U.S. patent number 3,927,662 [Application Number 05/522,171] was granted by the patent office on 1975-12-23 for ultrasonic transducer assembly.
This patent grant is currently assigned to Hoffmann-La Roche Inc.. Invention is credited to Janis Gunars Ziedonis.
United States Patent |
3,927,662 |
Ziedonis |
December 23, 1975 |
Ultrasonic transducer assembly
Abstract
A series of ultrasonic multi-element transducer assemblies is
disclosed for patient monitoring use and particularly fetal
monitoring prior to and during delivery. Each assembly is comprised
of a flexible material shaped, at least in part, in a cloverleaf
type configuration wherein the cloverleaf arms are independently
flexible relative to the center area and to each other for easy
conformity to the body. Each of the arms carries at least one
transmitting transducer and the cloverleaf center area is provided
with a receiving transducer. Each of the transducers is provided
with an appropriate lens arrangement for enabling overlapping
direct beam illumination of a substantial portion of the interior
of the body. The middle arm of the basic cloverleaf configuration
is extended to include additional transmitting and receiving
transducers for predetermined greater coverage, for example, a
straight extension to the middle arm bearing an additional
receiving and transmitting transducer in staggered arrangement or
mated together under a single lens yielding greater longitudinal
coverage of a fetus as it progresses down the birth canal during
labor. Disclosed variations thereof employ a Y-shaped extension to
the middle arm, wherein the branches of the Y extension are
provided with singular transmitting transducers or combined
transmitting and receiving transducers under a single lens, in
possible combination with an additional receiving transducer
located at the base of the Y extension. Such arrangements provide
greater-side-to side coverage as well as extended longitudinal
coverage of the lower portions of the abdomen with regard to moving
target such as a fetus undergoing the birth process.
Inventors: |
Ziedonis; Janis Gunars
(Cranbury, NJ) |
Assignee: |
Hoffmann-La Roche Inc. (Nutley,
NJ)
|
Family
ID: |
26900967 |
Appl.
No.: |
05/522,171 |
Filed: |
November 8, 1974 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
206012 |
Dec 8, 1971 |
3847016 |
|
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|
Current U.S.
Class: |
600/459; 73/642;
601/2; 73/641 |
Current CPC
Class: |
A61B
8/02 (20130101); B06B 1/0622 (20130101); A61B
8/4483 (20130101); A61B 8/0866 (20130101); A61B
8/488 (20130101) |
Current International
Class: |
A61B
8/02 (20060101); A61B 8/08 (20060101); B06B
1/06 (20060101); A61B 005/00 () |
Field of
Search: |
;128/2V,2.5P,2.6E,24A
;73/71.5Q,71.5US,67.7,67.8R |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Kamm; William E.
Attorney, Agent or Firm: Welt; Samuel L. Leon; Bernard S.
Hopkins; Mark L.
Parent Case Text
RELATED APPLICATIONS
This application is a continuation-in-part of Ser. No. 206,012,
filed Dec. 8, 1971 now U.S. Pat. No. 3,847,016.
Claims
What is claimed is:
1. An ultrasonic multiple-element transducer assembly for use
particularly in patient monitoring, comprising a substantially
flattened base of homogeneous, flexible material composition, which
includes a cloverleaf-like configured portion having a center area
with at least three arms extending outwardly therefrom, the
arrangement of said arms being such as to be independently flexible
relative to each other and to the center area, with each arm having
proximate said center area narrower width and thickness dimensions
than the other arm area and said center area, for enabling the
assembly to conform to varying body curvatures, each of said arms
being provided proximate the end thereof remote from said center
portion with at least one active element in the form of a
transmitting means, said transmitting means being arranged and
including lens means for providing overlapping direct beam
illumination of a predetermined volume of the interior of the
patient's body intended to be monitored, and said center area being
provided with at least one active element in the form of an
ultrasonic receiving means, said ultrasonic receiving means
including lens means arranged to provide illumination of a
substantially greater percentage of the portion of the patient
intended to be monitored than that provided by the said
transmitting means associated with any of said arms of said
cloverleaf portion, for enabling detection by said receiver means
of ultrasonic energy from whichever of said transmitting means is
illuminating the portion of the patient's body intended to be
monitored at any time, wherein the middle arm of said cloverleaf
configured portion is extended to provide for at least one
additional active element for predetermined greater longitudinal
and/or transverse coverage.
2. An assembly according to claim 1 wherein a pair of additional
active elements is provided on said extension portion of said
middle arm in the form of a transmitting means and a receiving
means.
3. An assembly according to claim 2 wherein both the cloverleaf and
extended portions of said base are constructed so as to virtually
eliminate cross-coupling of the ultrasonic energy therethrough
between active elements.
4. An assembly according to claim 2 wherein said cloverleaf portion
includes a stem appendage by way of which a pair of external
conductive coupling elements are introduced into said base to
extend therewithin to make electrical contact respectively with
said each receiver means and each transmitting means.
5. An assembly according to claim 4, wherein said conductive
coupling elements are of fine gauge and are predeterminably
disposed in general proximate the periphery of said base and
extending from active element to active element, the fine gauge and
routing of said coupling elements using such as to optimize the
flexibility of the assembly for conformity to the body.
6. An assembly according to claim 2 wherein the thickness and width
dimensions of the middle arm are uniformly narrowed between each of
the locations of active elements associated therewith in
predetermined amount.
7. An assembly according to claim 6 wherein the narrowed width
dimension constitutes approximately a 20 percent width reduction
and the narrowed thickness dimension constitutes approximately a 50
percent thickness reduction.
8. An assembly according to claim 2 wherein each of the
transmitting means associated with the left and right side arms of
said cloverleaf portion is predeterminably shaped relative to the
lens means associated therewith for limiting radiation of
ultrasonic energy to preselected directions, and wherein the
receiving means associated with said cloverleaf portion is provided
with an operational surface area approximately twice the operative
surface area of any one of said predeterminably shaped transmitting
means.
9. An assembly according to claim 8 wherein the total operating
surface area provided for said transmitting means associated with
said cloverleaf portion exceeds the total operative surface area
provided for said receiving means associated with said cloverleaf
portion approximately by the ratio of 11/2 to 1.
10. An assembly according to claim 8 wherein the lens means
associated with the individual transmitting and receiving means of
said cloverleaf portion have approximately the same radium of
curvature.
11. An assembly according to claim 10 wherein the beam spread
associated with said receiving means of said cloverleaf portion is
greater than the beam spread of any one of the transmitting means
associated with said cloverleaf portion.
12. An assembly according to claim 1 wherein the side arms of said
assembly are symmetrically disposed on either side of said middle
arm and wherein each said side arms forms a predetermined angle
.alpha. with the middle arm.
13. An assembly according to claim 1 wherein said extension to said
middle arm is a substantially straight extension having at least
one location at which there is provided said at least one
additional active element.
14. An assembly according to claim 13 wherein said transducer
assembly has a longitudinal axis of symmetry and the straight
extension to said middle arm is directed along said axis and said
at least one active element location is on said axis.
15. An assembly according to claim 14 wherein said extended portion
has a plurality of active element locations, each of which having
associated therewith at least one active element.
16. An assembly according to claim 15 wherein said transducer
assembly has a longitudinal axis of symmetry along which said
straight extension is situate and each of said plurality of active
element locations is centered on said axis, and wherein said
plurality of locations constitutes a pair of locations each having
a single active element and corresponding lens means associated
therewith.
17. An assembly according to claim 16 wherein the active element
location of said extended portion closest to said cloverleaf
portion is provided with a receiving means having a circular
operating surface, and the remaining active element location of
said extended portion is provided with a transmitting means having
an operative surface shaped relative to the lens means associated
therewith for limiting radiation of ultrasonic energy to
predetermined directions.
18. An assembly according to claim 17 wherein said cloverleaf
portion includes a stem appendage by way of which a pair of
external conductive coupling elements are introduced into said base
to extend therewithin to make electrical contact respectively with
each said receiving means and each transmitting means, the
conductive coupling element associated with the transmitting means
being extended along the periphery of said base to electrically
couple to said transmitting means associated with said extended
portion and the conductive element associated with the receiving
means being extended along the periphery of said base to
electrically couple to said receiving means associated with the
said extended portion, the extensions of said conductive coupling
elements into said extended portion being such as to preserve the
flexibility of said transducer assembly throughout.
19. An assembly according to claim 16 wherein the spaced separation
between adjacent ones of the active element locations associated
with the cloverleaf and extended portions positioned along said
axis is constant.
20. An assembly according to claim 16 wherein the active element
location of said cloverleaf portion which is closest to said
extended portion is provided with a transmitting means having a
circular operating surface and associated lens means.
21. An assembly according to claim 15 wherein the center-to-center
spaced separation between adjacent ones of said plurality of active
element locations is the same as the center-to-center separation
between adjacent active element locations associated with said
cloverleaf portion.
22. An assembly according to claim 13 wherein there is associated
with said straight extension a single active element location at
which single location there is provided a pair of active elements
in the form of a transmitting means and a receiving means.
23. An assembly according to claim 22 wherein said transmitting
means and said receiving means at said single active element
location are operatively arranged to be associated with a single
lens means.
24. An assembly according to claim 23 wherein the operative
surfaces of said receiving means and said transmitting means
associated with said single lens means are each shaped
substantially in a half circle, with the flat edges thereof facing
each other.
25. An assembly according to claim 24 wherein means are provided
between said half circle-shaped active elements for preventing
cross-coupling of ultrasonic energy therebetween.
26. An assembly according to claim 22 wherein said single active
element location is situate at a predetermined spaced separation,
center-to-center, from the active element location on said
cloverleaf portion closest thereto.
27. An assembly according to claim 26 wherein said predetermined
spaced separation is different from the center-to-center separation
of any two adjacent ones of the active element locations of said
cloverleaf portion.
28. An assembly according to claim 22 wherein said single active
element locations is situate closest to a transmitting means
location on said cloverleaf portion, said closest transmitting
means having a circular operative surface and associated lens
means.
29. An assembly according to claim 22 wherein said cloverleaf
portion includes a stem appendage by way of which a pair of
external conductive coupling elements are introduced into said base
to extend therewithin to make electrical contact respectively with
each said receiver means and each transmitting means, the
conductive coupling element associated with the transmitting means
being extended along the periphery of said base to electrically
couple to said transmitting means associated with said extended
portion and the conductive coupling element associated with the
receiving means being extended along the periphery of said base to
electrically couple to said receiving means associated with said
extended portion the extensions of said conductive coupling
elements into said extended portion being such as to preserve the
flexibility of said transducer assembly throughout.
30. An assembly according to claim 1 wherein said extension to said
middle arm is a substantially Y-shaped extension having an active
element location associated with each branch arm of said extension
and the base portion thereof communicating with said middle
arm.
31. An assembly according to claim 30 wherein said active element
location associated with each branch of said Y extension is situate
proximate the free end of the respective branch and wherein each
said active element location is provided with a pair of active
elements in the form of a transmitting means and a receiving
means.
32. An assembly according to claim 31 wherein said transmitting
means and said receiving means at each said single active element
location are operatively arranged to be associated with a single
lens means.
33. An assembly according to claim 31 wherein each said active
element location is situate a predetermined spaced separation,
center-to-center, from the active element location of said
cloverleaf portion closest thereto.
34. An assembly according to claim 33 wherein said spaced
separation of each branch active element location from the closest
cloverleaf portion active element location is the same as the
center-to-center separation of any two closest adjacent ones of
active element locations of said cloverleaf portion.
35. An assembly according to claim 31 wherein said Y extension is
arranged closest to a transmitting means location on said
cloverleaf portion, said closest transmitting means having a
circular operating surface and associated lens means.
36. An assembly according to claim 31 wherein the operative
surfaces of said receiving means and said transmitting means
associated with said single lens means are each shaped
substantially in a half circle, with the flat edges thereof facing
each other.
37. An assembly according to claim 36, wherein means are provided
between said half circle-shaped active element for preventing
cross-coupling of ultrasonic energy therebetween.
38. An assembly according to claim 31 wherein said cloverleaf
portion includes a stem appendage by way of which a pair of
external conductive coupling elements is introduced into said base
to extend therewithin to make electrical contact respectively with
each of said receiver means and each transmitting means, the
conductive coupling element associated with the transmitting means
being extended within said base to electrically couple to each said
transmitting means associated with said extended portion and the
conductive coupling element associated with the receiving means
being extended within said base to electrically couple to each said
receiving means associated with said extended portion, the
extensions of said conductive coupling elements into said extended
portion being such as to preserve the flexibility of said
transducer assembly throughout.
39. An assembly according to claim 31 wherein the center-to-center
separation of said active element locations associated with said
extended portion is different from the center-to-center separation
between any two active element locations associated with said
cloverleaf portion.
40. An assembly according to claim 30 wherein there is provided a
further active element location proximate the junction point of
said branches of said Y extension and wherein said active element
location associated with each branch of said Y extension is situate
proximate the free end of the respective branch.
41. An assembly according to claim 40 wherein a single active
element and associated lens means is provided at each active
element location associated with said extended portion.
42. An assembly according to claim 41 wherein the active element
location situate proximate the junction of said branches is
provided with a receiving means having a circular operative surface
and the active element location associated with each of said
branches of said Y extension is provided with a transmitting
means.
43. An assembly according to claim 42 wherein the operative surface
of each said transmitting means associated with said extended
portion is predeterminably shaped relative to the lens means
associated therewith for limiting radiation of ultrasonic energy to
preselected directions.
44. An assembly according to claim 40 wherein said transducer
assembly has complete longitudinal and transverse symmetry with
regard to the active element locations and with regard to the
overall shape of the transducer assembly relative to a center
position defined by the active element location on the cloverleaf
portion closest to said extended portion.
45. An assembly according to claim 40 wherein the center-to-center
spacing of adjacent active element locations is the same throughout
the transducer assembly.
46. An assembly according to claim 40 wherein the center-to-center
spacing between adjacent transmitting means locations is the same
throughout the transducer assembly.
47. An assembly according to claim 40 wherein said cloverleaf
portion includes a stem appendage by way of which a pair of
external conductive coupling elements is introduced into said base
to extend therewithin to make electrical contact respectively with
each said receiver means and each transmitting means, the
conductive coupling element associated with the transmitting means
being extended along the periphery of said base to electrically
couple to said transmitting means associated with said extended
portion, and the conductive coupling element associated with the
receiving means being extended along the periphery of said base to
electrically couple to said receiving means associated with said
extended portion, the extensions of said conductive coupling
elements into said extended portion being such as to preserve the
flexibility of said transducer assembly throughout.
Description
BACKGROUND OF THE INVENTION
The present invention relates generally to transducer assemblies
and more specifically to ultrasonic transducer assemblies for
monitoring targets within the body of a patient.
In ultrasonic exploratory systems for biological investigations,
several types of search units have been available. Most of these
units are of a type which is manually held against the body; they
are bulky in construction and do not readily accommodate for body
curvature. In the patient monitoring field, parameters are dictated
which indicate the desirability for quick and convenient placement
of transducer devices that would serve to provide for accurate and
reliable data, and simultaneously be of simple design and versatile
in application. However, most transducers are critical in placement
and are, therefore, less than ideal for monitoring where a large
area of illumination is desirable.
One particular area in the field of ultrasonics, for which little
exists or has been developed in the form of ultrasonic transducer
devices, concerns monitoring the heart activity of the unborn
fetus. In this particular field, it has been found difficult to
track the fetal heart for extended periods of time without having
to relocate the transducer, to accommodate the wide divergence of
fetal heart positions and depths encountered in long term fetal
heart monitoring, particularly during the birth process. In order
to operate without transducer placement criticality, large area
coverage is highly desirable.
Ideally, one would want the ultrasonic transducer assembly to
provide continuous satisfactory coverage of the moving target,
throughout, from the initial placement. The practitioner utilizing
a transducer assembly providing only limited volume coverage would
be faced, for example, with the undesirable prospect of having to
move the transducer assembly several times in the course of a
fetus' progress down the birth canal during labor and delivery.
Valuable information may be lost with each new placement of the
transducer assembly, particularly if supporting equipments need to
be readjusted. Also, a new placement itself could all too easily
prove to be unsatisfactory, thus necessitating further search for
an acceptable location. In the interim, however, no reliable data
is taken and the fetus during that time could be undergoing serious
yet undetected stress.
SUMMARY OF THE INVENTION
A principal objective of the present invention is to provide an
ultrasonic transducer assembly capable of assuring reliable long
term patient monitoring, such as fetal heart monitoring over a wide
range of fetal positions within the maternal abdomen prior to and
during labor, while minimizing the need for repositioning the
transducer assembly.
To attain this, the present invention contemplates an ultrasonic
multiple element transducer assembly at least a portion of which is
of cloverleaf type configuration, having at least one central
portion which is provided with a receiving transducer and at least
three peripheral transmitting transducers, each of the latter being
associated with a separate arm extending out from the center body
portion of the assembly where said at least one receiving
transducer is located. Each of the arms is designed to be
independently flexible relative to the other arms and to the center
portion so as to provide easy conformity to the body. The distances
between the centers of each of the transmitting transducers and to
the center of said at least one receiving transducer, in
conjunction with lenses individually provided on the transducers
for proper beam spreading, are such as to provide a
three-dimensional coverage of a relatively large portion of the
interior of the body, such as, for example, a maternal abdomen
anywhere from 5 cm below the abdomen surface inward.
According to the broader aspects of the invention there is provided
an ultrasonic multiple element transducer assembly for use
particularly in patient monitoring, comprising a substantially
flattened base of homogeneous, flexible material composition, which
includes a cloverleaf type configuration portion having a center
area with at least three arms extending outwardly therefrom, the
arrangement of each of said arms being such as to be independently
flexible relative to each other and to the center area, with each
arm having proximate said center area narrower width and thickness
dimensions from the outer arm area and said center area, for
enabling the assembly to conform to varying body curvatures, each
of said arms being provided proximate the end thereof remote from
said center portion with at least one active element in the form of
a transmitting means, said transmitting means being arranged and
including lens means for providing overlapping direct beam
illumination of a predetermined volume of the interior of the
patient's body intended to be monitored, and said center area being
provided with at least one active element in the form of an
ultrasonic receiving means, said ultrasonic receiving means
including lens means arranged to provide illumination of a
substantially greater percentage of the portion of the patient
intended to be monitored than that provided by the said
transmitting means associated with any of said arms of said
cloverleaf portion, for enabling detection by said receiving means
of ultrasonic energy from whichever of said transmitting means is
illuminating the portion of the patient's body intended to be
monitored at any time, wherein the middle arm of said cloverleaf
configuration portion is extended to provide for additional active
elements in the form of additional transmitting and receiving means
for predetermined greater longitudinal and/or transverse coverage,
with the base of said transducer assembly being constructed so as
to virtually eliminate cross coupling of ultrasonic energy
therethrough between active elements. For example, in certain
embodiments a straight extension to the middle arm is provided
bearing an additional receiving and transmitting transducer in
staggered arrangement or mated together under a single lens. This
type of transducer assembly is particularly effective, for
instance, in yielding greater longitudinal coverage of a fetus as
it progresses down the birth canal during labor.
Other disclosed arrangements incorporating the basic cloverleaf
design employ a Y-shaped extension to the middle arm, wherein the
branches of the Y extension are provided with singular transmitting
transducers and associated lenses or combined transmitting and
receiving transducers under a single lens. The base of the Y
extension may also be provided with an additional receiving
transducer. Such arrangements are particularly effective in
providing greater transverse, i.e. greater side-to-side, coverage
as well as extended longitudinal coverage of the lower portions of
the abdomen with regard to a moving target such as a fetus
undergoing the birth process.
BRIEF DESCRIPTION OF THE DRAWINGS
The above-mentioned and other objects and features of this
invention will become more apparent by reference to the following
description taken in conjunction with the accompanying drawings, in
which:
FIG. 1A is a plan view of the basic cloverleaf transducer assembly
illustrating the geometrical setting of the multiple transducer
elements;
FIG. 1B is a diagrammatical representation of the basic
configuration of FIG. 1A, illustrating in particular the
arrangement of the conductive wires running from the stem of the
assembly to the individual transducers;
FIGS. 2A-2C are sectional views of FIG. 1B taken respectively along
the lines of A--A, B--B and C--C;
FIG. 3 is a schematic cross-sectional view of the basic cloverleaf
type transducer assembly in operative application to a human
subject;
FIGS. 4A and 5A are respective plan views of additional preferred
embodiments of ultrasonic transducer assembly design according to
the invention, in which the central arm of the basic cloverleaf
assembly is extended to include additional transducers for extended
longitudinal coverage;
FIGS. 4B and 5B illustrate typical patterns of the respective
arrangements depicted in FIGS. 4A and 5A in relation to the actual
size of the assemblies;
FIGS. 6A and 7A are respective plan views of two further preferred
ultrasonic transducer assembly embodiments according to the
invention, in which the central arm of the basic assembly design is
modified to include a substantially Y-shaped extension provided
with additional transducers for increasing longitudinal and
transverse coverage; and
FIGS. 6B and 7B illustrate typical coverage patterns of the
respective arrangements depicted in FIGS. 6A and 7A relative to the
actual size thereof.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
With reference to the figures, there is shown in FIG. 1A a
preferred basic design coupling a four-element transducer assembly
shaped like a cloverleaf, having a body 11, a receiving transducer
or crystal 12 and receiving lens 13, and transmitting transducers
or crystals 14, 15 and 16 with transmitting lenses 17, 18 and 19
respectively. A cable 21 preferably coaxial, supplies power to the
respective transmitting crystals and is used for routing the
returned signals received by receiving crystal 12 to suitable
electrical monitoring instrumentation. The conductor leads are
particularly shown in FIGS. 1B, 2B and 2C. The transmitting
crystals 14-16 are electrically intercoupled as illustrated by
conducting wire 21a which extends about the periphery of the
assembly. Conducting wire 21b, on the other hand, leads to the
central receiving crystal 12. The illustrated pattern and fine gage
(e.g. 50 Mils) of the conducting wires are such as to enable a high
degree of flexibility being achieved in the transducer
assembly.
The general or basic configuration, as mentioned, is of cloverleaf
design, having the body 11 fabricated of flexible material such as,
for example, a polyurethane or other suitable composition which
also has high damping characteristics to minimize ultrasonic energy
cross-coupling characteristics between crystals. The three arms
extending from the center portion are provided with the
transmitting crystals 14, 15 and 16 at their extremities. Each of
the arms is wider at its outer or free end where the crystal is
mounted, as opposed to the neck portion 22 thereof intermediate the
center of the assembly and the outer end. In the present embodiment
the preferred difference in these width dimensions is approximately
20 percent, allowing greater flexibility of each of the arm units.
The ability to independently flex the respective arms containing
the transmitting crystals is further enhanced by thinning out (i.e.
reducing the thickness of) the neck portions 22 of the arms. This
is particularly illustrated in FIG. 2A. In this embodiment the
preferred ratio of the neck 22 thickness to the extremity thickness
at 23 is approximately a ratio of one to two. This overall
construction results in optimum flexibility of each of the arm
units. It allows each arm to more readily conform to the body
curvature and at the same time introduces almost no compression
upon body 11. This in turn avoids interfering stress on the other
transmitting crystals and the receiver crystal. The total
configuration of each arm of the flexible assembly is such that the
flexibility is increased by roughly the cube of the thickness.
Proximate the free end of each arm a cavity 20 (FIG. 2A) is
provided for housing the transmitting assembly, for example,
crystal 16 and its lens 19, and simultaneously allowing ample room
around the lens element for an ultrasonic coupling gel to stay in
place, once deposited therein, and thus enhancing the capability
for long term monitoring. It should be noted that the depth of the
cavities and the thickness of the gel are not critical. Almost any
fluid or gel would be operative, for example, water, cream, oil,
whether it be high or low viscosity, conductive or nonconductive. A
similar recess or cavity is provided with regard to receiving
crystal 12 and its lens 13.
It should be noted that the various dimensions between the
transmitting and receiving elements are likely to be critical to
each of the other dimensions. These dimensions have been developed
based on the consideration of utilizing the present transducer
assembly for fetal monitoring where an average curvature of the
body is about 20 cm. The distance between the centers of adjacent
transmitter crystals is approximately 8 cm and the distance
center-to-center from each transmitter crystal to the receiver
crystal is about 41/2 cm.
With regard to the crystal characteristics and make-up, the
crystals are preferably composed of lead-zirconate-titanate, which
material is especially efficient for converting electrical signals
to mechanical motion. For the receiving crystal the material used
could be quartz, lead-metaniobate or equivalent which has a high
efficiency in converting mechanical motion to electrical
signals.
Each of the transmitter crystals in a preferred arrangement is cut
in the shape illustrated in the dashed lines in FIG. 1A, so that
the ultrasonic energy is radiated in selected directions only. For
example, with reference to FIG. 3, at the cut-off edge 24 of
transmitter lens 18, the ultrasound beam spread radiated from
associated crystal 15 is hardly diverted as the cutoff edge is near
the center of the lens. Of course, the operative surface of each of
the transmitting crystals with its associated lens could also be
circular in shape, as shown via the dashed lines in FIG. 1A and
also shown in FIGS. 1B and 2A.
In the illustrated general embodiment of FIGS. 1-3, the angle
.alpha. (FIG. 1A) formed by the center arm and one of the side arms
is preferably 120.degree.. Moreover, the angle .beta. formed on the
one hand by a line drawn between the centers of the receive crystal
12 and a transmit crystal, e.g. 14, and on the other hand by a line
drawn through the center of that transmit crystal and the center of
an adjacent transmit crystal, e.g. 16, is preferably
30.degree..
Moreover, the transmitter crystals are preferably approximately 1.9
cm in diameter whereby the cutoff section would amount to a radial
distance of 0.635 cm from the outer edge. This provides for an
approximate area for each transmitting crystal of 2 cm.sup.2. The
receiving crystal arm is preferably approximately 3.87 cm.sup.2, or
roughly twice that of each of the transmitting crystals. The total
area of the transmitting crystals, on the other hand, exceeds the
area of the receiving crystal by a ratio of at least 11/2 to 1. The
receiving crystal is made considerably larger than the transmitting
crystals as it must detect the ultrasonic energy from a
considerably larger area then any one of the transmitting crystals
illuminated areas.
The lenses 17, 18, 19 for the transmitter crystals and lens 13 for
the receiver crystal have approximately the same radius of
curvature. However, it may be particularly seen in FIG. 3 that the
beam spread provided by the receiving crystal assembly is greater
due to the different size of crystal used. In the present
embodiment, the transmitter means have approximately an 8.degree.
beam spread while the receiver means has approximately 11.degree.
of beam spread, or a total beam spread of 16.degree. and 22.degree.
respectively.
In FIG. 3, the three transmitter units are shown to be mounted in
the transducer assembly in such a manner that the radiating beams
overlap each other to uniformly illuminate a large area. The
radiated patterns emitted by crystals 15 and 16 actually overlap to
a greater extent than that shown as a result of the side lobes of
ultrasonic energy off the crystal edges as well as the scattering
effect within the body tissue. In the preferred embodiment of FIGS.
1-3, it was found that the transmitter crystals would illuminate
roughly 8 cm.sup.2 at a depth of a 5 cm from the lens whereas the
receiving crystal would illuminate roughly 16 cm.sup.2.
From FIG. 3 it may be seen that utilization of the multiple element
transmitter assembly assures the shortest path of ultrasonic energy
between the transmitter, target and receiver. For example, assuming
that target 27 is at the point indicated, the
transmitter-target-receiver path 26, 27 and 28 is shown to be
approximately 13.25 cm whereas the transmitter-target-receiver path
29, 27 and 28 is shown to be 15.25 cm. Assuming use of the
conventional single transmitter and receiver assembly where
crystals 16 and 12 are positioned, then the path to be travelled
would take an additional 2 cm. which would reduce the amplitude of
the signal illuminating the target by approximately 4db, resulting
in a lower amplitude signal at the receiver.
It should be understood, of course, that various combinations and
permutations of crystal spacing and crystal sizes with lens
curvatures might be employed without loss of useful signal. In the
instant basic embodiment, for example, spacing between the adjacent
transmitter crystal centers might be anywhere from 7 to 9 cm and
the spacing between each transmitter crystal and receiver crystal
might be anywhere between 4 to 5 cm. Should, however, the spacing
between transmitters and receiver be increased considerably, then,
due to the 20 cm average body curvature, the transmitters might not
illuminate beyond the 11 cm depth, which might thus result in a
shallow area illumination. Thus a high percentage of fetal targets
which are often at the 14 cm and 16 cm depths, would be missed
altogether. On the other hand, with very close spacing between the
transmitters and receiver, the ultrasonic beam radiated would not
overlap at 5 cm below the surface of the body and, therefore, a
fetal target at this location would provide no monitoring
signal.
It is to be also noted that due to the symmetry of the basic
cloverleaf configuration and the lensing structures, the assembly
may be used effectively in a reverse mode, i.e. the transmit
crystals may be used in a receive mode and the receive crystal used
as a transmitter.
While in the above there has been described the basic cloverleaf
design as one preferred embodiment of the invention for an
ultrasonic transducer assembly, other preferred embodiments are
contemplated which, like the basic cloverleaf design, have achieved
a high level of success in experimental and/or clinical testing.
These embodiments essentially provide additional crystals in
predetermined array to extend the overall illumination in specified
manner such as for more specific applications, for example, with
regard to a moving target over an extended period of use.
It should be noted that with any of the embodiments of ultrasonic
transducer assembly described herein, the patient is electrically
isolated, i.e. there is no electrical contact, and the patient is
entirely safe.
The first of the preferred alternative embodiments will be
described in reference to FIGS. 4A and 4B wherein a six-element
transducer assembly is depicted. In the description of this and the
remaining embodiments disclosed herein, similar reference
designators to those used in describing the basic cloverleaf design
(FIGS. 1-3) are employed for purposes of clarity.
As in the basic design, the assembly according to FIG. 4A has a
body of flexible material 111, a receiving crystal and appropriate
lens structure 112-113, and transmitting crystals 114-116 also with
appropriate lens structures 117-119. A double coaxial type cable
121 supplies power to the respective transmitter crystals and
couples the received signals to the instrumentation. In this
embodiment, however, the middle or central arm 123 of the basic
design portion described hereinbefore has been extended outward
(extension 123a), as particularly illustrated in FIG. 4A by dashed
line 123b, to provide an additional receive crystal 124 and a
transmit crystal 125. These crystals are provided with appropriate
lens structures 126 and 127 respectively.
The transmitting crystal 125 is cut in substantially the same shape
as transmitting crystals 114 and 116 to effect radiation of
ultrasonic energy therefrom, as hereinbefore described, in only the
selected direction(s). Though not particularly shown, the thickness
of the extended portion 123a of middle or central arm 123 as well
as the width thereof is reduced in similar manner to that described
for the arms of the basic design portion for providing greater
flexibility and conformity to the body curvature. These dimensional
reductions, as before, occur between the locations of the active
elements, i.e. the transmit and receive crystals, including that
portion of the assembly of FIG. 4A lying proximate dashed line
123b.
The basic design center-to-center spacing between the transmitting
crystals 114-116 and the receiving crystal 113 has been preserved
in the extended portion of middle arm 123, wherein new receive
crystals 124 is spaced apart from transmit crystal 115 and new
transmit crystal 125 is spaced apart from receive crystal 124, each
by the dimension c. A preferred value for dimension c would be 41/2
cm. The cenger-to-center spacing d between transmitter crystals
114-116 in the basic design portion of the FIG. 4A embodiment also
remains the same. A preferred value for this dimension is 8 cm.
The full routing of the very fine (typically 45 mil) wires
intercoupling the various active elements shown in FIG. 4A retains
the design goal of the basic cloverleaf structure to maximize
flexibility of the assembly for conformity to the body curvature.
This is true of all remaining embodiments described herein. In this
particular instance the wire routing of the standard cloverleaf
portion is amended first of all by the inclusion of a conductor
running as shown between receive crystals 112 and 124, which
crosses over the already provided conductor wire running betwen
transmitting crystals 114 and 115. The conductors at this
cross-over point are, of course, well isolated. Additionally, there
is provided a new conductor running as shown between transmitting
elements 115 and 125. Thus it is, that all transmitting transducers
are electrically coupled together and all receiving transducers are
coupled likewise.
FIG. 4B illustrates a typical area coverage of the transducer
assembly of FIG. 4A. There is shown in FIG. 4B the area of most
active coverage 160 provided by the assembly, as well as an area of
additional but less active coverage 161. These areas are, relative
to the size of the assembly illustrated in FIG. 5B, essentially to
scale. Both the most active and lesser active areas of coverage
appropriately exhibit the abruptness of cutoff of activity
resulting from the cut shape of transmitting crystals 114, 116 and
125.
The configuration of transducer assembly depicted in FIGS. 4A and
4B was conceived principally for the purpose of increasing the
length of illumination of an expectant mother's abdomen. Of major
concern in leading to the development of this configuration is the
consideration that the fetus should be monitored continuously as it
moves down the birth canal, without requiring a repositioning of
the transducer assembly as a result of said fetal movement. Thus,
the transducer assembly would normally be placed such that the
extended arm portion points in the general direction of the fetal
movement during the birth process. It should be noted that as the
fetus moves closer to the cervix, it is more limited as to
side-to-side movement, due to the narrowing of the birth canal.
Therefore, with the transducer assembly configuration of FIGS. 4A
and 4B the desired continuous monitoring throughout the birth
process is achievable without the need for relocating the
assembly.
In this embodiment, as in all embodiments described herein, the
beam spread of the lenses is predetermined such that a fetal target
as close as 5 cm to the surface will be satisfactorily detected.
The pattern illustrated in FIG. 4B, for example, is that which
would exist for the configuration of FIG. 4A at a depth of about 11
cm. The transmitting crystals 114, 116 and 125 are cut in the
preferred shape illustrated such that when mounted in the
associated lens structures, they will illuminate the area
specifically selected for maximum fetal activity and best system
sensitivity. It is to be noted that the transmitting crystal 115 is
a round disc, the circular active surface being provided in this
case for illumination in all directions. This is in particular
relation to the fact that this active element is situate between
the two receive crystals 115 and 125, Both receiving crystals 113
and 124 are disc-shaped to provide circular active surfaces for
full 360.degree. coverage. They are larger than the transmitting
crystals for ensuring the capability of receiving energy from all
directions as generated by the transmitting crystals, and
particularly to ensure reception regardless which of the
transmitting crystals is most directly illuminating the target.
Thus, even as the fetal target moves and the return signal might
then be coming from another direction, there is every likelihood
that it would be satisfactorily received without having to move the
assembly.
Preferred area dimensions for the operational faces of the various
active elements are as follows. The area of the individual
transmitting crystals 114, 116 and 125 is 2.0 cm.sup.2 and the
remaining transmitting crystal 115 is 2.84 cm.sup.2. Thus, the
total transmitting crystal area in this configuration is 8.84
cm.sup.2, an increase of some 32 percent over the basic cloverleaf
design. The area of the receiving crystals 112 and 124 is in each
case 3.87 cm.sup.2, for a total receiving crystal area of 7.74
cm.sup.2, which doubles the area for receiving elements over the
basic cloverleaf design.
The lenses for the transmitting and receiving crystals have
approximately the same radius of curvature, i.e. preferably 2.5 cm,
but it should be noted that the receiver lenses provide greater
coverage due to the larger dimensioned active areas of the
receiving crystals. While a preferred spacing provided between
adjacent active elements is given as c=41/2 cm in the above, and
while this also represents the standard preferred dimension of the
basic design, it should be noted that if the lens curvatures were
to be changed, then different spacing could obtain for the same
area coverage.
Referring to FIGS. 5A and 5B, there is illustrated therein a
six-element transducer assembly which in essence represents an
intermediate between the basic cloverleaf design and the particular
embodiment illustrated in FIGS. 4A and 4B. The construction of the
FIG. 5A embodiment differs from that depicted in FIG. 4A only in
the specific arrangement of the extension of the middle arm 223. As
before, similar reference designators are used where appropriate.
In this instance, the middle arm 223 is extended, as defined by
dashed line 223b, by a portion 223a which houses only a single
additional transducer/lens location. However, in this embodiment
there is found under lens 223 a receiving crystal 230 and a
transmitting crystal 231. Each is slightly less than one-half the
area of the full size crystals employed elsewhere, such as crystals
212 and 215 respectively, and these additional crystals resemble
half circles in shape. The two crystals 230 and 231 face each other
via their cut-off sides, so as to entirely fit beneath the single
lens 233. This lens is preferably of a larger radius, such as
around 5 cm. The remaining lenses and crystals do not differ
substantially from those described with regard to the FIG. 4A
embodiment as to location or function, etc.
The conductive intercoupling wiring employed in the arrangement of
FIG. 5A retains that provided for the basic cloverleaf design,
amended only to add wiring to couple new elemets 230 and 231
thereto. In this instance a first new line runs as shown from
receiving crystal 212 to receiving element 230 and a second new
line runs in the manner shown between transmitting crystal 218 and
transmitting half-crystal 231.
Just as in the case with the FIG. 4A embodiment, it is seen that
the basic cloverleaf design has been extended in the one direction,
i.e. longitudinally, via the middle arm to illuminate the fetus as
it moves towards the cervix. However, this transducer assembly is
somewhat shorter in its overall longitudinal dimension than the one
depicted in FIG. 4A. In fact, the center-to-center separation e
between lens location 218 and lens location 233 preferably is 4 cm.
A major advantage of this embodiment would be for use on smaller
women as to whom this arrangement would likely prove superior over
the FIG. 4A assembly.
FIG. 5B illustrates the coverage provided by this smaller
embodiment, broken away, as before, into the most active 260 and
lesser active 261 areas. It is to be particularly noted that the
coverage of this assembly ranges significantly beyond the physical
tip of the extended middle arm, thus enabling greater coverage,
particularly for smaller women, throughout the birth process.
Referring now to FIG. 6A, there is illustrated therein an 8-crystal
transducer assembly designed to widen as well as lengthen the field
of illumination of the standard or basic cloverleaf design. In
place of the half-crystal pair arrangement on the straight extended
portion of the middle arm as depicted in FIG. 5A, this assembly
provides for a relatively wide Y-shaped or hammerhead type
extension of the middle arm, with both the left and right side
portions of the extension housing a half-crystal pair arrangement
under a single lens structure.
More particularly, middle arm 323 of the basic design has been
extended by a wide Y or hammerhead-shaped portion 323a, as defined
by dashed line 323b. Associated with the left side portion 323c of
extended portion 323a is a transmitting crystal 340, a receiving
crystal 341 and a lens 342 housing both the aforesaid crystals.
This is possible, again, because of the half-circle shapes of
active elements 340 and 341 facing each other via their cut-off
sides. Transmitting crystal 340 is, for example, of slightly less
than half the surface area of transmitting crystal 315. Receiving
crystal 341, moreover, has slightly less than half the surface area
of, for example, receiving crystal 312. Transmitting and receiving
crystals 340 and 341 are situate under a lens having essentially
the same dimensions, and in particular the same radius of
curvature, as lens 233 illustrated in FIG. 5A. In the FIG. 6A
embodiment the center-to-center separation between lens location
342 and lens location 318 is the dimension c, i.e. preferably 41/2
cm. Thus, the preferable separation here is the same as found in
the basic cloverleaf design between the central receiving
transducer and the outlying transmitting transducers.
As to the right side portion 323d of extension 323a the location,
shape, size and arrangement of the additional active elements and
lens provided, i.e. transmitting element 343, receiving element
344, and lens 345 are identical with that described with reference
to the left side portion 323c. It is noted that the parallel cutoff
edges of the crystals 340-343l and of the crystals 343-344
respectively form acute angles with a line drawn between the
location centers of their respective lenses, which angles
preferably would be in the vicinity of 45.degree.. The
center-to-center separation f between the lens locations 342 and
345 is in this assembly preferably 51/2 cm.
The routing of the fine gage wires intercoupling the various active
elements in this arrangement is somewhat more complicated as
regards the extended portion of the middle arm. In this case a new
line is run from receive crystal 312, much like that depicted in
FIG. 4A, crossing over the line intercoupling transmit crystals 314
and 315, and passing around the right side of the crystal 315
location to a junction point. There this line devides to run more
or less directly to receive half crystals 341 and 344. In a similar
manner, an extension lead is brought out from the left side of
transmit crystal 315 to be run up the left side of the extension of
arm 323 to a second junction point, whereat it divides in leading
to the two transmit half crystals 340 and 343. However, between
this second junction point and transmit crystal 343, this line
crosses over the extended receive conductor just below its junction
point. Again, adequate isolation is provided at these crossover
points.
Instead of the junction point arrangement described, it may be
advantageous from a commercial standpoint as well as flexibility to
provide a wire connection running from element 315 along the
periphery of the left side of the assembly to contact element 340
at about "9 o-clock." Another wire may be run from element 340 at
"12 o-clock" along the periphery of the top portion of the assembly
over to element 343 where it would make contact with the latter at
the 2 o-clock position. Similarly, a wire conductor could run from
receive element 312 along the periphery of the right side of the
assembly up to element 344 to make contact therewith at the 7
o-clock position. Then another conductor would be run between
element 344 and 341 making contact therewith respectively at the
eleven o-clock and one o-clock positions. This conductor would also
be arranged along the top periphery of the assembly but inside the
transmitting conductor running between elements 340 and 343.
A major advantage of this assembly is that it widens the field of
illumination in the lower abdominal area including the area around
the cervix, which is perhaps the most critical area for fetal
coverage during labor. This assembly is designed to anticipate the
situation where the target moves sideways during contractions, and
as a result, there would, barring extreme cases, obtain continuous
recognizable signals representative of the fetal heartbeat, by
reason of the additional wire coverage in the direction of
extension of the middle arm.
As is the case with the FIG. 4A and FIG. 5A assemblies, transmit
crystals 314 and 316 and receive crystal 312 of the FIG. 6A
assembly are identical in size, shape, position, lensing and
function to corresponding crystals described with reference to the
basic design. Transmit crystal 315 is, of course, circular in shape
to illuminate in all directions. Transmitting crystals 340 and 343,
while being cut to less than half the area of, for example,
transmit crystal 315, are intentionally mounted on the outside at
lens location 342 so as to illuminate beyond the assembly proper
(see FIG. 6B). Whereas receive crystal 312 is of standard size,
receiving crystals 341 and 344 are of a somewhat smaller
radius.
The typical field pattern for the FIG. 6A assembly is illustrated
in FIG. 6B. This pattern, as is the case in the other embodiments,
is dependent in large part on the lenses employed with the active
elements of the assembly. In the preferred case the lenses 313,
317, 318 and 319 respectively are the same radius of curvature as
that provided for the active elements in corresponding locations of
the basic design. The lenses 342 and 345 have equal radii of
curvature, considerably less than that of the other lenses. As a
result, it is assured that the return beam from a target, rather
than exceeding the critical operational angle, will be detected by
the adjacent receiving crystal.
As before, typical pattern depicted in FIG. 6B of the areas of most
sensitive illumination is broken into the most active 360 and
lesser active 361 areas of illumination. To be noted from this
coverage pattern, again is the usual lower half coverage
characteristic of the basic cloverleaf design, coupled in this
instance with the extended upper area of coverage featuring wider
illumination due to the presence of the active elements associated
with the hammerhead extension 323a of the middle arm.
The spacing between the transmit and receive half-crystals housed
by a single lens is filled with, for example, tungsten powder in
combination with an epoxy mixture. This reduces to acceptable
levels any ultrasonic cross-coupling between these elements, which
is a very important consideration for the type of
transmission-reception here depicted. This same provision is made
for the noted half-crystals employed in the assembly of FIG.
5A.
FIG. 7A illustrates yet another alternative embodiment of preferred
transducer assembly, which bears similarity in shape to the
assembly depicted in FIG. 6A. The seven-element assembly of FIG.
7A, like the FIG. 6A assembly, is provided with an extension 423a
(as defined by dashed line 423b) to the middle arm 423 of the basic
design, which extension is shaped like a wide Y. Proximate the base
of this extension as defined at 423b there is located in a
substantially straight line with standard crystals 412 and 415, an
additional receiving crystal 424 and appropriate lensing structure
426. Receive crystal 424 preferably may be spaced apart from
transmit crystal 415 in symmetry with the receive crystal 412
position (i.e. by a separation c).
Associated with the left (423c) and right 423d) side portions of
the Y-shaped extension 423a, proximate the free ends thereof, is an
additional transmit crystal 450, 451 respectively, together with
appropriate lensing structures 452 and 453. The center-to-center
spacing between these transmit crystal locations respectively and
the receive crystal 424 location may preferably be the same as that
existing in the basic design, i.e. the spaced separation between
receive crystal 424 and any adjacent transmit crystal (415, 450,
451), is c. Also, FIG. 7A shows the center-to-center separation
between transmit crystals 450 and 451 and transmit crystal 415 to
be the same as the basic design spacing between transmit crystals
414/416 and transmit crystal 415, i.e. the dimension d. That is,
the design of this assembly in the preferred configuration is not
unlike a mirror image type arrangement of two basic cloverleaf
configuration assembled together. However, it is to be noted that
whereas a double cloverleaf arrangement coupled together via the
respective middle arms would provide for two consecutive transmit
crystals adjacent to the junction point of the two center arms, the
arrangement of FIG. 7A intentionally provides instead a single
transmit crystal, i.e. 415, symmetrically placed at this junction
area.
The concept of a double cloverleaf design, though entirely operable
in concept and within the scope of the present invention, is not as
practical from a power standpoint as, for example, the FIG. 7A
assembly. A double cloverleaf arrangement would have a total of
eight crystals, i.e. two receive and six transmit. The FIG. 7A
arrangement, on the other hand, provides with very reliable
operation the same of superior coverage with only seven crystals.
This enables more ultrasonic power output relative to crystal
surface area. Since in most instances it is preferable, if not
essential, to have associated with such transducer assemblies as
described herein a fixed electrical power output from the
associated electronic equipment, and since ultrasonic output is
related to the area of the crystals, then the larger the total
crystal area, the lower the ultrasonic power output.
As to the conductive wires intercoupling the various active
elements, there is illustrated in FIG. 7A along with the Y-shaped
extended portion of middle arm 423 a conductive coupling line
provided which runs between receive elements 412 and 424, not
unlike that described with reference to the embodiment depicted in
FIG. 4A. Additional transmit conductive wires are provided which
run as shown respectively between transmit elements 415 and 450 on
the one hand and elements 450 and 451 on the other hand.
The principal purposes and advantages of this FIG. 7A assembly are
essentially the same as that of FIG. 6A arrangement, namely, for
example, to effectively extend the area of illumination both
transversely, i.e. side-to-side, and longitudinally. This may be
seen in FIG. 7B, wherein a typical coverage pattern is illustrated
for the most active (460) and lesser active (461) areas of assembly
sensitivity. The illumination and power distribution of this
embodiment can be made to appear almost exactly like that of the
FIG. 6 assembly, particularly if transmitting crystals 450 and 451
(and also transmitting crystals 414 and 416), instead of being
shaped and positioned as illustrated in FIG. 7A, have circular
surface area or are oriented essentially the same as to the
transmitting crystals 340 and 343 (and also 314 and 316) associated
with the FIG. 6A assembly. By this assembly, as is the case with
the FIG. 6A assembly, one can illuminate both sides of a normal
expectant mother, and more easily and quickly determine what
position the baby is in as well as on which side it is situate.
This type of wider coverage assembly, then, provides easier target
location for subsequent operation without having to relocate the
assembly as a result of substantial movements of the fetal target.
The assembly is particularly applicable for illuminating a highly
active fetus as it moves toward the cervix.
While the principles of this invention have been described above in
connection with specific apparatus, it is to be understood that
this description is made by way of example and not as a limitation
on the scope of the invention as set forth in the objects and
features thereof or in the accompanying claims.
* * * * *