Note: Descriptions are shown in the official language in which they were submitted.
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DEVICE AND METHOD FOR AUTOMATED INSERTION OF PENETRATING
MEMBER
CROSS-REFERENCE TO RELATED APPLICATIONS
The present application is a continuation-in-part of co-pending United States
Application
Serial No. 15/267,801 filed on September 16, 2016, which claims the benefit of
United States
Provisional Application Serial No. 62/220,567, filed on September 18, 2015,
now expired, the
contents of which are incorporated herein by reference in their entireties.
FTET,D OF THE INVENTION
The present invention relates generally to devices for penetrating tissues
within a body by
automated means for the delivery or removal of bodily fluids, tissues,
nutrients, medicines,
therapies, and for obtaining percutaneous access to body compartments (e.g.,
vasculature, spinal
cavity) for secondary placement of medical devices (e.g., guidewires,
catheters).
BACKGROUND
Central venous catheters (CVCs) allow access to the central circulation of
medical patients.
More than 5 million CVCs are placed each year in the United States. The CVC is
a key platform
from which to launch a multitude of critical medical interventions for acutely
ill patients, and
patients requiring major surgeries or procedures. There are over 15 million
CVC days per year
alone in Intensive Care Units (ICUs) of US hospitals, and 48% of ICU patients
have a CVC
inserted at some point during their ICU stay. A CVC is also necessary for
patients requiring urgent
hemodialysis, such as in acute kidney failure, plasma exchange for various
immune mediated
diseases, multiple forms of chemotherapy for cancer patients, parenteral
nutrition for patients
whose gastrointestinal tract cannot be used for feeding, and many other
medical interventions.
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CVC placement has, since the 1950s, been performed using the eponymous
technique
developed by the Swedish Radiologist Sven-Ivar Seldinger. Using this technique
a hollow bore
needle, also referred to as an introducer needle, is advanced through a
patient's skin and
subcutaneous tissue and finally into a central vein, located millimeters to
centimeters below the
skin surface. The "central veins" are the internal jugular, subclavian, and
femoral veins. Once the
central vein is entered, a wire is manually place through the hollow bore
needle and into the vein.
The needle is then removed, and often a plastic co-axial tissue dilator is
then run over the wire into
the vein, then removed, also over the wire. This dilates the tissue around the
wire, and allows
smooth passage of a CVC, next placed over the wire and into the vein. Once the
CVC is in place,
the wire is removed, leaving the CVC in the vein.
Since the original description of the Seldinger technique, the standard guide
for where to
place the introducer needle through the skin has been the patient's surface
anatomy. Veins are
usually located, millimeters to centimeters below the skin, in specific
relationship to certain surface
landmarks like bones or muscles. However, CVC placement failure rates and the
rates of serious
complications such as arterial puncture, laceration, and pneumothorax or
"collapsed lung" using
surface anatomy have been reported to be as high as 35%, and 21 %
respectively, in well-respected
studies. These failure rates are attributed to the fact that surface anatomy
does not reliably predict
the location of the deep central veins for every patient. In 1986,
ultrasonography (US) was used
to visualize veins below the skin surface and to use such images to more
accurately guide the
manual placement of CVCs. The use of this technique lowered the failure and
complications rate
for placement of CVCs to 5 ¨ 10%. However, the ultrasound guided CVC placement
technique
requires substantial training and experience to perform reliably. As such,
general and
cardiovascular surgeons, anesthesiologists, critical care specialists, and
interventional radiologists
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are typically required to place these catheters_ Unfortunately, these
specialists are often not
available for placement of a CVC in the urgent or emergent time frame in which
they are frequently
required.
Even well trained, experienced providers can fail at the same rates to place a
CVC due to
factors that are not possible to account for, or are beyond their control,
given the current state of
insertion technique. Two premier factors are tissue deformity and venous wall
deformation. When
the introducer needle is pushed through the skin and subcutaneous tissues, the
force can cause the
central vein target to move from its original position, causing what is
referred to as a -needle pass
miss.- When a needle comes to the venous wall, it can also push the vein into
a different position,
called "rolling," again causing needle pass miss. Needle pass misses can
result in the needle hitting
vital structures in the vicinity of the central vein such as arteries, lungs,
or nerves and can cause
serious complications. The vein wall can also be compressed by the force of
the needle, causing
the vein to collapse, making it nearly impossible to enter the vessel lumen
and usually promoting
passage of the needle through the back wall of the vessel, an event referred
to as "vein blowing."
Vein blowing usually results in bleeding into the pen-venous tissue. Not only
is bleeding a notable
complication of and by itself, but it disrupts local anatomy usually
precluding subsequent
successful CVC placement.
Therefore, there has been interest in various alternative systems of CVC
placement,
including automated systems that any clinician or medical personnel could
operate. Such a system
could allow more widely available, reliable, and faster placement of a CVC,
with lessened chance
of complications. To this point, however, most investigation has focused on
steerable needles to
solve the fundamental challenges of tissue and vessel deformity. However,
there has not been a
satisfactory automated CVC placement system developed.
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SUMNIA_RY
An automated insertion device, system and method is disclosed combining
actuated
positional guidance for targeted placement with vibration of a penetrating
member, such as a
needle, for penetrating the skin, subcutaneous tissues and venous wall that
mitigates the tissue and
vessel wall deformity problems that plague needle insertion. The device and
system includes a
series of mechanical actuators that direct the path of the penetrating member,
or needle, in
accordance with a processor that calculates and directs the positioning and
path of the needle
placement. The various actuators may be automated for action as directed by
the processor.
Although described as being used for automated insertion of a penetrating
member, such as a
needle, the same device and system may be used to insert additional medical
devices, including
guidewires and catheters, within any body cavity, vessel, or compartment.
The insertion device employs the use of a specific vibrating penetrating
member. Prior
research has demonstrated that vibrating needles during insertion leads to
reductions in both
puncture and friction forces. This phenomenon is utilized in nature by
mosquitos when they
vibrate their proboscis to penetrate the skin of their host. The increased
needle velocity from
oscillation results in decreased tissue deformation, energy absorption,
penetration force, and tissue
damage. These effects are partly due to the viscoelastic properties of the
biological tissue and can
be understood through a modified non-linear Kelvin model that captures the
force-deformation
response of soft tissue. Since internal tissue deformation for viscoelastic
bodies is dependent on
velocity, increasing the needle insertion speed results in less tissue
deformation. The reduced
tissue deformation prior to crack extension increases the rate at which energy
is released from the
crack, and ultimately reduces the force of rupture. The reduction in force and
tissue deformation
from the increased rate of needle insertion is especially significant in
tissues with high water
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content such as soft tissue In addition to reducing the forces associated with
cutting into tissue,
research has also shown that needle oscillation during insertion reduces the
frictional forces
between the needle and surrounding tissues.
Therefore, adding oscillatory motion, also referred to herein as vibration
and/or
reciprocating motion, to the needle during insertion can overcome three
challenges in advancing
the needle tip to the desired location, as compared to the use of a static
needle. First, tissue
deformation between the skin and the target vein is minimized by the
vibration. This tissue
deformation and the -pop through" that occurs as the needle tip traverses
different tissue layers
can cause the target to move relative to the planned path of the needle.
Second, the vibrating
needle mitigates the rolling of the target vein. Third, the vibrating needle
provides additional
contrast in an ultrasound image for the user to observe the advancing needle
and final placement
location. Imaging modes that are particularly sensitive to velocity changes,
such as ultrasound
with color Doppler overlay, are especially sensitive in detecting vibrated
needles.
The system also provides a way to change a target point before deploying the
penetrating
member. When the target point is changed, the processor recalculates and
updates the positional
information for the penetrating member, and provides updated adjustment data
for the various
actuators to perform, so as to align the penetrating member to the new target
point. Imaging may
be used with the insertion device, so that images of the subdermal area may be
visualized and seen
by a user. The target point may be selected and updated on the display by a
user, for interactive
control.
The insertion device may also be handheld for ease of use by a practitioner or
user.
In certain embodiments, the automated insertion device includes a vibration
assembly and
an extension assembly in electrical communication with one another and/or a
controller or
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processor. The vibration assembly includes a vibrational actuator that
generates axial vibrations
when activated and imparts or transmits these vibrations to a connected
penetrating member. The
extension assembly includes an extension actuator connected to the penetrating
member, either
directly or indirectly, which is capable of moving the penetrating member
along an insertion axis
to insert the penetrating member into target tissue to a desired preselected
target. The distance for
insertion may be calculated or determined by a controller or processor based
on imaging data from
a detector, such as an ultrasound probe, that is positioned to detect a
subcutaneous target site and
provide visualization of or three-dimensional coordinates for the target site.
The angle of insertion
for the penetrating member may also be adjusted based on the targeting
information and/or
imaging data on which the targeting information is derived
In action, the vibrational actuator vibrates the penetrating member axially
according to
operative parameters for the actuator. While vibration is occurring, the
extension actuator advances
the penetrating member along the insertion axis by the determined distance to
reach the target site.
The vibrational actuator and extension actuator operate at initial modes for
each by default. During
insertion, the load on the vibrational actuator and extension actuator are
monitored at intervals,
such as every few milliseconds. When the load and/or power consumption of the
vibrational
actuator or the extension actuator changes by a predetermined value, a control
signal may be sent
to the other actuator to change its operative parameters to compensate. For
instance, the extension
actuator may adopt a different operative mode with a faster or slower
insertion speed in response
to the load on the vibrational actuator. Similarly, a control signal may be
sent to the vibrational
actuator to change the vibration parameters, such as power, amplitude and/or
frequency of
oscillation, to adopt a different vibrational mode of higher or lower power,
amplitude or frequency
in response to the load on the extension actuator. If further deviation from
the predetermined values
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for load and/or power consumption of the vibrational and/or extension
actuators occurs, additional
signals may be sent to the extension actuator and/or to the vibrational
actuator to further adjust the
insertion speed and/or vibrations. This may be an increase or decrease in one
motor or actuator to
compensate for a decrease or increase, respectively, of the other motor or
actuator. Each
determination of whether the load and/or power consumption deviation of the
vibrational or
extension actuators has exceeded the predetermined values for each may be
based on or compared
to the load and/or power consumption levels most recently detected or to
initial starting load and/or
power consumption levels for each actuator.
Therefore, there may be a number of insertion speeds and modes of operation,
which are
adjusted automatically throughout the insertion process depending on the load
and/or power
consumption of the vibrational and/or extensional actuator. The vibrational
and extension actuators
act collectively, responsively, and automatically to adjust their operative
parameters during
insertion in response to what the other actuator is experiencing to achieve
the most effective and
efficient insertion of the penetrating member to a subcutaneous target. This
results in avoiding the
problems of tissue deformation that previously plagued practitioners.
In this manner, the insertion speed and rate of vibration are not constant
throughout the
insertion process. Rather, they may be sped up or slowed down based on input
from the other
motor. When one motor gets "bogged down" (e.g., is consuming increased power
beyond a
predefined amount as a result of excessive resistance during tissue
penetration), the other motor
adjusts to compensate. For instance, when the vibrational actuator is
vibrating with decreased
amplitude, the insertion speed of the extension actuator may be decreased.
Conversely, when the
penetrating member is vibrating without issue, the extension actuator may
operate at full insertion
speed. The vibration may also be adjusted based on the action of the extension
actuator. When the
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extension actuator begins to draw too much power, indicating it is meeting
with excessive
resistance during tissue penetration, this input is conveyed to the
vibrational actuator and triggers
a change to a more aggressive vibrational mode to assist penetrating denser
tissue. This
communication between the extension and vibrational actuators, whether it
occurs directly or
indirectly through the processor, is bidirectional.
The insertion device and method, together with their particular features and
advantages,
will become more apparent from the following detailed description and with
reference to the
appended drawings.
DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of one embodiment of the insertion device of the
present
invention.
FIG. 2 is a side view of the insertion device of Figure I and schematic
diagram of placement
for use.
FIG. 3 is a schematic diagram of the system for insertion of a penetrating
member.
FIG. 4A is a side view of the insertion device of Figure 2 showing adjustment
of the handle.
FIG. 4B is a top plan view of the insertion device of Figure 2 showing
adjustment of the
side arm for positioning.
FIG. 5A is a schematic diagram of the insertion device showing dimensions used
for
calculations by the processor.
FIG. 5B is a schematic diagram showing the target zone used for calculations
by the
processor.
FIG. 5C is an exemplary ultrasound display used in visually adjusting the
insertion device.
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FIG. 6 is side view of the insertion device of Figure 1 showing schematic
representations
of the various adjustments directed by the processor for automated insertion.
FIG. 7 shows perspective view of the insertion device of Figure 6 in partial
cut-away to
show the various actuators.
FIGS. 8A and 8B are side views showing the adjustment in the vertical
direction by a
vertical actuator.
FIG. 9 is a partial cut-away showing one embodiment of the vertical actuator
for vertical
adjustment.
FIG. 10 is a side view showing the angular adjustment by the angular actuator.
FIG. 11 is a partial cut-away showing one embodiment of the angular actuator
for angular
adjustment.
FIGS. 12A and 12B are exploded views of the portion of the insertion device
having an
angular actuator, showing a keyed relationship of the angular actuator from
opposite directions.
FIG. 13 is a side view showing the adjustment by linear extension.
FIG. 14 is a partial cut-away showing one embodiment of the extension actuator
for
extension.
FIG. 15A is a top view in partial cross-section showing the extension actuator
and
connected extension shaft in a retracted position.
FIG. 15B is a top view in partial cross-section showing the extension actuator
and
connected extension shaft of Figure 15A in an extended position.
FIG. 16A is a partial cut-away showing one embodiment of the vibrational
actuator for
vibrational motion.
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FIG. 16B is a cross-section of one embodiment of the vibrational actuator for
vibrational
motion.
FIG. 17 is a perspective view of another embodiment of the insertion device
including a
guidewire for insertion.
FIG. 18A i s a perspective view in partial cut-away of the embodiment of
Figure 17 showing
a guidewire actuator for guidewire placement.
FIG. 18B is a perspective view in partial cut-away of the embodiment of Figure
17 showing
guidewire positioning through the insertion device.
FIG. 19A shows a perspective view of one embodiment of the embodiment of
Figure 17
showing the guidewire housing attached.
FIG. 19B shows an exploded view of the embodiment of Figure 19A showing the
guidewire housing detached.
FIG. 20A is a perspective view of another embodiment of the insertion device
in which
reciprocating motion and the vibrational actuator is inline with the
penetrating member.
FIG. 20B shows a partial cross-section of the embodiment of Figure 20A showing
a
guidewire passing through the vibrational actuator.
FIG. 20C shows a close-up of the cross-section of Figure 20B.
FIG. 21A shows a perspective view of one embodiment of an inline housing
having a
sideport.
FIG. 21B shows a cross-sectional view of the embodiment of Figure 21A.
FIG. 22 shows another embodiment of the neck having a plurality of sideports.
Fig. 23 is a perspective view of another embodiment of the automatic insertion
device of
the present invention, shown in a retracted position.
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Fig_ 24 is a perspective of the insertion device of Fig. 23, shown in an
extended position.
Fig. 25 is a perspective view of the insertion device of Fig. 23, showing the
proximal end
of the device.
Fig. 26 is a schematic diagram of an embodiment of the automatic insertion
device showing
the interconnected operation of the extension assembly and vibration assembly.
Fig. 27 is an electrical flow diagram showing an embodiment of the operation
of the device.
Fig_ 28 is a schematic diagram of steps of a method of operating the automatic
insertion
device.
Like reference numerals refer to like parts throughout the several views of
the drawings.
DE TAILED DESCRIPTION
As shown in the accompanying drawings, the present invention is directed to an
insertion
device, system and method that permits subcutaneous access to body cavities,
such as blood
vessels, for needle insertion and potential placement of guidewires, dilators,
catheters such as
CVCs, and the like. The device and system includes a plurality of actuators
that may be automated
for adjusting the position and deploying a penetrating member into the tissue
of a subject, such as
the skin of a patient. A target point is preselected and used to calculate the
position and
adjustments to the penetrating member, and the series of actuators are
adjusted to control the
various components of the device to produce the proper alignment so as to
reach the preselected
target position upon deployment. The actuators may be adjusted automatically
based on
calculations made by a processor, and may further be adjusted as the target
point location is
changed. In at least one embodiment, an image-based modality is used to obtain
data on the tissue
or cavity to be targeted. The entire device is preferably handheld for ease of
use.
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The insertion device 100, such as shown in the embodiments of Figures 1 and 2,
includes
a detector 20 to obtain data and information on the tissue of a subcutaneous
area, a processor 22
to use this data to calculate various positioning and adjustment parameters
for a penetrating
member 10, such as a needle which may be an introducer needle, for insertion
to a desired
preselected target point 29 within the tissue based on the calculated
parameters. The target point
29 may be any point located subcutaneously within a patient, such as in a
blood vessel. Identifying
the target vessel is a skill typical of many trained medical professionals in
the healthcare industry.
Guiding a needle to that target is the challenge, however, given the
complications and risks to the
patient from tissue deformation and vein rolling.
In at least one embodiment, the insertion device 100 allows the user to obtain
information
about a target vessel within tissue through an imaging modality, such as by
ultrasound, and select
a target point 29 on a display 24 showing a corresponding image of the vessel.
The target point
29 can be adjusted on the display 24 by a user, such as on a touch screen, and
a processor 22
automatically calculates the resulting height, trajectory, angle and distance
the tip of a penetrating
member needs to travel from its current location to reach the targeted
location within the patient.
Using these calculations, the processor 22 provides operative data or
instructions to various
actuators 32, 42, 52 of the positioner 120 to move the tip of the penetrating
member 10 in various
directions in an automated fashion to arrive at the desired position ready for
deployment Each
actuator 32, 42, 52 may include sensors that send positional information to
the processor 20 to be
used in making the adjustment calculations. Once the desired position is
achieved, the device 100
may be actuated to deploy the penetrating member 10 to advance the calculated
distance. The
processor 22 may also instruct the penetrating member 10 to automatically stop
once it reaches the
preselected target point 29 so that it does not go past the target point 29.
The processor may also
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provide instructions to a vibrational actuator 62 to initiate and induce
vibrating, such as
reciprocating, motion to the penetrating member 10 during deployment to
overcome the tissue
deformation and vein rolling complications typically encountered in needle
insertion.
As seen in Figure 3, the insertion device 100 also includes a system 200 in
which
information or data representative of the tissue below the surface, including
cavities such as blood
vessels, is obtained by a detector 20. In some embodiments, these data are
images obtained by the
detector 20, which may be an imaging detector. The data of the tissue beneath
the surface are
transmitted to a processor 22, which calculates the distance between a
preselected target point 29
within the tissue or body cavity and the tissue surface. Computational
software, logic circuits, and
the like of the processor 22 uses this calculated distance to calculate
adjustment data for vertical
actuator 32, angular actuator 42, and extension actuator 52 and transmits this
data to the
corresponding actuator for movement of the penetrating member 10. The
processor 22 also
determines vibrational data for a vibrational actuator 62 based on the
operative parameters of the
actuator 62, and transmits this data to the vibrational actuator 62 for
activation and inducing
vibrational or reciprocating motion in the penetrating member 10 for
deployment. Transmission
of data to and activation of the various actuators 32, 42, 52, 62 may occur in
any order or in a
predetermined or defined order as set forth by the processor 22. The
penetrating member 10 may
be deployed automatically based on the extension adjustment data sent to the
extension actuator
52. In some embodiments, a user decides when the appropriate positioning for
the penetrating
member 10 has been reached to align with the projected path to intersect the
target point 29, and
he/she rnay activate a deployment command, which is transmitted to the
processor 22 and relayed
on to the extension actuator 52, which extends the penetrating member 10 by a
pre-calculated
distance to the target point 29 below the skin based on the information from
the images obtained.
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In some embodiments, the detector 20 is an imaging detector, such as an
ultrasound probe
or other transceiver. The data obtained by the detector 20 may be presented on
a display 24, which
can be viewed by a user. A representation of a pre-selected target point 29'
may be overlaid on the
image presented on the display 24, and may be moved around by a user. In at
least one
embodiment, the user may interact with the image or representations on the
display 24, such as
through an interactive touch screen or joystick, to move the representative
target point 29' around
on the display 24. As the representative target point 29' is moved on the
display 24, the processor
22 calculates updated adjustment data for the vertical actuator 32, angular
actuator 42, and
extension actuator 52 based on the new representative target point 29. This
may be performed
any number of times before a final target point is decided by a user, at which
point the user may
decide to deploy the penetrating member 10 for insertion and the corresponding
instruction is sent
to the extension actuator 52.
In use, the insertion device 100 is placed alongside or adjacent to the
tissue, such as skin,
of a patient in order to locate a target vessel, such as a vein. In at least
one embodiment, as in
Figures 1 and 2, the device 100 is handheld and includes a handle 21 which may
be gripped by a
user, such as a clinician or medical personnel. The handle 21 may be
ergonomically shaped for
increased efficiency and comfort in holding, particularly for a prolonged
period of time if
necessary. The handle 21 is preferably gripped by the non-dominant hand of a
user, such as in the
left hand of a right-handed person, to leave the dominant hand available for
selecting a target
location and deploying the device 100. Accordingly, the device 100 can be used
equally by right-
handed and left-handed individuals, and is not specific to grip direction.
Indeed, in some
embodiments the handle 21 may be rotatable about an axis, as shown in Figure
4A, to
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accommodate different grip orientations or positions or to obtain different
image views when
imaging.
In at least one embodiment, the insertion device 100 also includes a support
27 which may
be positioned in the elbow, shoulder, arm or chest of the user. The support 27
provides additional
stability for a user when positioning and using the device 100. As depicted in
Figure 4B, the
support 27 may be spaced apart from the handle 21, such as by a side arm 26
that corresponds to
a user's arm, and may be adjustable in length to accommodate a user's reach.
The side arm 26
may be movable in an arcuate path, as indicated by the directional arrow in
Figure 4B, to adjust
the angle of the side arm and permit a user positioned next to a patient to
comfortably use the
insertion device 100 while properly aligning it as desired to target a vessel.
The range of motion
for the side arm 26 may be up to 360 , and therefore may permit any desired
angle of approach.
For example, a user may sit or stand adjacent to the patient and perpendicular
to the desired target
blood vessel, and yet the insertion device 100 may still be used to position
the penetrating member
10 in alignment with the target blood vessel. The full range of motion of the
side arm 26 may also
permit switching from right-handed to left-handed use.
The insertion device 100 includes a detector 20 which is placed near, adjacent
to, or even
touching the area of the patient to be imaged, such as depicted in Figure 2.
In at least one
embodiment, the detector 20 is located at a terminal end of the handle 21,
such that the detector 20
may be positioned along the skin or other tissue 5 of a patient by moving the
handle 21 over the
patient. The detector 20 obtains information or data about the surrounding
area, such as the
subdermal area, and may including locational information of the tissue 5,
cavities 7 and other
structures therein. In at least one embodiment, the detector 20 is of an
imaging modality to
visualize a subcutaneous or percutaneous area of a patient, also referred to
as a target zone 28 as
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shown in Figure 5B, for targeting a particular blood vessel or body cavity 7.
The target zone 28
imaged may be any shape, volume, or depth D as the particular imaging modality
is capable of
producing. The imaging modality may be any suitable form of imaging the
subdermal area of a
patient, such as but not limited to ultrasound, computerized tomography, and
magnetic resonance
imaging. In a preferred embodiment, as shown in Figure 5C, ultrasound is
useful for its ability to
provide images that clearly distinguish between tissue 5 and body cavity 7,
such as the interior of
a blood vessel, below the surface of the skin_ As used herein, "tissue" may
refer to any tissue or
organ of the body, and refers specifically to substantive material having
mass. For instance, tissue
may refer equally to skin, muscle, tendon, fat, bone, and organ walls. In
contrast, "body cavity-
as used herein may refer to the cavity, open interior, lumen or volume of
space within a tissue or
organ, such as blood vessels, veins, arteries, and the like.
Therefore, in at least one embodiment, the detector 20 is an ultrasound
transducer that emits
and receives ultrasound waves through the skin and tissue of a patient for
visualization. Typical
B-mode ultrasound imaging may be used in the detector 20, though Doppler
ultrasound could also
be used to distinguish blood flows of different directions. Linear or
curvilinear ultrasound
transducers are preferable, though sector phased arrays may be used in some
embodiments. The
ultrasound detector 20 may operate in the frequency range of 3-15 MHz, but
more preferably in
the range of 6-10 MHz to provide a good contrast between resolution and depth
of penetration of
the ultrasound, since depth of penetration is inversely related to frequency.
Highly accurate
measurement of the pixel size is important as it relates to distance, or phase
velocity of sound in
tissue, for accurate placement of the penetrating member 10. The ultrasound
detector 20 may be
operated in a long-axis image plane view, where vessels are viewed
longitudinally, or a short-axis
view, where the vessels are viewed in cross-section and appear as circular
structures in resulting
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images, as in Figure SC. Imaging in the short-axis view is preferable in at
least one embodiment
to better visualize the body cavities 7, which appear as black spaces against
the tissue 5, shown in
white. The short-axis view permits the depth of the blood vessel to be seen
for determining optimal
placement of a target point 29 so as not to blow the vein or vessel. In either
view scheme, the
image plane produced by the detector 20 is at a known angle relative to the
various actuators,
discussed below, for proper positioning accuracy and co-registration of the
ultrasound image and
penetrating member 10 spatial coordinates.
The insertion device 100 further includes a processor 22 in electronic
communication with
the detector 20, and receives the data obtained by the detector 20 regarding
the location of tissue
5 and cavities 7 therein. In some embodiments, these data are arranged as
images of the subdermal
area obtained by the detector 20, and are transmitted to the processor 22 and
to a display 24, such
as a screen that presents the images for visualization by a user, as depicted
in Figures 1 and 2.
Figure 5C shows an example of an ultrasound image obtained by the detector 20
as presented on
the display 24. The display 24 also shows a pictorial representation of the
target point 29', such
as with crosshairs, a target sign, or other symbol in conjunction with the
images from the detector
20. The representative target point 29' image on the display 24 may be moved
around, such as up
and down on the display 24, by a user. As the representative target point 29'
is moved, the
positioning of the penetrating member 10 is adjusted, as described below,
which may occur
automatically and in real time. The display 24 may show additional
information, including but not
limited to parameters of the detector 20 (such as the frequency used), screen
resolution,
magnification, measurements or position information from the various
components of the
positioncr 120 (discussed in greater detail below), and buttons or areas to
activate various
components of the insertion device 100.
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The display 24 may be a passive or interactive screen_ In at least one
embodiment, the
display 24 is a touch screen that may operate through a resistive mechanism,
capacitive
mechanism, or other haptic feedback mechanism. For instance, the
representative target point 29'
on the display 24 may be movable by touch on the touch screen, such as by
sliding a finger, thumb
or selection device along the display 24 in a continuous path, or by touching
the display 24 screen
in discrete locations to select new positions for the representative target
point 29'. In some
embodiments, the display 24 and processor 22 may be included in a single
device, such as a smart
phone, personal digital assistant (PDA) or tablet computer that may be
removably connected to
the insertion device 100 through a wireless protocol such as Bluetooth or
through a wired, multi-
pin connector. In other embodiments, the display 24 and processor 22 are
included in a single
device, which may be integrated with the rest of the insertion device 100. In
further embodiments,
the processor 22 is an integrated component of the insertion device 100, and
may be located within
a housing 23 as in Figure 1, and the display 24 may be separately removable
from the remainder
of the insertion device 100.
In other embodiments, the display 24 is a passive screen, such as a monitor,
and the device
100 may include a joystick or directional button(s) (not shown) to enable the
user to guide the
imaging assembly 110 and target the vein. The joystick or directional
button(s) may output a
direction signal to the processor 22 based on the orientation and inclination
of the joystick lever,
or the particular directional button(s) pressed or selected. The output signal
from the joystick or
directional button(s) controls the position of a representative target point
29', such as a crosshair,
shown on the display 24 such that the target point 29 image overlays the
target location. In some
embodiments, the joystick or directional button(s) may be located at or near
the display 24, such
as along the edges of the frame of the monitor. In other embodiments, the
joystick or directional
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button(s) may be placed on the handle 21 to enable one-handed operation of the
device 100 for
imaging.
The processor 22 is in electrical communication with, receives information
from, the
display 24 on the location and change of location of the desired target point
29 as indicated by a
user from interacting with the representative target point 29' on the display
24, such as by touch
screen interaction. The processor 22 includes program(s), software, logic
circuits, or other
computational abilities to calculate how to adjust the penetrating member 10
from its existing
position to a position that will bring it to the target point 29 as indicated
by the user-indicated
information provided from the display 24 interaction.
For example, Figure 5A shows a schematic representation of the insertion
device 100
depicting various dimensions used in the calculations by the processor 22.
Some of these
dimensions are fixed dimensions of the device 100. For instance, H is the
height of the handle 21
from the detector 20 to a center of the primary arm 25. The distance A is the
length of the primary
arm 25 from the center of the handle 21 to the center of the positioner 120,
such as the vertical
actuator 32. In some embodiments, A is a fixed length, such as when the
primary arm 25 is of a
fixed length. The size of the mounting for the penetrating member 10, and the
length of the
penetrating tip 10, such as a needle, collectively referenced as G, is also
known and fixed. The
distance between the mounting for the penetrating member 10 and the angular
adjustment 30, F,
also remains fixed.
Other dimensions of the calculations will vary. For example, D is the distance
between the
detector 20, located at the surface of the tissue 5 or skin, to the target
point 29 within the body
cavity 7, such as the interior of a blood vessel beneath the skin. D will
therefore vary by patient,
as well as which blood vessel is used as the target, how much tissue lies
between the target blood
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vessel and the skin or surface on which the detector 20 is placed, and even
the position of the target
blood vessel and how full or compressed the blood vessel is. In at least one
embodiment, the height
L of the positioner 120 may be varied. In some embodiments, the height L of
Figure 5A may be
pre-set before use such that it is fixed when the insertion device 100 is in
use. Using this
information, the microprocessor may determine the angle of inclination, 0D,
and the distance from
the tip of the penetrating member 10 to the target point 29, P, using the
Pythagorean Theorem and
trigonometry. For instance, once way the calculations may be performed are as
follows:
A + F = sinOD
P= _________________________________________________
cosOD
(H + D ¨ L) = cosOD ¨ A = sin0D = F
Alternatively, the angle On could be pre-set by a user, and the height L and
distance P would be
calculated using similar mathematical relationships.
Looking at it another way, and still with reference to Figure 5A, the depth D
forms one
side of a triangle, distance X is the distance between the center of the
detector 20 to the tip of the
penetrating member 10 and forms a right angle with D and another leg of the
triangle. The distance
1.5
for insertion of the penetrating member 10 is P. which is the hypotenuse of
the triangle, and is
calculated by solving for P in the following equation:
D2 x2 = p2
The angle of insertion OD is therefore calculated as:
X
coseD ¨
P
Accordingly, there are many ways to perform the calculations based on the
known constant
dimensions and the variables. The above provide just a few examples. In other
embodiments,
height L may be adjustable and automated during the use of the insertion
device 100, such as when
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a shallow angle, or acute OD, is needed_ This may be the case if the target
blood vessel is itself very
shallow or partially collapsed, or if it is located superficially below the
surface of the skin. In such
illustrative embodiments, to achieve an appropriate angle, the height L may be
increased to
position the penetrating member 10 to reach the target point 29. The amount of
height L increase
or decrease is calculated in real-time by the processor of the processor 22 as
the angle OD is also
calculated for adjustment based on the information input at the display 24 by
the user. For instance,
as the user slides a finger up along the display 24, the target point 29
indicator also moves up and
the angle OD is made shallower or more acute. Conversely, as the user slides a
finger down along
the display 24, the target point 29 indicator also moves down and the angle OD
increases or becomes
deeper. Sliding a finger along a touchscreen display 24 is just one
embodiment. In other
embodiments, knobs or dials can be used to move the representative target
point 29' up or down
on the screen, which would correspond to adjustments in the angle OD as
determined by the
processor 22.
The processor 22 is also in electrical communication with a positioner 120
that is spaced
apart from the imaging assembly 110 of the insertion device 100, such as by a
primary arm 25.
The primary arm 25 may be of any suitable length sufficient to space the
penetrating member 10
from the detector 20 so that the penetrating member 10 can approach, and
reach, the desired target
point 29. The primary arm 25 may be adjustable, such as manually or automated
such as with an
actuator, but in at least one embodiment it is stationary and of a fixed
length.
With reference to Figures 1, 2 and 6, the positioner 120 includes a vertical
adjustment 30
that adjusts the penetrating member 10 in a vertical direction 31, an angular
adjustment 40 that
adjusts the angle of inclination of the penetrating member 10 along an angular
direction 41; and
an extension adjustment 50 that moves the penetrating member in a linear
direction 51 toward or
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away from the target point 29 for insertion and removal. A vibrator 60 that
provides reciprocating
motion in a longitudinal direction 61 along the penetrating member 10 is also
present in the
insertion device 100, but need not be a component of the positioner 120. As
seen in Figure 7, each
of the adjustment parameters is affected by actuators 32, 42, 52, 62 that
receive signals from the
processor 22 providing instruction on movement parameters and may
automatically move
according to those instructions to adjust the positioning of the penetrating
member 10.
For instance, with reference to Figures 7 ¨ 9, the vertical adjustment 30
provides a
mechanism for raising or lowering the mounted penetrating member 10.
Specifically, the vertical
adjustment 30 includes a vertical actuator 32 which is in electrical
communication with the
processor 22 to receive vertical adjustment data for activation and movement.
Upon receiving the
signal or data from the processor 22, the vertical actuator 32 activates and
moves according to the
vertical adjustment data calculated by the processor 22 so as to adjust the
penetrating member 10
in a vertical direction 31 with respect to the surface of the skin or other
tissue being imaged for
insertion. The vertical actuator 32 may be a motor that turns or acts on a
shaft. For example, in at
least one embodiment, as depicted in Figure 9, the vertical actuator 32 is a
rotational motor that
turns a pin 35 which extends from the vertical actuator 32. The pin 35 engages
a track 34, such as
in an interlocking fashion between corresponding teeth or grooves on the pin
35 and track 34, such
as in a rack and pinion system_ As the pin 35 rotates in one direction, its
extensions interdigitate
with those of the track 34, and move the track 34 up or down in the vertical
direction 31. When
the vertical actuator 32 turns the pin 35 in the opposite direction, the track
34 is correspondingly
moved in the opposite vertical direction. Accordingly, the vertical actuator
32 may be positioned
perpendicular to the track 34. The track 34 may be located within a vertical
housing 33. In other
embodiments, the track 34 may be a slide bar, and the vertical actuator 32 may
move a pin 35
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between different locking positions along the slide bar to move the slide bar
in the vertical
direction. In still other embodiments, the vertical actuator 32 may be a
linear motor disposed along
the vertical direction 31, such that upon activation it causes a pin 35 or
other elongate shaft to
extend, thereby causing movement of the housing 33 in the vertical direction
31. As discussed
above, in some embodiments, the vertical actuator 32 may be automated by the
processor 22 and
move in real-time as adjustments are made to the target point 29 at the
display 24. In some
embodiments, however, the vertical actuator 32 may not be activated, such as
if adjustment in the
vertical direction 31 is not needed or if the vertical height component is
intended to be fixed.
The positioner 120 also includes an angular adjustment 40, as depicted in
Figures 7 and 10
¨ 12B. The angular adjustment 40 includes an angular actuator 42 in electrical
communication
with the processor 22. The angular actuator 42 receives signals, such as
angular adjustment data,
from the processor 22 providing instructions on activation for changing the
angle of inclination of
the penetrating member 10. The angle of inclination may be any angle between
0' and 1800 with
respect to the surface of the tissue. In at least one embodiment, the angle of
inclination is an acute
angle between 00 and 90 . The angle of inclination is adjusted in the angular
direction 41 as seen
in Figure 10, according to the calculations performed by the processor 22.
Accordingly, the angle
for penetration can be made shallower or steeper as determined by a user. In
imaging
embodiments, when the user moves the representative target point 29' up or
down on the display
24, the corresponding signal is relayed from the processor 22, and the
processor 22 updates the
calculations to determine an updated or new angular adjustment data based on
the new position of
the representative target point 29'. This updated data is sent to the angular
actuator 42, which
activates to adjust the angle of the penetrating member 10 accordingly, which
may be in real-time.
This activation is automated by the processor 22. The angular actuator 42 may
be a motor suitable
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for changing the angle of inclination_ In a preferred embodiment, the angular
actuator 42 is a
rotational motor that rotates upon activation. In such embodiments, a shaft 43
extends from the
angular actuator 42 into a receiver 45 or other structure not fixed and
independently movable from
the angular actuator. The shaft 43 and corresponding receiver 45 may be
correspondingly shaped,
such as being matingly fit or in a complimenting keyed arrangement, so that
rotation of the shaft
43 imparted from the angular actuator 42 correspondingly turns the mating
receiver 45.
For example, in the embodiment of Figures 11, 12A and 12B, the shaft 43 has a
keyed
configuration such that it has an irregular shape, such as having a flat
surface along one side of an
otherwise cylindrical shape. The receiver 45 into which the shaft 43 extends
is similarly keyed,
having a flat surface along at least a portion of its perimeter_ Accordingly,
when the shaft 43 is
rotated by the angular actuator 42, the specific shape engages the
corresponding shape of the
receiver 45 and transfers the rotational motion on to the receiver 45, thereby
turning the receiver
45 as well. Since the receiver 45 is integral with a separate component of the
positioner 120 from
the angular actuator 42, the rotational motion conveyed to the receiver 45
through the
correspondingly shaped interaction with the shaft 43 also turns the remaining
portion of the
positioner 120, as shown in Figure 10. The angular actuator 42 may be
surrounded by angular
motor housing 44, which may include an aperture through which the shaft 43
extends, as seen in
Figures 11 and 12A_
The positioner 120 further includes an extender 50, shown in Figures 7 and 13
¨ 15B. The
extender 50 includes an extension actuator 52 in electrical communication with
the processor 22
to receive extension adjustment data and instructions on activation and
distance to move. When
data are received, the extension actuator 52 activates to move the penetrating
member 10 in a linear
direction 51, as seen in Figure 13, by a predetermined distance as calculated
by the processor 22.
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In at least one embodiment, as shown in Figures 13 ¨ 15B, the extension
actuator 52 is a linear
motor, although other forms of motors may be used for achieving movement of
the penetrating
member along the linear direction 51.
The extender 50 also includes an extension shaft 53 that extends out from the
extension
actuator 52 to an oppositely disposed extension mount 54 located on a separate
component of the
positioner 120. The extension shaft 53 may be secured to or integrally formed
with the extension
actuator 52, the extension mount 54, or both. The extension shaft 53 may
retract into or be housed
within the extension actuator 52 or share a common housing, and may be pushed
out of the housing
by the extension actuator. In some embodiments, as shown in Figure 13, the
extension shaft 53
may be a telescoping shaft In other embodiments, as in -Figures 15A and 15B,
the extension shaft
53 may be a uniform bar or elongate member that is moved into and out of the
extension actuator
52 upon activation. The distance the extension shaft 53 is pushed out of the
extension actuator 52
is directed and calculated by the processor of the processor 22, based on the
positioning
information for the target point 29 input by the user on the display 24. The
extension shaft 53 is
made of a rigid material, such that as the extension shaft 53 is moved, the
extension mount 54 in
which it terminates is correspondingly moved. In this manner, the penetrating
member 10 is
moved the calculated distance in the linear direction 51 by the extension
actuator 52, as shown in
Figure 13.
In some embodiments, the extension actuator 52 is used to move the penetrating
member
10 a calculated distance to align it or otherwise position it for use, such as
by moving it so the tip
of the penetrating member 10 touches the skin or tissue 5 of the patient. In
other embodiments,
the extension actuator 52 is used to deploy the penetrating member 10 such
that the tip of the
penetrating member 10 moves from a ready position to the location of the
target point 29. In at
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least one embodiment, the extension actuator 53 is used to both align and
deploy the penetrating
member 10 in a linear direction toward the target point 29. Both alignment and
deployment of the
penetrating member 10 may be automated. In at least one embodiment, deployment
of the
penetrating member 10 occurs as a result of activation of a button or
particular area of the display
24, such as a soft button or virtual button on a touch screen, or button on a
joystick or other part
of the insertion device 100, which may be activated separately from the
alignment and positioning
of the penetrating member 10 in the other various dimensions by the user's
placement of the
detector 20 and the action of the vertical and angular actuators 32, 42.
The insertion device 100 also includes a vibrator 60, for example as shown in
Figures 7,
16A and 16B. The vibrator 60 includes a vibrational actuator 62 in electrical
communication with
the processor 22 and receives vibrational data from the processor 20
instructing when to activate
and the operational parameters to use, which are determined by the processor
20 and may be based
on a variety of factors, including but not limited to the type of vibrational
actuator 62 used, and
the type and condition of the tissue 5 being penetrated. When activated, the
vibrational actuator
62 provides repetitive, reciprocating or oscillating motion to the penetrating
member 10 back and
forth along a longitudinal direction 61. The longitudinal direction 61 is
coincident with the axis
of the penetrating member 10. As used herein, the terms "reciprocating,"
"oscillating," and
"vibrating" may be used interchangeably, and refer to a back and forth motion
in a longitudinal
direction 61 coincident with or parallel to the length of the penetrating
member 10.
Upon receiving the activation signal from the processor 22, the vibrational
actuator 62 turns
on. Activation may occur automatically, or only at a certain point in the
insertion process, such as
once the penetrating member 10 is properly positioned and aligned but prior to
being deployed for
insertion. Activation of the vibrational actuator 62 may therefore occur only
once the proper
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positioning of the penetrating member 10 is confirmed by a user in some
embodiments, or may
automatically begin once the target point 29 is aligned.
The vibrator 60 includes a drive shaft 68 that extends from the vibrational
actuator 62 to a
coupler or housing connected to the penetrating member 10. The drive shaft 68
transfers the
mechanical vibrational motion generated by the vibrational actuator 62 to the
penetrating member
10. The vibrator 60, and therefore the vibrational actuator 62, may be axially
offset from the
penetrating member 10 in some embodiments, as in Figures 16A and 16B, or may
be inline or
coaxial with the penetrating member 10, as in Figures 20A and 20B.
In at least one embodiment, as shown in Figures 16A and 16B, the vibrational
actuator 62
is axially offset from the penetrating member 10. Here, the vibrating assembly
60 includes a drive
shaft 68 that extends from the vibrational actuator 62 to a driving coupler
69. In some
embodiments, the drive shaft 68 extends at least partially into the driving
coupler 69. The driving
coupler 69 coordinates with, such as by connecting to, an offset coupler 70.
For instance, at least
a portion of the driving coupler 69 may extend into the offset coupler 70, or
vice versa. The offset
coupler 70 includes a hub 71 at which a proximal end of the penetrating member
10 connects, such
as by a screw, twist, threaded, or keyed connection, or other suitable
connection. The driving
coupler 69 and offset coupler 70 run perpendicular to the drive shaft 68 and
the penetrating member
10. Therefore, the driving coupler 69 and offset coupler 70 collectively
transfer the vibratory
motion generated by the vibrational actuator 62 and propagated by the drive
shaft 68 to the
penetrating member 10 along a different, parallel axis.
In at least one other embodiment, as in Figures 20A and 20B, the vibrator 60'
and
vibrational actuator 62' of the insertion device 100' is coaxial, or inlinc,
with the penetrating
member 10. In such embodiments, the drive shaft 68' extends from the
vibrational actuator 62' to
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a portion of the housing 73. The housing 73 may include the vibrational
actuator 62' as well, and
connects to a hub 71 a distal end where the penetrating member 10 connects. In
some
embodiments, the housing 73 may further include a neck 74 that extends between
the housing 73
and the hub 71, such as if additional space is needed.
Regardless of whether the vibrator 60, 60' is offset or inline with the
penetrating member
10, vibration of the penetrating member 10 by the vibrational actuator 62 may
be accomplished in
a variety of ways, which may be selected based on the type of tissue being
penetrated. The
particular actuation mechanism useful to overcome the tissue deformation and
insertion force
depends on the resonance frequency and other electromechanical properties of
the system to
beneficially interact with the resonance and other mechanical properties of
the tissue, vessels or
other structures encountered by the advancing tip of the penetrating member
10.
For instance, in at least one embodiment, the vibrational actuator 62 is a
piezoelectric
motor. Transducer technologies that rely on conventional, single or stacked
piezoelectric ceramic
assemblies for actuation can be hindered by the maximum strain limit of the
piezoelectric materials
themselves. Because the maximum strain limit of conventional piezoelectric
ceramics is about
0.1% for poly crystalline piezoelectric materials, such as ceramic lead
zirconate titanate (PZT) and
0.5% for single crystal piezoelectric materials, it would require a large
stack of cells to approach
displacement or actuation of several millimeters or even many tens of microns_
Using a large stack
of cells to actuate components would also require that the medical tool size
be increased beyond
usable biometric design for handheld instruments.
Flextensional transducer assembly designs have been developed which provide
amplification in piezoelectric material stack strain displacement. The
flextensional designs com-
prise a piezoelectric material transducer driving cell disposed within a
frame, platen, endcaps or
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housing. The geometry of the frame, platen, endcaps or housing provides
amplification of the axial
or longitudinal motions of the driver cell to obtain a larger displacement of
the flextensional
assembly in a particular direction. Essentially, the flextensional transducer
assembly more
efficiently converts strain in one direction into movement (or force) in a
second direction.
Therefore, as shown in Figure 16B, the vibrational actuator 62 is a
flextensional transducer
which includes a plurality of piezoelectric elements 63 stacked together with
electrodes 65 placed
between adjacent piezoelectric elements 63. The plurality of piezoelectric
elements 63 and
electrodes 65 stacked together form a piezoelectric stack 64. An insulator 66
caps the end of the
stack 64 to shield the remainder of the device from the energy produced by the
piezoelectric
elements 63. A rear mass 67 located on the opposite side of the insulator 66
applies tension to the
piezoelectric stack 64 and keeps the stack 64 compressed together for
increased efficiency. At
least the piezoelectric stack 64, and preferably the insulator 66 and rear
mass 67 as well, are
cylindrical and formed with a hollow bore running through the center. The
drive shaft 68 extends
through this hollow bore through the vibrational actuator 62. When the
electrodes 65 are
electrically stimulated, such as when the vibrational actuator 62 receives a
signal from the
processor 22 to activate, the electrical energy channeled through the
electrodes 65 is converted
into mechanical vibrational energy by the piezoelectric elements 63, which in
turn is transferred
to the drive shaft 68 to move the drive shaft 68 in a repetitive, oscillatory
motion in the linear
direction 61.
A variety of flextensional transducers are contemplated for use as the
vibrational actuator
62, 62'. For example, in one embodiment, flextensional transducers are of the
cymbal type, as
described in U.S. Pat. No. 5,729,077 (Newnham), which is incorporated herein
by reference. In
another embodiment, flextensional transducers are of the amplified
piezoelectric actuator ("APA")
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type as described in U.S. Pat. No. 6,465,936 (Knowles), which is also
incorporated herein by
reference. In yet another embodiment, the transducer is a Langevin or bolted
dumbbell-type
transducer, similar to, but not limited to that which is disclosed in United
States Patent Application
Publication No. 2007/0063618 Al (Bromfield), which is also incorporated herein
by reference.
Figure 16B shows one particular example implementing a Langevin transducer as
the vibrational
actuator 62.
In one embodiment, the flextensional transducer assembly may utilize
flextensional
cymbal transducer technology or in another example, amplified piezoelectric
actuator (APA)
transducer technology. The flextensional transducer assembly provides for
improved amplification
and improved performance, which are above that of a conventional handheld
device. For example,
the amplification may be improved by up to about 50-fold. Additionally, the
flextensional
transducer assembly enables housing configurations to have a more simplified
design and a smaller
format. When electrically activated by an external electrical signal source,
the vibrational actuator
62, 62' converts the electrical signal into mechanical energy that results in
vibratory motion of the
penetrating member 10. The oscillations produced by the vibrational actuator
62, 62' are in short
increments (such as displacements of up to 1 millimeter) and at such a
frequency (such as
approximately 125-175 Hz) as to reduce the force necessary for puncturing and
sliding through
tissue, thereby improving insertion control with less tissue deformation and
trauma, ultimately
producing a higher vessel penetration/access success rate.
The vibratory motion produced by the vibrational actuator 62, 62' creates
waves, which
may be sinusoidal waves, square waves, standing waves, saw-tooth waves, or
other types of waves
in various embodiments. In the case of a Langevin actuator, as in Figure 16B,
the vibratory motion
produced by the piezoelectric elements 63 generates a standing wave through
the whole assembly.
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Because at a given frequency, a standing wave is comprised of locations of
zero-displacement
(node, or zero node) and maximum displacement (anti-node) in a continuous
manner, the
displacement that results at any point along the vibrational actuator 62
depends on the location
where the displacement is to be measured. Therefore, the horn of a Langevin
transducer is typically
designed with such a length so as to provide the distal end of the horn at an
anti-node when the
device is operated. In this way, the distal end of the horn experiences a
large vibratory displacement
in a longitudinal direction 61 with respect to the long axis of the
vibrational actuator 62.
Conversely, the zero node points are locations best suited for adding port
openings or slots so as
to make it possible to attach external devices.
In other embodiments, the vibrational actuator 62, 62' may be a voice coil for
the driving
actuator rather than piezoelectric elements. Voice coil actuator (also
referred to as a "voice coil
motor") creates low frequency reciprocating motion. The voice coil has a
bandwidth of
approximately 10-60 Hz and a displacement of up to 10 mm that is dependent
upon applied AC
voltage. In particular, when an alternating electric current is applied
through a conducting coil,
the result is a Lorentz Force in a direction defined by a function of the
cross-product between the
direction of current through the conductive coil and magnetic field vectors of
the magnetic
member. The force results in a reciprocating motion of the magnetic member
relative to the coil
support tube which is held in place by the body. With a magnetic member fixed
to a driving tube,
the driving tube communicates this motion to an extension member, such as a
drive shaft 68, which
in turn communicates motion to the penetrating member 10. A first attachment
point fixes the
distal end of the coil support tube to the body. A second attachment point
fixes the proximal end
of the coil support tube to the body. The magnetic member may be made of s
Neodymium-Iron-
Boron (NdFeB) composition. However other compositions such as, but not limited
to Samarium-
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Cobalt (SmCo), Alnico (AlNiCoCuFe), Strontium Ferrite (SrFe0), or Barium
Ferrite (BaFe0)
could be used. Slightly weaker magnets could be more optimal in some
embodiments, such as a
case where the physical size of the system is relatively small and strong
magnets would be too
powerful.
The conducting coil may be made of different configurations including but not
limited to
several layers formed by a single wire, several layers formed of different
wires either round or
other geometric shapes_ In a first embodiment of the conducting coil, a first
layer of conductive
wire is formed by wrapping the wire in a turn-like and spiral fashion and in a
radial direction
around the coil-support tube, with each complete revolution forming a turn
next to the previous
one and down a first longitudinal direction of the coil support tube. After a
predetermined number
of turns, an additional layer is formed over the first layer by overlapping a
first turn of a second
layer of the wire over the last turn of the first layer and, while continuing
to wrap the wire in the
same radial direction as the first layer, forming a second spiral of wiring
with at least the same
number of turns as the first layer, each turn formed next to the previous one
and in a longitudinal
direction opposite to that of the direction in which the first layer was
formed. Additional layers
may be added by overlapping a first turn of each additional layer of the wire
over the last turn of
a previous layer and, while continuing to wrap the wire in the same radial
direction as the previous
layer, forming an additional spiral of wiring with at least the same number of
turns as the previous
layer, each turn formed next to the previous one and in a longitudinal
direction opposite to that of
the direction in which the previous layer is formed. In an alternative voice
coil embodiment, the
locations of the magnetic member and conductive coil are switched. In other
words, the conductive
coil is wrapped around and attached to the driving tube and the magnetic
member is located along
an outside radius of the coil support tube. An electrical signal is applied at
the conductive
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attachment sites and causes the formation of the Lorentz force to form in an
alternating direction
that moves the conductive coil and extension member reciprocally along the
longitudinal axis of
the device. The conductive coils are physically in contact with the driving
tube in this embodiment.
In another embodiment, the vibrational actuator 62, 62' employs a dual-coil
mechanism in
which the magnetic member of the voice-coil is replaced with a second
conductive coil. In other
words, the second conductive coil is wrapped around and attached to the
driving tube and the first
conductive coil is located along an outside radius of the coil support tube as
before. In a first
version, the inner coil conducts direct current DC and the outer coil conducts
alternating current
AC. In a second version, the inner coil conducts alternating current AC and
the outer coil conducts
direct current DC. In a third version, both the inner and outer coils conduct
alternating current
AC. In all of the voice coil actuator configurations described, springs may be
used to limit and
control certain dynamic aspects of the penetrating member 10.
In still another embodiment, the vibrational actuator 62, 62' is a solenoid
actuator. As with
the other voice coil embodiments using coils, the basic principle of actuation
with a solenoid
actuator is caused by a time varying magnetic field created inside a solenoid
coil which acts on a
set of very strong permanent magnets. The magnets and the entire penetrating
member assembly
oscillate back and forth through the solenoid coil. Springs absorb and release
energy at each cycle,
amplifying the vibration seen at the penetrating member 10. The resonant
properties of the
vibrational actuator 62, 62' can be optimized by magnet selection, number of
coil turns in the
solenoid, mass of the shaft, and the stiffness of the springs.
While piezoelectric and voice coil mechanisms have been discussed for the
vibrational
actuator 62, 62', these are not the only approaches to actuating or
oscillating the penetrating
member 10. Other approaches, such as a rotating motor, could be used for the
vibrational actuator
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62, 62'. Generally, any type of motor comprising an actuator assembly, further
comprising a mass
coupled to a piezoelectric material, or a voice coil motor, or solenoid, or
any other translational
motion device, would also fall within the spirit and scope of the invention.
During use, feedback to track or confirm the vibrating tip of the penetrating
member 10
has reached the desired target point 29 location may be obtained in several
forms. First, the
vibrating tip of the penetrating member 10 may be visualized on the display 24
as its echo is picked
up by the detector 20 during ongoing imaging through the insertion process_
This can be performed
while viewing the image in long-axis view or short-axis view (as in Figure
5C), or a user may
toggle between long and short-axis views as desired to follow the progress of
the tip of the
penetrating member 10_ Second, the appearance of fluid, such as blood, in the
penetrating member,
also referred to as "flashback," may be detected through mechanisms such as
visual identification,
change in resistance to a sub-circuit, or change in resonance frequency or
phase of the vibrating
needle tip, to name but a few. Other methods of confirming the tip of the
penetrating member 10
has reached the preselected target point 29 may also be used.
After the tip of the penetrating member 10 is successfully inserted in the
target vessel and
positioned at the desired target point 29, the remainder of the procedure for
successful central
venous catheterization, discussed above according to the Seldinqer technique,
could be
accomplished. For instance, in one embodiment, a guidewire 83 may be fed
through the
penetrating member 10 for insertion into the target vessel. The penetrating
member 10 may
therefore be dimensioned to accommodate a guidewire 83, having an inner
diameter at least as
large as the diameter of a guidewire 83 which is to be inserted therein. For
instance, in some
embodiments the penetrating member 10 may be between 14 and 18 gauge, while
the outer
diameter of the guidewire 75 may range of 0.9 to 0.6 millimeters (0.035 -
0.024 inches). Of course,
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other sizes and gauges are also contemplated herein. The guidewire 83 may be
extended beyond
the tip of the penetrating member 10 by 1 ¨ 3 cm, although shorter and longer
distances for
guidewire insertion are also contemplated. For instance, the guidewire 83 may
be fed through an
interior 72 volume or space of the offset coupler 70 that has an opening in
alignment with the hub
71, and therefore, penetrating member 10, as seen in Figure 1 6B. In other
embodiments, as in
Figures 21A ¨ 22, the guidewire 83 may be fed through a lumen 76 in a side
port(s) 75 at the
housing 73 of the vibrator 60, such as the neck 74 before the hub 71. The
housing 73, neck 74,
sideport(s) 75 and hub 71 may all be integrally formed together, or may all be
separate components
that are selectively attachable to each other, such as with a Luer connection
or other suitable
selectively removable connection mechanism, or any combination thereof. For
instance, in some
embodiments, the sideport(s) 75 is integrally formed with the neck 74, which
is attachable to the
housing 73 on one end and the hub 71 on the opposite end, as shown in Figure
21B. Accordingly,
the neck 74 and sideport 75 may be a Wye adaptor. In other embodiments, the
sideport(s) 75 may
be separate from and attach to the housing 73 or neck 74. In still other
embodiments, the neck 74,
sideport(s) 75 and hub 71 may be integrally formed, and connect to the housing
73.
Once the guidewire 83 is inserted through the penetrating member 10 and placed
as desired
in the target vessel, the penetrating member 10 may then be retracted from the
vessel, such as by
the extension actuator 52 moving in the reverse direction along the linear
direction 51, leaving the
guidewire 83 in place. A dilator may also be inserted and retracted as needed
to expand the space.
A catheter may then be inserted over the guidewire, and the guidewire
retracted from the vessel,
leaving the catheter in place.
The vertical actuator 32, angular actuator 42, extension actuator 52 and
vibrational actuator
62 are integrated in the insertion device 100. Accordingly, in at least one
embodiment, the
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penetrating member 10 may be selectively removable from the insertion device
100, such as by
attachment and detachment at the hub 71, so that a sterile penetrating member
10 may be used
with each new patient or use. Accordingly, the penetrating member 10 may be
disposable and the
rest of the insertion device 100, including the detector 20, processor 22, and
various actuators 32,
42, 52, 62, all remain intact and are reusable.
In at least one embodiment, at least a portion of, but preferable the entire
insertion device
100 up to and including the hub 71 is reusable and may be included in a
sterility bag to maintain
sterile conditions. In some embodiments, the sterility bag may be wiped down,
such as with
alcohol or bleach, between patients or uses, such that full sterility measures
do not need to be taken
on the reusable insertion device 100 between uses every time. In other
embodiments, the hub 71
may be removable from the offset coupler 70 or housing 73 for sterilization
between uses or
disposal. In still other embodiments, the offset coupler 70 or housing 70 may
be removable from
the remainder of the device 100, 100" for sterilization between uses or
disposal. Throughout the
various embodiments, it is contemplated that the reusable portions of the
insertion device 100,
100" may be encased in a sterility bag or like structure to maintain sterile
conditions between use.
In at least one embodiment, as shown in Figures 17 ¨ 19B, the insertion device
100' may
include a guidewire adjustment 80 for inserting a guidewire 83 as directed by
the processor 22. A
guidewire actuator 82 is in electrical communication with the processor 22 and
receives operative
data from the processor 22 directing activation and operational parameters
based on the type of
actuator, location of guidewire, etc. For instance, in at least one embodiment
shown in Figures
18A and 18B, the guidewire actuator 82 is a rotational motor, which may have
at least one, but in
some instances, two elongate members 85 that extend from the guidewire
actuator 82. A gear(s)
84 of the guidewire actuator 82 turns at least one of the elongate member(s)
85. In some
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embodiments, only one elongate member 85 is active, being primarily engaged by
the gear 84 for
turning or rotating. Another elongate member 85 may also be present, such as
paired with the first
active elongate member, but may be passive such that it is not rotated by the
guidewire actuator
82. Accordingly, a passive elongate member 85 may only rotate by action in
response to
movement of a paired active elongate member 85, such as by interdigitation of
teeth on
coordinating gears 84 between the elongate member 85.
Opposite from the guidewire actuator 82, the elongate member(s) 85 include a
frictional
member 86. In at least one embodiment, each elongate member 85 includes a
frictional member
86, which may be at the terminal end of the elongate member 85. In other
embodiments, only the
primary elongate member 85 includes a frictional member 86, although
preferably both active and
passive elongate members 85 include their own respective frictional members
86. In embodiments
where there are multiple active elongate members 85, each one includes a
frictional member 86.
The frictional member(s) 86 grip the guidewire 83 and using frictional
engagement, move the
guidewire 83 as they rotate. Some embodiments, as shown in Figure 18A and 18B,
the guidewire
83 may be attached and enclosed in a guidewire housing 89, keeping the
guidewire 83 sterile when
not in use. In some embodiments, the guidewire 83 is retained as a spool 88
within the housing
89 for compact storage and easy unwinding when needed. In other embodiments,
the guidewire
83 may extend out from the insertion device 100' and may be fed through the
device 100' as needed_
Regardless of whether coiled in a spool or not, as the guidewire actuator 82
turns the elongate
member(s) 85, the frictional member(s) 86 engage the guidewire 83 and turn to
move the guidewire
83, either advancing or retracting the guidewire, depending on the direction
of rotation.
The guidcwirc 83 is moved through a guidewire channel 87 in the guidcwirc
housing 89.
The guidewire channel 87 is aligned with and in fluid communication with the
interior 72 of the
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offset coupler 70, such that the guidewire 83 is advanced through the channel
87, through the
interior 72 of the offset coupler 70, hub 71, and penetrating member 10. The
guidewire 83 may
be advanced beyond the tip of the penetrating member 10, as described
previously. The guidewire
83 may be retracted through the same route and mechanism of the insertion
device 100', but
rotating the elongate member(s) 85 and frictional member(s) 86 in the opposite
direction.
The guidewire 83 must also be sterile for use. Accordingly, in some
embodiments, such
as shown in Figures 19A and 19B, anything that the guidewire 83 touches may be
selectively
detachable and disposable, such as for one-time use. For instance, the
guidewire housing 89
containing the spool 88, together with the guidewire channel 87, offset
coupler 70, hub 71 and
penetrating member 10 may all be separable from the remainder of the insertion
device 100', such
that the detector 20, processor 22, and actuators 32, 42, 52, 62, and 82 all
remain sterile and
reusable. This is one benefit to having an offset alignment of the penetrating
member 10 from the
vibrational actuator 62. In other embodiments, just the guidewire 83 and
penetrating member 10
may be removable and disposable, and the guidewire channel 87, offset coupler
70 and hub 71
may be sterilized between uses.
In still other embodiments, such as depicted in Figure 20C, the guidewire 83
passes through
the vibrational actuator 62. In such embodiments, the vibrational actuator 62
and the drive shaft
68 may have aligned lumens extending therethrough which act as a guidewire
channel 87. The
guidewire 83 may be advanced and retracted through these lumens.
_ADDITIONAL EMBODIMENTS
Figures 23-28 depict further embodiments of an automated insertion device 300
and
method 400 of using the same. These embodiments are hand-held devices that can
be used to
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automatically insert a penetrating member 310 such as a needle or catheter
into a body cavity such
as blood vessels for access to blood and fluid as well as placement of
guidewires, dilators, catheters
such as CVCs, and the like.
As shown in Figure 23, the insertion device 300 includes a detector 326 to
visualize a
subcutaneous target site. As with previous embodiments, the detector 326 may
be an ultrasound
probe capable of using ultrasound to produce images of the target site, though
other types of
imaging detectors are also contemplated. The detector 326 is in electrical
communication with a
controller 319 and provides imaging data obtained by the detector 326 to the
controller 319. This
imaging data may be relayed to a display for viewing by a practitioner or user
of the device 300.
An arm 325 joins the detector 326 to the remainder of the device 300_ A handle
321 that may be
gripped by an operator when in use may connect to the arm 325 to enable
manipulation of the
device 300 to align the detector 326 until the appropriate target site is
identified. As used herein,
the terms "practitioner," "operator," "user" and other similar terminology may
be used
interchangeably to refer to a person who uses the device to control the
insertion of a penetrating
member.
The controller 319 further includes a processor 322, as shown in Figures 26
and 27, that
receives the imaging data from the detector 326 and may further process the
imaging data, such as
by converting the imaging data by automatic calculation 323a into targeting
information
corresponding to the coordinates of the indicated target site in three-
dimensional space, such as an
X and Y coordinate solution representative of the depth index of the target
site as determined from
the imaging data. The processor 322 may be a microprocessor or otherwise as
described above.
The controller 319 also includes memory 219, shown in Figure 26, where the
imaging data from
the detector 326 and targeting information may be saved. The processor 322
further includes
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capabilities to calculate an insertion angle for the penetrating member 310 to
enter the tissue based
on the depth and other three-dimensional targeting information. In some
embodiments, the
processor 322 includes a manual adjust 323b option in which the user may
manually adjust the
angle of the positioner 320 to optimize the angle of entry for the penetrating
member 310.
The detector 326 remains adjacent to the skin surface during use of the device
300. The
corresponding imaging data, including depth telemetry and X and Y target
coordinates of the target
site provided by the detector 326, may vary during the insertion process based
upon deformity or
movement of the underlying tissue. Imaging data is therefore iteratively
collected by the detector
326 at regular intervals, such as every 20 milliseconds in at least one
embodiment. Each iterative
image data is provided to the processor 322, which then uses the automatic
calculation 323a to
recalculate and update the targeting information for every iterative packet of
image data received
to ensure the penetrating member 310 proceeds to the selected and saved target
and remains on
course.
As shown in Figure 24, the device 300 may include a positioner 320 in which
the controller
319 may be mounted. The positioner 320 may also carry, house and otherwise
include a vibration
assembly 360 and extension assembly 350 as discussed below in greater detail.
The penetrating
member 310 is affixed to the distal end of the vibration assembly 360 and is
moved along an
insertion axis 311 defined by the targeting information for insertion into the
tissue by movement
of the extension assembly 350. The positioner 320 may be a platform or housing
enclosing the
components. In some embodiments, the processor 322 may further provide
instructions to the
positioner 320 on which the vibration assembly 360 and extension assembly 350
are located to
move, such as by rotation to adjust the angle of the penetrating member 310
according to the
targeting information discussed above.
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The positioner 320 may also include at least one surface proximity sensor 325,
depicted
schematically in Figure 27, located preferably at the exterior surface and/or
distal surface of the
positioner 320 to detect any contact of the positioner 320 with the tissue
surface. Such detection
may indicate the penetrating member 310 is not long enough to reach the
selected targeted site and
a different penetrating member 310 may be needed, or that the calculated
target information based
on the image data needs to be updated to change the angle of insertion to
avoid contact of the
positioner 320 with the tissue surface. Accordingly, the processor 322 may
receive contact
information from the surface proximity sensor 325 indicating contact of the
positioner 320 with
the tissue surface has been made. If such contact information is received, the
processor 322 may
recalculate the targeting information to avoid further contact. In the absence
of contact information
from the surface proximity sensor 325, the processor 322 may validate the
appropriateness of the
targeting information, be it initial targeting information or updated based on
iterative imaging data.
The controller 319, and specifically the processor 322, is in electronic
communication with
a vibration assembly 360 and an extension assembly 350, explained in greater
detail below, and is
capable of providing instructions such as by transmitting operative
instructions based on the
targeting information and updated targeting information to the vibration
assembly 360 and
extension assembly 350.
The device 300 includes a vibration assembly 360, shown in Figures 23 and 24,
configured
to generate oscillations in a longitudinal direction 61 as described above for
previous
embodiments. It is connected to a penetrating member 310, either directly or
through a hub 371 as
in Figure 24, such that vibrations or oscillations generated by the vibration
assembly 360 are
transferred to the penetrating member 310. The vibration assembly 360 includes
a vibrational
actuator 362 such as a motor that generates the vibrations or oscillations
when activated. As used
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herein, the terms "vibration" and "oscillation" may be used interchangeably.
The vibrational
actuator 362 may be any suitable motor, such as but not limited to a voice
coil motor (VCM),
piezoelectric motor having at least one piezo element therein, and a DC motor.
The vibrational
actuator 362 is capable of producing vibrations at a rate of 50 ¨ 50,000
oscillations per second
depending on the type of vibrational actuator, frequency and/or input power.
In at least one
embodiment, the vibration rate may preferably be up to a maximum of about 150
oscillations per
second. The vibrations produced can vibrate the penetrating member 310 at
amplitudes of about
Sum ¨ 1mm, and preferably 0.5 mm in at least one embodiment.
The vibrational actuator 362 is in electrical communication with the
controller 319, and
specifically the processor 322, and receives instructions for operation from
the controller 319. For
instance, the device 300 may include a vibrational power switch 368, shown in
Figure 25, which
may be an on-off switch in communication with the controller 319. When
activated or switched
on, the controller 319 sends a signal to the vibrational actuator 362 to turn
on and begin generating
vibrations as specified by the controller 319. Vibrations may be stopped by
turning the vibrational
power switch 368 off. It may also be in direct electrical communication with
the vibration actuator
362 in other embodiments, and in some embodiments may be a potentiometer or
otherwise have
the ability to adjust the power supplied to the vibrational actuator 362 along
a continuum rather
than on or off.
With reference to Figure 27 which shows an electrical flow diagram of the
device 300, the
vibration assembly 360 includes a vibrational control 372 which is an
electrical module that
determines the relative output level at which the vibrational actuator 362
should operate depending
on the signals received from the controller 319, processor 322, vibration
control mode 322c (an
optional subcomponent of the processor 322) and/or the extension assembly 350
discussed below.
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The output level of the vibrational actuator 362 is governed by the voltage
applied to the actuator
and or the drive signal frequency. Instructions may be sent from the
controller 319, processor 322
or vibration control mode 322c to the vibrational control 372, which relays
the operative
instructions to a vibrational driver 367 which sends a signal such as voltage
to the vibrational
actuator 367 to activate and/or continue operation of the vibrational actuator
367. The vibrational
actuator 362 may contain sensors that detect amplitude, power consumption and
load experienced
by the penetrating member 310 during insertion. This information is relayed to
the extension
assembly 350, either directly or indirectly through the controller 319 or
processor 322, as explained
in more detail below.
A vibrational load sensor 374 may be included that detects the load placed on
the
penetrating member 310 and consequent damping of the vibrations experienced by
the penetrating
member 310 during insertion. The vibrational actuator 362 operates at a
frequency, but this
frequency will shift when the connected and vibrating penetrating member 310
engages with tissue
because the additional elasticity of the biological tissue increases the
stiffness of the combined
system (the vibrational actuator 362 plus the tissue). When the vibrating
penetrating member 310
engages the tissue, the tissue dampens the amplitude and effectiveness of the
vibration. To limit
damping the amplitude and effectiveness of the vibration, the
frequency/voltage of the drive signal
to the vibrational actuator 362 must change. Changing the frequency/voltage of
the drive signal
requires additional power supplied to the vibrational actuator 362 to limit
the damping of the
amplitude. The amount of power (such as in watts) supplied to the vibrational
actuator 362 is
referred to as the vibrational power consumption. Vibrational power
consumption may also be
detected through voltage sensing elements within the vibration assembly 360
according to the
following formula:
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Power = I rms * V rms
where I rms is current and V rms is voltage. Vibrational power consumption can
be determined
from the current and voltage measured at the vibrational actuator 362.
Therefore, damping of
vibration amplitude requires additional power consumption to combat the
damping.
The "load" is the axial force applied to the penetrating member 310 in Newtons
(N), which
can be detected by the vibrational load sensor 374 that measures force. The
vibrational load sensor
374 may be a circuit or other suitable mechanism. In one embodiment, the
vibrational load sensor
374 may be a shunt resistor and amplifier. In other embodiments, the load and
damping on the
penetrating member 310 may be mechanically sensed using an LVDT sensor. The
vibrational
actuator 362 itself may also act as a vibrational load sensor receiving
feedback of the force applied
to the penetrating member 310 through the coils or magnets within the
vibrational actuator 362
also receiving such force. Additionally, the power consumed by the extensional
actuator when
tougher tissues are encountered by the penetrating needle could likewise
modulate based on "load"
as defined here. Alternately, the phase relationship between the load current
and voltage of the
vibrational actuator 362 may be monitored and the effect of damping or load on
the penetrating
member 310 may be inferred from changes in this phase relationship.
Feedback of the damping on the penetrating member 310 and load current on the
vibrational actuator 362 may be sent to a vibration power and load control 376
module which
determines the effect of the load and damping experienced by the penetrating
member 310 as it
relates to the operative parameters of the vibrational actuator 362. The
vibration load control 376
may send signals to the vibration motor control 372, processor 322 and/or
vibration mode control
322c to adjust the speed of oscillation based on the feedback from the
penetrating member 310. It
may also send this information to the extension assembly 350, either directly
or through the
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controller 319 and/or processor 322, to adjust the speed of insertion based on
the vibrational load
experienced by the penetrating member 310 under vibration.
The device 300 also includes an extension assembly 350 as shown throughout the
Figures.
As discussed above, the extension assembly 350 is configured to move the
penetrating member
310 in a linear direction 51 for insertion and retraction of the penetrating
member 310. The
extension assembly 350 includes an extension actuator 352 that is a motor,
such as but not limited
to a linear or translational motor and can operate by any suitable mechanism_
An extension shaft
353 is mechanically joined to the extension actuator 352 at one location and
at another, spaced
apart location to the penetrating member 310, hub 371, the vibrational
actuator 362 or any other
component movable with the penetrating member 310, such as through an
extension mount 354 as
shown in Figure 24. The extension shaft 353 is preferably rigid and may extend
by telescopic
action in at least one embodiment. The extension assembly 350 is in electronic
communication
with the controller 319 and/or processor 322 to provide and receive operative
instructions. For
instance, the extension assembly 350 may also include an extender power switch
357, which may
be attached anywhere on the device 300 such as to the controller 319, exterior
surface of the
positioner 320, or to the handle 321 as shown in Figure 25. The extender power
switch 357 can be
used to turn the extension assembly 350 on and off. In at least one
embodiment, the extender power
switch 357 closes a circuit to provide operative power to the extension
actuator 352 to move the
extension shaft 353 in the linear direction 351. The direction of movement may
be controlled by a
directional switch 356, shown in Figure 25, which may also be located anywhere
on the device
300. The directional switch 356 may be a switch that can be toggled between a
forward direction
for advancing the extension shaft 353 for insertion of the penetrating member
310 and a reverse
direction for retraction of the extension shaft 353 and removal of the
penetrating member 310. A
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ready or retracted position of the extension assembly 350 is shown in Figure
23 with the extension
shaft 353 fully retracted, and an insertion or deployed position is shown in
Figure 24 with the
extension shaft 353 fully extended in the linear direction 51.
The extension actuator 352 is configured to operate at various speeds for
inserting the
penetrating member 310 at different speeds, depending on the vibrational load
and/or damping
experienced by the penetrating member 310 during insertion. For instance, in
at least one
embodiment the extension actuator 352 is operative at a first operative speed
in a first mode, a
second operative speed in a second mode, and a third operative speed in a
third mode. Any number
of modes are contemplated each with their own respective operative speed. The
operative speeds
may be a range or a specific speed, and may be any speed along a continuum of
possible speeds
based on the capabilities of the particular extension actuator 352 used. For
instance, in at least one
embodiment, the extension actuator 352 is configured to operate at a first
operative speed of about
2.0 cm/s in a first mode, about 1.0 cm/s in a second mode, and 0.5 cm/s in a
third mode. The
various modes may therefore be used to adjust the speed of insertion depending
on what the
penetrating member 310 is encountering during insertion. For instance, slower
insertion speeds
may be used when increased load or vibrational damping is experienced by the
penetrating member
310, and faster insertion speeds may be used when less load or vibrational
damping is experienced
by the penetrating member 310_ Any of the operative modes may be set as the
default mode at
which the extension actuator 352 operates by default unless otherwise
determined, as explained
below. For instance, the extension actuator 352 may use the first mode with an
operational speed
of 2.0 cm/s in at least one embodiment and may reduce in insertion speed to
compensate for
increased vibrational loads experienced during insertion.
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Power consumption may also be defined by the power required by the extension
motor to
continue advancement as different tissues are penetrated by the attached
penetrating member 310.
This power consumption may be referred to as extension power consumption. The
extension
actuator 352 may itself be a sensor for how much resistance is being placed on
the penetrating
member 310 during insertion, such as may occur when denser tissue is
encountered, which would
increase the extension power consumption on the extension actuator 352 to
continue operating at
a particular insertion speed_ Accordingly, feedback of the extension power
consumption and
current insertion speed may be sent to the vibrational assembly 360, either
directly or indirectly
through the controller 319 and/or processor 322, to adjust the vibration based
on the extension
power load experienced by the penetrating member 310 experienced by the
extension actuator 352
during insertion.
The extension assembly 350 also includes electrical circuitry to receive and
transmit
signals and information with the controller 319, processor 322 and vibration
assembly 360. For
instance, as shown in Figure 27, the extension assembly 350 may include an
extension motor
control 358 that receives operative signals from the controller 319, such as
to activate the extender
actuator 352 when the extender power switch 357 is activated or to direct
which operative mode
and speed to use. The definitional parameters for each operative mode and its
corresponding
speed(s) may be stored in memory 318 within the controller 319 or may be
stored in the extension
motor control 358 or memory within the extension assembly 350. The extension
motor control 358
sends operative instructions to an extension driver 355 that in turn sends
signals to the extension
actuator 352, such as voltage, to activate the extension actuator 352 and move
the penetrating
member 310 in the direction indicated by the directional switch 356.
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The extension motor control 358 may also receive signals from the vibration
assembly 360,
such as from the vibration load control 376, regarding the load and damping
experienced by the
penetrating member 310. This may be in the form of vibrational amplitude
and/or motor power
consumption changes experienced by the vibrational actuator 362 coupled to the
penetrating
member 310. Preferably, these signals and/or adjustment occur at regular
intervals iteratively
throughout the insertion process, such every 20 milliseconds though other time
intervals less than
the total time for insertion are contemplated.
The speed of the extension actuator 352 may be adjusted by the extension motor
control
358 to increase or decrease depending on the vibrational amplitude damping
and/or changes in
power consumption of the vibrational actuator 362, which results from the load
on the penetrating
member 310 as it progresses through different tissue types. For instance, when
the penetrating
member 310 encounters stiffer, harder or more difficult to penetrate tissue,
such as tendon, it
dampens the vibration imparted to the penetrating member 310 and increases the
load on the
penetrating member 310 and the power consumption of the vibrating actuator 362
changes and/or
greater chive signal (e.g., voltage amplitude) is required to maintain
vibrational displacement.
When such signals of increased load are sent to the extension assembly 350,
the extension actuator
352 slows the insertion speed to accommodate for the increased load. For
instance, it may adjust
from a first mode to the second mode for a lower speed, or from the second
mode to the third mode
for a still slower speed, depending on which mode the extension actuator 352
is currently operating
in. Conversely, when decreased load is experienced by the penetrating member
310, such as
indicating softer tissue is now being encountered, signals of the decreased
vibrational load are sent
to the extender 352 and the extension actuator 352 is adjusted to a faster
operative speed, such as
moving from a third mode to the second mode for a faster speed, or from the
second mode to the
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first mode. Whenever a change reaching a predefined threshold is reached, the
operative mode of
the extension actuator 352 is changed to the next closest mode depending on
whether the change
reflects increased or decreased load.
The invention also includes a method 400 of using the device 300 described
above, shown
in Figure 28. The method 400 first includes determining a target angle and
trajectory, as at 410.
This may be accomplished by positioning the detector 326 on the skin or other
surface of the tissue
and using the automatic calculation 323a of the processor 322 to determine the
appropriate
insertion angle and distance from the current position of the penetrating
member 310 to the selected
target as previously described. In certain embodiments, it may include
determining the target angle
based on the manual adjust 323b previously discussed_ The selected target
site, determined or
calculated insertion angle and distance may be stored in the memory 318 of the
controller 319.
The method 400 continues with providing operative instructions of vibrational
parameters
to the vibration assembly 360 and of an insertion speed and distance to the
extension assembly
350, as at 415. For the vibration assembly 360, these may include the
amplitude, voltage, frequency
of vibration, and other parameters as discussed above. For the extension
assembly 350, the
operative parameters for insertion speed may be the speed corresponding to the
default mode. The
distance corresponds to the targeting information and trajectory determined
based on the imaging
information from the detector 326, such as may be determined by the controller
319 and/or
processor 322. The operative instructions may be provided to each assembly
350. 360 once the
device 300 is turned on or may be stored in the circuitry or memory of the
vibration assembly 360
or in the memory of the controller 319.
The method 400 continues with activating the positioncr 320, as at 420. This
may include
turning the power on for the positioner 320, the vibrating actuator 362, and
the extension actuator
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352. This may occur in stages, each one at a time, or simultaneously_ In at
least one embodiment,
the vibrational actuator 362 is activated prior to the extension actuator 352
so that the penetrating
member 310 is vibrating longitudinally before it is advanced for insertion.
Once activated, each of
the actuators 362, 352 will operate according to their initial or default
operative parameters, which
may be stored in their respective circuitry such as the vibration control 372
and extension motor
control 358, or may be stored and operative instructions provided from the
controller 319 and/or
processor 322 of the device 300. In at least one embodiment, the extension
actuator 352 begins
operating in the first mode and the vibrational actuator 362 may operate in a
first vibrational mode.
The method 400 includes monitoring the vibrational power consumption and/or
vibrational
displacement provided by the vibrational actuator 362 and the extension power
consumption
and/or load on the extension actuator 352, as at 430, such as by detecting the
respective workloads
continually or iteratively throughout the insertion process. Each iteration of
monitoring may occur
at any time interval, such as but not limited to 20 milliseconds, depending on
how sensitive it is
desired for the system to be. It may be accomplished by the vibrational load
sensor 374 and the
extension actuator 352 or other insertion load sensor as described abov e. The
method then includes
comparing the vibrational load detected to a predetermined vibrational value
and the insertion load
detected to a predetermined extension value, as at 440, and adjusting the
insertion speed of the
extension actuator 352 if and when a sufficient deviation from the vibrational
workload of the
vibrational actuator 362 is detected and/or adjusting the vibration of the
vibrational actuator 362
if and when a sufficient deviation from the extension workload of the
extension actuator 350 is
detected. These adjustments may occur by providing a signal to the appropriate
vibration assembly
360 and/or extension assembly 350 to make the corresponding adjustment, which
may depend on
the change in workload detected and whether it exceeds the predetermined
values in either a
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positive or negative direction. For example, the method 400 may include
decreasing the insertion
speed when the vibrational load of the vibrational actuator 362 increases by a
predetermined
vibrational threshold, as at 442. For instance, the predetermined vibrational
value may be an
increase of 30% amplitude and/or 50% power consumption compared to the either
the initial
starting value or the load sample from the most recent iterative sampling.
Similarly, the method
400 may include decreasing the vibration power, amplitude or other operative
parameter when the
insertion load of the extension actuator 352 increases by a predetermined
extension value, as at
443. In some embodiments, the predetermined extension value may be an increase
of 0.25x, 0.5x,
1.0x, 1.5x, or 2.0x in power over the initial starting power or the insertion
load sample from the
most recent iterative sampling The predetermined vibration and extension
values may be different
in other embodiments and may depend on a number of factors, including but not
limited to the
initial starting workload and speed, the tissue(s) being penetrated, the
characteristics and type of
vibrational actuator 362 and extension actuator 352 used, the amount of
initial power supplied and
others factors. This reduction in insertion speed may correspond to
transitioning from operating
the extension actuator 352 from one operative mode to the next available
operative mode to adjust
the insertion speed, such as moving from a first mode to a second mode, or
from a second mode
to a third mode, each with decreasing levels of insertion speed. It may also
correspond to
transiti on ing the vibrational actuator 362 from one vibrational mode to
another. The method 400
contemplates changing the operative parameters of both, just one of, or
neither of the vibrational
actuator 362 and extension actuator 352 depending on what the loads are on the
opposite actuator.
Conversely, the method 400 includes increasing the insertion speed when the
vibrational
load of the vibrational actuator 362 decreases by a predetermined vibrational
value, as at 444, or
increasing the vibration of the vibrational actuator 362 when the insertion
load on the extension
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actuator 352 decreases by a predetermined extension value, as at 445. The
predetermined vibration
value or extension value for increasing insertion speed or vibration may be
the same as that for
decreasing insertion speed or vibration, respectively. Therefore, the change
may also be described
as a deviation from the predetermined values, such as a deviation of 30%
amplitude and/or 50%
power consumption compared to a previous vibrational load sample on the
vibrational actuator
362 or a deviation of 0.5x insertion load compared to a previous insertion
load on the extension
actuator 352 . In other embodiments, however, the predetermined vibration and
extension values
for increasing insertion speed or vibration may be different than that for
decreasing insertion speed
or vibration. Here again, the increase in insertion speed or vibration may
occur by transitioning to
the next available operative mode, such as moving from the third mode to the
second mode or
from the second mode to the third mode for the extension actuator 352, each
with increasing
insertion speeds. In addition, the sampling rate or interval may continue to
be the same as
previously, such as every 20 milliseconds, or the sampling rate may change
over time. For instance,
the sampling interval may become smaller, providing more frequent feedback
when the vibrational
load increases and may then lengthen, providing less frequent feedback when
the vibrational load
decreases, or vice versa. In at least one embodiment, the sampling rate or
interval may remain
constant throughout the insertion process.
Monitoring the vibrational workload, as at 430, continues throughout the
insertion process,
with adjustments made to increase or decrease insertion speed or vibraiton,
preferably in a stepwise
fashion between operative modes of the extension actuator 352 and vibrational
actuator 362,
throughout the insertion process as needed based on what loads the other
actuator is experiencing.
The method 400 concludes by stopping insertion, as at 450, which may occur a
number of
ways, for instance, automatically when the preselected target is reached
according to the calculated
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or determined trajectory based on the imaging information. Achieving the
target site may be
confirmed by the presence of an appropriate volume of blood or fluid escaping
from the target,
indicating the distal tip of the penetrating member 310 is located within the
interior volume of a
blood vessel. Stopping insertion, as at 450, may also occur in the event
contact of the device 300
with the surface of the tissue is detected, such as by the surface proximity
sensor 325 discussed
above. In this event, the vibrational actuator 362 may will concurrently
suspend vibration and the
extension actuator 352 may reverse and retract the penetrating member 310. The
positioner 320
may also inform the operator that the length of the penetrating member 310 is
insufficient for the
intended target depth, such as by a light, sound or other indicator observable
to the operator.
Wu en insertion of the penetrating member 310 stops, active operations of the
vibrational
actuator 362 and extension actuator 352 are suspended by the processor 322.
Upon confirmation
of successful introduction of the penetrating member 310 to the intended
target, such as by the
appearance of blood or other bodily fluid appropriate for the tissue
penetrated, the interior of the
target site may be access for extracting or inserting materials through the
penetrating member 310.
For instance, blood may be collected, drugs or solutions may be applied,
and/or a flexible guide
wire may be inserted through hollow interior of the penetrating member 310.
The penetrating
member 310 still resident within the target site may be disconnected from the
device, as at 460,
such as by detaching from the vibration assembly 360 at the hub 371. The hub
371 may then be
used as a connection point for a syringe or vial for blood collection or
drug/solution delivery, or
as a connection point for an IV system. A guidewire may be inserted through
the penetrating
member 310 before or after disconnection from the remainder of the insertion
device 300. If the
guidcwirc is inserted through the penetrating member 310 while still connected
to the device 300,
the positioner 320 with attached penetrating member 310 and the remainder of
the device 300 may
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be gently withdrawn over the flexible guide wire from the tissue until the
operator can appreciate
evidence of the flexible guide wire extending from the skin surface, at which
point the operator
can safely disassociate the positioner 320 and penetrating member 310 from
interaction with the
flexible guide wire.
Since many modifications, variations and changes in detail can be made to the
described
preferred embodiments, it is intended that all matters in the foregoing
description and shown in
the accompanying drawings be interpreted as illustrative and not in a limiting
sense. Thus, the
scope of the invention should be determined by the appended claims and their
legal equivalents.
Now that the invention has been described,
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