U.S. patent application number 13/759969 was filed with the patent office on 2014-07-03 for systems, apparatus and methods for tissue dissection and modification.
The applicant listed for this patent is Paul Joseph Weber. Invention is credited to Paul Joseph Weber.
Application Number | 20140188128 13/759969 |
Document ID | / |
Family ID | 51018043 |
Filed Date | 2014-07-03 |
United States Patent
Application |
20140188128 |
Kind Code |
A1 |
Weber; Paul Joseph |
July 3, 2014 |
SYSTEMS, APPARATUS AND METHODS FOR TISSUE DISSECTION AND
MODIFICATION
Abstract
Systems, apparatus and methods for tissue dissection and
modification are disclosed herein. A method for tissue dissection
and modification may comprise inserting a tissue dissecting and
modifying wand (TDM) through an incision in a patient's body. The
TDM may comprise a tip having a plurality of protrusions with
lysing segments positioned between the protrusions to dissect
and/or modify tissue. The TDM may also comprise an energy window
positioned on top of the TDM that is configured to deliver energy
to modify tissues. After separating tissue using the lysing
segment(s) to define a target region, the energy window may be
activated and moved around within the target region to modify
tissues. In some implementations, the energy window may be
activated prior to and/or during dissection of the tissue such that
the tissue is separated while tissue is modified within the target
region.
Inventors: |
Weber; Paul Joseph;
(Queenstown, NZ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Weber; Paul Joseph |
Queenstown |
|
NZ |
|
|
Family ID: |
51018043 |
Appl. No.: |
13/759969 |
Filed: |
February 5, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61748037 |
Dec 31, 2012 |
|
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|
61751239 |
Jan 10, 2013 |
|
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Current U.S.
Class: |
606/130 |
Current CPC
Class: |
A61B 18/14 20130101;
A61B 2018/00642 20130101; A61B 2018/00761 20130101; A61B 2018/00797
20130101; A61B 18/1482 20130101; A61B 2017/00221 20130101; A61B
2018/00303 20130101; A61B 18/201 20130101; A61B 2018/00791
20130101; A61B 2218/002 20130101; A61B 18/149 20130101; A61B
2018/2211 20130101; A61B 90/98 20160201; A61B 2018/0072 20130101;
A61B 2018/00982 20130101; A61B 2018/00589 20130101; A61B 2218/007
20130101; A61N 7/00 20130101; A61B 34/30 20160201; A61B 2018/00714
20130101; A61N 2007/0047 20130101; A61B 18/1402 20130101; A61B
2018/00023 20130101; A61B 2018/00619 20130101; A61B 2018/00815
20130101; A61B 2018/00821 20130101; A61B 18/082 20130101; A61B
2018/00666 20130101; A61B 2018/00708 20130101; A61B 2018/00875
20130101; A61B 2090/3945 20160201; A61B 2018/0066 20130101; A61B
2018/00898 20130101; A61B 2018/00601 20130101; A61B 2018/00863
20130101; A61B 18/1815 20130101; A61B 2017/00106 20130101; A61B
18/148 20130101; A61B 2018/1807 20130101 |
Class at
Publication: |
606/130 |
International
Class: |
A61B 19/00 20060101
A61B019/00; A61B 18/08 20060101 A61B018/08 |
Claims
1. An apparatus for tissue separation and modification, comprising:
a tip comprising a first plurality of protrusions and a second
plurality of protrusions, wherein the first plurality of
protrusions is positioned to at least substantially extend in a
first direction, and wherein the second plurality of protrusions is
positioned to at least substantially extend in a second direction
distinct from the first direction; at least one lysing segment
positioned between at least two adjacent protrusions in the first
plurality of protrusions; and at least one lysing segment
positioned between at least two adjacent protrusions in the second
plurality of protrusions.
2. The apparatus of claim 1, wherein the first direction is at
least substantially perpendicular to the second direction.
3. The apparatus of claim 1, wherein the first direction extends at
an acute angle relative to the second direction.
4. The apparatus of claim 1, further comprising a third plurality
of protrusions positioned on the tip, wherein the third plurality
of protrusions is positioned to at least substantially extend in a
third direction.
5. The apparatus of claim 4, wherein the third direction is at
least substantially perpendicular to the first direction, and
wherein the third direction is at least substantially opposite from
the second direction.
6. The apparatus of claim 1, further comprising: a handle; and a
shaft positioned at a distal end of the handle, wherein the tip is
positioned at a distal end of the shaft.
7. The apparatus of claim 6, wherein the first direction extends at
least substantially parallel to a longitudinal axis of the
shaft.
8. The apparatus of claim 7, wherein the second direction extends
at least substantially perpendicular to the longitudinal axis of
the shaft.
9. The apparatus of claim 8, wherein the second plurality of
protrusions do not extend beyond a width of the shaft at a distal
end of the shaft.
10. The apparatus of claim 8, wherein the second plurality of
protrusions extend beyond a width of the shaft at a distal end of
the shaft.
11. The apparatus of claim 1, further comprising a robotic arm
configured to allow a surgeon to operate using the apparatus
indirectly, wherein the tip is positioned at a distal end of the
robotic arm.
12. The apparatus of claim 11, further comprising a robotic surgery
system coupled with the robotic arm.
13. The apparatus of claim 12, wherein the robotic surgery system
comprises a control element.
14. The apparatus of claim 13, wherein the control element
comprises at least one of a hand control toggle, a keyboard, a
mouse, a touchscreen display, a virtual reality system, and a
control pad.
15. The apparatus of claim 1, further comprising a temperature
sensor configured to sense a temperature of at least one of tissue
and fluid adjacent to the apparatus during an operation.
16. The apparatus of claim 15, wherein the temperature sensor is
positioned along an upper surface of the tip.
17. The apparatus of claim 15, wherein the temperature sensor
comprises at least one of a carbon resistor, film thermometer,
wire-wound thermometer, coil element, thermocouple, pyrometer, and
photoelectric sensor.
18. The apparatus of claim 1, further comprising a feedback means
for providing information to a user to avoid excess energy delivery
to tissue.
19. The apparatus of claim 18, wherein the feedback means is
configured to notify a user when a temperature of tissue adjacent
to the apparatus has reached a predetermined threshold
temperature.
20. The apparatus of claim 18, wherein the feedback means is
configured to notify a user when the apparatus has been positioned
in a particular location within a patient for a predetermined time
period.
21. The apparatus of claim 20, wherein the feedback means is
configured to notify a user when the apparatus has been motionless
for a predetermined period of time.
22. The apparatus of claim 18, wherein the feedback means comprises
a visual feedback means.
23. The apparatus of claim 22, wherein the feedback means comprises
at least one of an LED light, a LASER, an incandescent light
source, and a notification on a display screen.
24. The apparatus of claim 18, wherein the feedback means comprises
an audible feedback means.
25. The apparatus of claim 24, wherein the feedback means comprises
at least one of an alarm, a speaker, and an audible vibration
source.
26. The apparatus of claim 18, wherein the feedback means comprises
a tactile feedback means.
27. The apparatus of claim 26, wherein the tactile feedback means
comprises at least one of a heat generator, an electrical shock
generator, and a vibration generator.
28. The apparatus of claim 18, wherein the feedback means comprises
an antenna.
29. The apparatus of claim 28, wherein the antenna comprises a
radiofrequency identification tag.
30. The apparatus of claim 29, wherein the radiofrequency
identification tag comprises a passive tag.
31. The apparatus of claim 29, wherein the radiofrequency
identification tag is configured to allow for determining the
position of the tag relative to a patient using an alternating
electromagnetic field.
32. The apparatus of claim 31, further comprising a temperature
sensor configured to sense a temperature of tissue positioned
adjacent to the apparatus during an operation.
33. The apparatus of claim 32, further comprising a display unit
configured to display information to a user during an
operation.
34. The apparatus of claim 33, wherein the display unit is
configured to display visual information comprising information
from the temperature sensor and the radiofrequency identification
tag such that a user can visualize one or more regions within a
patient's body that have been sufficiently treated.
35. The apparatus of claim 34, wherein the visual information
comprises an indication of the one or more regions that have
reached a predetermined threshold temperature.
36. The apparatus of claim 31, wherein the alternating
electromagnetic field is one of a shortwave and UHF frequency.
37. The apparatus of claim 1, further comprising an energy window,
wherein the energy window is configured to deliver energy to tissue
adjacent to the apparatus during an operation.
38. The apparatus of claim 37, further comprising a second energy
window.
39. The apparatus of claim 37, wherein the energy window comprises
an impedance-matched microwave emission system.
40. The apparatus of claim 39, wherein the impedance-matched
microwave emission system comprises an array of impedance-matched
microwave emitting antennae.
41. The apparatus of claim 1, further comprising a sensor for
receiving and delivering information to a user.
42. The apparatus of claim 41, wherein the sensor comprises at
least one of a thermal sensor, a photoelectric sensor, a
photo-optic sensor, a camera, and a MEMS sensor.
43. The apparatus of claim 1, further comprising an electromagnetic
delivery element.
44. The apparatus of claim 43, wherein the electromagnetic delivery
element comprises at least one of an LED, a LASER, a fiberoptic
element, a filament, a photoelectric material, and an infrared
emitter.
45. The apparatus of claim 1, further comprising a vacuum port
configured to apply a vacuum for sucking excess fluids from a
surgical site during use.
46. The apparatus of claim 1, further comprising a fluid delivery
port configured to deliver one or more fluids to a surgical site
during use.
47. The apparatus of claim 46, wherein the fluid delivery port is
configured to be selectively opened to allow for selective delivery
of fluid therethrough.
48. The apparatus of claim 1, further comprising a vibration means
for vibrating the apparatus to at least one of help prevent buildup
of debris on the tip and assist in migrating the apparatus thought
tissue.
49. The apparatus of claim 48, wherein the vibration means
comprises at least one of a piezoelectric material, an ultrasonic
motor, a vibrational motor, and an electromagnetic driver.
50. The apparatus of claim 1, wherein the tip comprises an
asymmetrical tip wherein the first plurality of protrusions
comprise axial protrusions that extend at least substantially along
a longitudinal axis of the apparatus, wherein the second plurality
of protrusions comprise non-axial protrusions extending along a
first side of the tip, and wherein a second side of the tip
opposite from the first side lacks protrusions.
51. An apparatus for tissue separation and modification,
comprising: a handle; a shaft positioned at a distal end of the
handle; a tip positioned at a distal end of the shaft, wherein the
tip comprises a first plurality of protrusions and a second
plurality of protrusions, wherein the first plurality of
protrusions is positioned to at least substantially extend in a
first direction, wherein the second plurality of protrusions is
positioned to at least substantially extend in a second direction
distinct from the first direction, and wherein the first direction
is at least substantially perpendicular to the second direction; at
least one lysing segment positioned between at least two adjacent
protrusions in the first plurality of protrusions; and at least one
lysing segment positioned between at least two adjacent protrusions
in the second plurality of protrusions.
52. The apparatus of claim 51, wherein the tip comprises an
asymmetrical tip wherein the first plurality of protrusions
comprise axial protrusions that extend at least substantially along
a longitudinal axis of the shaft, wherein the second plurality of
protrusions comprise non-axial protrusions extending along a first
side of the tip, and wherein a second side of the tip opposite from
the first side lacks protrusions.
53. The apparatus of claim 51, further comprising a temperature
sensor configured to sense a temperature of tissue positioned
adjacent to the apparatus during an operation.
54. The apparatus of claim 53, further comprising a feedback means
for providing information to a user to avoid excess energy delivery
to tissue, wherein the feedback means is communicatively coupled
with the temperature sensor and configured to notify a user when a
temperature of tissue adjacent to the apparatus has reached a
predetermined threshold temperature.
55. An apparatus for tissue separation and modification,
comprising: a handle; a shaft positioned at a distal end of the
handle; a tip positioned at a distal end of the shaft, wherein the
tip comprises a first plurality of protrusions and a second
plurality of protrusions, wherein the first plurality of
protrusions is positioned to at least substantially extend in a
first direction, wherein the second plurality of protrusions is
positioned to at least substantially extend in a second direction
distinct from the first direction, and wherein the first direction
is at least substantially perpendicular to the second direction; a
first plurality of electrosurgical lysing segments positioned
between adjacent protrusions in the first plurality of protrusions;
a second plurality of electrosurgical lysing segments positioned
between adjacent protrusions in the second plurality of
protrusions; a temperature sensor configured to sense a temperature
of tissue positioned adjacent to the apparatus during an operation;
and an energy window, wherein the energy window is configured to
deliver energy to tissue adjacent to the apparatus during an
operation.
56. The apparatus of claim 55, further comprising a feedback means
for providing information to a user to avoid excess energy delivery
to tissue, wherein the feedback means is communicatively coupled
with the temperature sensor and configured to notify a user when a
temperature of tissue adjacent to the apparatus has reached a
predetermined threshold temperature.
57. The apparatus of claim 55, wherein the energy window is
positioned on the upper surface of the apparatus.
58. An apparatus for tissue separation, comprising: a handle; a
shaft positioned at a distal end of the handle; a tip positioned at
a distal end of the shaft, wherein the tip comprises a first
plurality of protrusions and a second plurality of protrusions,
wherein the first plurality of protrusions is positioned to at
least substantially extend in a first direction, wherein the second
plurality of protrusions is positioned to at least substantially
extend in a second direction distinct from the first direction,
wherein the first direction extends at least substantially along a
longitudinal axis of the shaft, and wherein the second direction
extends at an angle between zero degrees and 30 degrees of a normal
to the first direction; at least one lysing segment positioned
between at least two adjacent protrusions in the first plurality of
protrusions; and at least one lysing segment positioned between at
least two adjacent protrusions in the second plurality of
protrusions.
59. A method for separating and modifying tissue using a tissue
dissecting and modifying wand, the method comprising the steps of:
creating an incision into a patient's skin; inserting a tissue
dissecting and modifying wand into the incision, wherein the tissue
dissecting and modifying wand comprises: a tip comprising a
plurality of protrusions; at least one lysing segment positioned
between at least two adjacent protrusions among the plurality of
protrusions; a temperature sensor positioned on the tissue
dissecting and modifying wand and configured to sense a temperature
of at least one of tissue and fluid adjacent to the tissue
dissecting and modifying wand during an operation; and an antenna
positioned on the tissue dissecting and modifying wand and
configured to provide location data regarding a location of the
tissue dissecting and modifying wand during an operation; receiving
combined data from the tissue dissecting and modifying wand
generated from at least the temperature sensor and the antenna,
wherein the combined data allows a user to determine one or more
regions within a patient's body that have been sufficiently treated
using the tissue dissecting and modifying wand.
60. The method of claim 59, wherein the combined data allows a user
to visualize one or more regions within a patient's body that have
been sufficiently treated using the tissue dissecting and modifying
wand.
61. The method of claim 59, wherein the combined data comprises an
image corresponding with one or more regions of a patient's
body.
62. The method of claim 61, further comprising receiving
modifications to the image indicating regions of the patient's body
comprising tissue that has reached a predetermined threshold
temperature.
63. The method of claim 59, wherein the antenna comprises a
radiofrequency identification tag.
64. An apparatus for tissue separation, comprising: a shaft; a tip
positioned at a distal end of the shaft, wherein the tip comprises
a plurality of protrusions and a recessed region positioned between
at least a subset of the adjacent protrusions, wherein the recessed
region comprises means for delivering energy to separate tissue;
and an antenna positioned on apparatus and configured to provide
location data regarding a location of the apparatus during an
operation.
65. The apparatus of claim 64, wherein the antenna comprises a
radiofrequency identification tag.
66. The apparatus of claim 65, wherein the radiofrequency
identification tag comprises a passive tag.
67. The apparatus of claim 64, wherein the means for delivering
energy comprises at least one lysing segment.
68. A system for robotic tissue separation, comprising: an
apparatus for tissue separation, the apparatus comprising: a tip
positioned at a distal end of the shaft, wherein the tip comprises
a plurality of protrusions and a recessed region positioned between
at least a subset of the adjacent protrusions, wherein the recessed
region comprises means for delivering energy to separate tissue;
and a robotic arm configured to allow a surgeon to operate using
the apparatus indirectly, wherein the tip is positioned at a distal
end of the robotic arm; and a control element to allow a surgeon to
operate the robotic arm.
69. The system of claim 68, wherein the control element comprises
at least one of a hand control toggle, a keyboard, a mouse, a
touchscreen display, a virtual reality system, and a control
pad.
70. The system of claim 68, wherein the tip is removably positioned
on the robotic arm to allow for replacement of the tip with a new
tip.
71. The system of claim 68, wherein tip comprises a recessed region
positioned between each of the protrusions.
72. An apparatus for tissue separation, comprising: a shaft; a tip
positioned at a distal end of the shaft, wherein the tip comprises
a plurality of protrusions and a recessed region positioned between
at least a subset of the adjacent protrusions, wherein the recessed
region comprises means for delivering energy to separate tissue;
and a temperature sensor configured to sense a temperature of at
least one of tissue and fluid positioned adjacent to the apparatus
during an operation
73. The apparatus of claim 72, wherein the temperature sensor is
positioned along an upper surface of the apparatus.
74. The apparatus of claim 73, wherein the temperature sensor is
positioned along an upper surface of the tip.
75. The apparatus of claim 72, wherein the temperature sensor
comprises at least one of a carbon resistor, film thermometer,
wire-wound thermometer, coil element, thermocouple, pyrometer, and
photoelectric sensor.
76. A method for separating and modifying tissue using a tissue
dissecting and modifying wand, the method comprising the steps of:
creating an incision into a patient's skin; inserting a tissue
dissecting and modifying wand into the incision, wherein the tissue
dissecting and modifying wand comprises: a tip comprising a
plurality of protrusions; at least one lysing segment positioned
between at least two adjacent protrusions among the plurality of
protrusions; an energy window configured to deliver energy to
tissue adjacent to the tissue dissecting and modifying wand during
a procedure, wherein the energy window comprises an ultrasonic
energy emitter, wherein the ultrasonic energy emitter is configured
to emit ultrasound energy from the energy window, and wherein the
energy window is positioned and configured to deliver the heat
energy from the tissue dissecting and modifying wand to tissue
adjacent to the tissue dissecting and modifying wand during a
procedure; and an antenna positioned on the tissue dissecting and
modifying wand and configured to provide location data regarding a
location of the tissue dissecting and modifying wand during a
procedure; and receiving data from the tissue dissecting and
modifying wand generated from the antenna, wherein the data allows
a user to determine one or more regions within a patient's body
that have been treated using energy from the energy window.
77. A method for separating and modifying tissue using a tissue
dissecting and modifying wand, the method comprising the steps of:
creating an incision into a patient's skin; inserting a tissue
dissecting and modifying wand into the incision, wherein the tissue
dissecting and modifying wand comprises: a tip comprising a
plurality of protrusions; at least one lysing segment positioned
between at least two adjacent protrusions among the plurality of
protrusions; an energy window configured to deliver energy to
tissue adjacent to the tissue dissecting and modifying wand during
a procedure, wherein the energy window comprises an
impedance-matched microwave emission system; and an antenna
positioned on the tissue dissecting and modifying wand and
configured to provide location data regarding a location of the
tissue dissecting and modifying wand during a procedure; and
receiving data from the tissue dissecting and modifying wand
generated from the antenna, wherein the data allows a user to
determine one or more regions within a patient's body that have
been treated using energy from the energy window.
78. A method for separating and modifying tissue using a tissue
dissecting and modifying wand, the method comprising the steps of:
creating an incision into a patient's skin; inserting a tissue
dissecting and modifying wand into the incision, wherein the tissue
dissecting and modifying wand comprises: a tip comprising a first
plurality of protrusions and a second plurality of protrusions,
wherein the first plurality of protrusions is positioned to at
least substantially extend in a first direction, and wherein the
second plurality of protrusions is positioned to at least
substantially extend in a second direction distinct from the first
direction; at least one lysing segment positioned between at least
two adjacent protrusions in the first plurality of protrusions; at
least one lysing segment positioned between at least two adjacent
protrusions in the second plurality of protrusions; and an antenna
positioned on the tissue dissecting and modifying wand and
configured to provide location data regarding a location of the
tissue dissecting and modifying wand during a procedure; and
receiving data from the tissue dissecting and modifying wand
generated from the antenna, wherein the data allows a user to
locate the tissue dissecting and modifying wand during a procedure.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0001] The written disclosure herein describes illustrative
embodiments that are non-limiting and non-exhaustive. Reference is
made to certain of such illustrative embodiments that are depicted
in the figures, in which:
[0002] FIG. 1a is a perspective view of an embodiment of a tissue
dissector and modifier with an energy window on the upper side of
the device.
[0003] FIG. 1b is a side elevation view of the embodiment
previously depicted in FIG. 1a.
[0004] FIG. 1c is a front elevation view of the embodiment
previously depicted in FIG. 1a.
[0005] FIG. 1d is a front elevation view illustrating the
protrusions and lysing segment of an alternative embodiment of a
tissue dissector and modifier wherein the lysing segment connecting
the two protrusions is centered substantially midway between the
upper and lower portions of the protrusions.
[0006] FIG. 1e is a front elevation view illustrating the
protrusions and lysing segment of an alternative embodiment of a
tissue dissector and modifier, wherein the lysing segment
connecting the two protrusions is positioned above the midline
between the upper and lower portions of the protrusions.
[0007] FIG. 1f is a front elevation view illustrating the
protrusions and lysing segment of an alternative embodiment of a
tissue dissector and modifier, wherein the lysing segment
connecting the two protrusions is positioned below the midline
between the upper and lower portions of the protrusions.
[0008] FIG. 1g is a cross-sectional view of an embodiment of a TDM
illustrating some examples of some of the canals that may be used
with the device.
[0009] FIG. 2a is a perspective view of an embodiment of a tissue
dissector and modifier with a ultrasound-based energy window on the
upper side of the device.
[0010] FIG. 2b is a side elevation view of the embodiment
previously depicted in FIG. 2a.
[0011] FIG. 3a is a perspective view of an embodiment of a tissue
dissector and modifier with a
target-tissue-impedance-matched-microwave-based energy window on
the upper side of the device.
[0012] FIG. 3b is a side elevation view of the embodiment
previously depicted in FIG. 3a.
[0013] FIG. 3c is a front elevation view of some
target-tissue-impedance-matched-microwave-based energy window
components of an embodiment previously depicted in FIG. 3a.
[0014] FIG. 4a is a perspective view of an embodiment of a tissue
dissector and modifier without an energy window.
[0015] FIG. 4b is a side elevation view of the embodiment
previously depicted in FIG. 4a.
[0016] FIG. 5a is an upper plan view illustrating the protrusions
and lysing segments of an embodiment of a tissue dissector and
modifier, wherein some of the protrusions and lysing segments are
oriented in a non-axial direction and the non-axial protrusions do
not extend beyond the width of the distal shaft.
[0017] FIG. 5b is an upper plan view illustrating the protrusions
and lysing segments of an alternative embodiment of a tissue
dissector and modifier, wherein some of the protrusions and lysing
segments are oriented in a non-axial direction and some of the
non-axial protrusions extend beyond the width of the distal
shaft.
[0018] FIG. 5c is a lower plan view of the embodiment of FIG. 5a
illustrating the protrusions and lysing segments of a tissue
dissector and modifier, wherein some of the protrusions and lysing
segments are oriented in a non-axial direction and the non-axial
protrusions do not extend beyond the width of the distal shaft.
[0019] FIG. 5d is a lower plan view of the embodiment of FIG. 5b
illustrating the protrusions and lysing segments of a tissue
dissector and modifier, wherein some of the protrusions and lysing
segments are oriented in a non-axial direction and some of the
non-axial protrusions extend beyond the width of the distal
shaft.
[0020] FIG. 5e is an upper plan view illustrating the protrusions
and lysing segments of an embodiment of a tip area of a tissue
dissector and modifier.
[0021] FIG. 5f is an upper plan view illustrating the protrusions
and lysing segments of an alternative embodiment of a tip area of a
tissue dissector and modifier.
[0022] FIG. 5g is an upper plan view illustrating the protrusions
and lysing segments of an alternative embodiment of a tip area of a
tissue dissector and modifier.
[0023] FIG. 5h is a lower plan view illustrating the protrusions
and lysing segments of an alternative embodiment of a tip area of a
tissue dissector and modifier.
[0024] FIG. 6a is an upper plan view illustrating an embodiment of
a tissue dissector and modifier with an asymmetrical tip area,
wherein some of the protrusions and lysing segments are oriented in
a non-axial direction and the non-axial protrusions do not extend
beyond the width of the distal shaft.
[0025] FIG. 6b is an upper plan view illustrating another
embodiment of a tissue dissector and modifier with an asymmetrical
tip area, wherein some of the protrusions and lysing segments are
oriented in a non-axial direction and some the non-axial
protrusions extend beyond the width of the distal shaft.
[0026] FIG. 6c is an upper plan view illustrating the protrusions
and lysing segments of an embodiment of a tip area of a tissue
dissector and modifier, wherein the tip is asymmetrical.
[0027] FIG. 6d is an upper plan view illustrating the protrusions
and lysing segments of an embodiment of a tip area of a tissue
dissector and modifier, wherein the tip is asymmetrical.
[0028] FIG. 7a is a side view of a robotic surgery system
comprising a TDM.
[0029] FIG. 7b depicts an alternative robotic arm that may be used
with the system of FIG. 7a
[0030] FIG. 8 is a flow chart illustrating one implementation of a
method for energy delivery modulation via temperature
measurements.
[0031] FIG. 9 is a flow chart illustrating one implementation of a
method for accessing an organ using the TDM.
[0032] FIG. 10 is a flow chart of an implementation of a method for
separating and/or modifying tissue using a TDM.
DETAILED DESCRIPTION
[0033] The term dissection may indicate the separation of tissues
or of one tissue plane from another (ref: Free Online Medical
Dictionary). Some also consider dissection to comprise separation
of a single tissue into portions. Much of the bodies of animals and
humans are formed from embryonic fusion planes. Many of the organs
of the human body are categorized from the embryonic fusion planes
from whence they came. The interfaces between organs may often be
referred to as `tissue planes.` Such planes may be considered
substantially planar depending upon the size of a comparative
planar living or inanimate object (such as a surgical instrument).
As an example, a lobe of a human liver has a radius of curvature of
about 5 cm; however, compared to a surgical instrument of about 1
cm in width capable of separating tissue in a plane, the
curvilinear plane comprising the liver lobe may be `substantially`
planar and thus amenable to a tool capable of separating tissues in
a `substantially planar` fashion. Various vessels or ducts may also
traverse within a given organ thus providing for areas of
`substantially planar` boundaries even within a given organ.
Depending on the forces applied and/or available paths of least
resistance, the TDM may divide what may appear to be isodense
tissues. An example of separating isodense tissues may be
separating one lobe of liver from another lobe within that liver.
Depending on the density of a certain tumor, separation from the
involved organ may also be an isodense dissection/separation. The
TDM may perform the functions of sharp dissection, blunt dissection
and electrosurgical cutting and/or coagulation without a surgeon
having to switch instruments. Sharp dissection has been referred to
by some as separation of tissues by means of the sharp edge of a
knife or scalpel or with the inner sharp edge of scissors. Blunt
dissection has been defined by Webster as surgical separation of
tissue layers by means of an instrument without a cutting edge or
by the fingers. The term `Loose connective tissue` has been used to
refer to a category of connective tissue which includes areolar
tissue, reticular tissue, and adipose tissue. Loose connective
tissue is the most common type of connective tissue in vertebrates.
Loose connective tissue holds organs in place and attaches
epithelial tissue to other underlying tissues; it also surrounds
the blood vessels and nerves. Fibroblast cells are widely dispersed
in this tissue; they are irregular branching cells that secrete
strong fibrous proteins and proteoglycans as an extracellular
matrix. The cells of this type of tissue are generally separated by
quite some distance by a gel-like gelatinous substance primarily
made up of collagenous and elastic fibers. Loose connective tissue
is named based on the "weave" and type of its constituent fibers.
There are three main types: Collagenous fibers: collagenous fibers
are made of collagen and consist of bundles of fibrils that are
coils of collagen molecules. Elastic fibers: elastic fibers are
made of elastin and are "stretchable." Reticular fibers: reticular
fibers consist of one or more types of very thin collagen fibers;
these fibers join connective tissues to other tissues. (Reference:
Wikipedia). Areolar tissue (Latin for a little open space) is a
common type of connective tissue, and may also be referred to as
"loose connective tissue". It is strong enough to bind different
tissue types together, yet soft enough to provide flexibility and
cushioning. It exhibits interlacing loosely organized fibers,
abundant blood vessels, and significant low density space. Areolar
tissue fibers run in random directions and are mostly collagenous,
but elastic and reticular fibers are also present. Areolar tissue
is highly variable in appearance. In many serous membranes, it
appears as a loose arrangement of collagenous and elastic fibers,
scattered cells of various types, abundant ground substance, and
numerous blood vessels. In the skin and mucous membranes, areolar
tissue may be more compact and sometimes difficult to distinguish
from dense irregular connective tissue. Areolar tissue is the most
widely distributed connective tissue type in vertebrates. It is
sometimes equated with "loose connective tissue". In other cases,
"loose connective tissue" is considered a parent category that
includes mucous connective tissue, reticular connective tissue and
adipose tissue. It may be found in tissue sections from almost
every part of the body. It surrounds blood vessels and nerves and
penetrates with them even into the small spaces of muscles,
tendons, and other tissues. (wiki). Dr. Michael Kendrick, Surgeon
at Mayo Clinic, Rochester, says many Mayo surgeons today simply
refer to loose connective tissues between or within organs as
areolar tissue.
[0034] The term `minimally invasive surgery` has been used to
describe a procedure (surgical or otherwise) that is less invasive
than open surgery used for the same purpose. Some minimally
invasive procedures typically involve use of laparoscopic devices
and remote-control manipulation of instruments with indirect
observation of the surgical field through an endoscope or similar
device, and are carried out through the skin or through a body
cavity or anatomical opening. This may result in shorter hospital
stays, or allow outpatient treatment (reference: Wikipedia).
[0035] Various implementations of methods are disclosed herein for
dissecting and modifying various living tissues. The term
`modifying` in this context may refer to or may encompass
application of energy to tissue using one or more lysing segments
as discussed herein. The term `modifying` in this context may also
refer to application of energy to tissue by way of an energy window
as also described herein. Such methods may be performed using a
Tissue Dissecting and Modifying Wand ("TDM"). Examples of various
embodiments of such wands may be found in U.S. Pat. No. 6,203,540
titled "Ultrasound and Laser Face-Lift and Bulbous Lysing Device,"
U.S. Pat. No. 6,391,023 titled "Thermal Radiation Facelift Device,"
U.S. Pat. No. 6,432,101 titled "Surgical Device for Performing
Face-Lifting Using Electromagnetic Radiation," U.S. Pat. No.
6,440,121 titled "Surgical Device For Performing Face-Lifting
Surgery Using Radiofrequency Energy," U.S. Pat. No. 6,974,450
titled "Face-Lifting Device," and U.S. Pat. No. 7,494,488 titled
"Facial Tissue Strengthening and Tightening Device and Methods."
The "Detailed Description of the Invention" section of each of
these patents is hereby incorporated herein by specific reference.
With respect to U.S. Pat. No. 6,203,540 titled "Ultrasound and
Laser Face-Lift and Bulbous Lysing Device," the section titled
"Description of the Preferred Embodiments" is hereby incorporated
herein by specific reference.
[0036] Tissues or organs or tumors treated with the TDM may also
undergo post traumatic collagen deposition or scarring. Thermal
damage to collagen is likely brought about by hydrolysis of
cross-linked collagen molecules and reformation of hydrogen bonds
resulting in loss of portions or all of the characteristic collagen
triple-helix. New collagen formed as the result of trauma and some
diseases is technically scar tissue. The encroachment of post
traumatically derived collagen may influence already traumatized
dissected tissue.
[0037] Some tissues of the body are of varying sensitivity to
electrosurgical energy. Modulation and feedback may be helpful for
such tissues. For example, some liver tumors or tissues may allow
heating to temperature ranges higher than temperatures that
typically be involved in facial rejuvenation procedures In some
implementations, liver tumors or tissues may be operated upon by
heating the tissue to a temperature range of about 72-85.degree.
C.
[0038] The TDM may dissect tissue planes of dissimilar density as
well as isodense tissue planes. The TDM may also dissect different
types of tissues from one another as well as dissect within an
organ. It is possible that the cutting segments alone may
traumatize or lyse portions of tissues sufficiently to carry out a
given surgical method or procedure. It is also possible that when
electrically energized with electro-cutting current, the TDM may
possess a plasma field that may traumatize certain tumor cells in a
potentially lethal fashion. The TDM may be "energized" by various
forms of energy in its top side energy window, as described in
greater detail below. Such energy absorptions may result in the
formation of heat which may, in turn, damage tumor or other tissue
cells themselves, and/or their surrounding environment in order to
achieve a desired effect of a surgical method or procedure.
[0039] In some embodiments, energy may be delivered from one or
more energy windows so as to heat tissue to a temperature of about
72.degree. C. to about 80.degree. C. Various methods may therefore
be implemented in which the amount of energy and/or the delivery
time may be adjusted so as to heat the tissue to within a desired
temperature range. Temperature sensors may therefore be
incorporated on or near the energy windows to allow a surgeon to
heat the tissue to a desired temperature or within a desired
temperature range. In some embodiments, the sensor may be
configured to provide an average temperature over a particular
period of time and or over a particular range of distances within
the tissue. Systems consistent with the disclosure provided herein
may be configured to prevent or to shut down or otherwise limit
energy transfer if a particular tissue temperature were beyond a
threshold or alternatively if an average temperature threshold is
reached.
[0040] Temperature sensors that may be useful in connection with
embodiments disclosed herein include, but are not limited to,
resistance temperature sensors, such as carbon resistors, film
thermometers, wire-wound thermometers, or coil elements. Some
embodiments may comprise thermocouples, pyrometers, or non-contact
temperature sensors, such as total radiation or photoelectric
sensors. In some embodiments, one or more temperature sensors may
be coupled with a processor and/or a monitor to allow a surgeon to
better visualize or otherwise control the delivery of energy to
selected areas of target tissue. For example, some embodiments may
be configured such that a surgeon can visualize the temperature of
tissue positioned adjacent to one or more locations along the TDM
to ensure that such temperatures are within a desired temperature
range. Some embodiments may alternatively, or additionally, be
configured such that one or more temperature sensors are coupled
with a processor in a feedback loop such that energy delivery may
be automatically adjusted by the system in response to temperature
data. For example, when temperatures exceed a particular threshold,
such as somewhere between about 65.degree. C. and about 90.degree.
C., the system may be configured to shut down or otherwise limit
further energy delivery. In some such embodiments, the threshold
may be between about 68.degree. C. and about 75.degree. C.
[0041] Some embodiments may comprise a feedback means, such as a
visual, audible, or tactile feedback means, to provide information
to a user to avoid excess energy delivery to tissues. In some
embodiments, the feedback means may be configured to notify the
surgeon when the temperature has reached a particular threshold. In
some embodiments, the feedback means may be configured to notify
the surgeon when the TDM has been positioned in a particular
location within the target region for a particular time period.
Examples of visual feedback means include LED lights, LASERS,
visual light source, display screen, etc. Examples of audible
feedback means include speakers, alarms, audible vibration, etc.,
Examples of tactile feedback means include vibration, minimal
electrical shock, heat, etc. The feedback means may be configured
with multiple thresholds with different feedback at each threshold.
For example, at a first threshold, the TDM may be configured to
deliver a first noise and at a second threshold the TDM may be
configured to deliver a second noise. The second noise may be
louder than the first noise to indicate a greater urgency for
changing the energy delivery and/or moving the TDM from its current
location within a patient's body. In some embodiments, an
antenna(s) may be present on the shaft or tip of the TDM. In some
embodiments, a camera or fiberoptic may gather optical data to
allow the surgeon knowledge of the placement of the TDM.
[0042] In some implementations of methods according to the present
disclosure, the TDM may be used to induce post-surgical collagen
deposition and/or an inflammatory tissue reaction in the target
zone. Some procedures intended to increase post-surgical collagen
deposition, for example, around a mesh implant, using the TDM are
done by delivering energies of about 20 J/cm.sup.2. By contrast, in
certain preferred implementations of methods for increasing
post-surgical collagen deposition using the TDM, a higher energy
delivery may be employed than 20 J/cm.sup.2. For example, some
implementations for increasing post-surgical collagen deposition
may be performed by delivering energy at a level 20% or more than
20 J/cm.sup.2.
[0043] Further details regarding various embodiments will now be
provided with reference to the drawings.
[0044] FIG. 1a is a perspective view of an embodiment of a TDM with
an electrosurgically energized energy window 107 on the upper side
of the device. It should be noted that the term "energy window" is
intended to encompass what is referred to as a
planar-tissue-altering-window/zone in U.S. Pat. No. 7,494,488 and,
as described later, need not be electrosurgically energized in all
embodiments. In some embodiments, the "energy window" may comprise
a variety of other energy emitting devices, including
radiofrequency, intense pulsed light, LASER, thermal, microwave and
ultrasound. It should also be understood that the term "energy
window" does not necessarily imply that energy is delivered
uniformly throughout the region comprising the energy window.
Instead, some energy window implementations may comprise a series
of termini or other regions within which energy is delivered with
interspersed regions within which no energy, or less energy, is
delivered. This configuration may be useful for some
implementations to allow for alteration of certain tissue areas
with interspersed areas within which tissue is not altered, or at
least is less altered. This may have some advantages for certain
applications due to the way in which such tissue heals. It is
contemplated that in alternative embodiments, electronically
energized energy window 107 may be omitted.
[0045] FIG. 1a is a perspective view of an embodiment of a TDM
comprising a tip 101, a shaft 102 and a handle 103.
[0046] Electro-coagulation and electro-cutting energy arrives in
electrical conduits 111 and/or 112 and may travel by wiring through
the handle and shaft to termini 107a, which are part of energy
window 107. Electro-cutting and electro-coagulation currents may be
controlled outside the TDM at an electrosurgical generator, such as
the Bovie Aaron 1250.TM. or Bovie Icon GP.TM..
[0047] In the depicted embodiment, energy window 107 comprises an
electrosurgical energy window. In the depicted embodiment, energy
window 107 comprises one or more electrosurgical elements. In the
depicted embodiment, energy window 107 comprises one or more hollow
protruding ceramic termini 107a atop a nonconductive ceramic plate;
one or more conductive metal pins pass may through the hollow
termini and may be electrically connected to electrical leads which
may pass through said conduits. In the depicted embodiment, the
metal pins, of termini 107a, comprise surgical stainless steel
pins. In an alternative embodiment, the metal pins comprise an
electroconductive coating such as for example, Silverglide.RTM.
coating (from Stryker, Silverglide.RTM. Surgical, Kalamazoo, Mich.,
USA) and/or gold and/or titanium nitride (Strem Chemicals Inc.,
Newburyport, Mass., USA). Such electroconductive coats may reduce
carbonized debris build up and enhance electrical transmission into
target tissues. In the depicted embodiment, nonconductive hollow
ceramic termini 107a protrude about 2 mm above the plane of energy
window 107, which is flush with the plane of tip 101 and shaft 102.
In some embodiments, energy window 107 may protrude above the plane
of tip 101 and/or shaft 102. In an embodiment energy window 107 may
measure about 10 mm.times.15 mm. In some embodiments, energy window
107 may lie below the plane of tip 101 and/or shaft 102. In
contemplated embodiments, nonconductive hollow ceramic termini 107a
may protrude a range of about 0.5 mm-20 mm above the plane of the
energy window. In the depicted embodiment, one or more holes in
termini 107a measure about 1.5 mm in diameter and/or conductive
pins measure 1.2 mm in diameter. In the depicted embodiments,
electrocoagulation current reaches metallic termini 107a of window
107 from a standard hospital electrosurgical generator. Such
standard electrosurgical generators, which may be used to power an
electrosurgical energy window, may include those manufactured by
Bovie Medical, i.e. Model Aaron1250 and IconGP (Clearwater, Fla.,
USA) and/or Valleylab/Covidian Model Surgistat 2 (Boulder, Colo.)
and/or Erbe Electrosurgical (Tubingen, Germany) etc. Such
electrosurgical generators may have a maximal output power that may
range from about 80 W to 120 W. In some implementations for
electrosurgical energy window settings, said electrosurgical
generators are operated on a `Coag/Coagulation` power setting of
20-80% of maximal output while the TDM is motionless and/or moved
by the surgeon. In some implementations, the TDM is moved at about
1 cm per second by the surgeon. In some implementations the
electrocoagulation energy reaching electrosurgical energy window is
pulsed at a rate ranging from about 20 cycle per second to 50
cycles per second. In some implementations the electrocoagulation
energy reaching electrosurgical energy window is pulsed at rates
ranging from about 1 cycle per second to 200 cycles per second. In
some embodiments, the electrosurgically energized window current
can be further pulsed at varying rates, by interpolating gating
circuitry at some point external to the electrosurgical generator
by standard mechanisms known in the art. In some embodiments, the
electrosurgically energized window current can be further pulsed at
varying rates by gating circuitry within the electrosurgical
generator by standard mechanisms known in the art.
[0048] In some embodiments, the electrosurgical energy window 107
may be located on shaft 102. In alternative contemplated
embodiments, the electrosurgical energy window 107 comprises an
electroconductive plate with termini, encased by an electrical
insulator coat except at one or more points on termini. In some
embodiments termini are pressed into the electroconductive plate.
In some embodiments the electroconductive plate comprises a metal
plate and/or a cermet. In an embodiment, the metal plate comprises
surgical stainless steel. In some embodiments, the
electroconductive plate and/or termini may be directly coated with
an electroconductive coating such as for example, Silverglide.RTM.
coating (from Stryker, Silverglide.RTM. Surgical, Kalamazoo, Mich.,
USA) and/or gold and/or titanium nitride (Strem Chemicals Inc.,
Newburyport, Mass., USA). In some embodiments the electroconductive
plate may be coated with an electrically insulating coat. In some
embodiments, an electroconductive coat is placed upon the
electroconductive plate before an insulating coat. In some
embodiments, the electrical insulator comprises a nonconductive
anti-stick polymer such as polytetrafluroethylene. In some
embodiments a nonconductive coating may cover an electroconductive
place ranging from about 90% coverage to 98% coverage. In other
embodiments coverage may range from about 5% to about 90%. In
another embodiment, the insulated electroconductive plate may be
substantially planar and may comprise one or more defects in the
insulating surface coating which may allow one or more exit points
for electrons (electrosurgical energy). In some embodiments, the
geometry of one or more of such defects is circular and/or square
and/or triangular and/or geometric in shape. In some embodiments,
the diameter of the geometric defect in the insulating layer
covering may range from about 1 mm to about 20 mm In some
embodiments, the defects may form a pattern.
[0049] In an embodiment, the tip may measure about 1 cm in width
and about 1-2 mm in thickness. Sizes of about one-fifth to about
five times these dimensions may also have possible uses. In some
veterinary embodiments, tip sizes of about one-tenth to 20 times
the aforementioned dimensions may also have possible uses. In some
embodiments, the tip can be a separate piece that is secured to
shaft by a variety of methods such as a snap mechanism, mating
grooves, plastic sonic welding, etc. Alternatively, in some other
embodiments, the tip can be integral or a continuation of shaft
made of similar metal or materials. In some embodiments, the tip
may also be constructed of materials that are both electrically
non-conductive and of low thermal conductivity; such materials
might comprise, for example, porcelain, ceramics, glass-ceramics,
plastics, varieties of polytetrafluoroethylene, carbon, graphite,
and graphite-fiberglass composites.
[0050] In some embodiments, the tip may be constructed of a support
matrix of an insulating material (e.g., ceramic or glass material
such as alumina, zirconia). External conduits 111 and/or 112 may
connect to electrically conductive elements to bring RF
electrosurgical energy from an electrosurgical generator down the
shaft 102 to electrically conductive lysing elements 105 mounted in
the recessions in between the protrusions 104. In some embodiments,
the protrusions may comprise bulbous protrusions. The tip shown in
this embodiment has four relative protrusions and three relative
recessions and provides for a monopolar tip conductive element. All
of the axes of the relative protrusions of the tip depicted in this
embodiment extend at least substantially parallel to the axis of
the shaft of the TDM (as viewed from Top). In embodiments of tips
of such axial placement of protrusions and or relative recessions,
surgeons may use methods of defining and or dissecting a target
area by entering through an incision and then moving the TDM tip in
a primarily axial direction forward and backward and reorienting
the TDM after the backstroke in a spokewheel pattern the TDM to
access tissues adjacent to earlier strokes.
[0051] In the depicted embodiment, the tip 101 may alternatively be
made partially or completely of concentrically laminated or
annealed-in wafer layers of materials that may include plastics,
silicon, glass, glass/ceramics, cermets or ceramics. Lysing
elements 105 may also be made partially or completely of a cermet
material. Alternatively, in a further embodiment the tip may be
constructed of insulation covered metals or electroconductive
materials. In some embodiments, the shaft may be flat, rectangular
or geometric in cross-section or substantially flattened. In some
embodiments, smoothing of the edges of the shaft may reduce
friction on the skin surrounding the entrance wound. In some
further embodiments, the shaft may be made of metal or plastic or
other material with a completely occupied or hollow interior that
can contain insulated wires, electrical conductors, fluid/gas
pumping or suctioning conduits, fiber-optics, or insulation. In
some embodiments the shaft may have a length of about 10-20 cm. In
some embodiments the handle may have a length of about 8-18 cm.
[0052] In some embodiments, shaft plastics, such as
polytetrafluoroethylene may act as insulation about wire or
electrically conductive elements. In some embodiments, the shaft
may alternatively be made partially or completely of concentrically
laminated or annealed-in wafer layers of materials that may include
plastics, silicon, glass, glass/ceramics, ceramics carbon,
graphite, graphite-fiberglass composites. Depending upon the
intended uses for the device, an electrically conductive element
internal to shaft may be provided to conduct electrical impulses or
RF signals from an external power/control unit (such as a
Valleylab.TM. electrosurgical generator) to another energy window
108. In some embodiments, energy windows 107 and/or 108 may only be
substantially planar, or may take on other cross-sectional shapes
that may correspond with a portion of the shape of the shaft, such
as arced, stair-step, or other geometric shapes/curvatures. In the
embodiments depicted in FIGS. 1a & 1b, energy window 107 is
adjacent to protrusions 104, however other embodiments are
contemplated in which an energy window may be positioned elsewhere
on the shaft 102 or tip 101 of the wand, and still be considered
adjacent to protrusions 104. For example, in an embodiment lacking
energy window 107, but still comprising energy window 108, energy
window 108 would still be considered adjacent to protrusion 104.
However, if an energy window was placed on handle 103, such an
energy window would not be considered adjacent to the protrusions
104.
[0053] The conduit may also contain electrical control wires to aid
in device operation. Partially hidden from direct view in FIGS. 1a
& 1b, and located in the grooves defined by protrusions 104 are
electrically conductive tissue lysing elements 105, which, when
powered by an electrosurgical generator, effects lysing of tissue
planes on forward motion of the device. The lysing segments may be
located at the termini of conductive elements. In some embodiments,
one or more sensors such as for example sensors 110 and 114 may be
positioned on the device. The sensors 110 and 114 may comprise any
of the sensors described in the specification herein. Other
embodiments may comprise one or more sensors on any other suitable
location on the TDM, including but not limited to on the
protrusions or otherwise on the tip, and on the shaft. Sensors that
may be useful include thermal sensors, photoelectric or photo optic
sensors, cameras, etc. In some embodiments, one or more sensors may
be used to monitor the local post passage electrical impedance or
thermal conditions that may exist near the distal tip of the shaft
or on the tip. Some embodiments may also comprise one or more
sensors incorporating MEMS (Micro Electro-Mechanical Systems)
technology, such as MEMS gyroscopes, accelerometers, and the like.
Such sensors may be positioned at any number of locations on the
TDM, including within the handle in some embodiments. In some
embodiments, sensor 114 may comprise fiberoptic elements. In an
embodiment, the sensor can be configured to sense a temperature of
tissue adjacent to the apparatus. The temperature sensor may
alternatively be configured or sense a temperature of one or more
fluids adjacent to the apparatus such as for example tissue fluids
and/or fluids introduced by the surgeon.
[0054] Temperature and impedance values may be tracked on a display
screen or directly linked to a microprocessor capable of signaling
control electronics to alter the energy delivered to the tip when
preset values are approached or exceeded. Typical instrumentation
paths are widely known, such as thermal sensing thermistors, and
may feed to analog amplifiers which, in turn, feed analog digital
converters leading to a microprocessor. In some embodiments,
internal or external ultrasound measurements may also provide
information which may be incorporated into a feedback circuit. In
an embodiment, an optional mid and low frequency ultrasound
transducer may also be activated to transmit energy to the tip and
provide additional heating and may additionally improve lysing. In
some embodiments, a flashing visible light source, for example, an
LED, can be mounted on the tip may show through the tissues and/or
organs to identify the location of the device.
[0055] In some embodiments, one or more electromagnetic delivery
elements 115 may be positioned on tip or shaft. Other embodiments
may comprise one or more electromagnetic delivery elements on any
other suitable location on the TDM, including but not limited to on
the protrusions or otherwise on the tip, and on the shaft.
Electromagnetic delivery elements that may be useful include: LEDs,
LASERs, fiberoptics, filaments, photoelectric materials, infrared
emitters, etc.
[0056] Some embodiments may comprise a low cost, disposable, and
one-time-use device. However, in some embodiments intended for
multiple uses, the tip's electrically conductive tissue lysing
elements be protected or coated with materials that include, but
are not limited to, Silverglide.TM. non-stick surgical coating,
platinum, palladium, gold and rhodium. Varying the amount of
protective coating allows for embodiments of varying potential for
obsolescence capable of either prolonging or shortening instrument
life.
[0057] In some embodiments, the electrically conductive lysing
element portion of the tip may arise from a plane or plate of
varying shapes derived from the aforementioned materials by methods
known in the manufacturing art, including but not limited to
additive manufacturing, cutting, stamping, pouring, molding, filing
and sanding. In some embodiments, the electrically conductive
lysing element 105 may comprise an insert attached to a conductive
element in the shaft or continuous with a formed conductive element
coursing all or part of the shaft. In some embodiments, one or more
electrically conductive elements or wiring in conduit 111 and/or
112 brings RF electrosurgical energy down the shaft to electrically
conductive lysing elements 105 associated in part with the
recessions. In an embodiment, the electrosurgical energy via
conduit 111 is predominately electro-cutting and/or a blend.
[0058] In some embodiments, the electrically conductive element or
wiring may be bifurcated to employ hand switching if an optional
finger switch is located on handle. The electrically conductive
element or wiring leading from the shaft into the handle may be
bundled with other electrical conduits or energy delivering cables,
wiring and the like and may exit the proximal handle as insulated
general wiring to various generators (including electrosurgical),
central processing units, lasers and other sources as have been
described herein. In some embodiments, the plate making up lysing
segments 105 may be sharpened or scalloped or made to slightly
extend outwardly from the tip recessions into which the plate will
fit.
[0059] Alternatively, in some embodiments, since cutting or
electrical current may cause an effect at a distance without direct
contact, the lysing element may be recessed into the relative
recessions or grooves defined by the protrusions 104 or,
alternatively, may be flush with protrusions 104. In some further
adjustable embodiments, locations of the electrically conductive
lysing elements with respect to the protrusions may be adjusted by
diminutive screws or ratchets. In some further adjustable
embodiments, locations of the electrically conductive lysing
elements with respect to the protrusions may be adjusted by MEMS or
microelectronics. The plate, which in some embodiments is between
0.01 mm and 1 mm thick, can be sharpened to varying degrees on its
forward facing surface. It is possible that plate sharpness may
increase the efficiency with which electricity will pass from the
edge cutting the target tissue. Sometimes, however, proper function
even when variably dull or unsharpened may be unhampered since
electrosurgical cutting current may cut beyond the
electroconductive edge by a distance of over 1 mm. In some
embodiments, the plate thickness may vary from 0.001 mm to 3 mm
thick.
[0060] In some embodiments, the electrically conductive lysing
element may also exist in the shape of a simple wire of 0.1 mm and
1 mm 0.01 mm to 3 mm. In some embodiments, the wire may measure
between 0.01 mm to 3 mm. Such a wire may be singly or doubly
insulated as was described for the plate and may have the same
electrical continuities as was discussed for the planar (plate)
version. In some embodiments, an electrosurgical current for the
electrically conductive lysing element is of the monopolar
"cutting" variety and setting and may be delivered to the tip
lysing conductor in a continuous fashion or, alternatively, a
pulsed fashion. The surgeon can control the presence of current by
a foot pedal control of the electrosurgical generator or by button
control on the shaft (forward facing button). The amount of cutting
current may be modified by standard interfaces or dials on the
electrosurgical generator. For some embodiments, the electrically
conductive lysing element is a monopolar tip in contact with
conductive elements in the shaft leading to external surgical cable
leading to an electrosurgical generator from which emanates a
grounding or dispersive plate which may be placed elsewhere in
contact with the patient's body, such as the thigh. Such circuitry
may be controlled and gated/wired from the cutting current delivery
system of the electro surgical generator. In an embodiment, the tip
may also be manufactured from multilayer wafer substrates comprised
of bonded conductive strips and ceramics. Suitable conductive
materials include but are not limited to those already described
for tip manufacture.
[0061] In alternative embodiments, the electrically conductive
lysing elements may be bifurcated or divided into even numbers at
the relative recessions, insulated and energized by wiring to an
even number of electrical conduits in a bipolar fashion and
connected to the bipolar outlets of the aforementioned
electrosurgical generators. Rings partly or completely encircling
the shaft of the hand unit can be linked to a partner bipolar
electrode at the tip or on the energy window. Such bipolar versions
may decrease the available power necessary to electrically modify
certain tissues, especially thicker tissues. In alternative
embodiments, the lysing elements may be divided into odd numbers
yet still allow for bipolar flow between two or more elements as
those of ordinary skill in the art would appreciate.
[0062] FIG. 1b is a side elevation view of the embodiment
previously depicted in FIG. 1a. In the depicted embodiment, tip 101
may be made of materials that are both electrically non-conductive
and of low thermal conductivity such as porcelain, epoxies,
ceramics, glass-ceramics, plastics, or varieties of
polytetrafluoroethylene. Alternatively, the tip may be made from
metals or electroconductive materials that are completely or
partially insulated. Note the relative protrusions and relative
recessions are not completely visible from this viewing angle. In
some embodiments, the relative recessions of the tip is the
electrically conductive tissue lysing element 105 (usually hidden
from view at most angles) which may have any geometric shape
including a thin cylindrical wire; the electrically conductive
lysing element can be in the shape of a plate or plane or wire and
made of any metal or alloy that does not melt under operating
conditions or give off toxic residua. Optimal materials may include
but are not limited to steel, nickel, alloys, palladium, gold,
tungsten, silver, copper, and platinum. Metals may become oxidized
thus impeding electrical flow and function. In alternative
embodiments the geometry of the tip area may comprise protrusions
that are not oriented along the axis of the shaft (as seen from a
top view); some of these alternative embodiments for tip area
geometries are depicted in FIGS. 5a,b,c,d,e,f,g,h and FIGS.
6a,b,c,d. Some embodiments may be configured to be modular and/or
comprise disposable tips such that a surgeon can place an
appropriate tip for a particular surgery on the shaft.
Alternatively or additionally one or more of the tips may be
disposable such that a surgeon may dispose of the tip after
performing surgery and install a new tip for subsequent surgeries
or a continuation of the current surgery with a new tip.
[0063] In some embodiments, one or more suction/vacuum ports 117
may be provided on or about the tip or distal shaft. The port(s)
may be fluidly coupled with a vacuum; the vacuum may comprise a
pump or a negative pressure chamber or a syringe at the end of a
fluid conduit. Other embodiments may comprise one or more
suction/vacuum ports on any other suitable location on the TDM,
including but not limited to on the protrusions or otherwise on the
tip, and on the shaft. In some embodiments, a fluid delivery port
116 may be provided. In some embodiments the fluid delivery port
may be coupled with a pump or high pressure fluid. In some
embodiments the port may be perpetually open such that fluid may be
delivered therethrough upon actuation of a pump or fluid pressure
system. In other embodiments the port may be closed and selectively
opened to deliver fluid therethrough. Other embodiments may
comprise one or more fluid ports on any other suitable location on
the TDM, including but not limited to on the protrusions or
otherwise on the tip, and on the shaft. Fluid ports that may be
useful may comprise channels within the TDM, polymer lines, hoses,
etc. Fluids that may emanate from the outlet may comprise ionic
fluids such as saline, medicines (including but not limited to
antibiotics, anesthetics, antineoplastic agents, bacteriostatic
agents, etc.), non-ionic fluids, and or gasses (including but not
limited to nitrogen, argon, air, etc.). In some embodiments fluids
may be under higher pressures or sprayed. It should be understood
that although these elements (116 & 117) are not depicted in
every one of the other figures, any of the embodiments described
herein may include one or more such elements.
[0064] In some embodiments, a vibration means 170b may be
positioned in the handle. Other embodiments may comprise one or
more vibration means on any other suitable location on the TDM,
including but not limited to on the protrusions or otherwise on the
tip, and on the shaft. Examples of suitable vibration means may
include piezoelectric materials, ultrasonic motors with stators,
piezoelectric actuators, vibration motor such as an off-center
weight mounted on a gear, etc. Some vibration means may be
configured to emit ultrasound in the 20-40 kHz range. Yet other
vibration means may include electromagnet drivers with a frequency
of operation in the range of 150-400 Hz. In some embodiments, one
or more vibration means may be used to provide additional forces
which may facilitate passage of the TDM. In some embodiments, one
or more vibration means may be used to reduce debris on the
electrosurgical or other components of the TDM. In a further
embodiment, a vibration means may be directly or indirectly
connected to one or more of the lysing segments. Some vibration
means may help to decrease and/or remove debris. In some
embodiments use of a vibration means may, also or alternatively, be
used to assist in migrating the TDM through tissue during the
procedure. In some such embodiments, it is thought that use of a
vibration means having a lower frequency may be particularly useful
for assisting in such migration. In addition, positioning the
vibration means closer to a handle of the TDM may facilitate such
migration as well. By contrast, positioning the vibration means on
or near the tip, and/or using a higher frequency vibrations means
may be particularly useful for preventing buildup of debris on the
tip.
[0065] In the depicted embodiment, 118 represents an antenna
configured to deliver a signal to a receiver unit. In some
embodiments, antenna 118 may comprise a radiofrequency
identification (RFID) TAG. In some embodiments the RFID tag may
comprise an RFID transponder. In other embodiments the RFID tag may
comprise a passive tag. It should be understood that antenna 118 is
not depicted in every one of the other figures, any of the
embodiments described herein may comprise one or more such
elements. Other embodiments may comprise one or more antenna on any
other suitable location on the TDM, including but not limited to on
the protrusions or otherwise on the tip, and on the shaft. In
embodiments in which antenna 118 comprises an RFID transponder, the
RFID transponder may comprise a microchip, such as a microchip
having a rewritable memory. In some embodiments, the tag may
measure less than a few millimeters. In some embodiments a reader
may generate an alternating electromagnetic field which activates
the RFID transponder and data may be sent via frequency modulation.
In an embodiment, the position of the RFID tag or other antenna may
be determined by an alternating electromagnetic field in the
ultra-high frequency range. The position may be related to a 3
dimensional mapping of the subject. In an embodiment the reader may
generate an alternating electromagnetic field. In some such
embodiments, the alternating electromagnetic field may be in the
shortwave (13.56 MHz) or UHF (865-869 MHz) frequency. Examples of
potentially useful systems and methods for mapping/tracking a
surgical instrument in relation to a patient's body may be found in
U.S. Patent Application Publication No. 2007/0225550 titled "System
and Method for 3-D Tracking of Surgical Instrument in Relation to
Patient Body", which is hereby incorporated by reference in its
entirety.
[0066] In some embodiments, a transmission unit may be provided
that may generate a high-frequency electromagnetic field configured
to be received by an antenna of the RFID tag or another antenna.
The antenna may be configured to create an inductive current from
the electromagnetic field. This current may activate a circuit of
the tag, which may result in transmission of electromagnetic
radiation from the tag. In some embodiments, this may be
accomplished by modulation of the field created by the transmission
unit. The frequency of the electromagnetic radiation emitted by the
tag may be distinct from the radiation emitted from the
transmission unit. In this manner, it may be possible to identify
and distinguish the two signals. In some embodiments, the frequency
of the signal from the tag may lie within a side range of the
frequency of the radiation emitted from the transmission unit.
Additional details regarding RFID technology that may be useful in
connection with one or more embodiments discussed herein may be
found in, for example, U.S. Patent Application Publication No.
2009/0281419 titled "System for Determining the Position of a
Medical Instrument," the entire contents of which are incorporated
herein by specific reference.
[0067] In other embodiments, antenna 118 may comprise a Bluetooth
antenna. In such embodiments, multiple corresponding Bluetooth
receivers at known locations may be configured to sense signal
strengths from the Bluetooth antenna 118 and triangulate such data
in order to localize the signal from the Bluetooth antenna 118 and
thereby locate the TDM within a patient's body. Other embodiments
may be configured to use angle-based, electronic localization
techniques and equipment in order to locate the antenna 118. Some
such embodiments may comprise use of directional antennas, which
may be useful to increase the accuracy of the localization. Still
other embodiments may comprise use of other types of hardware
and/or signals that may be useful for localization, such as WIFI
and cellular signals, for example.
[0068] One or more receiver units may be set up to receive the
signal from the tag. By evaluating, for example, the strength of
the signal at various receiver units, the distances from the
various receiver units may be determined. By so determining such
distances, a precise location of the TDM relative to a patient
and/or a particular organ or other surgical site on the patient may
be determined. In some embodiments, a display screen with
appropriate software may be coupled with the RFID or other
localization technology to allow a surgeon to visualize at least an
approximate location of the tag/antenna, and therefore TDM,
relative to the patient's body.
[0069] Some embodiments may be further configured such that data
from the antenna(s) may be used in connection with sensor data from
the TDM. For example, some embodiments of TDMs comprising one or
more sensors may be further configured with one or more RFID tags.
As such, data from the one or more sensors may be paired or
otherwise used in connection with data from the one or more RFID
tags or other antennas. For example, some embodiments may be
configured to provide information to a surgeon regarding one or
more locations on the body from which one or more sensor readings
were obtained. To further illustrate using another example,
information regarding tissue temperature may be combined with a
location from which such tissue temperature(s) were taken. In this
manner, a surgeon may be provided with specific information
regarding which locations within a patient's body have already been
treated in an effective manner and thus which locations need not
receive further treatment using the TDM.
[0070] In some such embodiments, a visual display may be provided
comprising an image of the patient's body and/or one or more
selected regions of a patient's body. Such a system may be
configured so as to provide a visual indication for one or more
regions within the image corresponding to regions of the patient's
tissue that have been sufficiently treated. For example, a display
of a patient's liver may change colors at locations on the display
that correspond with regions of the liver that have experienced a
sufficient degree of fibrosis or other treatment. Such regions may,
in some embodiments, be configured such that pixels corresponding
to particular regions only light up after the corresponding tissue
in that region reaches a particular threshold temperature.
[0071] Such sensors 110 and/or 114, 210 and/or 214, 310 and/or 314,
410 and/or 414, 510a and/or 514a, 510b and/or 514b, 610a and/or
614a, 610b and/or 614b, may be coupled with an antenna, which may
send and/or receive one or more signals to/from a processing unit.
Alternatively, or additionally, data from such sensors resulting
from tissue and/or fluid analysis using such sensors may be stored
locally and transmitted later. As yet another alternative, such a
signal may be transmitted following surgery. In such
implementations, the signals need not necessarily be transmitted
wirelessly. In fact, some embodiments may be configured to store
data locally, after which a data module, such as a memory stick,
may be removed from the TDM and uploaded to a separate computer for
analysis.
[0072] In some embodiments tip 101 may be attached to a robotic
arm. In some embodiments, tip 101 and portion of shaft 102 may be
attached to a robotic arm. In some embodiments tip 101 and/or a
portion of shaft 102 and/or a portion shaft and/or portion of
handle 103 may be attached to a robotic arm. In some embodiments,
the robotic arm may comprise one or more motors such as a
screw-drive motor, gear motor, hydraulic motors, etc. In some
embodiments the robotic arm system may comprise worm gearheads,
video cameras, motor control circuits, monitors, remote control
devices, illumination sources, tactile interface, etc.
[0073] FIG. 1c is a front elevation view of an embodiment of the
embodiment previously depicted in FIG. 1a. In this depicted
embodiment, there are 4 protrusions and 3 lysing segment recessions
105c; the vertical height of a protrusion may be about 3 mm and the
horizontal width may be about 2 mm. In this depicted embodiment,
the relatively oval protrusions 104c may be shaped similarly to a
commercial jetliner nose cone in order to reduce drag and lower
resistance to facilitate tissue passage. In some embodiments, tip
protrusion shapes may take on a wide variety of geometric shapes
including, but not limited to, stacked rectangles or tapered thin
rectangles as discussed elsewhere. In some further embodiments the
relative projection shapes that may include, but should not be
limited to: spheroid, sphere, sphere on cylinder, sphere on
pyramid, sphere on cone, cone, cylinder, pyramid, and
polyhedron.
[0074] FIG. 1d is a front elevation view of an alternative
embodiment having two protrusions 104d and one lysing segment
(recession) wherein the lysing segment 105d connecting the two
protrusions is substantially centered midway between the upper and
lower portions of the protrusions. In the depicted embodiment, the
vertical height of the protrusions may be about 3 mm and the
horizontal width may be about 2 mm. Thus, the lysing segment may be
placed about 1.5 mm from the upper portion of the protrusion. FIG.
1e is a front elevation view of another embodiment having two
protrusions and one lysing segment 105e wherein the lysing segment
connecting the two protrusions 104e is substantially centered in
the upper third of the way (on the upper side) between the upper
and lower portions of the protrusions. In the depicted embodiment,
the vertical height of the protrusions may be about 3 mm and the
horizontal width may be about 2 mm. Thus, the lysing segment may be
placed about 1 mm from the upper portion of the protrusion.
[0075] FIG. 1f is a front elevation view of another embodiment
having two protrusions and one lysing segment wherein the lysing
segment 105f connecting the two protrusions 104f is substantially
centered in the lower third (on the lower side) between the upper
and lower portions of the protrusions. In the depicted embodiment,
the vertical height of the protrusions may be about 3 mm and the
horizontal width may be about 2 mm. Thus, the lysing segment may be
placed about 2 mm from the upper portion of the protrusion. As
discussed above, some embodiments may be configured such that the
position of the lysing segment(s) relative to the protrusions is
adjustable, such as adjustable between the embodiments shown in
FIGS. 1d-1f.
[0076] FIG. 1g is a cross-sectional view of an embodiment of a TDM
illustrating some examples of some of the canals that may be used
with the device. For example, canal 130 may comprise an electrode
canal for delivering electrical energy to one or more of the lysing
segments and/or the energy window(s). Canal 132 may comprise an
optics canal for delivering and/or receiving optical signals or
energy, such as a LASER, fiber optics, intense pulse light, or for
receiving an optical sensor. Canal 134 may comprise a vacuum tube
for sucking fluids away from the surgical site, such as bodily
fluids and/or fluids introduced by the TDM during the surgery. One
or more of these canals may be configured for delivering one or
more fluids using the TDM. For example, canal 136 may comprise a
fluid delivery canal for delivering an ionic fluid, such as a
saline solution. Canal 136 may be configured to deliver a fluid
that is both ionic and an anesthetic, such as a tumescent
anesthesia. In some embodiments, canal 136 may be configured to
deliver a fluid containing multiple individual fluids, such as a
Klein Formula. Canal 138 may serve as a coaxial cable canal, such
as for delivering a microwave signal to the energy window, for
example. Canals 140 and 142 may comprise duplicates of any one of
the foregoing canals 130-138. One or more of the canals 130-142 may
be coated with copper or another conductive metal to insulate the
signals from those within other canals. It should be understood
that although these canals are not depicted in other figures, any
of the embodiments described herein may comprise one or more such
canals configured for any of the uses described herein. It should
also be understood that although the canals shown in FIG. 1g are
shown as having rectangular cross sections, any other cross
sectional shape, including but not limited to circular cross
sections, may be used.
[0077] FIG. 2a is a perspective view of an embodiment of a TDM with
an alternative energy window 207 on the upper side of the device
configured to emit ultrasonic energy. It should be noted that the
term "energy window" is intended to encompass what is referred to
as a planar-tissue-altering-window/zone in U.S. Pat. No. 7,494,488
and, as described herein, need not contain an ultrasonic energy
emitter in all embodiments. In some embodiments, the "energy
window" may comprise a variety of other energy emitting devices,
including radiofrequency, intense pulsed light, LASER, thermal,
microwave and ultrasonic. It should also be understood that the
term "energy window" does not necessarily imply that energy is
delivered uniformly throughout the region comprising the energy
window. Instead, some energy window implementations may comprise a
series of termini or other regions within which energy is delivered
with interspersed regions within which no energy, or less energy,
is delivered. This configuration may be useful for some
implementations to allow for alteration of certain tissue areas
with interspersed areas within which tissue is not altered, or at
least is less altered. This may have some advantages for certain
applications due to the way in which such tissue heals. In some
embodiments, certain components of an energy window, such as the
electro-conductive components of the energy window, could comprise
a cermet. It is contemplated that in alternative embodiments,
ultrasound containing energy window 207 may be omitted.
[0078] FIG. 2a is a perspective view of an embodiment of a TDM
comprising a tip 201, a shaft 202 and a handle 203. Electrical
energy may be delivered in conduit 222 through the handle and shaft
to energy window 207, which may comprise an ultrasonic energy
emitter. A second energy window 208 may also be included in some
embodiments, and may comprise yet another ultrasonic energy emitter
or another variety of energy emitting device. An ultrasonically
energized energy window 207 may be present on the upper side of the
device. It is contemplated that in alternative embodiments, energy
window 207 may be omitted. It should be noted that the term "energy
window" is intended to encompass what is referred to as a
planar-tissue-altering-window/zone in U.S. Pat. No. 7,494,488 and,
as described later, need not be ultrasonically energized in all
embodiments. In some embodiments, the "energy window" may comprise
a variety of other energy emitting devices, including
radiofrequency, intense pulsed light, LASER, thermal, microwave and
electrical. It should also be understood that the term "energy
window" does not necessarily imply that energy is delivered
uniformly throughout the region comprising the energy window.
Instead, some energy window implementations may comprise a series
of energy delivering elements or other regions within which energy
is delivered with interspersed regions within which no energy, or
less energy, is delivered. An ultrasonic energy window
configuration may be useful for some implementations, depending
upon piezoelectric component and/or energy applied to less
aggressively disrupt tissues (in order to possibly increase the
concentration of target chemicals and/or biological compounds) at
the cellular level to increase the availability of biological
and/or chemical components to be sensed/analyzed and/or (may be at
higher energy levels) to allow for alteration and/or damage to
targeted tissues and/or heating for treatment. A second energy
window may also be included in some embodiments, and may comprise a
microwave emission device or another variety of energy emitting
device. Energy window 207 may only be at least substantially
planar, or may take on other cross-sectional shapes that may
correspond with a portion of the shape of the shaft, such as arced,
stair-step, or other geometric shapes/curvatures.
[0079] Ultrasonic Energy Window 207 may be configured to heat
target tissues and/or fluids. In the depicted embodiment,
Ultrasonic Energy Window 207 comprises a piezoelectric ceramic. In
an embodiment the piezoelectric ceramic may measure about 20
mm.times.8 mm.times.3 mm. In some embodiments, the piezoelectric
ceramic may measure up to about 50 mm in diameter. It is
contemplated that in alternative embodiments, Ultrasonic Energy
Window 207 may be omitted. In some embodiments the piezoelectric
ceramic is made from lead zirconate titanate piezoelectric ceramic
(which may be sold as PZT8 or PZT4 by Micromechatronics, State
College, Pa.). In some embodiments the piezoelectric may comprise
quartz and/or barium titanate and/or film polymer polyvinylidene
fluoride. In some embodiments the ultrasonic energy window measures
between 1 mm and 50 mm in any dimension. Some embodiments may
comprise a plurality of ultrasonic energy windows. Depending upon
the composition of a piezoelectric and/or the surrounding
environment and/or the structure(s) in which the piezo is mounted,
a given mounted piezoelectric ceramic may have one or more harmonic
frequencies. Increasing the contact of the Ultrasonic Energy Window
207 to the tissues, possibly by pressing on the TD, may reduce
intervening tissue fluids and/or water between the Ultrasonic
Energy Window and the target tissues and thus increase coupling
between the energy window and the target tissue which may increase
the efficiency of ultrasonic energy delivery. In some
implementations, ultrasonic energy window 207 may be used to heat
and/or treat and/or damage target tissues by applying an ultrasonic
frequency range such as a frequency range in excess of 40
kiloHertz. In some implementations, window 307 may be used to heat
and/or treat and/or damage target tissues by applying an energy
level with energy parameters that may range to about 10-20 Watts
and/or 30-50 Volts.
[0080] In some embodiments, an ultrasonic energy window may be
provided that is configured to allow for selective adjustment of
one or more such parameters, including power, voltage, and/or
frequency, as described above.
[0081] Examples of ultrasound technology that may be useful for
some of the embodiments disclosed herein such as for ultrasonic
energy windows 207 and/or 208 may be found in Miniaturized
Ultrasound Arrays for Interstitial Ablation and Imaging (Makin,
Mast, Faidi, et al.; Ultrasound Med Biol 2005;31(11):1539-50.)
and/or Design and Preliminary Results of an Ultrasound Applicator
for Interstitial Thermal Coagulation (Lafon, Chapelon, Prat, et
al.; Ultrasound Med Biol 1998;24(1):113-22.) and/or Optimizing the
Shape of Ultrasound Transducers for Interstitial Thermal Ablation
(Lafon, Theillere, et al.; Med Phys 2002;29(3):290-7.) and/or Rapid
Skin Permeablization by the Simultaneous Application of Dual
Frequency, High-Intensity Ultrasound (Schoelhammer, Polat,
Mendenhall, Langer, et al; Journal of Controlled Release, 2012,
163(2):154-160.) and/or Interstitial Ddevices for Minimally
Invasive Thermal Ablation by High Intensity Ultrasound (Lafon,
Melodelima, Salomir, Chaelon; Int J. Hyperther 2007; 23(2):153-63.)
and/or Theoretical Comparison of Two Interstitial Ultrasound
Applicators Designed to Induce Cylindrical Zones of Tissue Ablation
(Lafon, Chavrier, Prat, et al.; Med Biol Eng Comput
1999;37(3):298-303.) and/or Feasibility of Linear Arrays for
Interstitial Ultrasound Thermal Therapy (Chopra, Bronskill, Foster;
Med Phys 2000;27(6):1281-6.) and/or Development of an Interstitial
Ultrasound Applicator for Endoscopic Procedures: Animal
Experimentation (Lafon, Theillere, Prat, et al.; Ultrasound Med
Biol 2000;26(4):669-75.) and/or Multisectored Interstitial
Ultrasound Applicators for Dynamic Angular Control of Thermal
Therapy (Kinsey, Diederich, Tyreus, et al.; Med Phys
2006;33(5):1352-63.) and/or Evaluation of Multielement
catheter-cooled interstitial ultrasound applicators for
high-temperature thermal therapy (Nau, Diederich, Burdette; Med
Phys 2001;28(7):1525-34.) and/or Feasibility of Ultrasound
Hyperthermia with Waveguide Interstitial Applicator (Jarosz; IEEE
Trans Biomed Eng 1996;43(11):1106-15.) and/or Transurethral
Ultrasound Array for Prostate Thermal Therapy: Initial Studies
(Diederich, Burdette; IEEE Trans Ultrason Ferroelectr Freq Control
1996;43(6):1011-22.) which are hereby incorporated by reference in
its entirety.
[0082] Electro-cutting and electro-coagulation currents may be
controlled outside the TDM at an electrosurgical generator, such as
the Bovie Aaron 1250.TM. or Bovie Icon GP.TM.. In some embodiments,
the tip may measure about 1 cm in width and about 1-2 mm in
thickness. Sizes of about one-fifth to about five times these
dimensions may also have possible uses. In some veterinary
embodiments, tip sizes of about one-tenth to 20 times the
aforementioned dimensions may also have possible uses. In some
embodiments, the tip can be a separate piece that may be secured to
a shaft by a variety of methods, such as a snap mechanism, mating
grooves, plastic sonic welding, etc. Alternatively, in some other
embodiments, the tip can be integral or a continuation of a shaft
made of similar metal(s) or material(s). In some embodiments, the
tip may also be constructed of materials that are both electrically
non-conductive and of low thermal conductivity; such materials
might comprise, for example, porcelain, ceramics, glass-ceramics,
plastics, varieties of polytetrafluoroethylene, carbon, graphite,
and graphite-fiberglass composites.
[0083] In some embodiments, the tip may be constructed of a support
matrix of an insulating material (e.g., ceramic or glass material
such as alumina, zirconia). Conduits 211 and/or 212 may connect to
electrically conductive elements to bring RF electrosurgical energy
from an electrosurgical generator down the shaft 202 to
electrically conductive lysing elements 205 mounted in the
recessions in between protrusions 204. In some embodiments, the
protrusions may comprise bulbous protrusions. The tip shown in this
embodiment has four relative protrusions and three relative
recessions and provides for a monopolar tip conductive element. All
of the axes of the relative protrusions of the tip depicted in this
embodiment extend at least substantially parallel to the axis of
the shaft of the TDM (as viewed from Top). In embodiments of tips
of such axial placement of protrusions and or relative recessions,
surgeons may use methods of defining and or dissecting a target
area by entering through an incision and then moving the TDM tip in
a primarily axial direction forward and backward and reorienting
the TDM after the backstroke in a spokewheel pattern the TDM to
access tissues adjacent to earlier strokes. In the depicted
embodiment, the tip 201 may alternatively be made partially or
completely of concentrically laminated or annealed-in wafer layers
of materials that may include plastics, silicon, glass,
glass/ceramics or ceramics. Lysing elements 205 may also be made
partially or completely of a cermet material. Alternatively, in a
further embodiment, the tip may be constructed of insulation
covered metals or electroconductive materials. In some embodiments,
the shaft may be flat, rectangular, or geometric in cross-section,
or may be substantially flattened. In some embodiments, smoothing
of the edges of the shaft may reduce friction on the tissues
surrounding the entrance wound. In some further embodiments, the
shaft may be made of metal or plastic or other material with a
completely occupied or hollow interior that can contain insulated
wires, electrical conductors, fluid/gas pumping or suctioning
conduits, fiber-optics, or insulation.
[0084] In some embodiments, shaft plastics, such as
polytetrafluoroethylene, may act as insulation about wire or
electrically conductive elements. In some embodiments, the shaft
may alternatively be made partially or completely of concentrically
laminated or annealed-in wafer layers of materials that may include
plastics, silicon, glass, glass/ceramics, ceramics carbon,
graphite, and/or graphite-fiberglass composites. Depending upon the
intended uses for the device, an electrically conductive element
internal to the shaft may be provided to conduct electrical
impulses or RF signals from an external power/control unit (such as
a Valleylab.TM. electrosurgical generator) to another energy window
208. In some embodiments, energy windows 207 and/or 208 may only be
substantially planar, or may take on other cross-sectional shapes
that may correspond with a portion of the shape of the shaft, such
as arced, stair-step, or other geometric shapes/curvatures. In some
embodiments, energy window 208 may comprise another ultrasonic
energy window. In the embodiments depicted in FIGS. 2a & 2b,
energy window 207 is adjacent to protrusions 204, however other
embodiments are contemplated in which an energy window may be
positioned elsewhere on the shaft 202 or tip 201 of the wand, and
still be considered adjacent to protrusions 204. For example, in an
embodiment lacking energy window 207, but still comprising energy
window 208, energy window 208 would still be considered adjacent to
protrusion 204. However, if an energy window was placed on handle
203, such an energy window would not be considered adjacent to
protrusions 204.
[0085] The conduit(s) may also contain electrical control wires to
aid in device operation. Partially hidden from direct view in FIGS.
2a & 2b, and located in the recessions defined by protrusions
204, are electrically conductive tissue lysing elements 205, which,
when powered by an electrosurgical generator, effects lysing of
tissue planes on forward motion of the device. The lysing segments
may be located at the termini of conductive elements. In some
embodiments, one or more sensors such as for example sensors 210
and 214 may be positioned on the device. The sensors 210 and 214
may comprise any of the sensors described in the specification
herein. Other embodiments may comprise one or more sensors on any
other suitable location on the TDM, including but not limited to on
the protrusions or otherwise on the tip, and on the shaft. Sensors
that may be useful include thermal sensors, photoelectric or photo
optic sensors, cameras, etc. In some embodiments, one or more
sensors may be used to monitor the local post passage electrical
impedance or thermal conditions that may exist near the distal tip
of the shaft or on the tip. Some embodiments may also comprise one
or more sensors incorporating MEMS (Micro Electro-Mechanical
Systems) technology, such as MEMS gyroscopes, accelerometers, and
the like. Such sensors may be positioned at any number of locations
on the TDM, including within the handle in some embodiments. In
some embodiments, sensor 214 may comprise fiberoptic elements. In
an embodiment, the sensor can be configured to sense a temperature
of tissue adjacent to the apparatus. The temperature sensor may
alternatively be configured or sense a temperature of one or more
fluids adjacent to the apparatus such as for example tissue fluids
and/or fluids introduced by the surgeon.
[0086] Temperature and impedance values may be tracked on a display
screen or directly linked to a microprocessor capable of signaling
control electronics to alter the energy delivered to the tip when
preset values are approached or exceeded. Typical instrumentation
paths are widely known, such as thermal sensing thermistors, and
may feed to analog amplifiers which, in turn, feed analog digital
converters leading to a microprocessor. In some embodiments,
internal or external ultrasound measurements may also provide
information which may be incorporated into a feedback circuit. In
an embodiment, an optional mid and low frequency ultrasound
transducer may also be activated to transmit energy to the tip and
provide additional heating and may additionally improve lysing. In
some embodiments, a flashing visible light source, for example, an
LED, can be mounted on the tip may show through the tissues and/or
organs to identify the location of the device.
[0087] In some embodiments, one or more electromagnetic delivery
elements 215 may be positioned on tip or shaft. Other embodiments
may comprise one or more electromagnetic delivery elements on any
other suitable location on the TDM, including but not limited to on
the protrusions or otherwise on the tip, and on the shaft.
Electromagnetic delivery elements that may be useful include: LEDs,
LASERs, fiberoptics, filaments, photoelectric materials, infrared
emitters, etc.
[0088] FIG. 2b is a side elevation view of the embodiment
previously depicted in FIG. 2a. In the depicted embodiment, tip 201
which terminates in protrusions 206 may be made of materials that
are both electrically non-conductive and of low thermal
conductivity such as porcelain, epoxies, ceramics, glass-ceramics,
plastics, or varieties of polytetrafluoroethylene. Alternatively,
the tip may be made from metals or electroconductive materials that
are completely or partially insulated. Note the relative
protrusions and relative recessions are not completely visible from
this viewing angle. The tip shown in this embodiment has four
relative protrusions and three relative recessions and provides for
a monopolar tip conductive element. In some embodiments, the
electrically conductive tissue lysing element(s) 205 (usually
hidden from view at most angles), which may have any geometric
shape including a thin cylindrical wire, may be positioned within
the relative recessions of the tip. The electrically conductive
lysing element can be in the shape of a plate or plane or wire and
made of any metal or alloy that does not melt under operating
conditions or give off toxic residua. Optimal materials may include
but are not limited to steel, nickel, alloys, palladium, gold,
tungsten, silver, copper, and platinum. Metals may become oxidized
thus impeding electrical flow and function. In some further
adjustable embodiments, locations of the electrically conductive
lysing elements with respect to the protrusions may be adjusted by
MEMS or microelectronics.
[0089] In alternative embodiments the geometry of the tip area may
comprise protrusions that are not oriented along the axis of the
shaft (as seen from a top view); some of these alternative
embodiments for tip area geometries are depicted in FIGS.
5a,b,c,d,e,f,g,h and FIGS. 6a,b,c,d. Some embodiments may be
configured to be modular and/or comprise disposable tips such that
a surgeon can place an appropriate tip for a particular surgery on
the shaft. Alternatively or additionally one or more of the tips
may be disposable such that a surgeon may dispose of the tip after
performing surgery and install a new tip for subsequent surgeries
or a continuation of the current surgery with a new tip.
[0090] In some embodiments, one or more suction/vacuum ports 217b
may be provided on or about the tip or distal shaft. The port(s)
may be fluidly coupled with a vacuum; the vacuum may comprise a
pump or a negative pressure chamber or a syringe at the end of a
fluid conduit. Other embodiments may comprise one or more
suction/vacuum ports on any other suitable location on the TDM,
including but not limited to on the protrusions or otherwise on the
tip, and on the shaft. In some embodiments, a fluid delivery port
216b may be provided. In some embodiments the fluid delivery port
may be coupled with a pump or high pressure fluid. In some
embodiments the port may be perpetually open such that fluid may be
delivered therethrough upon actuation of a pump or fluid pressure
system. In other embodiments the port may be closed and selectively
opened to deliver fluid therethrough. Other embodiments may
comprise one or more fluid ports on any other suitable location on
the TDM, including but not limited to on the protrusions or
otherwise on the tip, and on the shaft. Fluid ports that may be
useful may comprise channels within the TDM, polymer lines, hoses,
etc. Fluids that may emanate from the outlet may comprise ionic
fluids such as saline, medicines (including but not limited to
antibiotics, anesthetics, antineoplastic agents, bacteriostatic
agents, etc.), non-ionic fluids, and or gasses (including but not
limited to nitrogen, argon, air, etc.). In some embodiments fluids
may be under higher pressures or sprayed. It should be understood
that although these elements (216b & 217b) are not depicted in
every one of the other figures, any of the embodiments described
herein may include one or more such elements.
[0091] In some embodiments, a vibration means 270b may be
positioned in the handle. Other embodiments may comprise one or
more vibration means on any other suitable location on the TDM,
including but not limited to on the protrusions or otherwise on the
tip, and on the shaft. Examples of suitable vibration means may
include piezoelectric materials, ultrasonic motors with stators,
piezoelectric actuators, vibration motor such as an off-center
weight mounted on a gear, etc. Some vibration means may be
configured to emit ultrasound in the 20-40 kHz range. Yet other
vibration means may include electromagnet drivers with a frequency
of operation in the range of 150-400 Hz. In some embodiments, one
or more vibration means may be used to provide additional forces
which may facilitate passage of the TDM. In some embodiments, one
or more vibration means may be used to reduce debris on the
electrosurgical or other components of the TDM. In a further
embodiment, a vibration means may be directly or indirectly
connected to one or more of the lysing segments.
[0092] In the depicted embodiment, 218b represents an antenna, such
as an RFID TAG or Bluetooth antenna. In embodiments in which
antenna 218b comprises an RFID tag, the RFID tag may comprise an
RFID transponder. In other embodiments the RFID tag may comprise a
passive tag. It should be understood that antenna 218b is not
depicted in every one of the other figures, any of the embodiments
described herein may comprise one or more such elements. Other
embodiments may comprise one or more antennas on any other suitable
location on the TDM, including but not limited to on the
protrusions or otherwise on the tip, and on the shaft. In some
embodiments an RFID transponder or another antenna may comprise a
microchip, such as a microchip having a rewritable memory. In some
embodiments, the tag may measure less than a few millimeters. In
some embodiments a reader may generate an alternating
electromagnetic field which activates the antenna/RFID transponder
and data may be sent via frequency modulation. In an embodiment,
the position of the RFID tag or other antenna may be determined by
an alternating electromagnetic field in the ultra-high frequency
range. The position may be related to a 3 dimensional mapping of
the subject. In an embodiment the reader may generate an
alternating electromagnetic field. In some such embodiments, the
alternating electromagnetic field may be in the shortwave (13.56
MHz) or UHF (865-869 MHz) frequency.
[0093] In some embodiments tip 201 may be attached to a robotic
arm. In some embodiments, tip 201 and portion of shaft 202 may be
attached to a robotic arm. In some embodiments tip 201 and/or a
portion of shaft 202 and/or a portion shaft and/or portion of
handle 203 may be attached to a robotic arm. In some embodiments,
the robotic arm may comprise one or more motors such as a
screw-drive motor, gear motor, hydraulic motors, etc. In some
embodiments the robotic arm system may comprise worm gearheads,
video cameras, motor control circuits, monitors, remote control
devices, illumination sources, tactile interface, etc.
[0094] FIG. 3a is a perspective view of an embodiment of a tissue
dissector and modifier with a
target-tissue-impedance-matched-microwave-based energy window on
the upper side of the device. A
target-tissue-impedance-matched-microwave emission system (TTIMMES)
may be advantageous over previously available microwave based
medical treatment systems because it is difficult to model tissue
against water because the dielectric associated with water differs
from that of blood, which differs from that of tissue, and so on,
especially after coagulum formation. Both
non-impedance-matched-microwave and radiofrequency treatments may
suffer from this concern. Beneficially for microwaves there is
limited coagulum formation, and deeper penetration of energy into
the tissues. With impedance matching, energy is not reflected back
from the tissues into the microwave emitting antennae as the energy
proceeds uni-directionally through the coaxial cable and into the
target tissue. A controllable solid state source (e.g.,
MicroBlate.TM.) of a super-high frequency (SHF) microwave emission
band of 14.5 GHz system that is impedance matched has been shown to
produce a depth of penetration of about 1.6 mm using coaxial
antennae measuring just 2.2 mm (Int'l Journal of Hyperthermia 28:
43-54, 2012).
[0095] FIG. 3a is a perspective view of an embodiment of a TDM with
an alternative energy window 307 on the upper side of the device
configured to hold an array of impedance-matched-microwave emitting
antennae. It should be noted that the term "energy window" is
intended to encompass what is referred to as a
planar-tissue-altering-window/zone in U.S. Pat. No. 7,494,488 and,
as described herein, need not contain a microwave emitter in all
embodiments. Additionally, the "energy window" may comprise a
variety of other energy emitting devices, including radiofrequency,
intense pulsed light, LASER, thermal, and ultrasonic. It should
also be understood that the term "energy window" does not
necessarily imply that energy is delivered uniformly throughout the
region comprising the energy window. Instead, some energy window
implementations may comprise a series of termini or other regions
within which energy is delivered with interspersed regions within
which no energy, or less energy, is delivered. This configuration
may be useful for some implementations to allow for alteration of
certain tissue areas with interspersed areas within which tissue is
not altered, or at least is less altered. This may have some
advantages for certain applications due to the way in which such
tissue heals. It is contemplated that in alternative embodiments,
impedance-matched-microwave energy window 307 may be omitted.
[0096] FIG. 3a is a perspective view of an embodiment of a TDM
comprising a tip 301, a shaft 302 and a handle 303. Electrosurgical
energy may be delivered in conduits 311 and/or 312, whereas
gigahertz microwave energy may be delivered by coaxial cable bundle
322 through the handle and shaft to energy window 307, which may
comprise four antennae termini. Some embodiments comprise between 1
and 10 antennae. Some embodiments may comprise a flat microwave
emitting device. A second energy window 308 may also be included in
some embodiments, and may comprise yet another microwave emitter or
another variety of energy emitting device. Electro-cutting and
electro-coagulation currents may be controlled outside the TDM at
an electrosurgical generator, such as the Bovie Aaron 1250.TM. or
Bovie Icon GP.TM.. In some embodiments, the tip may measure about 1
cm in width and about 1-2 mm in thickness. Sizes of about one-fifth
to about five times these dimensions may also have possible uses.
In some veterinary embodiments, tip sizes of about one-tenth to 20
times the aforementioned dimensions may also have possible
uses.
[0097] In some embodiments, the tip can be a separate piece that
may be secured to a shaft by a variety of methods, such as a snap
mechanism, mating grooves, plastic sonic welding, etc.
Alternatively, in some other embodiments, the tip can be integral
or a continuation of a shaft made of similar metal(s) or
material(s). In some embodiments, the tip may also be constructed
of materials that are both electrically non-conductive and of low
thermal conductivity; such materials might comprise, for example,
porcelain, ceramics, glass-ceramics, plastics, varieties of
polytetrafluoroethylene, carbon, graphite, and graphite-fiberglass
composites.
[0098] In some embodiments, the tip may be constructed of a support
matrix of an insulating material (e.g., ceramic or glass material
such as alumina, zirconia). Conduit 311 may connect to electrically
conductive elements to bring RF electrosurgical energy from an
electrosurgical generator down the shaft 302 to electrically
conductive lysing elements 305 mounted in the recessions in between
protrusions 304. In some embodiments, the protrusions may comprise
bulbous protrusions. In the depicted embodiment, the tip 301 may
alternatively be made partially or completely of concentrically
laminated or annealed-in wafer layers of materials that may include
plastics, silicon, glass, glass/ceramics or ceramics.
Alternatively, in a further embodiment, the tip may be constructed
of insulation covered metals or electroconductive materials. In
some embodiments, the shaft may be flat, rectangular, or geometric
in cross-section, or may be substantially flattened. In some
embodiments, smoothing of the edges of the shaft may reduce
friction on the tissues surrounding the entrance wound. In some
further embodiments, the shaft may be made of metal or plastic or
other material with a completely occupied or hollow interior that
can contain insulated wires, electrical conductors, fluid/gas
pumping or suctioning conduits, fiber-optics, or insulation.
[0099] In some embodiments, shaft plastics, such as
polytetrafluoroethylene may act as insulation about wire or
electrically conductive elements. In some embodiments, the shaft
may alternatively be made partially or completely of concentrically
laminated or annealed-in wafer layers of materials that may include
plastics, silicon, glass, glass/ceramics, ceramics carbon,
graphite, graphite-fiberglass composites. Depending upon the
intended uses for the device, an electrically conductive element
internal to shaft may be provided to conduct electrical impulses or
RF signals from an external power/control unit (such as a
Valleylab.TM. electrosurgical generator) to another energy window
308. In some embodiments, energy windows 307 and/or 308 may only be
substantially planar, or may take on other cross-sectional shapes
that may correspond with a portion of the shape of the shaft, such
as arced, stair-step, or other geometric shapes/curvatures. In some
embodiments, energy window 308 may comprise another microwave
emitter. In the embodiments depicted in FIGS. 3a & 3b, energy
window 307 is adjacent to protrusions 304, however other
embodiments are contemplated in which an energy window may be
positioned elsewhere on the shaft 302 or tip 301 of the wand, and
still be considered adjacent to protrusions 304. For example, in an
embodiment lacking energy window 307, but still comprising energy
window 308, energy window 308 would still be considered adjacent to
protrusion 304. However, if an energy window was placed on handle
303, such an energy window would not be considered adjacent to the
protrusions 304.
[0100] The conduit(s) may also contain electrical control wires to
aid in device operation. Partially hidden from direct view in FIGS.
3a & 3b, and located in the recessions defined by protrusions
304, are electrically conductive tissue lysing elements 305, which,
when powered by an electrosurgical generator, effects lysing of
tissue planes on forward motion of the device. The lysing segments
may be located at the termini of conductive elements.
[0101] In some embodiments, one or more sensors such as for example
sensors 310 and 314 may be positioned on the device. The sensors
310 and 314 may comprise any of the sensors described in the
specification herein. Other embodiments may comprise one or more
sensors on any other suitable location on the TDM, including but
not limited to on the protrusions or otherwise on the tip, and on
the shaft. Sensors that may be useful include thermal sensors,
photoelectric or photo optic sensors, cameras, etc. In some
embodiments, one or more sensors may be used to monitor the local
post passage electrical impedance or thermal conditions that may
exist near the distal tip of the shaft or on the tip. Some
embodiments may also comprise one or more sensors incorporating
MEMS (Micro Electro-Mechanical Systems) technology, such as MEMS
gyroscopes, accelerometers, and the like. Such sensors may be
positioned at any number of locations on the TDM, including within
the handle in some embodiments. In some embodiments, sensor 314 may
comprise fiberoptic elements. In an embodiment, the sensor can be
configured to sense a temperature of tissue adjacent to the
apparatus during one or methods described herein. The temperature
sensor may alternatively be configured or sense a temperature of
one or more fluids adjacent to the apparatus such as for example
tissue fluids and/or fluids introduced by the surgeon.
[0102] Temperature and impedance values may be tracked on a display
screen or directly linked to a microprocessor capable of signaling
control electronics to alter the energy delivered to the tip when
preset values are approached or exceeded. Typical instrumentation
paths are widely known, such as thermal sensing thermistors, and
may feed to analog amplifiers which, in turn, feed analog digital
converters leading to a microprocessor. In some embodiments,
internal or external ultrasound measurements may also provide
information which may be incorporated into a feedback circuit. In
an embodiment, an optional mid and low frequency ultrasound
transducer may also be activated to transmit energy to the tip and
provide additional heating and may additionally improve lysing. In
some embodiments, a flashing visible light source, for example, an
LED, can be mounted on the tip may show through the tissues and/or
organs to identify the location of the device.
[0103] In some embodiments, one or more electromagnetic delivery
elements 315 may be positioned on tip or shaft. Other embodiments
may comprise one or more electromagnetic delivery elements on any
other suitable location on the TDM, including but not limited to on
the protrusions or otherwise on the tip, and on the shaft.
Electromagnetic delivery elements that may be useful include: LEDs,
LASERs, fiberoptics, filaments, photoelectric materials, infrared
emitters, etc.
[0104] Alternatively, in some embodiments, since cutting or
electrical current may cause an effect at a distance without direct
contact, the lysing element may be recessed into the relative
recessions or grooves defined by the protrusions 304 or,
alternatively, may be flush with protrusions 304. In some further
adjustable embodiments, locations of the electrically conductive
lysing elements with respect to the protrusions may be adjusted by
diminutive screws or ratchets. In some further adjustable
embodiments, locations of the electrically conductive lysing
elements with respect to the protrusions may be adjusted by MEMS or
microelectronics.
[0105] In some embodiments, the electrically conductive lysing
element may also exist in the shape of a simple wire of 0.1 mm and
1 mm 0.01 mm to 3 mm. In some embodiments, the wire may measure
between 0.01 mm to 3 mm. Such a wire may be singly or doubly
insulated as was described for the plate and may have the same
electrical continuities as was discussed for the planar (plate)
version. In some embodiments, an electrosurgical current for the
electrically conductive lysing element is of the monopolar
"cutting" variety and setting and may be delivered to the tip
lysing conductor in a continuous fashion or, alternatively, a
pulsed fashion. The surgeon can control the presence of current by
a foot pedal control of the electrosurgical generator or by button
control on the shaft (forward facing button). The amount of cutting
current may be modified by standard interfaces or dials on the
electrosurgical generator. In some embodiments, the
electrosurgically energized tip current can be further pulsed at
varying rates, by interpolating gating circuitry at some point
external to the electrosurgical generator by standard mechanisms
known in the art, that may range from about 1 per second to about
60 per second. In some embodiments, the rate may vary from about 1
per second to about 150 per second. In some embodiments, the
electrosurgically energized tip current can be further pulsed at
varying rates by gating circuitry within the electrosurgical
generator by standard mechanisms known in the art.
[0106] In alternative embodiments the geometry of the tip area may
comprise protrusions that are not oriented along the axis of the
shaft (as seen from a top view); some of these alternative
embodiments for tip area geometries are depicted in FIGS.
5a,b,c,d,e,f,g,h and FIGS. 6a,b,c,d. Some embodiments may be
configured to be modular and/or comprise disposable tips such that
a surgeon can place an appropriate tip for a particular surgery on
the shaft. Alternatively or additionally one or more of the tips
may be disposable such that a surgeon may dispose of the tip after
performing surgery and install a new tip for subsequent surgeries
or a continuation of the current surgery with a new tip.
[0107] In some embodiments, one or more suction/vacuum ports 317b
may be provided on or about the tip or distal shaft. The port(s)
may be fluidly coupled with a vacuum; the vacuum may comprise a
pump or a negative pressure chamber or a syringe at the end of a
fluid conduit. Other embodiments may comprise one or more
suction/vacuum ports on any other suitable location on the TDM,
including but not limited to on the protrusions or otherwise on the
tip, and on the shaft. In some embodiments, a fluid delivery port
316b may be provided. In some embodiments the fluid delivery port
may be coupled with a pump or high pressure fluid. In some
embodiments the port may be perpetually open such that fluid may be
delivered therethrough upon actuation of a pump or fluid pressure
system. In other embodiments the port may be closed and selectively
opened to deliver fluid therethrough. Other embodiments may
comprise one or more fluid ports on any other suitable location on
the TDM, including but not limited to on the protrusions or
otherwise on the tip, and on the shaft. Fluid ports that may be
useful may comprise channels within the TDM, polymer lines, hoses,
etc. Fluids that may emanate from the outlet may comprise ionic
fluids such as saline, medicines (including but not limited to
antibiotics, anesthetics, antineoplastic agents, bacteriostatic
agents, etc.), non-ionic fluids, and or gasses (including but not
limited to nitrogen, argon, air, etc.). In some embodiments fluids
may be under higher pressures or sprayed. It should be understood
that although these elements (316b & 317b) are not depicted in
every one of the other figures, any of the embodiments described
herein may include one or more such elements.
[0108] In some embodiments, a vibration means 370b may be
positioned in the handle. Other embodiments may comprise one or
more vibration means on any other suitable location on the TDM,
including but not limited to on the protrusions or otherwise on the
tip, and on the shaft. Examples of suitable vibration means may
include piezoelectric materials, ultrasonic motors with stators,
piezoelectric actuators, vibration motor such as an off-center
weight mounted on a gear, etc. Some vibration means may be
configured to emit ultrasound in the 20-40 kHz range. Yet other
vibration means may include electromagnet drivers with a frequency
of operation in the range of 150-400 Hz. In some embodiments, one
or more vibration means may be used to provide additional forces
which may facilitate passage of the TDM. In some embodiments, one
or more vibration means may be used to reduce debris on the
electrosurgical or other components of the TDM. In a further
embodiment, a vibration means may be directly or indirectly
connected to one or more of the lysing segments.
[0109] In the depicted embodiment, 318b represents an antenna, such
as an RFID TAG. In embodiments in which antenna 318b comprises an
RFID tag, the RFID tag may comprise an RFID transponder. In other
embodiments the RFID tag may comprise a passive tag. It should be
understood that antenna 318b is not depicted in every one of the
other figures, any of the embodiments described herein may comprise
one or more such elements. Other embodiments may comprise one or
more antennas on any other suitable location on the TDM, including
but not limited to on the protrusions or otherwise on the tip, and
on the shaft. In some embodiments an RFID transponder or another
antenna may comprise a microchip, such as a microchip having a
rewritable memory. In some embodiments, the tag may measure less
than a few millimeters. In some embodiments a reader may generate
an alternating electromagnetic field which activates the RFID
transponder/antenna and data may be sent via frequency modulation.
In an embodiment, the position of the RFID tag/antenna may be
determined by an alternating electromagnetic field in the
ultra-high frequency range. The position may be related to a 3
dimensional mapping of the subject. In an embodiment the reader may
generate an alternating electromagnetic field. In some such
embodiments, the alternating electromagnetic field may be in the
shortwave (13.56 MHz) or UHF (865-869 MHz) frequency.
[0110] In some embodiments tip 301 may be attached to a robotic
arm. In some embodiments, tip 301 and portion of shaft 302 may be
attached to a robotic arm. In some embodiments tip 301 and/or a
portion of shaft 302 and/or a portion shaft and/or portion of
handle 303 may be attached to a robotic arm. In some embodiments,
the robotic arm may comprise one or more motors such as a
screw-drive motor, gear motor, hydraulic motors, etc. In some
embodiments the robotic arm system may comprise worm gearheads,
video cameras, motor control circuits, monitors, remote control
devices, illumination sources, tactile interface, etc.
[0111] FIG. 3c depicts an embodiment of the
target-tissue-impedance-matched-microwave-based emission system
(TTIMMES) previously depicted in FIG. 3a. This depicted embodiment
includes energy window 307, which is configured to comprise a
bundle of microwave antennae 322a further comprising singular
antennae, such as 320 and 321. Coaxial cable bundle 322 carries
gigahertz microwave energy derived from a super high frequency
(SHF) generator, into and through the handle, down the shaft and
into the coaxial antennae. In some embodiments, a flat microwave
emitter may be placed in energy window 307. In some embodiments,
flat microwave emission devices are comprised of a "microstrip" in
which an antenna is printed on a circuitboard. In some embodiments,
the circuitboard may be coated with polytetrafluroethylene, and may
be seated on an alumina substrate.
[0112] In some embodiments, a controllable solid state source
(N5183A MXG Microwave Analog Signal Generator from Agilent
Technologies.TM.) of a super-high frequency (SHF) microwave
emission band of 36 GHz system that is impedance matched drives the
coaxial cables to emit microwaves.
[0113] Additionally, an "energy window" may comprise a variety of
other energy emitting devices, including radiofrequency, microwave,
filament, light, intense pulsed light, LASER, thermal, and
ultrasonic. A second energy window 308 may also be included in some
embodiments, and may comprise yet another microwave or another
variety of energy emitting device.
[0114] Some embodiments of the energy window may also comprise one
or more LASERs that may also be used through the fiberoptic and may
be controlled at the electromagnetic energy source by a footswitch.
In some embodiments, the planar tissue-altering-window/zone may be
an optical window that allows laser light to exit the shaft and
irradiate nearby target tissue. In some embodiments, a light
delivery means, which can be a hollow waveguide or single or
multiple optical fibers (such as metal coated plastic manufactured
by Polymicro Technologies.TM., Inc. of Phoenix, Ariz.) may be
contained in an external conduit. The external conduit may
comprise, for example an articulating arm as is commonly used in
surgical laser systems. Additional control wires and power may be
delivered to the handpiece via the external conduit. However, using
foot-pedal control from an electromagnetic energy radiation source
or control interface, dial, or panel will likely be less cumbersome
for the surgeon and reduce the expense of handpiece finger-control
manufacture.
[0115] Some embodiments may use an energy window comprising
Germanium, which may allow for egress of laser light and collection
of data by thermal sensors, and such energy window may be of
varying size. In another embodiment, a multiplicity of optical
fibers may terminate at specific or random places within the energy
window. Such bare or coated fiberoptic termini may protrude from,
be flush with, or be recessed into, other materials comprising the
energy window. Such bare or coated fiberoptic termini may protrude
from, be flush with or be recessed into other materials comprising
the energy window. In some embodiments, bare fiberoptics comprising
ethylene oxide sterilizable may be seated in a thermally
nonconductive background, preferably at uniform 90 degree angles,
but variable angles between 0 and 180 degrees may also be
efficacious. The preferred light delivery means may depend on the
wavelength of the laser used. Infrared light emitted by the heated
tissue can also be collected through the window and sensed by an
infrared detector to measure the tissue temperature. For CO.sub.2
laser irradiance, reliable sources include standard operating room
units, such as the Encore Ultrapulse.RTM. from Lumenis Corp. of
Santa Clara, Calif., which is capable of providing continuous
CO.sub.2 laser energy outputs of 2-22 mJoules at 1-60 Watts. Older
models of the Coherent Ultrapulse.TM. may also be suitable
(Coherent.TM. now owned by Lumenis.TM.).
[0116] In some embodiments, a hollow section of shaft may act as a
waveguide or may contain a metal-coated plastic fiberoptic or
waveguide to allow laser light to pass through and exit from window
near tip. The window may allow egress for laser light delivered to
apparatus. In some embodiments, Lasers may include both pulsed and
continuous wave lasers, such as CO.sub.2, erbium YAG, Nd:YAG and
Yf:YAG. The beam diameter may be changed as desired, as those
skilled in the art will appreciate. However, this list is not
intended to be self-limiting and other wavelength lasers may be
used.
[0117] Some embodiments of the energy window may comprise an
intense, pulsed, non-coherent, non-LASER, such as a filtered
flashlamp that emits a broadband of visible light. The flashlamp,
such as a smaller version of that used by ESC/Sharplan.TM.,
Norwood, Mass. (500-1200 nm emission range; 50 J/sqcm fluence; 4 ms
pulse; 550 nm filter) may occupy the handle or window/zone of the
embodiment. In some embodiments, a flashlamp may emit optical and
thermal radiation that can directly exit the energy window, or may
be reflected off a reflector to exit through the window. In an
embodiment, a reflector may have a parabolic shape to effectively
collect radiation emitted away from the window, which may be made
of a wide variety of glass that transmits optical, near infrared,
and infrared light (e.g., quartz, fused silica and germanium.)
Emission spectra may be filtered to achieve the desired effects.
Thermal emissions or visible radiation absorption may locally heat
the dermis to alter collagen. Thermal sensors may also be used to
control or reduce overheating. In order to eliminate excessive
heating of the shaft and the surrounding facial tissue, the
flashlamp and reflector may be thermally isolated by low thermal
conductivity materials or cold nitrogen gas that may be pumped
through a hollow or recessed portion of the shaft and/or handle. In
an embodiment, the handle can be an alternative location for the
flashlamp so that emitted radiation may be reflected by a mirror
through the window/zone.
[0118] In some embodiments, direct piezoelectric versions of the
energy window may impart vibrational energy to water molecules
contained in target tissues passing adjacent to the piezo
material(s). Temperature elevations may cause collagenous change
and cell wall damage, however, ultrasonic energy application may
have disruptive effects at the subcellular level as well. Energy
output for piezoelectric window/zones may typically range from
about 1-30 J; in an embodiment, an energy output range of about 1-6
J may occur in a surgical device moving about 1 cm/second. In an
embodiment, temperature and impedance sensors may provide
intraoperative real-time data can modulate energy input into the
piezoelectric, which may be energized by one or more conductive
elements in the shaft in further connection with the control unit
and/or power supply. In some embodiments, the energy window for a
thermally energized embodiment may allow thermal energy to escape
from within the shaft, and wherein the tip can be integral or a
continuation of shaft made of similar metal or materials. The tip
may also be constructed of materials that are both electrically
non-conductive and of low thermal conductivity; such materials
might be porcelain, ceramics or plastics. Portions of the tip and
shaft may be covered with Teflon.RTM. to facilitate smooth
movement. Teflon.RTM. may also be used to coat portions of an
antenna, such as a microwave antenna, such that the energy is
delivered in a more uniform fashion.
[0119] In some embodiments, a filament may be fixedly attached to
the shaft. The hot filament may emit optical and thermal radiation
that can directly exit the energy window or be reflected off a
reflector to also exit through window. The reflector may have a
parabolic shape to effectively collect all optical and thermal
radiation emitted away from the window. In some embodiments, a hot
filament can be a tungsten carbide filament similar to those used
in high power light bulbs. The wavelength may be adjusted and
controlled by adjusting the filament temperature/current. In some
embodiments, the window may be selected from a wide variety of
glass that transmits optical, near infrared and infrared light
(e.g., quartz, fused silica and germanium.) The tissue penetration
depth may depend on the wavelength of the light (e.g., 1 .mu.m may
penetrate through about 10 mm, 10 .mu.m may penetrate through about
0.02 mm). In an embodiment, the broad emission spectrum from the
hot filament may be filtered to achieve the desired tissue effect.
In some embodiments, thermal sensors connected to the control unit
by electrical wire may be used to monitor the temperature of tissue
that is in contact with the shaft. In order to eliminate excessive
heating of the shaft and the surrounding facial tissue, the heating
element and/or reflector may be thermally isolated by low thermal
conductivity materials. The heating element may be isolated by
reducing contact with the shaft, whereas the reflector may have an
isolating layer where it attaches to the shaft. In an embodiment,
cold nitrogen gas may be injected through tube and pumped out
through the hollow shaft to cool the tip and shaft.
[0120] In some embodiments, the hot filament may be placed in the
handle while emitted optical and thermal radiation is reflected off
a mirror through the window. An alternative embodiment may allow
for tissue heating to be achieved by direct contact with a hot
surface where electric current flowing through wires heats a
resistive load made of single or multiple elements to a user
selected temperature. The resistive load could be a thin film
resistor and the film temperature could be estimated from the
measured resistance. In some embodiments, separate thermal sensors
placed close to the heating element may be used to measure
temperatures, which may be sent to a control unit to control the
current through the resistive load. Cold gas or liquid(s) can be
injected through tubes and pumped out through the shaft. In an
embodiment, the heating element could be the hot side of a Peltier
thermoelectric cooler which advantageously cools the opposite
surface below ambient temperature with differences of up to about
40.degree. C. In some thermal embodiments, heat may be derived via
magnetic or frictional methods to bring about similar tissue
alterations.
[0121] It has been discovered that some embodiments may also be
effective without means for and energy window. For example, in some
embodiments lacking an energy window, energy delivered by or
otherwise at the lysing elements may be sufficient to at least
partially induce fibrosis within a target region as the tissue is
separated. In some embodiments and implementations it may therefore
be useful to provide a higher energy such a higher level of
electrosurgical energy (for example current flow). In some
embodiments and implementations, the energy at the lysing elements
may be increased beyond what would otherwise be needed just to
separate tissue into planes. Although in some embodiments, one may
be able to induce target tissue fibrosis by using only the
requisite energy needed to separate tissue. In other embodiments,
energy may be increased (such as an increase of 5% to 500%) to
increase the probability of inducing target tissue fibrosis without
the use of an energy window. In other embodiments, energy may be
increased (such as an increase of 5% to 150%) to increase the
probability of target tissue fibrosis without the use of an energy
window In other embodiments, energy may be increased (such as an
increase of 10% to 30%) to increase the probability of target
tissue fibrosis without the use of an energy window.
[0122] FIG. 4a is a perspective view of an embodiment of a TDM
comprising a tip 401, a shaft 402 and a handle 403. The embodiment
depicted in FIG. 4a is a TDM without an electrosurgically energized
energy window. Electro-coagulation and electro-cutting energy
arrives in conduits 411 and/or 412 and may travel by wiring through
the handle and shaft 402 to electrically conductive lysing elements
405 mounted in the recessions in between the protrusions 404. In
the depicted embodiment, the tip 401 may alternatively be made
partially or completely of concentrically laminated or annealed-in
wafer layers of materials that may include plastics, silicon,
glass, glass/ceramics or ceramics. Alternatively, in a further
embodiment the tip may be constructed of insulation covered metals
or electroconductive materials. In some embodiments, the shaft may
be flat, rectangular or geometric in cross-section or substantially
flattened. In some embodiments, smoothing of the edges of the shaft
may reduce friction on the tissues surrounding the entrance wound.
In some further embodiments, the shaft may be made of metal or
plastic or other material with a completely occupied or hollow
interior that can contain insulated wires, electrical conductors,
fluid/gas pumping or suctioning conduits, fiber-optics, or
insulation.
[0123] In some embodiments, the tip may be constructed of a support
matrix of an insulating material (e.g., ceramic or glass material
such as alumina, zirconia). The tip shown in this embodiment has
four relative protrusions and three relative recessions and
provides for a monopolar tip conductive element. All of the axes of
the relative protrusions of the tip depicted in this embodiment
extend at least substantially parallel to the axis of the shaft of
the TDM (as viewed from Top). In embodiments of tips of such axial
placement of protrusions and or relative recessions, surgeons may
use methods of defining and or dissecting a target area by entering
through an incision and then moving the TDM tip in a primarily
axial direction forward and backward and reorienting the TDM after
the backstroke in a spokewheel pattern the TDM to access tissues
adjacent to earlier strokes.
[0124] In an embodiment, the tip may measure about 1 cm in width
and about 1-2 mm in thickness. Sizes of about one-fifth to about
five times these dimensions may also have possible uses. In some
embodiments, the tip can be a separate piece that is secured to
shaft by a variety of methods such as a snap mechanism, mating
grooves, plastic sonic welding, etc. Alternatively, in some other
embodiments, the tip can be integral or a continuation of shaft
made of similar metal or materials. In some embodiments, the tip
may also be constructed of materials that are both electrically
non-conductive and of low thermal conductivity; such materials
might comprise, for example, porcelain, ceramics, glass-ceramics,
plastics, varieties of polytetrafluoroethylene, carbon, graphite,
and graphite-fiberglass composites. In some embodiments the
geometry of the tip area may comprise protrusions that are not
oriented along the axis of the shaft (as seen from a top view);
some of these alternative embodiments for tip area geometries are
depicted in FIGS. 5a,b,c,d,e,f,g,h and FIGS. 6a,b,c,d.
[0125] In some embodiments, shaft plastics, such as
polytetrafluoroethylene may act as insulation about wire or
electrically conductive elements. In some embodiments, the shaft
may alternatively be made partially or completely of concentrically
laminated or annealed-in wafer layers of materials that may include
plastics, silicon, glass, glass/ceramics, ceramics carbon,
graphite, graphite-fiberglass composites.
[0126] The conduit may also contain electrical control wires to aid
in device operation. Partially hidden from direct view in FIGS. 4a
& 4b, and located in the grooves defined by protrusions 404 are
electrically conductive tissue lysing elements 405, which, when
powered by an electrosurgical generator, effects lysing of tissue
planes on forward motion of the device. The lysing segments may be
located at the termini of conductive elements.
[0127] In some embodiments, one or more sensors such as for example
sensors 410 and 414 may be positioned on the device. The sensors
410 and 414 may comprise any of the sensors described in the
specification herein. Other embodiments may comprise one or more
sensors on any other suitable location on the TDM, including but
not limited to on the protrusions or otherwise on the tip, and on
the shaft. Sensors that may be useful include thermal sensors,
photoelectric or photo optic sensors, cameras, etc. In some
embodiments, one or more sensors may be used to monitor the local
post passage electrical impedance or thermal conditions that may
exist near the distal tip of the shaft or on the tip. Some
embodiments may also comprise one or more sensors incorporating
MEMS (Micro Electro-Mechanical Systems) technology, such as MEMS
gyroscopes, accelerometers, and the like. Such sensors may be
positioned at any number of locations on the TDM, including within
the handle in some embodiments. In some embodiments, sensor 414 may
comprise fiberoptic elements. In an embodiment, the sensor can be
configured to sense a temperature of tissue adjacent to the
apparatus. The temperature sensor may alternatively be configured
or sense a temperature of one or more fluids adjacent to the
apparatus such as for example tissue fluids and/or fluids
introduced by the surgeon.
[0128] Examples of sensors that may be provided with one or more
embodiments disclosed herein include electromagnetic sensors,
electrical sensors, and temperature sensors. Examples of
electromagnetic sensors may include colorimeter, electro-optical
sensor, infrared sensor, photodetector, fiberoptic sensor, and/or
LEDs as sensors, etc.; also LEDs can be multiplexed in such a
circuit, such that it can be used for both light emission and
sensing at different times. Examples of electrical sensors may
include oxygen sensor, CO2 sensor, pH glass electrode, and/or a
current sensor, etc. Examples, of thermal sensors may include
Infrared thermometer, resistance temperature detector, resistance
temperature detector, resistance thermometer, thermistor,
thermocouple, thermometer, etc.
[0129] In some embodiments, temperature and impedance values may be
tracked on a display screen or directly linked to a microprocessor
capable of signaling control electronics to alter the energy
delivered to the tip when preset values are approached or exceeded.
Typical instrumentation paths are widely known, such as thermal
sensing thermistors, and may feed to analog amplifiers which, in
turn, feed analog digital converters leading to a microprocessor.
In some embodiments, internal or external ultrasound measurements
may also provide information which may be incorporated into a
feedback circuit. In an embodiment, an optional mid and low
frequency ultrasound transducer may also be activated to transmit
energy to the tip and provide additional heating and may
additionally improve lysing. In some embodiments, a flashing
visible light source, for example, an LED, can be mounted on the
tip may show through the tissues and/or organs to identify the
location of the device.
[0130] In some embodiments, one or more electromagnetic delivery
elements 415 may be positioned on tip or shaft. Other embodiments
may comprise one or more electromagnetic delivery elements on any
other suitable location on the TDM, including but not limited to on
the protrusions or otherwise on the tip, and on the shaft.
Electromagnetic delivery elements that may be useful include: LEDs,
LASERs, fiberoptics, filaments, photoelectric materials, infrared
emitters, etc.
[0131] Alternatively, in some embodiments, since cutting or
electrical current may cause an effect at a distance without direct
contact, the lysing element may be recessed into the relative
recessions or grooves defined by the protrusions 404 or,
alternatively, may be flush with protrusions 404. In some further
adjustable embodiments, locations of the electrically conductive
lysing elements with respect to the protrusions may be adjusted by
diminutive screws or ratchets. In some further adjustable
embodiments, locations of the electrically conductive lysing
elements with respect to the protrusions may be adjusted by MEMS or
microelectronics.
[0132] Some embodiments may comprise a low cost, disposable, and
one-time-use device. However, in some embodiments intended for
multiple uses, the tip's electrically conductive tissue lysing
elements be protected or coated with materials that include, but
are not limited to, Silverglide.TM. non-stick surgical coating,
platinum, palladium, gold and rhodium. Varying the amount of
protective coating allows for embodiments of varying potential for
obsolescence capable of either prolonging or shortening instrument
life.
[0133] In some embodiments, the electrically conductive lysing
element portion of the tip may arise from a plane or plate of
varying shapes derived from the aforementioned materials by methods
known in the manufacturing art, including but not limited to
cutting, stamping, pouring, molding, additive manufacturing, filing
and sanding. In some embodiments, the electrically conductive
lysing element 405 may comprise an insert attached to a conductive
element in the shaft or continuous with a formed conductive element
coursing all or part of the shaft. In some embodiments, an
electrically conductive element or wiring in conduit 411 brings RF
electrosurgical energy down the shaft to electrically conductive
lysing elements 405 associated in part with the recessions. In an
embodiment, the electrosurgical energy via conduit 411 is
predominately electro-cutting.
[0134] In some embodiments, the electrically conductive element or
wiring may be bifurcated to employ hand switching if an optional
finger switch is located on handle. The electrically conductive
element or wiring leading from the shaft into the handle may be
bundled with other electrical conduits or energy delivering cables,
wiring and the like and may exit the proximal handle as insulated
general wiring to various generators (including electrosurgical),
central processing units, lasers and other sources as have been
described herein. In some embodiments, the plate making up lysing
segments 405 may be sharpened or scalloped or made to slightly
extend outwardly from the tip recessions into which the plate will
fit.
[0135] Alternatively, in some embodiments, since cutting or
electrical current may cause an effect at a distance without direct
contact, the lysing element may be recessed into the relative
recessions or grooves defined by protrusions 404 or, alternatively,
may be flush with protrusions 404. In some further adjustable
embodiments, locations of the electrically conductive lysing
elements with respect to the protrusions may be adjusted by
diminutive screws or ratchets. The plate, which in some embodiments
is between 0.01 mm and 1 mm thick, can be sharpened to varying
degrees on its forward facing surface. It is possible that plate
sharpness may increase the efficiency with which electricity will
pass from the edge cutting the target tissue. Sometimes, however,
proper function even when variably dull or unsharpened may be
unhampered since electrosurgical cutting current may cut beyond the
electroconductive edge by a distance of over 1 mm.
[0136] In some embodiments, the electrically conductive lysing
element may also exist in the shape of a simple wire of 0.01 mm to
3 mm. In some embodiments, the wire may measure between 0.1 mm and
1 mm. Such a wire may be singly or doubly insulated as was
described for the plate and may have the same electrical
continuities as was discussed for the planar (plate) version. In
some embodiments, an electrosurgical current for the electrically
conductive lysing element is of the monopolar "cutting" variety and
setting and may be delivered to the tip lysing conductor in a
continuous fashion or, alternatively, a pulsed fashion. The surgeon
can control the presence of current by a foot pedal control of the
electrosurgical generator or by button control on the shaft
(forward facing button). The amount of cutting current may be
modified by standard interfaces or dials on the electro surgical
generator. In some embodiments, the electrosurgically energized tip
current can be further pulsed at varying rates by interpolating
gating circuitry at some point external to the electrosurgical
generator by standard mechanisms known in the art, that may range
from about 1 per second to about 60 per second. In some
embodiments, the rate may vary from about 1 per second to about 150
per second. In some embodiments, the electrosurgically energized
tip current can be further pulsed at varying rates by gating
circuitry within the electrosurgical generator by standard
mechanisms known in the art. For some embodiments, the electrically
conductive lysing element is a monopolar tip in contact with
conductive elements in the shaft leading to external surgical cable
leading to an electrosurgical generator from which emanates a
grounding or dispersive plate which may be placed elsewhere in
contact with the patient's body, such as the thigh.
[0137] Such circuitry may be controlled and gated/wired from the
cutting current delivery system of the electro surgical generator.
Acceptable electrosurgical generators may include Valley Lab Force
1 B.TM. with maximum P-P voltage of 2400 on "cut" with a rated load
of 300 Ohms and a maximum power of 200 Watts, 35 maximum P-P
voltage of 5000 on "coagulate" with a rated load of 300 Ohms, and a
maximum power of 75 Watts ValleyLab Force 4 has a maximum P-P
voltage of 2500 on "cut" with a rated load of 300 Ohms and a
maximum power of 300 Watts, 750 kHz sinusoidal waveform output,
maximum P-P voltage of 9000 on "coagulate" with a rated load of 300
Ohms and a maximum power of 120 Watts using a 750 kHz damped
sinusoidal with a repetition frequency of 31 kHz. In an embodiment,
the tip may also be manufactured from multilayer wafer substrates
comprised of bonded conductive strips and ceramics. Suitable
conductive materials include but are not limited to those already
described for tip manufacture. In some embodiments, electrically
non-conductive portions of the tip may comprise ceramics. In some
embodiments, electrically conductive portions of the tip may
comprise cermets.
[0138] In alternative embodiments the geometry of the tip area may
comprise protrusions that are not oriented along the axis of the
shaft (as seen from a top view); some of these alternative
embodiments for tip area geometries are depicted in FIGS.
5a,b,c,d,e,f,g,h and FIGS. 6a,b,c,d. Some embodiments may be
configured to be modular and/or comprise disposable tips such that
a surgeon can place an appropriate tip for a particular surgery on
the shaft. Alternatively or additionally one or more of the tips
may be disposable such that a surgeon may dispose of the tip after
performing surgery and install a new tip for subsequent surgeries
or a continuation of the current surgery with a new tip.
[0139] In some embodiments, a vibration means 470b may be
positioned in the handle. Other embodiments may comprise one or
more vibration means on any other suitable location on the TDM,
including but not limited to on the protrusions or otherwise on the
tip, and on the shaft. Examples of suitable vibration means may
include piezoelectric materials, ultrasonic motors with stators,
piezoelectric actuators, vibration motor such as an off-center
weight mounted on a gear, etc. Some vibration means may be
configured to emit ultrasound in the 20-40 kHz range. Yet other
vibration means may include electromagnet drivers with a frequency
of operation in the range of 150-400 Hz. In some embodiments, one
or more vibration means may be used to provide additional forces
which may facilitate passage of the TDM. In some embodiments, one
or more vibration means may be used to reduce debris on the
electrosurgical or other components of the TDM. In a further
embodiment, a vibration means may be directly or indirectly
connected to one or more of the lysing segments.
[0140] In alternative embodiments, the electrically conductive
lysing elements may be bifurcated or divided into even numbers at
the relative recessions, insulated and energized by wiring to an
even number of electrical conduits in a bipolar fashion and
connected to the bipolar outlets of the aforementioned
electrosurgical generators. Rings partly or completely encircling
the shaft of the hand unit can be linked to a partner bipolar
electrode at the tip or on the energy window. Such bipolar versions
may decrease the available power necessary to electrically modify
certain tissues, especially thicker tissues In alternative
embodiments, the lysing elements may be divided into odd numbers
yet still allow for bipolar flow between two or more elements as
those of ordinary skill in the art would appreciate. FIG. 4b is a
side elevation view of the embodiment previously depicted in FIG.
4a. In the depicted embodiment, tip 401b may be made of materials
that are both electrically non-conductive and of low thermal
conductivity such as porcelain, epoxies, ceramics, glass-ceramics,
plastics, or varieties of polytetrafluoroethylene. Alternatively,
the tip may be made from metals or electroconductive materials that
are completely or partially insulated. Note the relative
protrusions and relative recessions are not completely visible from
this viewing angle. The tip shown in this embodiment has four
relative protrusions and three relative recessions and provides for
a monopolar tip conductive element. In some embodiments, the
relative recessions of the tip is the electrically conductive
tissue lysing element 405 (usually hidden from view at most angles)
which may have any geometric shape including a thin cylindrical
wire; the electrically conductive lysing element can be in the
shape of a plate or plane or wire and made of any metal or alloy
that does not melt under operating conditions or give off toxic
residua. Optimal materials may include but are not limited to
steel, nickel, alloys, palladium, gold, tungsten, silver, copper,
and platinum. Metals may become oxidized thus impeding electrical
flow and function. In an embodiment, the lysing element may
comprise a cermet.
[0141] In some embodiments, one or more suction/vacuum ports 417b
may be provided on or about the tip or distal shaft. The port(s)
may be fluidly coupled with a vacuum; the vacuum may comprise a
pump or a negative pressure chamber or a syringe at the end of a
fluid conduit. Other embodiments may comprise one or more
suction/vacuum ports on any other suitable location on the TDM,
including but not limited to on the protrusions or otherwise on the
tip, and on the shaft. In some embodiments, a fluid delivery port
416b may be provided. In some embodiments the fluid delivery port
may be coupled with a pump or high pressure fluid. In some
embodiments the port may be perpetually open such that fluid may be
delivered therethrough upon actuation of a pump or fluid pressure
system. In other embodiments the port may be closed and selectively
opened to deliver fluid therethrough. Other embodiments may
comprise one or more fluid ports on any other suitable location on
the TDM, including but not limited to on the protrusions or
otherwise on the tip, and on the shaft. Fluid ports that may be
useful may comprise channels within the TDM, polymer lines, hoses,
etc. Fluids that may emanate from the outlet may comprise ionic
fluids such as saline, medicines (including but not limited to
antibiotics, anesthetics, antineoplastic agents, bacteriostatic
agents, etc.), non-ionic fluids, and or gasses (including but not
limited to nitrogen, argon, air, etc.). In some embodiments fluids
may be under higher pressures or sprayed. It should be understood
that although these elements (416b & 417b) are not depicted in
every one of the other figures, any of the embodiments described
herein may include one or more such elements.
[0142] In the depicted embodiment, 418b represents an antenna, such
as an RFID TAG. In embodiments in which antenna 418b comprises an
RFID tag, the RFID tag may comprise an RFID transponder. In other
embodiments the RFID tag may comprise a passive tag. It should be
understood that antenna 418b is not depicted in every one of the
other figures, any of the embodiments described herein may comprise
one or more such elements. Other embodiments may comprise one or
more antennas on any other suitable location on the TDM, including
but not limited to on the protrusions or otherwise on the tip, and
on the shaft. In some embodiments an RFID transponder or another
antenna may comprise a microchip, such as a microchip having a
rewritable memory. In some embodiments, the tag may measure less
than a few millimeters. In some embodiments a reader may generate
an alternating electromagnetic field which activates the RFID
transponder/antenna and data may be sent via frequency modulation.
In an embodiment, the position of the RFID tag/antenna may be
determined by an alternating electromagnetic field in the
ultra-high frequency range. The position may be related to a 3
dimensional mapping of the subject. In an embodiment the reader may
generate an alternating electromagnetic field. In some such
embodiments, the alternating electromagnetic field may be in the
shortwave (13.56 MHz) or UHF (865-869 MHz) frequency.
[0143] In some embodiments tip 401 may be attached to a robotic
arm. In some embodiments, tip 401 and portion of shaft 402 may be
attached to a robotic arm. In some embodiments tip 401 and/or a
portion of shaft 402 and/or a portion shaft and/or portion of
handle 403 may be attached to a robotic arm. In some embodiments,
the robotic arm may comprise one or more motors such as a
screw-drive motor, gear motor, hydraulic motors, etc. In some
embodiments the robotic arm system may comprise worm gearheads,
video cameras, motor control circuits, monitors, remote control
devices, illumination sources, tactile interface, etc.
[0144] FIG. 5a is an upper plan view illustrating the protrusions
and lysing segments of an embodiment of a tissue dissector and
modifier, wherein some of the protrusions and lysing segments are
oriented in a non-axial direction and the non-axial protrusions do
not extend beyond the width of the distal shaft (and the axis of
comparison is that of the shaft as seen from a top view). In some
embodiments, the tip may measure about 1 cm in width and about 1-2
mm in thickness. Sizes of about one-fifth to about five times these
dimensions may also have possible uses.
[0145] In the embodiment depicted in FIG. 5a, the non-axial
protrusions 551a of tip 501a do not extend beyond the width of the
distal shaft 502a, which leads to handle 503a. In this embodiment,
non-axial protrusions 551a extend in a direction that is at least
substantially perpendicular to the direction in which axial
protrusions 504a extend. More particularly, there are two sets of
non-axial protrusions 551a (one depicted on the right side and one
on the left side of the embodiment of FIG. 5a). Both sets of
non-axial protrusions 551a extend in directions that are at least
substantially perpendicular to the direction in which axial
protrusions 504a extend (namely, along a longitudinal axis of the
TDM shaft). In addition, it can be seen in FIG. 5a that the two
sets of non-axial protrusions 551a extend in directions that are at
least substantially opposite from one another.
[0146] In some embodiments, axial protrusions 504a may extend at
least substantially along a longitudinal axis of the shaft, as
described above, and non-axial protrusions 551a may extend at an
angle of between zero degrees and 30 degrees of a normal to the
direction in which the axial protrusions 504a extend. It is
contemplated that it may desirable for some implementations and
embodiments to provide non-axial tips extending in a direction or
directions falling within this range in order to, for example,
allow a surgeon to effectively perform both a to and fro, and a
side-to-side ("windshield wiper") motion using the TDM.
[0147] In some embodiments, the tip can be a separate piece that is
secured to the shaft by a variety of methods such as a snap
mechanism, mating grooves, plastic sonic welding, etc.
Alternatively, in some other embodiments, the tip can be integral
or a continuation of a shaft made of similar metal or materials. In
some embodiments, the tip may also be constructed of materials that
are both electrically non-conductive and of low thermal
conductivity; such materials might comprise, for example,
porcelain, ceramics, glass-ceramics, plastics, varieties of
polytetrafluoroethylene, carbon, graphite, and graphite-fiberglass
composites. In some embodiments, the tip may be constructed of a
support matrix of an insulating material (e.g., ceramic or glass
material such as alumina, zirconia). External power control bundles
as previously described in other embodiments may connect to
electrically conductive elements to bring RF electrosurgical energy
from an electrosurgical generator down the shaft 502a to
electrically conductive lysing elements 552a mounted in the
recessions in between the protrusions 551a. In some embodiments,
the protrusions may comprise bulbous protrusions. The tip shown in
this embodiment has two relative protrusions and three relative
recessions pointing along the main axis of the TDM and provides for
a monopolar tip conductive element; the tip shown also has fourteen
protrusions pointing in non-axial directions as well as fourteen
relative recessions pointing in non-axial directions. In other
embodiments the tip may have one or more non-axial protrusions and
one or more non-axial relative recessions. In some embodiments the
tip may have between 3 and 100 non-axial protrusions and relative
recessions. In the depicted embodiment, the tip 501a may
alternatively be made partially or completely of concentrically
laminated or annealed-in wafer layers of materials that may include
plastics, silicon, glass, glass/ceramics, cermets or ceramics.
Lysing elements 552a may also be made partially or completely of a
cermet material. Alternatively, in a further embodiment the tip may
be constructed of insulation covered metals or electroconductive
materials. The lysing segments may be located at the termini of
conductive elements.
[0148] In the depicted embodiment, tip 501a which terminates in
protrusions such as 504a and 551a may be made of materials that are
both electrically non-conductive and of low thermal conductivity
such as porcelain, epoxies, ceramics, glass-ceramics, plastics, or
varieties of polytetrafluoroethylene. Alternatively, the tip may be
made from metals or electroconductive materials that are completely
or partially insulated. In some embodiments, the electrically
conductive tissue lysing element(s) 552a may have any geometric
shape including a thin cylindrical wire, and may be positioned
within the relative recessions of the tip. The electrically
conductive lysing element can be in the shape of a plate or plane
or wire and made of any metal or alloy that does not melt under
operating conditions or give off toxic residua. Optimal materials
may include but are not limited to steel, nickel, alloys,
palladium, gold, tungsten, silver, copper, and platinum. Metals may
become oxidized thus impeding electrical flow and function.
[0149] In some embodiments, the shaft may be flat, rectangular or
geometric in cross-section and/or substantially flattened. In some
embodiments, smoothing of the edges of the shaft may reduce
friction on the tissues surrounding the entrance wound. In some
further embodiments, the shaft may be made of metal or plastic or
other material with a completely occupied or hollow interior that
can contain insulated wires, electrical conductors, fluid/gas
pumping or suctioning conduits, fiber-optics, or insulation.
[0150] In some embodiments, shaft plastics, such as
polytetrafluoroethylene, may act as insulation about wire or
electrically conductive elements. In some embodiments, the shaft
may alternatively be made partially or completely of concentrically
laminated or annealed-in wafer layers of materials that may include
plastics, silicon, glass, glass/ceramics, ceramics carbon,
graphite, and/or graphite-fiberglass composites.
[0151] In FIG. 5a the depicted view of an embodiment of a TDM with
an alternative energy window 507a on the upper side of the device
may be configured to hold an ultrasound energy emitter. It should
be noted that the term "energy window" is intended to encompass
what is referred to as a planar-tissue-altering-window/zone in U.S.
Pat. No. 7,494,488 and, as described herein, need not contain a
ultrasonic energy emitter in all embodiments. Additionally, the
"energy window" may comprise a variety of other energy emitting
devices, including but not limited to radiofrequency, microwave,
light, intense pulsed light, LASER, and thermal. Certain components
of the energy window, such as the electro-conductive components of
the energy window, could comprise a cermet. A second energy window
508a may also be included in some embodiments, and may comprise yet
another ultrasonic energy emitter or another variety of energy
emitting device. In some embodiments, energy windows 507a and/or
508a may only be substantially planar, or may take on other
cross-sectional shapes that may correspond with a portion of the
shape of the shaft, such as arced, stair-step, or other geometric
shapes/curvatures. In the embodiment depicted in FIG. 5a, energy
window 507a is adjacent to protrusions 504a and 551a, however other
embodiments are contemplated in which an energy window may be
positioned elsewhere on the shaft 502a or tip 501a of the wand, and
still be considered adjacent to protrusions 504a or 551a. For
example, in an embodiment lacking energy window 507a, but still
comprising energy window 508a, energy window 508a would still be
considered adjacent to protrusions 504a and 551a. However, if an
energy window was placed on handle 503a, such an energy window
would not be considered adjacent to protrusions 504a or 551a.
[0152] In some embodiments, one or more sensors such as for example
sensors 510a and 514a may be positioned on the device. The sensors
510a and 514a may comprise any of the sensors described in the
specification herein. Other embodiments may comprise one or more
sensors on any other suitable location on the TDM, including but
not limited to on the protrusions or otherwise on the tip, and on
the shaft. Sensors that may be useful include thermal sensors,
photoelectric or photo optic sensors, cameras, etc. In some
embodiments, one or more sensors may be used to monitor the local
post passage electrical impedance or thermal conditions that may
exist near the distal tip of the shaft or on the tip. Some
embodiments may also comprise one or more sensors incorporating
MEMS (Micro Electro-Mechanical Systems) technology, such as MEMS
gyroscopes, accelerometers, and the like. Such sensors may be
positioned at any number of locations on the TDM, including within
the handle in some embodiments. In some embodiments, sensor 514a
may comprise fiberoptic elements. In an embodiment, the sensor can
be configured to sense a temperature of tissue adjacent to the
apparatus during one or methods described herein. The temperature
sensor may alternatively be configured or sense a temperature of
one or more fluids adjacent to the apparatus such as for example
tissue fluids and/or fluids introduced by the surgeon.
[0153] Temperature and impedance values may be tracked on a display
screen or directly linked to a microprocessor capable of signaling
control electronics to alter the energy delivered to the tip when
preset values are approached or exceeded. Typical instrumentation
paths are widely known, such as thermal sensing thermistors, and
may feed to analog amplifiers which, in turn, feed analog digital
converters leading to a microprocessor. In some embodiments,
internal or external ultrasound measurements may also be taken
during a procedure with the TDM. Sensors that may be useful include
thermal sensors, photoelectric or photo optic sensors, cameras,
etc. Temperature sensors that may be useful in connection with
embodiments disclosed herein include, but are not limited to,
resistance temperature sensors, such as carbon resistors, film
thermometers, wire-wound thermometers, or coil elements. Some
embodiments may comprise thermocouples, pyrometers, or non-contact
temperature sensors, such as total radiation or photoelectric
sensors.
[0154] In some embodiments, one or more electromagnetic delivery
elements 515a may be positioned on tip or shaft. Other embodiments
may comprise one or more electromagnetic delivery elements on any
other suitable location on the TDM, including but not limited to on
the protrusions or otherwise on the tip, and on the shaft.
Electromagnetic delivery elements that may be useful include: LEDs,
LASERs, fiberoptics, filaments, photoelectric materials, infrared
emitters, etc.
[0155] In embodiments of tips with at least some non-axial
placement of protrusion and or relative recessions, surgeons may
implement the use of a fanning motion which may comprise a
`windshield wiper` motion.
[0156] FIG. 5b is an upper plan view illustrating the protrusions
and lysing segments of an alternative embodiment of a tissue
dissector and modifier, wherein some of the protrusions and lysing
segments are oriented in a non-axial direction and some of the
non-axial protrusions extend beyond the width of the distal shaft.
In the depicted embodiment 501b represents the tip area which lies
adjacent to shaft area 502b which is connected to handle area 503b;
504b represents an axially aligned protrusion; 551b represents a
non-axially aligned protrusion; 552b represents a non-axially
aligned relative recession; 507b represents a first energy window;
508b represents a second energy window; 510b and 514b represent
sensor elements; 515b represents an electromagnetic radiation
delivery element.
[0157] FIG. 5b is an upper plan view illustrating the protrusions
and lysing segments of an alternative embodiment of a tissue
dissector and modifier, wherein some of the protrusions and lysing
segments are oriented in a non-axial direction and some of the
non-axial protrusions extend beyond the width of the distal shaft.
In the depicted embodiment 501b represents the tip area which lies
adjacent to shaft area 502b which is connected to handle area 503b;
504b represents an axially aligned protrusion; 551b represents a
non-axially aligned protrusion; 552b represents a non-axially
aligned relative recession; 507b represents a first energy window;
508b represents a second energy window; 510b and 514b represent
sensor elements similar to those previously discussed in other
embodiments; 515b represents an electromagnetic radiation delivery
element similar to those previously discussed in other
embodiments.
[0158] FIG. 5c is a lower plan view of the embodiment of FIG. 5a
illustrating the protrusions and lysing segments of a tissue
dissector and modifier, wherein some of the protrusions and lysing
segments are oriented in a non-axial direction and the non-axial
protrusions do not extend beyond the width of the distal shaft. In
the depicted embodiment 501a represents the tip area which lies
adjacent to shaft area 502a which is connected to handle area 503a;
516a represents a fluid port; 517a represents a suction and/or
vacuum port; 518a represents an antenna, such as an RFID TAG. In
embodiments in which antenna 518a comprises an RFID tag, the RFID
tag may comprise a RFID transponder. In other embodiments the RFID
tag may comprise a passive tag. It should be understood that
although antenna 518a is not depicted in every one of the other
figures, any of the embodiments described herein may include one or
more such locations. Other embodiments may comprise one or more
antennas on any other suitable location on the TDM, including but
not limited to on the protrusions or otherwise on the tip, and on
the shaft. In some embodiments an RFID transponder or other antenna
may comprise a microchip such as a microchip having a rewritable
memory. In an embodiment the tag is millimeter sized. In some
embodiments a reader generates an alternating electromagnetic field
which activates the antenna/RFID transponder and data is sent via
frequency modulation. In an embodiment, the position of the
antenna/RFID tag is determined by an alternating electromagnetic
field in the ultra-high frequency range. The position may be
related to a 3 dimensional mapping of the subject. In an embodiment
the reader may generate an alternating electromagnetic field. In a
further embodiment the alternating electromagnetic field may be in
the shortwave (13.56 MHz) or UHF (865-869 MHz) frequency.
[0159] In some embodiments, a suction/vacuum port 517a may be
provided on or about the tip or distal shaft. The port may be
fluidly coupled with a vacuum; the vacuum may comprise a pump or a
negative pressure chamber or a syringe at the end of a fluid
conduit. Other embodiments may comprise one or more suction/vacuum
ports on any other suitable location on the TDM, including but not
limited to on the protrusions or otherwise on the tip, and on the
shaft. In some embodiments, a fluid delivery port 516a may be
provided. In some embodiments the fluid delivery port may be
coupled with a pump or high pressure fluid. In some embodiments the
port may be perpetually open such that fluid may be delivered
therethrough upon actuation of a pump or fluid pressure system. In
other embodiments the port may be closed and selectively opened to
deliver fluid therethrough. Other embodiments may comprise one or
more fluid ports on any other suitable location on the TDM,
including but not limited to on the protrusions or otherwise on the
tip, and on the shaft. Fluid ports that may be useful include
channels within the TDM, polymer lines, etc. Fluids that may
emanate from the port may include ionic fluids such as saline,
medicines (including but not limited to antibiotics, anesthetics,
antineoplastic agents, bacteriostatic agents, etc.), non-ionic
fluids, and or gasses (including but not limited to nitrogen,
argon, air, etc.). In some embodiments fluids and or gasses may be
under pressure or sprayed. It should be understood that although
elements 516a and/or 517a are not depicted in every one of the
other figures, any of the embodiments described herein may include
one or more such elements.
[0160] In some embodiments tip 501a may be attached to a robotic
arm. In some embodiments tip 501a and portion of shaft 502a may be
attached to a robotic arm. In some embodiments tip 501a and a
portion of shaft 502a and or a portion of handle 503a may be
attached to a robotic arm.
[0161] FIG. 5d is a lower plan view of the embodiment of FIG. 5b
illustrating the protrusions and lysing segments of a tissue
dissector and modifier, wherein some of the protrusions and lysing
segments are oriented in one or more non-axial directions and at
least some of the non-axial protrusions extend beyond the width of
the distal shaft. In the depicted embodiment tip area 501b
represents the tip area which lies adjacent to shaft area 502b
which is connected to handle area 503b; this particular embodiment
also comprises fluid port 516b; suction port 517b; 518b represents
an antenna, such as an RFID TAG. In embodiments in which the
antenna comprises an RFID tag, the RFID tag may comprise a RFID
transponder. In other embodiments the RFID tag may comprise a
passive tag. It should be understood that although antenna 518b is
not depicted in every one of the other figures, any of the
embodiments described herein may include one or more such
locations
[0162] FIG. 5e is an upper plan view illustrating the protrusions
and lysing segments of an embodiment of a tip area of a tissue
dissector and modifier. This embodiment comprises a plurality of
axial protrusions 504e (axially meaning at least substantially
parallel to an axis of a corresponding TDM shaft). This embodiment
further comprises a plurality of non-axial protrusions 551e along
the right side of the tip and a plurality of non-axial protrusions
positioned along the left side of the tip. The tip further
comprises two non-axial corner protrusions 554e. The tip further
comprises a plurality of recessions 552e. One or more of the
recessions may further comprise a lysing segment 553e. 556e is an
edge of the tip not populated with protrusions or relative
recessions. 507e is a first energy window located in the base 555e
of tip 501a; 557e is a tab that extends from base 555e and may be
used to secure the tip within a corresponding shaft of a TDM
device. Tab 557e may be made up of a ceramic material in some
embodiments. Tab 557e may further comprise cut-out regions 558e to
allow for a snap or fixation of the tip inside a corresponding TDM
shaft.
[0163] FIG. 5f is an upper plan view illustrating the protrusions
and lysing segments of another embodiment of a tip area of a tissue
dissector and modifier. This embodiment may comprise a plurality of
axial protrusions 504f and a plurality of non-axial protrusions
551f. In addition, this embodiment comprises two transitional or
corner protrusions 554f. A plurality of recessions 552f are also
depicted, one or more of which may comprise corresponding lysing
segments 553f. 556f is an edge of the tip not populated with
protrusions or relative recessions. 555f is the base of tip 501f; a
first energy window, may be at least partially located in a space
507f of hollow tab 557f of tip 501f. 557f is a tab that, as
described above, may be used to secure the tip inside a
corresponding shaft of a TDM device. The embodiment of FIG. 5f may
further comprise a slot 558f in tab 557f to allow for a snap or
fixation of the tip inside the shaft. In other embodiments, the
base of the tip may also have a cavity or space to accommodate a
portion of the distal shaft; also, the distal shaft may have a
cavity or space to accommodate a portion of a tab of a tip.
[0164] FIG. 5g is an upper plan view illustrating the protrusions
and lysing segments of an embodiment of a tip area of a tissue
dissector and modifier. This embodiment comprises a plurality of
axial protrusions; this embodiment further comprises a plurality of
non-axial protrusions 551g along the right side of the tip and a
plurality of non-axial protrusions positioned along the left side
of the tip. The tip further comprises two non-axial corner
protrusions. The tip further comprises a plurality of recessions
552g. One or more of the recessions may further comprise a lysing
segment 553g. 560g is a space within the base of the tip that may
be used to secure a portion of a shaft within this TDM device
tip.
[0165] FIG. 5h is a lower plan view illustrating the protrusions
and lysing segments of another embodiment of a tip area of a tissue
dissector and modifier. This embodiment may comprise a plurality of
axial protrusions and a plurality of non-axial protrusions 551h. In
addition, this embodiment comprises two transitional or corner
protrusions. A plurality of recessions 552h are also depicted, one
or more of which may comprise corresponding lysing segments. A
first energy window, may be at least partially located within a
hollow space 507h which is in turn located between the legs of tab
557h of tip 501h. Tab 557h may be used to secure the tip inside a
corresponding shaft of a TDM device. The embodiment of FIG. 5h may
further comprise one or more slots in tab 557h to allow for a snap
or fixation of the tip inside the shaft. The tip of FIG. 5h further
comprises antenna 518h, such as an RFID tag.
[0166] The tips depicted in FIGS. 5a,b,c,d,e,f,g,h and FIGS.
6a,b,c,d are contemplated to be able to be used with any of the
embodiments discussed herein. Said tips are not intended to be
restricted to symmetry and/or pattern and/or dimension. In other
embodiments said tips may be asymmetrical or lacking protrusions
and/or lysing segments on one side or another.
[0167] FIG. 6a is an upper plan view illustrating an embodiment of
a tissue dissector and modifier with an asymmetrical tip area. More
particularly, the embodiment of FIG. 6a comprises a plurality of
axial protrusions 604a along the distal end of the tip 601a, and a
plurality of non-axial protrusions 651a along a left side of the
tip 601a. The right side of the tip 601a lacks any protrusions and
thus also lacks recessions. Instead, the right side of the tip 601a
comprises an at least substantially flat surface 659a. Since the
left and right sides of tip 601a differ, the embodiment of FIG. 6a
comprises an asymmetrical tip 601a. In addition, the non-axial
protrusions 651a do not extend beyond the width of the distal shaft
602a, as shown in the figure. The embodiment of FIG. 6a further
comprises a first energy window 607a positioned on tip 601a and a
second energy window 608a positioned on shaft 602a. In addition,
the embodiment of FIG. 6a comprises an electromagnetic delivery
element 615a, a first sensor 610a and a second sensor 614a. Each of
these three components is positioned on the shaft 602a. However, as
previously described, in alternative embodiments, one or more such
components may be located elsewhere on the device, such as on the
tip 601a and/or handle 603a.
[0168] FIG. 6b is an upper plan view illustrating another
embodiment of a tissue dissector and modifier with an asymmetrical
tip area. Like the embodiment of FIG. 6a, this embodiment comprises
both axial and non-axial protrusions. However, unlike the
embodiment of FIG. 6a, this embodiment comprises non-axial
protrusions that extend beyond the width of the distal shaft
602b.
[0169] More particularly, the embodiment of FIG. 6b comprises a
plurality of axial protrusions 604b positioned along the distal end
of the tip 601b, and a plurality of non-axial protrusions 651b
positioned along a left side of the tip 601b. The right side of the
tip 601b lacks any protrusions and thus also lacks recessions. Like
the embodiment of FIG. 6a, the right side of the tip 601b comprises
an at least substantially flat surface 659b. Since the left and
right sides of tip 601b differ, the embodiment of FIG. 6b also
comprises an asymmetrical tip 601b. As previously mentioned, the
non-axial protrusions 651b extend beyond the width of the distal
shaft 602b.
[0170] Like the embodiment of FIG. 6a, the embodiment of FIG. 6b
further comprises a first energy window 607b positioned on tip 601b
and a second energy window 608b positioned on shaft 602b. In
addition, the embodiment of FIG. 6b comprises an electromagnetic
delivery element 615b, a first sensor 610b and a second sensor
614b. Each of these three components is positioned on the shaft
602b. However, as previously described, in alternative embodiments,
one or more such components may be located elsewhere on the device,
such as on the tip 601b and/or handle 603b.
[0171] FIG. 6c is an upper plan view illustrating the protrusions
and lysing segments of an embodiment of a tip area of a tissue
dissector and modifier. The tip depicted in this figure is
asymmetrical since side 659c lacks protrusions and the opposite
side comprises non-axial protrusions 651c. This embodiment also
comprises a corner protrusion 654c that extends at a transitional
angle relative to axial protrusions 604c and non-axial side
protrusions 651c. In some embodiments, one or more transitional
angle is acute. In some embodiments, one or more transitional
angles may be obtuse. As shown in the figure, protrusions 651c
extend beyond the profile of the tip, and therefore may extend
beyond a width of a corresponding shaft.
[0172] In some embodiments, the tip depicted in FIG. 6c may be
modular such that the tip may be selectively added to, and removed
from, a corresponding shaft of a TDM device. Such a modular system
may allow a surgeon to, for example, dispose of the tip after or
during a surgery due to debris build-up. Additionally, or
alternatively, such a modular tip may allow a surgeon to use a
variety of different tips useful for a variety of different types
of surgical procedures. Tab 657c, which extends from base 655c of
the tip, may be used to secure the tip to a corresponding TDM
shaft. For example, some embodiments of TDM shafts may be
configured with a slot configured to receive tab 657c. One or more
clips, recesses, protrusions, or the like, may be used to secure
the tab 657c within its corresponding slot, such as by way of a
snap-fit engagement, for example. Alternatively, tab 657c may be
configured to fit within a corresponding slot with a friction fit,
adhesive, screws, bolts, rivets, or other fasteners.
[0173] FIG. 6d is a lower plan view illustrating the protrusions
and lysing segments of another embodiment of a tip area of a tissue
dissector and modifier, wherein the tip is asymmetrical. The tip of
FIG. 6d also comprises a tab 657d extending from base 655d and
therefore, as described above in connection with the embodiment of
FIG. 6c, may be modular such that the tip can be removed from
and/or selectively coupled with a corresponding TDM shaft.
[0174] The tip of FIG. 6d further comprises a plurality of axial
protrusions 604d, a plurality of side, non-axial protrusions 651d,
and two corner protrusions 654d extending from opposing corners of
the distal end of the tip. Unlike the embodiment of FIG. 6c, the
side, non-axial protrusions 651d of the embodiment of FIG. 6d do
not extend beyond the profile of the tip, and therefore may be
configured so as to avoid extending beyond a width of a distal
portion of a corresponding shaft of a TDM. The tip of FIG. 6d
further comprises an antenna 618d, such as an RFID tag.
[0175] An embodiment of a system 700 for performing robotic surgery
using a TDM is depicted in FIG. 7a. System 700 may comprise a
tissue dissecting and modifying wand (TDM) 701. TDM 701 may
comprise a tissue dissecting and modifying wand (TDM) that may, as
described elsewhere herein, comprise a plurality of protrusions
with one or more recessions positioned therebetween. TDM 701 may be
coupled with one or more robotic surgery components, such as a
surgical arm.
[0176] In some embodiments, TDM 701 may comprise a shaft, a tip,
and/or a handle, as described elsewhere in this disclosure. In such
embodiments, TDM 701 may be selectively coupled to a robotic arm
such that the TDM 701 can either be used by hand, or coupled with
one or more robotic surgery components to allow a surgeon to
perform a surgical procedure with the TDM 701 remotely and/or
indirectly. In other embodiments, the TDM may be configured to be
integrally coupled with, or otherwise non-selectively coupled with,
one or more robotic surgery components. In such embodiments, it may
not be necessary to configure the TDM 701 with a handle and/or
shaft. In other words, in some embodiments, the TDM 701 may
comprise only a tip.
[0177] In some embodiments, the robotic surgery system 700 may
comprise one or more motors, such as a screw-drive motor, gear
motor, hydraulic motors, etc. In some embodiments, the robotic
surgery system 700 may comprise worm gearheads, video cameras,
motor control circuits, monitors, remote control devices,
illumination sources, tactile interface, etc. In the embodiment
depicted in FIG. 7a, TDM 700 comprises a TDM tip 701a that is
positioned at the end of a robotic arm. This robotic arm comprises
a plurality of arm segments 773 with corresponding joints 776
positioned therebetween. A primary joint 777 may be positioned to
support and articulate together each of the arm segments 773 and
smaller joints 776. Primary joint has a primary arm segment 774
that extends therefrom. Finer movements of the robotic arm may then
be accomplished using one or more of the smaller joints 776.
A stand 781 may also be provided to support the various robotic
arms. In some embodiments, stand 781 may also be configured to
support a monitor 779 and/or other display, input, or control
components, such as a control element 778. In some embodiments,
control element 778 may comprise a hand control toggle 778. In
other embodiments, control element 778 may comprise a keyboard,
mouse, touchscreen display, virtual reality system, control pad, or
the like. Monitor 779 and/or control element 778 may be
communicatively coupled with a central processing unit 780.
[0178] Central processing unit 780 may comprise, for example, one
or more microprocessors and/or other electronic components, such as
data connectivity elements, memory, non-transitory computer
readable media, etc. In some embodiments, central processing unit
780 may comprise a general-purpose computer. Central processing
unit 780 may further comprise a machine-readable storage device,
such as non-volatile memory, static RAM, dynamic RAM, ROM, CD-ROM,
disk, tape, magnetic storage, optical storage, flash memory, or
another machine-readable storage medium.
[0179] FIG. 7b illustrates an alternative embodiment of a robotic
arm 772 that may be used with system 700. Robotic arm 772 comprises
an endoscopic snake-like robotic arm 772 and also comprises a TDM
701b positioned at its distal end. As with the embodiment of FIG.
7a, TDM 701b may be selectively coupled to robotic arm 772 or,
alternatively, may be integrally or otherwise non-selectively
coupled to robotic arm 772. Further details regarding robotic
surgery components that may be useful in connection with the
various embodiments disclosed herein may be found in the following
U.S. patent Nos., each of which is hereby incorporated by reference
in its entirety: U.S. Pat. No. 4,259,876 titled Mechanical Arm,
U.S. Pat. No. 4,221,997 titled Articulated Robot Arm and Method Of
Moving Same, U.S. Pat. No. 4,462,748 titled Industrial Robot, U.S.
Pat. No. 4,494,417 titled Flexible Arm, Particularly a Robot Arm,
U.S. Pat. No. 4,631,689 titled Multi-Joint Arm Robot Apparatus,
U.S. Pat. No. 4,806,066 titled Robotic Arm, U.S. Pat. No. 5,791,231
titled Surgical Robotic System and Hydraulic Actuator Therefor,
U.S. Pat. No. 7,199,545 titled Robot For Surgical Applications,
U.S. Pat. No. 7,316,681 titled Articulated Surgical Instrument For
Performing Minimally Invasive Surgery With Enhanced Dexterity and
Sensitivity, U.S. Pat. No. 8,182,418 titled Systems and Methods for
Articulating An Elongate Body, U.S. Pat. No. 8,224,485 titled
Snaking Robotic Arm With Movable Shapers.
[0180] Any of the embodiments of TDM discussed herein including,
but not limited to, the embodiments discussed with FIGS. 1a-g,
FIGS. 2a-b, FIGS. 3a-c, FIGS. 4a-b, FIGS. 5a,b,c,d,e,f,g,h and
FIGS. 6a,b,c,d, etc. may be used in conjunction with one or more of
the robotic surgery elements disclosed in connection with FIGS.
7a-b.
[0181] FIG. 8 depicts a flow chart of an implementation of an
energy emission-sensor feedback loop 800 according to this
disclosure: Step 805 may comprise: setting one or more temperatures
(a desired maximal temperature threshold, or a range). In other
implementations one or more such temperatures may be preset by the
manufacturer. Step 810 may comprise setting one or more energy
levels to lysing area and/or energy windows (a desired maximal
energy threshold, or a range). In other implementations energy
levels may be preset by the manufacturer. Step 815 may comprise
passing the TDM through or by the target tissue area. Step 820 may
comprise applying electrosurgical energy at lysing areas. Step 825
may comprise applying energy at the energy window(s). In some
implementations energy may be only applied at the lysing segments.
In other implementations, energy may only be applied to the energy
window(s). Step 830 may comprise gathering sensor data, such as
temperature data. Step 835 may comprise comparing sensor data to
one or more set temperature levels. Step 840 may comprise, if the
sensed temperature exceeds the threshold, reducing the amount of
energy delivered through the lysing segments and/or the energy
window(s).
[0182] One implementation of a method 900 according to this
disclosure for accessing an organ with the assistance of a TDM is
shown in FIG. 9. In some implementations, surgeon(s) may need to
access tissue and/or an organ to repair or treat it. In some
implementations, the skin surrounding the anticipated entrance
wound for the surgical area may be cleansed by, for example, with
isopropyl alcohol (degreaser) followed by germicidal chlorhexidine
scrub. Then, a local anesthetic may be applied (such as by
injecting) 1% lidocaine+1:10,000 adrenaline to the skin.
[0183] Step 905 may comprise, for minimally invasive procedures or
minimally invasive entrance wounds, performing a limited incision
to allow passage of the maximal width of the tip or shaft of the
TDM. Step 905 may be performed with, for example, a #15
Bard-Parker.TM. Scalpel. This incision may be deepened by scalpel,
scissors or other surgical instrument to enter the desired body
structure or cavity. For larger approaches, such as open abdominal
surgery or trauma surgery step 905 may comprise the initial skin
opening or body cavity opening steps of such a procedure. In some
implementations, step 905 may comprise making the skin incision
using the lysing segments of the TDM. Step 910 may comprise:
applying one or more fluids to the tissues. In some
implementations, step 910 may comprise applying fluids to the
target tissue(s). In some implementations, step 910 may comprise
applying fluids to the tissues to be traversed en route to the
target tissue, in addition to, or as an alternative to applying
fluids directly to the target tissue(s). In some implementations,
the fluid(s) may comprise water. In some implementations, the
fluid(s) may comprise an ionic fluid, such as a saline solution.
The fluid(s) may be applied to the tissue via, for example,
injection, or TDM fluid port or via a separate cannula or catheter
or via pouring or via spray. In some implementations, the fluid(s)
may comprise an ionic fluid and an anesthetic, such as a tumescent
anesthesia. Non-ionic fluids may be used in other implementations;
such fluids may become more ionic by diffusion of some of the
patients' ions present in the surgical field. In some
implementations step 910 may comprise applying one or more fluids
that serve as an ionic fluid, and/or an anesthetic, and/or
adrenaline. In some such implementations, the fluid(s) may comprise
a Klein Formula. In some implementations, the Klein formula and
amount used may be about 100 cc of Klein Formula with saline, 0.1%
lidocaine, epinephrine 1:1,000,000, and NaHCO3 @5 meq/L of
saline).
[0184] Step 915 may comprise: passing the TDM through the various
layers of tissue to create a path to a target organ. In some
implementations, creating a path to a target organ or other target
tissue may comprise creating a path from the incision to the target
organ or other target tissue and/or creating a path around the
target organ or other target tissue to allow for access to other
regions of the target organ or other target tissue. In some
implementations step 915 may further comprise activating the lysing
segments and/or energy window to reduce bleeding or tissues
traversed on the way to the target organ. In some implementations,
the lysing segments and/or energy window may be used to induce
fibrosis along the path, including along a path that may traverse
the perimeter of the target organ/tissue. In some implementations,
the TDM and/or the anticipated path may be visualized using for
example an endoscope, a fiberoptic or camera, an RFID tag or other
antenna. In some implementations, such a device or devices may be
positioned on the TDM. In other implementations such a device or
devices may be separate from the TDM. In some implementations, heat
may be produced or energy may otherwise be released in the tissues
through which the TDM is passed. In some implementations, heating
portions of the tissues the TDM passes by may be undesirable. As
such, in some implementations, undesirable heating of such layers
may be mitigated by applying a cooling step antecedent and or
concurrent with energy delivery with the TDM. Such steps may
comprise use of one or more cooling fluids delivered via the TDM or
one or more separate catheters or cannulas or endoscopes. Such
cooling mechanism(s) may comprise for example, a closed water bag.
Such a bag may be at a temperature of less than 37.degree. C. In
some implementations, cooling objects such as fluid or gel filled
bags may be used that may range in temperature between about
1.degree. C. to about 20.degree. C. In some such implementations,
the fluid or gel may be about 15.degree. C. Other cooling
mechanisms may comprise a dynamic cooling system wherein a cool
liquid or gel is actively pumped into or through a contact cooling
object. Step 920 may comprise identifying important blood vessels,
nerves, ducts, organs or other anatomy in the area surrounding the
target tissue. Step 925 may comprise: adding additional fluids of
the types previously described to the target and/or surrounding
tissues via the TDM port(s) or via one or more separate catheters
or cannulas or endoscopes. Step 930 may comprise: expanding one or
more regions of the path to the target tissue. In some
implementations, step 930 may comprise expanding one or more
path(s) from the incision to the target tissue. In some
implementations, step 930 may comprise expanding a region around
the target tissue such as for example, via a fanning motion. In
some implementations, one or more of the other steps described
herein using the TDM may also be performed with a fanning motion.
In implementations using TDMs with axially oriented protrusions,
such a fanning motion may comprise a to and fro spokewheel pattern.
In implementations using TDMs with nonaxially oriented protrusions,
such a fanning motion may comprise a side-to-side fanning motion;
one example of a fanning motion using a TDM having at least one
nonaxially oriented protrusion may comprise a `windshield wiper`
motion. In some implementations, step 930 may further comprise
activating the energy to the TDM for example the energy to the
lysing segments and/or one or more energy windows. Step 935 may
comprise: observing for bleeding from larger vessels and achieving
hemostasis as needed. In some implementations achieving hemostasis
may be accomplished by cautery, electrifying, ligating, or chemical
methods. In some implementations, the lysing segment and/or the
energy window can be used to achieve the hemostasis. In some
implementations, one or more other devices and/or suture and/or
surgeon's hands may be used to achieve hemostasis for larger
vessels. Step 940 may comprise: removing the TDM with power off and
suturing the wound in the standard fashion. In some
implementations, the tissues traversed may require closure by
suturing and/or stapling. In some implementations, organs and/or
organ systems that the TDM may be useful to access may include but
not limited to muscle, and/or parotid, and/or salivary gland,
and/or thyroid, and/or lung, and/or heart, and/or gastrointestinal,
and/or liver, and/or pancreas, and/or spleen, and/or gallbladder,
and/or kidney, and/or adrenal, and/or prostate, and/or ovary,
and/or uterus, and/or bladder, and/or vascular, and/or lymph nodes
and/or skeleton, and/or lung.
[0185] In some implementations, the TDM may also aid in the
treatment of herniated tissues; for example, once the surgeon has
stabilized and/or repositioned herniated tissue in an acceptable
anatomic location and/or removed a portion and/or all of the
herniated tissues, the tissues peripheral to the hernia, which may
have been weak and/or allowed the herniation of the adjacent tissue
to take place, may be strengthened by such things as sutures and/or
postoperative fibrosis and/or a mesh implant and/or a combination
of the aforementioned things. Energy from the TDM's lysing segments
and/or energy windows may induce such postoperative fibrosis and
may contribute to tissue strengthening in the surgically repaired
area of herniation.
[0186] In some implementations, the TDM may also aid in the
treatment of trauma victims; for example, gunshot and/or blast
injuries and/blunt force trauma. Such patients may be in shock and
bleed to a greater degree than normal due to systemic changes, some
changes of which may consume and/or alter platelets and/or clotting
proteins in the blood. It may be beneficial for surgeons to reach a
vigorously bleeding area more rapidly while achieving a degree of
hemostasis by coagulating smaller vessels along the path to
reaching said vigorously bleeding area (likely due to trauma to a
larger blood vessel). The TDM may have smaller vessel hemostatic
capabilities when energy is applied to lysing segments and/or an
energy window. Having a field of surgery with less bleeding may be
beneficial to the surgeon who is working to find and repair a
larger blood vessel (for example, a femoral or brachial artery).
The size of the TDM's lysing areas may be such that a larger vessel
will not fit into the TDM and thus not be affected by the TDM;
thus, the surgeon may feel more confident that the TDM will not
risk traumatizing a larger blood vessel further.
[0187] FIG. 10 depicts a flow chart of an implementation of a
method for separating and/or modifying tissue using a TDM. In this
particular implementation, the use of combined data from the tissue
dissecting and modifying wand generated from at least the
temperature sensor and the antenna(s) may be used to provide
suitable feedback to a user during treatment. In some
implementations, the TDM Wand may comprise a tip comprising a
plurality of protrusions. One or more lysing segments may be
positioned between at least two adjacent protrusions among the
plurality of protrusions. A temperature sensor may be positioned on
the TDM. The temperature sensor may be configured to sense a
temperature of at least one of tissue and fluid adjacent to the
tissue dissecting and modifying wand during an operation. The fluid
of which a temperature reading is taken may comprise, for example,
fluid from adjacent tissue(s) and/or fluid introduced during the
procedure by way of the TDM and/or another device or procedure. The
TDM may also comprise an antenna(s) such as an RFID tag positioned
on the TDM. In some implementations, the antenna(s) may be
positioned on the tip and/or distal end of the shaft, such as on a
bottom surface of the tip and/or distal end of the shaft. The
antenna(s) may be configured to provide location data regarding a
location of the TDM, such as a particular portion or region of the
TDM for example, during an operation or procedure. Although method
1000 is shown in the figure beginning with step 1005, it should be
understood that any of the preliminary steps described above in
connection with other implementations may be performed in method
1000 as well. For example, one or more of steps (905-930) from
method 900 may be performed in method 1000 if desired. Similarly,
one or more other steps of any of the other implementations
described herein may also be included in the method depicted in
FIG. 10. In some implementations, step 1005 may comprise: receiving
data from the tissue dissecting and modifying wand temperature
sensor. Step 1010 may comprise receiving data from the antenna(s)
such as RFID tag data. Step 1015 may comprise combining the data
generated from at least the temperature sensor and the antenna(s).
In some implementations, the data from the temperature sensor and
the antenna(s) may be combined before it is received. In other
words, a step of "receiving combined data from the tissue
dissecting and modifying wand generated from at least the
temperature sensor and the antenna(s)" may comprise receiving
precombined data (data from the temperature sensor and the
antenna(s) that was combined before it was received) or,
alternatively, may comprise separately receiving temperature data
and antenna(s) data that may be combined to allow for one or more
particular features or functionalities. The combined data may be
used to allow a surgeon or other user to determine one or more
regions within a patient's body that have been adequately treated
using the TDM wand. For example, in some implementations, the
combined data may allow a user to visualize one or more regions
within a patient's body, such as one or more regions that have been
sufficiently treated. This may be accomplished, for example, by
creating an image corresponding with one or more regions of a
patient's body. Such image or images may be highlighted, receive
color changes, or otherwise modified on a display to indicate to
the user which regions have been adequately treated. In some
implementations, such regions may correspond with regions
comprising tissue that has reached a predetermined threshold
temperature.
[0188] In a more general implementation of a method according to
this disclosure for dissection and modification of tissues, a first
step may comprise creating an incision into a patient's skin.
[0189] A second step may comprise inserting a Tissue Dissecting and
Modifying Wand into the incision and positioning the Tissue
Dissecting and Modifying Wand within the body. The Tissue
Dissecting and Modifying Wand may comprise a tip having a plurality
of protrusions with lysing segments positioned between the
protrusions. The Tissue Dissecting and Modifying Wand may also
comprise an energy window positioned on top of the Tissue
Dissecting and Modifying Wand that is configured to deliver energy
to modify tissues.
[0190] A third step may comprise fanning out the Tissue Dissecting
and Modifying Wand to define a target region within which to
dissect and modify tissues. This step may comprise separating
tissue using the lysing segment(s) to define the target region.
During this step, in some implementations, the patient's target
tissue may be placed under tension by stretching/tightening tissues
in or adjacent the target region during the fanning/tissue
separation.
[0191] A fourth step may comprise activating the energy window and
moving the energy window around within the target region for
hemostasis and/or to induce postoperative fibrosis. Alternatively,
the energy window may be activated prior to the third step such
that the step of fanning out the Tissue Dissecting and Modifying
Wand to define the target region also comprises heating tissues to
induce fibrosis and/or hemostasis within the target region.
[0192] In another embodiment of a method for separating and
modifying tissue using a tissue dissecting and modifying wand, the
method may comprise creating an incision into a patient's skin. A
tissue dissecting and modifying wand may be inserted into the
incision. The tissue dissecting and modifying wand may comprise a
tip comprising a plurality of protrusions; at least one lysing
segment positioned between at least two adjacent protrusions among
the plurality of protrusions; and an energy window configured to
deliver energy to tissue adjacent to the tissue dissecting and
modifying wand during a procedure. The energy window may comprise
an ultrasonic energy emitter, wherein the ultrasonic energy emitter
is configured to use electrical energy and emit ultrasonic energy
from the energy window, and wherein the energy window is positioned
and configured to deliver the ultrasonic energy from the tissue
dissecting and modifying wand to tissue adjacent to the tissue
dissecting and modifying wand during a procedure.
[0193] The tissue dissecting and modifying wand may further
comprise a radiofrequency identification tag positioned on the
tissue dissecting and modifying wand and configured to provide
location data regarding a location of the tissue dissecting and
modifying wand during a procedure. In such implementations, data
may be received from the tissue dissecting and modifying wand
generated from the radiofrequency identification tag, wherein the
data allows a user to determine one or more regions within a
patient's body that have been treated using energy from the
ultrasonic energy window.
[0194] In alternative implementations, the energy window may
comprise an impedance-matched microwave emission system. In such
implementations, date may be received from the tissue dissecting
and modifying wand generated from the radiofrequency identification
tag, wherein the data allows a user to determine one or more
regions within a patient's body that have been treated using energy
from the energy window.
[0195] In another implementation of a method for separating and
modifying tissue using a tissue dissecting and modifying wand, the
tissue dissecting and modifying wand may comprise a tip comprising
a first plurality of protrusions and a second plurality of
protrusions, wherein the first plurality of protrusions is
positioned to at least substantially extend in a first direction,
and wherein the second plurality of protrusions is positioned to at
least substantially extend in a second direction distinct from the
first direction; at least one lysing segment positioned between at
least two adjacent protrusions in the first plurality of
protrusions; at least one lysing segment positioned between at
least two adjacent protrusions in the second plurality of
protrusions; and a radiofrequency identification tag positioned on
the tissue dissecting and modifying wand and configured to provide
location data regarding a location of the tissue dissecting and
modifying wand during a procedure. In such implementations, the
method may comprise a step of receiving data from the tissue
dissecting and modifying wand generated from the radiofrequency
identification tag, wherein the data allows a user to locate the
tissue dissecting and modifying wand during a procedure. In this
manner, the RFID tag data may allow a user to, for example,
visualize a current location of the TDM, view information
sufficient to guide a user toward a target area within a patient,
and/or view information sufficient to determine one or more
locations within a patient that have been sufficiently treated
using the TDM (such as the energy window, for example).
[0196] An example of an embodiment of an apparatus according to
this disclosure for tissue dissection and modification may
comprise:
[0197] a handle;
[0198] a tip comprising a plurality of protrusions having one or
more lysing segments positioned between the protrusions; and
[0199] an energy window positioned on an upper side of the
apparatus, wherein the energy window comprises a ultrasonic energy
emitter, and wherein the ultrasonic energy emitter is configured to
absorb electrical energy and emit ultrasonic energy from the energy
window.
[0200] In some embodiments as described above, the energy window
may comprise a electrical elements that are configured to deliver
electrical energy to the ultrasonic energy emitter such that the
ultrasonic energy emitter can then emit ultrasonic energy from the
energy window.
[0201] An example of an embodiment of an apparatus according to
this disclosure for tissue dissection and modification may
comprise:
[0202] a handle;
[0203] a tip comprising a plurality of protrusions having one or
more lysing segments positioned between the protrusions; and
[0204] an energy window positioned on an upper side of the
apparatus, wherein the energy window comprises an ultrasonic energy
emitter, and wherein the ultrasonic energy emitter is configured to
use electrical energy and emit ultrasonic energy from the energy
window.
[0205] In some embodiments as described above, the energy window
may comprise a electrical elements that are configured to deliver
energy to the ultrasound media such that the ultrasonic energy
emitter can then emit ultrasonic energy from the energy window.
[0206] Another example of an embodiment of an apparatus according
to this disclosure for tissue dissection and modification may
comprise:
[0207] a handle;
[0208] a tip comprising a plurality of protrusions having one or
more lysing segments positioned between the protrusions; and
[0209] an energy window positioned on an upper side of the
apparatus, wherein the energy window comprises an
target-tissue-impedance-matched-microwave-based energy window.
[0210] Another example of an embodiment of an apparatus according
to this disclosure for tissue dissection and modification may
comprise:
[0211] a handle;
[0212] a tip comprising a plurality of protrusions having one or
more lysing segments positioned between the protrusions; and
[0213] an energy window positioned on an upper side of the
apparatus, wherein the energy window comprises a LASER based energy
window.
[0214] Another example of an embodiment of an apparatus according
to this disclosure for tissue dissection and modification may
comprise:
[0215] a handle;
[0216] a tip comprising a plurality of protrusions having one or
more lysing segments positioned between the protrusions; and
[0217] an energy window positioned on an upper side of the
apparatus, wherein the energy window comprises an intense pulsed
light based energy window.
[0218] Another example of an embodiment of an apparatus according
to this disclosure for tissue dissection and modification may
comprise:
[0219] a handle;
[0220] a tip comprising a plurality of protrusions having one or
more lysing segments positioned between the protrusions; and
[0221] an energy window positioned on an upper side of the
apparatus, wherein the energy window comprises a microwave based
energy window.
[0222] Another example of an embodiment of an apparatus according
to this disclosure for tissue dissection and modification may
comprise:
[0223] a handle;
[0224] a tip comprising a plurality of protrusions having one or
more lysing segments positioned between the protrusions; and
[0225] an energy window positioned on an upper side of the
apparatus, wherein the energy window comprises an ultrasound based
energy window.
[0226] Another example of an embodiment of an apparatus according
to this disclosure for tissue dissection and modification may
comprise:
[0227] a handle;
[0228] a tip comprising a plurality of protrusions having one or
more lysing segments positioned between the protrusions; and
[0229] an energy window positioned on an upper side of the
apparatus, wherein the energy window comprises an electrosurgical
based energy window.
[0230] Another example of an embodiment of an apparatus according
to this disclosure for tissue dissection and modification may
comprise:
[0231] a handle;
[0232] a tip comprising a plurality of protrusions having one or
more lysing segments positioned between the protrusions; and
[0233] an energy window positioned on an upper side of the
apparatus, wherein the energy window comprises a light from
filament based energy window.
[0234] Another example of an embodiment of an apparatus according
to this disclosure for tissue dissection and modification may
comprise:
[0235] a handle;
[0236] a tip comprising a plurality of protrusions having one or
more lysing segments positioned between the protrusions; and
[0237] an energy window positioned on an upper side of the
apparatus, wherein the energy window comprises a thermal based
energy window.
[0238] It will be understood by those having skill in the art that
changes may be made to the details of the above-described
embodiments without departing from the underlying principles
presented herein. For example, any suitable combination of various
embodiments, or the features thereof, is contemplated.
[0239] Any methods disclosed herein comprise one or more steps or
actions for performing the described method. The method steps
and/or actions may be interchanged with one another. In other
words, unless a specific order of steps or actions is required for
proper operation of the embodiment, the order and/or use of
specific steps and/or actions may be modified.
[0240] Throughout this specification, any reference to "one
embodiment," "an embodiment," or "the embodiment" means that a
particular feature, structure, or characteristic described in
connection with that embodiment is included in at least one
embodiment. Thus, the quoted phrases, or variations thereof, as
recited throughout this specification are not necessarily all
referring to the same embodiment.
[0241] Similarly, it should be appreciated that in the above
description of embodiments, various features are sometimes grouped
together in a single embodiment, figure, or description thereof for
the purpose of streamlining the disclosure. This method of
disclosure, however, is not to be interpreted as reflecting an
intention that any claim require more features than those expressly
recited in that claim. Rather, inventive aspects lie in a
combination of fewer than all features of any single foregoing
disclosed embodiment. It will be apparent to those having skill in
the art that changes may be made to the details of the
above-described embodiments without departing from the underlying
principles set forth herein.
[0242] Furthermore, the described features, components, structures,
steps, or characteristics may be combined in any suitable manner in
one or more alternative embodiments and/or implementations. In
other words, any of the features, components, structures, steps, or
characteristics disclosed in any one disclosed embodiment may be
combined with features, components, structures, steps, or
characteristics of other disclosed embodiments.
* * * * *