U.S. patent application number 17/239109 was filed with the patent office on 2022-03-17 for tactile sensing and needle guidance device.
The applicant listed for this patent is IntuiTap Medical, Inc.. Invention is credited to Matthew CRUZ, Yashar GANJEH, Xavier GARCIA-ROJAS, Alexander Keith Gomer Pratten JONES, Jack Alexander LOWE, Nicole C. MOSKOWITZ, Jonathan Rae PLUMB, Jessica TRAVER.
Application Number | 20220079619 17/239109 |
Document ID | / |
Family ID | 1000005990507 |
Filed Date | 2022-03-17 |
United States Patent
Application |
20220079619 |
Kind Code |
A1 |
MOSKOWITZ; Nicole C. ; et
al. |
March 17, 2022 |
TACTILE SENSING AND NEEDLE GUIDANCE DEVICE
Abstract
Tactile sensing devices, systems, and methods to image a target
tissue location are disclosed. When force is applied to the tactile
sensing device, voltage data is detected and visualized on a
screen, indicating the target tissue location.
Inventors: |
MOSKOWITZ; Nicole C.;
(Monsey, NY) ; TRAVER; Jessica; (Sierra Madre,
CA) ; GARCIA-ROJAS; Xavier; (The Woodlands, TX)
; GANJEH; Yashar; (Chicago, IL) ; CRUZ;
Matthew; (Chicago, IL) ; PLUMB; Jonathan Rae;
(Halstead, GB) ; LOWE; Jack Alexander; (Leeds,
GB) ; JONES; Alexander Keith Gomer Pratten;
(Cambridge, GB) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
IntuiTap Medical, Inc. |
Houston |
TX |
US |
|
|
Family ID: |
1000005990507 |
Appl. No.: |
17/239109 |
Filed: |
April 23, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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16379695 |
Apr 9, 2019 |
11000311 |
|
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17239109 |
|
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16230566 |
Dec 21, 2018 |
10383610 |
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16379695 |
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PCT/US2018/057860 |
Oct 26, 2018 |
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16230566 |
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62700505 |
Jul 19, 2018 |
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62578147 |
Oct 27, 2017 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/3403 20130101;
A61B 2017/3413 20130101; A61B 2017/3405 20130101; A61B 17/3401
20130101 |
International
Class: |
A61B 17/34 20060101
A61B017/34 |
Claims
1-116. (canceled)
117. A tactile sensing device, comprising: a frame comprising a
scanning track; a scanhead moveable along the scanning track, the
scanhead comprising: a needle guide; and a sensor array; an
electronic unit comprising: a computing device comprising a
processor operatively coupled to the sensor array, and a
non-transitory computer readable storage medium with a computer
program including instructions executable by the processor causing
the processor to: output a pressure map corresponding to output
signals transmitted by the sensor array; and a display screen
operatively coupled to the computing device for displaying the
pressure map.
118. The device of claim 117, further comprising a fluid pressure
sensor.
119. The device of claim 118, further comprising a pressure sensor
connector for operatively connecting the fluid pressure sensor.
120. The device of claim 119, wherein the pressure sensor connector
is operatively coupled to the computing device, and wherein the
fluid pressure is displayed on the display screen.
121. The device of claim 118, wherein the fluid pressure sensor
measures a cerebrospinal fluid pressure.
122. The device of claim 119, wherein the pressure sensor connector
is a pressure port.
123. The device of claim 117, wherein the electronic unit is
reversibly coupled to the sensor array.
124. The device of claim 117, wherein the pressure map displays a
skin level location of the needle.
125. The device of claim 124, wherein computer program further
causes the processor of the computing device to output a prompt
when the needle guide is provided at a target tissue insertion
site.
126. The device of claim 125, wherein the needle guide is located
on a surface of a scanhead.
127. The device of claim 117, wherein the scanhead is moveable
along the scanning track over a distance of about 0.5 inches to
about 10 inches.
128. The device of claim 117, further comprising a carriage
coupling the scanhead to the scanning track.
129. The device of claim 128, wherein the needle guide is fixed to
the carriage.
130. The device of claim 128, wherein mating of the scanhead and
the carriage allows the scanhead to be depressed relative to the
carriage.
131. The device of claim 130, wherein depression of the scanhead
relative to the carriage prevents movement of the carriage along
the scanning track.
132. The device of claim 131, wherein a pintle locks the position
of the carriage along the scanning track when the scanhead is
depressed relative to the carriage.
133. The device of claim 130, wherein the scanhead is depressible
to a depth of about 1 centimeter to about 10 centimeters.
134. The device of claim 117, wherein the sensor array comprises a
plurality of piezoresistive sensors.
135. The device of claim 134, wherein the sensor array comprises at
least 50 sensors.
136. The device of claim 117, wherein a patient-contacting surface
of the frame is curved.
Description
CROSS-REFERENCE
[0001] This application is a continuation of U.S. application Ser.
No. 16/379,695, filed on Apr. 9, 2019, which is a continuation of
U.S. application Ser. No. 16/230,566, filed on Dec. 21, 2018, which
is a continuation of International Application No.
PCT/US2018/057860, filed on Oct. 26, 2018, which claims benefit of
U.S. Provisional Application No. 62/578,147, filed Oct. 27, 2017
and U.S. Provisional Application No. 62/700,505, filed Jul. 19,
2018, each of which are incorporated herein by reference in their
entireties.
SUMMARY
[0002] Disclosed herein, in certain embodiments, are tactile
sensing devices, comprising: a frame comprising a needle guide
comprising a proximal opening and a distal opening and a track
therebetween configured to guide a needle; and a slot in open
connection with the needle guide, the slot comprising a first slot
wall, a second slot wall, a slot opening and a slot terminus at the
proximal opening of the needle guide; and a sensor array, the
sensor array comprising: a first sensor comprising a first surface,
a second sensor comprising a second surface, and a sensor array
slit aligned with the slot of the frame and extending from a
boundary of the sensor array to the distal opening of the needle
guide, wherein the distal opening is positioned in between the
first sensor and the second sensor, wherein the first sensor is
configured to output a first voltage signal in response to a first
change in a first pressure applied to the first surface, and the
second sensor is configured to output a second voltage signal in
response to a second change in a second pressure applied to the
second surface.
[0003] In some embodiments, the needle guide comprises a notch
configured to reversibly and temporarily secure the needle in place
during needle insertion. In some embodiments, the needle guide is
fixed. In some embodiments, the frame comprises a needle alignment
guide. In some embodiments, the needle alignment guide is a notch
or a marking on the surface of the tactile sensing device. In some
embodiments, the sensor array is a matrix array. In some
embodiments, the sensor array is a flexible sensor array. In some
embodiments, the track is angled at a treatment angle ranging
between about 40.degree. to about 90.degree. with respect to the
sensor array. In some embodiments, the treatment angle is a
cephalad angle between about 0.degree. to about 15.degree. with
respect to an individual. In some embodiments, the slot is
perpendicular to the needle guide. In some embodiments, the sensor
array is attached to a sensor array attachment area. In some
embodiments, the frame comprises a handle. In some embodiments, the
handle is a curved handle, a power grip handle, or a pinch grip. In
some embodiments, the handle comprises a grip feature. In some
embodiments, the tactile sensing device comprises a pressure sensor
connector, the pressure sensor connector operatively connecting the
tactile sensing device with a fluid pressure sensor. In some
embodiments, the tactile sensing device comprises a scanhead
comprising the sensor array and wherein the frame comprises a
scanning track along which the scanhead comprising the sensor array
is configured to move relative to the frame. In some embodiments, a
part of the frame surrounding the needle guide is made out of clear
plastic. In some embodiments, a posterior surface of the tactile
sensing device has a curvature about a longitudinal axis. In some
embodiments, the posterior surface of the tactile sensing device
has a curvature about a lateral axis. In some embodiments, the slot
and the sensor array slit are substantially a same width from the
boundary of the sensor array to the needle guide distal opening. In
some embodiments, the sensor array is adhered to a posterior
surface of the tactile sensing device.
[0004] Disclosed herein, in certain embodiments, are tactile
sensing systems, comprising: a frame comprising a sensor unit and
an electronic unit; the sensor unit comprising: a needle guide
comprising a proximal opening and a distal opening and a track
therebetween configured to guide a needle; a slot in open
connection with the needle guide, the slot comprising a first slot
wall, a second slot wall, an slot opening and a slot terminus at
the proximal opening of the needle guide; and a sensor array, the
sensor array comprising: a first sensor comprising a first surface,
a second sensor comprising a second surface, and a sensor array
slit aligned with the slot of the frame and extending from a
boundary of the sensor array to the distal opening of the needle
guide, wherein the distal opening is positioned in between the
first sensor and the second sensor, wherein the first sensor is
configured to output a first voltage signal in response to a first
change in a first pressure applied to the first surface, and the
second sensor is configured to output a second voltage signal in
response to a second change in a second pressure applied to the
second surface, the electronic unit, comprising: a display screen
operatively coupled to the sensor array, the display screen
configured to display: a pressure map representing a target tissue
location in an individual in need thereof based upon the first
voltage signal and the second voltage signal from the sensor array
and a projected subcutaneous needle location to be inserted into
the individual; and a connector configured to operatively connect
the electronic unit to the sensor unit; and a computing device
comprising a processor operatively coupled to the sensor unit and
the electronic unit, and a non-transitory computer readable storage
medium with a computer program including instructions executable by
the processor causing the processor to: i) convert the first
voltage signal and the second voltage signal received from the
sensor array into the pressure map and display the pressure map on
the display screen and ii) calculate the projected subcutaneous
needle location to be inserted into the individual and output the
projected subcutaneous needle location on the display screen.
[0005] In some embodiments, the needle guide comprises a notch
configured to reversibly and temporarily secure the needle in the
needle guide from slipping along the slot during needle insertion.
In some embodiments, the needle guide is fixed. In some
embodiments, the frame comprises a needle alignment guide. In some
embodiments, the needle alignment guide is a notch or a marking on
the surface of the tactile sensing device. In some embodiments, the
sensor array is a matrix array. In some embodiments, the sensor
array is a flexible sensor array. In some embodiments, the track is
angled at a treatment angle ranging between about 40.degree. to
about 90.degree. with respect to the sensor array. In some
embodiments, the treatment angle is a cephalad angle between about
0.degree. to about 15.degree. with respect to the individual. In
some embodiments, the slot is perpendicular to the needle guide. In
some embodiments, the sensor array is attached to a sensor array
attachment area. In some embodiments, the frame comprises a handle.
In some embodiments, the handle is a curved handle, a power grip
handle, or a pinch grip. In some embodiments, the handle comprises
a grip feature. In some embodiments, the tactile sensing device
comprises a pressure sensor connector, the pressure sensor
connector operatively connecting the tactile sensing device with a
fluid pressure sensor. In some embodiments, the tactile sensing
device comprises a scanhead comprising the sensor array and wherein
the frame comprises a scanning track along which the scanhead
comprising the sensor array is configured to move relative to the
frame. In some embodiments, a part of the frame surrounding the
needle guide is made out of clear plastic. In some embodiments, a
posterior surface of the tactile sensing device has a curvature
about a longitudinal axis. In some embodiments, the posterior
surface of the tactile sensing device has a curvature about a
lateral axis. In some embodiments, the slot and the sensor array
slit are directly aligned with one another. In some embodiments,
the sensor array is adhered to a posterior surface of the tactile
sensing device. In some embodiments, the electronic unit comprises
a printed circuit board. In some embodiments, the tactile sensing
device comprises a sleeve configured for receiving the electronic
unit. In some embodiments, the tactile sensing device comprises a
power source. In some embodiments, the power source is a battery.
In some embodiments, the battery is located underneath the display
screen. In some embodiments, the sensor unit or the electronic unit
are disposable. In some embodiments, the sensor unit and the
electronic unit are reversibly connected. In some embodiments, the
tactile sensing device comprises a wireless transmitter, the
wireless transmitter operatively connected to the sensor array, for
remotely transmitting the first voltage signal generated by the
first voltage sensor and the second voltage signal generated by the
second sensor. In some embodiments, the processor is configured
with instructions to display the target tissue location and the
projected subcutaneous needle location on the display screen in
real time. In some embodiments, the processor is configured with
instructions to display the target tissue location and the
projected subcutaneous needle location on the display screen while
the needle is advanced along the needle guide through the distal
opening toward the target tissue location.
[0006] Disclosed herein, in certain embodiments, are methods of
positioning a needle in the tactile sensing device, comprising: a)
inserting the needle into the slot opening; b) guiding the needle
along an axis of the slot by sliding the needle in between the
first slot wall and the second slot wall towards the needle guide,
c) contacting the needle with the track of needle guide, and d)
sliding the needle along the track towards the distal opening of
the needle guide.
[0007] Disclosed herein, in certain embodiments, are methods of
positioning a needle, comprising: a) inserting the needle into the
needle guide of the tactile sensing device, b) contacting the
needle with the track of needle guide, c) sliding the needle along
the track towards the distal opening of the needle guide and into a
patient at an angle defined by the track, and d) removing the
device while the needle is in the patient by guiding the device
such that the needle is travels along the slot between the first
slot wall and the second slot wall toward and out of the slot
opening.
[0008] Disclosed herein, in certain embodiments, are tactile
sensing devices, comprising: a frame comprising a needle guide
comprising a proximal opening and a distal opening and a track
therebetween configured to guide a needle; and a sensor array, the
sensor array comprising: a first sensor comprising a first surface
and a second sensor comprising a second surface, wherein the first
sensor is configured to output a first voltage signal in response
to a first change in a first pressure applied to the first surface,
and the second sensor is configured to output a second voltage
signal in response to a second change in a second pressure applied
to the second surface.
[0009] In some embodiments, the needle guide comprises a notch
configured to reversibly and temporarily secure the needle in place
during needle insertion. In some embodiments, the needle guide is
fixed. In some embodiments, the needle guide is reversibly attached
to the tactile sensing device. In some embodiments, the frame
comprises a needle alignment guide. In some embodiments, the needle
alignment guide is a notch or a marking on the surface of the
tactile sensing device. In some embodiments, the sensor array is a
matrix array. In some embodiments, the sensor array is a flexible
sensor array. In some embodiments, the track is angled at a
treatment angle ranging between about 40.degree. to about
90.degree. with respect to the sensor array. In some embodiments,
the treatment angle is a cephalad angle between about 0.degree. to
about 15.degree. with respect to an individual. In some
embodiments, the tactile sensing device comprises a slot in open
connection with the needle guide, the slot comprising a first slot
wall, a second slot wall, a slot opening and a slot terminus at the
proximal opening of the needle guide. In some embodiments, the slot
is perpendicular to the needle guide. In some embodiments, the
sensor array comprises a sensor array slit aligned with the slot of
the frame and extending from a boundary of the sensor array to the
distal opening of the needle guide. In some embodiments, the slot
and the sensor array slit are substantially a same width from the
boundary of the sensor array to the needle guide distal opening. In
some embodiments, the sensor array is attached to a sensor array
attachment area. In some embodiments, the frame comprises a handle.
In some embodiments, the handle is a curved handle, a power grip
handle, or a pinch grip. In some embodiments, the handle comprises
a grip feature. In some embodiments, the tactile sensing device
comprises a pressure sensor connector, the pressure sensor
connector operatively connecting the tactile sensing device with a
fluid pressure sensor. In some embodiments, the tactile sensing
device comprises a scanhead comprising the sensor array and wherein
the frame comprises a scanning track along which the scanhead
comprising the sensor array is configured to move relative to the
frame. In some embodiments, a part of the frame surrounding the
needle guide is made out of clear plastic. In some embodiments, a
posterior surface of the tactile sensing device has a curvature
about a longitudinal axis. In some embodiments, the posterior
surface of the tactile sensing device has a curvature about a
lateral axis. In some embodiments, the slot and the sensor array
slit are substantially a same width from the boundary of the sensor
array to the needle guide distal opening. In some embodiments, the
sensor array is adhered to a posterior surface of the tactile
sensing device. In some embodiments, the distal opening is
positioned in between the first sensor and the second sensor.
[0010] Disclosed herein, in certain embodiments, are tactile
sensing systems, comprising: a frame comprising a sensor unit and
an electronic unit; the sensor unit comprising: a needle guide
comprising a proximal opening and a distal opening and a track
therebetween configured to guide a needle; and a sensor array, the
sensor array comprising: a first sensor comprising a first surface,
a second sensor comprising a second surface, wherein the first
sensor is configured to output a first voltage signal in response
to a first change in a first pressure applied to the first surface,
and the second sensor is configured to output a second voltage
signal in response to a second change in a second pressure applied
to the second surface, the electronic unit, comprising: a display
screen operatively coupled to the sensor array, the display screen
configured to display: a pressure map representing a target tissue
location in an individual in need thereof based upon the first
voltage signal and the second voltage signal from the sensor array
and a projected subcutaneous needle location to be inserted into
the individual; and a connector configured to operatively connect
the electronic unit to the sensor unit; and a computing device
comprising a processor operatively coupled to the sensor unit and
the electronic unit, and a non-transitory computer readable storage
medium with a computer program including instructions executable by
the processor causing the processor to: i) convert the first
voltage signal and the second voltage signal received from the
sensor array into the pressure map and display the pressure map on
the display screen and ii) calculate the projected subcutaneous
needle location to be inserted into the individual and output the
projected subcutaneous needle location on the display screen.
[0011] In some embodiments, the needle guide comprises a notch
configured to reversibly and temporarily secure the needle in the
needle guide from slipping along the slot during needle insertion.
In some embodiments, the needle guide is fixed. In some
embodiments, the needle guide is reversibly attached to the tactile
sensing device. In some embodiments, the frame comprises a needle
alignment guide. In some embodiments, the needle alignment guide is
a notch or a marking on the surface of the tactile sensing device.
In some embodiments, the sensor array is a matrix array. In some
embodiments, the sensor array is a flexible sensor array. In some
embodiments, the track is angled at a treatment angle ranging
between about 40.degree. to about 90.degree. with respect to the
sensor array. In some embodiments, the treatment angle is a
cephalad angle between about 0.degree. to about 15.degree. with
respect to the individual. In some embodiments, the tactile sensing
device comprises a slot in open connection with the needle guide,
the slot comprising a first slot wall, a second slot wall, a slot
opening and a slot terminus at the proximal opening of the needle
guide. In some embodiments, the slot is perpendicular to the needle
guide. In some embodiments, the sensor array comprises a sensor
array slit aligned with the slot of the frame and extending from a
boundary of the sensor array to the distal opening of the needle
guide. In some embodiments, the slot and the sensor array slit are
substantially a same width from the boundary of the sensor array to
the needle guide distal opening. In some embodiments, the sensor
array is attached to a sensor array attachment area. In some
embodiments, the frame comprises a handle. In some embodiments, the
handle is a curved handle, a power grip handle, or a pinch grip. In
some embodiments, the handle comprises a grip feature. In some
embodiments, the tactile sensing device comprises a pressure sensor
connector, the pressure sensor connector operatively connecting the
tactile sensing device with a fluid pressure sensor. In some
embodiments, the tactile sensing device comprises a scanhead
comprising the sensor array and wherein the frame comprises a
scanning track along which the scanhead comprising the sensor array
is configured to move relative to the frame. In some embodiments, a
part of the frame surrounding the needle guide is made out of clear
plastic. In some embodiments, a posterior surface of the tactile
sensing device has a curvature about a longitudinal axis. In some
embodiments, the posterior surface of the tactile sensing device
has a curvature about a lateral axis. In some embodiments, the slot
and the sensor array slit are directly aligned with one another. In
some embodiments, the sensor array is adhered to a posterior
surface of the tactile sensing device. In some embodiments, the
electronic unit comprises a printed circuit board. In some
embodiments, the tactile sensing device comprises a sleeve
configured for receiving the electronic unit. In some embodiments,
the tactile sensing device comprises a power source. In some
embodiments, the power source is a battery. In some embodiments,
the battery is located underneath the display screen. In some
embodiments, the sensor unit or the electronic unit are disposable.
In some embodiments, the sensor unit and the electronic unit are
reversibly connected. In some embodiments, the tactile sensing
device comprises a wireless transmitter, the wireless transmitter
operatively connected to the sensor array, for remotely
transmitting the first voltage signal generated by the first
voltage sensor and the second voltage signal generated by the
second sensor. In some embodiments, the processor is configured
with instructions to display the target tissue location and the
projected subcutaneous needle location on the display screen in
real time. In some embodiments, the processor is configured with
instructions to display the target tissue location and the
projected subcutaneous needle location on the display screen while
the needle is advanced along the needle guide through the distal
opening toward the target tissue location. In some embodiments, the
distal opening is positioned in between the first sensor and the
second sensor.
[0012] Disclosed herein, in certain embodiments, are methods of
positioning a needle in the tactile sensing device, comprising: a)
inserting the needle into the needle guide opening; b) contacting
the needle with the track of needle guide, and c) sliding the
needle along the track towards the distal opening of the needle
guide.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The novel features of the subject matter disclosed herein
are set forth with particularity in the appended claims. A better
understanding of the features and advantages of the subject matter
disclosed herein will be obtained by reference to the following
detailed description that sets forth illustrative embodiments, in
which the principles of the subject matter disclosed herein are
utilized, and the accompanying drawings of which:
[0014] FIGS. 1A and 1B illustrate a tactile sensing device with a
needle guide comprising a slot and track. FIG. 1A shows a
perspective view of the tactile sensing device 100 with an
exemplary output image displayed on its display screen 4. FIG. 1B
shows an additional perspective view of the tactile sensing device
100.
[0015] FIGS. 2A and 2B illustrate an embodiment of a tactile
sensing device 200 comprising a lateral slot and a needle guide
comprising a notch. FIG. 2A shows a perspective view of the tactile
sensing device 200 with an exemplary output image displayed on its
display screen 4. FIG. 2B shows a front view of the tactile sensing
device 200.
[0016] FIG. 3 exemplifies an embodiment of the tactile sensing
device 300 comprising a wide cutout alternatively called a slot
herein and a notch with a lip protruding from the slot wall to aid
in retaining a needle in the track during insertion of the needle
into the subject.
[0017] FIGS. 4A and 4B show an embodiment of the tactile sensing
device 400 comprising a battery and a printed circuit board. FIG.
4A shows a front view of the tactile sensing device 400. FIG. 4B
shows a side, wire frame view of the tactile sensing device
400.
[0018] FIG. 5 shows an embodiment of the tactile sensing device 500
comprising an extended handle.
[0019] FIG. 6 shows an embodiment of the tactile sensing device 600
comprising a disposable sensor unit 32.
[0020] FIG. 7 shows an embodiment of the tactile sensing device 700
comprising an enhanced pinch grip.
[0021] FIG. 8 shows an embodiment of the tactile sensing device 800
comprising an exaggerated undercut grip.
[0022] FIG. 9 shows an embodiment of the tactile sensing device 900
comprising a pinch grip control.
[0023] FIG. 10 shows an embodiment of the tactile sensing device
1000 comprising an undercut body grip.
[0024] FIG. 11 shows an embodiment of the tactile sensing device
1100 comprising a power grip.
[0025] FIGS. 12A, 12B, and 12C show an embodiment of the tactile
sensing device 1200 comprising an electronic unit 34 and a sensor
unit 32 that includes the handle 54. FIG. 12A shows a front view of
the tactile sensing device 1200 comprising a sliding sleeve and a
sliding electronic unit 34. FIG. 12B shows a front view of the
tactile sensing device 1200 comprising a handle comprising an
indent specific for a left thumb. FIG. 12C shows a front view of
the tactile sensing device 1200 comprising a snap-on disposable
sleeve.
[0026] FIG. 13 shows a needle being inserted into a spinal canal or
an epidural space 100 using the tactile sensing device 1300.
[0027] FIG. 14 shows an exploded view of an embodiment tactile
sensing device 1400.
[0028] FIG. 15 shows an exploded view of the screen-printed
force-sensitive resistor (FSR) array 108.
[0029] FIG. 16 shows a perspective view of a screen-printed
force-sensitive resistor (FSR) array 108 being adhered onto the
tactile sensing device 1600.
[0030] FIG. 17 shows a computer control system that is programmed
or otherwise configured to implement methods provided herein.
[0031] FIGS. 18A-C show an embodiment rocker tactile sensing
device. FIG. 18A shows a perspective view of the tactile sensing
device. FIG. 18B shows a side view of the tactile sensing device
comprising a curved sensor applicator. FIG. 18C shows a side,
cutaway view of the tactile sensing device.
[0032] FIGS. 19A-C shows an embodiment curved sensor applicator and
needle guide insert of the tactile sensing device comprising a
rocker design. FIG. 19A shows an isometric view of an embodiment
curved sensor applicator. FIG. 19B shows a cutaway view of an
embodiment needle guide insert comprising a needle guide. FIG. 19C
shows a front view of an embodiment needle guide insert comprising
a needle guide.
[0033] FIGS. 20A-E show the workflow of an embodiment rocker
tactile sensing device. FIG. 20A shows a user applying an
embodiment rocker tactile sensing device against the skin surface
of a patient. FIG. 20B shows the user moving an embodiment rocker
tactile sensing device in a rocking motion. FIG. 20C shows the user
identifying the correct needle insertion position. FIG. 20D shows
the user removing an embodiment handle. FIG. 20E shows the user
securing the needle with an embodiment needle retention gate
17.
[0034] FIGS. 21A-C show an embodiment slider tactile sensing
device. FIG. 21A shows an isometric view of an embodiment slider
tactile sensing device. FIG. 21B shows a side, cutaway view of an
embodiment slider tactile sensing device with an undepressed
scanhead. FIG. 21C shows a side, cutaway view of an embodiment
slider tactile sensing device with a depressed scanhead.
[0035] FIGS. 22A-C show an embodiment slider tactile sensing device
scanhead subassembly 23 including a scanning track 45 and locking
rack and release button or scanning knob retention clip. FIG. 22A
shows a front, isometric view of the scanhead subassembly. FIG. 22B
shows a back, isometric view of the scanhead subassembly. FIG. 22C
shows a back, cutaway view of the scanhead subassembly.
[0036] FIGS. 23A-B show assembled and assembly view embodiment of a
carriage and scanning knob including two scanning knob retention
clips of an embodiment slider tactile sensing device. FIG. 23A
shows an isometric view of the scanhead subassembly. FIG. 23B shows
an exploded view of the scanhead subassembly.
[0037] FIGS. 24A-C show embodiment scanning knobs for the tactile
sensing device. FIG. 24A shows a scanning knob with ribs. FIG. 24B
shows a concave scanning knob. FIG. 24C shows a convex scanning
knob.
[0038] FIGS. 25A-B show embodiment scanhead including a needle
track having a proximal needle track opening that tapers to the
distal needle track opening. FIG. 25A shows an isometric view of
the scanhead. FIG. 25B shows the scanhead of FIG. 25A, cut away
through the needle track.
[0039] FIGS. 26A-D show the workflow of how a user utilizes the
tactile sensing device comprising the slider design when imaging a
target tissue location of a patient. FIG. 26A shows a user
inserting the scanning knob into the tactile sensing device. FIG.
26B shows the user sliding the scanning knob. FIG. 26C shows the
user identifying the correct needle insertion position. FIG. 26D
shows the user removing the scanning knob.
DETAILED DESCRIPTION
[0040] While preferred embodiments of the subject matter disclosed
herein have been shown and described herein, it will be obvious to
those skilled in the art that such embodiments are provided by way
of example only. Numerous variations, changes, and substitutions
will now occur to those skilled in the art without departing from
the subject matter disclosed herein. It should be understood that
various alternatives to the embodiments of the subject matter
disclosed herein may be employed in practicing the subject matter
disclosed herein. It is intended that the following claims define
the scope of the subject matter disclosed herein and that methods
and structures within the scope of these claims and their
equivalents be covered thereby.
Certain Definitions
[0041] The terminology used herein is for the purpose of describing
particular cases only and is not intended to be limiting. As used
herein, the singular forms "a", "an" and "the" are intended to
include the plural forms as well, unless the context clearly
indicates otherwise. Furthermore, to the extent that the terms
"including", "includes", "having", "has", "with", or variants
thereof are used in either the detailed description and/or the
claims, such terms are intended to be inclusive in a manner similar
to the term "comprising".
[0042] The term "about" or "approximately" means within an
acceptable error range for the particular value as determined by
one of ordinary skill in the art, which will depend in part on how
the value is measured or determined, e.g., the limitations of the
measurement system. In certain embodiments, the term "about" or
"approximately" means within 1, 2, 3, or 4 standard deviations. In
certain embodiments, the term "about" or "approximately" means
within 30%, 25%, 20%, 15%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%,
0.5%, 0.1%, or 0.05% of a given value or range. In certain
embodiments, the term "about" or "approximately" means within 20.0
degrees, 15.0 degrees, 10.0 degrees, 9.0 degrees, 8.0 degrees, 7.0
degrees, 6.0 degrees, 5.0 degrees, 4.0 degrees, 3.0 degrees, 2.0
degrees, 1.0 degrees, 0.9 degrees, 0.8 degrees, 0.7 degrees, 0.6
degrees, 0.5 degrees, 0.4 degrees, 0.3 degrees, 0.2 degrees, 0.1
degrees, 0.09 degrees. 0.08 degrees, 0.07 degrees, 0.06 degrees,
0.05 degrees, 0.04 degrees, 0.03 degrees, 0.02 degrees or 0.01
degrees of a given value or range.
[0043] The terms "individual," "patient," or "subject" are used
interchangeably. None of the terms require or are limited to
situation characterized by the supervision (e.g. constant or
intermittent) of a health care worker (e.g. a doctor, a registered
nurse, a nurse practitioner, a physician's assistant, an orderly,
or a hospice worker).
[0044] The terms "user," "health care worker," "doctor," and
"physician" are used interchangeably. These terms refer to any
person that operates the devices described herein. Additional
non-liming examples of a user include "registered nurse," "nurse
practitioner," and "physician's assistant."
[0045] The terms "intracranial pressure (ICP)" and "cerebrospinal
fluid (CSF) pressure" are used interchangeably. ICP is the pressure
inside a skull and thus, it is the pressure in the brain tissue and
CSF.
[0046] The terms "lumbar puncture" and "spinal tap" and "spinal
puncture" are used interchangeably herein. Generally speaking, a
"spinal puncture" is used herein to refer to lumbar puncture,
spinal tap, epidural spinal injection, spinal injection, and/or
neuraxial anesthesia, and thus is interchangeably therewith. The
use of any one of these terms herein does not limit the devices,
systems, or methods described herein to only the stated use or type
of injection, but is exemplary only and such uses and
interchangeable with any other type of injection or puncture for
which a device or system or method described herein would be
helpful or appropriate.
[0047] The term "needle hub," as used herein, refers to the hub at
one end of a needle that commonly attaches to a syringe. The shaft
of the needle is an elongated, slender stem of the needle that
extends from the needle hub and is beveled at the end opposite to
the needle hub end.
[0048] The term "proximal," as used herein, is defined as being
closest or nearer to the user holding and/or operating the tactile
sensing device, unless otherwise indicated. For example, a user
pressing the tactile sensing device onto a patient.
[0049] The term "distal," as used herein, is defined as being
farthest to the user holding and/or operating the tactile sensing
device, unless otherwise indicated. For example, pressing the
tactile sensing device onto a patient.
[0050] The terms "frame" and "main housing frame" are used
interchangeable herein.
Accessing a Target Tissue Location
[0051] Accessing a target tissue location, for example, the
epidural or subarachnoid space via a spinal puncture is a
technically challenging procedure that is performed quite commonly
in the clinic, especially in the Emergency Room. The procedure
involves "blindly" landmarking, or landmarking by manually
palpating, the lumbar spine, to identify a gap between two spinous
processes through which a needle is inserted into the epidural or
subarachnoid space for fluid collection or injection. The "blind"
landmarking technique improves with time and practice therefore,
physicians with limited experience find the spinal puncture
procedure challenging. Furthermore, regardless of experience, the
spinal puncture procedure becomes difficult to perform with obese
patients or patients with a high body mass index (BMI) because
their high accumulation of subcutaneous adipose tissue prevents the
physician to accurately landmark the lumbar spine via manual
palpation. Current landmarking techniques only have a 30% accuracy,
making it necessary for an average of >4 attempts to properly
puncture the space, and resulting in >25% of patients having
traumatic spinal punctures and >32% of patients left with
post-dural puncture headaches (PDPHs). Additionally, elderly
patients or pregnant patients have limited flexibility and are
unable to maximally flex the hips, knees, and back, as is required
during a spinal puncture procedure in order to increase the opening
space between the intervertebral disks.
[0052] Beyond just landmarking and localization, other functional
steps of performing a diagnostic spinal puncture, where
cerebrospinal fluid (CSF) samples are collected and intracranial
pressure is measured, are severely inefficient. In order to obtain
an intracranial pressure reading, physicians use a two-piece
manometer connected to a needle hub by a three-way stopcock, which
requires estimation of fluid levels in determining intracranial
pressure. To simultaneously balance a manometer and one or more
cerebrospinal fluid collection tubes requires significant dexterity
and/or sometimes more than one pair of hands. Thus, the risk of CSF
spillages is high and further increases the risk of contamination.
Accordingly, there is a need for improved or alternative devices,
methods, systems, and kits to perform a spinal puncture.
[0053] There is also a need for improved or alternative devices,
methods, systems and kits to visualize bone and non-bone structures
at any given target tissue location. In view of these deficiencies
in the current state of the art, the subject matter presented
herein addresses these and other needs. The devices, systems, and
methods disclosed herein are highly advantageous. Some examples of
advantages provided by the devices, systems, and methods disclosed
herein include, but are not limited to, providing highly accurate
imaging system as means for needle guidance to a target tissue
location, imaging a target tissue location in real time, while a
user simultaneously advances a needle into the target tissue
location, and providing features that help guide, align, and secure
the needle at a specific treatment angle.
Lumbar Punctures and Spinal Punctures
[0054] A spinal puncture (alternatively referred to as a lumbar
puncture) is an invasive procedure performed in a clinical setting
for diagnostic or therapeutic purposes. A diagnostic spinal
puncture, also known as "spinal tap," is one of the most commonly
invasive tests performed in the clinic. Every year, approximately
400,000 diagnostic spinal punctures are performed in the United
States. During a spinal puncture, cerebrospinal fluid is collected
and in some cases, cerebrospinal fluid (CSF) opening pressure is
measured. Therapeutic spinal punctures are most commonly performed
to deliver spinal anesthesia, intrathecal chemotherapeutics,
intrathecal pain killers, intrathecal antibiotics, and contrast
agents.
[0055] In some instances, a spinal puncture is performed with a
patient in a lateral decubitus position or lying down on their
side, knees bent, and head in a neutral position. In some
instances, a spinal puncture is performed with a patient upright,
seated with the chin down and feet supported. Aseptic technique is
used when performing a spinal puncture. In some instances, to
perform a spinal puncture, a practitioner performs a series of
steps including: identifying an intraspineous process space between
the 4.sup.th and 5.sup.th lumbar vertebrae (L4 and L5), between L3
and L4, or between L2 and L3; cleaning the patient's skin in the
lumbar area with iodinated solution, ethanol or isopropyl alcohol,
and chlorhexidine; administering a local anesthetic such as, but
not limited to, xylocaine or lidocaine, in a manner such that it
raises a small bleb on the skin; administering additional local
anesthetic, such as lidocaine, to deeper subcutaneous and
intraspinous tissues; slowly inserting a spinal needle angling
towards the patient's head until the epidural or subarachnoid space
is entered.
[0056] A critical component of a spinal puncture is the recording
of intracranial (ICP) pressure, represented by the ultra-low
pressure of the cerebrospinal fluid. ICP or cerebrospinal fluid
pressure is typically in the 8-15 mmHg (10-20 mbar) range.
Cerebrospinal fluid pressure is typically determined using a
two-piece manometer attached to a 3-way stopcock valve which is
connected to a spinal needle.
[0057] During a diagnostic spinal puncture, alternatively called a
spinal tap or a spinal puncture, a needle is inserted between two
lumbar vertebrae and into the spinal canal in order to remove a
sample(s) of cerebrospinal fluid (CSF), which surrounds the brain
and the spinal cord. In some instances, the CSF is collected and
its physical, chemical, microscopic, and infectious properties are
inspected. Physical properties of CSF that are checked include:
color, turbidity, and viscosity. Chemical components of CSF that
are routinely tested for include glucose and proteins. However,
additional testing includes: protein electrophoresis to distinguish
different types of protein; immunoglobulin G (IgG) detection;
myelin basic protein detection; lactic acid detection; lactate
dehydrogenase detection; glutamine detection; C-reactive protein
detection; tumor markers such as carcinoembryonic antigen (CEA),
alpha-fetoprotein (AFP), and human chorionic gonadotropin (hCG);
amyloid beta 42 (A.beta.42) protein detection; and tau protein
detection. Microscopic examination of CSF comprises analyzing the
sample for total cell counts including red and white blood cells;
additionally, in some instances, a cytology test is performed to
determine the presence or absence of abnormal cells such as tumor
cells or immature blood cells. Infectious tests performed include:
CSF gram stain, culture, and sensitivity test to detect
microorganisms and predict best choices for antimicrobial therapy;
detection of viruses using polymerase chain reaction (PCR);
detection of CSF cryptococcal antigen to detect a fungal infection
caused by yeast; detection of specific antibodies; CSF acid-fast
bacilli (AFB) test to detect mycobacteria such as Mycobacterium
tuberculosis; detection of parasites; and CSF syphilis test.
[0058] In some instances, diagnostic spinal punctures are used to
diagnose: bacterial, fungal, and viral infections including
meningitis, encephalitis, and neurosyphilis or syphilis; bleeding
around the brain or spinal cord including subarachnoid hemorrhages;
inflammation of the brain, spinal cord, or bone marrow including
myelitis; cancer including brain cancer, spinal cord cancer, and
leukemia; neurological disorders including demyelinating diseases
such as multiple sclerosis and demyelination polyneuropathy,
Guillain-Barre syndrome, mitochondrial disorders,
leukencephalopathies, paraneoplastic syndromes, Reye syndrome;
headaches of unknown cause; and intracranial pressure disorders
including pseudotumor cerebri also known as idiopathic intracranial
hypertension (IIH), spontaneous intracranial hypotension, and
normal pressure hydrocephalus.
[0059] Therapeutic lumbar punctures (alternatively called
therapeutic spinal punctures) are performed in the same manner as
diagnostic spinal punctures however, instead of collecting a sample
of CSF, a therapeutic agent is delivered to the subarachnoid space.
In some embodiments, therapeutic agents delivered via a spinal
puncture include but are not limited to: anesthetics such as
bupivacaine, lidocaine, tetracaine, procaine, ropivacaine,
levobupivacaine, prilocaine, and cinchocaine; opioids such as
morphine, fentanyl, diamorphine, buprenorphine, and pethidine or
meperidine; non-opioids such as clonidine; chemotherapeutic agents
such as methotrexate, cytarabine, hydrocortisone, and thiotepa;
contrast agents or dyes such as iohexol, metrizamide, iopamidol,
ioversol, iopromide, iodixanol, iolotran, and iodophenylundecylic
acid; anti-spasmodic agents such as baclofen; antibiotics such as
gentamicin sulphate; proteins such as idursulfase.
Tactile Sensing Devices and Systems
[0060] Disclosed herein, in certain embodiments, are tactile
sensing devices comprising: a) a frame comprising a needle guide,
the needle guide having a proximal opening and a distal opening and
a track therebetween configured to guide a needle, the track
comprising a notch configured to reversibly and/or temporarily
secure the needle in place; wherein the needle guide is in open
connection with a slot such that a needle is moved toward the track
along the slot until the needle reaches the notch of the track, the
slot comprising a first slot wall and a second slot wall configured
to guide a needle towards the needle guide; and b) a sensor array,
the sensor array comprising: a first sensor comprising a first
surface, a second sensor comprising a second surface, and a sensor
array slit positioned in between the first sensor and the second
sensor, the first sensor configured to output a first voltage
signal in response to a first change in a first pressure applied to
the first surface, and the second sensor configured to output a
second voltage signal in response to a second change in a second
pressure applied to the second surface; wherein the sensor array is
coupled to and positioned directly underneath the needle guide.
[0061] Disclosed herein, in certain embodiments, are tactile
sensing systems, comprising: a frame comprising a sensor unit and
an electronic unit; the sensor unit comprising: i) a needle guide,
the needle guide having a proximal opening and a distal opening and
a track therebetween configured to guide a needle, the track
comprising a notch configured to secure the needle in place;
wherein the needle guide is in open connection with a slot, the
slot comprising a first slot wall and a second slot wall configured
to guide a needle towards the needle guide; and
ii) a sensor array, the sensor array comprising: a first sensor
comprising a first surface, a second sensor comprising a second
surface, and a sensor array slit positioned in between the first
sensor and the second sensor, the first sensor configured to output
a first voltage signal in response to a first change in a first
pressure applied to the first surface, and the second sensor
configured to output a second voltage signal in response to a
second change in a second pressure applied to the second surface;
wherein the sensor array is positioned directly underneath the
needle guide; the electronic unit, comprising: i) a display screen
operatively coupled to the sensor array, the display screen
configured to display: a pressure map representing a target tissue
location in an individual in need thereof based upon the first
voltage signal and the second voltage signal from the sensor array
and a projected subcutaneous needle location to be inserted into
the individual; and ii) a connector configured to operatively
connect the electronic unit to the sensor unit; and a computing
device comprising a processor operatively coupled to the sensor
unit and the electronic unit, and a non-transitory computer
readable storage medium with a computer program including
instructions executable by the processor causing the processor to:
i) convert the first voltage signal and the second voltage signal
received from the sensor array into the pressure map and display
the pressure map on the display screen and ii) calculate the
projected subcutaneous needle location to be inserted into the
individual and output the projected needle location on the display
screen.
[0062] FIGS. 1A and 1B show an illustration of one embodiment of
the tactile sensing device 100. In some embodiments, the tactile
sensing device 100 comprises a sensor array (not shown in FIGS.
1A-B), a display screen 4, a needle guide 2, and a pressure sensor
connector 12. In some embodiments, the tactile sensing device 100
is configured to image a desired target tissue location and guide a
needle to the desired target tissue location. In some embodiments,
the tactile sensing device 100 provides the user with targeted
needle placement. In some embodiments, the tactile sensing device
100 provides the user with visual needle guidance.
Target Tissue Location
[0063] In some embodiments, the tactile sensing device images a
target tissue location. In some embodiments, the desired target
tissue location is the bone marrow. In some embodiments, the
desired target tissue location is the epidural or subarachnoid
space. In some embodiments, the desired target tissue location is
gap between two spinous processes. In some embodiments, the tactile
sensing device images bone and non-bone structures around a target
tissue location. In some embodiments, the tactile sensing device
images the lumbar vertebrae and the non-bone structures surrounding
the lumbar vertebrae. In some embodiments, the tactile sensing
device images the sacral vertebrae and the non-bone structures
surrounding the sacral vertebrae. In some embodiments, the tactile
sensing device images the lumbar and sacral vertebrae and the
non-bone structures surrounding the lumbar and sacral vertebrae. In
some embodiments, the tactile sensing device images the spinous
processes and the non-bone structures surrounding the spinous
processes. In some embodiments, the tactile sensing device images
the L3 and L4 spinous processes and the non-bone structures
surrounding the L3 and L4 spinous processes. In some embodiments,
the tactile sensing device images the L4 and L5 spinous processes
and the non-bone structures surrounding the L4 and L5 spinous
processes. In some embodiments, the tactile sensing device images
the L5 and S1 spinous processes and the non-bone structures
surrounding the L5 and S1 spinous processes.
[0064] In some embodiments, the tactile sensing device images a
first and second bone and non-bone structures. In some embodiments,
the tactile sensing device images a plurality of bone and non-bone
structures. In some embodiments, a bone structure is a rib. In some
embodiments, a bone structure is an articular surface. In some
embodiments an articular surface is a vertebral articulation, an
articulation of a first bone of a hand with a second bone of the
hand, an elbow joint, a wrist joint, an axillary articulation of a
first bone of a shoulder with a second bone of the shoulder, a
sternoclavicular joint, a temporomandibular joint, a sacroiliac
joint, a hip joint, a knee joint, or an articulations of a first
bone of a foot with a second bone of the foot. In some instances, a
vertebral articulation is a spinous process. In some embodiments, a
non-bone structure is subcutaneous tissue, a muscle, a ligament,
adipose tissue, a cyst, or a cavity.
[0065] FIG. 1A shows a perspective view of the tactile sensing
device 100. FIG. 1B shows an additional perspective view of the
tactile sensing device 100 illustrating a user 28 actively using
the tactile sensing device 100 in conjunction with a needle 14 and
a pressure sensor 16. The user 28 is shown holding the needle 14
with the right hand while holding the tactile sensing device 100
with the left hand. In some embodiments, the user 28 holds the
needle 14 with the left hand while holding the tactile sensing
device 100 with the right hand. In some embodiments, the tactile
sensing device 100 accommodates left and right handedness.
Needles
[0066] In some embodiments, the systems disclosed herein further
comprise a needle 14, a stylet, or a catheter. In some embodiments,
the needle is an atraumatic, also known as pencil-point type
needle, or a traumatic needle, also known as a classic needle or a
Quincke type needle. In some embodiments, the system further
comprises a spinal needle. In some embodiments, the spinal needle
is a Quincke spinal needle, a Whitacre spinal needle, or a Sprotte
spinal needle. In some embodiments, the system further comprises an
epidural needle. In some embodiments, the epidural needle is a
Weiss epidural needle, a Tuohy epidural needle, or a Hustead
epidural needle. In some embodiments, the needle incudes, by way of
non-limiting examples, a 6-gauge needle, an 8-gauge needle, a
13-gauge needle, a 15-gauge needle, a 17-gauge needle, an 18-gauge
needle, a 19-gauge needle, a 20-gauge needle, a 21-gauge needle, a
22-gauge needle, a 23-gauge needle, a 24-gauge needle, a 25-gauge
needle, a 26-gauge needle, a 27-gauge needle, a 28-gauge needle, a
29-gauge needle, a 30-gauge needle, a 31-gauge needle, and a
32-gauge needle. In some embodiments, the needle is a spinal needle
ranging between 1-10 inches in length. In some embodiments, the
needle contains a stylet, also known as an obturator or an
introducer, which is a fine wire, a slender probe, or a solid rod
with a metal hub fitted to match a needle's bevel. In diagnostic
spinal punctures, a stylet is withdrawn from the needle to allow
cerebrospinal fluid to flow out from the spinal canal and through
the needle hub.
[0067] In some embodiments, the system further comprises a
catheter. In some embodiments, the catheter is an epidural tunneled
catheter, which is implanted into the epidural space as a
medication delivery port. In some embodiments, the catheter is used
to monitor intracranial pressure during a diagnostic spinal
puncture procedure. In some embodiments, the catheter is used as
means to continuously remove cerebrospinal fluid and relieve
pressure on the brain of a patient suffering from
hydrocephalus.
[0068] In some embodiments, the pressure sensor 16 is operatively
connected to the tactile sensing device 100 by a pressure sensor
cable 18 that operatively couples the pressure sensor 16 to the
tactile sensing device 100 via a pressure sensor connector 12. In
some embodiments, the pressure sensor connector 12 operatively
connects the tactile sensing device with a fluid pressure sensor.
In some embodiments, the pressure sensor connector 12 is located
distally away from the needle guide 2. In some embodiments, the
pressure sensor connector 12 is a male connector. In some
embodiments, the pressure sensor connector 12 is a female
connector. In some embodiments, the pressure sensor connector 12 is
a pressure sensor port.
[0069] In some embodiments, pressure sensor 16 is operatively
connected to the tactile sensing device 100 and configured to
measure a cerebrospinal fluid pressure. In some embodiments, the
pressure sensor is an electronic pressure sensor. In some
embodiments, the electronic pressure sensor is medical grade. In
some embodiments, the electronic pressure sensor is a Honeywell
TruStability.RTM., board mount pressure sensor, which is capable of
sensing 0-60 mbar. In some embodiments, the electronic pressure
sensor is an uncompensated and unamplified piezoresistive silicon
pressure sensor. In some embodiments, the pressure sensor 16
provides feedback of internal needle pressure during needle
insertion.
[0070] In some embodiments, the pressure sensor 16 is a digital
pressure sensor. In some embodiments, pressure sensor 16 is a
pressure gauge. In some instances, pressure sensor 16 is a
piezoresistive, capacitive, electromagnetic, piezoelectric,
optical, or potentiometric pressure sensor. In some embodiments, a
cerebrospinal fluid pressure measured with the pressure sensor 16
is displayed digitally. In some embodiments, a cerebrospinal fluid
pressure measured with pressure sensor 16 is displayed on display
screen 4 in real-time. In some embodiments, the display screen 4
provides visual needle guidance. In some embodiments, a
cerebrospinal fluid pressure measured with the pressure sensor 16
is displayed digitally on an external display screen. In some
embodiments, a cerebrospinal fluid pressure measured with the
pressure sensor 16 is displayed digitally on an external display
screen of a computing device operatively connected to the tactile
sensing device 100. In some embodiments, a cerebrospinal fluid
pressure measured with pressure sensor 16 is displayed on display
screen 4 in real-time, while user 28 simultaneous advances the
needle 14 into a desired target tissue location.
[0071] In some embodiments, once the needle is guided to and
inserted into a desired target tissue location and the tactile
sensing device 100 is no longer needed, user 28 slides the tactile
sensing device 100 distally away from himself or herself in order
to maintain the needle in place while removing the tactile sensing
device 100 and optionally disconnects the pressure sensor 16.
[0072] In some embodiments, the tactile sensing device 100
comprises a main housing frame 19. In some embodiments, the main
housing frame 19 is the housing of the tactile sensing device 100.
In some embodiments, the main housing frame 19 protects internal
elements of the tactile sensing device 100 such as, but not limited
to, electric circuitry, a power source, and sensor array electric
connections. In some embodiments, the main housing frame 19 is
composed of a plastic or elastomer material including, but not
limited to: polyethylene; polypropylene; polystyrene; polyester;
polylactic acid (PLA); polycarbonate, polyvinyl chloride,
polyethersulfone, polyacrylate or acrylic or polymethylmethacrylate
(PMMA); polysulfone; polyetheretherketone (PEEK); thermoplastic
elastomers or thermoplastic urethanes; or poly-p-xylylene or
parylene.
[0073] In some embodiments, the main housing frame 19 comprises an
electronic unit 34 and a sensor unit 32, as shown in FIG. 1B. In
some embodiments, the main housing frame 19 encompasses, surrounds,
protects, supports, encases, or houses the electronic unit 34 and
the sensor unit 32. In some embodiments, the electronic unit 34 is
disposable. In some embodiments, the electronic unit 34 is
reusable. In some embodiments, the electronic unit 34 is durable.
In some embodiments, the tactile sensing device 100 comprises a
sleeve (not shown in FIGS. 1A-B) that is configured to receive the
electronic unit 34. In some embodiments, the sleeve is a
vacuum-formed sleeve. In some embodiments, the sleeve is sterile.
In some embodiments, the sleeve is composed of a plastic or
elastomer material including, but not limited to: polyethylene;
polypropylene; polystyrene; polyester; polylactic acid (PLA);
polycarbonate, polyvinyl chloride, polyethersulfone, polyacrylate
or acrylic or polymethylmethacrylate (PMMA); polysulfone;
polyetheretherketone (PEEK); thermoplastic elastomers or
thermoplastic urethanes; or poly-p-xylylene or parylene. In some
embodiments, the sleeve is composed of a rubber material including,
but not limited to: silicone rubber, natural rubber,
acrylonitrile-butadiene rubber, hydrogenated
acrylonitrile-butadiene rubber, ethylene propylene diene rubber,
fluorocarbon rubber, chloroprene rubber, fluorosilicone rubber,
polyacrylate rubber, ethylene acrylic rubber, styrene-butadiene
rubber, polyester urethane rubber, or polyether urethane rubber. In
some embodiments, a part of the main housing frame 19 surrounding
the needle guide 2 is made out of clear plastic. In some
embodiments, the main housing frame 19 is made out of clear
plastic. In some embodiments, having the main housing frame 19 or
part of the main housing frame 19 near the needle guide be made out
of clear plastic, enables user 28 to better visualize and guide the
needle 14 as it penetrates the skin of the individual. In some
embodiments, the frame 20 comprises a handle (not shown in FIGS.
1A-B). In some embodiments, the handle is a curved handle, a power
grip handle, or a pinch grip. In some embodiments, the handle
comprises a grip feature.
[0074] In some embodiments, the sensor unit has a length 91, as
shown in FIG. 1A. In some embodiments, the length 91 of the sensor
unit is about 130 mm. In some embodiments, the length 91 of the
sensor unit is about 100 mm. In some embodiments, the length 91 of
the sensor unit is about 50 mm. In some embodiments, the length 91
of the sensor unit is about 150 mm. In some embodiments, the length
91 of the sensor unit is about 25 mm. In some embodiments, the
length 91 of the sensor unit is about 200 mm.
[0075] In some embodiments, the sensor unit has a width 93, as
shown in FIG. 1A. In some embodiments, the width 93 of the sensor
unit is at least about 25 mm to about 200 mm at most. In some
embodiments, the width 93 of the sensor unit is at least about 25
mm to about 150 mm at most. In some embodiments, the sensor unit is
at least about 25 mm to about 130 mm at most. In some embodiments,
the width 93 of the sensor unit is at least about 25 mm to about 50
mm at most. In some embodiments, the width 93 of the sensor unit is
at least about 50 mm to about 200 mm at most. In some embodiments,
the width 93 of the sensor unit is at least about 50 mm to about
150 mm at most. In some embodiments, the width 93 of the sensor
unit is at least about 50 mm to about 130 mm at most. In some
embodiments, the width 93 of the sensor unit is at least about 130
mm to about 200 mm at most. In some embodiments, the width 93 of
the sensor unit is at least about 130 mm to about 150 mm at most.
In some embodiments, the width 93 of the sensor unit is at least
about 150 mm to about 200 mm at most.
[0076] In some embodiments, the electronic unit 34 comprises the
display screen 4. In some embodiments, the display screen 4 is
operatively coupled to the sensor array (not shown in FIGS. 1A-B).
In some embodiments, sensor array 24 is located on the posterior
surface of the tactile sensing device 100. In some embodiments,
sensor array 24 is coupled to the posterior surface of the tactile
sensing device 100. In some embodiments, sensor array 24 is adhered
to the posterior surface of the tactile sensing device 100. In some
embodiments, sensor array 24 is connected to the posterior surface
of the tactile sensing device 100. In some embodiments, the
posterior surface of the tactile sensing device 100 has a curvature
about a longitudinal axis (not shown in FIGS. 1A-B). In some
embodiments, the posterior surface of the tactile sensing device
100 has a curvature about a lateral axis (not shown in FIGS. 1A-B).
In some embodiments, the curvature about a longitudinal axis is
designed to reduce adverse effects of surrounding muscle. In some
embodiments, the curvature about a lateral axis helps the user
comprehend the need to rock the device in instances where there is
significant spinal flexion.
Sensor Arrays
[0077] In some embodiments, the tactile sensing device comprises an
array of sensors. In some embodiments, the sensor array is a
tactile sensor array. In some embodiments, the sensor array
comprises sensors that are piezoresistive sensors. In some
embodiments, the sensor array comprises sensors are piezoelectric
sensors. In some embodiments, the sensor array comprises sensors
are piezoresistive sensors. In some embodiments, the sensor array
comprises sensors that are optical sensors. In some embodiments,
the sensor array comprises sensors that are electromagnetic
sensors. In some embodiments, the sensor array comprises sensors
that are capacitive sensors. In some embodiments, the sensor array
comprises sensors that are potentiometric sensors.
[0078] In some embodiments, the sensor array 8 comprises pressure
sensors. In some embodiments, the pressure sensors are
force-sensitive resistors. Force-sensitive resistors (FSRs) change
their resistance in response to a change in pressure applied to
their surface. In some embodiments, the force-sensitive resistors
decrease their resistance with an increase in pressure applied the
surface of the sensor. In some embodiments, the sensor array
comprises at least one sensor configured to output a signal in
response to a change in pressure applied to its surface.
Force-sensitive resistors are two wire devices with a resistance
that depends on applied force. In some embodiments, the
force-sensitive resistors comprise a voltage divider. In some
embodiments, the voltage divider outputs a voltage value that is
correlated to the resistance; thus, the output voltage value also
changes in response to a pressure applied to the surface of the
sensor. In some embodiments, an increase in voltage indicates an
increase in a pressure applied to the surface of the sensor. In
some instances, the force-sensitive resistors output voltage
signals. In some embodiments, the array of force-sensitive
resistors is a 6.times.3 array comprising eighteen force-sensitive
resistors. In some embodiments, the array of force-sensitive
resistors is an 8.times.4 array comprising thirty two
force-sensitive resistors. In some embodiments, the size of the
array of force-sensitive resistors is dependent upon the surface
area of the individual's body to be examined. In some embodiments,
the array of force-sensitive resistors is configured in a way that
is sufficient to visualize the bone and non-bone structures in the
individual.
[0079] In some embodiments, the sensor array is a screen-printed
pressure sensor array. In some embodiments, the screen-printed
pressure sensor array is also known as a matrix. In some
embodiments, screen-printed pressure sensor arrays offer enhanced
construction, resolution, sensitivity, and customizability, all at
a reduced cost. In some embodiments, the screen-printed pressure
sensor array comprises a ThruMode configuration. As used herein, a
ThruMode configuration refers to an array comprising two parallel
sheets, one with conductive rows; the other with conductive
columns; the locations at which these overlap form sensing cells
(sensels). In some embodiments, the screen-printed pressure sensor
array comprises two parallel sheets, one with conductive rows; the
other with conductive columns; the locations at which these overlap
form sensing cells (sensels). In some embodiments, the
screen-printed pressure sensor array comprises a ShuntMode
configuration. In some embodiments, the drive electronics to
support these arrays necessitate a 16-line shift register and
16-channel multiplexer. In some embodiments, the 16-line shift
register and 16-channel multiplexer are driven by a
microcontrolled.
[0080] In some embodiments, the sensor array is an array of sensor
elements also known as "sensels." In some embodiments, the sensels
are not discrete sensors. In some embodiments, the sensor elements
or sensels are configured to connect to each other. In some
embodiments, the sensor elements are arranged in a grid, with each
sensor element (or "sensel") located at the intersection of a row
and column. In some embodiments, the rows and columns are pinned
out, rather than individual sensors being pinned out, as is the
case with an array of discrete sensors. In some embodiments, the
sensor array is an array of cells. In some embodiments, the sensor
array is an array of sensing cells. In some embodiments, the sensor
array slit is positioned between two rows of sensels. In some
embodiments, the sensor array slit is positioned between two
columns of sensels. In some embodiments, the sensor array slit is
within the bounds of the sensor array, and/or within the bounds of
the sensor array outer edges, and/or within the edges bounding of
the sensor array. In some embodiments, the distal opening of the
needle guide opening is positioned between two rows of sensels. In
some embodiments, the distal opening of the needle guide is
positioned between two columns of sensels. In some embodiments the
distal opening of the needle guide is within the bounds of the
sensor array, and/or within the bounds of the sensor array outer
edges, and/or within the edges bounding of the sensor array.
[0081] In some embodiments, the screen-printed pressure sensor
array comprises a plurality of sensors. In some embodiments, the
sensors are sensing elements or sensels. In some embodiments, the
sensels comprise interdigitated fingers. In some embodiments, the
screen-printed pressure sensor array is a 10.times.5 array. In some
embodiments, the screen-printed pressure sensor array comprises
about 10 columns of sensels and about 5 rows of sensels. In some
embodiments, the screen-printed pressure sensor array comprises
about 5 columns of sensels and about 10 rows of sensels. In some
embodiments, the screen-printed pressure sensor array is designed
to accommodate a slot for needle guidance and device removal. In
some embodiments, the slot interrupts the sensor array. In some
embodiments, the slot extends from a bounding edge of the array to
the distal opening of the track, and is sized and configured to
allow the needle to stay in place once inserted into the subject
while the device itself is removed from the treatment area on the
subject. That is, the spacing at the distal end of the slot is
designed to accommodate a needle, which is angled at a range of
0-30 degrees cephalad. For example, in some embodiments, the slot
comprises a minimum width from a first slot wall to a second slot
wall of 0.5 mm to 15 mm, from 0.5 mm to 10 mm, from 0.5 mm to 6 mm,
from 0.25 mm to 10 mm, from 0.25 mm to 5 mm, about 1.5 mm, about 2
mm, about 2.5 mm, about 3 mm, 2 mm, 3 mm, 2.5 mm, 1.5 mm or about
1-3 mm. For example, in some embodiments, the slot comprises a
terminus width at the slot terminus from a first slot wall to a
second slot wall of 0.5 mm to 15 mm, from 0.5 mm to 10 mm, from 0.5
mm to 6 mm, from 0.25 mm to 10 mm, from 0.25 mm to 5 mm, about 1.5
mm, about 2 mm, about 2.5 mm, about 3 mm, 2 mm, 3 mm, 2.5 mm, 1.5
mm or about 1-3 mm. For example, in some embodiments, the slot
comprises a notch width at the track from a first slot wall to the
notch at the distal opening of 0.5 mm to 15 mm, from 0.5 mm to 10
mm, from 0.5 mm to 6 mm, from 0.25 mm to 10 mm, from 0.25 mm to 5
mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, 2 mm, 3 mm,
2.5 mm, 1.5 mm or about 1-3 mm. For example, in some embodiments,
the slot comprises a distal track width at the distal opening of
the track from a first slot wall to the distal opening of the track
of 0.5 mm to 15 mm, from 0.5 mm to 10 mm, from 0.5 mm to 6 mm, from
0.25 mm to 10 mm, from 0.25 mm to 5 mm, about 1.5 mm, about 2 mm,
about 2.5 mm, about 3 mm, 2 mm, 3 mm, 2.5 mm, 1.5 mm or about 1-3
mm. In some embodiments of the device, the slot comprises a distal
end that is between two sensors or between two sensels. In some
embodiments, the sensor array comprises a slit that substantially
corresponds in size and shape with the distal end of the slot of
the device, and the slit terminates at the distal opening of the
needle guide. In some embodiments the slit of the sensor array
comprises a minimum width along the length of the slit from a first
slit wall to a second slit wall of 0.5 mm to 15 mm, from 0.5 mm to
10 mm, from 0.5 mm to 6 mm, from 0.25 mm to 10 mm, from 0.25 mm to
5 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, 2 mm, 3
mm, 2.5 mm, 1.5 mm or about 1-3 mm. The position of the slot and or
of the slit may be various, depending on the embodiment. That is,
depending on the embodiment, the slot and slit may be leftward
extending from a right boundary of the sensor array, upward
extending from a bottom boundary of the sensor array, downward
extending from a top boundary of the sensor array, rightward
extending from a left boundary of the sensor array, or diagonally
extending from any boundary of the array that is not only leftward
extending, rightward extending, upward extending, or downward
extending from a boundary of the sensor array toward the needle
guide distal opening, all of which directions of extension are
relative to the sensor array when the array is positioned against a
subject and the top boundary is closest to the head of the subject.
In some embodiments, the screen-printed pressure sensor array
comprises increased spacing between the upper and lower 5 rows of
sensels. In some embodiments, the screen-printed pressure sensor
array comprises a symmetric cutout or sensor array slit in that
space. In some embodiments, the cutout or slit in the sensor array
is designed for a slot, which accommodates leftward sliding of the
device off the patient. In some embodiments, the screen-printed
pressure sensor array comprises an opening or an orifice through
which a needle is inserted therethrough. In some embodiments, the
tactile sensing device does not comprise a slot. For example, in
certain embodiments, the tactile sensing device comprises a needle
guide that is reversibly attached to the tactile sensing device, in
which case there is no need for a slot. In some embodiments, the
sensor array does not comprise a slit.
[0082] In some embodiments, the sensor array slit is about 2 mm
wide at the slit minimum width from a first slit wall to a second
slit wall. In some embodiments, the sensor array slit is about 1 mm
wide at the slit minimum width from a first slit wall to a second
slit wall. In some embodiments, the sensor array slit is about 0.5
mm wide at the slit minimum width from a first slit wall to a
second slit wall. In some embodiments, the sensor array slit is
about 3 mm wide at the slit minimum width from a first slit wall to
a second slit wall. In some embodiments, the sensor array slit is
about 0.1 mm wide at the slit minimum width from a first slit wall
to a second slit wall. In some embodiments, the sensor array slit
is about 4 mm wide at the slit minimum width from a first slit wall
to a second slit wall. In some embodiments, the sensor array slit
is about 5 mm wide at the slit minimum width from a first slit wall
to a second slit wall. In some embodiments, the sensor array slit
is about 6 mm wide at the slit minimum width from a first slit wall
to a second slit wall. In some embodiments, the sensor array slit
is about 6 mm wide at the slit minimum width from a first slit wall
to a second slit wall. In some embodiments, the sensor array slit
is about 7 mm wide at the slit minimum width from a first slit wall
to a second slit wall. In some embodiments, the sensor array slit
is about 8 mm wide at the slit minimum width from a first slit wall
to a second slit wall. In some embodiments, the sensor array slit
is about 9 mm wide at the slit minimum width from a first slit wall
to a second slit wall. In some embodiments, the sensor array slit
is about 10 mm wide at the sensor boundary. In some embodiments,
the sensor array slit is about 15 mm wide at the sensor boundary.
In some embodiments, the sensor array slit is about 20 mm wide at
the sensor boundary. In some embodiments, the sensor array slit is
about 30 mm wide or more at the sensor boundary. In some
embodiments, the array slit is a constant width from the distal
opening to the sensor array boundary. In some embodiments, the
array slit gets narrower from the sensor array boundary to the
distal opening of the needle guide. In some embodiments, the array
slit gets wider from the sensor array boundary to the needle guide
distal opening. In some embodiments, the array slit width varies
from the sensor array boundary to the distal opening of the needle
guide.
[0083] In some embodiments, the sensor array slit is at least about
0.1 mm to about 30 mm wide at most from a first slit wall to a
second slit wall. In some embodiments, the sensor array slit is at
least about 0.1 mm to about 25 mm wide at most from a first slit
wall to a second slit wall. In some embodiments, the sensor array
slit is at least about 0.1 mm to about 20 mm wide at most from a
first slit wall to a second slit wall. In some embodiments, the
sensor array slit is at least about 0.1 mm to about 15 mm wide at
most from a first slit wall to a second slit wall. In some
embodiments, the sensor array slit is at least about 0.1 mm to
about 10 mm wide at most from a first slit wall to a second slit
wall. In some embodiments, the sensor array slit is at least about
0.1 mm to about 9 mm wide at most from a first slit wall to a
second slit wall. In some embodiments, the sensor array slit is at
least about 0.1 mm to about 8 mm wide at most from a first slit
wall to a second slit wall. In some embodiments, the sensor array
slit is at least about 0.1 mm to about 7 mm wide at most from a
first slit wall to a second slit wall. In some embodiments, the
sensor array slit is at least about 0.1 mm to about 6 mm wide at
most from a first slit wall to a second slit wall. In some
embodiments, the sensor array slit is at least about 0.1 mm to
about 5 mm wide at most from a first slit wall to a second slit
wall. In some embodiments, the sensor array slit is at least about
0.1 mm to about 4 mm wide at most from a first slit wall to a
second slit wall. In some embodiments, the sensor array slit is at
least about 0.1 mm to about 3 mm wide at most from a first slit
wall to a second slit wall. In some embodiments, the sensor array
slit is at least about 0.1 mm to about 2 mm wide at most from a
first slit wall to a second slit wall. In some embodiments, the
sensor array slit is at least about 0.1 mm to about 1 mm wide at
most from a first slit wall to a second slit wall. In some
embodiments, the sensor array slit is at least about 0.1 mm to
about 0.5 mm wide at most from a first slit wall to a second slit
wall.
[0084] In some embodiments, the screen-printed pressure sensor
array detects a plurality of spinous processes in the lumbar
region. In some embodiments, the screen-printed pressure sensor
array has a center-to-center (C2C) distance of about 6.86 mm
between sensels. In some embodiments, the screen-printed pressure
sensor array has a center-to-center (C2C) distance of about 6.86 mm
between sensels. In some embodiments, the screen-printed pressure
sensor array has a center-to-center (C2C) distance of about at
least 0.5 mm to about 7 mm between sensels. In some embodiments,
the screen-printed pressure sensor array has a center-to-center
(C2C) distance of about 1 mm between sensels. In some embodiments,
the screen-printed pressure sensor array has a center-to-center
(C2C) distance of about 2 mm between sensels. In some embodiments,
the screen-printed pressure sensor array has a center-to-center
(C2C) distance of about 3 mm between sensels. In some embodiments,
the screen-printed pressure sensor array has a center-to-center
(C2C) distance of about 4 mm between sensels. In some embodiments,
the screen-printed pressure sensor array has a center-to-center
(C2C) distance of about 5 mm between sensels. In some embodiments,
the screen-printed pressure sensor array has a center-to-center
(C2C) distance of about 6 mm between sensels. In some embodiments,
the screen-printed pressure sensor array has a center-to-center
(C2C) distance of about 7 mm between sensels. In some embodiments,
the screen-printed pressure sensor array has a center-to-center
(C2C) distance of about 8 mm between sensels. In some embodiments,
the screen-printed pressure sensor array has a center-to-center
(C2C) distance of about 9 mm between sensels. In some embodiments,
the screen-printed pressure sensor array has a center-to-center
(C2C) distance of about 10 mm between sensels.
[0085] In some embodiments, the screen-printed pressure sensor
array has an effective resolution of about 13.72 mm. In some
embodiments, the screen-printed pressure sensor array has an
effective resolution of at least about 1 mm to at most about 15 mm.
In some embodiments, the screen-printed pressure sensor array has
an effective resolution of at least about 5 mm to at most about 10
mm. In some embodiments, the screen-printed pressure sensor array
has an effective resolution of at least about 1 mm to at most about
2.5 mm. In some embodiments, the screen-printed pressure sensor
array has an effective resolution of about 1 mm. In some
embodiments, the screen-printed pressure sensor array has an
effective resolution of about 2 mm. In some embodiments, the
screen-printed pressure sensor array has an effective resolution of
about 3 mm. In some embodiments, the screen-printed pressure sensor
array has an effective resolution of about 4 mm. In some
embodiments, the screen-printed pressure sensor array has an
effective resolution of about 5 mm. In some embodiments, the
screen-printed pressure sensor array has an effective resolution of
about 6 mm. In some embodiments, the screen-printed pressure sensor
array has an effective resolution of about 7 mm. In some
embodiments, the screen-printed pressure sensor array has an
effective resolution of about 8 mm. In some embodiments, the
screen-printed pressure sensor array has an effective resolution of
about 9 mm. In some embodiments, the screen-printed pressure sensor
array has an effective resolution of about 10 mm. In some
embodiments, the screen-printed pressure sensor array has an
effective resolution of about 11 mm. In some embodiments, the
screen-printed pressure sensor array has an effective resolution of
about 12 mm. In some embodiments, the screen-printed pressure
sensor array has an effective resolution of about 13 mm. In some
embodiments, the screen-printed pressure sensor array has an
effective resolution of about 14 mm. In some embodiments, the
screen-printed pressure sensor array has an effective resolution of
about 15 mm. In some embodiments, the effective resolution of the
screen-printed pressure sensor array is determined by Nyquist
criterion. In some embodiments, the effective resolution of the
screen-printed pressure sensor array is determined by the total
number of sensels in the sensor array. In some embodiments, the
sensitivity of the screen-printed pressure sensor array is defined
by array construction (i.e. related to spacer depth, silver-ink
conductivity, and FSR thickness).
[0086] In some embodiments, the sensor array visualizes two
vertebral gaps. In some embodiments, the sensor array visualizes
the upper- and lower-most spinous processes (SPs) in the imaged
area under the sensor array or within range of the sensor array. In
some embodiments, the sensor array resolves the midline of a spine.
In some embodiments, the active area imaged by the sensor array is
rectangular (for example comprising a 50 mm.times.20 mm active
area) a polygonal, triangular, circular, or another shape generally
corresponding to the shape of the sensor array shape. In some
embodiments, the screen-printed pressure sensor array visualizes
only two SPs. In some embodiments, height of the screen-printed
pressure sensor array is the sum of the height of two SPs (average
in addition to one standard deviation) and the interspinous process
distance (IPD) (higher-end average in addition to one standard
deviation). In some embodiments, the width of the screen-printed
pressure sensor array is defined as the caudal width of an SP
(though the cranial width, which is significantly smaller than the
caudal width of an SP, is the more superficial feature). In some
embodiments, width of the screen-printed pressure sensor array is
defined is by the shallowest area between the muscle on either side
of the vertebral column. In some embodiments, the caudal width of
an SP is at least about at least 6 mm to about 16 mm at most. In
some embodiments, the cranial width of an SP is at least at least
about 2 mm to about 10 mm at most. In some embodiments, the caudal
width is about 90% larger than the cranial width. In some
embodiments, the caudal width is about 80% larger than the cranial
width. In some embodiments, the caudal width is about 70% larger
than the cranial width. In some embodiments, the caudal width is
about 60% larger than the cranial width. In some embodiments, the
caudal width is about 50% larger than the cranial width. In some
embodiments, the caudal width is about 40% larger than the cranial
width. In some embodiments, the width of the screen-printed
pressure sensor array is at least about 6 mm to about 16 mm at
most. In some embodiments, the width of the screen-printed pressure
sensor array is at least about 7 mm to about 16 mm at most. In some
embodiments, the width of the screen-printed pressure sensor array
is at least about 8 mm to about 16 mm at most. In some embodiments,
the width of the screen-printed pressure sensor array is at least
about 9 mm to about 16 mm at most. In some embodiments, the width
of the screen-printed pressure sensor array is at least about 10 mm
to about 16 mm at most. In some embodiments, the width of the
screen-printed pressure sensor array is at least about 11 mm to
about 16 mm at most. In some embodiments, the width of the
screen-printed pressure sensor array is at least about 12 mm to
about 16 mm at most. In some embodiments, the width of the
screen-printed pressure sensor array is at least about 13 mm to
about 16 mm at most. In some embodiments, the width of the
screen-printed pressure sensor array is at least about 14 mm to
about 16 mm at most. In some embodiments, the width of the
screen-printed pressure sensor array is at least about 15 mm to
about 16 mm at most.
[0087] In some embodiments, the width of the screen-printed
pressure sensor array is at least about 6 mm. In some embodiments,
the width of the screen-printed pressure sensor array is at least
about 7 mm. In some embodiments, the width of the screen-printed
pressure sensor array is at least about 8 mm. In some embodiments,
the width of the screen-printed pressure sensor array is at least
about 9 mm. In some embodiments, the width of the screen-printed
pressure sensor array is at least about 10 mm. In some embodiments,
the width of the screen-printed pressure sensor array is at least
about 11 mm. In some embodiments, the width of the screen-printed
pressure sensor array is at least about 12 mm. In some embodiments,
the width of the screen-printed pressure sensor array is at least
about 13 mm. In some embodiments, the width of the screen-printed
pressure sensor array is at least about 14 mm. In some embodiments,
the width of the screen-printed pressure sensor array is at least
about 15 mm. In some embodiments, the width of the screen-printed
pressure sensor array is at least about 16 mm. In some embodiments,
the width of the screen-printed pressure sensor array is at least
about 17 mm. In some embodiments, the width of the screen-printed
pressure sensor array is at least about 18 mm. In some embodiments,
the width of the screen-printed pressure sensor array is at least
about 19 mm. In some embodiments, the width of the screen-printed
pressure sensor array is at least about 20 mm. In some embodiments,
the width of the screen-printed pressure sensor array is at least
about 25 mm.
Multiplexer
[0088] In some embodiments, the tactile sensing device further
comprises a multiplexer. In some embodiments, there may be more
than one multiplexer. The multiplexer selects voltage output
signals from the sensor and forwards the selected voltage output
signals into a single line. In some embodiments, the multiplexer is
an analog multiplexer. In some embodiments, the analog multiplexer
is a 16:1 or an 8:1 multiplexer. In some embodiments, the analog
multiplexer is a frequency division multiplexer or a wave division
multiplexer. In various further embodiments, the multiplexer is a
digital multiplexer. In some instances, the digital multiplexer is
a time division multiplexer. In some embodiments, the time division
multiplexer is a synchronous time division multiplexer or an
asynchronous time division multiplexer. In some embodiments, the
multiplexer is mounted onto a printed circuit board.
Voltage Divider
[0089] In some embodiments, the tactile sensing device further
comprises a voltage divider. In some embodiments, the voltage
divider is a component of a pressure sensor such as a resistive
force sensor or of an array of sensors. In some embodiments, there
may be more than one voltage divider. In some embodiments, the
pressure sensor array or a sensor thereof which may be a resistive
sensor is coupled to a measuring resistor R.sub.M in a voltage
divider. In some embodiments, the output voltage signal from the
force-sensitive resistors is read out using a voltage divider. In
some embodiments, the output voltage signal read out using the
voltage divider is described by Equation 1 below.
[0090] Equation 1: V.sub.OUT=(R.sub.M
V.sub.IN)/(R.sub.M+R.sub.FSR); wherein V.sub.OUT is the output
voltage signal, R.sub.M is the measuring resistor, V.sub.IN is the
input voltage signal, and R.sub.FSR is the resistance detected by
the pressure-sensitive resistor. In some embodiments, the voltage
divider is a resistive voltage divider, a low-pass RC filter
voltage divider, an inductive voltage divider, or a capacitive
voltage divider.
Voltage Source
[0091] In some embodiments, the tactile sensing device further
comprises a voltage source. In some embodiments, the voltage source
is a battery. In some embodiments, the voltage source is
rechargeable. In some embodiments, the voltage source is removable.
In some embodiments, the voltage source includes, but is not
limited to: a nickel cadmium (NiCd) battery, nickel-metal hydride
(NiMH) battery, a nickel zinc (NiZn) battery, a lead acid battery,
a lithium ion battery (Li-ion), or a lithium ion polymer (Li-ion
polymer) battery.
[0092] In some embodiments, the electronic unit 34 comprises the
display screen 4 and a connector (not shown in FIGS. 1A-B)
configured to operatively connect the electronic unit 34 to the
sensor unit 32. In some embodiments, the display screen 4 is
configured to display: a pressure map 6 representing a target
tissue location in an individual in need thereof based upon a first
voltage signal and a second voltage signal from the sensor array
24, a projected subcutaneous needle location 10 to be inserted into
the individual, and an original skin level needle location 8.
Display Screen
[0093] In some embodiments, the tactile sensing device 100
comprises a display screen 4 to provide visual information to a
user. In some embodiments, the display screen 4 is operatively
connected to the tactile sensing device 100. In some embodiments,
the display screen 4 is a computer screen, a mobile device screen,
or a portable device screen. In some embodiments, the display
screen 4 is a liquid crystal display (LCD). In further embodiments,
the display screen 4 is a thin film transistor liquid crystal
display (TFT-LCD). In some embodiments, the display screen 4 is an
organic light emitting diode (OLED) display. In various further
embodiments, an OLED display is a passive-matrix OLED (PMOLED) or
active-matrix OLED (AMOLED) display. In some embodiments, the
display screen 4 is a plasma display. In some embodiments, the
display screen 4 is a video projector. In still further
embodiments, the display screen 4 is a combination of devices such
as those disclosed herein. In some embodiments, the display screen
4 is a full color display. In some embodiments, the display screen
4 is a monochromatic display.
[0094] In some embodiments, the visual information provided to the
user via a display screen 4 is a pressure map 6 representing bone
and non-bone structures. In some embodiments, the pressure map 6 is
a heat map. In some embodiments, the sensor array comprises at
least one sensor configured to output a signal in response to a
change in pressure applied to its surface, wherein the signal is
represented as a heat map 6. In some embodiments, the heat map 6 is
a graphical representation of voltage signals wherein the
individual voltage output signals are represented as a plurality of
colors, color hues, color saturations, graphical patterns, shading,
geometrical figures, or any combination thereof. In some
embodiments, high voltage output signals are represented in a
red-based color and low voltage output signals are represented in
blue-based color. In some embodiments, high voltages are about 5V.
In some embodiments, high voltages in a heat map correspond to a
bone. In some embodiments, high voltages in a heat map correspond
to spinous processes. In some embodiments, the heat map displays
high voltages in a red color. In some embodiments, the heat map
displays low voltages in a blue color. In some embodiments, low
voltages in a heat map correspond to tissue softer than bone. In
some embodiments, low voltages in a heat map correspond to inter
interspinous ligaments.
[0095] In some embodiments, the pressure map is overlaid onto a
second image. In some embodiments, the second image is a type of
diagnostic image including, but not limited to: radiography image,
magnetic resonance imaging (MM) image, computed tomography (CT)
image, nuclear medicine image, ultrasound image, photoacoustic
image, or thermography image. In some embodiments, the second image
is an image of bone and non-bone structures. In some embodiments,
the second image of a bone and non-bone structure is an image of a
rib; an articular surface such as, a vertebral articulation, an
articulation of a first bone of a hand with a second bone of the
hand, an elbow joint, a wrist joint, an axillary articulation of a
first bone of a shoulder with a second bone of the shoulder, a
sternoclavicular joint, a temporomandibular joint, a sacroiliac
joint, a hip joint, a knee joint, or an articulations of a first
bone of a foot with a second bone of the foot; non-bone structure
is subcutaneous tissue, a muscle, a ligament, adipose tissue, a
cyst, or a cavity.
[0096] In some embodiments, the pressure map 6 is a heat map. In
some embodiments, the pressure map 6 shows the needle position of
the needle 14 at the skin level ("original"), and its adjusted,
projected location, accounting for the depth of the subcutaneous
tissue. In some embodiments, the pressure map 6 displays the
original skin level location of the needle 8. In some embodiments,
the pressure map 6 displays the projected subcutaneous position of
the needle 10, adjusted for the depth of the subcutaneous tissue.
In some embodiments, the pressure map 6 shown in FIG. 1A is
generated by using the tactile sensing device on a lumbar spine
model. In some embodiments, the pressure map 6 shown in FIG. 1A is
generated by using the tactile sensing device on the lumbar region
of a patient. In some embodiments, the pressure map 6 shown in FIG.
1A displays two spinous processes (darker areas) and the soft
tissue (lighter areas) surrounding the spinous processes. In some
embodiments, pressing the tactile sensing device 100 against bone,
outputs a higher voltage signal compared to the voltage signal
output when pressing the tactile sensing device 100 against soft
tissue. In some embodiments, the pressure map 6 enables a user to
correctly identify and distinguish hard tissue (e.g. bone and bony
landmarks) from soft tissue (e.g. adipose tissue, muscle,
ligaments, and tendons).
[0097] In some embodiments, the original skin level needle location
8 is the location at which the needle penetrates the skin of the
individual. In some embodiments, the original skin level needle
location 8 is also termed the original needle location, the
original skin level needle location, or the needle entry location.
In some embodiments, the original skin level needle location 8 is
depicted with a circle. In some embodiments, the projected
subcutaneous needle location 10 is depicted with a cross shape or a
star shape or a crosshair display indicator. In some embodiments,
the original skin level needle location 8 and the projected
subcutaneous needle location 10 are labeled with words, such as
"original" and "projected" or "adjusted," or abbreviations, such as
"0" and "P" in order for a user to identify them correctly on the
display screen 4. In some embodiments, the original skin level
needle location (for example, which is indicated by a crosshair
display indicator) stays at the center of the display, and the heat
map itself is translated based on algorithm output (by the same
factor the crosshair would be in an embodiment where the crosshair
moves based on the movement of the sensor array on the
subject/patient).
[0098] In some embodiments, a trigonometric algorithm, as shown in
Equation 2 below, is used to determine the projected subcutaneous
needle location 10 at which the needle will be once it traverses
the subcutaneous tissue. Equation 2: h=tan(.theta.)*d; wherein h is
solved for in this equation, d refers to the tissue depth; and
.theta. is the cephalad angle in radians at which the needle is
inserted. FIG. 1A shows representative X-, Y-, and Z-axes defining
an origin at the original skin level needle location 8. In some
embodiments, h is the distance along the Y-axis between the
original skin level needle location 8 and the projected
subcutaneous location of the needle 10. That is, while the features
such as bones are shown are in their correct locations, due to the
depth the needle will have to traverse, it will not hit those
features at the angle it's inserted due to adjustment the device
provides in angle and insertion location. Similarly, while the
target location is in its correct location, due to the depth the
needle will traverse, without the adjustment of angle and insertion
direction at the skin level that the device provides, the needle
might otherwise miss its target location subcutaneously. In some
embodiments, the projected subcutaneous needle location 10 is
located distally away from the original skin level needle location
8. In some embodiments, the original skin level needle location 8
has coordinates (x,y,z), as shown in FIG. 1A. In some embodiments,
the Z-axis, shown in FIG. 1A, represents the tissue depth at which
the needle is inserted into a patient. In some embodiments, the
original skin level needle location 8 has coordinates (x,y,0),
wherein z=0 represents the needle has not penetrated the
subcutaneous tissue and is at the level of the skin. In some
embodiments, the projected subcutaneous needle location 10 has
coordinates (x,y+h,z+d), as shown in FIG. 1A. In some embodiments,
z+d represents z-coordinate of the point in space where the tip of
the needle is located once it traverses the subcutaneous tissue. In
some embodiments, d represents the tissue depth. In some
embodiments, .theta. is assumed to be the angulation (i.e. cephalad
angulation, that is, h*tan (treatment angle)=d; tangent of
complementary angles). In some embodiments, .theta. is the
treatment angle defined as the space between the posterior face of
the sensor array and the needle.
[0099] In some embodiments, the (x,y,z) coordinates (x,y+h,z+d) of
the projected subcutaneous location of the needle 10 are displayed
on the display screen 4. In some embodiments, the (x,y) coordinates
(x,y+h) of the projected subcutaneous needle location 10 are
displayed on the display screen 4. In some embodiments, the
y-coordinate y+h of the projected subcutaneous needle location 10
are displayed on the display screen 4. In some embodiments, the
projected subcutaneous needle location 10 is displayed
two-dimensionally on the display screen 4, as shown in FIGS. 1A and
1B. In some embodiments, the projected subcutaneous needle location
10 is displayed two-dimensionally on the display screen 4 by
displaying the (x,y) coordinates (x,y+h). In some embodiments, the
projected subcutaneous needle location 10 is displayed
three-dimensionally on the display screen 4. In some embodiments,
the projected subcutaneous needle location 10 is displayed
three-dimensionally on the display screen 4 by displaying the
coordinates (x,y+h,z+d). In some embodiments, a 3D representation
of the needle, terminating at the projected, subcutaneous site, is
displayed on the display.
[0100] In some embodiments, the depth, d, at which the needle will
be once it traverses the subcutaneous tissue (e.g. adipose tissue,
muscle, ligaments, and/or tendons) is calculated. In some
embodiments, the depth, d, is calculated based on the signal output
of the sensor array. In some embodiments, the depth, d, is
calculated based on a voltage signal ratio, V.sub.max/V.sub.min
produced by the sensor array. In some embodiments, the voltage
signal ratio, V.sub.max/V.sub.min is defined as the ratio between a
maximum voltage reading, V.sub.max, (for example, over a spinous
process) and a minimum voltage reading (for example, over
subcutaneous tissue). In some embodiments, the voltage signal ratio
V.sub.max/V.sub.min is determined by aligning the sensor array such
that the Y-axis shown in FIG. 1A vertically traverses the midline
of the spinous processes (i.e. the Y-axis shown in FIG. 1A
represents the midline of the spinous processes). In some
embodiments, the maximum voltage reading, V.sub.max, and the
minimum voltage reading, V.sub.min, are determined by selecting the
maximum and minimum voltage readings detected along the midline of
the active area subjected to tactile sensing by the sensor array
(e.g. along the Y-axis shown in FIG. 1A). In some embodiments, the
voltage signal ratio V.sub.max/V.sub.min is determined by using the
voltage signal readings located along the midline of a pressure map
6 (i.e. along the Y-axis shown in FIG. 1A).
[0101] In some embodiments, the depth, d, is calculated based on a
first voltage signal ratio V.sub.max1/V.sub.min1 and a second
voltage signal V.sub.max2/V.sub.min2 produced by the sensor array.
In some embodiments, the voltage signal ratio V.sub.max1/V.sub.min1
is acquired by placing the tactile sensing device (i.e. the sensor
array) on the skin surface of a patient. In some embodiments, the
second voltage signal V.sub.max2/V.sub.min2 is an empirically
determined ratio of the maximum voltage reading, V.sub.max2, to the
minimum voltage reading, V.sub.min2 In some embodiments, the
empirically determined second voltage signal ratio
V.sub.max2/V.sub.min2 corresponds to a known depth, d. In some
embodiments, a plurality of second voltage signal ratios
V.sub.max2/V.sub.min2 are empirically obtained using the tactile
sensing device and correlated to a known tissue depth. In some
embodiments, a plurality of second voltage signal ratios,
V.sub.max2/V.sub.min2, are empirically obtained using the tactile
sensing device and correlating the second voltage signal ratios to
a plurality of corresponding tissue depths in a spinal lumbar
model. In some embodiments, a plurality of second voltage signal
ratios, V.sub.max2/V.sub.min2, are empirically obtained using the
tactile sensing device and correlating the second voltage signal
ratios to a plurality of corresponding tissue depths in a human
cadaver. In some embodiments, the plurality of empirically
determined second voltage signal ratios, V.sub.max2/V.sub.min2, and
corresponding tissue depths are compiled in a tissue depth
database. In some embodiments, the tissue depth database is
accessed by the computing device of the tactile sensing system. In
some embodiments, the computing device obtains a first voltage
signal ratio, V.sub.max1/V.sub.min1, accesses the tissue depth
database, compares the first voltage signal ratio,
V.sub.max1/V.sub.min1 to an empirically determined second voltage
signal ratio V.sub.max2/V.sub.min2, obtains the tissue depth
corresponding to the second voltage signal ratio
V.sub.max2/V.sub.min2 (and consequently, also corresponding to the
first voltage signal ratio V.sub.max1/V.sub.min1), and uses the
obtained tissue depth to calculate the subcutaneous projected
needle location 10 based on Equation 2.
[0102] In some embodiments, the tissue depth, d, used in Equation 2
(i.e. the level at which the needle will be once it traverses the
subcutaneous tissue) is calculated based on a machine-learning
algorithm. In some embodiments, the machine-learning algorithm is
selected from a plurality of machine-learning algorithms. In some
embodiments, the machine-learning algorithm selected to calculate
tissue depth, d, used in Equation 2, is the machine-learning
algorithm that outputs the best approximation of the tissue depth
(i.e. that outputs the least amount of error). In some embodiments,
the machine-learning algorithm learns a target function (f) that
best maps a voltage signal ratio V.sub.max/V.sub.min to a tissue
depth. In some embodiments, the machine-learning algorithm learns a
target function (f) that predicts a tissue depth based on a voltage
signal ratio V.sub.max/V.sub.min. In some embodiments, the
machine-learning algorithm includes an irreducible error to account
for not having sufficient attributes to predict the tissue depth.
In some embodiments, the function (f) is linear. In some
embodiments, the function (f) is nonlinear.
[0103] In some embodiments, the tactile sensing device comprises a
machine-learning system. In some embodiments, the machine-learning
system comprises a machine-learning model, a set of parameters, and
a learner. In some embodiments, the machine-learning model makes
predictions or approximations of a tissue depth. In some
embodiments, the parameters are the input that is used by the model
to make its approximations. In some embodiments, the parameters are
the first voltage signal ratio V.sub.max1/V.sub.min1, the second
voltage signal ratio V.sub.max2/V.sub.min2, and the known tissue
depths (e.g. obtained from human cadavers, patients (e.g. actual
outcome), and/or spinal lumbar models). In some embodiments, the
learner is the system that adjusts the parameters, and in turn the
machine-learning model, by looking at differences in the
predictions versus actual outcome. In some embodiments, the
machine-learning system uses a mathematical equation to express the
relationship between the second voltage signal ratio
V.sub.max2/V.sub.min2 and a known tissue depth. In some
embodiments, the first voltage signal ratio V.sub.max1/V.sub.min1
is given to the machine-learning system. In some embodiments, the
first voltage signal ratio V.sub.max1/V.sub.min1 is the training
data used by the learner to train the machine-learning model and
improve the predicted approximations of the tissue depth. In some
embodiments, the learner makes adjustments to the parameters in
order to refine the machine-learning model. In some embodiments,
the machine-learning model predicts a tissue depth by: a) having
the machine-learning model receive input data or training data
(i.e. the first voltage signal ratio V.sub.max1/V.sub.min1) using a
mathematical equation to represent the training data, c) having the
learner compare the training data to the mathematical equation; d)
having the learner adjust the training data to reshape the
machine-learning model (i.e. to adjust the mathematical equation
used by the machine-learning model in step b)), repeating steps
a)-d) until a high degree of confidence is achieved on the
predicted tissue depth.
[0104] In some embodiments, the machine-learning algorithm enhances
the accuracy of the displayed, projected subcutaneous needle
location. In some embodiments, the visualization of a projected
subcutaneous needle location helps the user optimally gauge when
they have positioned the sensor array at a location that will allow
them to accurately and reliably reach the midline of the target
tissue location (e.g. the spine) with the needle.
[0105] In some embodiments, the sensor unit 32 is disposable. In
some embodiments, the sensor unit 32 is reusable. In some
embodiments, the sensor unit 32 comprises the needle guide 2. In
some embodiments, the sensor unit 32 comprises a sensor array 24.
In some embodiments, the sensor array 24 comprises: a first sensor
comprising a first surface, a second sensor comprising a second
surface, the first sensor configured to output a first voltage
signal in response to a first change in a first pressure applied to
the first surface, and the second sensor configured to output a
second voltage signal in response to a second change in a second
pressure applied to the second surface. In some embodiments, the
sensor array 24 is coupled to and positioned directly underneath
the needle guide 2. In some embodiments, the sensor array 24 is a
matrix array. In some embodiments, the sensor array 24 is a
flexible sensor array. In some embodiments, the sensor array 24 is
attached to a sensor array attachment area (not shown in FIGS.
1A-B). In some embodiments, the sensor array 24 is adhered to the
posterior surface of the tactile sensing device 100.
[0106] In some embodiments, the tactile sensing device 100
comprises a recess 124 comprising a first recess wall 126a and a
second recess wall (not shown in FIGS. 1A and 1B). In some
embodiments, the first recess wall 126a and the second recess wall
are connecting walls. In some embodiments, the first recess wall
126a and the second recess wall form a first "U" shape. In some
embodiments, the needle guide 2 comprises a slot 38. In some
embodiments, the needle guide 2 comprises a first slot wall 130a
and a second slot wall (not shown in FIGS. 1A and 1B). In some
embodiments, the first slot wall 130a and the second slot wall are
connecting. In some embodiments, the first slot wall 130a and the
second slot wall form a second "U" shape. In some embodiments, the
needle guide 38 comprises a slot opening 38a and a slot terminus
38b. In some embodiments, the needle guide 2 has a proximal opening
134a and a distal opening 134b and a track therebetween configured
to guide the needle 14 at a predetermined angle relative to the
surfaces of the sensors and/or relative to the face of the sensor
array as the needle 14 travels into the subject.
[0107] In some embodiments, the sensor array (not shown in FIGS.
1A-B) is an array of sensor elements also known as "sensels." In
some embodiments, the sensels are not discrete sensors. In some
embodiments, the sensor elements or sensels are configured to
connect to each other. In some embodiments, the sensor elements are
arranged in a grid (not shown in FIGS. 1A-B), with each sensor
element (or "sensel") located at the intersection of a row and
column. In some embodiments, the rows and columns are pinned out,
rather than individual sensors being pinned out, as is the case
with an array of discrete sensors. In some embodiments, the sensor
array (not shown in FIGS. 1A-B) is an array of cells. In some
embodiments, the sensor array (not shown in FIGS. 1A-B) is an array
of sensing cells. In some embodiments, the sensor array slit (not
shown in FIGS. 1A-B) is positioned between two rows or more of
sensels. In some embodiments, the sensor array slit (not shown in
FIGS. 1A-B) is positioned between two columns or more of sensels.
In some embodiments, the sensor array slit (not shown in FIGS.
1A-B) is within the bounds of the sensor array, and/or within the
bounds of the sensor array outer edges, and/or within the edges
bounding of the sensor array. In some embodiments, the distal
opening 134b of the needle guide 2 is positioned between two rows
of sensels. In some embodiments, the distal opening 134b of the
needle guide 2 is positioned between two columns of sensels. In
some embodiments the distal opening 134b of the needle guide 2 is
within the bounds of the sensor array, and/or within the bounds of
the sensor array outer edges, and/or within the edges bounding of
the sensor array. In some embodiments, the distal opening 134b is
between two or more sensors of the sensor array. In some
embodiments, the distal opening 134b is positioned between two rows
or more of sensels. In some embodiments, the distal opening 134b is
positioned between two columns or more of sensels.
[0108] In some embodiments, track is shaped as a "V." In some
embodiments, track is shaped as a "U." In some embodiments, the
track comprises a lip that protrudes from one of the slot walls
(i.e., from the first slot wall 130a or from the second slot wall
(not shown in FIGS. 1A and 1B)). In some embodiments, the lip
aligns with an arm of the V or of the U shape. The track shape and
the lip thereof allows the needle to be seated in the track and not
slip toward the opening of the slot prior to or during insertion of
the needle into the subject.
[0109] In some embodiments, the needle guide 2 is flexible. In some
embodiments, the needle guide 2 comprises a flexible catch. In some
embodiments, the flexible catch comprises a flexible material. In
some embodiments, the first slot wall 130a and the second slot wall
130b are composed of a soft, flexible material. Non-limiting
examples of the soft, flexible materials include: silicone rubber,
natural rubber, acrylonitrile-butadiene rubber, hydrogenated
acrylonitrile-butadiene rubber, ethylene propylene diene rubber,
fluorocarbon rubber, chloroprene rubber, fluorosilicone rubber,
polyacrylate rubber, ethylene acrylic rubber, styrene-butadiene
rubber, polyester urethane rubber, or polyether urethane rubber. In
some embodiments, the catch is shaped as a disc with a slit therein
that aligns with an axis of the slot that extends from the terminus
to the opening of the slot. In some embodiments, the catch allows
for reversible and temporary holding of the needle or of the
injector device and results in alignment with and seating of the
needle in the track such that the needle does not slip toward the
opening of the slot prior to or during the movement of the needle
into the subject.
[0110] In some embodiments, the recess 124 has an axis Y2, as shown
in FIG. 1A, that extends from the base of the first "U" to between
the first recess wall 126a and the second recess wall. In some
embodiments, the slot 38 shares the axis Y2 of the recess 124. In
some embodiments, the needle guide 2 is located at the apex of the
second "U." In some embodiments, the needle guide 2 is located at
the apex of the first "U." In some embodiments, the recess 124
provides a stop for the needle 14 such that the syringe barrel
and/or the needle hub have a limited distal distance that they are
advanced along the slot 38. In some embodiments, the needle 14
rests on the recess 124.
[0111] In some embodiments, the pressure sensor connector 12 is
located along axis Y2. In some embodiments, the pressure sensor
connector 12 is located at an offset relative to axis Y2. In some
embodiments, the pressure sensor connector 12 is located distally
away from the recess 124, between the posterior end of the display
screen 4 and the recess 124. In some embodiments, the recess 124
comprises the needle guide 2. In some embodiments, the first recess
wall 126a or the second recess wall, or both, comprise a top bevel
128, such that the recess 124 is narrower closer to the slot 38
than the recess 124 is further from the slot 38. In some
embodiments, the tactile sensing device 100 does not comprise a
slot 38. In some embodiments, the needle 14 is inserted in the
recess 124, along the edges of the top bevel 128, when the tactile
sensing device 100 does not comprise a slot 38. In some
embodiments, the top bevel 128 is positioned on top of the anterior
surface of the sensor array.
[0112] In some embodiments, one or more of the walls of the slot 38
are perpendicular to the track. In some embodiments, the track
comprises a notch (not shown in FIGS. 1A-B) or catch configured to
reversibly or temporarily secure the needle in place. In some
embodiments, the slot 38 is parallel to the track. In some
embodiments, one or more of the walls of the slot 38 parallel to
the top bevel 128, as shown in FIG. 1A. In some embodiments, the
slot 38 is enclosed by the first slot wall 130a and the second slot
wall, (the second slot wall is not shown in FIGS. 1A-B). In some
embodiments, the needle guide 2 is in open connection with the slot
38. In some embodiments, the slot 38 comprises a first slot wall
and a second slot wall (not shown in FIGS. 1A-B). In some
embodiments, the slot walls are configured to guide a needle 14
towards the needle guide 2. In some embodiments, the needle guide 2
is fixed.
[0113] In some embodiments, the track 144 is angled at a treatment
angle ranging between about 40.degree. to about 90.degree. with
respect to the posterior face of the sensor array 24. In some
embodiments, the track 144 is angled at a treatment angle ranging
between about 69.degree. to about 81.degree. with respect to the
posterior face of the sensor array 24. In some embodiments, the
track 144 is angled at a treatment angle ranging between about
75.degree. to about 90.degree. with respect to the posterior face
of the sensor array 24.
[0114] In some embodiments, the top bevel 128 comprises a first
needle alignment guide 36a, a second needle alignment guide 36b,
and a third needle alignment guide 36c. In some embodiments, the
needle alignment guide 36 is a marking, a notch, an indentation, a
sticker, a light, a light bulb, a light emitting diode (LED), or
any combination of these, configured to provide the user with an
alignment reference tool to align the needle along a proper axis or
in a proper location that is adequate for needle insertion into an
individual along the track. In some embodiments, the needle
alignment guide 36 is a visual cue for midline alignment. In some
embodiments, the needle alignment guide 36 is a mechanical feature
(e.g., a notch) in the area located along an edge of the needle
guide 2 and/or slot 38. In some embodiments, the frame comprises a
needle alignment guide. In some embodiments, the needle alignment
guide is a notch or a marking on the surface of the tactile sensing
device. In some embodiments, the needle alignment guide 36 alerts
the user when the needle is or is not in a proper or correct
alignment or position. For instance, in one embodiment, the needle
alignment guide 36 is an LED that turns on and emits a green light
when the needle is aligned properly or in the correct position for
insertion. For instance, in some embodiments, the needle alignment
guide 36 is an LED that turns on and emits a red light when the
needle is aligned improperly or is not in the correct position for
insertion. In some embodiments, the needle alignment guide 36 is an
LED that only turns on when the needle is aligned properly or in
the correct position for insertion. In some embodiments, the needle
alignment guide 36 is an LED that only turns on when the needle is
not aligned properly or is not in the correct position for
insertion.
[0115] FIGS. 2A and 2B show an illustration of an embodiment of the
tactile sensing device 200. In some embodiments, the tactile
sensing device 200 comprises a sensor array (not shown in FIGS.
2A-B), a display screen 4, a needle guide 2, and a pressure sensor
connector 12. In some embodiments, the display screen 4 comprises
pressure map features, such as a simple centerline, or a plurality
of active lines, which connect detected peaks and offer a visual
indication of alignment (e.g. flashing or an once it's within
5.degree. of the centerline). In some embodiments, the pressure map
6 displayed on the display screen 4 comprises visual cues such as
crosshairs 30, as shown in FIG. 2A. In some embodiments, the
crosshairs 30 provide the user with a visual indication of midline
alignment (i.e. alignment both along longitudinal and lateral axes
on the display screen 4). In some embodiments, the tactile sensing
device 200 provides visual, auditory, and/or haptic cues to
indicate to a user when the tactile sensing device 200 and/or the
needle are aligned or not aligned with the target tissue
location.
[0116] In some embodiments, the tactile sensing device 200
comprises a needle guide 2. In some embodiments, the needle guide 2
comprises a proximal opening 134a and a distal opening 134b. In
some embodiments, a track 144 is in between the proximal opening
134a and the distal opening 134b. In some embodiments, the track
144 is configured to guide a needle into a target tissue location
at a predetermined treatment angle. FIGS. 2A-B show the tactile
sensing device 200 comprising a slot 38. In some embodiments, the
slot 38 is perpendicular to the needle guide 2, as shown in FIG.
2A. FIG. 2A shows the tactile sensing device 200 comprising a
recess 124. In some embodiments, the recess 124 comprises a
pressure sensor connector 12. In some embodiments, the recess 124
ends on a second slot wall (not shown in FIGS. 2A-B).
[0117] FIG. 2B shows a user 28 resting a needle 14 on notch 132 and
on the track 144 (not shown in FIG. 2B, but shown in FIG. 2A). In
some embodiments, the notch 132 reversibly secures the needle onto
the track 144. In some embodiments, the notch 132 reversibly
secures the needle in place. In some embodiments, the notch 132
aligns the needle at a correct angle aligned with the angle of the
track. In some embodiments, the notch 132 aligns the needle with a
target tissue location. In some embodiments, the notch 132
comprises a lip that interrupts and protrudes from one or more slot
wall and temporarily and reversibly reduces the chance of or
prevents the needle from moving off the track 144. In some
embodiments, the notch 132 prevents the needle from being inserted
off center into the target tissue location. In some embodiments,
the needle 14 rides over and/or along the notch (not shown in FIGS.
2A-B).
[0118] In some embodiments, the notch 132 is or comprises a lip. In
some embodiments, the notch 132 comprises a rubber or plastic lip
that must be overcome by the needle in order to move the needle 14
along the track 144 and toward the distal opening 134b. In some
embodiments, the lip is shaped as a "U" and comprises an opening.
In some embodiments, the lip is flexible. In some embodiments, the
lip is rigid. In some embodiments, the opening of the lip is
narrower than the proximal opening 134a in order to prevent a
needle 14 from moving off the track 144 once inserted through the
notch 132. In some embodiments, the notch 132 comprises more than
one lips or rings positioned along the track 144. In some
embodiments, the notch 132 comprises at least two lips or rings
positioned along the track 144. In some embodiments, the notch 132
comprises at least three lips or rings positioned along the track
144. In some embodiments, the notch 132 comprises at least four
lips or rings positioned along the track 144. In some embodiments,
the notch 132 comprises at least five lips or rings positioned
along the track 144. In some embodiments, the notch 132 comprises
at least ten lips or rings positioned along the track 144.
[0119] In some embodiments, the notch 132 comprises a groove. In
some embodiments, the groove has a "U" shaped form and has a first
lateral wall and a second lateral wall that have both extremities
(or arms) open. In some embodiments, one pair of projections are
located in the first lateral wall and in the second lateral wall,
opposite from one another and with a profile that defines the
continuation of the curved wall of each groove, in a way that
accommodates the cylindrical cannula of the needle 14. In some
embodiments, the user inserts the needle 14 into the groove by
pushing the needle into the groove, with a light force so that the
body of the needle overcomes the projections of the groove. In some
embodiments, the user releases the needle 14, by pulling on its
proximal extremity, with a light force so that the body of the
needle passes the projections of the groove. In some embodiments,
alternatively, the user releases the needle 14, by sliding the
needle 14 along the track 144, towards the proximal opening 134a.
In some embodiments, the groove is composed of a soft, flexible
material in order to enable separation of the extremities of the
"U" when the needle 14 is either inserted or released.
[0120] In some embodiments, the notch 132 comprises a beveled edge.
In some embodiments, the beveled edge must be overcome in order to
move the needle 14 along the track 144 and toward the distal
opening 134b. In some embodiments, the notch 132 comprises more
than beveled edges positioned along the track 144. In some
embodiments, the beveled edge is positioned at the proximal opening
134a. In some embodiments, the beveled edge is positioned at the
distal opening 134b.
[0121] In some embodiments, the notch 132 comprises a bump. In some
embodiments, the bump is positioned at the proximal opening 134a.
In some embodiments, the bump is positioned at the distal opening
134b. In some embodiments, the bump is composed of a soft, flexible
material such as, but not limited to rubber or silicone. In some
embodiments, the bump is shaped as a "U." In some embodiments, the
bump is shaped as a "V." In some embodiments, the bump mates with
the notch 132. In some embodiments, the bump interrupts the wall of
the slot or protrudes from the wall of the slot.
[0122] In some embodiments, the notch 132 is a plastic piece. In
some embodiments, the notch 132 is a rubber piece. In some
embodiments, the notch 132 is a stopper notch. In some embodiments,
the notch 132 is a grip.
[0123] In some embodiments, the notch 132 is a snap-on notch. In
some embodiments, the user snaps the needle into the snap-on notch
to secure the needle in the track 144. In some embodiments, the
snap-on notch has a "U" shaped form and has a first lateral wall
and a second lateral wall that have both ends open. In some
embodiments, one pair of projections are located in the first
lateral wall and in the second lateral wall, opposite from one
another and with a profile that defines the continuation of the
curved wall of each snap-on notch, in a way that perfectly
accommodates the cylindrical cannula of the needle 14. In some
embodiments, the user inserts the needle 14 into the snap-on notch
by pushing the needle into the snap-on notch, with a light force so
that the cannula of the needle overcomes the projections of the
snap-on notch. In some embodiments, the user releases the needle
14, by pulling on its proximal end, with a light force so that the
body of the needle passes the projections of the snap-on notch. In
some embodiments, alternatively, the user releases the needle 14,
by sliding the needle 14 along the track 144, towards the proximal
opening 134a. In some embodiments, the snap-on notch is composed of
a soft, flexible material in order to enable separation of the ends
of the "U" when the needle 14 is either inserted or released. In
some embodiments, the snap-on notch is composed of a rigid
material.
[0124] In some embodiments, the notch 132 comprises a magnet
located at the proximal opening 134a. In some embodiments, the
notch 132 comprises a magnet located at the distal opening 134b. In
some embodiments, the notch 132 comprises a magnet located along
the track 144. In some embodiments, the notch 132 comprises a
magnet located along the track and shaped as a "U." In some
embodiments, the notch 132 comprises a magnet located along the
track and shaped as a cylinder. In some embodiments, the needle 14
comprises a magnet. In some embodiments, the needle 14 comprises a
magnet located on the needle hub. In some embodiments, the needle
14 comprises a magnet that is coaxially aligned with the needle
cannula. In some embodiments, the needle 14 comprises a magnet
located on the tip of the needle 14. In some embodiments, the
magnet on the notch 132 defines a magnetic axis that is aligned in
a desired predetermined orientation with respect to the needle. In
some embodiments, the magnet on the needle 14 defines a magnetic
axis that is aligned in a desired predetermined orientation with
respect to the notch 132. In some embodiments, the desired
predetermined orientation is the desired treatment angle. In some
embodiments, the magnet on the notch 132 attracts the magnet on the
needle 14 and secures the needle onto the track 144. In some
embodiments, the position of the needle 14 is tracked by tracking
the magnet on the notch 132 and by tracking the magnet on the
needle 14. In some embodiments, the tactile sensing system
comprises a magnetic tracking system to track the position of a
needle in real time.
[0125] In some embodiments, the sensor array (not shown in FIGS.
2A-B) is an array of sensor elements also known as "sensels." In
some embodiments, the sensels are not discrete sensors. In some
embodiments, the sensor elements or sensels are configured to
connect to each other. In some embodiments, the sensor elements are
arranged in a grid (not shown in FIGS. 2A-B), with each sensor
element (or "sensel") located at the intersection of a row and
column. In some embodiments, the rows and columns are pinned out,
rather than individual sensors being pinned out, as is the case
with an array of discrete sensors. In some embodiments, the sensor
array (not shown in FIGS. 2A-B) is an array of cells. In some
embodiments, the sensor array (not shown in FIGS. 2A-B) is an array
of sensing cells. In some embodiments, the sensor array slit (not
shown in FIGS. 2A-B) is positioned between two rows or more of
sensels. In some embodiments, the sensor array slit (not shown in
FIGS. 2A-B) is positioned between two columns or more of sensels.
In some embodiments, the sensor array slit (not shown in FIGS.
2A-B) is within the bounds of the sensor array, and/or within the
bounds of the sensor array outer edges, and/or within the edges
bounding of the sensor array. In some embodiments, the distal
opening 134b of the needle guide 2 is positioned between two rows
of sensels. In some embodiments, the distal opening 134b of the
needle guide 2 is positioned between two columns of sensels. In
some embodiments the distal opening 134b of the needle guide 2 is
within the bounds of the sensor array, and/or within the bounds of
the sensor array outer edges, and/or within the edges bounding of
the sensor array. In some embodiments, the distal opening 34b is
between two or more sensors of the sensor array. In some
embodiments, the distal opening 34b is positioned between two rows
or more of sensels. In some embodiments, the distal opening 34b is
positioned between two columns or more of sensels.
Tactile Sensing Device Methods
[0126] Disclosed herein, in certain embodiments, are methods of
positioning a needle in the tactile sensing device, comprising:
inserting the needle through the slot; guiding the needle in the
slot by sliding the needle in between the first slot wall and the
second slot wall towards the needle guide, wherein a first needle
guide wall connects to the second needle guide wall at the proximal
opening of the needle guide to form a notch at the proximal
opening; securing the needle in place by inserting the needle into
the notch; and sliding the needle along the track that extends from
the notch at the proximal opening to the distal opening of the
needle guide.
Spinal Puncture Methods
[0127] In some embodiments, methods for performing a spinal
puncture in an individual in need thereof, comprise: placing a
tactile sensing device on a lumbar region of the individual;
applying force to the tactile sensing device against the lumbar
region; viewing voltage signals, corresponding to vertebral
articulations, detected by the tactile sensing device resulting
from the application of force to the tactile sensing device against
the lumbar region, on a display screen; localizing two spinous
processes on the image; identifying a gap between a first spinous
process and a second spinous process of the individual; using a
needle guide to insert a needle between the first and second
spinous processes of the individual and into a subarachnoid space;
and collecting cerebrospinal fluid or administering a therapeutic
agent. In some embodiments, the method comprises use of an
operatively connected pressure sensor for fluid-pressure
measurement.
Epidural Methods
[0128] In some embodiments, methods for administering a therapeutic
agent to an epidural space of an individual in need thereof,
comprise: placing a tactile sensing device on a lumbar region of
the individual; applying force to the tactile sensing device
against the lumbar region; viewing voltage signals, corresponding
to vertebral articulations, detected by the tactile sensing device
resulting from the application of force to the tactile sensing
device against the lumbar region, on a display screen; localizing
two spinous processes on the image; identifying a gap between a
first spinous process and a second spinous process of the
individual; using a needle guide to insert a needle between the
first and second spinous processes and into the epidural space of
the individual; and injecting a therapeutic agent into the epidural
space. In some embodiments, this method comprises attachment of a
loss-of-resistance syringe to facilitate detection of
epidural-space entry.
Therapeutic Agents
[0129] In some embodiments, therapeutic agents are delivered via a
spinal puncture. In some embodiments, therapeutic agents delivered
via a spinal puncture include but are not limited to: anesthetics,
analgesics, chemotherapeutic agents, contrast agents or dyes,
anti-spasmodic agents, antibiotics, or proteins. In some
embodiments, anesthetics delivered via a spinal puncture include
but are not limited to: bupivacaine, lidocaine, tetracaine,
procaine, ropivacaine, levobupivacaine, prilocaine, and
cinchocaine. In some embodiments, analgesics delivered via a spinal
puncture include but are not limited to: opioids such as morphine,
fentanyl, diamorphine, buprenorphine, and pethidine or meperidine;
and non-opioids such as clonidine. In some embodiments,
chemotherapeutic agents delivered via a spinal puncture include but
are not limited to: methotrexate, cytarabine, hydrocortisone, and
thiotepa. In some embodiments, contrast agents or dyes delivered
via a spinal puncture include but are not limited to: iohexol,
metrizamide, iopamidol, ioversol, iopromide, iodixanol, iolotran,
and iodophenylundecylic acid. In some embodiments, anti-spasmodic
agents delivered via a spinal puncture include baclofen. In some
embodiments, antibiotics delivered via a spinal puncture include
gentamicin sulphate. In some embodiments, proteins delivered via a
spinal puncture include idursulfase.
Spinous Processes
[0130] In some embodiments, methods for performing a spinal
puncture in an individual in need thereof comprise using a needle
guide to insert a needle between the first and second spinous
processes and into the subarachnoid space of the individual. In
some embodiments, methods for administering a therapeutic agent to
an epidural space of an individual in need thereof comprise using a
needle guide to insert a needle between the first and second
spinous processes and into the epidural space of the individual. In
some embodiments, the first spinous process is a part of the first
lumbar vertebra (L1), L2, L3, or L4 lumbar vertebrae and the second
spinous process is a part of L2, L3, L4, or L5 lumbar vertebrae. In
some further embodiments, the first and spinous process is a
part
[0131] In some embodiments, a kit for performing a diagnostic
spinal puncture in an individual in need thereof, comprises: a
tactile sensing device to image bone and non-bone structures in the
individual; a computer to process voltage signals detected by the
tactile sensing device; a display screen to visualize the bone and
non-bone structures; an electronic pressure sensor to measure
cerebrospinal fluid pressure; and a sleeve.
[0132] In some embodiments, the slot 38 is the entry point or
entrance for the needle 14. In some embodiments, the user first
inserts the needle 14 through the slot opening 38a. In some
embodiments, the user guides the needle 14 in the slot 38 towards
the slot terminus 38b, by sliding the needle 14 in between the
first slot wall 142a and the second slot wall (not shown in FIGS.
2A-B). In some embodiments, the user guides the needle 14 in the
slot 38 t towards the needle guide 2. In some embodiments, the
needle guide 2 comprises a first needle guide wall and a second
needle guide wall (not shown in FIGS. 2A-B). In some embodiments,
the first needle guide wall connects to the second needle guide
wall. In some embodiments, the user contacts the needle 14 with the
first needle guide wall and the second needle guide wall. In some
embodiments, the user secures the needle 14 in place by inserting
the needle 14 into the notch 32 located in between the first needle
guide wall and the second needle guide wall. In some embodiments,
the user slides the needle 14 along the track 144 towards the
distal opening of the needle guide, in order to insert the needle
into a target tissue location of an individual.
[0133] In some embodiments, the tactile sensing device 200
comprises an indentation in the frame 20. In some embodiments, the
indentation is configured to act as a grip for a user. FIG. 2B
demonstrates user 28 utilizing the indentation 42 to hold the
tactile sensing device 200. In some embodiments, the tactile
sensing device 200 comprises a sensor unit 32 and an electronic
unit 34. In some embodiments, the sensor unit 32 and the electronic
unit 34 are operatively coupled to each other. In some embodiments,
the sensor unit 32 and the electronic unit 34 are non-reversibly,
operatively coupled to each other. In some embodiments, the sensor
unit 32 and the electronic unit 34 are reversibly, operatively
coupled to each other. In some embodiments, the tactile sensing
device 200 comprises a tab (not shown in FIGS. 2A-B) on one or more
lateral sides of the sensor unit 32 configured to release the
electronic unit 34 from the sensor unit 32, once it is depressed by
a user. In some embodiments, the tactile sensing device 200
comprises one or more tabs configured to be pinched, depressed, or
pushed by a user in order to detach the electronic unit 34 from the
sensor unit 32. In some embodiments, the sensor unit 32 and the
electronic unit 34 are reversibly, operatively coupled to each
other via a mechanism that includes an audible indication, such as,
but not limited to, a clicking noise, a recording, and/or a ding
sound, that indicates when the sensor unit 32 and the electronic
unit 34 are attached or detached by a user.
[0134] FIG. 3 shows an embodiment of the tactile sensing device
300. In some embodiments, the tactile sensing device 300 comprises
a wide cutout 46 that enables the user to access the needle guide
2. In some embodiments, the wide cutout 46 enables the user to
remove the tactile sensing device 300 by sliding the device
laterally away from the needle, once the needle has been inserted
into an individual.
[0135] In some embodiments, the tactile sensing device 300
comprises a display screen 4 located laterally from the needle
guide 4, as shown in FIG. 3. In some embodiments, the tactile
sensing device 300 comprises a display screen 4 located laterally
from the needle alignment guide 36, as shown in FIG. 3. In some
embodiments, the display screen 4 is a monochromatic screen. In
some embodiments, the display screen 4 is a monochromatic OLED
screen. In some embodiments, the display screen 4 comprises a real
time, on-screen targeting 40. In some embodiments, the on-screen
targeting 40 provides the user with a visual cue that shows the
position of the needle in real time, as the user moves and adjusts
the tactile sensing device 300 to a desired location. In some
embodiments, the on-screen targeting 40 identifies the target
tissue location and alerts the user via an auditory, visual, or
haptic cue. In some embodiments, the on-screen targeting 40
identifies the midpoint between two spinous processes where a
needle is to be inserted in order to access the epidural or the
subarachnoid space.
[0136] In some embodiments, the pressure sensor connector 12 is
positioned at an offset relative to the Y-axis shown in FIG. 3. In
some embodiments, tactile sensing device 300 comprises an
electronic unit 34 comprising the display screen 4 and the pressure
sensor connector 12. In some embodiments, the electronic unit 34 is
elevated and forms a C-grip where the user 28 is able to grip the
device, as shown in FIG. 3. In some embodiments, tactile sensing
device 300 comprises a sensor unit 32. In some embodiments, the
sensor unit 32 acts as a mounting platform, wherein the sensor unit
32 receives the electronic unit 34. In some embodiments, the
electronic unit 34 is non-reversibly mounted on top of the sensor
unit 32. In some embodiments, the electronic unit 34 is reversibly
mounted on top of the sensor unit 32. In some embodiments, the
sensor unit 32 is disposable. In some embodiments, the sensor unit
32 comprises a bifurcated sensor array (not shown in FIG. 3). In
some embodiments, the sensor unit 32 comprises a disposable sensor
array.
[0137] In some embodiments, the tactile sensing device 300
comprises a needle guide platform 136 further comprising a lateral
side needle guide platform wall (not shown in FIG. 3) and an
anterior side needle guide platform wall 140. In some embodiments,
the needle guide platform 136 elevates the needle guide 2. In some
embodiments, the needle guide 2 is fixed. In some embodiments, the
needle guide 2 is adjustable and a user is able to manually or
automatically adjust the height and angle of the needle guide 2. In
some embodiments, the slot of the needle guide 2 comprises a first
slot wall 130a and a second slot wall 130b that connect with each
other. In some embodiments, the first slot wall 130a connects to
the second slot wall 130b to form the slot. In some embodiments,
the slot has an opening and a terminus. In some embodiments, the
proximal opening 134a is at the terminus of the slot on the side of
the device not having the sensors thereon. In some embodiments, the
needle guide 2 comprises a track 144. In some embodiments, the
track 144 is positioned in between a proximal opening 134a and a
distal opening 134b of the needle guide 2. In some embodiments, the
needle guide 2 comprises a notch 132 positioned on the proximal
opening 134a of the needle guide. In some embodiments, the notch
132 is directly aligned with the anterior side needle guide
platform wall 140.
[0138] In some embodiments, notch 132 is at least about 1 mm to
about 5 mm at most wide. In some embodiments, notch 132 is about 1
mm wide. In some embodiments, notch 132 is about 2 mm wide. In some
embodiments, notch 132 is about 3 mm wide. In some embodiments,
notch 132 is about 4 mm wide. In some embodiments, notch 132 is
about 5 mm wide. In some embodiments, notch 132 is at least about 1
mm to about 5 mm at most wide. In some embodiments, notch 132 is
about 6 mm wide. In some embodiments, notch 132 is about 7 mm wide.
In some embodiments, notch 132 is about 8 mm wide. In some
embodiments, notch 132 is about 9 mm wide. In some embodiments,
notch 132 is about 10 mm wide. In some embodiments, notch 132 is at
least about 6 mm to about 15 mm at most wide. In some embodiments,
notch 132 is wider than notch 132. In some embodiments, notch 132
is 90% wider than notch 132. In some embodiments, notch 132 is 80%
wider than notch 132. In some embodiments, notch 132 is 70% wider
than notch 132. In some embodiments, notch 132 is 60% wider than
notch 132. In some embodiments, notch 132 is 50% wider than notch
132. In some embodiments, notch 132 is 40% wider than notch 132. In
some embodiments, notch 132 is 30% wider than notch 132. In some
embodiments, notch 132 is 20% wider than notch 132. In some
embodiments, notch 132 is 10% wider than notch 132.
[0139] In some embodiments, notch 132 is shaped as a wide "V." In
some embodiments, notch 132 is shaped as a wide "U." In some
embodiments, the notch comprises a lip that protrudes from one of
the slot walls 130a or 130b, and in some embodiments aligns with an
arm of the V or of the U shape. The notch and the lip thereof allow
the needle to be seated in the track and not slip toward the
opening of the slot prior to or during insertion of the needle into
the subject.
[0140] In some embodiments, the tactile sensing device 300
comprises a needle alignment guide 36. In some embodiments, the
needle alignment guide 36 is a notch traversing the center of the
tactile sensing device 300 through a longitudinal axis that is
parallel to the track 144, as shown in FIG. 3.
[0141] In some embodiments, the sensor array (not shown in FIG. 3)
is an array of sensor elements also known as "sensels." In some
embodiments, the sensels are not discrete sensors. In some
embodiments, the sensor elements or sensels are configured to
connect to each other. In some embodiments, the sensor elements are
arranged in a grid (not shown in FIG. 3), with each sensor element
(or "sensel") located at the intersection of a row and column. In
some embodiments, the rows and columns are pinned out, rather than
individual sensors being pinned out, as is the case with an array
of discrete sensors. In some embodiments, the sensor array (not
shown in FIG. 3) is an array of cells. In some embodiments, the
sensor array (not shown in FIG. 3) is an array of sensing cells. In
some embodiments, the sensor array slit (not shown in FIG. 3) is
positioned between two rows or more of sensels. In some
embodiments, the sensor array slit (not shown in FIG. 3) is
positioned between two columns or more of sensels. In some
embodiments, the sensor array slit (not shown in FIG. 3) is within
the bounds of the sensor array, and/or within the bounds of the
sensor array outer edges, and/or within the edges bounding of the
sensor array. In some embodiments, the distal opening 134b of the
needle guide 2 is positioned between two rows of sensels. In some
embodiments, the distal opening 134b of the needle guide 2 is
positioned between two columns of sensels. In some embodiments the
distal opening 134b of the needle guide 2 is within the bounds of
the sensor array, and/or within the bounds of the sensor array
outer edges, and/or within the edges bounding of the sensor array.
In some embodiments, the distal opening 34b is between two or more
sensors of the sensor array. In some embodiments, the distal
opening 34b is positioned between two rows or more of sensels. In
some embodiments, the distal opening 34b is positioned between two
columns or more of sensels.
[0142] In some embodiments, the tactile sensing device comprises a
display screen 4 that is adjacent to the needle guide 2, as shown
in FIG. 3. In some embodiments, the display screen 4 is adjacent to
the track 144. In some embodiments, the tactile sensing device
comprises a display screen 4 that is laterally offset from the
midline of the tactile sensing device. In some embodiments, the
display screen 4 is adjacent to the needle alignment guide 36. In
some embodiments, the display screen 4 comprises on-screen
targeting 44. In some embodiments, the on-screen targeting 44 is
one or more axes (e.g., an x-axis and a y-axis) that appear on the
display screen 4 and help the user to align the tactile sensing
device with the target tissue location, an insertion site of the
needle, and/or a projected subcutaneous location of a needle. In
some embodiments, the on-screen targeting 44 is a software tool
that helps the user with alignment of the needle and/or the tactile
sensing device. In some embodiments, the on-screen targeting 44
comprises crosshairs, as shown in FIG. 3. In some embodiments, the
on-screen targeting 44 responds in real time to any movement of the
needle and/or the tactile sensing device carried out by the user.
For example, in some embodiments, the crosshairs displayed on the
display screen 4 moves on the display screen 4 as the user adjusts
the position of the tactile sensing device. In some embodiments,
the on-screen targeting 44 indicates the proximity of the
crosshairs (and/or the target circle at the center of the
crosshairs) to the calculated needle insertion point. In some
embodiments, the on-screen targeting 44 uses a light, a sound
(e.g., a beeping sound), a visual cue (e.g., blinking of the
crosshairs on the display screen), or any other suitable indicator
to inform the user of an accurate alignment between the insertion
device (e.g., the needle guide) and the calculated needle insertion
point.
[0143] FIGS. 4A-B show a high-level concept configuration of the
tactile sensing device 400. FIG. 4A shows a front view of the
tactile sensing device 400. In some embodiments, the tactile
sensing device 400 comprises a frame 20 that comprises a display
screen 4 and a needle guide 2. In some embodiments, the needle
guide 2 comprises a slot 38. In some embodiments, the slot 38
comprises a lateral entrance area (i.e., the slot opening 38a) and
a medial area (i.e. the slot terminus 38b). In some embodiments,
the slot terminus 38b is in open connection with the needle guide
2. In some embodiments, the needle guide 2 is a fixed needle guide.
In some embodiments, the display screen 4 is angled with respect to
the skin surface of the patient. In some embodiments, the display
screen is flat. In some embodiments, the angle of the display
screen 4 is adjustable. In some embodiments, the tactile sensing
device comprises one or more hinges at the junction of the sensor
unit 32 and the electronic unit 34, which allows the user to adjust
the angle of the display screen.
[0144] In some embodiments, the tactile sensing device 400 has a
length 49 of about 198 millimeters (mm). In some embodiments, the
tactile sensing device 400 has a length 49 of about 150 mm to about
300 mm. In some embodiments, the tactile sensing device 400 has a
length 49 of at least about 150 mm. In some embodiments, the
tactile sensing device 400 has a length 49 of at most about 300 mm.
In some embodiments, the tactile sensing device 400 has a length 49
of about 150 mm to about 160 mm, about 150 mm to about 170 mm,
about 150 mm to about 180 mm, about 150 mm to about 190 mm, about
150 mm to about 200 mm, about 150 mm to about 210 mm, about 150 mm
to about 220 mm, about 150 mm to about 230 mm, about 150 mm to
about 240 mm, about 150 mm to about 250 mm, about 150 mm to about
300 mm, about 160 mm to about 170 mm, about 160 mm to about 180 mm,
about 160 mm to about 190 mm, about 160 mm to about 200 mm, about
160 mm to about 210 mm, about 160 mm to about 220 mm, about 160 mm
to about 230 mm, about 160 mm to about 240 mm, about 160 mm to
about 250 mm, about 160 mm to about 300 mm, about 170 mm to about
180 mm, about 170 mm to about 190 mm, about 170 mm to about 200 mm,
about 170 mm to about 210 mm, about 170 mm to about 220 mm, about
170 mm to about 230 mm, about 170 mm to about 240 mm, about 170 mm
to about 250 mm, about 170 mm to about 300 mm, about 180 mm to
about 190 mm, about 180 mm to about 200 mm, about 180 mm to about
210 mm, about 180 mm to about 220 mm, about 180 mm to about 230 mm,
about 180 mm to about 240 mm, about 180 mm to about 250 mm, about
180 mm to about 300 mm, about 190 mm to about 200 mm, about 190 mm
to about 210 mm, about 190 mm to about 220 mm, about 190 mm to
about 230 mm, about 190 mm to about 240 mm, about 190 mm to about
250 mm, about 190 mm to about 300 mm, about 200 mm to about 210 mm,
about 200 mm to about 220 mm, about 200 mm to about 230 mm, about
200 mm to about 240 mm, about 200 mm to about 250 mm, about 200 mm
to about 300 mm, about 210 mm to about 220 mm, about 210 mm to
about 230 mm, about 210 mm to about 240 mm, about 210 mm to about
250 mm, about 210 mm to about 300 mm, about 220 mm to about 230 mm,
about 220 mm to about 240 mm, about 220 mm to about 250 mm, about
220 mm to about 300 mm, about 230 mm to about 240 mm, about 230 mm
to about 250 mm, about 230 mm to about 300 mm, about 240 mm to
about 250 mm, about 240 mm to about 300 mm, or about 250 mm to
about 300 mm. In some embodiments, the tactile sensing device 400
has a length 49 of about 150 mm, about 160 mm, about 170 mm, about
180 mm, about 190 mm, about 200 mm, about 210 mm, about 220 mm,
about 230 mm, about 240 mm, about 250 mm, or about 300 mm.
[0145] In some embodiments, the tactile sensing device 400 has a
width 51 of about 78 mm. In some embodiments, the tactile sensing
device 400 has a width 51 of about 50 mm to about 200 mm. In some
embodiments, the tactile sensing device 400 has a width 51 of at
least about 50 mm. In some embodiments, the tactile sensing device
400 has a width 51 of at most about 200 mm. In some embodiments,
the tactile sensing device 400 has a width 51 of about 50 mm to
about 60 mm, about 50 mm to about 70 mm, about 50 mm to about 80
mm, about 50 mm to about 90 mm, about 50 mm to about 100 mm, about
50 mm to about 110 mm, about 50 mm to about 120 mm, about 50 mm to
about 130 mm, about 50 mm to about 140 mm, about 50 mm to about 150
mm, about 50 mm to about 200 mm, about 60 mm to about 70 mm, about
60 mm to about 80 mm, about 60 mm to about 90 mm, about 60 mm to
about 100 mm, about 60 mm to about 110 mm, about 60 mm to about 120
mm, about 60 mm to about 130 mm, about 60 mm to about 140 mm, about
60 mm to about 150 mm, about 60 mm to about 200 mm, about 70 mm to
about 80 mm, about 70 mm to about 90 mm, about 70 mm to about 100
mm, about 70 mm to about 110 mm, about 70 mm to about 120 mm, about
70 mm to about 130 mm, about 70 mm to about 140 mm, about 70 mm to
about 150 mm, about 70 mm to about 200 mm, about 80 mm to about 90
mm, about 80 mm to about 100 mm, about 80 mm to about 110 mm, about
80 mm to about 120 mm, about 80 mm to about 130 mm, about 80 mm to
about 140 mm, about 80 mm to about 150 mm, about 80 mm to about 200
mm, about 90 mm to about 100 mm, about 90 mm to about 110 mm, about
90 mm to about 120 mm, about 90 mm to about 130 mm, about 90 mm to
about 140 mm, about 90 mm to about 150 mm, about 90 mm to about 200
mm, about 100 mm to about 110 mm, about 100 mm to about 120 mm,
about 100 mm to about 130 mm, about 100 mm to about 140 mm, about
100 mm to about 150 mm, about 100 mm to about 200 mm, about 110 mm
to about 120 mm, about 110 mm to about 130 mm, about 110 mm to
about 140 mm, about 110 mm to about 150 mm, about 110 mm to about
200 mm, about 120 mm to about 130 mm, about 120 mm to about 140 mm,
about 120 mm to about 150 mm, about 120 mm to about 200 mm, about
130 mm to about 140 mm, about 130 mm to about 150 mm, about 130 mm
to about 200 mm, about 140 mm to about 150 mm, about 140 mm to
about 200 mm, or about 150 mm to about 200 mm. In some embodiments,
the tactile sensing device 400 has a width 51 of about 50 mm, about
60 mm, about 70 mm, about 80 mm, about 90 mm, about 100 mm, about
110 mm, about 120 mm, about 130 mm, about 140 mm, about 150 mm, or
about 200 mm.
[0146] In some embodiments, the display screen 4 has a display
screen length 53 of about 99 mm. In some embodiments, the display
screen 4 has a display screen length 53 of about 40 mm to about 150
mm. In some embodiments, the display screen 4 has a display screen
length 53 of at least about 40 mm. In some embodiments, the display
screen 4 has a display screen length 53 of at most about 150 mm. In
some embodiments, the display screen 4 has a display screen length
53 of about 40 mm to about 50 mm, about 40 mm to about 60 mm, about
40 mm to about 70 mm, about 40 mm to about 90 mm, about 40 mm to
about 100 mm, about 40 mm to about 110 mm, about 40 mm to about 120
mm, about 40 mm to about 130 mm, about 40 mm to about 140 mm, about
40 mm to about 150 mm, about 50 mm to about 60 mm, about 50 mm to
about 70 mm, about 50 mm to about 90 mm, about 50 mm to about 100
mm, about 50 mm to about 110 mm, about 50 mm to about 120 mm, about
50 mm to about 130 mm, about 50 mm to about 140 mm, about 50 mm to
about 150 mm, about 60 mm to about 70 mm, about 60 mm to about 90
mm, about 60 mm to about 100 mm, about 60 mm to about 110 mm, about
60 mm to about 120 mm, about 60 mm to about 130 mm, about 60 mm to
about 140 mm, about 60 mm to about 150 mm, about 70 mm to about 90
mm, about 70 mm to about 100 mm, about 70 mm to about 110 mm, about
70 mm to about 120 mm, about 70 mm to about 130 mm, about 70 mm to
about 140 mm, about 70 mm to about 150 mm, about 90 mm to about 100
mm, about 90 mm to about 110 mm, about 90 mm to about 120 mm, about
90 mm to about 130 mm, about 90 mm to about 140 mm, about 90 mm to
about 150 mm, about 100 mm to about 110 mm, about 100 mm to about
120 mm, about 100 mm to about 130 mm, about 100 mm to about 140 mm,
about 100 mm to about 150 mm, about 110 mm to about 120 mm, about
110 mm to about 130 mm, about 110 mm to about 140 mm, about 110 mm
to about 150 mm, about 120 mm to about 130 mm, about 120 mm to
about 140 mm, about 120 mm to about 150 mm, about 130 mm to about
140 mm, about 130 mm to about 150 mm, or about 140 mm to about 150
mm. In some embodiments, the display screen 4 has a display screen
length 53 of about 40 mm, about 50 mm, about 60 mm, about 70 mm,
about 90 mm, about 100 mm, about 110 mm, about 120 mm, about 130
mm, about 140 mm, or about 150 mm.
[0147] In some embodiments, the display screen 4 has a display
screen width 55 of about 57 mm. In some embodiments, the display
screen 4 has a display screen width 55 of about 40 mm to about 150
mm. In some embodiments, the display screen 4 has a display screen
width 55 of at least about 40 mm. In some embodiments, the display
screen 4 has a display screen width 55 of at most about 150 mm. In
some embodiments, the display screen 4 has a display screen width
55 of about 40 mm to about 50 mm, about 40 mm to about 60 mm, about
40 mm to about 70 mm, about 40 mm to about 90 mm, about 40 mm to
about 100 mm, about 40 mm to about 110 mm, about 40 mm to about 120
mm, about 40 mm to about 130 mm, about 40 mm to about 140 mm, about
40 mm to about 150 mm, about 50 mm to about 60 mm, about 50 mm to
about 70 mm, about 50 mm to about 90 mm, about 50 mm to about 100
mm, about 50 mm to about 110 mm, about 50 mm to about 120 mm, about
50 mm to about 130 mm, about 50 mm to about 140 mm, about 50 mm to
about 150 mm, about 60 mm to about 70 mm, about 60 mm to about 90
mm, about 60 mm to about 100 mm, about 60 mm to about 110 mm, about
60 mm to about 120 mm, about 60 mm to about 130 mm, about 60 mm to
about 140 mm, about 60 mm to about 150 mm, about 70 mm to about 90
mm, about 70 mm to about 100 mm, about 70 mm to about 110 mm, about
70 mm to about 120 mm, about 70 mm to about 130 mm, about 70 mm to
about 140 mm, about 70 mm to about 150 mm, about 90 mm to about 100
mm, about 90 mm to about 110 mm, about 90 mm to about 120 mm, about
90 mm to about 130 mm, about 90 mm to about 140 mm, about 90 mm to
about 150 mm, about 100 mm to about 110 mm, about 100 mm to about
120 mm, about 100 mm to about 130 mm, about 100 mm to about 140 mm,
about 100 mm to about 150 mm, about 110 mm to about 120 mm, about
110 mm to about 130 mm, about 110 mm to about 140 mm, about 110 mm
to about 150 mm, about 120 mm to about 130 mm, about 120 mm to
about 140 mm, about 120 mm to about 150 mm, about 130 mm to about
140 mm, about 130 mm to about 150 mm, or about 140 mm to about 150
mm. In some embodiments, the display screen 4 has a display screen
width 55 of about 40 mm, about 50 mm, about 60 mm, about 70 mm,
about 90 mm, about 100 mm, about 110 mm, about 120 mm, about 130
mm, about 140 mm, or about 150 mm.
[0148] FIG. 4B shows a side view of the tactile sensing device 400.
In some embodiments, the tactile sensing device 400 comprises a
sensor attachment area 52. In some embodiments, sensor attachment
area 52 receives a sensor array (not shown in FIGS. 4A-B). In some
embodiments, sensor attachment area 52 is located on the posterior
surface of the tactile sensing device 400. In some embodiments, the
sensor attachment area 52 comprises a slit corresponding in shape
and size to the slot opening 38a and needle guide 2. In some
embodiments, needle guide 2 has a proximal opening 134a and a
distal opening 134b, with respect to the user, as shown in FIG. 4B.
In some embodiments, the frame 20 comprises a battery 48. In some
embodiments, the battery 48 is located on the posterior side of the
tactile sensing device 400, as shown in FIG. 4B. In some
embodiments, the battery 48 is located within the frame 20, in the
handle area. In some embodiments, the battery 48 is located on the
posterior surface of the display screen 4, as shown in FIG. 4B. In
some embodiments, the battery 48 is located beneath the display
screen 4. In some embodiments, the tactile sensing device 400
comprises a printed circuit board (PCB) 50 sitting on the anterior
surface of the sensor attachment area 52, within the frame 20. In
some embodiments, the tactile sensing device 400 comprises a
printed circuit board (PCB) 50 located directly sitting on the
anterior surface of the sensor array, within the frame 20. In some
embodiments, the PCB 50 is located over the sensor array, within
the frame 20. In some embodiments, the printed circuit board (PCB)
50 is located within the frame 20. In some embodiments, an
additional printed circuit board is located between the battery 48
and the display screen 4.
[0149] In some embodiments, the needle guide 2 is angled. In some
embodiments, the needle guide 2 is at an angle with respect to the
sensor array (not shown in FIGS. 4A-B). In some embodiments, the
needle guide 2 is at an angle with respect to the sensor attachment
area 52. In some embodiments, the needle guide 2 is at an angle
with respect to the posterior or bottom surface of the tactile
sensing device 400. In some embodiments, the angle is a treatment
angle 86, as shown in FIG. 4B. In some embodiments, the needle
guide forms a treatment angle 86 with respect to the sensor array.
In some embodiments, the needle guide forms a treatment angle 86
with respect to the posterior surface of the tactile sensing device
400. In some embodiments, the track (not shown in FIGS. 4A-B) forms
a treatment angle 86 with respect to the sensor array. In some
embodiments, the track forms a treatment angle 86 with respect to
the posterior surface of the tactile sensing device 400. In some
embodiments, the needle is guided at a treatment angle 86 when
inserted in the needle guide 2 and advanced along the track of the
needle guide. In some embodiments, the treatment angle 86 is a
cephalad angle. In some embodiments, the needle is pointed towards
the head or the anterior end of the body of a patient when guided
at a cephalad angle. In some embodiments, the treatment angle 86 is
a cephalad angle when the user places the tactile sensing device
400 such that the anterior end of the tactile sensing device 400 is
pointed towards the anterior end of the body of the patient. In
some embodiments, the treatment angle 86 is a cephalad angle when
the user places the needle in the needle guide and angles the
needle away from the upper face 39 of the slot. In some
embodiments, the treatment angle 86 is a caudal angle. In some
embodiments, the needle is pointed towards the feet or the
posterior end of the body of a patient when guided at a cephalad
angle. In some embodiments, the treatment angle 86 is a caudal
angle when the patient is in a lateral decubitus position. In some
embodiments, the treatment angle 86 is a caudal angle when the user
places the tactile sensing device 400 such that the anterior end of
the tactile sensing device 400 is pointed towards the posterior end
of the body of the patient.
[0150] In some embodiments, the treatment angle is about 30 degrees
to about 90 degrees. In some embodiments, the treatment angle is
about 69 degrees to about 81 degrees. In some embodiments, the
treatment angle is at least about 30 degrees. In some embodiments,
the treatment angle is at most about 90 degrees. In some
embodiments, the treatment angle is about 30 degrees to about 35
degrees, about 30 degrees to about 40 degrees, about 30 degrees to
about 45 degrees, about 30 degrees to about 50 degrees, about 30
degrees to about 55 degrees, about 30 degrees to about 60 degrees,
about 30 degrees to about 65 degrees, about 30 degrees to about 70
degrees, about 30 degrees to about 75 degrees, about 30 degrees to
about 80 degrees, about 30 degrees to about 90 degrees, about 35
degrees to about 40 degrees, about 35 degrees to about 45 degrees,
about 35 degrees to about 50 degrees, about 35 degrees to about 55
degrees, about 35 degrees to about 60 degrees, about 35 degrees to
about 65 degrees, about 35 degrees to about 70 degrees, about 35
degrees to about 75 degrees, about 35 degrees to about 80 degrees,
about 35 degrees to about 90 degrees, about 40 degrees to about 45
degrees, about 40 degrees to about 50 degrees, about 40 degrees to
about 55 degrees, about 40 degrees to about 60 degrees, about 40
degrees to about 65 degrees, about 40 degrees to about 70 degrees,
about 40 degrees to about 75 degrees, about 40 degrees to about 80
degrees, about 40 degrees to about 90 degrees, about 45 degrees to
about 50 degrees, about 45 degrees to about 55 degrees, about 45
degrees to about 60 degrees, about 45 degrees to about 65 degrees,
about 45 degrees to about 70 degrees, about 45 degrees to about 75
degrees, about 45 degrees to about 80 degrees, about 45 degrees to
about 90 degrees, about 50 degrees to about 55 degrees, about 50
degrees to about 60 degrees, about 50 degrees to about 65 degrees,
about 50 degrees to about 70 degrees, about 50 degrees to about 75
degrees, about 50 degrees to about 80 degrees, about 50 degrees to
about 90 degrees, about 55 degrees to about 60 degrees, about 55
degrees to about 65 degrees, about 55 degrees to about 70 degrees,
about 55 degrees to about 75 degrees, about 55 degrees to about 80
degrees, about 55 degrees to about 90 degrees, about 60 degrees to
about 65 degrees, about 60 degrees to about 70 degrees, about 60
degrees to about 75 degrees, about 60 degrees to about 80 degrees,
about 60 degrees to about 90 degrees, about 65 degrees to about 70
degrees, about 65 degrees to about 75 degrees, about 65 degrees to
about 80 degrees, about 65 degrees to about 90 degrees, about 70
degrees to about 75 degrees, about 70 degrees to about 80 degrees,
about 70 degrees to about 90 degrees, about 75 degrees to about 80
degrees, about 75 degrees to about 90 degrees, or about 80 degrees
to about 90 degrees.
[0151] In some embodiments, the treatment angle is about 30
degrees. In some embodiments, the treatment angle is about 35
degrees. In some embodiments, the treatment angle is about 40
degrees. In some embodiments, the treatment angle is about 45
degrees. In some embodiments, the treatment angle is about 50
degrees. In some embodiments, the treatment angle is about 55
degrees. In some embodiments, the treatment angle is about 60
degrees. In some embodiments, the treatment angle is about 65
degrees. In some embodiments, the treatment angle is about 70
degrees. In some embodiments, the treatment angle is about 75
degrees. In some embodiments, the treatment angle is about 80
degrees. In some embodiments, the treatment angle is about 90
degrees.
[0152] In some embodiments, the treatment angle is about 69
degrees. In some embodiments, the treatment angle is about 70
degrees. In some embodiments, the treatment angle is about 71
degrees. In some embodiments, the treatment angle is about 72
degrees. In some embodiments, the treatment angle is about 73
degrees. In some embodiments, the treatment angle is about 74
degrees. In some embodiments, the treatment angle is about 75
degrees. In some embodiments, the treatment angle is about 76
degrees. In some embodiments, the treatment angle is about 77
degrees. In some embodiments, the treatment angle is about 78
degrees. In some embodiments, the treatment angle is about 79
degrees. In some embodiments, the treatment angle is about 80
degrees. In some embodiments, the treatment angle is about 81
degrees.
[0153] In some embodiments, the treatment angle 86 is a cephalad
angle between about 0.degree. to about 15.degree. with respect to
the individual. In some embodiments, the treatment angle 86 is a
cephalad angle between about 9.degree. to about 21.degree.. In some
embodiments, the treatment angle 86 is a cephalad angle that is at
least about 0 degrees. In some embodiments, the treatment angle 86
is a cephalad angle that is at most about 15 degrees. In some
embodiments, the treatment angle 86 is a cephalad angle that is
about 0 degrees to about 1 degree, about 0 degrees to about 2
degrees, about 0 degrees to about 3 degrees, about 0 degrees to
about 4 degrees, about 0 degrees to about 5 degrees, about 0
degrees to about 6 degrees, about 0 degrees to about 7 degrees,
about 0 degrees to about 8 degrees, about 0 degrees to about 9
degrees, about 0 degrees to about 10 degrees, about 0 degrees to
about 15 degrees, about 1 degree to about 2 degrees, about 1 degree
to about 3 degrees, about 1 degree to about 4 degrees, about 1
degree to about 5 degrees, about 1 degree to about 6 degrees, about
1 degree to about 7 degrees, about 1 degree to about 8 degrees,
about 1 degree to about 9 degrees, about 1 degree to about 10
degrees, about 1 degree to about 15 degrees, about 2 degrees to
about 3 degrees, about 2 degrees to about 4 degrees, about 2
degrees to about 5 degrees, about 2 degrees to about 6 degrees,
about 2 degrees to about 7 degrees, about 2 degrees to about 8
degrees, about 2 degrees to about 9 degrees, about 2 degrees to
about 10 degrees, about 2 degrees to about 15 degrees, about 3
degrees to about 4 degrees, about 3 degrees to about 5 degrees,
about 3 degrees to about 6 degrees, about 3 degrees to about 7
degrees, about 3 degrees to about 8 degrees, about 3 degrees to
about 9 degrees, about 3 degrees to about 10 degrees, about 3
degrees to about 15 degrees, about 4 degrees to about 5 degrees,
about 4 degrees to about 6 degrees, about 4 degrees to about 7
degrees, about 4 degrees to about 8 degrees, about 4 degrees to
about 9 degrees, about 4 degrees to about 10 degrees, about 4
degrees to about 15 degrees, about 5 degrees to about 6 degrees,
about 5 degrees to about 7 degrees, about 5 degrees to about 8
degrees, about 5 degrees to about 9 degrees, about 5 degrees to
about 10 degrees, about 5 degrees to about 15 degrees, about 6
degrees to about 7 degrees, about 6 degrees to about 8 degrees,
about 6 degrees to about 9 degrees, about 6 degrees to about 10
degrees, about 6 degrees to about 15 degrees, about 7 degrees to
about 8 degrees, about 7 degrees to about 9 degrees, about 7
degrees to about 10 degrees, about 7 degrees to about 15 degrees,
about 8 degrees to about 9 degrees, about 8 degrees to about 10
degrees, about 8 degrees to about 15 degrees, about 9 degrees to
about 10 degrees, about 9 degrees to about 15 degrees, or about 10
degrees to about 15 degrees. In some embodiments, the treatment
angle 86 is a cephalad angle that is about 0 degrees, about 1
degree, about 2 degrees, about 3 degrees, about 4 degrees, about 5
degrees, about 6 degrees, about 7 degrees, about 8 degrees, about 9
degrees, about 10 degrees, or about 15 degrees. In some
embodiments, the treatment angle 86 is a cephalad angle that is
about 10 degrees to about 15 degrees. In some embodiments, the
treatment angle 86 is a cephalad angle that is at least about 10
degrees. In some embodiments, the treatment angle 86 is a cephalad
angle that is at most about 15 degrees. In some embodiments, the
treatment angle 86 is a cephalad angle that is about 10 degrees to
about 11 degrees, about 10 degrees to about 12 degrees, about 10
degrees to about 13 degrees, about 10 degrees to about 14 degrees,
about 10 degrees to about 15 degrees, about 11 degrees to about 12
degrees, about 11 degrees to about 13 degrees, about 11 degrees to
about 14 degrees, about 11 degrees to about 15 degrees, about 12
degrees to about 13 degrees, about 12 degrees to about 14 degrees,
about 12 degrees to about 15 degrees, about 13 degrees to about 14
degrees, about 13 degrees to about 15 degrees, or about 14 degrees
to about 15 degrees.
[0154] In some embodiments, the treatment angle 86 is a cephalad
angle that is about 9 degrees. In some embodiments, the treatment
angle 86 is a cephalad angle that is about 10 degrees. In some
embodiments, the treatment angle 86 is a cephalad angle that is
about 11 degrees. In some embodiments, the treatment angle 86 is a
cephalad angle that is about 12 degrees. In some embodiments, the
treatment angle 86 is a cephalad angle that is about 13 degrees. In
some embodiments, the treatment angle 86 is a cephalad angle that
is about 14 degrees. In some embodiments, the treatment angle 86 is
a cephalad angle that is about 15 degrees. In some embodiments, the
treatment angle 86 is a cephalad angle that is about 16 degrees. In
some embodiments, the treatment angle 86 is a cephalad angle that
is about 17 degrees. In some embodiments, the treatment angle 86 is
a cephalad angle that is about 18 degrees. In some embodiments, the
treatment angle 86 is a cephalad angle that is about 19 degrees. In
some embodiments, the treatment angle 86 is a cephalad angle that
is about 20 degrees. In some embodiments, the treatment angle 86 is
a cephalad angle that is about 21 degrees.
[0155] In some embodiments, the sensor array (not shown in FIGS.
4A-B) is an array of sensor elements also known as "sensels." In
some embodiments, the sensels are not discrete sensors. In some
embodiments, the sensor elements or sensels are configured to
connect to each other. In some embodiments, the sensor elements are
arranged in a grid (not shown in FIGS. 4A-B), with each sensor
element (or "sensel") located at the intersection of a row and
column. In some embodiments, the rows and columns are pinned out,
rather than individual sensors being pinned out, as is the case
with an array of discrete sensors. In some embodiments, the sensor
array (not shown in FIGS. 4A-B) is an array of cells. In some
embodiments, the sensor array (not shown in FIGS. 4A-B) is an array
of sensing cells. In some embodiments, the sensor array slit (not
shown in FIGS. 4A-B) is positioned between two rows or more of
sensels. In some embodiments, the sensor array slit (not shown in
FIGS. 4A-B) is positioned between two columns or more of sensels.
In some embodiments, the sensor array slit (not shown in FIGS.
4A-B) is within the bounds of the sensor array, and/or within the
bounds of the sensor array outer edges, and/or within the edges
bounding of the sensor array. In some embodiments, the sensor array
does not comprise a slit. In some embodiments, the distal opening
134b of the needle guide 2 is positioned between two rows of
sensels. In some embodiments, the distal opening 134b of the needle
guide 2 is positioned between two columns of sensels. In some
embodiments the distal opening 134b of the needle guide 2 is within
the bounds of the sensor array, and/or within the bounds of the
sensor array outer edges, and/or within the edges bounding of the
sensor array. In some embodiments, the distal opening 34b is
between two or more sensors of the sensor array. In some
embodiments, the distal opening 34b is positioned between two rows
or more of sensels. In some embodiments, the distal opening 34b is
positioned between two columns or more of sensels.
[0156] FIGS. 5-12 show the tactile sensing device comprising a
display screen, a needle guide, and a handle. Specifically, FIGS.
5-12 show different variations and types of handles and/or
grips.
[0157] FIG. 5 shows the tactile sensing device 500 comprising a
handle 54 that is an extended handle. In some embodiments, the
extended handle provides numerous advantages which include, but are
not limited to, maximizing the ability to apply force, better
balance and linear movement control, separate handling area from
interaction point, accommodating both left and right handed users,
easy to be used when used on both a seated and a lateral
decubitus-positioned individual. In some embodiments, a battery is
located inside or within the handle 54. In some embodiments, the
extended handle accommodates all fingers of a user to better hold
the device. In some embodiments, the extended handle allows the
user to use his/her thumb to apply more force on the surface where
the tactile sensing device 500 is being pressed upon. In some
embodiments, the tactile sensing device 500 comprises a needle
guide 2 that is a fixed needle guide. In some embodiments, the
tactile sensing device 500 comprises a slot opening 38a. In some
embodiments, the slot opening 38a c provides the user (i.e.,
holding a syringe and/or needle) with access to the needle guide 2.
In some embodiments, the slot opening 38a provides an opening to
remove the tactile sensing device from a needle resting on the
needle guide 2.
[0158] In some embodiments, the tactile sensing device 500 has a
length 49 of about 296 mm. In some embodiments, the tactile sensing
device 500 has a length 49 of about 250 mm to about 400 mm. In some
embodiments, the tactile sensing device 500 has a length 49 of at
least about 250 mm. In some embodiments, the tactile sensing device
500 has a length 49 of at most about 400 mm. In some embodiments,
the tactile sensing device 500 has a length 49 of about 250 mm to
about 260 mm, about 250 mm to about 270 mm, about 250 mm to about
280 mm, about 250 mm to about 290 mm, about 250 mm to about 300 mm,
about 250 mm to about 310 mm, about 250 mm to about 320 mm, about
250 mm to about 330 mm, about 250 mm to about 340 mm, about 250 mm
to about 350 mm, about 250 mm to about 400 mm, about 260 mm to
about 270 mm, about 260 mm to about 280 mm, about 260 mm to about
290 mm, about 260 mm to about 300 mm, about 260 mm to about 310 mm,
about 260 mm to about 320 mm, about 260 mm to about 330 mm, about
260 mm to about 340 mm, about 260 mm to about 350 mm, about 260 mm
to about 400 mm, about 270 mm to about 280 mm, about 270 mm to
about 290 mm, about 270 mm to about 300 mm, about 270 mm to about
310 mm, about 270 mm to about 320 mm, about 270 mm to about 330 mm,
about 270 mm to about 340 mm, about 270 mm to about 350 mm, about
270 mm to about 400 mm, about 280 mm to about 290 mm, about 280 mm
to about 300 mm, about 280 mm to about 310 mm, about 280 mm to
about 320 mm, about 280 mm to about 330 mm, about 280 mm to about
340 mm, about 280 mm to about 350 mm, about 280 mm to about 400 mm,
about 290 mm to about 300 mm, about 290 mm to about 310 mm, about
290 mm to about 320 mm, about 290 mm to about 330 mm, about 290 mm
to about 340 mm, about 290 mm to about 350 mm, about 290 mm to
about 400 mm, about 300 mm to about 310 mm, about 300 mm to about
320 mm, about 300 mm to about 330 mm, about 300 mm to about 340 mm,
about 300 mm to about 350 mm, about 300 mm to about 400 mm, about
310 mm to about 320 mm, about 310 mm to about 330 mm, about 310 mm
to about 340 mm, about 310 mm to about 350 mm, about 310 mm to
about 400 mm, about 320 mm to about 330 mm, about 320 mm to about
340 mm, about 320 mm to about 350 mm, about 320 mm to about 400 mm,
about 330 mm to about 340 mm, about 330 mm to about 350 mm, about
330 mm to about 400 mm, about 340 mm to about 350 mm, about 340 mm
to about 400 mm, or about 350 mm to about 400 mm. In some
embodiments, the tactile sensing device 500 has a length 49 of
about 250 mm, about 260 mm, about 270 mm, about 280 mm, about 290
mm, about 300 mm, about 310 mm, about 320 mm, about 330 mm, about
340 mm, about 350 mm, or about 400 mm.
[0159] In some embodiments, the tactile sensing device 500 has a
width 51 of about 78 mm. In some embodiments, the tactile sensing
device 500 has a width 51 of about 10 mm to about 200 mm. In some
embodiments, the tactile sensing device 500 has a width 51 of at
least about 10 mm. In some embodiments, the tactile sensing device
500 has a width 51 of at most about 200 mm. In some embodiments,
the tactile sensing device 500 has a width 51 of about 50 mm to
about 60 mm, about 50 mm to about 70 mm, about 50 mm to about 80
mm, about 50 mm to about 90 mm, about 50 mm to about 100 mm, about
50 mm to about 110 mm, about 50 mm to about 10 mm, about 50 mm to
about 130 mm, about 50 mm to about 140 mm, about 50 mm to about 150
mm, about 50 mm to about 200 mm, about 60 mm to about 70 mm, about
60 mm to about 80 mm, about 60 mm to about 90 mm, about 60 mm to
about 100 mm, about 60 mm to about 110 mm, about 60 mm to about 10
mm, about 60 mm to about 130 mm, about 60 mm to about 140 mm, about
60 mm to about 150 mm, about 60 mm to about 200 mm, about 70 mm to
about 80 mm, about 70 mm to about 90 mm, about 70 mm to about 100
mm, about 70 mm to about 110 mm, about 70 mm to about 10 mm, about
70 mm to about 130 mm, about 70 mm to about 140 mm, about 70 mm to
about 150 mm, about 70 mm to about 200 mm, about 80 mm to about 90
mm, about 80 mm to about 100 mm, about 80 mm to about 110 mm, about
80 mm to about 10 mm, about 80 mm to about 130 mm, about 80 mm to
about 140 mm, about 80 mm to about 150 mm, about 80 mm to about 200
mm, about 90 mm to about 100 mm, about 90 mm to about 110 mm, about
90 mm to about 10 mm, about 90 mm to about 130 mm, about 90 mm to
about 140 mm, about 90 mm to about 150 mm, about 90 mm to about 200
mm, about 100 mm to about 110 mm, about 100 mm to about 10 mm,
about 100 mm to about 130 mm, about 100 mm to about 140 mm, about
100 mm to about 150 mm, about 100 mm to about 200 mm, about 110 mm
to about 10 mm, about 110 mm to about 130 mm, about 110 mm to about
140 mm, about 110 mm to about 150 mm, about 110 mm to about 200 mm,
about 10 mm to about 130 mm, about 10 mm to about 140 mm, about 10
mm to about 150 mm, about 10 mm to about 200 mm, about 130 mm to
about 140 mm, about 130 mm to about 150 mm, about 130 mm to about
200 mm, about 140 mm to about 150 mm, about 140 mm to about 200 mm,
or about 150 mm to about 200 mm. In some embodiments, the tactile
sensing device 500 has a width 51 of about 50 mm, about 60 mm,
about 70 mm, about 80 mm, about 90 mm, about 100 mm, about 110 mm,
about 10 mm, about 130 mm, about 140 mm, about 150 mm, or about 200
mm.
[0160] In some embodiments, the tactile sensing device 500 has a
height 57 of about 81 mm. In some embodiments, the tactile sensing
device 500 has a height 57 of about 10 mm to about 150 mm. In some
embodiments, the tactile sensing device 500 has a height 57 of at
least about 10 mm. In some embodiments, the tactile sensing device
500 has a height 57 of at most about 150 mm. In some embodiments,
the tactile sensing device 500 has a height 57 of about 50 mm to
about 60 mm, about 50 mm to about 70 mm, about 50 mm to about 80
mm, about 50 mm to about 90 mm, about 50 mm to about 100 mm, about
50 mm to about 110 mm, about 50 mm to about 10 mm, about 50 mm to
about 130 mm, about 50 mm to about 140 mm, about 50 mm to about 150
mm, about 60 mm to about 70 mm, about 60 mm to about 80 mm, about
60 mm to about 90 mm, about 60 mm to about 100 mm, about 60 mm to
about 110 mm, about 60 mm to about 10 mm, about 60 mm to about 130
mm, about 60 mm to about 140 mm, about 60 mm to about 150 mm, about
70 mm to about 80 mm, about 70 mm to about 90 mm, about 70 mm to
about 100 mm, about 70 mm to about 110 mm, about 70 mm to about 10
mm, about 70 mm to about 130 mm, about 70 mm to about 140 mm, about
70 mm to about 150 mm, about 80 mm to about 90 mm, about 80 mm to
about 100 mm, about 80 mm to about 110 mm, about 80 mm to about 10
mm, about 80 mm to about 130 mm, about 80 mm to about 140 mm, about
80 mm to about 150 mm, about 90 mm to about 100 mm, about 90 mm to
about 110 mm, about 90 mm to about 10 mm, about 90 mm to about 130
mm, about 90 mm to about 140 mm, about 90 mm to about 150 mm, about
100 mm to about 110 mm, about 100 mm to about 10 mm, about 100 mm
to about 130 mm, about 100 mm to about 140 mm, about 100 mm to
about 150 mm, about 110 mm to about 10 mm, about 110 mm to about
130 mm, about 110 mm to about 140 mm, about 110 mm to about 150 mm,
about 10 mm to about 130 mm, about 10 mm to about 140 mm, about 10
mm to about 150 mm, about 130 mm to about 140 mm, about 130 mm to
about 150 mm, or about 140 mm to about 150 mm. In some embodiments,
the tactile sensing device 500 has a height 57 of about 50 mm,
about 60 mm, about 70 mm, about 80 mm, about 90 mm, about 100 mm,
about 110 mm, about 10 mm, about 130 mm, about 140 mm, or about 150
mm.
[0161] In some embodiments, the sensor array (not shown in FIG. 5)
is an array of sensor elements also known as "sensels." In some
embodiments, the sensels are not discrete sensors. In some
embodiments, the sensor elements or sensels are configured to
connect to each other. In some embodiments, the sensor elements are
arranged in a grid (not shown in FIG. 5), with each sensor element
(or "sensel") located at the intersection of a row and column. In
some embodiments, the rows and columns are pinned out, rather than
individual sensors being pinned out, as is the case with an array
of discrete sensors. In some embodiments, the sensor array (not
shown in FIG. 5) is an array of cells. In some embodiments, the
sensor array (not shown in FIG. 5) is an array of sensing cells. In
some embodiments, the sensor array slit (not shown in FIG. 5) is
positioned between two rows or more of sensels. In some
embodiments, the sensor array slit (not shown in FIG. 5) is
positioned between two columns or more of sensels. In some
embodiments, the sensor array slit (not shown in FIG. 5) is within
the bounds of the sensor array, and/or within the bounds of the
sensor array outer edges, and/or within the edges bounding of the
sensor array. In some embodiments, the sensor array does not
comprise a slit. In some embodiments, the distal opening (not shown
in FIG. 5) of the needle guide 2 is positioned between two rows of
sensels. In some embodiments, the distal opening (not shown in FIG.
5) of the needle guide 2 is positioned between two columns of
sensels. In some embodiments the distal opening (not shown in FIG.
5) of the needle guide 2 is within the bounds of the sensor array,
and/or within the bounds of the sensor array outer edges, and/or
within the edges bounding of the sensor array. In some embodiments,
the distal opening (not shown in FIG. 5) is between two or more
sensors of the sensor array. In some embodiments, the distal
opening (not shown in FIG. 5) is positioned between two rows or
more of sensels. In some embodiments, the distal opening (not shown
in FIG. 5) is positioned between two columns or more of
sensels.
[0162] FIG. 6 shows the tactile sensing device 600 comprising a
curved handle 56. In some embodiments, the curved handle 56 is a
reduced-sized handle compared to the handle shown in FIG. 5. In
some embodiments, the reduced-sized handle provides numerous
advantages which include, but are not limited to, enhancing the
ability to apply force using a thumb, better balance and linear
movement control, separate handling area from penetration area
(i.e. needle guide area), accommodating both left and right handed
users, better hand posture when used on both a seated and a lateral
decubitus-positioned individual. In some embodiments, a battery is
located inside or within a curved handle 56. In some embodiments,
the reduced-sized handle accommodates all fingers of a user to
better hold the device. In some embodiments, the reduced-sized
handle allows the user to use their prominent fingers to control
the tactile sensing device 600. In some embodiments, the
reduced-sized handle allows the user to use his/her thumb to apply
more force on the surface where the tactile sensing device 600 is
being pressed upon. In some embodiments, the tactile sensing device
600 comprises a tilted display.
[0163] FIG. 6 shows the architecture of different components of the
tactile sensing device 600. In some embodiments, the tactile
sensing device 600 comprises a frame 20 that encloses a sensor unit
32 and an electronic unit 34. In some embodiments, the sensor unit
32 is disposable. In some embodiments, the sensor unit 32 is
detachable or reversibly attached to the tactile sensing device
1300. In some embodiments, the sensor unit 32 is sterile. In some
embodiments, the sensor unit 32 comprises the needle guide (not
shown in FIG. 6). In some embodiments, the sensor unit 32 that has
a length of about 50 mm to about 100 mm.
[0164] In some embodiments, the sensor unit 32 comprises a sensor
attachment area 52. In some embodiments, the sensor attachment area
52 is sterile. In some embodiments, the sensor attachment area 52
receives a sensor array. In some embodiments, the sensor array is
adhered to the sensor attachment area 52. In some embodiments, the
sensor array is a screen-printed force-sensitive resistor (FSR)
array. In some embodiments, the frame 20 comprises a printed
circuit board (PCB) 50 located underneath the display screen 4, as
shown in FIG. 6.
[0165] In some embodiments, the tactile sensing device 600
comprises a screen (not shown in FIG. 6). In some embodiments, the
display screen measures 99 mm by 57 mm.
[0166] In some embodiments, the sensor unit 32 comprises a pressure
sensor connector 12, a needle guide 2, an electronic unit connector
74, and a sensor array area 72. In some embodiments, the needle
guide 2 is sterile. In some embodiments, the needle guide 2 is at a
treatment angle 86 with respect to the sensor array area 72. In
some embodiments, the pressure sensor connector 12 is a pressure
port. In some embodiments, the pressure sensor connector 12 is
sterile. In some embodiments, the electronic unit connector 74
operatively couples the sensor unit 32 with the electronic unit 34.
In some embodiments, a battery 48 is located inside a handle
54.
[0167] In some embodiments, the sensor unit 32 is a disposable
cassette. In some embodiments, the disposable sensor unit is
designed to minimize the overall size of the disposable part of the
tactile sensing device while keeping the skin and needle contact
areas sterile. In some embodiments, the disposable sensor unit is
inserted from the bottom or from the side of the device. In some
embodiments, the disposable sensor unit remains in place via a
snapping mechanism. The disposable sensor unit is loaded into place
in a multitude of ways. Non-limiting examples of loading the
disposable sensor unit into the tactile sensing device, include,
pressing the disposable sensor unit into the tactile sensing
device, including snap fit features that allow the disposable
sensor unit to stay in place once loaded onto the tactile sensing
device, any magnetic means to hold the disposable sensor unit in
place, any mechanical means to hold the disposable sensor unit in
place. In some embodiments, a tugging string is used to snap the
disposable sensor unit out of the tactile sensing device. In some
embodiments the disposable sensor unit comprises snap ledges, or
other reversible means of loading the disposable sensor unit into
the tactile sensing device. In some embodiments, the disposable
sensor unit remains in place simply because it abuts a ledge of the
tactile sensing device. In some embodiments, one or more tabs are
present on the external surface of the tactile sensing device. In
some embodiments, the disposable sensor unit is reversibly loaded
onto the tactile sensing device.
[0168] In some embodiments, the tactile sensing device 600 has a
length 49 of about 248 mm. In some embodiments, the tactile sensing
device 600 has a length 49 of about 200 mm to about 350 mm. In some
embodiments, the tactile sensing device 600 has a length 49 of at
least about 200 mm. In some embodiments, the tactile sensing device
600 has a length 49 of at most about 350 mm. In some embodiments,
the tactile sensing device 600 has a length 49 of about 200 mm to
about 210 mm, about 200 mm to about 220 mm, about 200 mm to about
230 mm, about 200 mm to about 240 mm, about 200 mm to about 250 mm,
about 200 mm to about 260 mm, about 200 mm to about 270 mm, about
200 mm to about 280 mm, about 200 mm to about 290 mm, about 200 mm
to about 300 mm, about 200 mm to about 350 mm, about 210 mm to
about 220 mm, about 210 mm to about 230 mm, about 210 mm to about
240 mm, about 210 mm to about 250 mm, about 210 mm to about 260 mm,
about 210 mm to about 270 mm, about 210 mm to about 280 mm, about
210 mm to about 290 mm, about 210 mm to about 300 mm, about 210 mm
to about 350 mm, about 220 mm to about 230 mm, about 220 mm to
about 240 mm, about 220 mm to about 250 mm, about 220 mm to about
260 mm, about 220 mm to about 270 mm, about 220 mm to about 280 mm,
about 220 mm to about 290 mm, about 220 mm to about 300 mm, about
220 mm to about 350 mm, about 230 mm to about 240 mm, about 230 mm
to about 250 mm, about 230 mm to about 260 mm, about 230 mm to
about 270 mm, about 230 mm to about 280 mm, about 230 mm to about
290 mm, about 230 mm to about 300 mm, about 230 mm to about 350 mm,
about 240 mm to about 250 mm, about 240 mm to about 260 mm, about
240 mm to about 270 mm, about 240 mm to about 280 mm, about 240 mm
to about 290 mm, about 240 mm to about 300 mm, about 240 mm to
about 350 mm, about 250 mm to about 260 mm, about 250 mm to about
270 mm, about 250 mm to about 280 mm, about 250 mm to about 290 mm,
about 250 mm to about 300 mm, about 250 mm to about 350 mm, about
260 mm to about 270 mm, about 260 mm to about 280 mm, about 260 mm
to about 290 mm, about 260 mm to about 300 mm, about 260 mm to
about 350 mm, about 270 mm to about 280 mm, about 270 mm to about
290 mm, about 270 mm to about 300 mm, about 270 mm to about 350 mm,
about 280 mm to about 290 mm, about 280 mm to about 300 mm, about
280 mm to about 350 mm, about 290 mm to about 300 mm, about 290 mm
to about 350 mm, or about 300 mm to about 350 mm. In some
embodiments, the tactile sensing device 600 has a length 49 of
about 200 mm, about 210 mm, about 220 mm, about 230 mm, about 240
mm, about 250 mm, about 260 mm, about 270 mm, about 280 mm, about
290 mm, about 300 mm, or about 350 mm.
[0169] In some embodiments, the tactile sensing device 600 has a
width of about 78 mm. In some embodiments, the tactile sensing
device 600 has a width of about 40 mm to about 150 mm. In some
embodiments, the tactile sensing device 600 has a width of at least
about 40 mm. In some embodiments, the tactile sensing device 600
has a width of at most about 150 mm. In some embodiments, the
tactile sensing device 600 has a width of about 40 mm to about 50
mm, about 40 mm to about 60 mm, about 40 mm to about 70 mm, about
40 mm to about 80 mm, about 40 mm to about 90 mm, about 40 mm to
about 100 mm, about 40 mm to about 110 mm, about 40 mm to about 120
mm, about 40 mm to about 130 mm, about 40 mm to about 140 mm, about
40 mm to about 150 mm, about 50 mm to about 60 mm, about 50 mm to
about 70 mm, about 50 mm to about 80 mm, about 50 mm to about 90
mm, about 50 mm to about 100 mm, about 50 mm to about 110 mm, about
50 mm to about 120 mm, about 50 mm to about 130 mm, about 50 mm to
about 140 mm, about 50 mm to about 150 mm, about 60 mm to about 70
mm, about 60 mm to about 80 mm, about 60 mm to about 90 mm, about
60 mm to about 100 mm, about 60 mm to about 110 mm, about 60 mm to
about 120 mm, about 60 mm to about 130 mm, about 60 mm to about 140
mm, about 60 mm to about 150 mm, about 70 mm to about 80 mm, about
70 mm to about 90 mm, about 70 mm to about 100 mm, about 70 mm to
about 110 mm, about 70 mm to about 120 mm, about 70 mm to about 130
mm, about 70 mm to about 140 mm, about 70 mm to about 150 mm, about
80 mm to about 90 mm, about 80 mm to about 100 mm, about 80 mm to
about 110 mm, about 80 mm to about 120 mm, about 80 mm to about 130
mm, about 80 mm to about 140 mm, about 80 mm to about 150 mm, about
90 mm to about 100 mm, about 90 mm to about 110 mm, about 90 mm to
about 120 mm, about 90 mm to about 130 mm, about 90 mm to about 140
mm, about 90 mm to about 150 mm, about 100 mm to about 110 mm,
about 100 mm to about 120 mm, about 100 mm to about 130 mm, about
100 mm to about 140 mm, about 100 mm to about 150 mm, about 110 mm
to about 120 mm, about 110 mm to about 130 mm, about 110 mm to
about 140 mm, about 110 mm to about 150 mm, about 120 mm to about
130 mm, about 120 mm to about 140 mm, about 120 mm to about 150 mm,
about 130 mm to about 140 mm, about 130 mm to about 150 mm, or
about 140 mm to about 150 mm. In some embodiments, the tactile
sensing device 600 has a width of about 40 mm, about 50 mm, about
60 mm, about 70 mm, about 80 mm, about 90 mm, about 100 mm, about
110 mm, about 120 mm, about 130 mm, about 140 mm, or about 150
mm.
[0170] In some embodiments, the tactile sensing device 600 has a
height 57 of about 72 mm. In some embodiments, the tactile sensing
device 600 has a height 57 of about 10 mm to about 100 mm. In some
embodiments, the tactile sensing device 600 has a height 57 of at
least about 10 mm. In some embodiments, the tactile sensing device
600 has a height 57 of at most about 100 mm. In some embodiments,
the tactile sensing device 600 has a height 57 of about 10 mm to
about 20 mm, about 10 mm to about 30 mm, about 10 mm to about 40
mm, about 10 mm to about 50 mm, about 10 mm to about 60 mm, about
10 mm to about 70 mm, about 10 mm to about 80 mm, about 10 mm to
about 90 mm, about 10 mm to about 100 mm, about 20 mm to about 30
mm, about 20 mm to about 40 mm, about 20 mm to about 50 mm, about
20 mm to about 60 mm, about 20 mm to about 70 mm, about 20 mm to
about 80 mm, about 20 mm to about 90 mm, about 20 mm to about 100
mm, about 30 mm to about 40 mm, about 30 mm to about 50 mm, about
30 mm to about 60 mm, about 30 mm to about 70 mm, about 30 mm to
about 80 mm, about 30 mm to about 90 mm, about 30 mm to about 100
mm, about 40 mm to about 50 mm, about 40 mm to about 60 mm, about
40 mm to about 70 mm, about 40 mm to about 80 mm, about 40 mm to
about 90 mm, about 40 mm to about 100 mm, about 50 mm to about 60
mm, about 50 mm to about 70 mm, about 50 mm to about 80 mm, about
50 mm to about 90 mm, about 50 mm to about 100 mm, about 60 mm to
about 70 mm, about 60 mm to about 80 mm, about 60 mm to about 90
mm, about 60 mm to about 100 mm, about 70 mm to about 80 mm, about
70 mm to about 90 mm, about 70 mm to about 100 mm, about 80 mm to
about 90 mm, about 80 mm to about 100 mm, or about 90 mm to about
100 mm. In some embodiments, the tactile sensing device 600 has a
height 57 of about 10 mm, about 20 mm, about 30 mm, about 40 mm,
about 50 mm, about 60 mm, about 70 mm, about 80 mm, about 90 mm, or
about 100 mm.
[0171] In some embodiments, the sensor array (not shown in FIG. 6)
is an array of sensor elements also known as "sensels." In some
embodiments, the sensels are not discrete sensors. In some
embodiments, the sensor elements or sensels are configured to
connect to each other. In some embodiments, the sensor elements are
arranged in a grid (not shown in FIG. 6), with each sensor element
(or "sensel") located at the intersection of a row and column. In
some embodiments, the rows and columns are pinned out, rather than
individual sensors being pinned out, as is the case with an array
of discrete sensors. In some embodiments, the sensor array (not
shown in FIG. 6) is an array of cells. In some embodiments, the
sensor array (not shown in FIG. 6) is an array of sensing cells. In
some embodiments, the sensor array slit (not shown in FIG. 6) is
positioned between two rows or more of sensels. In some
embodiments, the sensor array slit (not shown in FIG. 6) is
positioned between two columns or more of sensels. In some
embodiments, the sensor array slit (not shown in FIG. 6) is within
the bounds of the sensor array, and/or within the bounds of the
sensor array outer edges, and/or within the edges bounding of the
sensor array. In some embodiments, the sensor array does not
comprise a slit. In some embodiments, the distal opening (not shown
in FIG. 6) of the needle guide 2 is positioned between two rows of
sensels. In some embodiments, the distal opening (not shown in FIG.
6) of the needle guide 2 is positioned between two columns of
sensels. In some embodiments the distal opening (not shown in FIG.
6) of the needle guide 2 is within the bounds of the sensor array,
and/or within the bounds of the sensor array outer edges, and/or
within the edges bounding of the sensor array. In some embodiments,
the distal opening (not shown in FIG. 6) is between two or more
sensors of the sensor array. In some embodiments, the distal
opening (not shown in FIG. 6) is positioned between two rows or
more of sensels. In some embodiments, the distal opening (not shown
in FIG. 6) is positioned between two columns or more of
sensels.
[0172] FIG. 7 shows the tactile sensing device 700 comprising an
enhanced support pinch grip 58. In some embodiments, the
reduced-sized handle provides numerous advantages, which include,
but are not limited to, enhancing the ability to apply moderate
force, an increased, medium sized device, and using prominent
fingers to hold the device. In some embodiments, a battery is
located inside or within the enhanced support pinch grip 58. In
some embodiments, the surface of the enhanced support pinch grip 58
comprises texture detail. In some embodiments, the surface of the
enhanced support pinch grip 58 is textured. In some embodiments,
the enhanced support pinch grip 58 provides the user with palm
support. In some embodiments, the enhanced support pinch grip 58
allows the user to use prominent fingers to hold the tactile
sensing device 700. In some embodiments, the tactile sensing device
700 comprises a fixed needle guide 2. In some embodiments, the
tactile sensing device 700 comprises a slot further comprising a
first slot wall 142a and a second slot wall (not shown in FIG.
7).
[0173] In some embodiments, the tactile sensing device 700 has a
length 49 of about 223 mm. In some embodiments, the tactile sensing
device 700 has a length 49 of about 150 mm to about 300 mm. In some
embodiments, the tactile sensing device 700 has a length 49 of at
least about 150 mm. In some embodiments, the tactile sensing device
700 has a length 49 of at most about 300 mm. In some embodiments,
the tactile sensing device 700 has a length 49 of about 150 mm to
about 200 mm, about 150 mm to about 210 mm, about 150 mm to about
220 mm, about 150 mm to about 230 mm, about 150 mm to about 240 mm,
about 150 mm to about 250 mm, about 150 mm to about 270 mm, about
150 mm to about 280 mm, about 150 mm to about 290 mm, about 150 mm
to about 300 mm, about 200 mm to about 210 mm, about 200 mm to
about 220 mm, about 200 mm to about 230 mm, about 200 mm to about
240 mm, about 200 mm to about 250 mm, about 200 mm to about 270 mm,
about 200 mm to about 280 mm, about 200 mm to about 290 mm, about
200 mm to about 300 mm, about 210 mm to about 220 mm, about 210 mm
to about 230 mm, about 210 mm to about 240 mm, about 210 mm to
about 250 mm, about 210 mm to about 270 mm, about 210 mm to about
280 mm, about 210 mm to about 290 mm, about 210 mm to about 300 mm,
about 220 mm to about 230 mm, about 220 mm to about 240 mm, about
220 mm to about 250 mm, about 220 mm to about 270 mm, about 220 mm
to about 280 mm, about 220 mm to about 290 mm, about 220 mm to
about 300 mm, about 230 mm to about 240 mm, about 230 mm to about
250 mm, about 230 mm to about 270 mm, about 230 mm to about 280 mm,
about 230 mm to about 290 mm, about 230 mm to about 300 mm, about
240 mm to about 250 mm, about 240 mm to about 270 mm, about 240 mm
to about 280 mm, about 240 mm to about 290 mm, about 240 mm to
about 300 mm, about 250 mm to about 270 mm, about 250 mm to about
280 mm, about 250 mm to about 290 mm, about 250 mm to about 300 mm,
about 270 mm to about 280 mm, about 270 mm to about 290 mm, about
270 mm to about 300 mm, about 280 mm to about 290 mm, about 280 mm
to about 300 mm, or about 290 mm to about 300 mm. In some
embodiments, the tactile sensing device 700 has a length 49 of
about 150 mm, about 200 mm, about 210 mm, about 220 mm, about 230
mm, about 240 mm, about 250 mm, about 270 mm, about 280 mm, about
290 mm, or about 300 mm.
[0174] In some embodiments, the tactile sensing device 700 has a
width 51 of about 78 mm. In some embodiments, the tactile sensing
device 700 has a width 51 of about 50 mm to about 150 mm. In some
embodiments, the tactile sensing device 700 has a width 51 of at
least about 50 mm. In some embodiments, the tactile sensing device
700 has a width 51 of at most about 150 mm. In some embodiments,
the tactile sensing device 700 has a width 51 of about 50 mm to
about 60 mm, about 50 mm to about 70 mm, about 50 mm to about 80
mm, about 50 mm to about 90 mm, about 50 mm to about 100 mm, about
50 mm to about 110 mm, about 50 mm to about 120 mm, about 50 mm to
about 130 mm, about 50 mm to about 140 mm, about 50 mm to about 150
mm, about 60 mm to about 70 mm, about 60 mm to about 80 mm, about
60 mm to about 90 mm, about 60 mm to about 100 mm, about 60 mm to
about 110 mm, about 60 mm to about 120 mm, about 60 mm to about 130
mm, about 60 mm to about 140 mm, about 60 mm to about 150 mm, about
70 mm to about 80 mm, about 70 mm to about 90 mm, about 70 mm to
about 100 mm, about 70 mm to about 110 mm, about 70 mm to about 120
mm, about 70 mm to about 130 mm, about 70 mm to about 140 mm, about
70 mm to about 150 mm, about 80 mm to about 90 mm, about 80 mm to
about 100 mm, about 80 mm to about 110 mm, about 80 mm to about 120
mm, about 80 mm to about 130 mm, about 80 mm to about 140 mm, about
80 mm to about 150 mm, about 90 mm to about 100 mm, about 90 mm to
about 110 mm, about 90 mm to about 120 mm, about 90 mm to about 130
mm, about 90 mm to about 140 mm, about 90 mm to about 150 mm, about
100 mm to about 110 mm, about 100 mm to about 120 mm, about 100 mm
to about 130 mm, about 100 mm to about 140 mm, about 100 mm to
about 150 mm, about 110 mm to about 120 mm, about 110 mm to about
130 mm, about 110 mm to about 140 mm, about 110 mm to about 150 mm,
about 120 mm to about 130 mm, about 120 mm to about 140 mm, about
120 mm to about 150 mm, about 130 mm to about 140 mm, about 130 mm
to about 150 mm, or about 140 mm to about 150 mm. In some
embodiments, the tactile sensing device 700 has a width 51 of about
50 mm, about 60 mm, about 70 mm, about 80 mm, about 90 mm, about
100 mm, about 110 mm, about 120 mm, about 130 mm, about 140 mm, or
about 150 mm.
[0175] In some embodiments, the tactile sensing device 700 has a
height 57 of about 70 mm. In some embodiments, the tactile sensing
device 700 has a height 57 of about 10 mm to about 100 mm. In some
embodiments, the tactile sensing device 700 has a height 57 of at
least about 10 mm. In some embodiments, the tactile sensing device
700 has a height 57 of at most about 100 mm. In some embodiments,
the tactile sensing device 700 has a height 57 of about 10 mm to
about 20 mm, about 10 mm to about 30 mm, about 10 mm to about 40
mm, about 10 mm to about 50 mm, about 10 mm to about 60 mm, about
10 mm to about 70 mm, about 10 mm to about 80 mm, about 10 mm to
about 90 mm, about 10 mm to about 100 mm, about 20 mm to about 30
mm, about 20 mm to about 40 mm, about 20 mm to about 50 mm, about
20 mm to about 60 mm, about 20 mm to about 70 mm, about 20 mm to
about 80 mm, about 20 mm to about 90 mm, about 20 mm to about 100
mm, about 30 mm to about 40 mm, about 30 mm to about 50 mm, about
30 mm to about 60 mm, about 30 mm to about 70 mm, about 30 mm to
about 80 mm, about 30 mm to about 90 mm, about 30 mm to about 100
mm, about 40 mm to about 50 mm, about 40 mm to about 60 mm, about
40 mm to about 70 mm, about 40 mm to about 80 mm, about 40 mm to
about 90 mm, about 40 mm to about 100 mm, about 50 mm to about 60
mm, about 50 mm to about 70 mm, about 50 mm to about 80 mm, about
50 mm to about 90 mm, about 50 mm to about 100 mm, about 60 mm to
about 70 mm, about 60 mm to about 80 mm, about 60 mm to about 90
mm, about 60 mm to about 100 mm, about 70 mm to about 80 mm, about
70 mm to about 90 mm, about 70 mm to about 100 mm, about 80 mm to
about 90 mm, about 80 mm to about 100 mm, or about 90 mm to about
100 mm. In some embodiments, the tactile sensing device 700 has a
height 57 of about 10 mm, about 20 mm, about 30 mm, about 40 mm,
about 50 mm, about 60 mm, about 70 mm, about 80 mm, about 90 mm, or
about 100 mm.
[0176] In some embodiments, the sensor array (not shown in FIG. 7)
is an array of sensor elements also known as "sensels." In some
embodiments, the sensels are not discrete sensors. In some
embodiments, the sensor elements or sensels are configured to
connect to each other. In some embodiments, the sensor elements are
arranged in a grid (not shown in FIG. 7), with each sensor element
(or "sensel") located at the intersection of a row and column. In
some embodiments, the rows and columns are pinned out, rather than
individual sensors being pinned out, as is the case with an array
of discrete sensors. In some embodiments, the sensor array (not
shown in FIG. 7) is an array of cells. In some embodiments, the
sensor array (not shown in FIG. 7) is an array of sensing cells. In
some embodiments, the sensor array slit (not shown in FIG. 7) is
positioned between two rows or more of sensels. In some
embodiments, the sensor array slit (not shown in FIG. 7) is
positioned between two columns or more of sensels. In some
embodiments, the sensor array slit (not shown in FIG. 7) is within
the bounds of the sensor array, and/or within the bounds of the
sensor array outer edges, and/or within the edges bounding of the
sensor array. In some embodiments, the sensor array does not
comprise a slit. In some embodiments, the distal opening (not shown
in FIG. 7) of the needle guide 2 is positioned between two rows of
sensels. In some embodiments, the distal opening (not shown in FIG.
7) of the needle guide 2 is positioned between two columns of
sensels. In some embodiments the distal opening (not shown in FIG.
7) of the needle guide 2 is within the bounds of the sensor array,
and/or within the bounds of the sensor array outer edges, and/or
within the edges bounding of the sensor array. In some embodiments,
the distal opening (not shown in FIG. 7) is between two or more
sensors of the sensor array. In some embodiments, the distal
opening (not shown in FIG. 7) is positioned between two rows or
more of sensels. In some embodiments, the distal opening (not shown
in FIG. 7) is positioned between two columns or more of
sensels.
[0177] FIG. 8 shows the tactile sensing device 800 comprising an
exaggerated undercut grip 60. In some embodiments, the exaggerated
undercut grip 60 provides numerous advantages which include, but
are not limited to, the ability to apply more force with the palm
of the user's hand, offering a surface area that is larger than the
surface area of handle 56 shown in FIGS. 6A-D, for example, which
the user uses to press or apply a force, and an integrated form
factor. In some embodiments, the exaggerated undercut grip 60
comprises a three-sided undercut wall 62 for grip. In some
embodiments, the tactile sensing device 800 measures approximately
213 mm in length, 79 mm in width, and 72 mm in height.
[0178] In some embodiments, the sensor array (not shown in FIG. 8)
is an array of sensor elements also known as "sensels." In some
embodiments, the sensels are not discrete sensors. In some
embodiments, the sensor elements or sensels are configured to
connect to each other. In some embodiments, the sensor elements are
arranged in a grid (not shown in FIG. 8), with each sensor element
(or "sensel") located at the intersection of a row and column. In
some embodiments, the rows and columns are pinned out, rather than
individual sensors being pinned out, as is the case with an array
of discrete sensors. In some embodiments, the sensor array (not
shown in FIG. 8) is an array of cells. In some embodiments, the
sensor array (not shown in FIG. 8) is an array of sensing cells. In
some embodiments, the sensor array slit (not shown in FIG. 8) is
positioned between two rows or more of sensels. In some
embodiments, the sensor array slit (not shown in FIG. 8) is
positioned between two columns or more of sensels. In some
embodiments, the sensor array slit (not shown in FIG. 8) is within
the bounds of the sensor array, and/or within the bounds of the
sensor array outer edges, and/or within the edges bounding of the
sensor array. In some embodiments, the sensor array does not
comprise a slit. In some embodiments, the distal opening (not shown
in FIG. 8) of the needle guide 2 is positioned between two rows of
sensels. In some embodiments, the distal opening (not shown in FIG.
8) of the needle guide 2 is positioned between two columns of
sensels. In some embodiments the distal opening (not shown in FIG.
8) of the needle guide 2 is within the bounds of the sensor array,
and/or within the bounds of the sensor array outer edges, and/or
within the edges bounding of the sensor array. In some embodiments,
the distal opening (not shown in FIG. 8) is between two or more
sensors of the sensor array. In some embodiments, the distal
opening (not shown in FIG. 8) is positioned between two rows or
more of sensels. In some embodiments, the distal opening (not shown
in FIG. 8) is positioned between two columns or more of
sensels.
[0179] FIG. 9 shows the tactile sensing device 900 comprising a
pinch grip 64. In some embodiments, the pinch grip 64 provides
numerous advantages which include, but are not limited to, better
control to make small adjustments in positioning of the tactile
sensing device 900 with fingers, compact size, ability to apply
force or press directly over the sensor array, and better control
when used on a lateral decubitus-positioned individual. In some
embodiments, the pinch grip 64 comprises a pressing support 66 that
has an increased posterior surface area that allows for a user to
apply force directly over the sensor array. In some embodiments,
the tactile sensing device 900 measures approximately 213 mm in
length, 78 mm in width, and 72 mm in height.
[0180] In some embodiments, the sensor array (not shown in FIG. 9)
is an array of sensor elements also known as "sensels." In some
embodiments, the sensels are not discrete sensors. In some
embodiments, the sensor elements or sensels are configured to
connect to each other. In some embodiments, the sensor elements are
arranged in a grid (not shown in FIG. 9), with each sensor element
(or "sensel") located at the intersection of a row and column. In
some embodiments, the rows and columns are pinned out, rather than
individual sensors being pinned out, as is the case with an array
of discrete sensors. In some embodiments, the sensor array (not
shown in FIG. 9) is an array of cells. In some embodiments, the
sensor array (not shown in FIG. 9) is an array of sensing cells. In
some embodiments, the sensor array slit (not shown in FIG. 9) is
positioned between two rows or more of sensels. In some
embodiments, the sensor array slit (not shown in FIG. 9) is
positioned between two columns or more of sensels. In some
embodiments, the sensor array slit (not shown in FIG. 9) is within
the bounds of the sensor array, and/or within the bounds of the
sensor array outer edges, and/or within the edges bounding of the
sensor array. In some embodiments, the sensor array does not
comprise a slit. In some embodiments, the distal opening (not shown
in FIG. 9) of the needle guide 2 is positioned between two rows of
sensels. In some embodiments, the distal opening (not shown in FIG.
9) of the needle guide 2 is positioned between two columns of
sensels. In some embodiments the distal opening (not shown in FIG.
9) of the needle guide 2 is within the bounds of the sensor array,
and/or within the bounds of the sensor array outer edges, and/or
within the edges bounding of the sensor array. In some embodiments,
the distal opening (not shown in FIG. 9) is between two or more
sensors of the sensor array. In some embodiments, the distal
opening (not shown in FIG. 9) is positioned between two rows or
more of sensels. In some embodiments, the distal opening (not shown
in FIG. 9) is positioned between two columns or more of
sensels.
[0181] FIG. 10 show the tactile sensing device 1000 comprising an
undercut body grip 61. In some embodiments, the undercut body grip
61 provides numerous advantages which include, but are not limited
to, better control to make small adjustments in positioning of the
tactile sensing device 1000 with fingers, compact size of device,
integrated form factor, and ability of a user to apply force or
press directly over the sensor array. In some embodiments, the
undercut body grip 61 comprises an undercut wall 62 on its lateral
side that enables the user to have improved handling of the device.
In some embodiments, the tactile sensing device 1000 measures
approximately 207 mm in length, 78 mm in width, and 72 mm in
height.
[0182] In some embodiments, the sensor array (not shown in FIG. 10)
is an array of sensor elements also known as "sensels." In some
embodiments, the sensels are not discrete sensors. In some
embodiments, the sensor elements or sensels are configured to
connect to each other. In some embodiments, the sensor elements are
arranged in a grid (not shown in FIG. 10), with each sensor element
(or "sensel") located at the intersection of a row and column. In
some embodiments, the rows and columns are pinned out, rather than
individual sensors being pinned out, as is the case with an array
of discrete sensors. In some embodiments, the sensor array (not
shown in FIG. 10) is an array of cells. In some embodiments, the
sensor array (not shown in FIG. 10) is an array of sensing cells.
In some embodiments, the sensor array slit (not shown in FIG. 10)
is positioned between two rows or more of sensels. In some
embodiments, the sensor array slit (not shown in FIG. 10) is
positioned between two columns or more of sensels. In some
embodiments, the sensor array slit (not shown in FIG. 10) is within
the bounds of the sensor array, and/or within the bounds of the
sensor array outer edges, and/or within the edges bounding of the
sensor array. In some embodiments, the sensor array does not
comprise a slit. In some embodiments, the distal opening (not shown
in FIG. 10) of the needle guide 2 is positioned between two rows of
sensels. In some embodiments, the distal opening (not shown in FIG.
10) of the needle guide 2 is positioned between two columns of
sensels. In some embodiments the distal opening (not shown in FIG.
10) of the needle guide 2 is within the bounds of the sensor array,
and/or within the bounds of the sensor array outer edges, and/or
within the edges bounding of the sensor array. In some embodiments,
the distal opening (not shown in FIG. 10) is between two or more
sensors of the sensor array. In some embodiments, the distal
opening (not shown in FIG. 10) is positioned between two rows or
more of sensels. In some embodiments, the distal opening (not shown
in FIG. 10) is positioned between two columns or more of
sensels.
[0183] FIG. 11 shows the tactile sensing device 1100 comprising a
power grip handle 68. In some embodiments, the power grip handle 68
enhances the ability of a user to apply force or press directly
over the sensor array. In some embodiments, the power grip handle
68.
In some embodiments, the tactile sensing device 1100 measures
approximately 286 mm in length, 78 mm in width, and 95 mm in
height.
[0184] In some embodiments, the tactile sensing device measures at
least about 150 mm to at most about 350 mm in length. In some
embodiments, the tactile sensing device measures at least about 150
mm to at most about 200 mm in length. In some embodiments, the
tactile sensing device measures at least about 200 mm to at most
about 250 mm in length. In some embodiments, the tactile sensing
device measures at least about 250 mm to at most about 300 mm in
length. In some embodiments, the tactile sensing device measures
about 150 mm in length. In some embodiments, the tactile sensing
device measures about 160 mm in length. In some embodiments, the
tactile sensing device measures about 170 mm in length. In some
embodiments, the tactile sensing device measures about 180 mm in
length. In some embodiments, the tactile sensing device measures
about 190 mm in length. In some embodiments, the tactile sensing
device measures about 200 mm in length. In some embodiments, the
tactile sensing device measures about 210 mm in length. In some
embodiments, the tactile sensing device measures about 220 mm in
length. In some embodiments, the tactile sensing device measures
about 230 mm in length. In some embodiments, the tactile sensing
device measures about 240 mm in length. In some embodiments, the
tactile sensing device measures about 250 mm in length. In some
embodiments, the tactile sensing device measures about 260 mm in
length. In some embodiments, the tactile sensing device measures
about 270 mm in length. In some embodiments, the tactile sensing
device measures about 280 mm in length. In some embodiments, the
tactile sensing device measures about 290 mm in length. In some
embodiments, the tactile sensing device measures about 300 mm in
length. In some embodiments, the tactile sensing device measures
about 350 mm in length. In some embodiments, the tactile sensing
device measures about 316 mm in length.
[0185] In some embodiments, the tactile sensing device measures at
least about 50 mm to at most about 150 mm in width. In some
embodiments, the tactile sensing device measures at least about 50
mm to at most about 100 mm in width. In some embodiments, the
tactile sensing device measures at least about 100 mm to at most
about 150 mm in width. In some embodiments, the tactile sensing
device measures at least about 50 mm to at most about 80 mm in
width. In some embodiments, the tactile sensing device measures
about 70 mm in width. In some embodiments, the tactile sensing
device measures about 75 mm in width. In some embodiments, the
tactile sensing device measures about 80 mm in width. In some
embodiments, the tactile sensing device measures about 85 mm in
width. In some embodiments, the tactile sensing device measures
about 100 mm in width. In some embodiments, the tactile sensing
device measures about 150 mm in width. In some embodiments, the
tactile sensing device measures about 50 mm in width. In some
embodiments, the tactile sensing device measures about 60 mm in
width. In some embodiments, the tactile sensing device measures
about 78 mm in width. In some embodiments, the tactile sensing
device measures about 79 mm in width. In some embodiments, the
tactile sensing device measures about 77 mm in width.
[0186] In some embodiments, the sensor array (not shown in FIG. 11)
is an array of sensor elements also known as "sensels." In some
embodiments, the sensels are not discrete sensors. In some
embodiments, the sensor elements or sensels are configured to
connect to each other. In some embodiments, the sensor elements are
arranged in a grid (not shown in FIG. 11), with each sensor element
(or "sensel") located at the intersection of a row and column. In
some embodiments, the rows and columns are pinned out, rather than
individual sensors being pinned out, as is the case with an array
of discrete sensors. In some embodiments, the sensor array (not
shown in FIG. 11) is an array of cells. In some embodiments, the
sensor array (not shown in FIG. 11) is an array of sensing cells.
In some embodiments, the sensor array slit (not shown in FIG. 11)
is positioned between two rows or more of sensels. In some
embodiments, the sensor array slit (not shown in FIG. 11) is
positioned between two columns or more of sensels. In some
embodiments, the sensor array slit (not shown in FIG. 11) is within
the bounds of the sensor array, and/or within the bounds of the
sensor array outer edges, and/or within the edges bounding of the
sensor array. In some embodiments, the sensor array does not
comprise a slit. In some embodiments, the distal opening (not shown
in FIG. 11) of the needle guide 2 is positioned between two rows of
sensels. In some embodiments, the distal opening (not shown in FIG.
11) of the needle guide 2 is positioned between two columns of
sensels. In some embodiments the distal opening (not shown in FIG.
11) of the needle guide 2 is within the bounds of the sensor array,
and/or within the bounds of the sensor array outer edges, and/or
within the edges bounding of the sensor array. In some embodiments,
the distal opening (not shown in FIG. 11) is between two or more
sensors of the sensor array. In some embodiments, the distal
opening (not shown in FIG. 11) is positioned between two rows or
more of sensels. In some embodiments, the distal opening (not shown
in FIG. 11) is positioned between two columns or more of
sensels.
[0187] In some embodiments, the tactile sensing device comprises an
angled display screen. In some embodiments, the display screen 4 is
at a display angle with respect to the sensor array. In some
embodiments, the angled display screen is at a display angle with
respect to the posterior surface of the tactile sensing device. In
some embodiments, the angled display screen provides more
visibility when used on a seated individual compared to when used
on a lateral decubitus-positioned individual. In some embodiments,
the tactile sensing device comprises a flat display screen. In some
embodiments, the flat display screen is parallel to the sensor
array. In some embodiments, the flat display screen is parallel to
the posterior surface of the tactile sensing device. In some
embodiments, the flat display screen is at a display angle of zero
degrees with respect to the posterior surface of the tactile
sensing device. In some embodiments, the display angle is
adjustable. In some embodiments, the display is manually or
automatically adjustable. In some embodiments, the flat display
screen provides good visibility when used on a seated individual
and when used on a lateral decubitus-positioned individual.
[0188] FIGS. 12A-C show a tactile sensing device 1200 comprising a
sleeve 80, an electronic unit 34, and a sensor unit 32. FIGS. 12A-C
show different designs of the tactile sensing device 1200,
particularly different features of the handle 54. For example, in
some embodiments, the tactile sensing device 1200 comprises a
handle 54 comprising a texture feature 82 and a needle alignment
guide 36, as shown in FIG. 12A. In some embodiments, the texture
feature 82 provides a textured surface to increase traction on and
enhance a thumb grip. In some embodiments, the tactile sensing
device 1200 comprises a grip feature 76, as shown in FIGS. 12B-C.
In some embodiments, the grip feature 76 is an indentation on the
handle 54 that enhances grip.
[0189] In some embodiments, the tactile sensing device comprises a
larger sterile area compared to the embodiments presented in FIG.
6. In some embodiments, the sensor unit 32 is disposable. In some
embodiments, the sensor unit 32 comprises a handle 54. In some
embodiments, the sensor unit 32 comprises a pressure sensor
connector 12, a needle guide 2, an electronic unit connector 74,
and a sensor array area 72. In some embodiments, the sensor unit 32
comprises the main body of the tactile sensing device 1400. In some
embodiments, the electronic unit connector 74 is positioned
distally away from the pressure sensor connector 12. In some
embodiments, the electronic unit connector 74 operatively couples
the sensor unit 32 with the electronic unit 34. In some
embodiments, the electronic unit connector 74 is a male connector.
In some embodiments, the sensor unit 32 comprises a port or female
connector configured to receive the electronic unit connector 74.
In some embodiments, the electronic unit connector 74 operatively
couples the sensor unit 32 with the electronic unit 34 when the
electronic unit connector 74 is inserted into a port or female
connector located in the sensor unit 32. In some embodiments, the
sensor unit 32 is operatively coupled to the electronic unit 34 by
sliding the sensor unit 32 into a socket in the electronic unit 34,
where the electronic connectors are located.
[0190] In some embodiments, the tactile sensing device comprises a
sleeve 80. In some embodiments, the sleeve 80 enables the tactile
sensing device to achieve complete sterility during use. In some
embodiments, having two sterile disposable units completely covers
the electronic unit connector and a sensor unit connector.
[0191] FIGS. 12 A-B are front views of two different embodiments of
the tactile sensing device 1200 that illustrate how the sleeve 80
slides onto the electronic unit 34. Additionally, in some
embodiments, FIGS. 12 A-B illustrate how the electronic unit 34
inserts into the sensor unit 32 (note the arrows in FIGS. 12 A-C
indicate the direction of movement of each element during
assembly). FIG. 12C illustrates yet another embodiment of the
tactile sensing device 1200 where the electronic unit 34 snaps onto
the distal portion of the tactile sensing device 1200, and the
sleeve 80 snaps onto the electronic unit 34, as shown by the
arrows. In some embodiments, the sleeve 80 is loaded onto the
electronic unit via a snap-on mechanism, as shown in FIG. 12C. In
some embodiments, the electronic unit 34 is loaded onto the sensor
unit via a snap-on mechanism, as shown in FIG. 12C.
[0192] In some embodiments, the electronic unit 34 is reversibly
loaded onto the sensor unit from the top of the device. In some
embodiments, the electronic unit 34 reversibly and operatively
connects to the sensor unit 32 and/or the tactile sensing device
via a magnetic force. In some embodiments, the electronic unit 34
comprises a magnet. In some embodiments, the distal portion of the
tactile sensing device comprises a magnet. In some embodiments, the
sleeve 80 reversibly attaches to the electronic unit 34 and/or to
the tactile sensing device via a magnetic force. In some
embodiments, the sleeve 80 comprises a magnet. In some embodiments,
the electronic unit 34 is reversibly and operatively connected to
the tactile sensing device and/or to the sensor unit 32 by any
other suitable means (e.g., by using one or more clips, one or more
fasteners, and/or one or more clamps). In some embodiments, the
sleeve 80 is reversibly and operatively connected to the tactile
sensing device and/or to the electronic unit 34 by any other
suitable means (e.g., by using one or more clips, one or more
fasteners, and/or one or more clamps).
[0193] In some embodiments, the electronic unit 34 comprises an
electronic unit connector 74. In some embodiments, the electronic
unit connector 74 is a tab. In some embodiments, the sleeve 80 is
composed of clear plastic. In some embodiments, the sleeve 80 is a
disposable sleeve. In some embodiments, the sleeve 80 is a plastic
sleeve. In some embodiments, the sleeve 80 is a reusable sleeve. In
some embodiments, the sleeve 80 is a sterile sleeve. In some
embodiments the tactile sensing device 1200 comprises a needle
guide 2 comprising a rectangular shape. In some embodiments the
tactile sensing device 1200 comprises a needle guide 2, wherein the
needle guide 2 does not comprise a notch. In some embodiments the
tactile sensing device 1200 comprises a needle guide 2, wherein the
needle guide 2 only comprises a slot 38. In some embodiments the
tactile sensing device 1200 comprises a needle guide 2, wherein the
needle guide 2 does not comprise a track. In some embodiments the
tactile sensing device 1200 comprises a needle guide 2 comprising a
flared proximal opening.
[0194] In some embodiments, the sensor array (not shown in FIGS.
12A-C) is an array of sensor elements also known as "sensels." In
some embodiments, the sensels are not discrete sensors. In some
embodiments, the sensor elements or sensels are configured to
connect to each other. In some embodiments, the sensor elements are
arranged in a grid (not shown in FIGS. 12A-C), with each sensor
element (or "sensel") located at the intersection of a row and
column. In some embodiments, the rows and columns are pinned out,
rather than individual sensors being pinned out, as is the case
with an array of discrete sensors. In some embodiments, the sensor
array (not shown in FIGS. 12A-C) is an array of cells. In some
embodiments, the sensor array (not shown in FIGS. 12A-C) is an
array of sensing cells. In some embodiments, the sensor array slit
(not shown in FIGS. 12A-C) is positioned between two rows or more
of sensels. In some embodiments, the sensor array slit (not shown
in FIGS. 12A-C) is positioned between two columns or more of
sensels. In some embodiments, the sensor array slit (not shown in
FIGS. 12A-C) is within the bounds of the sensor array, and/or
within the bounds of the sensor array outer edges, and/or within
the edges bounding of the sensor array. In some embodiments, the
sensor array does not comprise a slit. In some embodiments, the
distal opening (not shown in FIGS. 12A-C) of the needle guide 2 is
positioned between two rows of sensels. In some embodiments, the
distal opening (not shown in FIGS. 12A-C) of the needle guide 2 is
positioned between two columns of sensels. In some embodiments the
distal opening (not shown in FIGS. 12A-C) of the needle guide 2 is
within the bounds of the sensor array, and/or within the bounds of
the sensor array outer edges, and/or within the edges bounding of
the sensor array. In some embodiments, the distal opening (not
shown in FIGS. 12A-C) is between two or more sensors of the sensor
array. In some embodiments, the distal opening (not shown in FIGS.
12A-C) is positioned between two rows or more of sensels. In some
embodiments, the distal opening (not shown in FIGS. 12A-C) is
positioned between two columns or more of sensels.
[0195] FIG. 13 illustrates a sagittal section of the lumbar spine
of an individual with a first needle 14a in the spinal canal 100,
in the subarachnoid space. The illustration of the sagittal section
of the lumbar spine shows a third lumbar vertebra 88, a fourth
lumbar vertebra 90, and a fifth lumbar vertebra 92. FIG. 13 further
shows a spinous process of the third lumbar vertebra (L3) 94, a
spinous process of the fourth lumbar vertebra (L4) 96, and a
spinous process of the fifth lumbar (L5) vertebra 98, which are
located laterally across from the third lumbar vertebra 88, from
the fourth lumbar vertebra 90, and from the fifth lumbar vertebra
92, respectively. The illustration of the sagittal section of the
lumbar spine further shows a spinal cord 102 located in the space
between the lumbar vertebrae and the spinous processes (i.e., the
spinal canal). Additionally, FIG. 13 shows a subarachnoid space 100
located in the space between the lumbar vertebrae and the spinous
processes and surrounding the spinal cord 102. FIG. 13 shows an
epidural space 59, which is shown as encasing the subarachnoid
space 100. FIG. 13 further shows a tissue 104 of the individual
located laterally across from the spinous processes. In some
embodiments, the tissue 104 is soft tissue. In some embodiments,
the tissue 104 is subcutaneous adipose tissue, muscle, ligaments,
tendons, and/or skin. In some embodiments, the surface of tissue
104, as shown by the X-axis on FIG. 13, is skin.
[0196] FIG. 13 shows a first tactile sensing device 1300a and a
second tactile sensing device 1300b placed on top of the skin of an
individual. The second tactile sensing device in this image is not
meant to indicate that there is a system with two devices, rather,
it is meant to show how the location the needle gets inserted into
the subject might differ in cases of different spinous process
depths. FIG. 13 shows a first Y1-axis and a second Y2-axis that are
both perpendicular to the X-axis. In some embodiments, a first
needle 14a is inserted at a first treatment angle 86a, as shown in
FIG. 13. In some embodiments, the first treatment angle 86a is
defined as the space measured in degrees between the X-axis and the
first needle 14a. In some embodiments, the first treatment angle
86a is defined as the space measured in degrees between the
posterior surface of the tactile sensing device 1900a and the first
needle 14a. In some embodiments, the first treatment angle 86a is
defined as the space measured in degrees between a posterior face
of the sensor array and the first needle 14a.
[0197] In some embodiments, a second needle 14b is inserted at a
second treatment angle 86b. In some embodiments, the second
treatment angle 86b is defined as the space measured in degrees
between the X-axis and the second needle 14b. In some embodiments,
the second treatment angle 86b is defined as the space measured in
degrees between the posterior surface of the second tactile sensing
device 1900b and the second needle 14b. In some embodiments, the
second treatment angle 86b is defined as the space measured in
degrees between a posterior face of the sensor array and the first
needle 14b.
[0198] In some embodiments, a first needle 14a is inserted at a
first cephalad angle 85a. In some embodiments, the first cephalad
angle 85a is defined as the space measured in degrees between the
first Y1-axis and the first needle 14a. In some embodiments, a
second needle 14b is shown as being inserted at a second cephalad
angle 85b. In some embodiments, the second cephalad angle 85b is
defined as the space measured in degrees between the second Y2-axis
and the second needle 14b. In some embodiments, the treatment angle
is a cephalad angle. In some embodiments, the treatment angle is a
caudal angle.
[0199] In addition, FIG. 13 shows the first tactile sensing device
1300a being moved in the direction of arrow 103 resulting in the
tactile sensing device being positioned as illustrated by the
second tactile second device 1300b. In some embodiments, the user
moves the tactile sensing device in the direction of arrow 103 in
order to adjust the level at which the needle enters the epidural
space 100. In some embodiments, the user does not need to tilt the
tactile sensing device in order to adjust the level at which the
needle enters the epidural space 100.
[0200] Furthermore, FIG. 13 shows a display screen offset 101. In
some embodiments, the display screen (not shown in FIG. 13) is
raised at a display screen offset 101 from the posterior surface of
the tactile sensing device 1900. In some embodiments, the display
screen is raised at a display screen offset 101 from the posterior
face of the sensor array. In some embodiments, the display screen
is raised at a display screen offset 101 from the skin surface of
the patient when pressing the tactile sensing device against the
patient.
[0201] In some embodiments, the display screen offset 101 is about
17 mm. In some embodiments, the display screen offset 101 is about
5 mm. In some embodiments, the display screen offset 101 is about
10 mm. In some embodiments, the display screen offset 101 is about
11 mm. In some embodiments, the display screen offset 101 is about
12 mm. In some embodiments, the display screen offset 101 is about
13 mm. In some embodiments, the display screen offset 101 is about
14 mm. In some embodiments, the display screen offset 101 is about
15 mm. In some embodiments, the display screen offset 101 is about
16 mm. In some embodiments, the display screen offset 101 is about
18 mm. In some embodiments, the display screen offset 101 is about
19 mm. In some embodiments, the display screen offset 101 is about
20 mm. In some embodiments, the display screen offset 19101 is
about 25 mm. In some embodiments, the display screen offset 101 is
about 30 mm. In some embodiments, the display screen offset 101 is
about 35 mm. In some embodiments, the display screen offset 101 is
about 40 mm. In some embodiments, the display screen offset 101 is
about 45 mm. In some embodiments, the display screen offset 101 is
about 50 mm.
[0202] In some embodiments, the display screen offset 101 is at
least about 1 mm to about 5 mm at most. In some embodiments, the
display screen offset 101 is at least about 5 mm to about 10 mm at
most. In some embodiments, the display screen offset 101 is at
least about 10 mm to about 15 mm at most. In some embodiments, the
display screen offset 101 is at least about 15 mm to about 20 mm at
most. In some embodiments, the display screen offset 101 is at
least about 20 mm to about 25 mm at most. In some embodiments, the
display screen offset 101 is at least about 25 mm to about 30 mm at
most. In some embodiments, the display screen offset 101 is at
least about 30 mm to about 35 mm at most. In some embodiments, the
display screen offset 101 is at least about 35 mm to about 40 mm at
most. In some embodiments, the display screen offset 101 is at
least about 40 mm to about 45 mm at most. In some embodiments, the
display screen offset 101 is at least about 45 mm to about 50 mm at
most. In some embodiments, the display screen offset 101 is at
least about 50 mm to about 55 mm at most. In some embodiments, the
display screen offset 101 is at least about 55 mm to about 60 mm at
most. In some embodiments, the display screen offset 101 is at
least about 1 mm to about 100 mm or more.
[0203] In some embodiments, the display screen is at a display
screen angle 99 with respect to the display screen offset 101. In
some embodiments, the display screen rotates relative to the sensor
array around a hinge to adjust the display screen angle 99. In some
embodiments, the display screen rotates relative to the sensor unit
around a hinge to adjust the display screen angle 99. In some
embodiments, the display screen is pivotally mounted to the tactile
sensing device via hinges (not shown in FIG. 13). In some
embodiments, the display screen angle 99 is manually adjusted by
moving the display screen around a hinge (not shown).
[0204] In some embodiments, the display screen is fixed to a rotary
shaft that is further connected to the sensor array (not shown in
FIG. 13). In some embodiments, the display screen is fixed to a
rotary shaft that is further connected to the sensor unit. In some
embodiments, the display screen rotates freely and
multidirectionally relative to the sensor array. In some
embodiments, the display screen rotates freely and
multidirectionally relative to the sensor unit. In some
embodiments, the display screen rotates bidirectionally relative to
the sensor array. In some embodiments, the display screen rotates
bidirectionally relative to the sensor unit. In some embodiments,
the display screen rotates clockwise or counterclockwise relative
to the sensor array. In some embodiments, the display screen
rotates clockwise or counterclockwise relative to the sensor
unit.
[0205] In some embodiments, the display screen angle 99 is about 90
degrees. In some embodiments, the display screen angle 99 is about
100 degrees. In some embodiments, the display screen angle 99 is
about 110 degrees. In some embodiments, the display screen angle 99
is about 120 degrees. In some embodiments, the display screen angle
99 is about 130 degrees. In some embodiments, the display screen
angle 99 is about 135 degrees. In some embodiments, the display
screen angle 99 is about 140 degrees. In some embodiments, the
display screen angle 99 is about 80 degrees. In some embodiments,
the display screen angle 99 is about 70 degrees. In some
embodiments, the display screen angle 99 is about 60 degrees. In
some embodiments, the display screen angle 99 is about 50 degrees.
In some embodiments, the display screen angle 99 is about 45
degrees. In some embodiments, the display screen angle 99 is at
least about 45 degrees to about 140 degrees or more. In some
embodiments, the display screen angle 99 is at least about 45
degrees to about 90 degrees at most. In some embodiments, the
display screen angle 99 is at least about 90 degrees to about 140
degrees at most.
[0206] In some embodiments, the sensor array (not shown in FIG. 13)
is an array of sensor elements also known as "sensels." In some
embodiments, the sensels are not discrete sensors. In some
embodiments, the sensor elements or sensels are configured to
connect to each other. In some embodiments, the sensor elements are
arranged in a grid (not shown in FIG. 13), with each sensor element
(or "sensel") located at the intersection of a row and column. In
some embodiments, the rows and columns are pinned out, rather than
individual sensors being pinned out, as is the case with an array
of discrete sensors. In some embodiments, the sensor array (not
shown in FIG. 13) is an array of cells. In some embodiments, the
sensor array (not shown in FIG. 13) is an array of sensing cells.
In some embodiments, the sensor array slit (not shown in FIG. 13)
is positioned between two rows or more of sensels. In some
embodiments, the sensor array slit (not shown in FIG. 13) is
positioned between two columns or more of sensels. In some
embodiments, the sensor array slit (not shown in FIG. 13) is within
the bounds of the sensor array, and/or within the bounds of the
sensor array outer edges, and/or within the edges bounding of the
sensor array. In some embodiments, the sensor array does not
comprise a slit. In some embodiments, the distal opening (not shown
in FIG. 13) of the needle guide (not shown in FIG. 13) is
positioned between two rows of sensels. In some embodiments, the
distal opening (not shown in FIG. 13) of the needle guide (not
shown in FIG. 13) is positioned between two columns of sensels. In
some embodiments the distal opening (not shown in FIG. 13) of the
needle guide (not shown in FIG. 13) is within the bounds of the
sensor array, and/or within the bounds of the sensor array outer
edges, and/or within the edges bounding of the sensor array. In
some embodiments, the distal opening (not shown in FIG. 13) is
between two or more sensors of the sensor array. In some
embodiments, the distal opening (not shown in FIG. 13) is
positioned between two rows or more of sensels. In some
embodiments, the distal opening (not shown in FIG. 13) is
positioned between two columns or more of sensels.
[0207] FIG. 14 shows the assembly of the various elements of the
tactile sensing device 1400. In some embodiments, the tactile
sensing device 1400 comprises a sleeve 80 that is slipped onto the
electronic unit 34. In some embodiments, the electronic unit 34
comprises a display screen 4, a graphic overlay 106, and an
electronic unit connector 74. In some embodiments, the electronic
unit 34 is inserted into a sensor unit 32 comprising a sensor unit
port (not shown in FIG. 14). In some embodiments, the sensor unit
32 comprises a needle guide 2, a pressure sensor connector 12, a
slot opening 38a, a needle alignment guide 36, and a handle 54. In
some embodiments, the handle 54 comprises a grip feature 76 to
enhance grip. In some embodiments, the grip feature 76 is an
indentation in the underside of the handle 54.
[0208] In some embodiments, the sensor array (not shown in FIG. 14)
is an array of sensor elements also known as "sensels." In some
embodiments, the sensels are not discrete sensors. In some
embodiments, the sensor elements or sensels are configured to
connect to each other. In some embodiments, the sensor elements are
arranged in a grid (not shown in FIG. 14), with each sensor element
(or "sensel") located at the intersection of a row and column. In
some embodiments, the rows and columns are pinned out, rather than
individual sensors being pinned out, as is the case with an array
of discrete sensors. In some embodiments, the sensor array (not
shown in FIG. 14) is an array of cells. In some embodiments, the
sensor array (not shown in FIG. 14) is an array of sensing cells.
In some embodiments, the sensor array slit (not shown in FIG. 14)
is positioned between two rows or more of sensels. In some
embodiments, the sensor array slit (not shown in FIG. 14) is
positioned between two columns or more of sensels. In some
embodiments, the sensor array slit (not shown in FIG. 14) is within
the bounds of the sensor array, and/or within the bounds of the
sensor array outer edges, and/or within the edges bounding of the
sensor array. In some embodiments, the sensor array does not
comprise a slit. In some embodiments, the distal opening (not shown
in FIG. 14) of the needle guide 2 is positioned between two rows of
sensels. In some embodiments, the distal opening (not shown in FIG.
14) of the needle 2 is positioned between two columns of sensels.
In some embodiments the distal opening (not shown in FIG. 20) of
the needle guide 2 is within the bounds of the sensor array, and/or
within the bounds of the sensor array outer edges, and/or within
the edges bounding of the sensor array. In some embodiments, the
distal opening (not shown in FIG. 14) is between two or more
sensors of the sensor array. In some embodiments, the distal
opening (not shown in FIG. 14) is positioned between two rows or
more of sensels. In some embodiments, the distal opening (not shown
in FIG. 14) is positioned between two columns or more of
sensels.
[0209] FIG. 15 shows an exploded view of the sensor array. In some
embodiments, the sensor array comprises an elastomer on the
patient-facing side to improve force output and/or tissue
displacement. In some embodiments, the sensor array is a
screen-printed force-sensitive resistor (FSR) array 108. In some
embodiments, the screen-printed force-sensitive resistor (FSR)
array 108 comprises a lower circuit 110, a spacer 112, an FSR layer
114, and an adhesive 116. In some embodiments, the screen-printed
force-sensitive resistor (FSR) array 108 is constructed by first
placing the spacer 112 directly over the lower circuit 110, then
placing the FSR layer 114 directly over the spacer 112, and finally
placing the adhesive 116 directly over the FSR layer 114. In some
embodiments, the screen-printed force-sensitive resistor (FSR)
array 108 is adhered to the posterior surface of the tactile
sensing device by using the adhesive 116. In some embodiments, the
screen-printed force-sensitive resistor (FSR) array 108 comprises a
sensor array slit 146. In some embodiments, the screen-printed
force-sensitive resistor (FSR) array 108 does not comprise a sensor
array slit 146. In some embodiments, the sensor array slit 146 is
directly aligned with slot featured in some of the embodiments,
presented herein (e.g. slot opening 38a in FIG. 14). In some
embodiments, the sensor array slit 146 matches the posterior
surface design and shape of the tactile sensing device.
[0210] In some embodiments, the sensor array slit 146 is positioned
between two rows or more of sensels. In some embodiments, the
sensor array slit 146 is positioned between two columns or more of
sensels. In some embodiments, the sensor array slit 146 is within
the bounds of the sensor array, and/or within the bounds of the
sensor array outer edges, and/or within the edges bounding of the
sensor array. In some embodiments, the distal opening (not shown in
FIG. 15) of the needle guide (not shown in FIG. 15) is positioned
between two rows of sensels. In some embodiments, the distal
opening (not shown in FIG. 15) of the needle (not shown in FIG. 15)
is positioned between two columns of sensels. In some embodiments
the distal opening (not shown in FIG. 15) of the needle guide (not
shown in FIG. 15) is within the bounds of the sensor array, and/or
within the bounds of the sensor array outer edges, and/or within
the edges bounding of the sensor array. In some embodiments, the
distal opening (not shown in FIG. 15) is between two or more
sensors of the sensor array. In some embodiments, the distal
opening (not shown in FIG. 15) is positioned between two rows or
more of sensels. In some embodiments, the distal opening (not shown
in FIG. 15) is positioned between two columns or more of
sensels.
[0211] FIG. 16 shows how the screen-printed force-sensitive
resistor (FSR) array 108 is adhered onto the posterior surface of
the tactile sensing device 2200. In some embodiments, the
screen-printed force-sensitive resistor (FSR) array 108 is adhered
onto the sensor attachment area 52. As seen in FIG. 16, the sensor
array slit 146 is the same shape and size as the slot 38 of the
device, which enables the user to slide the needle through the slot
38 without any obstructions. In some embodiments, the
screen-printed force-sensitive resistor (FSR) array 108 comprises a
conductive adhesive 118 configured to operatively couple the
screen-printed force-sensitive resistor (FSR) array 108 with a
printed circuit board (not shown in FIG. 16). In dome embodiments,
the screen-printed force-sensitive resistor (FSR) array 108
comprises a connector configured to operatively couple the array
108 with the printed circuit board, such as a zero insertion force
electrical connector. In some embodiments, the part of the
screen-printed force-sensitive resistor (FSR) array 108 comprising
(i.e., the part resembles a tab in FIG. 16) a conductive adhesive
118 is folded into a sensor array slot 147 of the tactile sensing
device. In some embodiments, the sensor array slot 147 is slot
located along a lateral edge of the bottom surface of the tactile
sensing device, as shown in FIG. 16. In some embodiments, the
sensor array slot 147 is located along any edge of the bottom
surface of the tactile sensing device. In some embodiments, the
sensor array slot 147 is a slot that is configured to receive the
conductive adhesive 118. In some embodiments, the conductive
adhesive 118 is inserted into the sensor array slot 147 in order to
operatively connect the FSR array to one or more electronic
components of the tactile sensing device. Also shown in FIG. 16, is
a posterior face 109 of the sensor array 108. In some embodiments,
the posterior face 109 comes in contact with the skin surface of a
patient. In some embodiments, the posterior face 109 is located on
the posterior surface of the tactile sensing device 2200. In some
embodiments, a tail of the sensor array will terminate with a
connector, which will further be assembled with an intermediary
PCBA in disposable versions of the device described herein
(requiring some sort of connector, e.g. a zero insertion force
connector, or a Z-axis adhesive). In some embodiments, the
intermediary PCBA will comprise a durable connector, that
facilitates connection with the reusable portion of the device
(e.g. via a card-edge connector).
[0212] In some embodiments, the sensor array slit 146 is positioned
between two rows or more of sensels. In some embodiments, the
sensor array slit 146 is positioned between two columns or more of
sensels. In some embodiments, the sensor array slit 146 is within
the bounds of the sensor array, and/or within the bounds of the
sensor array outer edges, and/or within the edges bounding of the
sensor array. In some embodiments, the distal opening (not shown in
FIG. 16) of the needle guide (not shown in FIG. 16) is positioned
between two rows of sensels. In some embodiments, the distal
opening (not shown in FIG. 16) of the needle (not shown in FIG. 16)
is positioned between two columns of sensels. In some embodiments
the distal opening (not shown in FIG. 16) of the needle guide (not
shown in FIG. 16) is within the bounds of the sensor array, and/or
within the bounds of the sensor array outer edges, and/or within
the edges bounding of the sensor array. In some embodiments, the
distal opening (not shown in FIG. 16) is between two or more
sensors of the sensor array. In some embodiments, the distal
opening (not shown in FIG. 16) is positioned between two rows or
more of sensels. In some embodiments, the distal opening (not shown
in FIG. 16) is positioned between two columns or more of
sensels.
[0213] In some embodiments, the sensor array is a tactile sensor
array. In some embodiments, the sensor array is an ultrasound
sensor array. In some embodiments, the sensor array is an infrared
radiation (IR) sensor array. Sensor array is a sensor array
cartridge that is pressed into a sensor array holder. In some
embodiments, the sensor array turns on once it is loaded into the
sensor array holder.
[0214] The sensors in the sensor array generate output voltage
signals when the user applies a force using the tactile sensing
device onto a surface, for example, onto a tissue of a patient. The
sensor array is operatively connected to the display screen and a
computing device (not shown in in the figures). The sensor array
relays its output voltage signals to the computing device (not
shown in FIGS. 1A and 1B), the computing device processes the
output voltage signals, and an image of the output voltage signals
is visualized on the display screen.
[0215] In some embodiments, a method of using a tactile sensing
device to obtain an image comprises a first step comprising
pressing the tactile sensing device against an area that is to be
imaged and pressing or applying force to the sensor array of the
tactile sensing device. In some embodiments, in second a step, a
computing device is provided, and the computing device is
operatively connected to the tactile sensing device. In some
embodiments, the computing device is operatively connected to the
display screen, the sensor array, and optionally connected to a
pressure sensor. In some embodiments, the computing device collects
voltage signals that are generated by the sensor array of the
tactile sensing device after a force is applied onto the surface of
the sensors in the sensor array. In a third step, the computing
device processes the collected voltage signals such that the
voltage signals are converted into an image. In fourth step, the
image is displayed on a display screen of the tactile sensing
device. In some embodiments, the image displayed is a heat map. In
some embodiments, the image displayed provides the user feedback
regarding the uniformity of their application of force to the
tactile sensing device. In some embodiments, the image displayed
includes the approximate position of a needle at the skin surface
as well as the approximate depth of a needle. In some embodiments,
the pressure map is a three-dimensional display of a target tissue
location (e.g. vertebral features). In some embodiments, the
three-dimensional display entails acquiring, registering, and
visualizing pressure data at varying depths. In some embodiments,
the three-dimensional display is achieved with an actuated system.
In some embodiments, the depth detection algorithm facilitates a
collection of depth (i.e. z-axis) layers, resulting in a
three-dimensional display.
Computer Control Systems
[0216] The present disclosure provides computer control systems
that are programmed to implement methods of the disclosure. FIG. 17
shows a computer system 201 that is programmed or otherwise
configured to output a signal in response to a change in pressure
applied to its surface; wherein the signal is converted to a
pressure map. In some embodiments, the computer system 201
regulates various aspects of the tactile sensing device of the
present disclosure, such as, for example, calculate a projected
subcutaneous needle location, display the projected subcutaneous
location of a needle in real time, display the original insertion
site of the needle (i.e., original needle location) in real time,
and output a pressure map corresponding to the output signals
transmitted by the sensor array also in real time. In some
embodiments, the computer system 201 is an electronic device of a
user or a computer system that is remotely located with respect to
the electronic device. In some embodiments, the electronic device
is a mobile electronic device. In some embodiments, the electronic
device is located within the tactile sensing device.
[0217] The computer system 201 includes a central processing unit
(CPU, also "processor" and "computer processor" herein) 205. In
some embodiments, the CPU20 205 is a single core or multi core
processor. In some embodiments, the computer system 201 includes a
plurality of processors for parallel processing. The computer
system 201 also includes memory or memory location 210 (e.g.,
random-access memory, read-only memory, flash memory), electronic
storage unit 215 (e.g., hard disk), communication interface 220
(e.g., network adapter) for communicating with one or more other
systems, and peripheral devices 225, such as cache, other memory,
data storage and/or electronic display adapters. In some
embodiments, the memory 210, storage unit 215, interface 220 and
peripheral devices 225 are in communication with the CPU 205
through a communication bus (solid lines), such as a motherboard.
In some embodiments, the storage unit 215 is a data storage unit
(or data repository) for storing data. In some embodiments, the
computer system 201 is operatively coupled to a computer network
("network") 230 with the aid of the communication interface 220. In
some embodiments, the network 230 is the Internet, an internet
and/or extranet, or an intranet and/or extranet that is in
communication with the Internet. In some embodiments, the network
230 in some cases is a telecommunication and/or data network. In
some embodiments, the network 230 includes one or more computer
servers, which enable distributed computing, such as cloud
computing. In some embodiments, the network 230, in some cases with
the aid of the computer system 201, implements a peer-to-peer
network, which enables devices coupled to the computer system 201
to behave as a client or a server.
[0218] In some embodiments, the CPU 205 executes a sequence of
machine-readable instructions, which are embodied in a program or
software. In some embodiments, the instructions may be stored in a
memory location, such as the memory 210. In some embodiments, the
instructions are directed to the CPU 205, which subsequently
program or otherwise configure the CPU 205 to implement methods of
the present disclosure. Examples of operations performed by the CPU
205 include fetch, decode, execute, and writeback.
[0219] In some embodiments, the CPU 205 is part of a circuit, such
as an integrated circuit. In some embodiments, one or more other
components of the system 201 are included in the circuit. In some
cases, the circuit is an application specific integrated circuit
(ASIC).
[0220] In some embodiments, the storage unit 215 stores files, such
as drivers, libraries and saved programs. In some embodiments, the
storage unit 205 stores user data, e.g., user preferences and user
programs. In some embodiments, the computer system 201 in some
cases includes one or more additional data storage units that are
external to the computer system 201, such as located on a remote
server that is in communication with the computer system 201
through an intranet or the Internet.
[0221] In some embodiments, the computer system 201 communicates
with one or more remote computer systems through the network 230.
For instance, the computer system 201 communicates with a remote
computer system of a user. Examples of remote computer systems
include personal computers (e.g., portable PC), slate or tablet
PC's (e.g., Apple.RTM. iPad, Samsung.RTM. Galaxy Tab), telephones,
Smart phones (e.g., Apple.RTM. iPhone, Android-enabled device,
Blackberry.RTM.), or personal digital assistants. In some
embodiments, the user accesses the computer system 201 via the
network 230.
[0222] Methods as described herein are implemented by way of
machine (e.g., computer processor) executable code stored on an
electronic storage location of the computer system 1, such as, for
example, on the memory 210 or electronic storage unit 215. In some
embodiments, the machine executable or machine-readable code is
provided in the form of software. In some embodiments, during use,
the code is executed by the processor 5. In some cases, the code is
retrieved from the storage unit 215 and stored on the memory 210
for ready access by the processor 5. In some situations, the
electronic storage unit 215 is precluded, and machine-executable
instructions are stored on memory 210.
[0223] In some embodiments, the code is pre-compiled and configured
for use with a machine having a processor adapted to execute the
code, or is compiled during runtime. In some embodiments, the code
is supplied in a programming language that is selected to enable
the code to execute in a pre-compiled or as-compiled fashion.
[0224] Aspects of the systems and methods provided herein, such as
the computer system 1, are embodied in programming. In some
embodiments, various aspects of the technology are thought of as
"products" or "articles of manufacture" typically in the form of
machine (or processor) executable code and/or associated data that
is carried on or embodied in a type of machine-readable medium. In
some embodiments, the machine-executable code is stored on an
electronic storage unit, such as memory (e.g., read-only memory,
random-access memory, flash memory) or a hard disk. In some
embodiments, "storage" type media includes any or all of the
tangible memory of the computers, processors or the like, or
associated modules thereof, such as various semiconductor memories,
tape drives, disk drives and the like, which provide non-transitory
storage at any time for the software programming. In some
embodiments, the entirety of the software or portions of the
software, at times, is communicated through the Internet or various
other telecommunication networks. Such communications, for example,
enable loading of the software from one computer or processor into
the other, for example, from a management server or host computer
into the computer platform of an application server. Thus, another
type of media that bears the software elements includes optical,
electrical and electromagnetic waves, such as used across physical
interfaces between local devices, through wired and optical
landline networks and over various air-links. In some embodiments,
the physical elements that carry such waves, such as wired or
wireless links, optical links or the like, also are considered as
media bearing the software. As used herein, unless restricted to
non-transitory, tangible "storage" media, terms such as computer or
machine "readable medium" refer to any medium that participates in
providing instructions to a processor for execution.
[0225] Hence, in some embodiments, a machine-readable medium, such
as computer-executable code, takes many forms, including but not
limited to, a tangible storage medium, a carrier wave medium or
physical transmission medium. Non-volatile storage media include,
for example, optical or magnetic disks, such as any of the storage
devices in any computer(s) or the like, such as are used to
implement the databases, etc. shown in the drawings. In some
embodiments, volatile storage media include dynamic memory, such as
main memory of such a computer platform. In some embodiments,
tangible transmission media include coaxial cables; copper wire and
fiber optics, including the wires that comprise a bus within a
computer system. In some embodiments, carrier-wave transmission
media takes the form of electric or electromagnetic signals, or
acoustic or light waves such as those generated during radio
frequency (RF) and infrared (IR) data communications. In some
embodiments, common forms of computer-readable media therefore
include for example: a floppy disk, a flexible disk, hard disk,
magnetic tape, any other magnetic medium, a CD-ROM, DVD or DVD-ROM,
any other optical medium, punch cards paper tape, any other
physical storage medium with patterns of holes, a RAM, a ROM, a
PROM and EPROM, a FLASH-EPROM, any other memory chip or cartridge,
a carrier wave transporting data or instructions, cables or links
transporting such a carrier wave, or any other medium from which a
computer may read programming code and/or data. In some
embodiments, many of these forms of computer readable media are
involved in carrying one or more sequences of one or more
instructions to a processor for execution.
[0226] The computer system 1 includes or is in communication with
an electronic display 235 that comprises a user interface (UI) 1
(alternatively called a user interface (UI) module elsewhere
herein) for providing, for example, a real time pressure map, a
real time fluid pressure reading, a real time location of a needle
once it is inserted into an individual, and a projected
subcutaneous location of a needle prior to insertion. Examples of
UI's include, without limitation, a graphical user interface (GUI)
and web-based user interface.
[0227] Methods and systems of the present disclosure are
implemented by way of one or more algorithms. In some embodiments,
an algorithm is implemented by way of software upon execution by
the central processing unit 205. In some embodiments, the
algorithm, for example, calculates a real time projected
subcutaneous needle location prior to insertion, acquires a
plurality of voltage signals, and converts them into a pressure
sensor array.
[0228] In some embodiments, a sensor array comprising at least one
sensor is configured to output a signal in response to a change in
pressure applied to its surface; wherein the signal is converted to
a pressure map. In a first step, the output voltage signals
generated by the force-sensitive resistors via a voltage divider
are inputted into the computing device via a multiplexer. In a
second step, the inputted voltage signals are written to a serial
monitor. In some embodiments, the second step further comprises
organizing the inputted voltage signals. In some embodiments, a
first computer program that includes instructions executable by a
processor performs the second step. In some embodiments, the
instructions to perform the second step, which are included in the
computer program, are written in Arduino programming language. In
third step, a second computer program includes instructions to
acquire the inputted voltage signals that were written to the
serial monitor and generates an array of sensor data. In some
embodiments, the instructions to perform the third step, which are
included in the second computer program, are executable by a
processor. In a fourth step, a second computer program includes
instructions to process the inputted voltage signals that were
written to the serial monitor and rescales the previously generated
array of sensor data to a second array of sensor data. In some
embodiments, the instructions to perform the fourth step use cubic
interpolation methods to rescale the array of sensor data. In some
embodiments, the instructions to perform the fourth step, which are
included in the second computer program, are executable by a
processor. In a fifth step, a second computer program includes
instructions to update the display for real-time target tissue
visualization. In some embodiments, the instructions to perform the
third, fourth, and fifth steps, which are included in the second
computer program are written in Python programming language. In
some embodiments, the display is updated for real-time
visualization of a patient's spine. In some embodiments, these five
steps comprise the process of transforming a sensor output into a
visual display. In some embodiments, the visual display is a
pressure map.
Computing Device
[0229] In some embodiments, the tactile sensing device further
comprises a computing device. In some embodiments, the computing
device is a microcontroller. In some embodiments, the
microcontroller is an 8-bit, 16-bit, or 32-bit microcontroller. In
some embodiments, the microcontroller is an 8051 microcontroller, a
programmable interface controller (PIC), an AVR or Advanced Virtual
RISC microcontroller, or an ARM.RTM. microcontroller. In some
embodiments, the microcontroller is, by way of non-limiting
examples, an Arduino Uno microcontroller or a Raspberry Pi
microcontroller.
[0230] In some embodiments, the computing device is a
microprocessor. In some embodiments, the microprocessor is
manufactured by AMD.RTM., Intel.RTM., or ARM.RTM.. In some
embodiments, the AMD.RTM. microprocessors include, but are not
limited to: AMD Sempron.TM., AMD Turion II.TM. AMD Athlon II.TM.,
AMD Sempron.TM., AMD Phenom II.TM., AMD A-Series, or AMD FX.TM.. In
some embodiments, the Intel.RTM. microprocessors include, but are
not limited to: Intel Atom.TM., Intel Celeron.TM., Intel
Pentium.TM., Intel Core i3.TM., Intel Core i5.TM., or Intel Core
i7.TM.. In some embodiments, the ARM.RTM. microprocessors include,
but are not limited to: ARM OMAP 3, ARM MAP 4, ARM OMAP 5, ARM
SnapDragon S2, ARM SnapDragon S, ARM SnapDragon S4, ARM Tegra, ARM
Tegra 2, ARM Tegra 3, ARM Exynos 3 Single, ARM Exynos 4 Dual, ARM
Exynos 4 Quad, ARM Exynos 5 Dual, ARM A4, ARM A5, or ARM A5X.
[0231] In some embodiments, the computing device further comprises
a memory device. In some embodiments, the processing device
includes a memory device. A memory device is one or more physical
apparatus used to store data or programs on a temporary basis, a
permanent basis, or combinations thereof. In some embodiments, a
memory device is volatile and requires power to maintain stored
information. In some embodiments, a memory device is non-volatile
and retains stored information and does not require power to
maintain stored information.
[0232] In some embodiments, the computing device further comprises
a non-transitory computer readable storage medium with a computer
program including instructions executable by the processor causing
the processor to convert the voltage signals into an image. In some
embodiments, the computer program includes instructions executable
by the processor that cause the processor to encode the voltage
signals into a first and second computer signals.
[0233] In some embodiments, the computer program includes
instructions executable by the processor that cause the processor
to calculate a projected needle position (i.e. location) and
display it on the display screen. In some embodiments, the computer
program includes instructions executable by the processor that
cause the processor to calculate a projected needle position (i.e.
location) for any potential needle guide when using a tactile
sensing device 200 comprising a needle guide cartridge 12, as shown
in FIGS. 2A and 2B. In some embodiments, a needle projection
calculation is a trigonometric algorithm. In some embodiments, the
trigonometric algorithm determines the depth of the needle once it
traverses subcutaneous adipose tissue. In some embodiments, the
needle projection calculation is adjusted based on amount of
subcutaneous adipose tissue.
[0234] In some embodiments, the computer program includes
instructions executable by the processor causing the processor to:
determine, as a first requirement, a location of a bone detected by
the tactile sensing device; ii) determine, as a second requirement,
the space between said bone structures; and iii) perform predictive
analysis based on application of machine-learning. In some
embodiments, the predictive analysis performed by the processor
enhances the accuracy of a needle projection calculation. In some
embodiments, the predictive analysis performed by the processor
locates a desired bone and non-bone structure. In some embodiments,
the predictive analysis performed by the processor locates a gap
between bone and non-bone structures. In some embodiments, the
predictive analysis performed by the processor suggests a needle
insertion location to the user based on the voltage signals
detected by the tactile sensing device. In some embodiments, the
predictive analysis performed by the processor comprises midline
alignment (e.g. determining rotation of detected peaks about the
device's midline, thereby alerting user to align the device).
[0235] The computer program is, for example, software, including
computer algorithms, computer codes, programs, and data, which
manages the device's hardware and provides services for execution
of instructions. Suitable computer program languages include, by
way of non-limiting examples, C, C++, C#, Objective C, Perl, Scala,
Haskell, Go, Arduino C, Python, Java, SQL, JavaScript, PHP, iOS
Swift, or Ruby.
[0236] In some embodiments, the computing device is a desktop
computer or a laptop computer. In some embodiments, the computing
device is a mobile device. In some embodiments, the mobile device
is a smart phone or a smart watch. In some embodiments, the
computing device is a portable device. In accordance with the
description herein, suitable computing devices further include, by
way of non-limiting examples, notebook computers, tablet computers,
netbook computers, smart book computers, subnotebook computers,
ultra-mobile PCs, handheld computers, personal digital assistants,
Internet appliances, smart phones, music players, and portable
video game systems. Many mobile smart phones are suitable for use
in the systems described herein. Suitable tablet computers include
those with booklet, slate, and convertible configurations. Suitable
portable video game systems include, by way of non-limiting
examples, Nintendo DS.TM. and Sony.RTM. PSP.TM..
Signal Transmitter and Receiver
[0237] In some embodiments, the processor encodes the voltage
signals into a first and second computer signals. In some
embodiments, the tactile sensing device comprises a signal
transmitter. In some embodiments, the tactile sensing device
comprises a signal receiver. In some embodiments, a transmitter is
configured to transmit the first computer signal to a computing
device. In some embodiments, a receiver is configured to receive
the second computer signal from a tactile sensing device. In some
embodiments, the first and second computer signals are transmitted
via a USB (Universal Serial Bus) cable. In some embodiments, the
first and second computer signals are wireless signals.
[0238] In some embodiments, the signal receiver is a wireless
element. In some embodiments, the signal transmitter is a wireless
element. In some embodiments, the wireless element is configured to
receive a signal from a computing device, for example, a mobile
device. In some embodiments, the signal receiver is a wireless
element which is configured to receive a signal from the tactile
sensing device. In some embodiments, the wireless element is a
wireless network technology. In some embodiments, the wireless
network technology is ANT, ANT+, INSTEON, IrDA, Wireless USB,
Bluetooth, Z-Wave, or ZigBee, IEEE 802.15.4, 6LoWPAN, or Wi-Fi.
Marking Tools
[0239] In some embodiments, the tactile sensing device further
comprises a marking tool. The marking tool helps the user identify
the tissue target location. In some embodiments, the marking tool
enables the user to mark the entry point of a needle on the skin
surface of the patient. In some embodiments, the marking tool
enables the user to mark or label a tissue target location. In some
embodiments, marking or labeling the tissue target location is done
subcutaneously, intramuscularly, or on the skin surface. In some
embodiments, the marked tissue location is detected by a medical
imaging device. In some embodiments, the marking tool enables the
user to mark or label a target tissue location in order to be
identified by a medical imaging device or system. In some
embodiments, the target tissue location is marked by indenting the
skin over the target tissue location. In some embodiments, the skin
over the target tissue location is indented using the posterior
surface of the tactile sensing device. In some embodiments, the
skin over the target tissue location is indented using a mechanism
attached to the tactile sensing device. In some embodiments, the
mechanism attached to the tactile sensing device is an indenting
tool. In some embodiments, the skin over the target tissue location
is indented by placing an indenting tool through the needle guide.
In some embodiments, the marking tool is a light, an ink, a
hydrogel, a nanoparticle. In some embodiments, the light is a laser
light or a light emitting diode (LED). In some embodiments, the ink
is a permanent ink, a gentian violent ink, a water-based ink, an
oil-based in, a liquid ink, or a gel ink. In some embodiments, the
hydrogel further comprises a contrast agent. In some embodiments,
the nanoparticle further comprises a contrast agent. In some
embodiments, the contrast agent includes, but is not limited to: a
magnetic contrast agent, a radiocontrast agent, a radioactive
contrast agent, a magnetic resonance imaging contrast agent, and a
microbubble contrast agent. Non-limiting examples of the magnetic
contrast agent include: gadolinium-based agents or nanoparticles,
iron oxide-based agents or nanoparticles, iron platinum-based
agents or nanoparticles, and manganese-based agents or
nanoparticles. Non-limiting examples of the radiocontrast agent
include: iodine-based agents or nanoparticles, air, thorium
dioxide, carbon dioxide, gastrografin, and barium-based agents or
nanoparticles. Non-limiting examples of the radioactive contrast
agent include: .sup.64Cu
diacetyl-bis(N.sup.4-methylthiosemicarbazone), also called ATSM or
Copper 64, .sup.18F-fluorodeoxyglucose (FDG), .sup.18F-fluoride,
3'-deoxy-3'-[.sup.18F]fluorothymidine (FLT),
.sup.18F-fluoromisonidazole, gallium, techtenium-99m, and
thallium.
Rocker Tactile Sensing Device
[0240] In some embodiments, the tactile sensing device is a rocker
tactile sensing device 1800, as shown in embodiments shown in FIGS.
18A-C, 19A-C, and 20A-E, alternatively referred to herein as
embodiment tactile sensing devices having rocker designs. In such
embodiments, the tactile sensing devices include aspects and
functionality described elsewhere herein, with the substitution of
a curved sensor applicator in place of a flat-faced sensor array,
and including historical and real time visualization as described
herein. In some embodiments, the rocker tactile sensing device
comprises a main housing frame 19. In some embodiments, the main
housing frame 19 comprises a needle alignment guide 36. In some
embodiments, the needle alignment guide 36 is an indicator for the
midline of the device to facilitate alignment with the spine. In
some embodiments, the needle alignment guide 36 is a colored line.
In some embodiments, the needle alignment guide 36 is a colored
notch. In some embodiments, the main housing frame 19 is reusable.
In some embodiments, the main housing frame 19 is disposable. In
some embodiments, the main housing frame 19 is made of
medical-grade, injection-molded plastic. In some embodiments, the
main housing frame 19 is comprised of two parts.
[0241] In some embodiments, the rocker tactile sensing device
comprises a curved sensor applicator 13, as shown in FIG. 18B. In
some embodiments, the curved sensor applicator 13 has a curvature
with a radius of about 1.5 inches to about 3.5 inches. In some
embodiments, the curved sensor applicator 13 is part of the main
housing frame 19. In some embodiments, the curved sensor applicator
13 is assembled with the main housing frame 19. In some
embodiments, the curved sensor applicator 13 protrudes from the
main housing frame 19 to allow for more concentrated application of
force. In some embodiments, the curved sensor applicator 13 is
rocked relative to a fixed main housing frame 19. In some
embodiments, the curved sensor applicator 13 is pressed against the
skin surface of the patient. In some embodiments, the sensor array
captures a series of images when the user "rocks" the curved sensor
applicator 13 against the skin surface of a patient (e.g., against
the lower back of a patient, if the target tissue location is the
lumbar vertebrae). In some embodiments, partial images of captured
areas are displayed as the rocking cycle is completed. In some
embodiments, portions of the image currently being acquired are
highlighted for clarity.
[0242] In some embodiments, the tactile sensing device comprises a
needle guide 2 to facilitate insertion of a needle or marking tool
or removal of the tactile sensing device. In some embodiments, the
needle guide facilitates insertion of a needle that is attached to
a syringe. In some embodiments, the syringe is a fluid-filled
syringe or an air-filled syringe. In some embodiments, the needle
guide is transparent to allow for maximal visibility of the target
tissue. In some embodiments, the needle guide 2 is part of the
curved sensor applicator. In some embodiments, the curved sensor
applicator 13 comprises a needle guide insert 25, as shown in FIG.
19A. In some embodiments, the needle guide insert 25 comprises a
needle guide 2, as shown in FIGS. 19B-C. In some embodiments, the
needle guide 2 comprises a first needle guide wall 131a and a
second needle guide wall 131b. In some embodiments, the first
needle guide wall 131a and a second needle guide wall 131b are in
contact with a needle that is inserted into the needle guide 2. In
some embodiments, the first needle guide wall 130a and a second
needle guide wall 131b guide the angle of a needle that is inserted
into the needle guide 2. In some embodiments, the first needle
guide wall 131a and a second needle guide wall 131b restrict the
angle of a needle that is inserted into the needle guide 2. In some
embodiments, the needle guide is reversibly attached to the tactile
sensing device. In some embodiments, the needle comprises a
notch.
[0243] In some embodiments, the needle guide insert 25 comprises a
slot 38. In some embodiments, the slot 38 comprises a first slot
wall 130a (not shown in FIGS. 19B-C) and a second slot wall 130b
(shown in FIG. 19C). In some embodiments, the slot 38 provides the
user with lateral access to the needle guide 2, as described
elsewhere herein in other embodiments. In some embodiments, the
first needle guide wall 131a and a second needle guide wall 131b
connect and form the track 144 of the needle guide 2.
[0244] In some embodiments, the main housing frame 19 comprises a
needle guide recess 31 configured to receive the needle guide
insert 25. In some embodiments, the needle guide insert 25 is
removable and is assembled with the curved sensor applicator 13. In
some embodiments, the needle guide insert 25 is inserted into a
needle guide recess 31. In some embodiments, the portion of the
curved sensor surrounding the needle guide slot is flat to
facilitate stabilization of the device during needle insertion. In
some embodiments, the flat surface is about 0.1 inches to about 1
inch in length. In some embodiments, the needle guide comprises a
needle guide opening 134a and a needle guide terminus 134b. In some
embodiments, the slot extends from the center of the sensor
applicator to the left edge of the sensor applicator, when viewed
from the back of the device. In some embodiments, the needle guide
2 comprises a wall to restrict lateral needle movement. In some
embodiments, the needle guide 2 comprises a needle retention gate
17, which is engaged to prevent the needle from sliding out of the
slot and disengaged to allow the device to be removed from the
needle after insertion. In some embodiments, the needle guide 2 is
a fixed angle needle guide. In some embodiments, the needle guide
allows for about 3.degree. of flexibility. In some embodiments, the
needle guide 2 is oriented at about 15.degree. cephalad.
[0245] In some embodiments, the needle guide contains a mechanism
that secures the needle. In some embodiments, the securing
mechanism restricts the needle to the midline plane. In some
embodiments, the securing mechanism is part of the needle guide. In
some embodiments, the securing mechanism is attached to the needle
guide. In some embodiments, the proximal end of the securing
mechanism is filleted to allow for greater travel of the needle
hub. In some embodiments, the securing mechanism is telescopic, to
allow for greater travel of the needle hub. In some embodiments,
the width of the securing mechanism is adjusted to accommodate a
variety of needle gauges. In some embodiments, the securing
mechanism comprises one or more parallel sets of tabs, which are
separated or brought together via a scissor mechanism to
accommodate a variety of gauges. In some embodiments, the tabs are
elastic, such that smaller needles are easily accommodated. In some
embodiments, a separation of the tabs is tracked with an electronic
sensor. In some embodiments, a separation of the tabs is determined
based on markers. In some embodiments, the tabs are orientated such
the distance between their outer edges is greater than the distance
between their inner edges, which allows for support of the needle,
and facilitates easier removal of the device from the needle. In
some embodiments, separate securing mechanisms are available for
different needle gauges. In some embodiments, the needle is
advanced through the securing mechanism and into the target tissue.
In some embodiments, the securing mechanism is fixed relative to
the needle guide. In some embodiments, the needle guide and/or the
securing mechanism are rotated relative to the device. In some
embodiments, the securing mechanism is rotated relative to the
needle guide. In some embodiments, the securing mechanism is
rotated to allow for insertion at any angle between about 0.degree.
and 30.degree. cephalad. In some embodiments, the needle guide
contains markers to indicate insertion angle. In some embodiments,
the securing mechanism is locked at increments between about
0.degree. and 30.degree. cephalad to allow for fixed movement. In
some embodiments, the securing mechanism is locked at about
1.degree. increments. In some embodiments, increments for rotation
of the securing mechanism are adjusted. In some embodiments, the
axis of rotation of the securing mechanism is located at the
midpoint of the securing mechanism. In some embodiments, the axis
of rotation of the securing mechanism is located at the distal end
of the securing mechanism. In some embodiments, the needle guide
comprises a tab that is used to rotate the securing mechanism. In
some embodiments, the needle guide comprises a dial that is rotated
to rotate the securing mechanism. In some embodiments, the securing
mechanism is automatically rotated based on input to the device. In
some embodiments, the needle guide comprises a mechanism that
allows the securing mechanism to release the needle after
insertion. In some embodiments, minimal retaining force allows the
device to be pulled away from the needle without the need for a
release mechanism. In some embodiments, the needle guide contains a
separate channel for insertion of a needle or other tool that is
inserted offset from the target tissue location. In some
embodiments, the needle guide contains a channel laterally offset
from the securing mechanism that allows for insertion of a needle
for local-anesthetic injection. In some embodiments, the sensor
applicator is assembled with a main housing frame 19, which
contains a slot extending from the slot in the sensor applicator to
the left edge of the main housing frame 19 when viewed from the
back of the device.
[0246] In some embodiments, the curved sensor applicator 13
comprises a sensor array. In some embodiments the sensor array is
mounted on the curved bottom surface of the sensor applicator via
an adhesive layer spanning its active area. In some embodiments,
the non-active area of the sensor further comprises through holes
for registration with the sensor applicator or the main housing
frame 19 during assembly. In some embodiments, the sensor
terminates in a zero-insertion force (ZIF) connector to connect
with device sensor circuitry.
[0247] In some embodiments, the sensor array features a slot to
facilitate insertion of a needle or marking tool, and device
removal. In some embodiments, the slot extends from the center of
the array to the outer left edge of the array, when observed
print-side up. In some embodiments, the slot in the sensor array
aligns with the needle guide slot in the sensor applicator. In some
embodiments, the inner edge of the slot terminates in a through
hole of about 2.1 millimeters (mm) in diameter at the center of the
array to accommodate a needle or other marking tool.
[0248] In some embodiments, the sensor array (not shown in FIGS.
18-26) is a calibrated, custom screen-printed sensor array that
detects pressure. In some embodiments, the sensor array comprises
two thin, polyester sheets, with conductive silver traces deposited
in row and column patterns on the inner surface of each sheet,
respectively. In some embodiments, the polyester sheets are about 3
mil (i.e., 0.003 inches) in depth. In some embodiments, each
intersection of the columns and rows forms a sensing element (i.e.,
a sensel), which acts as a variable resistor. In some embodiments,
the resistance of each sensel varies inversely with an applied
load. In some embodiments, the sequentially scanning of these
sensels via voltage-divider circuitry enables for 2D mapping of the
pressure distribution over a target tissue location (e.g.,
vertebrae). In some embodiments, traces and spaces are about 1.9 mm
in width. In some embodiments, the center-to-center spacing of rows
and columns in the sensor array is about 1.9 millimeters (mm). In
some embodiments, the sensor array has a spatial resolution of
about 3.8 mm.
[0249] In some embodiments, the center-to-center spacing of rows
and columns in the sensor array is about 0.5 mm to about 5 mm. In
some embodiments, the center-to-center spacing of rows and columns
in the sensor array is at least about 0.5 mm. In some embodiments,
the center-to-center spacing of rows and columns in the sensor
array is at most about 5 mm. In some embodiments, the
center-to-center spacing of rows and columns in the sensor array is
about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 0.5
mm to about 2 mm, about 0.5 mm to about 2.5 mm, about 0.5 mm to
about 3 mm, about 0.5 mm to about 3.5 mm, about 0.5 mm to about 4
mm, about 0.5 mm to about 4.5 mm, about 0.5 mm to about 5 mm, about
1 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about
2.5 mm, about 1 mm to about 3 mm, about 1 mm to about 3.5 mm, about
1 mm to about 4 mm, about 1 mm to about 4.5 mm, about 1 mm to about
5 mm, about 1.5 mm to about 2 mm, about 1.5 mm to about 2.5 mm,
about 1.5 mm to about 3 mm, about 1.5 mm to about 3.5 mm, about 1.5
mm to about 4 mm, about 1.5 mm to about 4.5 mm, about 1.5 mm to
about 5 mm, about 2 mm to about 2.5 mm, about 2 mm to about 3 mm,
about 2 mm to about 3.5 mm, about 2 mm to about 4 mm, about 2 mm to
about 4.5 mm, about 2 mm to about 5 mm, about 2.5 mm to about 3 mm,
about 2.5 mm to about 3.5 mm, about 2.5 mm to about 4 mm, about 2.5
mm to about 4.5 mm, about 2.5 mm to about 5 mm, about 3 mm to about
3.5 mm, about 3 mm to about 4 mm, about 3 mm to about 4.5 mm, about
3 mm to about 5 mm, about 3.5 mm to about 4 mm, about 3.5 mm to
about 4.5 mm, about 3.5 mm to about 5 mm, about 4 mm to about 4.5
mm, about 4 mm to about 5 mm, or about 4.5 mm to about 5 mm. In
some embodiments, the center-to-center spacing of rows and columns
in the sensor array is about 0.5 mm, about 1 mm, about 1.5 mm,
about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm,
about 4.5 mm, or about 5 mm.
[0250] In some embodiments, a center-to-center spacing of about 1.9
mm effectively resolves the lowest extreme of observed interspinous
spaces. In some embodiments, the sensor array produces an image
with an effective resolution of an interspinous space of about 3 mm
to about 6.5 mm. In some embodiments, the sensor array produces an
image with an effective resolution of an interspinous space of at
least about 3 mm. In some embodiments, the sensor array produces an
image with an effective resolution of an interspinous space of at
most about 6.5 mm. In some embodiments, the sensor array produces
an image with an effective resolution of an interspinous space of
about 3 mm to about 3.5 mm, about 3 mm to about 4 mm, about 3 mm to
about 4.5 mm, about 3 mm to about 5 mm, about 3 mm to about 5.5 mm,
about 3 mm to about 6 mm, about 3 mm to about 6.5 mm, about 3.5 mm
to about 4 mm, about 3.5 mm to about 4.5 mm, about 3.5 mm to about
5 mm, about 3.5 mm to about 5.5 mm, about 3.5 mm to about 6 mm,
about 3.5 mm to about 6.5 mm, about 4 mm to about 4.5 mm, about 4
mm to about 5 mm, about 4 mm to about 5.5 mm, about 4 mm to about 6
mm, about 4 mm to about 6.5 mm, about 4.5 mm to about 5 mm, about
4.5 mm to about 5.5 mm, about 4.5 mm to about 6 mm, about 4.5 mm to
about 6.5 mm, about 5 mm to about 5.5 mm, about 5 mm to about 6 mm,
about 5 mm to about 6.5 mm, about 5.5 mm to about 6 mm, about 5.5
mm to about 6.5 mm, or about 6 mm to about 6.5 mm. In some
embodiments, the sensor array produces an image with an effective
resolution of an interspinous space of about 3 mm, about 3.5 mm,
about 4 mm, about 4.5 mm, about 5 mm, about 5.5 mm, about 6 mm, or
about 6.5 mm.
[0251] In some embodiments, the pressure rating of the sensor array
is about 20 psi. In some embodiments, the pressure rating of the
sensor array is about 1 psi to about 150 psi. In some embodiments,
the pressure rating of the sensor array is at least about 1 psi. In
some embodiments, the pressure rating of the sensor array is at
most about 150 psi. In some embodiments, the pressure rating of the
sensor array is about 1 psi to about 7 psi, about 1 psi to about 25
psi, about 1 psi to about 50 psi, about 1 psi to about 75 psi,
about 1 psi to about 100 psi, about 1 psi to about 125 psi, about 1
psi to about 150 psi, about 7 psi to about 25 psi, about 7 psi to
about 50 psi, about 7 psi to about 75 psi, about 7 psi to about 100
psi, about 7 psi to about 125 psi, about 7 psi to about 150 psi,
about 25 psi to about 50 psi, about 25 psi to about 75 psi, about
25 psi to about 100 psi, about 25 psi to about 125 psi, about 25
psi to about 150 psi, about 50 psi to about 75 psi, about 50 psi to
about 100 psi, about 50 psi to about 125 psi, about 50 psi to about
150 psi, about 75 psi to about 100 psi, about 75 psi to about 125
psi, about 75 psi to about 150 psi, about 100 psi to about 125 psi,
about 100 psi to about 150 psi, or about 125 psi to about 150 psi.
In some embodiments, the pressure rating of the sensor array is
about 1 psi, about 7 psi, about 25 psi, about 50 psi, about 75 psi,
about 100 psi, about 125 psi, or about 150 psi. In some
embodiments, a pressure rating of 20 psi effectively resolves a
target tissue location (e.g., an interspinous space). In some
embodiments, a pressure rating of about 20 psi effectively resolves
bony landmarks as deep as about 60 mm. In some embodiments, a depth
of about 60 mm corresponds to a tissue depth of an obese patient
having a body mass index (BMI) of about 40 kg/m.sup.2.
[0252] In some embodiments, the sensor array comprises about 38
rows and about 9 columns, which corresponds to an active sensing
area comprising about 70.5 mm in length by about 15.2 mm in width.
In some embodiments, the sensor array comprises an active sensing
area with a width of about 5 mm to about 30 mm. In some
embodiments, the sensor array comprises an active sensing area with
a width of at least about 5 mm. In some embodiments, the sensor
array comprises an active sensing area with a width of at most
about 30 mm. In some embodiments, the sensor array comprises an
active sensing area with a width of about 5 mm to about 6 mm, about
5 mm to about 7 mm, about 5 mm to about 8 mm, about 5 mm to about 9
mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 5
mm to about 20 mm, about 5 mm to about 25 mm, about 5 mm to about
30 mm, about 6 mm to about 7 mm, about 6 mm to about 8 mm, about 6
mm to about 9 mm, about 6 mm to about 10 mm, about 6 mm to about 15
mm, about 6 mm to about 20 mm, about 6 mm to about 25 mm, about 6
mm to about 30 mm, about 7 mm to about 8 mm, about 7 mm to about 9
mm, about 7 mm to about 10 mm, about 7 mm to about 15 mm, about 7
mm to about 20 mm, about 7 mm to about 25 mm, about 7 mm to about
30 mm, about 8 mm to about 9 mm, about 8 mm to about 10 mm, about 8
mm to about 15 mm, about 8 mm to about 20 mm, about 8 mm to about
25 mm, about 8 mm to about 30 mm, about 9 mm to about 10 mm, about
9 mm to about 15 mm, about 9 mm to about 20 mm, about 9 mm to about
25 mm, about 9 mm to about 30 mm, about 10 mm to about 15 mm, about
10 mm to about 20 mm, about 10 mm to about 25 mm, about 10 mm to
about 30 mm, about 15 mm to about 20 mm, about 15 mm to about 25
mm, about 15 mm to about 30 mm, about 20 mm to about 25 mm, about
20 mm to about 30 mm, or about 25 mm to about 30 mm. In some
embodiments, the sensor array comprises an active sensing area with
a width of about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9
mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm, or about 30
mm.
[0253] In some embodiments, the sensor array comprises an active
sensing area with a length of about 30 mm to about 90 mm. In some
embodiments, the sensor array comprises an active sensing area with
a length of at least about 30 mm. In some embodiments, the sensor
array comprises an active sensing area with a length of at most
about 90 mm. In some embodiments, the sensor array comprises an
active sensing area with a length of about 30 mm to about 35 mm,
about 30 mm to about 40 mm, about 30 mm to about 45 mm, about 30 mm
to about 50 mm, about 30 mm to about 55 mm, about 30 mm to about 60
mm, about 30 mm to about 65 mm, about 30 mm to about 70 mm, about
30 mm to about 75 mm, about 30 mm to about 80 mm, about 30 mm to
about 90 mm, about 35 mm to about 40 mm, about 35 mm to about 45
mm, about 35 mm to about 50 mm, about 35 mm to about 55 mm, about
35 mm to about 60 mm, about 35 mm to about 65 mm, about 35 mm to
about 70 mm, about 35 mm to about 75 mm, about 35 mm to about 80
mm, about 35 mm to about 90 mm, about 40 mm to about 45 mm, about
40 mm to about 50 mm, about 40 mm to about 55 mm, about 40 mm to
about 60 mm, about 40 mm to about 65 mm, about 40 mm to about 70
mm, about 40 mm to about 75 mm, about 40 mm to about 80 mm, about
40 mm to about 90 mm, about 45 mm to about 50 mm, about 45 mm to
about 55 mm, about 45 mm to about 60 mm, about 45 mm to about 65
mm, about 45 mm to about 70 mm, about 45 mm to about 75 mm, about
45 mm to about 80 mm, about 45 mm to about 90 mm, about 50 mm to
about 55 mm, about 50 mm to about 60 mm, about 50 mm to about 65
mm, about 50 mm to about 70 mm, about 50 mm to about 75 mm, about
50 mm to about 80 mm, about 50 mm to about 90 mm, about 55 mm to
about 60 mm, about 55 mm to about 65 mm, about 55 mm to about 70
mm, about 55 mm to about 75 mm, about 55 mm to about 80 mm, about
55 mm to about 90 mm, about 60 mm to about 65 mm, about 60 mm to
about 70 mm, about 60 mm to about 75 mm, about 60 mm to about 80
mm, about 60 mm to about 90 mm, about 65 mm to about 70 mm, about
65 mm to about 75 mm, about 65 mm to about 80 mm, about 65 mm to
about 90 mm, about 70 mm to about 75 mm, about 70 mm to about 80
mm, about 70 mm to about 90 mm, about 75 mm to about 80 mm, about
75 mm to about 90 mm, or about 80 mm to about 90 mm. In some
embodiments, the sensor array comprises an active sensing area with
a length of about 30 mm, about 35 mm, about 40 mm, about 45 mm,
about 50 mm, about 55 mm, about 60 mm, about 65 mm, about 70 mm,
about 75 mm, about 80 mm, or about 90 mm.
[0254] In some embodiments, the tactile sensing device is a rocker
tactile sensor device 1800 comprising a removable handle 68, as
shown in FIGS. 18A-C. In some embodiments, the removable handle is
a power grip handle. In some embodiments, the removable handle is
similar to the power grip handle 68 shown in FIG. 11. In some
embodiments, the removable handle is removed to expose the needle
guide 2. In some embodiments, the removable handle comprises a
first post and a second post that are inserted into a first opening
and a second opening in the top surface of the sensor applicator or
main housing frame 19 of the tactile sensing device 1800. In some
embodiments, the handle and the main housing frame 19 are
reversibly coupled to each other via a mechanism that includes an
audible indication, such as, but not limited to, a clicking noise.
In some embodiments, the handle has a handle release button 27, as
shown in FIGS. 18A-C. In some embodiments, the handle release
button 27 is located at the posterior or anterior end of the
handle. In some embodiments, the handle release button 27 is pushed
to disengage the handle from the curved sensor applicator 13 or
main housing frame 19. In some embodiments, the handle is comprised
of a two-part housing. In some embodiments, the posts of the handle
comprise a skirt that secures the posts in the openings after
insertion.
[0255] In some embodiments, the tactile sensing device is a rocker
tactile sensing device 2400 comprising a reusable user interface
(UI) module 1. In some embodiments, the UI module 1 is part of a
main housing frame 19. In some embodiments the UI module is
comprised of a two-part housing. In some embodiments the UI module
has a back plate for access to electronics. In some embodiments,
the UI module is assembled with the main housing frame 19. In some
embodiments, the UI module 1 is a non-sterile,
non-patient-contacting part, to be made of medical-grade,
injection-molded plastic. In some embodiments, the main housing
frame 19 comprises hubs for UI module attachment at the top and
bottom when the device is viewed from the top to facilitate use in
right- and left-handed users. In some embodiments, the UI module 1
comprises a printed circuit board assembly (PCBA). In some
embodiments, the PCBA serves as the motherboard of the system of
the tactile sensing device. In some embodiments, the PCBA comprises
a microprocessor. In some embodiments, the PCBA interfaces to the
sensor breakout board, display module, external sensors, and
user-input mechanisms. In some embodiments, the PCBA comprises the
fusing, charging, and protection circuitry for the rechargeable
battery. In some embodiments, the PCBA processes and displays
pressure sensor data. In some embodiments, the PCBA handles
interrupts, such as a physical or touchscreen menu button press and
physical or touchscreen refresh button press. In some embodiments,
a sample runtime task for live imaging (about 50 milliseconds (ms))
comprises data capture, data analysis, error checks, frame drawing,
and frame display. In some embodiments, the PCBA comprises
circuitry to support adjustment of maximum sensor pressure between
a factor of 1/7 and a factor of 3 of the sensor's pressure rating.
In some embodiments, sensitivity is adjusted via a dial or external
buttons, or a touchscreen display. In some embodiments drive
voltage is automatically adjusted based on an equilibration file.
In some embodiments, the PCBA comprises sensors and circuitry to
track device orientation and trigger alerts to device movement
during rocking. In some embodiments, the UI module is powered on by
a switch.
[0256] In some embodiments, the tactile sensing device comprises a
sensor breakout board (not shown in the figures). In some
embodiments, the sensor breakout board comprises minimal
electronics that are disposable. In some embodiments, the sensor
breakout board is configured to connect the sensor driver and
acquisition circuitry from the UI module to the sensor array. In
some embodiments, the sensor breakout board comprises a zero
insertion force (ZIF) connector for sensor array connection. In
some embodiments, the sensor breakout board comprises an analog
multiplexer (MUX) and a bit shifter to support scanning and output.
In some embodiments, position sensors to track device movement are
comprised in the disposable breakout board. In some embodiments,
the UI module is powered on upon connection to the breakout
board.
[0257] In some embodiments, the UI module comprises a display
screen. In some embodiments, the display screen is a touchscreen.
In some embodiments, the display screen has an adjustable angle. In
some embodiments, the display screen is a full-color LCD display.
In some embodiments, the display screen is connected to the PCBA
and mechanically integrated in the anterior surface of the housing
of the module, to allow for output visualization. In some
embodiments, the tactile sensing device wirelessly interfaces with
an external display, such as a tablet or computer. In some
embodiments, the display is collapsed to reduce tactile sensing
device footprint.
[0258] In some embodiments, the tactile sensing device is a rocker
tactile sensing device 2400 comprising a sleeve 80. In some
embodiments, the sleeve is a single-component part that is sterile.
In some embodiments, the sleeve shrouds the reusable UI module
during use. In some embodiments, the sleeve is made of
medical-grade polyethylene terephthalate glycol-modified (PETG). In
some embodiments, the sleeve is vacuum-formed to a mold of the
reusable UI module. In some embodiments, the sleeve comprises a
low-reflectivity, transparent component over the display area. In
some embodiments, the sleeve has openings for user-input
buttons.
[0259] In some embodiments, the UI module comprises a battery. In
some embodiments, the battery is a rechargeable battery. In some
embodiments, the rechargeable battery interfaces with the PCBA. In
some embodiments, the tactile sensing device comprises a battery
indicator. In some embodiments, the battery indicator is a charging
indicator. In some embodiments, the charging indicator alerts the
user of a low battery. In some embodiments, the charging indicator
alerts the user of the amount of battery charged during the
charging process. In some embodiments, the battery indicator is
on-screen. In some embodiments, the battery indicator is an LED. In
some embodiments, the device is powered via USB connection to a
computer.
[0260] In some embodiments, the rechargeable battery located within
the tactile sensing device is charged using a reusable charging
station (not shown in the figures). In some embodiments, the
charging unit comprises standard electronics, including electrical
contacts for mating with the computing unit (i.e., with PCBA). In
some embodiments, the charging station is housed in a two-part
injection molded plastic. In some embodiments, the charging station
comprises a charging indicator. In some embodiments, the charging
station employs induction charging.
[0261] FIGS. 18-21 show embodiments of a tactile sensing device
2400 comprising a rocker design, referred to herein as rocker
tactile sensing devices. In some embodiments, the rocker tactile
sensing device 1800 comprises a UI module 1, a power grip handle
68, and a main housing frame 19. In some embodiments, the UI module
1 comprises a display screen 4, a pressure map 6, and a UI module
connector 9. In some embodiments, a sleeve 80 shrouds the UI module
1. In some embodiments, the main housing frame 19 comprises a first
handle opening 5a and a second handle opening 5b configured to
receive the power grip handle 68. In some embodiments, the handle
and the main housing frame are reversibly coupled to each other via
a mechanism that includes an audible indication, such as, but not
limited to, a clicking noise. In some embodiments, the power grip
handle 68 comprises a first handle notch 3a and a second handle
notch 3b. In some embodiments, the power grip handle 68 comprises a
handle skirt 11. In some embodiments, the handle skirt 11 is
configured to secure the power grip handle 68 once inserted into
the first handle opening 5a and the second handle opening 5b. In
some embodiments, the main housing frame 19 comprises a UI module
slot 7 configured to receive the UI module connector 9. In some
embodiments, the UI module 1 is powered upon connection with the
housing comprising the sensor platform and array. In some
embodiments, the UI module is powered by a switch.
[0262] As shown in FIG. 18B, the tactile sensing device comprising
the rocker design comprises a curved sensor applicator 13. In some
embodiments, the curved sensor applicator comprises the sensor
array. In some embodiments, the sensor array is adhered to the
surface of the curved sensor applicator. In some embodiments, the
curved sensor platform 13 and the sensor array comprise a slot to
facilitate needle insertion and tactile sensing device removal. As
shown in FIG. 18A, the tactile sensing device comprises a needle
guide. In some embodiments, the needle guide is a slot 38. In some
embodiments, the slot 38 comprises a first needle guide wall 131a
and a second needle guide wall 131b. In some embodiments, the
needle guide comprises a slot opening 38a and a slot terminus
38b.
[0263] FIGS. 20A-E show the workflow of how a user utilizes the
tactile sensing device 1800 comprising the rocker design,
alternatively referred to a rocker tactile sensing device, when
imaging a target tissue location of a patient. In some embodiments,
the user inserts the handle 68 into the main housing frame 19 via
the handle openings. Next, in some embodiments, the user visually
locates the general area of the target tissue location (e.g.,
spinous processes). Next, in some embodiments, the user places the
tactile sensing device on the skin surface of the patient, ensuring
the midline of the device aligns with the target tissue location
(i.e., the spine). FIG. 20A shows the user 28 applying a constant
downward pressure on the power grip handle 68, through the sensor
array, and onto the skin surface of the patient. Furthermore, FIG.
20A illustrates how the user 28 obtains a first image of the target
tissue location when exerting a forward rocking motion of the
device while pressing against the skin surface of the patient 15.
In some embodiments, the sleeve 80 is used as a sterile barrier
between the patient 15 and the reusable UI module 1.
[0264] FIG. 20B shows how the user 28 obtains a second image of the
target tissue location when exerting a backward rocking motion of
the device while pressing against the skin surface of the patient
15. In some embodiments, the user partially images the target
tissue location when exerting either a forward or backward rocking
motion of the device while pressing it against the patient. In some
embodiments, a complete image of the target tissue location is
acquired once the user exerts both a forward or backward rocking
motion of the device while pressing it against the patient. In some
embodiments, the user rocks the tactile sensing device forward to
its maximum position and subsequently rocks the tactile sensing
device backward to the maximum downward position, and then back to
center in order to fully image the target tissue location (e.g.,
spinous processes). In some embodiments, the user continues to rock
the tactile sensing device as necessary until the display screen
displays the hotspots of the target tissue location (e.g., the
spinous processes) and the midline. In some embodiments, the
display screen displays a line corresponding to the midline. In
some embodiments, the display screen displays a crosshair
corresponding to location of the needle guide relative to the
spine. In some embodiments, the display screen displays an arrow
indicating to the user the direction in which the tactile sensing
device needs to be moved in order to localize the target tissue
location. In some embodiments, the user refreshes the device output
and starts the imaging process again at another location along the
spine.
[0265] In some embodiments, once the complete image of the target
tissue location is acquired, the tactile sensing device prompts the
user when the needle guide is at correct location, as shown in FIG.
20C. In some embodiments, upon correct alignment of the needle
guide, the user 28 detaches the power grip handle 68 by pulling the
handle up in order to release it from the main housing frame 19, as
shown in FIG. 20D. In some embodiments, the handle is detached by
pressing at least one button that releases the handle from the main
housing frame 19. Next, in some embodiments, the user proceeds to
insert the needle or marking tool into the needle guide. In some
embodiments, the needle guide allows for a certain degree of
angular movement that enables the user to pinpoint the exact needle
insertion position required. In some embodiments, the tactile
sensing device is removed after needle insertion by sliding the
device leftward along the skin surface. In some embodiments, the
tactile sensing device comprises a needle retention clip 17, as
shown in FIG. 20E. The needle retention clip 17 is configured to
keep the needle 14 fixed in place. In some embodiments, the needle
retention clip is disengaged to allow release the needle from the
device in order to slide the device off the skin surface.
Slider Tactile Sensing Device
[0266] In some embodiments, the tactile sensing device is a slider
tactile sensing device 2100, as shown in the embodiments depicted
in FIGS. 21A-B, 22A-C, 23A-B, 24A-C, 25A-B, and 26A-D alternatively
referred to a tactile sensing device including a slider design
herein. In embodiments of the tactile sensing device that are
slider tactile sensing devices, the devices include aspects and
functionality of the tactile sensing devices described elsewhere
herein with the sensor array being movable relative to the body of
the device and that uses and includes historical and real time
image visualization thereby requiring a smaller sensor array to
build an image for display of the anatomy of a subject as compared
to a non-sliding tactile sensing device, and as compared to a
rocker tactile sensing device sensor array.
[0267] FIG. 21A shows an isometric view of the slider tactile
sensing device 2100. In some embodiments, the slider tactile
sensing device 2100 comprises a scanning knob 21. In some
embodiments, the slider tactile sensing device 2100 comprises a
scanhead subassembly 23. In some embodiments, the scanning knob 21
is configured to enable the user to translate the carriage-scanhead
subassembly along a distance (e.g., along the vertebrae of a
patient). In some embodiments, the scanning knob 21 is configured
to enable the user to press the sensor array onto the surface of
the skin of the patient. In some embodiments, the scanning knob 21
is configured to lock the scanhead 33 in place once a target tissue
insertion site is identified. In some embodiments, the scanning
knob 21 is supplied as a separate component.
[0268] In some embodiments, the scanhead 33 allows the sensor array
to be translated over a distance (e.g., along a 3 inch distance
along the vertebrae). In some embodiments, the scanhead 33 is
translated over a distance of about 0.5 inches (in.) to about 10
in. In some embodiments, the scanhead 33 is translated over a
distance of at least about 0.5 in. In some embodiments, the
scanhead 33 is translated over a distance of at most about 10 in.
In some embodiments, the scanhead 33 is translated over a distance
of about 0.5 in. to about 1 in., about 0.5 in. to about 2 in.,
about 0.5 in. to about 3 in., about 0.5 in. to about 4 in., about
0.5 in. to about 5 in., about 0.5 in. to about 6 in., about 0.5 in.
to about 7 in., about 0.5 in. to about 8 in., about 0.5 in. to
about 9 in., about 0.5 in. to about 10 in., about 1 in. to about 2
in., about 1 in. to about 3 in., about 1 in. to about 4 in., about
1 in. to about 5 in., about 1 in. to about 6 in., about 1 in. to
about 7 in., about 1 in. to about 8 in., about 1 in. to about 9
in., about 1 in. to about 10 in., about 2 in. to about 3 in., about
2 in. to about 4 in., about 2 in. to about 5 in., about 2 in. to
about 6 in., about 2 in. to about 7 in., about 2 in. to about 8
in., about 2 in. to about 9 in., about 2 in. to about 10 in., about
3 in. to about 4 in., about 3 in. to about 5 in., about 3 in. to
about 6 in., about 3 in. to about 7 in., about 3 in. to about 8
in., about 3 in. to about 9 in., about 3 in. to about 10 in., about
4 in. to about 5 in., about 4 in. to about 6 in., about 4 in. to
about 7 in., about 4 in. to about 8 in., about 4 in. to about 9
in., about 4 in. to about 10 in., about 5 in. to about 6 in., about
5 in. to about 7 in., about 5 in. to about 8 in., about 5 in. to
about 9 in., about 5 in. to about 10 in., about 6 in. to about 7
in., about 6 in. to about 8 in., about 6 in. to about 9 in., about
6 in. to about 10 in., about 7 in. to about 8 in., about 7 in. to
about 9 in., about 7 in. to about 10 in., about 8 in. to about 9
in., about 8 in. to about 10 in., or about 9 in. to about 10 in. In
some embodiments, the scanhead 33 is translated over a distance of
about 0.5 in., about 1 in., about 2 in., about 3 in., about 4 in.,
about 5 in., about 6 in., about 7 in., about 8 in., about 9 in., or
about 10 in.
[0269] In some embodiments, the surface of the distal end with
respect to the user (i.e., the bottom surface) of the scanhead
subassembly 23 comprises the sensor array. In some embodiments, the
scanhead 33 is configured to receive the scanning knob 21. In some
embodiments, the sensor array (not shown in FIGS. 21A-B) is mounted
on the bottom surface of the scanhead 33. In some embodiments, the
scanhead 33 has a size and curvature designed to mimic palpation
and optimize vertebral resolution. As shown in FIG. 21A, the slider
tactile sensing device 2100 comprises a grip feature 76. In some
embodiments, the grip feature 76 is the outer portion of the main
housing frame 19. In some embodiments, the user uses the grip
feature 76 to press the device against the patient. In some
embodiments, the grip feature 76 is any of the previously described
grip features.
[0270] In some embodiments, the slider device comprises a main
housing frame 19. In some embodiments, the main housing frame 19
comprises an indicator for the midline of the tactile sensing
device to facilitate alignment with the spine. In some embodiments
the indicator for the midline of the tactile sensing device is a
needle alignment guide 36. In some embodiments, the indicator is a
colored notch. In some embodiments, the main housing frame 19 is
reusable. In some embodiments, the main housing frame 19 is
disposable. In some embodiments, the main housing frame 19 is made
of medical-grade, injection-molded plastic. In some embodiments,
the main housing frame 19 is comprised of two parts. In some
embodiments, the main housing frame 19 comprises a
patient-attachment mechanism on the bottom surface. In some
embodiments the patient-attachment feature employs a vacuum, an
adhesive, or a belt mechanism. In some embodiments, the
patient-contacting surface of the main housing frame 19 is curved.
In some embodiments, the patient-contacting surface of the main
housing frame 19 has a downward concave curvature to conform to one
or more vertebrae in flexion. In some embodiments, the
patient-contacting surface of the main housing frame 19 has an
upward concave curvature to conform to the tissue between the
thoracolumbar fascia. In some embodiments, the patient-contacting
surface of the main housing frame 19 has an M-shaped curvature to
optimize conformance in the mediolateral direction. In some
embodiments, the main housing frame 19 comprises a grip area for
the user's non-dominant hand. In some embodiments, the grip area is
on the left side of the main housing frame 19 when viewed from the
front. In some embodiments, the grip area is rounded. In some
embodiments the grip area comprises multiple materials. In some
embodiments, the grip area comprises an undercut to improve
purchase. In some embodiments, the grip area is a removable palm
pad that is assembled with the main housing frame 19. In some
embodiments, removable palm pads are available in different sizes
and grips.
[0271] FIG. 21B shows a cut away view of the slider tactile sensing
device 2100 with no force being applied onto the proximal end (with
respect to the user) of the scanning knob 21. In contrast, FIG. 21C
shows a cut away view of the slider tactile sensing device 2100
while a force is being applied onto the proximal end (with respect
to the user) of the scanning knob 21. In other words, FIG. 21C
shows the tactile sensing device 2100 as a user (not shown in FIGS.
21A-B) presses down onto the scanning knob 21 and depresses the
entire scanhead subassembly 23 (e.g., onto the surface of the skin
of a patient). In some embodiments, the scanning knob 21 is
reversibly attached to the tactile sensing device 2100 via a first
release clip 43a and a second release clip 43b at the top of the
scanhead 33, as shown in FIG. 21B. In some embodiments, the first
release clip 43a comprises a first foot 63a. In some embodiments,
the first release clip 43a comprises a second foot 63b. In some
embodiments, the slider tactile sensing device 2100 comprises a
first ledge 65a. In some embodiments, the slider tactile sensing
device 2100 comprises a second ledge 65b. In some embodiments, the
first ledge 65a is configured to receive the first foot 63a.
Likewise, in some embodiments, the second ledge 65b is configured
to receive the second foot 63b.
[0272] In some embodiments, the slider tactile sensing device 2100
comprises a first retention clip spring 67a. In some embodiments,
the slider tactile sensing device 2100 comprises a second retention
clip spring 67b. In some embodiments, the scanning knob 21
comprises a first scanning knob notch 69a and a second scanning
knob notch 69b, as shown in FIG. 21B. In some embodiments, the
first scanning knob notch 69a is configured to receive the first
retention clip spring 67a and the second retention clip spring 67b.
In some embodiments, the first retention clip 43a comprises a first
indentation that is configured to receive the first retention clip
spring 67a. Similarly, in some embodiments, the second retention
clip 43b comprises a second indentation that is configured to
receive the second retention clip spring 67b. Thus, in some
embodiments, the first retention clip spring 67a is positioned
between the scanning knob and the first retention clip 43a and the
second retention clip spring 67b is positioned between the scanning
knob 21 and the second retention clip 43b, as illustrated in FIG.
21B. In some embodiments, the first retention clip 43a and the
second retention clip spring 67b have a compressed state and an
uncompressed state. In some embodiments, the first retention clip
43a and the second retention clip spring 67b are in a biased,
uncompressed position or in an unbiased, compressed position.
[0273] In some embodiments, the first retention clip spring 67a and
the second retention clip 67b serve as a locking mechanism of the
scanning knob 21. FIG. 21C illustrates the scanning knob 21 in a
locked state or position. In some embodiments, the first foot 63a
is inserted into the first ledge 65a and the second foot 63b is
inserted into the second ledge 65b when the scanning knob 21 is in
a locked position (i.e., when the scanning knob 21 is attached to
the tactile sensing device 2100), as shown in FIG. 21C. In some
embodiments, the user pinches the first retention clip 43a and the
second retention clip 43b in order to disengage the first foot 63a
from the first ledge 65a and the second foot 63b from the second
ledge 65b. FIG. 21B illustrates the unlocked state of the scanning
knob 21. In some embodiments, when the scanning knob 21 is in the
unlocked state, the first retention clip spring 67a is in an
unbiased, compressed position, which causes the first foot 63a to
point laterally away and disengage from the first ledge 65a.
Similarly, in some embodiments, when the scanning knob 21 is in the
unlocked state, the second retention clip spring 67b is in an
unbiased, compressed position, which causes the second foot 63b to
point laterally away and disengage from the second ledge 65b.
[0274] FIG. 21B illustrates the slider tactile sensing device 2100
comprising a scanhead subassembly 23 that is in a non-depressed
state. On the other hand, FIG. 21C shows the slider tactile sensing
device 2100 comprising a scanhead subassembly 23 that is in a
depressed state. In other words, FIG. 21C shows the scanhead
subassembly 23 at a lower position or depth along the X-axis
compared to the initial position or depth along the X-axis of the
scanhead subassembly 23 that is shown in FIG. 21B. In some
embodiments, the scanhead subassembly 23 comprises a first spring
71a and a second spring 71b. In some embodiments, the scanhead
subassembly 23 comprises an indentation located distally from and
underneath the first ledge 65a, that is configured to receive the
first spring 71a. Similarly, in some embodiments, the scanhead
subassembly 23 comprises a first indentation located distally from
and underneath the second ledge 65b, that is configured to receive
the second spring 71b. In some embodiments, the first spring 71a is
located distally from and underneath the first ledge 65a. In some
embodiments, the second spring 71b is located distally from and
underneath the second ledge 65b. In some embodiments, the first
spring 71a is positioned within the first indentation of the
scanhead subassembly 23. In some embodiments, the second spring 71b
is positioned within the second indentation of the scanhead
subassembly 23.
[0275] In some embodiments, the user applies a force on or presses
down on the scanning knob 21 in order to depress the scanhead
subassembly 23. In some embodiments, the user applies a force or
presses down on the scanning knob 21 in order to change the
position of the scanhead subassembly 23 to a lower position or
depth. In some embodiments, the first spring 71a and the second
spring 71b change from a biased, uncompressed position to an
unbiased, compressed position when the user applies a force on or
presses down on the scanning knob 21. FIG. 21B illustrates the
first spring 71a and the second spring 71b in a biased,
uncompressed position. Meanwhile, FIG. 21C illustrates the first
spring 71a and the second spring 71b in an unbiased, compressed
position.
[0276] In some embodiments, the first spring 71a and the second
spring 71b are located directly below the first ledge 65a and the
second ledge 65b, respectively, when they are in an unbiased,
compressed position (i.e., when the user applies a force on or
presses down on the scanning knob 21), as shown in FIG. 21C. In
some embodiments, the slider tactile sensing device 2100 comprises
a third ledge 65c and a fourth ledge 65d. In some embodiments, the
third ledge 65c is located distally away and below the first ledge
65a, as shown in FIG. 21C. In some embodiments, the fourth ledge
65d is located distally away and below the second ledge 65b, as
shown in FIG. 21C. In some embodiments, the first spring 71a is
located in between the first ledge 65a and the third ledge 65c when
the first spring 71a is in an unbiased, compressed position (i.e.,
when the user applies a force on or presses down on the scanning
knob 21). In some embodiments, the second spring 71b is located in
between the second ledge 65b and the fourth ledge 65d when the
second spring 71b is in an unbiased, compressed position (i.e.,
when the user applies a force on or presses down on the scanning
knob 21).
[0277] In alternative embodiments, not illustrated in the figures,
the first spring 71a and the second spring 71b are located directly
within the third ledge 65c and the fourth ledge 65d, respectively,
when they are in an unbiased, compressed position. In other words,
in alternative embodiments, the first spring 71a and the second
spring 71b are displaced into the third ledge 65c and the fourth
ledge 65d, respectively, when the user applies a force on or
presses down on the scanning knob 21. In some embodiments, the
first spring 71a and the second spring 71b are located in a more
proximal position (with respect to the user) than the third ledge
65c and the fourth ledge 65d, respectively, when they are in an
unbiased, compressed position (i.e., when the user applies a force
on or presses down on the scanning knob 21), as shown in FIG.
21C.
[0278] FIG. 21C illustrates a depth 73 (along the X-axis) of the
scanhead subassembly. In some embodiments, the user controls the
depth 73 of the scanhead subassembly 23 along the X-axis by varying
the amount of force that she or he applies to the scanning knob 21.
In some embodiments, the first spring 71a and the second spring 71b
determine a maximum depth 73 (along the X-axis) of the scanhead
subassembly 23. In some embodiments, the maximum depth 73 (along
the X-axis) of the scanhead subassembly 23 occurs when the first
spring 71a and the second spring 71b are at a fully unbiased,
compressed position. In some embodiments, the depth 73 of the
scanhead subassembly ranges from about 0 centimeters (cm) to about
10 cm. In some embodiments, the depth 73 of the scanhead
subassembly ranges from at least about 0 cm. In some embodiments,
the depth 73 of the scanhead subassembly ranges from at most about
10 cm. In some embodiments, the depth 73 of the scanhead
subassembly ranges from about 0 cm to about 1 cm, about 0 cm to
about 2 cm, about 0 cm to about 3 cm, about 0 cm to about 4 cm,
about 0 cm to about 5 cm, about 0 cm to about 6 cm, about 0 cm to
about 7 cm, about 0 cm to about 8 cm, about 0 cm to about 9 cm,
about 0 cm to about 10 cm, about 1 cm to about 2 cm, about 1 cm to
about 3 cm, about 1 cm to about 4 cm, about 1 cm to about 5 cm,
about 1 cm to about 6 cm, about 1 cm to about 7 cm, about 1 cm to
about 8 cm, about 1 cm to about 9 cm, about 1 cm to about 10 cm,
about 2 cm to about 3 cm, about 2 cm to about 4 cm, about 2 cm to
about 5 cm, about 2 cm to about 6 cm, about 2 cm to about 7 cm,
about 2 cm to about 8 cm, about 2 cm to about 9 cm, about 2 cm to
about 10 cm, about 3 cm to about 4 cm, about 3 cm to about 5 cm,
about 3 cm to about 6 cm, about 3 cm to about 7 cm, about 3 cm to
about 8 cm, about 3 cm to about 9 cm, about 3 cm to about 10 cm,
about 4 cm to about 5 cm, about 4 cm to about 6 cm, about 4 cm to
about 7 cm, about 4 cm to about 8 cm, about 4 cm to about 9 cm,
about 4 cm to about 10 cm, about 5 cm to about 6 cm, about 5 cm to
about 7 cm, about 5 cm to about 8 cm, about 5 cm to about 9 cm,
about 5 cm to about 10 cm, about 6 cm to about 7 cm, about 6 cm to
about 8 cm, about 6 cm to about 9 cm, about 6 cm to about 10 cm,
about 7 cm to about 8 cm, about 7 cm to about 9 cm, about 7 cm to
about 10 cm, about 8 cm to about 9 cm, about 8 cm to about 10 cm,
or about 9 cm to about 10 cm. In some embodiments, the depth 73 of
the scanhead subassembly ranges from about 0 cm, about 1 cm, about
2 cm, about 3 cm, about 4 cm, about 5 cm, about 6 cm, about 7 cm,
about 8 cm, about 9 cm, or about 10 cm. Alternatively, in other
embodiments not illustrated in the drawings, the scanning head 21
has a second locking mechanism to lock the scanning knob 21 at
various depths along the X-axis. For example, in some embodiments,
the user pinches the first retention clip 43a and the second
retention clip 43b and disengages the first foot 63a and the second
foot 63b, the user is able to depress the entire scanhead
subassembly 23 along the X-axis by pressing down on the scanning
knob 21 while maintaining both retention clips pinched. In some
embodiments, the user further locks the scanhead subassembly 23 in
a depressed state (i.e., at a determined depth) by releasing the
first retention clip 43a and the second retention clip 43b and
allowing the first foot 63a to insert into a third ledge (not shown
in the figures) and allowing the second foot 63b to insert into a
fourth ledge (not shown in the figures). In some embodiments, the
scanhead assembly 23 comprises two or more ledges that enable the
user to lock the scanhead assembly 23 at a predetermined depth. In
some embodiments, the scanhead assembly 23 comprises about 4, 6, 8,
10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, or more ledges.
[0279] FIGS. 22A-C show how the scanhead subassembly 23 attaches to
the slider tactile sensing device 2100. FIG. 22A illustrates an
isometric view of the scanhead subassembly 23. In some embodiments,
the scanhead subassembly 23 comprises a scanhead 33, a scanning
knob 21, and a carriage 35. In some embodiments, the slider tactile
sensing device 2100 comprises a scanning track 45 and a locking
rack 75. In some embodiments, the slider design comprises a
scanning track 45. In some embodiments, the scanning track 45 is
part of the main housing frame 19. In some embodiments the scanning
track 45 is a removable part that is assembled with the main
housing frame 19. In some embodiments, the scanning track 45
comprises a track 45 that is configured to translate the scanhead
33 along the skin surface of the patient. In some embodiments, the
scanning track 45 is configured to translate the scanhead 33 along
the direction of the arrows shown in FIG. 22A. In some embodiments,
the scanning track 45 is configured to receive the carriage 35. In
some embodiments, the carriage 35 sits on the scanning track 45. In
some embodiments, the carriage 35 glides over the scanning track
45. In some embodiments, the carriage 35 snaps onto the scanning
track 45. In some embodiments, the scanning track 45 comprises
grooves that allow a scanhead to be locked into place after an
insertion site is identified. In some embodiments, the subassembly
comprises a locking rack 75 and a release button (not shown in the
figures).
[0280] In some embodiments, the scanning track 45 allows for about
2.75 inches to about 3 inches of scanhead travel. In some
embodiments, the length of the scanning track is based on the
distance between the top and bottom of consecutive spinous
processes. In some embodiments, the scanning track 45 allows for a
scanhead travel distance of about 1 cm to about 10 cm. In some
embodiments, the scanning track 45 allows for a scanhead travel
distance of at least about 1 cm. In some embodiments, the scanning
track 45 allows for a scanhead travel distance of at most about 10
cm. In some embodiments, the scanning track 45 allows for a
scanhead travel distance of about 1 cm to about 2 cm, about 1 cm to
about 3 cm, about 1 cm to about 4 cm, about 1 cm to about 5 cm,
about 1 cm to about 6 cm, about 1 cm to about 7 cm, about 1 cm to
about 8 cm, about 1 cm to about 9 cm, about 1 cm to about 10 cm,
about 2 cm to about 3 cm, about 2 cm to about 4 cm, about 2 cm to
about 5 cm, about 2 cm to about 6 cm, about 2 cm to about 7 cm,
about 2 cm to about 8 cm, about 2 cm to about 9 cm, about 2 cm to
about 10 cm, about 3 cm to about 4 cm, about 3 cm to about 5 cm,
about 3 cm to about 6 cm, about 3 cm to about 7 cm, about 3 cm to
about 8 cm, about 3 cm to about 9 cm, about 3 cm to about 10 cm,
about 4 cm to about 5 cm, about 4 cm to about 6 cm, about 4 cm to
about 7 cm, about 4 cm to about 8 cm, about 4 cm to about 9 cm,
about 4 cm to about 10 cm, about 5 cm to about 6 cm, about 5 cm to
about 7 cm, about 5 cm to about 8 cm, about 5 cm to about 9 cm,
about 5 cm to about 10 cm, about 6 cm to about 7 cm, about 6 cm to
about 8 cm, about 6 cm to about 9 cm, about 6 cm to about 10 cm,
about 7 cm to about 8 cm, about 7 cm to about 9 cm, about 7 cm to
about 10 cm, about 8 cm to about 9 cm, about 8 cm to about 10 cm,
or about 9 cm to about 10 cm. In some embodiments, the scanning
track 45 allows for a scanhead travel distance of about 1 cm, about
2 cm, about 3 cm, about 4 cm, about 5 cm, about 6 cm, about 7 cm,
about 8 cm, about 9 cm, or about 10 cm.
[0281] FIG. 22B shows a posterior view of the scanhead subassembly
23 while being attached to the main housing frame 19 of the slider
tactile sensing device 2100. Furthermore, FIG. 22C is a cutaway
illustration of this same posterior view that further shows the
locking mechanism between the scanhead subassembly 23 and the main
housing frame 19 of the slider tactile sensing device 2100. In some
embodiments, the scanhead 33 comprises a locking insert 77. In some
embodiments, the locking insert 77 comprises a sawtooth edge. In
some embodiments, the sawtooth edge of the locking insert 77
projects downwards. In some embodiments, the locking insert 77 is
protrudes from the posterior side of the scanhead 33. In some
embodiments, the locking insert 77 is configured to couple with the
locking rack 75. In some embodiments, the locking rack 75 comprises
a sawtooth edge. In some embodiments, the locking rack 75 is a
sawtooth rack. In some embodiments, the sawtooth edge of the
locking rack 75 projects upwards. In some embodiments, the locking
insert 77 and the locking rack 75 comprise sawtooth projections
that have a same pitch. In some embodiments, the locking insert 77
and the locking rack 75 are configured to lock in place when
coupled.
[0282] In some embodiments, the locking insert 77 and the locking
rack 75 serve as a locking mechanism for the scanhead subassembly
23. In some embodiments, the locking insert 77 and the locking rack
75 lock the carriage in place when the teeth from the locking
insert 77 engage with the teeth of the locking rack 75. In some
embodiments, in order to translate the scanhead 33 along the
scanning track 45, the user depresses, pushes down on, or applies a
downward force onto the scanhead subassembly 23 that is enough to
disengage the locking insert 77 from the locking rack 75. In some
embodiments, when the locking insert 77 and the locking rack 75 are
engaged, the scanhead 33 cannot be translated along the scanning
track 45. In some embodiments, the user locks the scanhead 33 in
place by releasing (i.e., stops pushing down on or applying a
downward force to) the scanhead subassembly 23 to its initial
position (i.e., a depth of 0 cm), thereby causing the teeth of the
locking insert 77 to engage or mate with the teeth of the locking
rack 75. In some embodiments, the translation of the scanhead 33 is
automated and controlled by the computing device of the slider
tactile sensing device 2100.
[0283] FIGS. 23A-B show an assembled and exploded view of the
scanning scanhead subassembly 23, respectively. In some
embodiments, the scanhead subassembly 23 comprises a scanning knob
21, scanhead 33, and a carriage 35.
[0284] In some embodiments, the scanning knob 21 comprises a first
retention clip 43a and a second retention clip 43b. In some
embodiments, the scanning knob 21 enables the user to translate the
scanhead 33 along the scanning track 45. In some embodiments, the
scanning knob 21 comprises the first retention clip 43a and the
second retention clip 43b. In some embodiments, the scanning knob
21 comprises the first retention clip spring 67a and the second
retention clip spring 67b. In some embodiments, the first retention
clip spring 67a and the second retention clip spring 67b are placed
in between the scanning knob 21 and first retention clip 43a and
the second retention clip 43b, respectively, under some tension. In
some embodiments, the first retention clip 43a comprises a first
pin 79a, as shown in FIG. 23B. In some embodiments, the second
retention clip 43b comprises a second pin 79b, as shown in FIG.
23B. In some embodiments, the first pin 79a is anchored into a
first cavity 89a of the scanhead 33. In some embodiments, the first
foot 63a rests on the first ledge 65a that is found within the
first cavity 89a. In some embodiments, the second foot 63b rests on
the second ledge 65b that is found within the second cavity (not
shown in FIG. 23B). In some embodiments, the first pin 79a is
anchored into a second cavity (not shown in FIG. 23B) of the
scanhead 33. In some embodiments, the first retention clip 43a
pivots on the first pin 79a and compresses the first retention clip
spring 67a. In some embodiments, the second retention clip 43b
pivots on the second pin 79b and compresses the second retention
clip spring 67b.
[0285] In some embodiments, the first retention clip 43a and the
second retention clip 43b are further held in place by use of a
first plate 81a and a second plate 81b. In some embodiments, the
first plate 81 is secured to a posterior side of the scanhead
subassembly 23, as shown in FIG. 23B. In some embodiments, the
first plate 81a is fastened to the second plate 81b via a third
bolt 85c, a fourth bolt 85d, a third nut 87c, and a fourth nut 87d.
In some embodiments, the third bolt 85c traverses the anterior
surface of the second plate 81b and the first plate 81a and is
furthered fastened by the third nut 87c, which is placed and
secured on the end of the third bolt 85c that protrudes from the
first plate 81a. In some embodiments, the fourth bolt 85d traverses
the anterior surface of the second plate 81b and the first plate
81a and is furthered fastened by the fourth nut 87d, which is
placed and secured on the end of the fourth bolt 85d that protrudes
from the first plate 81a.
[0286] In some embodiments the first plate 81a and the second plate
81b sit on or attach to the top surface of the scanhead 33, as
shown in FIGS. 22A-B. In some embodiments, the scanhead 33 is
placed and/or fits within the inner frame of the carriage 35. In
other words, in some embodiments, the carriage 35 wraps around the
scanhead 33. In some embodiments, the scanhead 33 comprises a third
ledge 65c and a fourth ledge (not shown in FIG. 23B). In some
embodiments, the first spring 71a and the second spring 71b are
located within the carriage 35. In some embodiments, the distal end
of the first spring 71a sits on the fourth ledge (not shown in FIG.
23B) of the carriage 35, and the distal end of the second spring
71a sits on the third ledge 65c of the carriage 35. In some
embodiments, the proximal end of the first spring 71a and the
second spring 71b contact the distal surface of the scanhead 33.
Thus, in some embodiments, the first spring 71a and the second
spring 71b are located in between the scanhead 33 and the carriage
35.
[0287] In some embodiments, the distal surface of the scanhead 33
comprises the sensor array. In some embodiments, the scanhead 33
comprises a base 83. In some embodiments, the base 83 secures the
distal end of the scanhead 33. In some embodiments, the base 83
wraps around the distal end of the scanhead 33, as shown in FIG.
22A. In some embodiments, the base 83 is fastened to the scanhead
33 via a first bolt 85a, a second bolt 85b, a first nut 87a, and a
second nut 87b. In some embodiments, the first bolt 85a traverses
the lateral surface of the base 83 and is furthered fastened by the
first nut 87a, which is placed and secured on the end of the first
bolt 85a that protrudes from the base 83, once the bolt is inserted
through the base 83. Similarly, in some embodiments, the second
bolt 85b traverses the lateral surface of the base 83 that is
directly opposite to the lateral surface in which the first bolt
85a was inserted. In some embodiments, the second bolt 85b is
furthered fastened by the second nut 87b, which is placed and
secured on the end of the second bolt 85b that protrudes from the
base 83, once the bolt is inserted through the base 83.
Scanhead
[0288] In some embodiments, the slider design comprises a scanhead
33. In some embodiments, the scanhead 33 is mated to the carriage
35 and moved along the scanning track 45. In some embodiments, the
scanhead is depressed relative to the carriage in order to better
displace tissue and facilitate imaging. In some embodiments, a
first spring and a second spring are strategically placed on the
interior, anterior, and posterior edges of the scanhead, between
the scanhead and the carriage. In some embodiments, the springs
facilitate a range of about 3 centimeters (cm) of scanhead
depression into the tissue. In some embodiments, the scanhead is
depressed by applying downward pressure to the top of the scanhead.
In some embodiments, the scanhead is moved along the scanning track
by applying anterior or posterior pressure to the scanhead. In some
embodiments, the scanhead is a rolling scanhead, which is rotated
to travel the full length of the track. In some embodiments, the
bottom surface of the scanhead serves as a platform for a sensor
array, as described supra. In some embodiments, the sensor array
has 11 rows and 9 columns of sensels, with 1.9 mm spacing. In some
embodiments, the sensor array has 12 rows and 8 columns of sensels,
with 1.9 mm spacing. In some embodiments, the bottom surface of the
scanhead is curved. In some embodiments, the bottom surface of the
scanhead has a curvature with a radius of about 75 mm opposite that
of the vertebrae.
[0289] In some embodiments, the bottom surface of the scanhead is
about 20.times.16 mm. In some embodiments, the bottom surface of
the scanhead is about 30 mm.times.21 mm. In some embodiments, the
anterior and posterior edges of the scanhead are rounded to allow
the scanhead to traverse more smoothly along the skin surface. In
some embodiments, the anterior and posterior edges of the bottom of
the scanhead are filleted with a diameter of about 8 mm, to allow
the scanhead to traverse more smoothly along the skin surface. In
some embodiments, edge softeners with fillets of about 10 mm in
diameter are connected to the anterior and posterior edges of the
bottom surface of the scanhead. In some embodiments, the sensor
array is mounted to the bottom surface of the scanhead via an
adhesive. In some embodiments, the tails of the sensor are tucked
into clips on the side of the carriage. In some embodiments, the
tails of the sensor are aligned with registration holes on the
interior or exterior anterior and posterior faces of the
scanhead.
[0290] In some embodiments, the scanhead 33 comprises a needle
guide 2, as described supra. In some embodiments, the needle guide
is inside of the scanhead. In some embodiments, the needle guide is
attached to the scanhead once a target tissue location is
identified. In some embodiments, the bottom surface of the needle
guide 2 serves as a platform for a sensor array, as described
supra. In some embodiments, the bottom surface of the needle guide
serves as the distal opening of the needle guide, and is aligned
with the slot in the sensor array. In some embodiments, the
proximal opening of the needle guide is always exposed. In some
embodiments, the needle guide is exposed by removing a top surface
from the scanhead. In some embodiments, once the target tissue
location is identified, the needle guide is exposed by rotating the
scanhead. In some embodiments, once the target tissue location is
identified, the scanhead and mounted sensor array are removed to
expose the needle guide. In some embodiments, a release mechanism
exists that enables the device to be pulled away from the needle
after insertion.
[0291] In some embodiments, the needle guide, as described supra,
is located outside of the scanhead. In some embodiments, the sensor
array mounted to the bottom of the surface does not require a slot,
as it is not mounted directly beneath the needle guide. In some
embodiments, the needle guide is located anterior or posterior to
the scanhead. In some embodiments, the needle guide is laterally
offset from the scanhead during scanning. In some embodiments, the
needle guide is fixed to the carriage. In some embodiments, the
needle guide is fixed to the scanhead. In some embodiments, the
needle guide is attachable. In some embodiments, a cut exists on
the interior of the frame to accommodate the needle guide and allow
the scanhead to complete its travel along the scanning track. In
some embodiments, the proximal opening of the needle is always
exposed. In some embodiments, once a target tissue location is
identified, the scanhead and carriage are manually moved along the
scanning track until the needle guide aligns with the target tissue
location. In some embodiments, once a target tissue location is
identified, the scanhead and carriage are automatically moved along
the sliding track until the needle guide aligns with the target
tissue location. In some embodiments, once the target tissue
location is identified, the scanhead is rotated to allow the needle
guide to be aligned over the target tissue location. In some
embodiments, once a target tissue location is identified, the
scanhead and carriage are removed, and the needle guide is attached
to the device so as to align with the target tissue location. In
some embodiments, the device is detached from the needle guide
before insertion. In some embodiments, a release mechanism exists
that enables the device to be pulled away from the needle after
insertion. In some embodiments, the needle is inserted at a
location that is anterior to the scanhead 33. In some embodiments,
the needle guide 2 is located on a surface (e.g., an anterior
surface or a posterior surface) of the scanhead 33 rather than
through the center of the scanhead 33. In some embodiments, the
needle is inserted at a location that is posterior to the scanhead
33. In some embodiments, the needle is not inserted through the
scanhead 33. In other words, in some embodiments, the scanhead 33
does not comprise a needle guide 2 traversing the center of the
scanhead 33. In some embodiments, the scanhead 33 does not comprise
the needle guide 2. For example, in some embodiments, the needle
guide 2 is reversibly attached to the scanhead 33. In some
embodiments, the needle guide is not located through the center of
the scanhead 33. In some embodiments, the scanhead does not
comprise a slot 38.
Scanning Knob
[0292] In some embodiments, the slider design comprises a scanning
knob 21. In some embodiments, the scanning knob is removable. In
some embodiments, the scanning knob is fixed. FIGS. 24A-C show
embodiment scanning knobs for the tactile sensing device. In some
embodiments, the scanning knob is part of the scanhead. In some
assemblies, the scanning knob 21 is attached to the top surface of
the scanhead. In some embodiments, the scanning knob 21 comprises
ribs 91, as shown in FIG. 24A. In some embodiments, the scanning
knob 21 does not comprise ribs. In some embodiments, the scanning
knob is a convex scanning knob 37, as shown in FIG. 24B. In some
embodiments, the convex scanning knob 37 is a scanning knob
comprising a proximal surface (with respect to the user) that is
curved like the exterior of a circle and/or a sphere. In some
embodiments, the convex scanning knob 37 comprises ribs. In some
embodiments, the convex scanning knob 37 does not comprise ribs. In
some embodiments, the scanning knob is a concave scanning knob 41,
as shown in FIG. 24C. In some embodiments, the concave scanning
knob 41 is a knob that comprises a proximal surface (with respect
to the user) that curves inward like the interior of a circle
and/or a sphere. In some embodiments, the concave scanning knob 37
comprises ribs. In some embodiments, the concave scanning knob 37
does not comprise ribs. In some embodiments, the scanning knob 21
is used to move the scanhead and carriage along the scanning track
45. In some embodiments, the scanning knob is used to move the
scanhead proximally and distally (i.e. toward and away from the
patient, respectively) relative to the carriage. In some
embodiments, the travel of the scanhead 33 along the scanning
track, and proximal and distal movement are controlled by the same
mechanism. In some embodiments, the travel of the scanhead 33 along
the track and the travel of the scanhead 33 relative to the
carriage are controlled by independent mechanisms. In some
embodiments, movement relative to the carriage prevents movement
along the track. In some embodiments a pintle is used to lock the
position of the carriage and scanhead during proximal and distal
movement of the scanhead. In some embodiments, the scanning knob
comprises a button that is configured to release the scanhead from
its locked position relative to the carriage. In some embodiments,
the scanning knob comprises a button that is configured to release
the carriage from its locked position along the track. In some
embodiments, an indicator exists to alert to locking of the
scanhead in its position along the track or relative to the
carriage. In some embodiments, movement of the scanhead is
automated. In some embodiments, movement of the scanhead is
non-automated and controlled by a user. In some embodiments,
movement of the scanhead is controlled by a user via buttons. In
some embodiments, movement in the proximal and distal direction is
controlled by a mechanism located at the top of the scanning knob.
In some embodiments, movement along the scanning track is
controlled by a mechanism located on the side of the scanning knob.
In some embodiments, movement along the scanning track is
controlled by a user via push buttons. In some embodiments, the
scanning knob is pushed proximally and distally to allow for travel
relative to the carriage. In some embodiments, the scanning knob is
pushed anteriorly and posteriorly to allow for travel along the
scanning track. In some embodiments, the scanning knob has a rotary
dial that is rotated to move the carriage along the scanning track
45. In some embodiments, the scanning knob has a rotary dial that
is rotated to move the scanhead proximally and distally relative to
the carriage. In some embodiments, the scanhead is moved relative
to the carriage via a mechanical actuator. In some embodiments, the
scanhead is automatically moved relative to the carriage to a level
dictated by patient characteristics, such as body mass index (BMI).
In some embodiments, the tactile sensing device comprises a
mechanism that locks movement along the track and relative to the
carriage. In some embodiments, partial images of captured areas are
displayed while the scanning cycle is being completed. In some
embodiments, areas currently being acquired are highlighted for
clarity. In some embodiments, the scanning process of the slider
workflow is most similar to the manual palpation-landmarking
process. In some embodiments, the scanning knob is removed to
expose a needle guide. In some embodiments, the scanning knob
comprises at least one scanning knob retention clip 43a or 43b to
secure it to the scanhead 33, as shown in FIGS. 23A and 23B. In
some embodiments, scanning knob retention clips are metal or
plastic clips that may include living springs or hinges. In some
embodiments, scanning knob retention clips are secured to the
scanhead. In some embodiments, scanning knob retention clips are
pinched to disengage the scanning knob. In some embodiments, at
least one button is included to detach the scanning knob. In some
embodiments, the carriage 35 is fixed upon disengagement of the
scanning knob.
Carriage
[0293] In some embodiments, the carriage 35 is reversibly secured
around one or more sides of the scanhead 33. In some embodiments,
the carriage 35 interacts with the locking rack 75 thereby causing
the scanhead subassembly 23 to lock in place. In some embodiments,
the carriage 35 contacts the scanning track 45, thereby enabling
the scanhead 33 to be translated along the scanning track 45. In
some embodiments, the carriage 35 is inserted into the scanning
track 45 and used to traverse a scanhead 33 along the spine. In
some embodiments, the carriage is magnetically mated to the track.
In some embodiments, mating of the carriage 35 with the scanning
track 45 is further bolstered through the use of pre-compressed
springs. In some embodiments, silicone or other materials are used
on the sliding surface between the carriage 35 and scanning track
45 to provide friction and support mating.
[0294] In some embodiments, the slider design comprises a position
sensor (not shown in the figures). In some embodiments, the
position sensor tracks the position of the carriage 35 relative to
the scanning track 45. In some embodiments, the position sensor is
a linear or multi-turn rotary potentiometer. In some embodiments
the position sensor is a magnetic linear encoder, such as, but not
limited to a Hall-effect sensor. In some embodiments, the position
sensor is a potentiometer, with a wiper contact connected to a
linear or rotational shaft, which forms an adjustable voltage
divider relative to two end connections, and outputs a resistance
proportional to wiper position along the shaft. In some
embodiments, a reference voltage is applied across the fixed end
connections, and the output voltage is taken from the wiper contact
as it moves along the shaft. In some embodiments, the output
voltage is inputted to the PCBA in the UI module 1.
[0295] In some embodiments, the tactile sensing device comprises a
computer program that converts the output voltage to a relative
wiper position. In some embodiments the position sensor is a slide
potentiometer, which is integrated into the frame parallel to the
scanning track 45, with the wiper inserted into a cut in the
scanhead 33, such that the output voltage is proportional to the
position of the scanhead 33 during scanning. In some embodiments,
the calculated position is displayed or reflected in the real-time
pressure map 6. In some embodiments, the position sensor is a
linear potentiometer with a separate wiper attached to the scanhead
33. In some embodiments, the position sensor is a multi-turn rotary
potentiometer. In some embodiments, the position sensor is a
magnetic linear encoder, with one or more Hall-effect sensors in
the frame. In some embodiments, the position sensor is an optical
linear encoder. In some embodiments, the position sensor is a
time-of-flight sensor.
[0296] FIGS. 25A-B show an embodiment scanhead 33 comprising a
needle guide 2 having a proximal opening 134a that tapers to the
distal opening 134b; FIG. 25B shows the scanhead 33 of FIG. 25A cut
away through the needle guide 2. In some embodiments, the scanhead
33 comprises a slot 38, as shown in FIG. 25A. In some embodiments,
the slot 38 comprises a first slot wall 130a (not shown in FIG.
25A) and a second slot wall 130b (shown in FIG. 25A). In some
embodiments, the slot 38 provides the user with lateral access to
the needle guide 2, as described elsewhere herein in other
embodiments. In some embodiments, the needle guide 2 comprises a
first needle guide wall 131a and a second needle guide wall 131b,
as shown in FIG. 25B. In some embodiments, the first needle guide
wall 131a and a second needle guide wall 131b connect and form the
track 144 of the needle guide 2. In some embodiments, the needle
guide is reversibly attached to the tactile sensing device. In some
embodiments, the needle comprises a notch.
[0297] FIGS. 26A-D show the workflow of how a user utilizes the
tactile sensing device 2900 comprising the slider design when
imaging a target tissue location of a patient. In some embodiments,
the tactile sensing device comprising a slider design comprises a
reusable UI module, a sleeve, and a reusable charging station, as
described supra. In some embodiments, the tactile sensing device
comprises a UI module 1 and a scanning knob 21 that are reversibly
coupled to the main housing frame 19. In some embodiments, the user
inserts the scanning knob 21 into the main housing frame 19 (i.e.,
into the scanhead 33). Next, in some embodiments, the user visually
locates the general area of the target tissue location (e.g.,
spinous processes). Next, in some embodiments, the user places the
tactile sensing device on the skin surface of the patient, ensuring
the device is perpendicular to the target tissue location (e.g.,
the spine), as shown in FIG. 26A. FIG. 26B shows the user 28
applying a constant downward pressure on the scanning knob 21,
through the sensor array, and onto the skin surface of the patient.
In some embodiments, the user 28 translates the scanning knob 21 up
and down over the skin surface of the patient (e.g., over the
spinous processes of the patient).
[0298] In some embodiments, once the complete image of the target
tissue location is acquired, the tactile sensing device prompts the
user when the needle guide is at correct location, as shown in FIG.
26C. In some embodiments, upon correct alignment of the needle
guide, the user 28 detaches the scanning knob 21 by pulling it up
in order to release it from the main housing frame 19, as shown in
FIG. 26D. In some embodiments, the scanning knob is detached by
pinching at least two clips that releases the knob from the main
housing frame 19. In some embodiments, the user locks the scanhead
33 in place by releasing the scanning knob from the main housing
frame 19. In some embodiments, releasing the scanning knob from the
main housing frame 19 exposes the needle guide. Next, in some
embodiments, the user proceeds to insert the needle into the needle
guide. In some embodiments, the tactile sensing device comprises a
needle retention clip configured to keep the needle and device in
place.
Kits
[0299] In some embodiments, a tactile sensing device kit comprises
a disposable needle; sleeve; subassembly comprising a main housing
frame 19 and scanning track 45; and subassembly comprising a
scanning knob, carriage, and scanhead. In some embodiments, a
tactile sensing device kit comprises a disposable needle; sleeve;
power grip handle; and subassembly comprising a main housing frame
19 and curved sensor applicator. In some embodiments, the tactile
sensing device kit consists of sterilized and disposable
components. In some embodiments, the tactile sensing device kit is
packaged in a pre-sealed sterilized bag or blister tray. In some
embodiments, the UI module is part of a reusable main housing frame
19 and is not part of the tactile sensing device kit. In some
embodiments reusable tactile sensing device components are
hygienically cleaned.
Historical and Real Time Image Visualization
[0300] In some embodiments, the tactile sensing device comprises a
computing device. In some embodiments, the computing device
comprises a computer program. In some embodiments, the computer
program is, for example, software, including computer algorithms,
computer codes, and/or programs, which manages the device's
hardware and provides services for execution of instructions such
as real-time imaging. In some embodiments, the tactile sensing
device comprises a computer algorithm to build up an image from at
least two images. In some embodiments, the algorithm takes as an
input the type of tactile sensing device being used. In some
embodiments, the algorithm automatically determines the type of
tactile sensing device being used. In some embodiments, the
algorithm automatically selects image-display steps depending on
the type of tactile sensing device being used. In some embodiments,
the algorithm adjusts drive voltage based on a header in an
equilibration file. In some embodiments, imaging is initiated by
pressing a touchscreen or physical button. In some embodiments,
imaging is automatically initiated when the device is pressed
against a skin surface. In some embodiments, the algorithm drives
the sensor array and captures sensor data for the current time. In
some embodiments, the algorithm applies a Gaussian filter to
current data. In some embodiments, the algorithm determines the
active area of the current data. In some embodiments, the active
area of the current data is determined by obtaining an ordered list
of data rows, ignoring rows below a cutoff, and determining the
indices of the largest contiguous region of rows above a cutoff. In
some embodiments, the active area of the current data is
automatically determined based on known scanhead size and current
scanhead position. In some embodiments, current scanhead position
is determined from a position sensor, such as a potentiometer. In
some embodiments, a polynomial approximation of the current data is
used in order to apply a flat-field correction to remove artifacts.
In some embodiments, the current data are scaled between 0 and 1 by
dividing by the sum of the current data and mapping to the scale of
displayed data for the previous time. In some embodiments, current
displayed data is determined by finding the maximum for each pixel
when comparing the current data to the previous displayed data. In
some embodiments, the current displayed data is the cumulative sum
of previously displayed data. In some embodiments, the current
displayed data is then saved as the previous displayed data. In
some embodiments, the current displayed data is displayed to the
screen of the tactile sensing device. In some embodiments, an
imaging cycle is completed when the full sensor array area has been
rocked against the target tissue location. In some embodiments, an
imaging cycle is completed when a scanhead has been translated
along the full length of a scanning track 45. In some embodiments,
the active area is highlighted on the display using rectangular or
circular patches. In some embodiments, the algorithm displays a
line corresponding to the midline. In some embodiments, the
algorithm displays a crosshair corresponding to the location of the
needle relative to the current display data. In some embodiments,
the display screen displays an arrow indicating the direction in
which the tactile sensing device should be moved to localize the
target tissue location. In some embodiments, the algorithm takes as
inputs a patient identifier, patient weight, and patient height. In
some embodiments, the algorithm can change screen brightness based
on brightness input from a touchscreen or physical button. In some
embodiments, the algorithm can change the colormap based on input
from a touchscreen or physical button. In some embodiments, the
algorithm takes as an input a sensitivity factor. In some
embodiments, the sensitivity factor is selected using a touchscreen
or physical button, or a dial. In some embodiments, the sensitivity
factor is used to rescale the colormap of currently displayed data.
In some embodiments the sensitivity factor is used to adjust the
drive voltage. In some embodiments, the sensitivity factor is used
as the cutoff in determining the active area of current data. In
some embodiments, sensitivity is automatically adjusted based on
patient BMI, as inputted or calculated from height and weight. In
some embodiments, the algorithm displays a splash screen before
imaging is initiated. In some embodiments the user can press a
touchscreen or physical button to access a menu of input items. In
some embodiments, the user can scroll through menu items using
touchscreen or physical buttons or a dial. In some embodiments, the
algorithm contains steps for equilibration and calibration of the
sensor array. In some embodiments, the user can remove high points
that show up in current displayed data during application of no
force by pressing a touchscreen or physical tare button. In some
embodiments, the algorithm automatically removes high points during
zero-force application. In some embodiments, the user can refresh
the current displayed data by pressing a touchscreen or physical
refresh button. In some embodiments, the algorithm can detect if
the device is aligned with the midline. In some embodiments the
algorithm uses position sensors, such as an accelerometer, to
detect if the device is aligned with the midline. In some
embodiments, the algorithm can alert the user to off-midline
imaging. In some embodiments, the algorithm can automatically
refresh the currently displayed data if it corresponds to
off-midline imaging. In some embodiments, the algorithm can detect
if the tactile sensing device has changed orientation or been moved
laterally during an imaging cycle. In some embodiments the
algorithm can detect device movement using a position sensor, such
as a potentiometer, or a magnetic or optical sensor. In some
embodiments, the algorithm can alert the user to device movement
during an imaging cycle. In some embodiments, the algorithm can
automatically refresh currently displayed data if it detects
incorrect device reorientation or movement.
[0301] While preferred embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. It is not intended that the invention be limited by
the specific examples provided within the specification. While the
invention has been described with reference to the aforementioned
specification, the descriptions and illustrations of the
embodiments herein are not meant to be construed in a limiting
sense. Numerous variations, changes, and substitutions will now
occur to those skilled in the art without departing from the
invention. Furthermore, it shall be understood that all aspects of
the invention are not limited to the specific depictions,
configurations or relative proportions set forth herein which
depend upon a variety of conditions and variables. It should be
understood that various alternatives to the embodiments of the
invention described herein may be employed in practicing the
invention. It is therefore contemplated that the invention shall
also cover any such alternatives, modifications, variations or
equivalents. It is intended that the following claims define the
scope of the invention and that methods and structures within the
scope of these claims and their equivalents be covered thereby.
EXAMPLES
Example 1: Diagnostic Spinal Puncture Using a Tactile Sensing
Device
[0302] A health care worker performing a spinal puncture on an
obese subject places the tactile sensing device on the lumbar
region of the subject. A pressure map, viewed as a heat map by the
health care worker, appears on the display screen 4 of the tactile
sensing device 100. The heat map indicates bone structures, in this
case spinous processes of the lumbar vertebrae, by representing
these in red color base and indicates non-bone structures by
representing these in a blue color base. The tactile sensing device
simultaneously computes a needle projection and displays it on the
pressure map in real time as the health care worker advances a
needle into the subject. The health care worker adjusts the tactile
sensing device's needle guide angle to a cephalad angle degree
between 9.degree. and 15.degree.. After identifying a gap between
two of the lumbar vertebrae, for example L2 and L3, the health care
worker inserts a spinal needle into the tactile sensing device's
needle guide. The health care worker uses the needle guide and the
needle projection (adjusted in real time) and heat map (shown in
real time) on the screen to simultaneously guide the needle into
the subarachnoid space. The health care worker then collects the
cerebrospinal fluid (CSF). Once all CSF samples are collected, the
health care worker uses the tactile sensing device's 100 electronic
pressure sensor, which automatically displays the CSF pressure on
the display screen in real time, to measure and record the
subject's intracranial pressure.
Example 2: Epidural Administration of a Therapeutic Using a Tactile
Sensing Device
[0303] A health care worker performing an epidural administration
of an anesthetic on a pregnant patient to places the tactile
sensing device on the lumbar region of the pregnant patient. A
pressure map, viewed in real time as a heat map by the health care
worker, appears on the display screen of the tactile sensing
device. The heat map indicates bone structures, in this case,
spinous processes of the lumbar vertebrae, by representing these in
a darker hue and indicates non-bone structures by representing
these in a lighter hue. The tactile sensing device simultaneously
computes a projected subcutaneous needle location in real time and
displays it on the pressure map. The health care worker adjusts the
tactile sensing device's needle guide track angle to a cephalad
angle degree between 0.degree. and 15.degree.. After identifying a
gap between two of the lumbar vertebrae, for example L2 and L3, the
health care worker inserts a spinal needle into the tactile sensing
device's needle guide from the proximal opening of the needle guide
toward the distal opening of the needle guide, which is closest to
the patient, aligning the needle in a track of the needle guide. In
the epidural case, the health care worker optionally attaches a
loss-of-resistance syringe to the needle hub, to better detect
epidural-space entry before or after placement of the needle into
the needle guide. The health care worker uses the projected
subcutaneous needle location, the original needle insertion site,
and the heat map, both shown in real time and continuously
adjusting their output (i.e. voltage data and needle location),
displayed on the display screen to guide the needle into the
epidural space and inject the anesthetic. The device is removed by
the health care worker prior to removing the needle from the
patient by moving the device such that the needle tracks along the
slot of the device, which slot connects to the needle guide.
Example 3: Epidural Administration of a Therapeutic Using a Tactile
Sensing Device Having a Notch
[0304] A health care worker performing an epidural administration
of an anesthetic on a pregnant patient to places the tactile
sensing device on the lumbar region of the pregnant patient. A
pressure map, viewed in real time as a heat map by the health care
worker, appears on the display screen of the tactile sensing
device. The heat map indicates bone structures, in this case,
spinous processes of the lumbar vertebrae, by representing these in
a darker hue and indicates non-bone structures by representing
these in a lighter hue. The tactile sensing device simultaneously
computes a projected subcutaneous needle location in real time and
displays it on the pressure map. The health care worker adjusts the
tactile sensing device's needle guide track angle to a cephalad
angle degree between 0.degree. and 15.degree.. After identifying a
gap between two of the lumbar vertebrae, for example L2 and L3, the
health care worker inserts a spinal needle into the notch of a
tactile sensing device's needle guide, aligning the needle in a
track of the needle guide. In the epidural case, the health care
worker optionally attaches a loss-of-resistance syringe to the
needle hub, to better detect epidural-space entry before or after
placement of the needle into the needle guide. The health care
worker uses the projected subcutaneous needle location, the
original needle insertion site, and the heat map, both shown in
real time and continuously adjusting their output (i.e. voltage
data and needle location), displayed on the display screen to guide
the needle into the epidural space and inject the anesthetic. The
device is removed by the health care worker prior to removing the
needle from the patient by moving the device such that the needle
overcomes the lip of the notch and thereafter tracks along the slot
of the device.
* * * * *