U.S. patent application number 13/919433 was filed with the patent office on 2013-10-24 for ultrasound device for probe guidance and sterilizable shield for same.
The applicant listed for this patent is Soma Development, LLC. Invention is credited to M. Dexter Hagy, Steven Ridley.
Application Number | 20130281837 13/919433 |
Document ID | / |
Family ID | 43347951 |
Filed Date | 2013-10-24 |
United States Patent
Application |
20130281837 |
Kind Code |
A1 |
Ridley; Steven ; et
al. |
October 24, 2013 |
Ultrasound Device for Probe Guidance and Sterilizable Shield for
Same
Abstract
Disclosed are medical probe devices and methods for use guiding
of percutaneous probes during medical procedures. The probe devices
include an ultrasound transducer housing having a passage
therethrough configured to accommodate a probe. The devices can be
utilized to guide a probe through the probe guide to a percutaneous
target with real time visualization of the probe during the
procedure. In addition, the devices can include a sterilizable
shield including a sterile probe guide such that the transducer
housing itself can be separated from a subject by a sterile
barrier. The sterilizable shield can be a single-use shield that
can prevent contamination and re-use of the shield. The devices can
define a beneficial geometry conducive to use by a single operator
that can be utilized for percutaneous targets near the skin surface
and can enable excellent contact between the device and the skin
surface of a subject.
Inventors: |
Ridley; Steven; (Columbia,
SC) ; Hagy; M. Dexter; (Greenville, SC) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Soma Development, LLC |
Greenville |
SC |
US |
|
|
Family ID: |
43347951 |
Appl. No.: |
13/919433 |
Filed: |
June 17, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12576487 |
Oct 9, 2009 |
|
|
|
13919433 |
|
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|
Current U.S.
Class: |
600/424 |
Current CPC
Class: |
A61B 8/4281 20130101;
A61B 2017/3413 20130101; A61B 8/4209 20130101; A61B 2017/3405
20130101; A61B 8/4422 20130101; A61B 8/4254 20130101; A61B 1/00142
20130101; A61B 8/461 20130101; A61B 2017/00296 20130101; A61B 46/10
20160201; A61B 8/0833 20130101; A61B 2017/00858 20130101; A61B
8/0841 20130101; A61B 17/3403 20130101 |
Class at
Publication: |
600/424 |
International
Class: |
A61B 8/00 20060101
A61B008/00 |
Claims
1. A medical probe device comprising a first portion comprising an
ultrasound transducer housing; a second portion, the second portion
defining at least a portion of a probe guide for passage of a probe
therethrough, the probe guide providing an unimpeded passageway
through the medical probe device, the second portion being
removably attachable to the first portion; a detector for detecting
motion of a probe within the probe guide, the detector being in
communication with a processor for displaying information
concerning the motion or position of the probe within the probe
guide.
2. The medical probe device of claim 1, further comprising a
sterilizable shield for encasing at least a portion of the
device.
3. The medical probe device of claim 2, the first portion defining
a first surface, the ultrasound transducer being located in the
first portion such that an ultrasonic beam issued from the
ultrasound transducer is emitted from the first surface, wherein
the sterilizable shield encases the first surface of the first
portion and remaining surfaces of the first portion are not encased
by the sterilizable shield.
4. The medical probe device of claim 2, wherein the sterilizable
shield encases the entire first portion, the second portion being
directly or indirectly removably attachable to the sterilizable
shield.
5. The medical probe device of claim 1, the first portion defining
a skin contacting surface, wherein the second portion does not
contact the skin of a subject when the skin contacting surface of
the first portion is in contact with the subject's skin.
6. The medical probe device of claim 1, wherein the information is
displayed as an image of a virtual probe on a monitor in
communication with the processor.
7. The medical probe device of claim 1, wherein the sensor is
integral to the first portion.
8. The medical probe device of claim 1, wherein a portion of the
probe guide is defined by the first portion and a portion of the
probe guide is defined by the second portion.
9. The medical probe device of claim 1, wherein the entire probe
guide is defined by the second portion.
10. The medical probe device of claim 1, wherein the second portion
is sterile.
11. The medical probe device of claim 1, wherein the second portion
comprises multiple removably attachable pieces.
12. The medical probe device of claim 11, wherein one of the
removably attachable pieces is a clamp.
13. A method for guiding a probe to a percutaneous target
comprising attaching a first portion of a medical probe device to a
second portion of the medical probe device, the first portion
comprising an ultrasound transducer housing and the second portion
defining at least a portion of a probe guide for passage of a probe
therethrough, the probe guide providing an unimpeded passageway
through the medical probe device, the second portion being
removably attachable to the first portion; passing a probe through
the probe guide to a percutaneous target; detecting motion of the
probe within the probe guide, the detector being in communication
with a processor; and displaying information concerning the motion
or position of the probe within the probe guide.
14. The method of claim 13, further comprising encasing at least a
portion of the device with a sterilizable shield.
15. The method of claim 13, wherein the second portion does not
contact the skin of a subject during use and the probe exits the
probe guide at a distance from the skin of the subject.
16. The method of claim 13, further comprising forming an image of
a virtual probe on a monitor in communication with the
processor.
17. The method of claim 13, wherein the complete probe guide is
formed only upon attachment of the first portion to the second
portion.
18. The method of claim 13, wherein the second portion is
sterile.
19. The method of claim 13, further comprising combining multiple
removably attachable pieces to form the second portion.
20. The method of claim 13, further comprising clamping the probe
in the probe guide when the probe guide is at the percutaneous
target.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application is a divisional application of and claims
filing priority to U.S. patent application Ser. No. 12/576,487
having a filing date of Oct. 9, 2009, which is incorporated herein
by reference.
BACKGROUND OF THE INVENTION
[0002] Medical probe devices are utilized for many purposes, chief
of which include catheterization, centesis, and biopsy procedures.
Percutaneous placement of probes using these devices is often
performed with techniques which rely on ascertaining the correct
locations of palpable or visible structures. This is neither a
simple nor a risk-free procedure. For instance, proper insertion
and placement of a percutaneous probe depends on correct
localization of anatomical landmarks, proper positioning of the
patient in relation to the care provider, and awareness of both the
target's depth and angle from the point of probe insertion. Risks
of unsuccessful placement of a probe can range from minor
complications, such as patient anxiety and discomfort due to
repetition of the procedure following incorrect initial placement,
to severe complications, such as pneumothorax, arterial or venous
laceration, or delay of delivery of life-saving fluids or
medications in an emergency situation.
[0003] Ultrasound guided techniques and devices have been developed
to aid in correct placement of percutaneous probes. Ultrasound
guided techniques often utilize two people, an ultrasound operator
who locates the internal target and keeps an image of the target
centrally located on a monitor, and a care provider who attempts to
guide the probe to the target based upon the sonogram. Such
techniques are very difficult perceptually. For instance, these
techniques are complicated by the fact that the person targeting
the tissue with the probe is not the same person as is operating
the ultrasound. In addition, the generally thin, cylindrical probe
is usually small and reflects very little of the ultrasound beam.
Moreover, as the cylindrical probe and the ultrasound beam are not
generally normal to one another, the small amount of ultrasonic
energy that is reflected from the probe will reflect at an angle to
the incident beam, resulting in little if any of the reflected
energy being detected by the ultrasound transducer. As a result,
the probe itself is difficult to visualize in the sonogram and the
person placing the probe must attempt to guide the probe to the
correct location using minimal visual feedback. For example, the
only visual feedback available is often only subtle artifacts of
the motion of the probe such as slight changes in the sonogram as
the probe deflects and penetrates the surrounding tissue. The
trained observer can pick up subtle ultrasonic shadow artifacts
deep to the probe created when the probe blocks the transmission of
the ultrasound beam to the tissue below, and such subtle artifacts
can be used to help guide the probe to the targeted location.
[0004] In an attempt to relieve the difficulties of ultrasound
guided probe techniques, systems have been developed including a
probe guide which can be attached to an ultrasound transducer
housing. Problems still exist with such devices however. For
instance, the probe guide is to one side of the ultrasound
transducer housing in these devices, and the probe is often
inserted at a fixed angle to the scanned plane displayed on the
sonogram, restricting the intersection of the scanned plane and the
point of the probe to a very small area in space. In addition, and
as with hand-guided ultrasound techniques, very little, if any,
ultrasonic energy is reflected from the probe back to the
transducer. In fact, due to the lack of lateral motion of the
probe, visual cues to the location of the probe tip may be even
more difficult to discern on a sonogram when using these devices.
In addition, in many of these devices, the probe passes through the
ultrasound beam at a fixed depth range depending on the set angle
of the probe guide, and this may not correspond to the depth of the
target, in which case it may not be possible to show the juncture
of the target and the probe tip on the sonogram at all.
[0005] What are needed in the art are improved ultrasound devices
and methods for using such devices. For instance, what are needed
in the art are ultrasound probe devices that can be utilized by a
single operator to accurately visualize the delivery of a probe to
a percutaneous target.
SUMMARY OF THE INVENTION
[0006] Disclosed in one embodiment is a medical probe device. The
skin contacting surface can include a first portion and a second
portion that are angled with respect to one another. More
specifically, the first portion can define a first plane and the
second portion can define a second plane, and these two planes can
intersect one another to define an angle therebetween that is
greater than about 150.degree. and less than 180.degree.. In
addition, the first portion of the skin contacting surface can
define a probe guide therethrough, and the second portion can be
associated with an ultrasound transducer such that an ultrasonic
beam transmitted from the ultrasound transducer issues from the
second portion. In one embodiment, the first portion of the skin
contacting surface can be defined by a first portion of the medical
probe device and the second portion of the skin contacting surface
can be defined by a second portion of the medical probe device, and
the first and second portions of the medical probe device can be
removably cooperable with one another.
[0007] The probe device can be an ultrasound transducer housing,
or, in another embodiment, can include a sterilizable shield that
can enclose an ultrasound transducer housing.
[0008] A probe device as disclosed herein can also include a clamp
for clamping a probe in the probe guide of the device, for instance
after the probe tip has reached a targeted percutaneous target.
[0009] Disclosed devices can be connectable to a monitor for
displaying a sonogram. Moreover, the path of a probe guided through
the probe guide can define a line that is coincident (i.e., within)
the scanned plane of a sonogram formed by the ultrasound
device.
[0010] A device can include a detector for detecting motion of a
probe within the probe guide. Information from the detector can be
processed and, in one embodiment, can be displayed as an image of a
virtual probe on the monitor overlaying the sonogram, providing a
real-time visualization of the location of the probe tip during a
procedure.
[0011] A probe device can include additional beneficial features.
For example, in one embodiment, a skin contacting surface of a
probe device can include at least one raised ridge on the surface
that can improve coupling between the skin and the probe device,
generally in conjunction with ultrasonic gel between the two. In
another embodiment, a skin contacting surface can include a wedge
formed of an ultrasonic transmissive material to improve coupling
between the skin and the probe device and/or to improve
visualization of percutaneous targets that are close to the surface
of the skin.
[0012] Also disclosed herein is a single-use sterilizable shield as
can be utilized with an ultrasound transducer. In one embodiment, a
sterilizable shield can include a first section, a second section
and a fastener for connecting the first section and the second
section to one another. Beneficially, the fastener can be a
single-use fastener that can be permanently disabled upon
disconnection and separation of the first section and the second
section from one another that can prevent reuse of a shield and
enhance patient safety.
[0013] Also disclosed is a multi-piece device including multiple
removably attachable portions. For instance, a device can include a
first portion that incorporates an ultrasound transducer and a
second portion that defines all or a portion of a probe guide, and
the two portions can be removably attached to one another. A device
can also include a detector for detecting the presence or the
motion of a probe within the probe guide.
[0014] Also disclosed are methods for guiding a probe to a
percutaneous target. Methods can include, for example, utilizing a
probe guide including an ultrasound device with a single-use
sterilizable shield and disabling the shield upon disassembly of
the device. Beneficially, disclosed methods can be carried out by a
single operator during a medical procedure.
BRIEF DESCRIPTION OF THE FIGURES
[0015] A full and enabling disclosure of the present subject
matter, including the best mode thereof to one of ordinary skill in
the art, is set forth more particularly in the remainder of the
specification, including reference to the accompanying figures in
which:
[0016] FIG. 1A illustrates one embodiment of an ultrasound device
as disclosed herein;
[0017] FIG. 1B illustrates a side view of the base of the device of
FIG. 1A;
[0018] FIG. 1C illustrates a side view of the base of another
embodiment of an ultrasound device as disclosed herein;
[0019] FIG. 2 illustrates a bottom view of the device of FIG.
1;
[0020] FIG. 3 illustrates one embodiment of a multi-section
sterilizable shield as disclosed herein;
[0021] FIG. 4 illustrates the lower section of the sterilizable
shield illustrated in FIG. 3;
[0022] FIG. 5A illustrates a bottom view of the lower section of
the sterilizable shield illustrated in FIG. 3;
[0023] FIG. 5B illustrates a partial bottom view of another
embodiment of a sterilizable shield as disclosed herein;
[0024] FIG. 6 illustrates the upper section of the sterilizable
shield illustrated in FIG. 3;
[0025] FIGS. 7A and 7B illustrate two views of the clamping
mechanism of the sterilizable shield of FIG. 3; and
[0026] FIG. 8 illustrates one embodiment of a method for utilizing
a device as disclosed herein.
[0027] FIG. 9 illustrates an ultrasound transducer housing that can
be removably attachable to a portion of a probe device defining a
probe guide;
[0028] FIG. 10A and 10B illustrate a probe device including the
ultrasound transducer housing of FIG. 9 enclosed in a sterilizable
shield portion, a separable portion removably attachable thereto
that defines a probe guide, and a clamp removably attachable
thereto, with FIG. 10A showing the sections removed from one
another and FIG. 10B showing the sections when attached
together.
[0029] FIG. 11 illustrates another embodiment of a probe device as
disclosed herein.
[0030] FIG. 12 is a side view of the probe device illustrated in
FIG. 11.
[0031] FIG. 13 is a front view of the probe device illustrated in
FIG. 11.
[0032] FIG. 14 illustrates the device of FIG. 11 including a
removably attachable probe guide portion.
[0033] FIG. 15 is a side view of the device of FIG. 14.
[0034] FIG. 16 is a front view of the device of FIG. 14.
[0035] FIG. 17 illustrates the device of FIG. 14 with a clamp
removably attached to the probe guide portion.
[0036] FIG. 18 is a side view of the device of FIG. 17.
[0037] FIG. 19 is a front view of the device of FIG. 17.
[0038] Repeat use of reference characters in the present
specification and drawings is intended to represent the same or
analogous features of elements of the disclosed subject matter.
Other objects, features and aspects of the subject matter are
disclosed in or are obvious from the following detailed
description.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0039] Reference will now be made in detail to various embodiments
of the disclosed subject matter, one or more examples of which are
set forth below. Each embodiment is provided by way of explanation
of the subject matter, not limitation of the subject matter. In
fact, it will be apparent to those skilled in the art that various
modifications and variations may be made in the present disclosure
without departing from the scope or spirit of the subject matter.
For instance, features illustrated or described as part of one
embodiment, may be used in another embodiment to yield a still
further embodiment. Thus, it is intended that the present
disclosure cover such modifications and variations as come within
the scope of the appended claims and their equivalents.
Definitions
[0040] As utilized herein, the term "probe" generally refers to a
device that can be guided to a percutaneous location, for instance
for delivery of a therapeutic, e.g., a compound or a treatment, to
the location; for removal of material from the location; and so
forth. For example, the term "probe" can refer to a needle, a tube,
a biopsy device, or any other item that can be guided to a
percutaneous location. In general, a probe can be guided by and
used in conjunction with an ultrasound device as described
herein.
[0041] As utilized herein, the term "probe device" generally refers
to a device that can be utilized in conjunction with a probe, but
does not necessarily include the probe itself.
DETAILED DESCRIPTION
[0042] According to one embodiment, disclosed herein are devices
and methods for use in guiding a percutaneous probe during a
medical procedure. In one preferred embodiment, disclosed herein
are probe devices that can include an ultrasound transducer
therein. Devices can define an opening to accommodate a probe
therethrough so as to improve coordination between a sonogram
formed by the ultrasound device and the path of a probe passing
through the opening. In one embodiment, disclosed devices can
include a visualization system so as to provide a real-time image
of a virtual probe on a sonogram and improve delivery of a probe to
a percutaneous target.
[0043] Also disclosed herein are sterilizable shields that can
surround all or a portion of an ultrasound transducer to form a
sterilizable probe device. Thus, disclosed probe devices can be
utilized in an ultrasound guided medical procedure that requires a
sterile field to ensure the safety of a patient. For instance,
disclosed devices can be used in a central venous catheterization
procedure, in a biopsy procedure, and the like.
[0044] Beneficially, disclosed devices can be formed so as to
conveniently be utilized by a single operator who can control an
ultrasound transducer and also deliver a probe using the probe
guidance system. Disclosed devices can include a variety of other
beneficial features as well. For example, features of disclosed
devices can improve contact and gel coupling between a skin surface
and the surface of a device, can improve the effective field of the
sonogram formed with the ultrasound transducer, and can prevent
non-sterile use of a sterilizable shield of a device, all of which
are described in greater detail herein.
[0045] In one preferred embodiment, disclosed devices can
incorporate a system that can be used to visualize a percutaneous
probe as it is being guided with a device. One preferred embodiment
of a visualization system as may be incorporated with disclosed
devices has been described in U.S. Pat. No. 7,244,234 to Ridley, et
al., which is incorporated herein by reference. Through utilization
of a visualization system, the path of a probe guided with a device
and hence the location of the probe tip can be more clearly known
in relation to a target imaged by the ultrasound device.
[0046] In accord with the present disclosure, FIG. 1A illustrates
one embodiment of an ultrasound transducer housing generally 100.
Transducer housing 100 includes handle 102, post 104, and base 106.
FIG. 2 provides a bottom view of the transducer housing 100. An
ultrasound transducer 120 that transmits and receives ultrasonic
waves can be located in base 106, as shown. Ultrasound transducer
housing 100 can be formed of any suitable materials. For instance,
any moldable polymeric material that can securely encase the
ultrasound transducer 120 as well as contain associated
electronics, wiring, switches, and the like and will not interfere
with the functioning of the transducer 120 can be utilized,
[0047] Any type of ultrasound transducer as is generally known in
the art can be incorporated in transducer housing 100. By way of
example, a piezoelectric transducer formed of one or more
piezoelectric crystalline materials arranged in a two or
three-dimensional array can be utilized. Such materials generally
include ferroelectric piezoceramic crystalline materials such as
lead zirconate titanate (PZT). In one embodiment, the elements that
form the array can be individual electrode or electrode segments
mounted on a single piezoelectric substrate, such as those
described in U.S. Pat. No. 5,291,090 to Dias, which is incorporated
herein by reference thereto.
[0048] In general, an ultrasound transducer 120 can be formed of
multiple elements; however, single crystal devices are also
encompassed by the present disclosure. The use of a multiple
element ultrasound transducer can be advantageous in certain
embodiments, as the individual elements that make up the array can
be controlled so as to limit or prevent any break or edge effects
in the sonogram. For instance, the firing sequence of individual
crystals can be manipulated through various control systems and
prevent any possible `blind spots` in the sonogram as well as to
clarify the edges of individual biological structures in the
sonogram. Such control systems are generally known in the art and
thus will not be described in detail.
[0049] Referring again to FIG. 1A, ultrasound transducer housing
100 defines a probe guide opening 126 that passes through base 106.
As can be seen in FIG. 2, probe guide opening 126 can be aligned
with transducer 120. A probe that is guided through the probe guide
opening 126 can travel on a path that is generally parallel to the
scanned plane of a sonogram formed by use of the ultrasound device.
In general, the scanned plane (i.e., the plane of the sonogram) is
the geometric central plane of the beam transmitted from the
ultrasound transducer 120. In one preferred embodiment, the path of
a probe guided through probe guide opening 126 can be within the
scanned plane. This is not a requirement of the present disclosure,
however. For instance, the path of a probe passing through probe
guide opening 126 can be at an angle to the scanned plane such that
it intersects the scanned plane at a point. By way of example, the
line defined by the path of a probe passing through the probe guide
opening 126 can be at an angle of .times.1.degree. of the scanned
plane, or at a greater angle, in another embodiment. For instance,
a line defined by the path of a probe passing through the probe
guide opening 126 can be at an angle of .+-.10, .degree.
.+-.20.degree.,.+-.45.degree., or even greater, in other
embodiments.
[0050] Generally, ultrasound transducer 120 can be connected via
signal wires in a cable 124 that leads to a processor that
processes the data to form a sonogram on a monitor, as is generally
known in the art. In the particular embodiment as illustrated in
FIG. 1A, cable 124 is internal to handle 102 of the ultrasound
transducer housing 100, though this particular arrangement is not a
requirement of the disclosure. Handle 102 can generally be set at
an angle to post 104 of transducer housing 100 so as to be
comfortably held in the hand while the device is being utilized.
For instance, in the illustrated embodiment, handle 102 is about
90.degree. to post 104, though this angle can be varied as desired.
Moreover, in another embodiment described further herein, a device
need not include an extending handle portion at all.
[0051] Referring to FIG. 1B, base 106 defines a lower surface 108
defining probe guide opening 126 and lower surface 110 from which
an ultrasonic beam emitted by transducer 120 can issue. Surfaces
108 and 110 together can form a skin contacting surface on the base
106 of the device 100. As can be seen, surfaces 108 and 110 are
contiguous and angled with respect to one another. The angle
between surface 108 and 110 can vary. For instance, in one
embodiment the angle marked as .theta. in FIG. 1B can vary from 0
to about 30.degree. or from about 10.degree. to about 20.degree. in
another embodiment. Accordingly, the angle between surfaces 108 and
110 can be greater than about 150.degree. and less than 180.degree.
in one embodiment, or greater than about 160.degree. and less than
about 170.degree. in another embodiment.
[0052] It has been found that such geometry can be beneficial in
certain embodiments. For instance, referring to FIG. 1B, base 106
is illustrated with the edges of a scanned plane formed by
ultrasound transducer 120 shown within broken lines 4 and 6. The
distance 8 from the termination of probe guide opening 126 to the
edge 4 of the scanned plane is also shown. During use, the portion
of base 106 including surface 110 can press into the skin of a
subject somewhat and ensure good contact between the ultrasound
transducer 120, ultrasonic gel, and the skin. Upon passing a probe
through the probe guide opening 26, the probe will contact the skin
and travel the short percutaneous distance 8 before entering the
ultrasound beam. The distance 8 can depend upon the angle between
the surfaces 108 and 110, but can be relatively small. For
instance, distance 8 can be less than about 25 mm, less than about
10 mm, less than about 5 mm or less than about 1 mm.
[0053] In comparison, FIG. 1C illustrates a base 205 in which the
entire bottom edge of base 205 is planar, i.e., the skin contacting
surface of base 205 does not include angled portions. FIG. 1C also
illustrates the edges of a scanned plane formed by transducer 120
by use of broken lines 204 and 206. As can be seen, the distance
208 between the point a probe will exit probe guide opening 226 and
enter the scanned plane at 204 is greater than the distance 8 in
the embodiment in FIG. 1B. An embodiment including a base that
defines an angled bottom surface, as is illustrated in FIG. 1B may
be preferred in those embodiments in which a percutaneous target
may be close to the skin surface.
[0054] It should also be understood that while the skin contacting
surface and portions thereof of the illustrated probe devices are
generally planar, this is not a requirement of the disclosed
subject matter. For instance, with regard to FIG. 1B, surface 108
and/or surface 110 can be curved, e.g., can define an arcuate
profile along either or both of the axes of the surface. In this
embodiment, a curved surface can define a plane between the
intersection line of two portions (e.g., surface 108 and surface
110) forming the skin contacting surface and a point at the outer
edge of the curved surface. Planes defined by a curved skin
contacting surface can correspond in a like manner to a planar skin
contacting surface (or portions thereof) as described above.
[0055] In another embodiment, the skin contacting surface of a
device can be associated with a removably cooperable material so as
to encourage improved imaging of a percutaneous location. For
instance, a planar skin contacting surface, such as is illustrated
in FIG. 1C, or a portion of an angled skin contacting surface, such
as surface 108 of FIG. 1B, can be associated with an ultrasound
transmissive wedge formed of an ultrasonic transmissive material so
as to alter the relative orientation between the skin surface and
an ultrasound device. For instance a pliable saline-filled
container can be held against or attached to the base of surface
108 to alter the relative orientation of the surfaces. Such a
device can be utilized to, e.g., more clearly visualize
percutaneous targets that are close to the skin surface. An
ultrasound transmissive wedge can be located on the skin contacting
surface of a device utilizing a small amount of ultrasonic gel for
a temporary attachment, or utilizing a biocompatible adhesive for a
more permanent attachment, or by any other suitable adherence
method.
[0056] It should be understood that any particular geometric
configuration for transducer housing 100 and its individual
sections is not essential to the present invention. For example,
the base 106 of transducer housing 100 may be oblong, square,
round, rectangular or any other suitable shape. In certain
embodiments, the shape of ultrasound housing 100 may be
particularly designed to fit specific locations of the anatomy. For
example, ultrasound housing 100 may be shaped to be utilized
specifically for infraclavicular approach to the subclavian vein,
approach to the internal jugular vein, specific biopsy procedures
including, without limitation, breast biopsy, thyroid nodule
biopsy, prostate biopsy, lymph node biopsy, and so forth, or some
other specific use. Variations in shape for any particular
application can include, for example, a specific geometry for the
footprint of base 106, alteration in the size of post 104 and/or
handle 102, as well as variation in angles at which various
elements of a device meet each other, such as the angle defined by
the bottom of base 106 previously discussed. For example, the
footprint of base 106 can be any suitable shape and size, e.g.,
rectangular, round, oblong, triangular, etc. By way of example, the
skin contacting surface of base 106 can be between about 0.5 inches
and about 6 inches on its greatest length. In one embodiment, the
footprint of base 106 can be about 0.5 inches on its greatest width
so as to promote stability of the device during use. In other
embodiments, it can be larger, however, such as about 1 inch on its
greatest width, about 2 inches on its greatest width, or even
larger.
[0057] Transducer housing 100 can be used as is, with no additional
shield or covering over the housing 100. According to this
embodiment, a probe, e.g., a needle, can pass through probe guide
opening 126 and can be directed to a target that is visualized on a
sonogram formed by use of ultrasound transducer 120. According to
another embodiment, however, all or a portion of transducer housing
100 can be encased in a sterilizable shield, for instance in those
embodiments in which a probe is intended for use in a sterile
field. According to this embodiment, a transducer housing can be
encased in a sterilizable shield that can provide a sterile barrier
between a patient and the ultrasound transducer housing 100 during
a medical procedure.
[0058] A sterilizable shield can generally be formed of a number of
different sterilizable, biocompatible materials. For instance, a
sterilizable shield can be formed of relatively inexpensive
single-use materials that can be sterilized as are generally known
in the art such that the entire shield can be properly disposed of
following use. In another embodiment, a sterilizable shield can be
utilized multiple times, in which case it can be formed of a
material that can be properly sterilized between uses. By way of
example, a sterilizable shield can be formed of a moldable or
extrudable thermoplastic or thermoset polymeric material including,
without limitation, polyethylene, polypropylene, polymethylpentene
(TPX), polyester, polyvinyl chloride, polycarbonate, polystyrene,
and so forth.
[0059] FIG. 3 illustrates one example of a sterilizable shield 130
as may be utilized to encase ultrasound transducer housing 100.
Sterilizable shield 130 can include a lower section 132, details of
various embodiments of which are shown in FIG. 4 and FIG. 5, and an
upper section 134, details of which are shown in FIG. 6.
[0060] With reference to FIG. 4, shield section 132 can include a
base 136 formed of an ultrasonic transmissive material. Base 136
can be of any suitable size and shape, but formed such that
ultrasound transducer housing base 106 may be seated firmly in
shield base 136. Generally, a small amount of an ultrasonic gel can
be placed between the bottom surface of transducer housing base 106
and shield base 136 during seating to prevent any air between the
two and promote transmission of ultrasonic waves.
[0061] Arising out of shield base 136 is guide post 138. Guide post
138 defines at least a portion of a probe guide 139 therethrough.
Probe guide 139 extends uninterrupted completely through both guide
post 138 and shield base 136. Guide post 138 can include tabs as
shown, or other formations such as hooks, insets, or the like that
can be utilized to properly assemble shield base 136 about
ultrasound transducer housing 100. In one embodiment, guide post
138 may include a removable cap (not shown) for protection of the
interior sterile surface of probe guide 139 during assembly of
shield 130 with ultrasound transducer housing 100.
[0062] As can be seen, shield section 132 can also include tabs
140, 142, 144, etc. that can be utilized in properly seating
ultrasound housing 100 within shield 130 as well as aligning shield
section 132 with shield section 134 when assembling the complete
shield 130 about an ultrasound transducer housing 100.
[0063] In the illustrated embodiment, tabs 140 on shield section
132 match corresponding notch 141 on shield section 134 shown in
FIG. 6, Together tabs 140 and notch 141 form a fastener that can
secure shield section 132 and shield section 134 to one another.
During assembly, tabs 140 can snap into notch 141 to securely
fasten the two sections together and prevent separation of the
sections 132, 134 during use. Of course, a shield can include
additional fasteners at other locations between the two sections,
or can include a single fastener at an alternative location, as
would be known to one of skill in the art.
[0064] In order to disassemble shield 130, tabs 140 can be simply
pinched together and slid out of notch 141. In another embodiment,
a single-use fastening mechanism can be employed to secure sections
of a sterilizable shield to one another. According to this
embodiment, in order to disassemble a shield following use, the
tabs of the fastener can be permanently disabled. For instance,
tabs 140 and/or notch 141 can be permanently broken away from the
shield by a pulling or twisting motion, allowing the shield
sections to come apart and also ensuring that the shield, which is
no longer sterile, cannot be utilized again. Any method that can
ensure that a fastener can only be utilized a single time may
alternatively be utilized.
[0065] Referring to FIG. 5A, the bottom of shield section 132 can
be seen. The bottom surface of base 136 of section 132 includes a
series of ridges 150 running along a portion of base 136. It has
been found that inclusion of such ridges on the skin-contacting
surface of a device can provide benefits to disclosed devices and
methods. For instance, the inclusion of ridges on the skin
contacting surface can push and better hold ultrasonic gel between
the device and the skin surface, preventing formation of an air gap
between the two and improving coupling between a subject's skin and
the device. In addition, ridges along the skin contacting surface
can also add an extra pushing force against the skin itself, better
holding the skin tightly against the base of the transducer, and
further improving contact between the device and a subject's skin,
thereby further improving coupling between the subject and the
device and providing an optimal ultrasound image.
[0066] Though illustrated as two ridges running along the length of
the shield base, this particular arrangement is not required for
the ridges. For instance, FIG. 5B illustrates another embodiment,
including a plurality of ridges 150 running across the width of the
bottom surface of a base 236 of a sterilizable shield. Moreover, in
those embodiments in which an ultrasound transducer housing is
intended for use without a sterile shield, either in a non-sterile
field or in those embodiments in which the ultrasound device itself
is sterilizable, ridges can be included on the skin contacting
surface of the ultrasound transducer housing itself.
[0067] Ridges formed on the skin contacting surface of a device can
cover the entire skin contacting surface, or only a part of the
surface, as desired. For instance, the ridges can cover at least a
portion of the skin contacting surface through which an ultrasonic
beam is transmitted, or can also cover other portions of the skin
contacting surface, and in particular, that portion in the vicinity
of the probe guide (e.g., on either or both surfaces 108 and 110 of
FIG. 1A). Ridges can be of particular benefit on a planar skin
contacting surface, such as that illustrated in FIG. 1B, so as to
encourage good contact and coupling between a subject's skin,
ultrasound coupling gel, and the skin contacting surface of the
device,
[0068] Ridges 150 can be formed to any size and shape and of any
suitable biocompatible material that can also be, in certain
embodiments, a sterilizable material. For example, ridges can have
a rounded or straight edge, an individual ridge can lie in a
straight line across a skin contacting surface or can curve across
the surface, they can vary in height as measured from the base
surface to the top edge of the ridge, multiple ridges on a single
device can be identical to one another or can vary, ridges can be
continuous over a surface or discontinuous, and so forth.
[0069] In one embodiment, ridges 150 can be formed of the same
material as other portions of a shield or transducer housing. For
instance, the entire section 132, including ridges 150 can be
injection molded from a single polymeric material. In another
embodiment, different portions of a sterilizable shield can be
formed of different materials. For instance, ridges 150 can be
formed of a polymeric material that is softer than is used to form
the remainder of sterilizable shield. By way of example, a
relatively soft elastomeric polymer (e.g., rubber,
styrene-butadiene, soft polyurethanes, etc.) can be utilized. In
such cases, ridges can be attached to a device following formation,
for instance utilizing a biocompatible adhesive as is known in the
art. In one embodiment, ridges can be formed on a specifically
shaped component to be attached to the base of the device. For
instance, a series of ridges can be formed on an ultrasound wedge
as previously discussed, that can be attached either temporarily or
permanently to the base of a device.
[0070] As previously stated, the sterilizable shield need not cover
the entire ultrasound transducer house. For example, in one
embodiment, a sterilizable shield can cover just that portion of an
ultrasound transducer housing from which an ultrasonic beam can be
emitted. For instance, a shield defining one or more ridges thereon
can simply snap onto the base of an ultrasound transducer housing,
covering that portion of the housing that will contact a user's
skin.
[0071] Another beneficial feature of disclosed devices can be the
geometry of a handle of a device. For instance, as previously
mentioned with regard to the transducer housing, the angle at which
a handle is placed on a probe device can be varied so as to obtain
a more comfortable grip on the device while holding the transducer
base tightly against the skin. Additional aspects of a can be
improved as well. For example, as can be seen on FIG. 5A the handle
of shield section 132 can include a finger grip 152 that can
improve the grip of a user on the device. In other embodiments
additional finger grips can be included, as desired. For instance,
in one embodiment finger grips can be provided on a handle such
that the handle is specifically designed for left-handed or
right-handed use.
[0072] Sterilizable shield 130 also includes section 134,
illustrated in FIG. 6. Section 134 can be removably attached to
section 132 to enclose an ultrasound transducer housing 100, as
previously discussed. Section 134 defines the terminal portion 151
of probe guide 139 in portion 160. Terminal portion 151 is sized so
as to snugly reside over the top of guide post 138 of section 132
and form uninterrupted probe guide 139 extending from the top
surface of portion 160 of section 134 to the bottom surface of base
136 of section 132.
[0073] It should be understood that a sterilizable shield as
disclosed herein is not limited to two completely separable
portions. For instance, a sterilizable shield can be hinged and/or
can include additional portions, as desired. For instance, a
sterilizable shield can be formed of two, three, or more separable
sections that can be assembled to enclose all or a portion of an
ultrasound housing and form a sterile barrier between the enclosed
housing and an exterior field. In another embodiment, a
sterilizable shield can be of a unitary construction. For instance,
a sterilizable shield can be of a pliant material that can enclose
all or a portion of an ultrasound housing and form a sterile
barrier between the enclosed housing and an exterior field.
[0074] To assemble a shielded device, ultrasound transducer housing
100 defining probe guide opening 126 can be seated in shield base
136 of section 132 such that guide post 138 extends through
transducer housing probe guide opening 126. As probe guide opening
126 of transducer housing 100 is slid over guide post 138, tabs on
guide post 138 can slide or snap into recesses of probe guide
opening 126 (not shown), helping to properly seat transducer
housing 100 in section 132. After ultrasound transducer housing 100
is seated in section 132, section 134 can be aligned with section
132 and fastened into place to cover the top of transducer housing
100. If a protective cap covers the end of guide post 138, it can
be removed during assembly and maintain the sterility of the
interior of the probe guide 139 throughout the assembly process.
Tabs 140 can snap or slide into recesses notch 141 to fasten and
secure section 132 and 134 together.
[0075] Following the above described assembly process, probe guide
139 can extend continuously from the top of portion 160 of shield
portion 134 through the shield base 136. Moreover, and of great
benefit to the device, probe guide 139 can be sterile and within
the probe guide opening 126 of ultrasound transducer housing
100.
[0076] Many procedures require a probe to remain at the
subcutaneous target for a period of time following insertion of a
probe. For example, during the Seldinger technique common for
central venous catheter placement, a cannulated needle attached to
a syringe is first guided into a vein. After the needle tip is in
the lumen of the vein, the needle is held in place while a guide
wire is fed down through the needle and into the vein. During this
process, only a slight movement of the needle can cause the needle
tip to move out of the vein, and the entire procedure must be
repeated.
[0077] In order to prevent excessive motion of a probe tip
following insertion to a target, one embodiment includes a clamp
for the probe. In this embodiment, a device can include a clamp
that can firmly hold a probe in the probe device and prevent motion
of the probe during subsequent procedures such as catheter
insertion, biopsy procedures, fluid aspiration, or the like. Motion
of the percutaneous probe tip can be much less likely when the
probe is securely clamped to the probe device and the probe device
is in turn held and stabilized by pressing against the subject's
skin surface as compared to when only the probe itself is held
without clamping to the larger probe device.
[0078] One embodiment of a clamp for use with disclosed probe
devices can be seen in FIG. 3. As can be seen, a probe 154 can
extend through the probe guide of sterilizable shield 130. Clamp
156 sits atop shield section 134 such that probe 154 passes through
clamp aperture 158 as shown.
[0079] Additional details of clamp 156 can be seen with reference
to FIGS. 7A and 7B. Aperture 158 includes a wide portion and a
narrow portion and defines a clamping surface. The wide portion can
be of a size such that a probe can pass freely through the wide
portion without hindrance. Aperture 158 can gradually narrow from
the wide portion of the aperture to form the narrow portion
extending to a tip. Thus, when a probe is located in the wide
portion of aperture 158, the clamp can be slid, rotated, or
otherwise moved in relation to the probe such that the clamping
portion of the clamp crosses the axis of the probe and a clamping
surface of the clamp, e.g., a surface of aperture 158 at the narrow
portion, can contact the probe and the probe can become tightly
trapped in the narrow portion of the aperture 158 as the width of
the narrow portion of aperture 158 decreases.
[0080] In another embodiment, rather than trapping a probe between
two opposing clamping surfaces, as is the case for the clamp of
FIGS. 7A and 7B, a clamping surface can force a probe against the
wall of the probe guide to secure the probe in place. For example a
clamping surface can be set on a clamp and at an angle with
reference to the probe guide. Thus, as the clamp is moved and
crosses the probe guide axis, the probe held in the probe guide
contacts the clamping surface and becomes pressed against the wall
of the probe guide by the force of the single opposing clamping
surface and can be firmly gripped between the clamping surface and
the wall of the probe guide. In such an embodiment, the clamping
surface of the clamp need not be one side of an aperture defined by
the clamp, but may be, by way of example, an outer edge of a clamp
section, with no opposing piece on the clamp.
[0081] A clamp can be formed of any biocompatible, sterilizable
material. For instance, in one embodiment, at least that portion of
a clamp that defines a clamping surface can be formed of a material
that is harder than a probe to be held by the clamp, for example a
hard polymer or a stainless steel. In this embodiment, the clamping
surface(s) can cut into the surface of a probe, providing
additional holding power in addition to the friction hold provided
by trapping the clamp with the clamping surface(s). In another
embodiment, however, a clamp, and particularly a clamping surface
of a clamp, can be formed of a material that is softer than a probe
held in the clamp. For example, a clamp can be formed of a
relatively soft polymer such as soft polyurethane or other
biocompatible polymeric material. In this embodiment, the clamping
surface(s) can deform somewhat as a probe is forced against the
clamping surface. The deformation of a clamping surface about a
probe can increase the force on the probe, more securely holding
the probe in place in the clamp.
[0082] A clamp can define additional features that can improve its
holding ability. For instance, a clamping surface can define a
series of serrations. Upon contact between a probe and the clamping
surface, the serrations of the edges can provide increased surface
area for contact between the clamp and the probe, improving hold
between the two. Moreover, in those embodiments in which the
material forming the clamping surface is harder than that of the
probe, serrations on the surface of the clamping surface can cut
into the surface of the probe at the points of contact, further
improving hold between the two.
[0083] Referring again to FIGS. 7A and 7B, clamp 156 includes
formations 162, 163 that can be used to move clamp 156 and trap
probe 154 in the aperture 158 as previously discussed. For example,
as illustrated in FIG. 8, a sterilized shield 130 can be held
against the skin surface of a subject and the user can move the
clamp 156 with his/her thumb to force the probe into the narrow
section of aperture 158 and firmly clamp the probe 154 in
place.
[0084] In the illustrated embodiment, clamp 156 includes two
formations 162, 163, one on either side of clamp 156 such that the
clamp can be operated while held in either the right or left hand
of a user. In other embodiments, clamp 156 can include only a
single formation, for instance in those embodiments in which a
probe device is designed for only right-handed or left-handed use,
or alternatively, when the single formation can be accessed from
either side of the device. Moreover, the shape of the formations
162, 163 can be any shape that can be accessed by a user and can be
pushed, pulled, twisted or otherwise activated to move a clamp and
tightly grip a probe in a probe guide. For example a formation can
be round, as illustrated, or can be a flat, paddle-shaped
formation, a post, or any other convenient shape. Moreover, any
formation can be utilized to aid in moving the clamp to force a
clamping surface against a probe. For instance, a clamp can define
an indentation to be used in moving a clamp. In another embodiment,
a clamp can define a rough tactility at a location that can aid in
moving the clamp with a thumb or finger. Equivalent or alternative
formations would be obvious to one of ordinary skill in the art.
For instance, in another embodiment, a portion of the clamp can be
rotated so as to force the clamping surface of the clamp against a
probe held in the probe guide. By way of example, a probe clamp as
is illustrated in U.S. Pat. No. 7,244,234 to Ridley, et al.,
previously incorporated by reference, can be utilized in
conjunction with disclosed devices.
[0085] Referring again to FIG. 3, clamp 156 is attached to shield
130 at a pivot point. For instance, tabs 164 of clamp 156 can fit
into recesses 165 formed in the lower section 132 of sterilizable
shield 130 (see, e.g., FIG. 5A). During use, clamp 156 can rotate
about the pivot point of tabs 164 and over the rounded upper
surface of portion 160 of upper section 134 such that the clamping
portion, i.e., that portion of clamp 156 that defines the aperture
158 crosses the axis of the probe 154 to lock the probe in
place.
[0086] The rotation of a clamp about a pivot to secure a probe is
not a requirement of disclosed clamps. For example, in another
embodiment, the entire clamp can slide laterally across a portion
of a probe device, e.g., a shield or a transducer housing, to clamp
a probe in place. In general, any motion of all or a portion of a
clamp that can be controlled by a user and can grip a probe as
described is encompassed in the present disclosure.
[0087] When a probe is to be removed from a percutaneous location,
or if during a procedure, a probe is to be moved from one
percutaneous location to another, a projection can be moved in the
opposite direction as was used to clamp the probe, freeing the
probe.
[0088] FIG. 9 illustrates another embodiment of an ultrasound
transducer housing 800 that can be removably attached to a
sterilizable shield. According to this embodiment, ultrasound
transducer housing 800 can include a handle 802, a post 804, and a
base 806. Ultrasound transducer housing 800 also defines a lower
surface 810, as shown. In this particular embodiment, however, the
ultrasound transducer housing does not include a probe guide
opening. Instead, ultrasound transducer housing 800 is removably
attachable to a second portion of a device that defines a probe
guide opening. For instance, ultrasound transducer housing 800 can
be utilized in conjunction with a sterilizable shield that defines
the probe guide. Moreover, the sterilizable shield can be formed of
single or multiple removably attachable pieces.
[0089] FIGS. 10A and 10B illustrate one embodiment of a
sterilizable shield 930 that can be used in conjunction with an
ultrasound device 800 illustrated in FIG. 8. With reference to FIG.
10A, sterilizable shield 930 can be formed of multiple attachable
pieces. Specifically, sterilizable shield 930 includes section 932
and section 961 that defines a probe guide for passage of a probe
therethrough. Accordingly, section 961 can alternatively be
referred to as a probe guide portion. Additionally, section 932 can
be separable into two or more sections, as illustrated for device
230 of FIGS. 3-6. Section 961 can also include clamp 956 defining
aperture 958 and formations 962, 963 that rotates about pivot 964
for clamping probe 954 in the probe guide. During use, section 961
can be attached to shield 932, for instance by use of aligned tabs
and notches, and so forth, so as to attach the probe guide portion
to the sterilizable shield, as shown in FIG. 10B.
[0090] Of course, any other arrangements of the individual portions
of a device are encompassed within the present disclosure. For
instance, in one embodiment, an ultrasound transducer housing that
does not define a probe guide opening, as illustrated in FIG. 9,
can be removably attached to a probe guide portion that can define
a probe guide opening and include the clamp, without enclosing all
or a portion of the ultrasound transducer housing in a shield. In
another embodiment, a sterilizable shield portion can cover only
the skin contacting surface of a device. For instance, a shield
portion can snap onto the base of a device. In yet another
embodiment, all or a portion of a sterilizable shield can be formed
of a pliant material that can enclose an ultrasound transducer
housing. According to such an embodiment, a probe guide portion can
be indirectly attached to the pliant sterilizable shield portion,
for instance by use of a frame or other attachment device that is
on the pliant material or optionally on the ultrasound transducer
housing itself, such that the pliant material of the shield is held
between the frame and the probe guide portion.
[0091] Yet another embodiment is illustrated in FIG. 11. As can be
seen according to this embodiment, a device 1000 need not include a
separate handle portion. Such a device can be comfortably held by
the rounded back portion 1002, while holding the angled skin
contacting surface 1110 against a subject. A side view of device
1000 shown in FIG. 12 better illustrates the angle of skin
contacting surface 1110. Of course, as discussed above, a device
need not include an angle in the skin contacting surface, and in
another embodiment the skin contacting surface of a device can be
flat with no angle as is shown for the device of FIG. 11, or
arcuate.
[0092] A front view of device 1000 is shown in FIG. 13. As can be
seen, device 1000 includes attachment slots 1004, 1006 on either
side of the device. These attachment slots 1004, 1006 can be
utilized to attach another portion to device 1000. For example,
FIG. 14 illustrates device 1000 including a probe guide portion
1061 attached to device 1000 via slots 1004, 1006. When attached,
probe guide portion 1061 can, in one embodiment, be attached such
that probe guide 1039 is aligned with an ultrasound transducer
located in the base of device 1000. Of course, device 1000 need not
include an ultrasound transducer in the base. FIG. 15 illustrates a
side view of device 1000 including probe guide portion 1061
attached thereto. As can be seen, probe guide portion 1061 can
define skin contacting surface 1008 and device 1000 can device skin
contacting surface 1010, with the two surfaces 1008, 1010 held at
an angle to one another to promote improved contact between a
device and a subject, as previously discussed. FIG. 16 is a front
view of the embodiment illustrated in FIGS. 14 and 15.
[0093] In one embodiment, all or a portion of device 1000 can be
covered or encased with a sterilizable shield. For instance all of
the body 1000 of the device can be encased in a sterilizable
shield, and the probe guide portion 1061 can then be attached to
the sterilizable shield. Alternatively, one a portion of the
device, for instance the skin contacting portion, can be covered by
a sterilizable shield. In one embodiment, the probe guide portion
1061 can be sterile, and the portion 1000 can be nonsterile.
[0094] In one embodiment, a probe guide portion need not include a
skin contacting surface. For instance, a separably removable probe
guide portion can be attached to a device such that the base of the
probe guide portion will be above and not contacting the skin of a
subject. According to this embodiment, contact between a subject
and a device will only be between the body of a device that
encompasses the ultrasound transducer, For instance, when the body
of a device incorporates an ultrasound transducer therein, the skin
contacting surface can be at the surface from which an ultrasonic
beam is emitted, and the probe guide portion can be aligned with
the transducer, but held above the skin contacting surface of the
body of the device. In this embodiment, a probe passing through a
probe guide will exit the probe guide and pass for a distance
through the surrounding air prior to contacting the skin of a
subject and passing therethrough.
[0095] Additionally, though illustrated in FIG. 14 with probe guide
portion 1061 completely defining and surrounding the probe guide
1039 that passes therethrough, this is not a requirement of the
present disclosure. For example, in another embodiment, a probe
guide can be defined between a probe guide portion 1061 and the
side of device 1000. According to this embodiment, a probe guide
portion can define a V-shaped notch, a slot, a semi-circular cut
out or the like in the side of the probe guide portion that will
contact the device 1000. Upon attachment of the probe guide portion
to the body of the device, the probe guide can be completely
formed. Moreover, the side of the body of the device can also
define a portion of a probe guide, in one embodiment, and the probe
guide can be formed between the two removably attachable portions
of the device.
[0096] A probe guide portion can also be formed of multiple
removably attachable pieces, if desired.
[0097] FIG. 17 illustrates the device 1000 following attachment of
a clamp 1056 to the probe guide portion 1061. FIG. 17 illustrates
this embodiment in a side view and FIG. 18 illustrates this
embodiment in a front view. During use, a device can be held
against the skin and a probe can be passed through the probe guide.
Upon reaching the desired subdermal location, the clamp 1056 can be
activated, for instance by the user pulling formation 1063 from the
unclamped to the clamped position.
[0098] Utilizing presently disclosed devices, a probe tip can be
guided to a percutaneous target on a line that is parallel to the
plane imaged on a sonogram formed by use of an ultrasound
transducer incorporated in a device. For instance, the probe tip
can travel on a path that defines a line that is coincident in the
scanned plane, is parallel to the scanned plane, or intersects the
scanned plane at a point. When utilizing the presently disclosed
devices, the path of the probe to the target can be known, even if
it cannot be discerned on the sonogram: the probe will advance
toward the target on a straight line and at a predetermined angular
relationship to the ultrasound housing base from the probe guide
opening to the target that is imaged by the ultrasound. Thus, the
path of the probe and the scanned plane of the sonogram image can
both be defined by the orientation of the transducer and can be
coordinated on the target. In order to strike the target, the probe
can be merely guided along this known path the desired
distance.
[0099] In an ideal situation, the probe itself can be visualized on
the scanned plane. For instance, in those embodiments in which the
path of the probe is on a line within the scanned plane, the probe
can be seen in the sonogram, depending on the density of
surrounding tissue and other process parameters. However, in one
embodiment, even if the path of the probe is coincident with the
scanned plane, the probe itself may not be visible on the sonogram,
but artifacts of the passage of the probe can be visualized, e.g.,
shadows, motions of internal structures as the probe passes, and so
forth.
[0100] In one preferred embodiment, the known path of the probe can
be added to the sonogram, and the targeting procedures can be even
further simplified. For example, one embodiment includes the
addition of a targeting line on the sonogram extending from that
point on the sonogram where the probe guide opening exits the
housing (or passes the transducer) and projecting across the
ultrasonic field in a straight line at the known angle. Thus, if
this targeting line is made to intersect the target that is imaged
by the device, the operator can be confident that the probe is
accurately directed to the target. In other embodiments, other
targeting information can be displayed on the sonogram. For
example, in one embodiment, information showing the approach of the
probe to the target can be displayed.
[0101] In one particular embodiment, a motion detector can register
motion of a probe in the probe guide, and that information can be
displayed, for instance, as a real time image of the probe on a
screen or monitor. In this embodiment, the location of the probe
tip in relation to the target and the moment when the probe tip
strikes the target can be seen in real time by an operator watching
the virtual probe on the monitor during the procedure.
[0102] FIG. 8 illustrates one embodiment of the presently disclosed
subject matter during use in which an image of a virtual probe may
be overlaid on a sonogram. In this particular embodiment, the probe
device can include a detector 170 located in the post of the
sterilizable shield or in the post of the transducer housing.
Detector 170 can recognize and monitor the movement of probe 154 as
it passes through probe guide and into a subject. Information from
detector 170 and the ultrasound transducer can pass through cable
124 to monitor 174. The probe 154 can then be imaged on a monitor
174 as probe image 178. The monitor 174 can also show the internal
target, for instance a blood vessel 176.
[0103] A variety of different possible detectors as are generally
known in the art may be utilized as detector 170. For instance,
detector 170 can utilize infrared (IR), ultrasound, optical, laser,
magnetic or other motion detection mechanisms. In addition, the
location of detector 170 is not critical to the invention. In the
embodiment illustrated in FIG. 8, detector 170 is located in the
post of either the shield 130 or the ultrasound transducer housing
enclosed within the shield 130. In other embodiments, however, the
detector may be located elsewhere in the system including, for
example, on a portion of the probe itself.
[0104] Signals from detector 170 can create a data stream which can
be sent to a processor. A processing unit can be internal or
external to the hand-held device. For example, data from detector
170 can be sent to a standard lap top or desk top computer
processor or part of a self-contained ultrasound system as is known
in the art. A processor can be loaded with suitable recognition and
analysis software and can receive and analyze the stream of data
from detector 170. The processing unit can also include standard
imaging software as is generally known in the art to receive data
from the ultrasound transducer via cable 124. Probe 154 can be of a
predetermined length which can be input data entered into a
processor by the user or can be preprogrammed into the system as
default data. Thus, through analysis of the data stream received
from detector 170 and from ultrasound transducer 120, a processor
can be programmed to calculate the relative position of the probe
tip in relation to the ultrasound transducer 120, in relation to
detector 170, in relation to the exit of the probe guide, or to any
other convenient reference point. A processor can communicate this
position information digitally to monitor 174 and the information
can be displayed on the monitor such as in a numerical format or
optionally as a real time image of a virtual probe 178 shown in
conjunction with the sonogram including an image 176 of the target,
such as a blood vessel.
[0105] In such a manner, disclosed devices can be utilized to
actually show the approach of the probe toward the target on the
monitor throughout the entire procedure. In addition, in certain
embodiments, disclosed devices can be utilized to ensure the probe
tip remains at the target during subsequent procedures. For
example, in those embodiments wherein the detector 170 monitors the
motion of the probe 154, as long as probe 154 remains `visible` to
detector 170, the image 176 of probe 154 can remain on the monitor
174. Thus, any motion of the probe tip in relation to the target
can be noted by an observer.
[0106] The presently disclosed ultrasound guided probe devices and
methods may be utilized in many different medical procedures.
Exemplary applications for the devices can include, without
limitation [0107] Central Venous Catheterization [0108] Cardiac
Catheterization (Central Arterial Access) [0109] Dialysis Catheter
Placement [0110] Breast Biopsies [0111] Paracentesis [0112]
Pericardiocentesis [0113] Thoracentesis [0114] Arthrocentesis
[0115] Lumbar Puncture [0116] Epidural Catheter Placement [0117]
Peripherally Inserted Central Catheter (PICC) line placement [0118]
Thyroid Nodule Biopsies [0119] Cholecystic Drain Placement [0120]
Amniocentesis [0121] Regional Anesthesia--Nerve Block
[0122] Some of these exemplary procedures have employed the use of
ultrasound in the past, and all of these procedures, as well as
others not specifically listed, could utilize the disclosed
ultrasound guided devices to improve procedural safety as well as
patient safety and comfort, in addition to provide more economical
use of ultrasound devices. In addition, the presently disclosed
devices may be utilized with standard probe kits already available
on the market.
[0123] It will be appreciated that the foregoing examples, given
for purposes of illustration, are not to be construed as limiting
the scope of this invention. Although only a few exemplary
embodiments of this invention have been described in detail above,
those skilled in the art will readily appreciate that many
modifications are possible in the exemplary embodiments without
materially departing from the novel teachings and advantages of
this invention. Accordingly, all such modifications are intended to
be included within the scope of this invention which is defined in
the following claims and all equivalents thereto. Further, it is
recognized that many embodiments may be conceived that do not
achieve all of the advantages of some embodiments, yet the absence
of a particular advantage shall not be construed to necessarily
mean that such an embodiment is outside the scope of the present
invention.
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