrooved surface 230. Grooved surface 228 contain 3 grooves, 232, 234,
and 236. Therein for receiving different sized needles.
It is thought that the monolithic disposable needle guide for ultrasound
transducers of the present invention, and many of its attendant
advantages, will be understood from the foregoing description, at it will
be apparent that various changes may be made in the form, construction,
and arrangement of the parts thereof without departing from the spirit and
scope of the invention, or sacrificing all of its material advantages, the
form herein before described being merely a preferred or exemplary
embodiment thereof. It is the intention of the appended claims to cover
all of such changes.
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