Note: Descriptions are shown in the official language in which they were submitted.
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TITLE
INTEGRATED FIXATION DEVICE COMPRISING AN EMISSION AND
RECOVERY SOURCE WITH THE PURPOSE OF TARGET LOCALIZATION AND
LOCKING RELATIVE TO THE FIXATION POINT IN ORDER TO FACILITATE
INTERVENTION TO SAID TARGET
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims priority to U.S. Provisional Patent Application No.
62/206,636 filed August 18, 2015 and U.S. Provisional Patent Application No.
62/266,077 filed December 11, 2015, the contents of which are incorporated by
reference
herein in their entirety.
BACKGROUND OF THE INVENTION
Stereotactic surgical procedures generally employ navigation equipment
that utilizes optical and/or electromagnetic technologies. These technologies
rely on
previously obtained and processed images calibrated to patient landmarks. The
systems
are large, expensive, and have several parts that require a stable,
unencumbered platform
for use. In addition, practitioners have no navigational devices for use in
unstable
patients in the ICU who require precise placement of devices, such as external
ventricular
drains (EVD) to prevent ischemia or herniation. For example, EVDs are
typically placed
by neurosurgeons using anatomical landmarks to guide their passage. This
technique
relies heavily on the practitioner's skill level and may require multiple
passes through
normal, undamaged brain.
Some devices in the art employ features that attempt to improve device
targeting and placement. These devices use a pivoting housing to stably hold a
device for
insertion. However, the housings generally do not have inherent imaging
capabilities.
As a result, the devices require the use of a separate imaging device, such as
an
ultrasound probe, to be used for the selection of a desired direction of
insertion. The
ultrasound probe must then be removed before the device can be inserted, and
the
operator is unable to visualize the device insertion without using another
imaging device.
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There is a need in the art for better devices and methods for accurate
localization and intervention of targets within a patient. The present
invention meets this
need.
SUMMARY OF THE INVENTION
The present invention provides fixation devices, locking assemblies, and
methods for using the same. The fixation devices of the invention are capable
of accurate
insertion of medical devices by providing detection means of a patient's
internal anatomy
and localizing a desired target. The devices are capable of at least partially
locking into
position to maintain accuracy.
In one aspect, the invention relates to a fixation device comprising: an
elongate body having a proximal end opening, a distal end opening, and a lumen
connecting the proximal and distal end openings; at least one emission means
at a distal
end region of the elongate body; and at least one receiving means for
receiving at least
some emissions from said emission means.
In one embodiment, the elongate body lumen is sized suitably for an
instrument, tool, implant, or biological material to pass therethrough. In one
embodiment, the elongate body lumen is sized suitably for an inserted
instrument, tool,
implant, or biological material to rotate. In one embodiment, the elongate
body lumen
has a cross-section that is circular, elliptical, polygonal, or keyed. In one
embodiment,
the elongate body lumen may be centered or off-center in the elongate body.
In one embodiment, the emission means are selected from the group
consisting of: ultrasonic transducers, optical sensors, thermal sensors,
electromagnetic
sensors, photoelectric transducers, laser diodes, radio transducers, Doppler,
x-ray, particle
sensors, chemical sensors, and piezoelectric sensors. In one embodiment, the
ultrasonic
transducers are either piezoelectric ultrasonic transducers or capacitive
ultrasonic
transducers. In one embodiment, the distal end region of the elongate body is
composed
of a material which is at least partially transmissive to said emission.
In one embodiment, the device further comprises: a grommet having a
proximal end opening, a distal end opening, and a lumen connecting the
proximal and
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distal end openings; and at least one locking member; wherein the grommet
lumen is
sized such that the elongate body of the fixation device can pass through the
grommet
lumen and be at least partially locked into place by the at least one locking
member.
In one embodiment, the grommet comprises one or more materials
selected from the group consisting of: metals, ceramics, and polymers. In one
embodiment, the grommet comprises one or more materials selected from the
group
consisting of: stainless steel, cobalt, titanium, aluminum oxide, zirconia,
calcium
phosphate, silicon, polyethylene, polyvinyl chloride, polyurethane, and
polylactide.
In one embodiment, the device further comprises: a cup having a base
member and perimeter sidewalls forming an open top, wherein the base member
includes
at least one opening, and at least one locking member; wherein the cup is
sized such that
the distal end region of the elongate body of the fixation device can be at
least partially
locked into place within the cup by the at least one locking member.
In one embodiment, the cup comprises one or more materials selected
from the group consisting of: metals, ceramics, and polymers. In one
embodiment,
wherein the cup comprises one or more materials selected from the group
consisting of:
stainless steel, cobalt, titanium, aluminum oxide, zirconia, calcium
phosphate, silicon,
polyethylene, polyvinyl chloride, polyurethane, and polylactide. In one
embodiment, the
at least one locking member is selected from the group consisting of: a screw,
a bolt, a
pin, an adhesive, and a clamp. In one embodiment, the at least one locking
member is
engaged mechanically, electro-mechanically, magnetically, or adhesively.
In one embodiment, the device further comprises an anchoring patch
comprising: a flexible substrate having a first and a second surface; and a
rigid housing
positioned within the flexible substrate; wherein the housing is dimensioned
to engage
the devices of the present invention.
In one embodiment, the flexible substrate comprises a material selected
from the group consisting of plastics, polymers, metals, and gels. In one
embodiment,
the device further comprises an adhesive material on at least a portion of the
first surface
of the flexible substrate.
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In one embodiment, the device further comprises a first angled shim
housing having a space at its center and a cranial burr anchor, wherein the
first angled
shim housing is attached to the cranial burr anchor, wherein the fixation
device fits within
and is rotatable within the space of the first angled shim housing, and the
first angled
shim housing is rotatable about the cranial burr anchor.
In one embodiment, the device further comprises a second angled shim
housing, wherein the second angled shim housing is attached between the first
angled
shim housing and the cranial burr anchor, and wherein the second angled shim
housing is
rotatable about the first angled shim housing and the cranial burr anchor.
In one embodiment, the device further comprises a lever attachment
having a lumen attached to and continuous with the lumen of the fixation
device, wherein
the lumen of the lever attachment is sized to accept a medical instrument.
In one embodiment, the device further comprises a rotatable housing, a
cranial burr anchor, and a lever attachment having a lumen connected to the
proximal end
opening of the fixation device, wherein the rotatable housing is attached to
the cranial
burr anchor, wherein the fixation device is encased and rotatable within the
rotatable
housing, wherein the rotatable housing is rotatable about the cranial burr
anchor, and
wherein the lumen of the lever attachment is sized to accept a medical
instrument.
In one embodiment, the device further comprises a cranial interface
component having at least two angular rails, an anterior-posterior angle
control
component having at least two angular rails, a lateral angle control component
having a
space at its center, and a lever attachment having a lumen connected to the
proximal
opening of the fixation device, wherein the anterior-posterior angle control
component is
movable along the at least two angular rails of the cranial interface
component, wherein
the lateral angle control component is movable along the at least two angular
rails of the
anterior-posterior angle control component, wherein the fixation device fits
within and is
rotatable within the space of the lateral angle control component, and wherein
the lumen
of the lever attachment is sized to accept a medical instrument.
In one embodiment, the device further comprises a hemispherical cap
having a first track and a hemispherical cranial burr anchor having a second
track,
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wherein the first track spans the diameter of the hemispherical cap, wherein
the second
track spans the diameter of the hemispherical cranial burr anchor, wherein the
hemispherical cap is movable along the second track, wherein the fixation
device is
movable along the first track, and wherein the first track and the second
track are
perpendicular to each other.
In another aspect, the present invention relates to a method of localizing
and interacting with a target site within a patient's anatomy, comprising the
steps of:
attaching the device of the present invention to the patient's body near the
target site;
generating emissions using the attached device; receiving the emissions from
the attached
device; adjusting the orientation of the attached device to aim the attached
device at the
target site; at least partially locking the attached device; determining a
target site first
boundary having a minimum depth and a target site second boundary having a
maximum
depth; and inserting medical devices through the lumen of the attached device
to interact
with the target site such that the medical devices pass the minimum depth but
do not
exceed the maximum depth.
In another aspect, the present invention relates to a method for accurate
insertion of an external ventricular drain (EVD), comprising the steps of:
inserting the
device of the present invention into a burr hole in a patient's skull; imaging
a region
within the patient's brain using the attached device; aligning the lumen of
the attached
device with a desired site of drainage; at least partially locking the
attached device in
place; determining a desired site of drainage first boundary having a minimum
depth and
a desired site of drainage second boundary having a maximum depth; and guiding
an
EVD through the lumen of the attached device into the desired site of drainage
for
draining such that the EVD passes the minimum depth but does not exceed the
maximum
depth. In one embodiment, an ultrasonic reflective strip is attached to the
EVD.
In another aspect, the present invention relates to a method for accurate
insertion of a medical device to a target site, comprising the steps of:
affixing an
anchoring patch having a flexible substrate and a rigid housing onto a patient
at a desired
site of insertion of a medical device; engaging the device of claims 9 or 12
to the rigid
housing of the anchoring patch; aligning the lumen of the attached device with
the target
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site; at least partially locking the attached device in place; determining a
target site first
boundary having a minimum depth and a target site second boundary having a
maximum
depth; and guiding the medical device through the lumen of the attached device
to the
target site such that the medical device passes the minimum depth but does not
exceed
the maximum depth.
In one embodiment, the medical device is selected from the group
consisting of: catheters, microforceps, microscalpels, biopsy needles,
radiofrequency
ablation probes, cryoablation probes, suturing instruments, and syringes. In
one
embodiment, an ultrasonic reflective strip is attached to the medical device.
In another aspect, the present invention relates to a method of stereotactic
mapping; comprising the steps of: attaching at least two devices of the
present invention
to a patient's body; generating emissions using at least one of the attached
devices; and
receiving the emissions using at least one of the attached devices.
In another aspect, the present invention relates to a method of using a
fixation device to insert a ventricular catheter into a subject's brain,
comprising the steps
of: marking the skin at Kocher's point above a subject's skull; making an
incision at the
marked skin; perforating the skull; inserting a fixation device having
ultrasonic
transducers; aligning the ultrasonic transducers to capture a cross-sectional
ultrasound
image of the brain and the positional, angular, and rotational orientation of
the ultrasonic
transducers; actuating the ultrasonic transducers; acquiring a series of
ultrasonic images
of the brain and associated positional, angular, and rotational orientation of
the ultrasonic
transducers during actuation; assembling the ultrasonic images into a 3D
reconstruction
of the brain ventricles using the associated positional, angular, and
rotational orientation
of the ultrasonic transducers; performing an automatic segmentation of the 3D
reconstruction to isolate an anatomy of interest; acquiring the positional,
angular, and
rotational orientation of the anatomy of interest; aligning the fixation
device to target the
anatomy of interest; fixing the alignment of the fixation device relative to
the skull;
inserting a catheter and ventricular drain through the fixation device into
the anatomy of
interest; and removing the fixation device over the catheter and ventricular
drain..
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In another aspect, the present invention relates to a fixation device
comprising: an elongate body having a proximal end opening, a distal end
opening, and a
lumen connecting the proximal and distal end openings; a first angled shim
housing
having a space at its center; and a cranial burr anchor; wherein the first
angled shim
housing is attached to the cranial burr anchor, wherein the elongate body fits
within and
is rotatable within the space of the first angled shim housing, and wherein
the first angled
shim housing is rotatable about the cranial burr anchor.
In another aspect, the present invention relates to a fixation device
comprising: an elongate body having a proximal end opening, a distal end
opening, and a
lumen connecting the proximal and distal end openings; a first angled shim
housing
having a space at its center; a second angled shim housing; and a cranial burr
anchor;
wherein the first angled shim housing is attached to the second angled shim
housing,
wherein the second angled shim housing is attached to the cranial burr anchor,
wherein
the elongate body fits within and is rotatable within the space of the first
angled shim
housing, wherein the first angled shim housing is rotatable about the second
angled shim
housing, and wherein the second angled shim housing is rotatable about the
cranial burr
anchor.
In another aspect, the present invention relates to a fixation device
comprising: an elongate body having a proximal end opening, a distal end
opening, and a
lumen connecting the proximal and distal end openings; a first angled shim
housing
having a space at its center; a lever attachment having a lumen; and a cranial
burr anchor;
wherein the lever attachment is attached to the first angled shim housing,
wherein the
first angled shim housing is attached to the cranial burr anchor, wherein the
lumen of the
elongate body is attached to and continuous with the lumen of the lever
attachment,
wherein the elongate body fits within and is rotatable within the space of the
first angled
shim housing, and wherein the first angled shim housing is rotatable about the
cranial
burr anchor.
In another aspect, the present invention relates to a fixation device
comprising: an elongate body having a proximal end opening, a distal end
opening, and a
lumen connecting the proximal and distal end openings; a rotatable housing; a
cranial
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burr anchor; and a lever attachment having a lumen attached to and continuous
with the
lumen of the elongate body; wherein the rotatable housing is attached to the
cranial burr
anchor, wherein the elongate body is encased and rotatable within the
rotatable housing,
wherein the rotatable housing is rotatable about the cranial burr anchor, and
wherein the
lumen of the lever attachment is sized to accept a medical instrument.
In another aspect, the present invention relates to a fixation device
comprising: an elongate body having a proximal end opening, a distal end
opening, and a
lumen connecting the proximal and distal end openings; a cranial interface
component
having at least two angular rails; an anterior-posterior angle control
component having at
least two angular rails; a lateral angle control component having a space at
its center; and
a lever attachment having a lumen attached to and continuous with the lumen of
the
elongate body; wherein the anterior-posterior angle control component is
movable along
the at least two angular rails of the cranial interface component, wherein the
lateral angle
control component is movable along the at least two angular rails of the
anterior-posterior
angle control component, wherein the elongate body fits within and is
rotatable within the
space of the lateral angle control component, and wherein the lumen of the
lever
attachment is sized to accept a medical instrument.
In another aspect, the present invention relates to a fixation device
comprising: an elongate body having a proximal end opening, a distal end
opening, and a
lumen connecting the proximal and distal end openings; a hemispherical cap
having a
first track; and a hemispherical cranial burr anchor having a second track;
wherein the
first track spans the diameter of the hemispherical cap, wherein the second
track spans
the diameter of the hemispherical cranial burr anchor, wherein the
hemispherical cap is
movable along the second track, wherein the elongate body is movable along the
first
track, and wherein the first track and the second track are perpendicular to
each other.
In another aspect, the present invention relates to a kit comprising: the
device of the present invention; a hair clipper; a tape measure; a surgical
marking
implement; skin preparation material; a scalpel; and a drilling instrument.
In one embodiment, the kit further comprises display equipment. In one
embodiment, the kit further comprises a portable power source.
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In another aspect, the present invention relates to a kit comprising: a
devices of any of claims 34-39; a power source; a hair clipper; a tape
measure; a surgical
marking implement; skin preparation material; a scalpel; and a drilling
instrument.
In one embodiment, the kit further comprises at least one emission means
and at least one receiving means for receiving at least some emissions from
said emission
means. In one embodiment, the kit further comprises display equipment. In one
embodiment, the kit further comprises a portable power source.
BRIEF DESCRIPTION OF THE DRAWINGS
The following detailed description of preferred embodiments of the
invention will be better understood when read in conjunction with the appended
drawings. For the purpose of illustrating the invention, there are shown in
the drawings
embodiments which are presently preferred. It should be understood, however,
that the
invention is not limited to the precise arrangements, geometry, and
instrumentalities of
the embodiments shown in the drawings.
Figure 1 depicts one embodiment of an exemplary fixation device.
Figure 2A and Figure 2B depict an exemplary fixation device coupled
with a grommet locking assembly.
Figure 3 depicts an exemplary fixation device coupled with a cup locking
assembly.
Figure 4A and Figure 4B depict an exemplary single shim 3 Degrees of
Freedom (DoF) device.
Figure 5 depicts an exemplary double shim 3 DoF device.
Figure 6 depicts an exemplary single shim 4 DoF device.
Figure 7A through Figure 7C depict an exemplary levered 3 DoF device.
Figure 8A and Figure 8B depict an exemplary 5 DoF device.
Figure 9A through Figure 9D depict an exemplary compact 4 DoF device.
Figure 10A and Figure 10B depict (Figure 10A) an exemplary fixation
device coupled with a cup locking assembly and an anchoring patch and (Figure
10B) a
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schematic depicting a cross sectional view of the entire assembly adhered to a
patient's
calf.
Figure 11 is a flowchart for an exemplary method of using a fixation
device.
Figure 12A and Figure 12B depict an exemplary method of using a
fixation device for accurate depth determination.
Figure 13 depicts a top-down view of a skull with a fixation device
inserted at Kocher's point.
Figure 14A and Figure 14B depict the malplacement of a shunt in a three
dimensional model of the ventricles of a brain. Wherein the goal of a
ventriculostomy is
to deliver the shunt (solid line) to the anterior ipsilateral horn of the
ventricle by
transiting the burr location on the cranium known as Kocher's point, the
traditional free-
hand technique via a trajectory normal to the cranium surface (dashed line) is
prone to
malplacement of the shunt into the contralateral ventricle or other, less
desirous or
contrary locations.
Figure 15A through Figure 15F depict a method of stepwise rotation of an
ultrasound transducer to generate the three dimensional model of the
ventricles depicted
in Figure 14A and Figure 14B. Figure 15A: initial position; Figure 15B: 15
degree
rotation from initial; Figure 15C: 30 degree rotation from initial; Figure
15D: 45 degree
rotation from initial; Figure 15E: 60 degree rotation from initial: Figure
15F: 75 degree
rotation from initial.
Figure 16 is a flowchart for an exemplary method of using a fixation
device to insert a ventricular drain.
Figure 17 depicts an exemplary method of marking the skin by locating
the point between the pupils (nasion), drawing a line 10 cm from the nasion
along the
skull heading posterior to the occiput, and measuring 3 cm laterally.
Figure 18 depicts an exemplary method of making an incision at the skin
marked in Figure 17.
Figure 19 depicts an exemplary method of perforating the skull at the
incision made in Figure 18.
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Figure 20 depicts an exemplary skull perforation dimensioned to fit a
device of the present invention.
Figure 21 depicts the insertion of a device of the present invention into a
skull perforation.
Figure 22 depicts a device of the present invention inserted into a skull
perforation.
Figure 23 depicts an exemplary alignment of a device of the present
invention to capture a cross-sectional ultrasound image of the ventricles of
the brain.
Figure 24 depicts a device of the present invention actuated slightly from
Figure 23 to capture a second cross-sectional ultrasound image of the
ventricles of the
brain.
Figure 25 depicts a device of the present invention actuated slightly from
Figure 23 to capture a third cross-sectional ultrasound image of the
ventricles of the
brain.
Figure 26 depicts a device of the present invention actuated slightly from
Figure 23 to capture a fourth and a fifth cross-sectional ultrasound image of
the ventricles
of the brain.
Figure 27 depicts a device of the present invention actuated slightly from
Figure 23 to capture a sixth cross-sectional ultrasound image of the
ventricles of the
brain.
Figure 28 depicts an exemplary 3D reconstruction of the ventricles of the
brain using the ultrasound images captured in Figure 23 through Figure 27.
Figure 29 depicts an exemplary method of determining an ideal angle of
entry from the skull perforation performed in Figure 20 into the ventricles of
the brain.
Figure 30 depicts an exemplary method of targeting a location in the
ventricles of the brain using the exemplary 3D reconstruction of the
ventricles of the
brain in Figure 28, wherein the targeted location is indicated by the outlined
circle, the
crosshairs are aimed at the targeted location, and the ultrasound images are
supplemented
with angle, rotation, and tilt data.
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Figure 31 depicts the alignment of a device of the present invention to
match the ideal angle of entry determined in Figure 29.
Figure 32 depicts an exemplary method of accurate insertion of a medical
device through a device of the present invention, wherein the location of the
medical
device is monitored using out-of-plane ultrasound imaging.
Figure 33 depicts the result of accurately inserting an external ventricular
drain using a device of the present invention.
Figure 34 depicts the removal of a device of the present invention over an
inserted medical device, leaving the medical device behind.
DETAILED DESCRIPTION
The present invention provides fixation devices, locking assemblies, and
methods for using the same. The fixation devices of the invention are capable
of accurate
insertion of medical devices by providing detection means of a patient's
internal anatomy
to localize a desired target. The devices are capable of at least partially
locking into
position to maintain accuracy.
Definitions
It is to be understood that the figures and descriptions of the present
invention have been simplified to illustrate elements that are relevant for a
clear
understanding of the present invention, while eliminating, for the purpose of
clarity,
many other elements found in typical medical devices. Those of ordinary skill
in the art
may recognize that other elements and/or steps are desirable and/or required
in
implementing the present invention. However, because such elements and steps
are well
known in the art, and because they do not facilitate a better understanding of
the present
invention, a discussion of such elements and steps is not provided herein. The
disclosure
herein is directed to all such variations and modifications to such elements
and methods
known to those skilled in the art.
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Unless defined elsewhere, all technical and scientific terms used herein
have the same meaning as commonly understood by one of ordinary skill in the
art to
which this invention belongs. Although any methods and materials similar or
equivalent
to those described herein can be used in the practice or testing of the
present invention,
the preferred methods and materials are described.
As used herein, each of the following terms has the meaning associated
with it in this section.
The articles "a" and "an" are used herein to refer to one or to more than
one (i.e., to at least one) of the grammatical object of the article. By way
of example, "an
element" means one element or more than one element.
"About" as used herein when referring to a measurable value such as an
amount, a temporal duration, and the like, is meant to encompass variations of
20%,
10%, 5%, 1%, and 0.1% from the specified value, as such variations are
appropriate.
As used herein, "imaging" may include ultrasonic imaging, be it one
dimensional, two dimensional, three dimensional, or real-time three
dimensional imaging
(4D). Two dimensional images may be generated by one dimensional transducer
arrays
(e.g., linear arrays or arrays having a single row of elements). Three
dimensional images
may be produced by two dimensional arrays (e.g., those arrays with elements
arranged in
an n by n planar configuration) or by mechanically reciprocated, one
dimensional
transducer arrays. The term "imaging" also includes optical imaging,
tomography,
including optical coherence tomography (OCT), radiographic imaging,
photoacoustic
imaging, and thermography.
The terms "patient," "subject," "individual," and the like are used
interchangeably herein, and refer to any animal, or cells thereof whether in
vitro or in
situ, amenable to the methods described herein. In certain non-limiting
embodiments, the
patient, subject or individual is a human.
As used herein, "sonolucent" is defined as a property wherein a material is
capable of transmitting ultrasound pulses without introducing significant
interference,
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such that an acceptable acoustic response can be obtained from the body
structure(s) of
interest.
Throughout this disclosure, various aspects of the invention can be
presented in a range format. It should be understood that the description in
range format
is merely for convenience and brevity and should not be construed as an
inflexible
limitation on the scope of the invention. Accordingly, the description of a
range should
be considered to have specifically disclosed all the possible subranges as
well as
individual numerical values within that range. For example, description of a
range such
as from 1 to 6 should be considered to have specifically disclosed subranges
such as from
1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc.,
as well as
individual numbers within that range, for example, 1, 2, 2.7, 3, 4, 5, 5.3, 6,
and any whole
and partial increments there between. This applies regardless of the breadth
of the range.
Locking Fixation Device
The present invention provides fixation devices, locking assemblies, and
methods for using the same. The fixation devices of the invention are capable
of accurate
insertion of medical devices by providing detection means of a patient's
internal anatomy
and localizing a desired target. The devices are capable of at least partially
locking into
position to maintain accuracy.
Referring now to Figure 1, an exemplary fixation device 10 is depicted.
Fixation device 10 comprises elongate body 14, lumen 16, proximal end opening
2, distal
end opening 4, and a plurality of transducers 22. Elongate body 14 can have
any suitable
shape. In one embodiment, elongate body 14 is cylindrical. There are no
limitations to
the particular sizes and dimensions elongate body 14 may have. Elongate body
14 can be
made from any suitable material. For example, elongate body 14 can comprise
silicones,
plastics, polymers, metals, and the like. In one embodiment, elongate body 14
comprises
a sonolucent material throughout. In one embodiment, elongate body 14
comprises a
sonolucent material only at its distal end.
Elongate body 14 comprises lumen 16 and transducers 22. Lumen 16
extends through the entire length of elongate body 14 and connects proximal
opening 2
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and distal opening 4. Lumen 16 can have any suitable diameter. In one
embodiment,
lumen 16 has a diameter of at least 0.1 mm. In one embodiment, lumen 16 has a
diameter of 1.2 mm. In various embodiments, lumen 16 has a diameter between
0.5 mm
and 10 mm. In one embodiment, lumen 16 is dimensioned to fit a catheter.
Transducers 22 can be any suitable device capable of emitting energy,
receiving energy, or both energy emission and reception. In various
embodiments,
elongate body 14 comprises one, two, three, four, or more transducers 22.
Elongate body
14 may also comprise combinations of different transducers 22. For example,
elongate
body 14 may comprise a combination of emitting transducers and receiving
transducers,
or a combination of transducers that respond to different types of energy. Non-
limiting
examples of types of transducers suitable for use with the present invention
include:
ultrasonic transducers, optical sensors, thermal sensors, electromagnetic
sensors,
photoelectric transducers, laser diodes, radio transducers, Doppler, x-ray,
particle sensors,
chemical sensors, piezoelectric sensors, and the like.
Lumen 16 can have any suitable cross-section, such as a cross-section that
is circular, elliptical, polygonal, or keyed. Lumen 16 may be centered or off-
center in
fixation device 10. Lumen 16 of fixation device 10 is amenable to guiding any
various
types of medical devices. For example, lumen 16 may accommodate additional
probes or
instruments appropriate for any given medical procedure. Non-limiting examples
of
additional components include catheters, microforceps, microscalpels, biopsy
needles,
radiofrequency ablation probes, cryoablation probes, suturing instruments,
syringes, and
the like. In some embodiments, lumen 16 comprises a circular cross-section and
is sized
and dimensioned to permit an inserted instrument to rotate.
Referring now to Figure 2A, a top-down view of an exemplary grommet
locking assembly 11 is depicted. Grommet locking assembly 11 comprises grommet
12,
fixation device 10, fulcrum 18, and locking member 20. Referring now to Figure
2B, an
isometric view of an exemplary grommet locking assembly 11 is depicted.
Grommet 12
fits within an opening on a patient to provide access to the interior of a
patient's anatomy.
In various embodiments, the exterior surface of grommet 12 can comprise
features to enhance the fit of grommet 12 within a patient, such as ridges,
flanges,
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threads, barbs, and the like. Grommet 12 can be made from any suitable
biocompatible
material, such as stainless steel, cobalt, titanium, aluminum oxide, zirconia,
calcium
phosphate, silicon, polyethylene, polyvinyl chloride, polyurethane,
polylactide, and the
like. In one embodiment, grommet 12 comprises a sonolucent material
throughout. In
one embodiment, grommet 12 comprises a sonolucent material only at its distal
end.
Grommet 12 can have any suitable shape. Non-limiting examples of
grommet 12 shapes include cylinders, cubes, cuboids, and the like. There are
no
limitations to the particular sizes and dimensions grommet 12 may have.
Grommet 12 comprises a lumen that extends through the entire length of
grommet 12. Within the lumen, grommet 12 comprises a plurality of fulcrums 18.
For
example, in one exemplary embodiment, grommet 12 comprises at least two
fulcrums 18.
Fulcrums 18 attach to the lumen of grommet 12 and to the exterior surface of
fixation
device 10. Fulcrums 18 may be made from any suitable material. In one
embodiment,
fulcrums 18 are made from a pliable material, such as a biocompatible rubber,
polymer,
or gel. Fulcrums 18 secure fixation device 10 to grommet 12 while providing
fixation
device 10 with the ability to move independently from grommet 12. For example,
pliable
fulcrums 18 are deformable to allow fixation device 10 to be oriented within
grommet 12.
Fixation device 10 can be oriented by angling to any degree. In one
embodiment,
fixation device 10 can be oriented by angling up to 20 degrees from vertical.
In another
embodiment, fixation device 10 can be oriented by angling by up to 45 degrees
from
vertical. In one embodiment, instead of fulcrums 18, fixation device 10 is
attached to
grommet 12 by a pliable membrane.
Grommet 12 further comprises at least one locking member 20. Locking
member 20 can be any suitable locking member, including but not limited to: a
screw, a
bolt, a pin, an adhesive, and a clamp. For example, in one exemplary
embodiment, a
grommet locking assembly 11 may comprise locking members 20 that are screws
that
pass through grommet 12 to contact fixation device 10. The screws may be
screwed in or
out of grommet 12 to vary and lock the orientation of fixation device 10. In
other
embodiments, the locking member 20 may be mechanical, electro-mechanical,
magnetic,
or adhesive.
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Referring now to Figure 3, a side view cross section of an exemplary cup
locking assembly 30 is depicted. Cup locking assembly 30 comprises fixation
device 10
and cup 32. Fixation device 10 further comprises ball adapter 36. Cup 32 fits
within an
opening on a patient to provide access to the interior of a patient's anatomy.
In various embodiments, the exterior surface of cup 32 can comprise
features to enhance the fit of cup 32 within a patient, such as ridges,
flanges, threads,
barbs, and the like. Cup 32 can be made from any suitable biocompatible
material, such
as stainless steel, cobalt, titanium, aluminum oxide, zirconia, calcium
phosphate, silicon,
polyethylene, polyvinyl chloride, polyurethane, polylactide, and the like. In
one
embodiment, cup 32 comprises a sonolucent material throughout. In one
embodiment,
cup 32 comprises a sonolucent material only at its distal end.
Cup 32 comprises a base member and perimeter sidewalls forming an
open top. The base member comprises at least one opening 34. Cup 32 can have
any
suitable shape. In some embodiments, cup 32 has the shape of a conical frustum
with
wide diameter facing away from the patient and a narrow diameter facing
towards the
patient. Cup 32 can have any suitable dimensions. For example, cup 32 can have
a
height of 5 to 50 mm, and a diameter of 5 to 50 mm.
The interior of cup 32 is dimensioned to fit ball adapter 36 of fixation
device 10. Ball adapter 36 is able to rotate freely within cup 32, like a ball
joint, to
provide fixation device 10 with an orientation. Fixation device 10 can be
oriented by
angling to any degree. In one embodiment, fixation device 10 can be oriented
by angling
up to 20 degrees from vertical. In another embodiment, fixation device 10 can
be
oriented by angling up to 45 degrees from vertical.
Cup 32 further comprises locking member 20. Locking member 20 can be
any suitable locking member, including but not limited to: a screw, a bolt, a
pin, an
adhesive, and a clamp. For example, in one embodiment, locking member 20 is a
screw.
The screw may be screwed in or out of cup 32 such that when the screw contacts
ball
adapter 36, the screw arrests the movement of ball adapter 36, thereby locking
the
orientation of fixation device 10. In other embodiments, the locking member 20
may be
mechanical, electro-mechanical, magnetic, or adhesive.
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In various embodiments, the present invention relates to fixation devices
having fixed degrees of freedom for precise movement. Referring now to Figure
4A and
Figure 4B, an exemplary single shim 3 Degrees of Freedom (DoF) fixation device
110 is
depicted. Device 110 comprises anchor 112, rotating shim 114, and rotating
transducer
housing 116. Anchor 112 is secured within a burr hole, such as that of a skull
depicted in
Figure 4A and Figure 4B. Rotating shim 114 fits within anchor 112. In various
embodiments, rotating shim 114 comprises an angle, wherein the angle can be
any
suitable angle between 1 and 10 degrees. Rotating shim 114 comprises a space
at its
center for accepting rotating transducer housing 116. Transducer housing 116
comprises
at least one ultrasonic transducer and at least one aperture for accepting a
medical
instrument 38. The first DoF of device 110 is the vertical travel of medical
instrument
38. The second DoF is the rotation of transducer housing 116. The third DoF is
the
rotation of shim 114.
Referring now to Figure 5, an exemplary double shim 3 DoF fixation
device 120 is depicted. Device 120 comprises anchor 122, a first rotating shim
124, a
second rotating shim 126, and a rotating transducer housing 128. Similarly to
the
components of device 110, anchor 122 secures within a burr hole, wherein
anchor 122
holds a first rotating shim 124. The second rotating shim 126 fits on top of
the first
rotating shim 124, and the second rotating shim 126 comprises a space at its
center for
accepting rotating transducer housing 128. In various embodiments, transducer
housing
128 comprises at least one ultrasonic transducer and at least one aperture for
accepting a
medical instrument 38. The first rotating shim 124 and the second rotating
shim 126 each
comprise an angle, wherein the angle can be any suitable angle between 1 and
10
degrees. In various embodiments, the first rotating shim 124 can have the same
angle or
a different angle than the second rotating shim 126. The first DoF of device
120 is the
vertical travel of medical instrument 38. The second DoF of device 120 is the
rotation of
transducer housing 128. The third DoF of device 120 is the rotation of first
shim 124,
second shim 126, or both.
Referring now to Figure 6, an exemplary single shim 4 DoF fixation
device 130 is depicted. Device 130 comprises anchor 132, rotating shim 134,
transducer
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housing 136, and lever 138. As described elsewhere herein, anchor 132 secures
within a
burr hole. Rotating shim 134 fits within anchor 132. In various embodiments,
rotating
shim 134 comprises an angle, wherein the angle can be any suitable angle
between 1 and
degrees. Rotating shim 134 comprises a space at its center for accepting
transducer
5 housing 136. Transducer housing 136 comprises at least one ultrasonic
transducer and a
lever housing, whereupon lever 138 actuates. The lever housing may comprise
regularly
spaced markings to indicate the relative position of lever 138. In various
embodiments,
lever 138 may be angled between 5 and 15 degrees from vertical. Lever 138
comprises at
least one aperture for accepting a medical instrument 38. The first DoF of
device 130 is
10 the vertical travel of medical instrument 38. The second DoF of device
130 is the
angulation of lever 138. The third DoF of device 130 is the rotation of
transducer
housing 136. The fourth DoF of device 130 is the rotation of shim 134.
Referring now to Figure 7A through Figure 7B, an exemplary levered 3
DoF fixation device 140 is depicted. Device 140 comprises anchor 142,
rotatable
housing 144, transducer housing 146, and lever 148. As described elsewhere
herein,
anchor 142 secures within a burr hole, and articulating component 144 fits
within anchor
142. Rotatable housing 144 comprises a space at its center for accepting
transducer
housing 146. Transducer housing 146 comprises at least one ultrasonic
transducer and a
lever housing, whereupon lever 148 actuates. The lever housing may comprise
regularly
spaced markings to indicate the relative position of lever 148. In various
embodiments,
lever 148 may be angled between 5 and 15 degrees from vertical. Lever 148
comprises at
least one aperture for accepting a medical instrument 38. The first DoF of
device 140 is
the vertical travel of medical instrument 38. The second DoF of device 140 is
the
angulation of lever 148. The third DoF of device 140 is the rotation of
transducer
housing 146.
Referring now to Figure 8A and Figure 8B, an exemplary 5 DoF fixation
device 150 is depicted. Device 150 comprises cranial interface component 152,
anterior-
posterior angle control 154, lateral angle control 156, transducer housing
158, and lever
159. Cranial interface component 152 is at least partially secured into a burr
hole.
Cranial interface component 152 features a frame and at least two angular
rails for
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guiding the movement of anterior-posterior angle control 154. Anterior-
posterior angle
control 154 in turn comprises at least two angular rails for guiding the
movement of
lateral angle control 156. Lateral angle control 156 comprises a space at its
center for
accepting transducer housing 158. Transducer housing 158 comprises at least
one
ultrasonic transducer located within a conical region that fits within cranial
interface
component 152, wherein the conical region serves as a pivot point while the
orientation
of transducer housing 158 is adjusted. Transducer housing 158 comprises a
lever
housing, whereupon lever 159 actuates. The lever housing may comprise
regularly
spaced markings to indicate the relative position of lever 159. In various
embodiments,
lever 159 may be angled between 5 and 15 degrees from vertical. Lever 159
comprises at
least one aperture for accepting a medical instrument 38. The first DoF of
device 150 is
the vertical travel of medical instrument 38. The second DoF of device 150 is
the
angulation of lever 159. The third DoF of device 150 is the rotation of
transducer
housing 158. The fourth DoF of device 150 is the angulation of lateral angle
control 156.
The fifth DoF of device 150 is the angulation of anterior-posterior angle
control 154.
Referring now to Figure 9A through Figure 9D, an exemplary compact 4
DoF fixation device 160 is depicted. Device 160 comprises anchor 162,
hemispheric cap
164, and transducer housing 166. Anchor 162 is at least partially secured into
a burr hole
and comprises a hemispheric top with track 168 on its surface, track 168
spanning the
diameter of anchor 162. Hemispheric cap 164 sits on top of anchor 162 and
moves along
track 168. Hemispheric cap 164 comprises track 169 on its surface, track 169
being
perpendicular to track 168 and spanning the diameter of hemispheric cap 164.
Both
anchor 162 and hemispheric cap 164 comprise an open space at their centers to
fit
transducer housing 166. Transducer housing 166 sits on top of hemispheric cap
164 and
moves along track 169. Transducer housing 166 comprises at least one
ultrasonic
transducer and at least one aperture for accepting a medical instrument 38.
In various embodiments, the fixation devices of the present invention may
be sterilized or autoclaved. In certain embodiments, the fixation devices of
the present
devices may be partially disposable. For example, certain components enclosing
transducers 22 and any associated circuitry and electronics may be detachable
and
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cleaned between uses, while other components may be discarded and replaced
between
uses.
The fixation devices of the present invention can be combined with
additional components to facilitate their use in various applications. The
additional
components may include features that help automate the use of the fixation
devices, such
as actuators for mechanical movement and adjustment of the fixation device.
The
actuators may comprise position sensors to record positional orientations of
the fixation
device. For example, the fixation devices of the present invention may further
include
encoders, multi-degree of freedom mems devices (e.g., Bosch BN0055 9 degrees
of
freedom absolute orientation sensor), or any other suitable device for
sensing,
communicating, and recording data relating to the position, angle, and
rotation of the
transducer. In some embodiments, the position, angle, and rotation data may be
mapped
to a specific image set to correspond to the orientation of the fixation
device when the
image set was taken. The position, angle, and rotation data may be used to
generate a 3D
map from a series of image sets, to calculate volume rendering, to determine
orientation
parameters for a particular angle of entry, and the like. In certain
embodiments, the
sensing, communicating, and recording may be activated and deactivated by a
remote
switch, such that a user may choose when to begin and when to terminate the
collection
of location data. The remote switch enables a user to capture data in an
efficient manner.
The positional data may, for example, be later conveyed to the actuators such
that a
fixation device may quickly reacquire the positional orientation needed to
find a target
site, with subsequent emissions from the transducers to confirm accurate
targeting.
In one embodiment, the additional component is an anchoring patch. For
example, as depicted in Figure 10A, cup locking assembly 30 may be adhered to
anchoring patch 52 to form fixation device patch 50. Fixation device patch 50
is useful
in applications where guided accurate insertion of medical instruments is
required but the
surrounding tissue is too soft to secure a cup locking assembly 30. As shown
in Figure
10B, anchoring patch 52 provides cup locking assembly 30 with a stable
substrate to
anchor into. Cup locking assembly 30 is then able to image, for example, the
interior of
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the calf between the tibia and the fibula and accurately insert medical
instrument 38 as
depicted in Figure 10B.
Anchoring patch 52 may be made from any suitable material, including
plastics, polymers, metals, gels, and the like. In one embodiment, anchoring
patch 52
may be flexible. In another embodiment, anchoring patch 52 may be rigid.
Anchoring
patch 52 may comprise an adhesive on the surface that contacts a patient. Cup
locking
assembly 30 may be adhered to anchoring patch 52 in any suitable way, such as
by an
adhesive or by friction. In one embodiment, anchoring patch 52 may comprise a
rigid
housing having features such as screw threads, clips, latches, and the like to
connect to
cup locking assembly 30.
In some embodiments, the devices of the present invention may operate in
conjunction with a computer platform system, such as a local or remote
executable
software platform, or as a hosted internet or network program or portal. In
certain
embodiments, portions of the system may be computer operated, or in other
embodiments, the entire system may be computer operated. As contemplated
herein, any
computing device as would be understood by those skilled in the art may be
used with the
system, including desktop or mobile devices, laptops, desktops, tablets,
smartphones or
other wireless digital/cellular phones, televisions or other thin client
devices as would be
understood by those skilled in the art.
The computer platform is fully capable of sending and interpreting device
emissions signals as described herein throughout. For example, the computer
platform
can be configured to control emissions parameters such as frequency,
intensity,
amplitude, period, wavelength, pulsing, and the like, depending on the
emissions type.
The computer platform can also be configured to control the actuation of the
device, such
as angulation and partial locking. The computer platform can be configured to
record
received emissions signals, and subsequently interpret the emissions. For
example, the
computer platform may be configured to interpret the emissions as images and
subsequently transmit the images to a digital display. The computer platform
may further
perform automated calculations based on the received emissions to output data
such as
density, distance, temperature, composition, imaging, and the like, depending
on the type
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of emissions received. The computer platform may further provide a means to
communicate the received emissions and data outputs, such as by projecting one
or more
static and moving images on a screen, emitting one or more auditory signals,
presenting
one or more digital readouts, providing one or more light indicators,
providing one or
more tactile responses (such as vibrations), and the like. In some
embodiments, the
computer platform communicates received emissions signals and data outputs in
real
time, such that an operator may adjust the use of the device in response to
the real time
communication. For example, in response to a stronger received emission, the
computer
platform may output a more intense light indicator, a louder auditory signal,
or a more
vigorous tactile response to an operator, such that the operator may adjust
the device to
receive a stronger signal or the operator may partially lock the device in a
position that
registers the strongest signal. In a further example, the computer platform
may display
image overlays to represent an inserted medical device in relation to a
displayed
ultrasound image or volume rendering (3D reconstruction) on screen.
In some embodiments, the computer platform is integrated into the devices
of the present invention. For example, in some embodiments, at least one
component of
the computer platform described elsewhere herein is incorporated into a
fixation device
of the present invention, such as emissions parameter controlling means,
emissions
recording and interpretation means, communication means for the received
emissions and
data outputs, and one or more features for displaying the received emissions,
data, and
images. Fixation devices having at least one integrated computer platform
component
may be operable as a self-contained unit, such that additional computer
platform
components apart from the device itself are not necessary. Self-contained
units provide a
convenient means of using the devices of the present invention by performing a
plurality
of functions related to the devices. Self-contained units may be swappable and
disposable, improving portability and decreasing the risk of contamination.
The computer operable component(s) may reside entirely on a single
computing device, or may reside on a central server and run on any number of
end-user
devices via a communications network. The computing devices may include at
least one
processor, standard input and output devices, as well as all hardware and
software
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typically found on computing devices for storing data and running programs,
and for
sending and receiving data over a network, if needed. If a central server is
used, it may
be one server or, more preferably, a combination of scalable servers,
providing
functionality as a network mainframe server, a web server, a mail server and
central
database server, all maintained and managed by an administrator or operator of
the
system. The computing device(s) may also be connected directly or via a
network to
remote databases, such as for additional storage backup, and to allow for the
communication of files, email, software, and any other data formats between
two or more
computing devices. There are no limitations to the number, type or
connectivity of the
databases utilized by the system of the present invention. The communications
network
can be a wide area network and may be any suitable networked system understood
by
those having ordinary skill in the art, such as, for example, an open, wide
area network
(e.g., the internet), an electronic network, an optical network, a wireless
network, a
physically secure network or virtual private network, and any combinations
thereof The
communications network may also include any intermediate nodes, such as
gateways,
routers, bridges, internet service provider networks, public-switched
telephone networks,
proxy servers, firewalls, and the like, such that the communications network
may be
suitable for the transmission of information items and other data throughout
the system.
The software may also include standard reporting mechanisms, such as
generating a printable results report, or an electronic results report that
can be transmitted
to any communicatively connected computing device, such as a generated email
message
or file attachment. Likewise, particular results of the aforementioned system
can trigger
an alert signal, such as the generation of an alert email, text or phone call,
to alert a
manager, expert, researcher, or other professional of the particular results.
Further
embodiments of such mechanisms are described elsewhere herein or may standard
systems understood by those skilled in the art.
Methods of Use
The invention provides methods for using the fixation device and locking
assemblies of the present invention. The methods of using the fixation device
and
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locking assemblies provide accurate insertion of various medical devices by
providing
detection means of a patient's internal anatomy and at least partially locking
the
orientation and position of the fixation device.
In one embodiment, a single fixation device with transducers having
energy emission means and energy reception means is used to provide detection
means of
a patient's internal anatomy for the accurate insertion of medical devices.
Referring now
to Figure 11, an exemplary method 100 begins with step 110 of attaching a
single fixation
device to the patient's body near a target site within the patient's anatomy.
In step 120,
the single fixation device generates emissions, and in step 130, at least some
emissions
are received by the single fixation device to determine the location of the
target site
within the patient's anatomy. In step 140, the orientation of the single
fixation device is
adjusted such that the lumen of the fixation device is pointed at the target
site, and in step
150, the single fixation device is at least partially locked. In step 160, a
target site first
boundary having a minimum depth is determined, and a target site second
boundary
having a maximum depth is determined. Finally, in step 170, medical devices
may then
be accurately inserted through the single fixation device lumen to interact
with the target
site as needed, wherein the medical devices pass the minimum depth but do not
exceed
the maximum depth.
Referring now to Figure 12A and Figure 12B, the method step of
determining a target site first boundary and a target site second boundary is
depicted. In
Figure 12A, a plurality of emissions 60 are emitted from fixation device 30 in
the
direction of target site 62. In Figure 12B, at least a portion of the
plurality of emissions
60 are reflected back and received by fixation device 30. For example,
reflected emission
64 indicates the depth of a fat-muscle boundary interface. Reflected emission
66
indicates the depth of the target site first boundary having a minimum depth,
which is the
location of the target site that is closest to fixation device 30. Reflected
emission 68
indicates the depth of the target site second boundary having a maximum depth,
which is
the location of the target site that is furthest from fixation device 30.
Medical device 38
may then be inserted into target site 62 with accuracy by passing the minimum
depth and
not exceeding the maximum depth.
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In some embodiments, depth of insertion may be determined by measuring
the length of medical device 38 as it passes through fixation device 30.
Medical device
38 will have reached the correct depth once the measured length is between the
minimum
depth and the maximum depth. In other embodiments, depth of insertion may be
determined using a medical device having an ultrasonic reflective material.
For example,
a medical device having an ultrasonic reflective material at its distal end
can have its
distance from fixation device 30 continually monitored such that the medical
device will
have reached the correct depth once fixation device 30 detects that the
ultrasonic
reflective material is located between the minimum depth and the maximum
depth.
In one embodiment, one or more fixation devices are used to provide
detection means of a patient's internal anatomy for the accurate insertion of
medical
devices. For example, one or more fixation devices are attached to the
exterior of a
patient's body near a target site within the patient's anatomy. In one
embodiment, the
transducers of the one or more fixation devices may comprise both energy
emission
means and energy reception means. In another embodiment, at least one fixation
device
comprises transducers with emission means while the remaining fixation devices
comprise transducers with reception means. In another embodiment, at least one
fixation
device comprises transducers with reception means while the remaining fixation
devices
comprise transducers with emission means.
In one embodiment, one or more fixation devices are used to map the
internal anatomy of a patient in three dimensions. The fixation devices are
useful in
stereotactic mapping and stereotactic surgery. For example, one or more
fixation devices
are attached to the exterior of a patient's body, whereupon energy emission
and reception
determines the internal anatomy of the patient and maps it in three
dimensions. The
mapping data can be interpreted using a coordinate system, and surgery may be
performed upon precise coordinates using the devices and methods of the
present
invention.
In one embodiment, the invention provides methods for inserting an
external ventricular drain (EVD) into a patient using a fixation device and a
grommet
locking assembly. The grommet locking assembly may be inserted into a burr
hole in the
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skull, preferably at Kocher's point (Figure 13), approximately 10 cm along the
sagittal
axis as measured from the nasion and 3 cm laterally towards the right or left
ear. The
grommet locking assembly spans the thickness 24 of the skull (Figure 2B).
Ultrasound
imaging is performed using the ultrasonic transducers located in the fixation
device to
determine the brain's anatomy, including location and depth. An operator may
vary the
orientation of the fixation device such that the fixation device is aimed at
the right lateral
ventricle, preferably the frontal horn of the right lateral ventricle. The
operator may then
at least partially lock the fixation device in place by actuating the at least
one locking
member so that the grommet locking assembly maintains the aim of the fixation
device at
the frontal horn of the right lateral ventricle. An operator may then
determine a first
boundary of the right lateral ventricle closest to the fixation device having
a minimum
depth and a second boundary of the right lateral ventricle furthest from the
fixation
device having a maximum depth. The operator may then insert a drainage
catheter into
the frontal horn of the right lateral ventricle by guiding the catheter into
the lumen of the
at least partially locked fixation device such that the drainage catheter
passes the
minimum depth but does not exceed the maximum depth. In one embodiment, the
drainage catheter may be fitted with an ultrasonic reflective strip for
enhanced
visualization of the catheter.
In another embodiment, the invention provides methods for inserting an
EVD into a patient using a fixation device and a cup locking assembly. For
example, a
cup may be first inserted into a burr hole in the skull, preferably at
Kocher's point (Figure
13), approximately 10 cm along the sagittal axis as measured from the nasion
and 3 cm
laterally towards the right or left ear. The cup spans the thickness 24 of the
skull (Figure
4). The fixation device with ball adapter is then inserted into the cup, and
ultrasound
imaging is performed using the ultrasonic transducers located in the fixation
device to
determine the brain's anatomy, including location and depth. An operator may
vary the
orientation of the fixation device such that the fixation device is aimed at
the right lateral
ventricle, preferably the frontal horn of the right lateral ventricle. The
operator may then
at least partially lock the fixation device in place by actuating the at least
one locking
member so that the cup locking assembly maintains the aim of the fixation
device at the
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frontal horn of the right lateral ventricle. An operator may then determine a
first
boundary of the right lateral ventricle closest to the fixation device having
a minimum
depth and a second boundary of the right lateral ventricle furthest from the
fixation
device having a maximum depth. The operator may then insert a drainage
catheter into
the frontal horn of the right lateral ventricle by guiding the catheter into
the lumen of the
at least partially locked fixation device such that the drainage catheter
passes the
minimum depth but does not exceed the maximum depth. In one embodiment, the
drainage catheter may be fitted with an ultrasonic reflective strip for
enhanced
visualization of the catheter.
In certain embodiments, the present invention provides methods of using
the fixation devices of the present invention in conjunction with imaging
software,
wherein the imaging software acquires ultrasound images of the body to form
real-time
three dimensional display models from the reconstruction of gathered image
data sets
(Figure 14A, Figure 14B). The ultrasound transducer portion of a fixation
device is
controllably moved to image the anatomy of the body (Figure 15A through Figure
15F).
While the fixation device is moved, position, angle, and rotation data
relative to the
fixation device are collected for each image (such as via a mems sensor) to
generate a
three-dimensional model. The combination of the 3D data and the position,
angle, and
rotation data allows a physician to determine the ideal trajectory and
stopping point of an
inserted medical instrument into the body. Upon selection of target
coordinates, the
computer, attached by either wired or wireless means to the fixation device,
will calculate
the correct orientation of the individual components of the fixation device,
assuring
precise and efficient placement of the medical instrument. In some
embodiments, the
fixation device further comprises one or more motors, such that the computer
may further
automatically adjust the orientation of the fixation device to match the
selected target
coordinates.
In some embodiments, the methods of using the fixation devices in
conjunction with imaging software are suitable for placing ventricular
catheters. As
described elsewhere herein, the fixation devices incorporate at least one
ultrasound
transducer component capable of selectively moving its sonic energy wave
front. In
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some embodiments, the sonic energy wave front can be moved in a pivoting
manner such
that the axis of rotation is parallel to the face of the transmission surface.
The sonic
energy wave front is moved along, and normal to, a given plane face such as
the sagittal
or coronal planes of the brain, wherein "normal" is referred to in the
geometric sense as
perpendicular to a line tangential to the skull. The sonic energy wave front
can also be
rotated about a fixed axis that is generally oriented in an axial direction,
normal to the
ultrasound transducer transmission face; rotating in this manner causes the
sonic energy
wave front to cross the sagittal plane, the coronal plane, or both. As the
transducer is
either pivoted or spun about an axis of rotation, encoders mounted in the
fixation devices
are capable of providing real-time positional (rotational and angular
information) of the
transducer's position. The positional information of the transducer face
angle, referenced
from a starting zero position, is combined with the associated image pixel
data acquired
at that specific point of data collection in space and time. In some
embodiments, the
fixation devices also provide real-time positional data of the inserted
medical
instruments.
It should be appreciated that movement of the transducers to capture
imaging and positional data is not limited to a single rotation. For example,
the
transducers may be actuated in a single sweeping direction. The transducers
may also be
actuated in more than once rotation, or more than one sweeping direction. The
transducers may also be actuated in a combination of one or more rotations and
one or
more sweeping directions. Using a sweeping actuation, volumetric image
formation can
be obtained by sequential anterior to posterior translation of a transducer
relative to a
subject. In the context of imaging a brain, a sweep of the transducer may be
performed in
the sagittal plane to render a three dimensional image of a desired structure.
If, for
instance, an object of interest is not represented in the sagittal sweep, the
transducer can
be translated along the coronal plane and a repeated anterior to posterior
sweep of the
transducer can be made to obtain the volumetric image of the desired
structure.
Referring now to Figure 16, an exemplary method 200 of using a fixation
device of the present invention to insert a ventricular catheter is depicted.
Method 200
begins with step 202, wherein the skin is marked at Kocher's point above a
subject's
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skull. Typically, Kocher's point is located with reference to the point
between the
subject's pupils, known as the nasion. A 10 cm line is drawn from the nasion
along the
skull in a posterior direction to the occiput. At the endpoint of the 10 cm
line, a 3 cm line
is drawn laterally towards the left or right ear. The endpoint of the 3 cm
line is roughly
Kocher's point. In step 204, an incision is made at the marked skin. The
incision is
preferable large enough to accommodate a fixation device of the present
invention.
Hemostasis should be established. To provide easier access to the skull, the
skin may be
spread with a retraction device. In step 206, the skull is perforated. The
skull may be
perforated using any suitable drill bit. In some embodiments, it is
recommended not to
exceed 800 RPM when drilling. In step 208, a fixation device of the present
invention
having ultrasonic transducers is inserted into the skull perforation. In step
210, the
ultrasonic transducers are aligned to capture a cross-sectional ultrasound
image of the
brain with the positional, angular, and rotational orientation of the
ultrasonic transducers.
In step 212, the ultrasonic transducers are actuated. In step 214, a series of
ultrasonic
images of the brain and associated positional, angular, and rotational
orientation of the
ultrasonic transducers are acquired during actuation. Typically, anechoic
regions visible
in the ultrasonic images represent the brain ventricles. In step 216, the
ultrasonic images
are assembled to form a 3D reconstruction of the brain ventricles using the
associated
positional, angular, and rotational orientation of the ultrasonic transducers.
In step 218,
an automatic segmentation of the 3D reconstruction is performed to isolate an
anatomy of
interest. The 3D reconstruction and segmentation views can be displayed from
multiple
angles, such as from a sagittal, coronal, and axial plane view, as well as a
3D view. Any
suitable software can be used to generate the views, such as Osirix, ITK-Snap,
3D-Slicer,
and Mimics. In step 220, the positional, angular, and rotational orientation
of the
anatomy of interest are acquired. The location can be confirmed on the 3D
reconstruction and segmentation views. In step 222, the fixation device is
aligned to
target the anatomy of interest. In step 224, the alignment of the fixation
device is fixed
relative to the skull. In step 226, a catheter and ventricular drain are
inserted through the
fixation device into the anatomy of interest. In some embodiments, the
ultrasonic
transducers may be activated to monitor the entry of the catheter and
ventricular drain.
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For example, out-of-plane imaging using the ultrasonic transducers can verify
accurate
catheter and ventricular drain insertion. In step 228, the fixation device is
removed over
the catheter and ventricular drain.
In one embodiment, the invention provides improved methods for accurate
biopsies. For example, a fixation device patch may be adhered to the soft
tissue near the
desired sample site. Emissions from the fixation device transducers determine
the
patient's internal anatomy, including structure depth. An operator may vary
the
orientation of the fixation device such that the fixation device is aimed at
the desired
sample site. The operator may then at least partially lock the fixation device
in place by
actuating the at least one locking member so that the fixation device
maintains its aim at
the desired sample site. The operator may then accurately direct a biopsy
needle into the
sample site by guiding the biopsy needle into the lumen of the locked fixation
device. In
one embodiment, the biopsy needle may be fitted with an ultrasonic reflective
strip for
enhanced visualization of the catheter.
In various embodiments, the invention provides improved methods for
accurate insertion of any medical apparatus into the internal anatomy of a
patient. The
partial locking feature of the invention enables medical apparatuses to be
freely
interchanged while maintaining positional accuracy to a target site. Examples
of
procedures that the present invention may be applied to and improve include,
but are not
limited to: brachytherapy, tracheotomy, localized drug delivery, microsurgery,
and the
like.
Kits of the Invention
The invention also includes a kit comprising components useful within the
methods of the invention and instructional material that describes, for
instance, the
method of using the fixation devices and locking assemblies as described
elsewhere
herein. The kit may comprise components and materials useful for performing
the
methods of the invention. For instance, the kit may comprise a fixation
device, a
grommet locking assembly, a cup locking assembly, and catheters. In other
embodiments, the kit may include separately the transducer components and the
locking
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assemblies, such that the transducer components may be sterilized and
reusable, while the
locking assemblies may be sterilized and reusable or discarded and replaced.
In other
embodiments, the kit may further comprise software and electronic equipment to
convert
received waves into images. The software and electronic equipment may be
presented in
a compact form for portable use.
In certain embodiments, the kit comprises instructional material.
Instructional material may include a publication, a recording, a diagram, or
any other
medium of expression which can be used to communicate the usefulness of the
device
described herein. The instructional material of the kit of the invention may,
for example,
be affixed to a package which contains one or more instruments which may be
necessary
for the desired procedure. Alternatively, the instructional material may be
shipped
separately from the package, or may be accessible electronically via a
communications
network, such as the Internet.
In one embodiment, the invention includes a kit for portable use. To
facilitate portable use, a kit of the present invention may further include a
razor or clipper
for removing hair from a subject, a ruler or tape measure for measuring the
location of a
site for incision, a surgical marker or other implement for marking the site
of incision,
skin preparation material (i.e., antiseptic, alcohol pads) to clean the site
of incision, a
scalpel to perform the incision, a drilling instrument to perforate any bone,
and any
additional surgical and medical elements that may be useful for such an
operation, such
as surgical tape, gauze, bandages, surgical thread and needle, and the like.
The disclosures of each and every patent, patent application, and
publication cited herein are hereby incorporated herein by reference in their
entirety.
While this invention has been disclosed with reference to specific
embodiments, it is
apparent that other embodiments and variations of this invention may be
devised by
others skilled in the art without departing from the true spirit and scope of
the invention.
The appended claims are intended to be construed to include all such
embodiments and
equivalent variations.
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