U.S. patent application number 11/651123 was filed with the patent office on 2007-05-17 for tissue ablation apparatus and method.
This patent application is currently assigned to RITA Medical Systems, Inc.. Invention is credited to Daniel J. Balbierz, Steve A. Daniel, Martha Getaneh, Kee S. Lee, Jessica Liang, Rob Pearson.
Application Number | 20070112342 11/651123 |
Document ID | / |
Family ID | 23114376 |
Filed Date | 2007-05-17 |
United States Patent
Application |
20070112342 |
Kind Code |
A1 |
Pearson; Rob ; et
al. |
May 17, 2007 |
Tissue ablation apparatus and method
Abstract
A method and apparatus for controlling the extent of tissue
ablation are disclosed. The method utilizes delivering energy from
an energy deliver device to a plurality of deployed electrodes and
regulating energy delivered to the electrodes based on the
temperature sensed by at least one remote elongate sensor element.
A control device may be used to supply energy to the electrodes, to
produce tissue ablation that advances from individual-electrode
ablation regions to fill a combined-electrode ablation volume.
Information from the sensor element(s) is used for determining the
extent of ablation in the regions of the sensor elements. The
supply of energy to the electrodes can thus be regulated to control
the level and extent of tissue ablation throughout the
combined-electrode volume.
Inventors: |
Pearson; Rob; (San Jose,
CA) ; Daniel; Steve A.; (Fremont, CA) ;
Balbierz; Daniel J.; (Redwood City, CA) ; Lee; Kee
S.; (Newark, CA) ; Liang; Jessica; (Redwood
City, CA) ; Getaneh; Martha; (San Jose, CA) |
Correspondence
Address: |
PERKINS COIE LLP
P.O. BOX 2168
MENLO PARK
CA
94026
US
|
Assignee: |
RITA Medical Systems, Inc.
|
Family ID: |
23114376 |
Appl. No.: |
11/651123 |
Filed: |
January 8, 2007 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
10142713 |
May 10, 2002 |
7160296 |
|
|
11651123 |
Jan 8, 2007 |
|
|
|
60290060 |
May 10, 2001 |
|
|
|
Current U.S.
Class: |
606/34 ;
606/41 |
Current CPC
Class: |
A61B 2018/1475 20130101;
A61B 2018/00702 20130101; A61B 2018/00797 20130101; A61B 2018/0016
20130101; A61B 2018/143 20130101; A61B 2018/1472 20130101; A61B
2018/00875 20130101; A61B 2018/00714 20130101; A61B 18/1477
20130101; A61B 2018/00654 20130101; A61B 2018/00577 20130101; A61B
2018/00791 20130101 |
Class at
Publication: |
606/034 ;
606/041 |
International
Class: |
A61B 18/18 20060101
A61B018/18 |
Claims
1. A method of controlling the extent of tissue ablation,
comprising: deploying a plurality of electrodes from an elongate
delivery device, the electrodes defining a tissue volume; deploying
at least one elongate sensor element in the tissue volume at a
position remote from the plurality of electrodes; delivering energy
from an energy delivery device to ablate or necrose at least a
portion of the tissue volume; sensing a temperature of the tissue
volume with the sensor element; and regulating energy delivery
based on the temperature sensed by the sensor element.
2. The method of claim 1, wherein the elongate sensor element is
deployed between the plurality of electrodes.
3. The method of claim 1, further comprising: determining a
treatment endpoint responsive to the temperature of the tissue
volume.
4. The method of claim 1, wherein the sensor element measures
temperature at two or more locations along the element.
5. The method of claim 1, wherein the sensor element includes a
thermal sensor for sensing temperature.
6. The method of claim 1, wherein said electrodes and sensor
element are deployed from their retracted to their deployed
positions as a unit.
7. The method of claim 1, wherein said electrodes are deployed
independent of the deployment of the sensor element.
8. The method of claim 1, wherein said electrodes are hollow-needle
electrodes, further comprising: injecting a liquid through said
electrodes into the tissue volume.
9. The method of claim 8, further comprising: controlling liquid
flow through each electrode individually.
10. The method of claim 8, wherein at least one electrode has a
plurality of infusion ports along its distal end region and a
sheath, further comprising: moving the sheath axially between
deployment and infusion positions at which the infusion ports are
covered and exposed, respectively.
11. The method of claim 1, further comprising: applying power
between the plurality of electrodes and a body-surface electrode
adapted to be applied to the surface of a patient.
12. The method of claim 1, wherein said electrodes are RF
electrodes and the energy delivered is RF energy.
13. The method of claim 1, wherein said electrodes are microwave
electrodes and the energy delivered is microwave energy.
14. The method of claim 1, wherein said at least one elongate
sensor element is deployed from the elongate delivery device.
Description
[0001] This application is a continuation of U.S. patent
application Ser. No. 10/142,713 filed May 10, 2002, now allowed,
which claims the benefit of U.S. Provisional Application No.
60/290,060 filed May 10, 2001, both of which are incorporated
herein by reference in their entirety.
TECHNICAL FIELD
[0002] This invention relates generally to a method for treating
tissue, tissue masses, tissue tumors and lesions. More
particularly, the invention relates to an apparatus and method for
minimally invasive therapeutic treatment of tumors and tissue mass.
Still more particularly, the invention relates to a method and
apparatus utilizing fluid to enhance the delivery of energy to
tumor and tissue masses to produce larger, faster ablation volumes
with improved clinical outcomes.
BACKGROUND
[0003] Current methods for treating tumors using RF energy have
several key shortcomings including incomplete ablation volumes,
small ablation volumes, tissue desiccation and charring or
protracted ablation times. The present invention provides a method
and apparatus to solve these and other related problems.
SUMMARY
[0004] The invention includes, in one aspect, a tissue-ablation
apparatus composed of an elongate delivery device having a lumen
terminating at a distal end and a plurality of electrodes carried
in the device for movement between retracted positions at which the
electrodes are disposed within the device's lumen, and deployed
positions at which the electrodes are deployed from the distal end
at a plurality of arcuate, laterally extending, angularly spaced
positions. Each deployed electrode defines an individual-electrode
ablation volume which, in the early phases of ablation, is
proximate to that electrode when an RF current is applied to that
electrode, with such deployed in tissue, where contained
application of RF current to the electrodes causes the
individual-electrode ablation volumes to grow and merge with each
other to form a combined-electrode ablation volume.
[0005] Also in the apparatus is a plurality of elongate sensor
elements carried in the device for movement between retracted
positions at which the sensor elements are disposed within the
device's lumen, and deployed positions at which the sensor are
deployed from the distal end at a plurality of angularly spaced
positions within the volume corresponding to the combined-electrode
ablation volume.
[0006] A control device or unit in the apparatus is operatively
connected to the electrodes and to the sensor elements for (i)
supplying an RF power to the electrodes, with such deployed in
tissue, to produce tissue ablation that advances from the
individual-electrode ablation volumes to fill the
combined-electrode ablation volume, and (ii) determining the extent
of ablation in the regions of the sensor elements. The supply of RF
power to the electrodes can thus be regulated to control the level
and extent of tissue ablation throughout the combined-electrode
volume.
[0007] The electrodes and sensor elements may be operatively
connected for movement as a unit from their retracted to their
deployed positions. Alternatively, the electrodes may be movable
from their retracted to their retracted and deployed positions
independent of the movement of the sensor elements from their
retracted and deployed positions.
[0008] The sensor elements are in their deployed positions may be
disposed outside of the individual-electrode ablation volumes,
preferably midway between pairs of adjacent electrodes in their
deployed state.
[0009] In one embodiment, the sensor elements are conductive wires,
and the control device is operable to determine the impedance of
tissue in the regions of the wires, as a measure of extent of
ablation in the region of the sensor elements.
[0010] In another embodiment, the sensor elements have thermal
sensors, and the control device is operable to determine tissue
temperature in the region of the thermal sensors, as a measure of
the extent of ablation in the region of the sensor elements.
[0011] In still another embodiment, the sensor elements are optical
fibers, and the control device is operable to determine optical
properties in the region of the fibers, as a measure of the extent
of ablation in the region of the sensor elements.
[0012] The electrodes may be hollow-needle electrodes, allowing
liquid to be injected through said electrodes into tissue, with the
electrodes deployed in tissue. An exemplary liquid is an
electrolyte, such as a physiological salt solution. In a preferred
embodiment, the electrodes are designed to allow controlled fluid
flow through each electrode individually.
[0013] Each infusion electrode may have a plurality of infusion
ports along its distal end regions, and may be covered by a sheath
that is axially movable between deployment and infusion positions
at which the infusion ports are covered and exposed,
respectively.
[0014] The control unit may include a display function for
displaying to a user the extent of ablation of in the regions of
the sensor elements, and an adjustable function, such as an RF
power function, or liquid-infusion function, by which the user can
adjust or modulate the rate or extent of ablation by modulating
power level or amount of liquid infused into the ablation volume.
Preferably the power of infusion functions can be controlled at the
level of the individual electrodes, allowing for control over the
rate and extent of individual-electrode volumes during the ablation
procedure.
[0015] Alternatively, or in addition, the control unit may
automatically control the power level and/or rate of infusion of
liquid to one or more electrodes, during an ablation procedure, to
modulate the rate and/or extent of individual regions of the
desired ablation volume, for example, to ensure a uniform rate and
extent of ablation throughout the desired combined-electrode
ablation volume.
[0016] In one general embodiment, the electrodes, when deployed,
are positioned near the center of the faces of a platonic solid
that defines a desired combined-electrode ablation volume. The
number of faces of the platonic solid, and therefore the number of
electrodes deployed will be determined, for example, by the size of
the desired ablation volume. The sensor elements, when deployed,
may be positioned near the vertices of the platonic solid. For
example, for ablating a substantially spherical volume that
circumscribes a pyramid, the apparatus may have four electrodes
that are positioned near the center of the faces of the pyramid
when deployed, and four sensors that are placed near the vertices
of the pyramid when deployed.
[0017] In another aspect, the invention includes a method for
ablating a selected volume of tissue in a patient. The method
includes inserting into the tissue, a tissue-ablation apparatus
having (a) an elongate delivery device with a lumen terminating at
a distal end, and (b) a plurality of hollow-needle electrodes
carried in the device for movement between retracted positions at
which the electrodes are disposed within the device's lumen, and
deployed positions at which the electrodes are deployed from the
distal end at a plurality of arcuate, laterally extending,
angularly spaced positions. The electrodes, in their deployed
positions, define the selected tissue volume to be ablated. Liquid,
such as an electrolyte is introduced into the tissue through the
hollow-needle electrodes, by separately controlling the rate of
liquid flow through each hollow-needle electrode. RF power is
applied to the electrodes, to produce RF ablation of the
tissue.
[0018] The liquid may be introduced at substantially equal flow
rates through each electrode. An electrolyte having a desired
electrolyte concentration may be selected. The liquid may be
introduced prior to, during, or following the RF ablation step.
[0019] The method may further include monitoring the extent of
ablation in the tissue volume during said applying step, and
adjusting the rate at which liquid is introduced through individual
hollow-needle electrodes in response to the monitoring, for
example, to produce a uniform rate and extent of ablation
throughout tissue volume being ablated.
[0020] These and other objects and features of the invention will
become more fully apparent when the following detailed description
of the invention is read in conjunction with the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] FIG. 1 is a perspective view illustrating the placement and
deployment of an embodiment of a tissue infusion ablation apparatus
for the treatment of tumors.
[0022] FIGS. 2a and 2b are perspective views illustrating the key
components of a tissue infusion ablation including configurations
of the infusion device having multiple syringes and multi-channel
tubing.
[0023] FIG. 3 is a lateral view illustrating various components of
the handpiece and associated coupled devices.
[0024] FIG. 4 is a lateral view illustrating an embodiment of the
apparatus of FIG. 1 or 2 having a deflectable introducer.
[0025] FIG. 5 is a lateral view illustrating an embodiment of the
apparatus of FIG. 1 or 2 having a deflectable portion at the distal
end of the introducer.
[0026] FIG. 6 is a lateral view illustrating an embodiment having a
hingedly attached deflectable portion of the introducer.
[0027] FIGS. 7a and 7b are lateral views illustrating use of an
apparatus having a deflectable introducer useful in an embodiment
of method the invention.
[0028] FIGS. 8a-8j are cross sectional views illustrating various
cross sectional shapes of the introducer and lumen.
[0029] FIGS. 9a-9h are lateral views illustrating various
configurations of the electrode including ring-like, ball,
hemispherical, cylindrical, conical and needle-like.
[0030] FIG. 10 is lateral view illustrating an embodiment of a
needle electrode configured to penetrate tissue.
[0031] FIG. 11 is lateral view illustrating a needle electrode
having at least one radii of curvature.
[0032] FIG. 12 is a lateral view illustrating an embodiment of an
electrode having a lumen and apertures for the delivery of fluid
and the use of infused electrolytic fluid to create an enhanced
electrode.
[0033] FIG. 13a is a lateral view illustrating an embodiment of an
electrode or introducer having apertures with increasing diameters
moving in a distal direction, and FIG. 13b is a plot showing change
in aperture size on progressing toward a needle end.
[0034] FIG. 14a is a lateral view illustrating an embodiment of an
electrode or introducer having one or more apertures positioned on
a force neutral axis.
[0035] FIG. 14b is a lateral view illustrating an embodiment of an
electrode having apertures positioned on opposite lateral sides of
the electrode.
[0036] FIG. 15a is a lateral view illustrating an embodiment of an
RF electrode with apertures configured to provide a cooling fluid
to the electrode and surrounding tissue.
[0037] FIG. 15b is an enlarged sectional view showing distribution
of infused liquid from different shaped orifices.
[0038] FIG. 16 is a lateral view illustrating an embodiment of the
electrode having laterally positioned apertures (e.g. side
holes).
[0039] FIG. 17 is a lateral view illustrating an embodiment of the
electrode having a non-stick coating to reduce plugging of fluid
apertures by adherent and/or coagulated tissue.
[0040] FIGS. 18a-18c are lateral views illustrating use of an
embodiment of the electrode having a protective sheath configured
to reduce fluid aperture plugging.
[0041] FIG. 19 is a lateral view illustrating an embodiment of the
electrode having a bevel angle configured to minimize plugging.
[0042] FIGS. 20a and 20b are lateral views illustrating an
embodiment of the electrode or trocar having a porous or braided
distal portion.
[0043] FIG. 21 is a lateral view illustrating an embodiment of a
method of the invention in which fluid is infused through multiple
electrodes to create infusion zones that coalesce to form a larger
infusion volume.
[0044] FIGS. 22a and 22b are lateral perspective views illustrating
the use of multiple infusing electrodes to generate an ablation
volume.
[0045] FIG. 23 is a perspective view illustrating an embodiment of
a tissue infusion ablation having one or more passive monitoring
members and ablation electrodes/active members positionable at a
tissue site.
[0046] FIG. 24 is a perspective view illustrating various
embodiments of positioning of sensors on the passive member and
coupling of sensors to monitoring resources.
[0047] FIG. 25 is a perspective view illustrating the position of
passive members to define a sampling volume.
[0048] FIG. 26 is a perspective view illustrating the relative
positioning of the active electrodes to define a tetrahedron shaped
sampling volumes bounded by a spherical ablation volume.
[0049] FIG. 27 is a perspective view illustrating an embodiment of
the apparatus having passive and active arrays configured such that
the passive elements are equally spaced between the active
elements/electrodes.
[0050] FIGS. 28a-28c are perspective views illustrating different
embodiment of the trocar, FIG. 28a illustrates a standard trocar
having a sharpened leading edge; FIG. 28b illustrates an embodiment
of a trocar configured with a leading inner edge; and FIG. 28c
illustrates an embodiment of a trocar having a coated leading inner
edge.
[0051] FIG. 29 is a frontal view illustrating an embodiment of the
apparatus with a packing arrangement of active and passive member
configured to prevent the passive members from contacting and being
scythed or abraded by the sharpened edges of the trocar.
[0052] FIG. 30 is lateral view illustrating an embodiment of the
trocar having an abrupt transition from the insulate to
non-insulated trocar sections.
[0053] FIG. 31 is lateral view illustrating an embodiment of the
trocar having a stepped distal end with a diameter configured to
achieve a smooth transition form the insulated to non insulates
trocar section.
[0054] FIG. 32 is a lateral view illustrating an embodiment of an
energy delivery device with a radioactive section and its use in an
embodiment of a method of the invention.
[0055] FIG. 33 is a lateral view illustrating use of
photo-therapeutic agents in an embodiment of a method of the
invention.
[0056] FIG. 34 is a block diagram illustrating the inclusion of a
controller, energy source and other electronic components of the
present invention.
[0057] FIG. 35 is a block diagram illustrating an analog amplifier,
analog multiplexer and microprocessor used with the present
invention.
[0058] FIG. 36 is a perspective view illustrating the use of
platonic solids to optimize ablation volume in a method of the
invention.
[0059] FIGS. 37a-37e are perspective views illustrating various
platonic solids applicable to the embodiment of FIG. 36.
DETAILED DESCRIPTION
[0060] Embodiments of the present invention provide the benefit of
a method and apparatus to treat tumors and lesions such as hepatic
tumors by utilizing conductivity enhancing solutions to deliver
ablative electromagnetic energy to produce faster, larger and more
consistent ablation volumes than by conventional means. However one
of the potential problems in infusing fluids through a hollow tube
or hollow electrode is plugging of the electrode fluid lumen as the
electrode is inserted into tissue, or a resulting of tissue
coagulation from heating of the electrode during energy delivery or
a combination of both. Further embodiments of the present invention
provide a number of solutions to problem of tissue plugging of
electrodes and infusion lumens occurring during insertion of the
electrode into tissue or during the delivery of ablative
energy.
[0061] An embodiment of a tissue infusion ablation apparatus 10 to
treat tumors and lesions is shown in FIG. 1. The apparatus is
configured to be positioned at a bone tissue site 5' to treat or
ablate a tumor or lesion 5''. Tissue site 5' can be located in any
location in various tissue including but not limited to liver,
bone, breast, brain and lung. The apparatus can be configured to
treat a number of lesions and ostepathologies including but not
limited to metastatic lesions, osteolytic lesions, osteoblastic
lesions, tumors, fractures, infected site, inflamed sites and the
like. Once positioned at target tissue site 5', apparatus 10 can be
configured to treat and ablate tissue at that site as well as
collect a tissue sample using a bone biopsy device described herein
or known in the art.
[0062] Referring now to FIG. 2, an embodiment of a tissue infusion
ablation apparatus 10 includes an elongated member or shaft 12 with
a proximal end 14, a distal end 16, and an internal lumen extending
therebetween or at least through a portion of the distal end
region. Distal end 16 may be sufficiently sharp to penetrate tissue
including bone, cartilage, muscle and fibrous and/or encapsulated
tumor masses. In an embodiment, distal end 16 can be a needle that
is integral or otherwise coupled to introducer 12 by joining means
known in the art such as adhesive bonding, soldering, RF welding,
crimping and the like. Shaft 12 may have one or more lumens 13 that
may extend over all or a portion of its length. An energy delivery
device, generally denoted as 18, is coupled to distal end 16'.
Energy delivery device 18 can be configured to be coupled to an
energy or power source 20. A sensor 22 may be coupled to shaft 12
including distal end 16' and energy delivery device 18.
[0063] For ease of discussion, shaft 12 will now be referred to as
an introducer or delivery device 12, but all other embodiments
discussed herein are equally applicable. Referring now to FIGS.
1-4, in various embodiments, introducer 12 can also be coupled at
its proximal end 14 to a handle or handpiece 24. The shaft or
introducer is also referred to herein as an elongate delivery
device. All or portions of handpiece 24 can be detachable and can
include ports 24' and actuators 24''. Ports 24' can be coupled to
one or more lumens 13 and can include fluid and gas
ports/connectors and electrical, optical connectors. In various
embodiments, ports 24' can be configured for aspiration (including
the aspiration of tissue), and the delivery of cooling,
conductivity enhancing, electrolytic, irrigation, polymer and other
fluids (both liquid and gas) described herein. Ports 24' can
include but are not limited to luer fittings, valves (one-way,
two-way), toughy-bourst connectors, swage fittings and other
adaptors and medical fittings known in the art. Ports 24' can also
include lemo-connectors, computer connectors (serial, parallel,
DIN, etc) micro connectors and other electrical varieties well
known to those skilled in the art.
[0064] Further, ports 24' can include opto-electronic connections
which allow optical and electronic coupling of optical fibers
and/or viewing scopes (such as an orthoscope) to illuminating
sources, eye pieces, video monitors and the like. Actuators 24''
can include rocker switches, pivot bars, buttons, knobs, ratchets,
cams, rack and pinion mechanisms, levers, slides and other
mechanical actuators known in the art, all or portion of which can
be indexed. These actuators can be configured to be mechanically,
electro-mechanically, or optically coupled to pull wires,
deflection mechanisms and the like allowing selective control and
steering of introducer 12. Hand piece 24 can be coupled to tissue
aspiration/collection devices 26, fluid delivery devices 28 (e.g.
infusion pumps) fluid reservoirs (cooling, electrolytic, irrigation
etc) 30 or power source 20 through the use of ports 24'. Tissue
aspiration/collection devices 26 can include syringes, vacuum
sources coupled to a filter or collection chamber/bag. Fluid
delivery device 28 can include medical infusion pumps, Harvard
pumps, peristaltic pumps, syringe pumps, syringes and the like.
[0065] Referring back to FIG. 2, in various embodiments fluid
delivery device can be a syringe pump configured with multiple
syringes 28s, multiple-bore syringes 28b with each syringe coupled
to a separate fluid lumen or channel 72 directly or via a valve
such as an indexing valve 28i. Related embodiments of infusion
device 28 can include an indexing valve 28i as well as multi-lumen
tubing or multichannel tubing 72b (which can be made from PEBAX,
silicone or other resilient polymer) connected to one or more
lumens 72 via lumen 13 or other channel within external to
introducer 12.
[0066] In various embodiments, at least portions of tissue infusion
ablation apparatus 10 including introducer 12 and distal end 16 may
be sufficiently radiopaque to be visible under fluoroscopy and the
like and/or sufficiently echogenic to be visible using
ultrasonography. In specific embodiments, introducer 12 can include
radiopaque, magnopaque or echogenic markers 11, at selected
locations including along all or portions of introducer 12
including distal end 16'. Markers 11 can be disposed along
introducer 12 to facilitate identification and location of tissue
penetrating portion 16 including tissue collection portions, ports,
sensors as well as other components and sections of tissue infusion
ablation apparatus 10 described herein. In an embodiment, markers
11 can be ultrasound emitters known in the art. Also tissue
infusion ablation apparatus 10 can include imaging capability
including, but not limited to, fiber optics, viewing scopes such as
a orthoscope, an expanded eyepiece, video imaging devices,
ultrasound imaging devices and the like.
[0067] In various embodiments, apparatus 10 can be configured to be
percutaneously introduced into tissue through a trocar, biopsy
device, or orthoscope or other percutaneous or surgical access
device known in the art. For any of these devices, apparatus 10 can
be introduced with the aid of a guide wire 15 which introducer 12
is configured to track over. Guide wire 15 can be any of a variety
of flexible and/or steerable guide wires or hypotubes known in the
art. Introducer 12 can have sufficient length to position distal
tip 16' in any portion or lobe of the bone 5 using either a
percutaneous or a bronchial/transoral approach. The length of
introducer 12 can range from 5 to 180 cm with specific embodiments
of 20, 40, 80, 100, 120 and 140 cm. A preferred range includes 25
to 60 cm. The length and other dimensional aspects of introducer 12
can also be configured for pediatric applications with a preferred
range in these embodiments of 15 to 40 cm. The diameter of
introducer 12 can range from 0.020 to 0.5 inches with specific
embodiments of 0.05, 0.1 and 0.3 inches as well as 1, 3, 6, 8 and
10 french sizes as is known in the art. Again, the diameter can be
configured for pediatric applications with pediatric sizes of 1, 3
and 6 french. In various embodiments, the diameter of distal end 16
can range from 0.010 to 0.1 inches, with specific embodiments of
0.020, 0.030 and 0.040 inches. The diameter of distal end 16' can
be configured to be positioned in various anatomical ducts,
vasculature and bronchioles, such embodiment includes diameters of
0.40'' or smaller.
[0068] In various embodiments, introducer 12 can be a catheter,
multi-lumen catheter, or a wire-reinforced or metal-braided polymer
shaft, port device (such as those made by the Heartport.RTM. Corp.,
Redwood City, Calif.), subcutaneous port or other medical
introducing device known to those skilled in the art. In a specific
embodiment introducer 12 is a trocar or a safety trocar and the
like. Introducer 12 can be constructed of a variety of metal grade
metals known in the art including stainless steel such as 304 or
304V stainless steel as well shape memory metal such as Nitino.
Introducer 12 can also be constructed from rigid polymers such as
polycarbonate or ABS or resilient polymers including Pebax.RTM.,
polyurethane, silicones HDPE, LDPE, polyesters and combinations
thereof.
[0069] In various embodiments, introducer 12 can be rigid,
semi-rigid, flexible, articulated and steerable and can contain
fiber optics (including illumination and imaging fibers), fluid and
gas paths, and sensor and electronic cabling. In an embodiment
introducer 12 is sufficiently rigid (e.g. has sufficient column
strength) to pierce tissue including bone tissue without
significant deflection along it longitudinal axis so as to maintain
a longitudinal or other position within a tissue site. In another
embodiment, all or portions (e.g. the distal portion) of introducer
12 are sufficiently flexible to pierce tissue, and move in any
desired direction through tissue to a desired tissue site 5'. In
yet another embodiment, introducer 12 is sufficiently flexible to
reverse its direction of travel and move in direction back upon
itself.
[0070] Referring now to FIGS. 3 and 4, in other embodiments all or
portions of introducer 12 can be configured to be deflectable
and/or steerable using deflection mechanisms 25 which can include
pull wires, ratchets, latch and lock mechanisms, piezoelectric
materials and other deflection means known in the art. Deflection
mechanism 25 can be coupled to or integral with a moveable or
slidable actuator 25' on handpiece 24. Mechanism 25 and coupled
actuator 25' are configured to allow the physician to selectively
control the amount of deflection 25'' of distal tip 16' or other
portion of introducer 12. Actuator 25' can be configured to both
rotate and deflect distal tip 16 by a combination of rotation and
longitudinal movement of the actuator. In a preferred embodiment
deflection mechanism 25 comprises a pull wire coupled 15 to an
actuator 24' on handpiece 24 described herein.
[0071] The amount of deflection of introducer 12 is selectable and
can be configured to allow the maneuvering of introducer 12 through
very tortuous anatomy and negotiate both obtuse or oblique turns in
around various and anatomical structures including vasculature,
ducts and bone. In specific embodiments, the distal portions of
introducer 12 can be configured to deflect 0-180.degree. or more in
up to three axes to allow the tip of introducer 12 to have
retrograde positioning capability. The deflection can be continuous
or indexed to pre-determined amounts selectable on handpiece 24
using an indexed actuator 25'.
[0072] Referring now to FIGS. 5, 6 (lateral view of an embodiment
having deflectable section 12d near the distal end of the
introducer) and (lateral view showing a hingedly attached
deflectable section), in a specific embodiment introducer 12 has a
deflectable or articulated section 12d at or near its distal
portion 16. Deflectable portion 12d can be formed by use of
corrugated or flexible materials (e.g. materials having a lower
durometer than the adjoining less flexible section of the
introducer) crimping, sectioning, molding, or other polymer metal
working or catheter processing methods known in the art.
Deflectable portion 12d can be deflected by a number of means
including pull wires, ratchet mechanism, a can mechanism, a gear
mechanism (including a rack and pinion or worm gear mechanism)
coupled to a pull wire or a stiffening mandrel which is advanced
and withdrawn through lumen 13 of the introducer. Deflectable
portion 12d can also be hingedly or pivotally attached to
introducer 12 using a hinge mechanism which comprises one or more
hinged sections 12h actuated by a pull wire or stiffening mandrel
15. Sections 12h can be mechanically coupled to introducer 12 and
each other using one or more hinged or pivot joints 12j known in
the art.
[0073] Referring to FIGS. 7a and 7b (perspective views illustrating
the use of the deflectable section 12d). In use, deflectable
portion 12d allows the introducer to be introduced into tissue site
5' in a first fixed position (preferably straight with respect to a
longitudinal axis 12al of the introducer) and then deflected a
selectable amount to a second position in order to facilitate
deployment of one or more energy delivery devices 18 into tumor
mass 5'' or tissue site 5'. Further, deflectable portion 12d allows
the energy delivery devices to be deployed at a selectable angle
(including ranges from acute to oblique) with respect to the
longitudinal axis 12al of the introducer. These capabilities
provides several benefits including (i) ensuring a more complete
deployment of the energy delivery devices into the selected tumor
mass; (ii) allowing faster deployment and withdrawal of the energy
delivery devices reducing procedure time; (iii) allows the energy
delivery device 18 to be positioned and deployed in an irregularly
shaped tumor masses (e.g. oblong, oval); (iv) allows the apparatus
and energy delivery devices to be positioned and deployed in curved
or otherwise difficult to reach portions of the anatomy including
the orthopedic anatomy; and (v) allows the apparatus and energy
delivery devices to be deployed at tumor site near or adjacent a
delicate or sensitive anatomical structure(e.g. the spinal cord,
artery) with a reduced or otherwise inappreciable risk of injuring
that structure). In alternative embodiments, deflectable portion
12d can also be used to direct the delivery of an infusion fluid
(including a jet or stream of fluid) described herein to a
selectable portion of the tissue site 5' or tumor mass 5''.
[0074] In another embodiment introducer 12 can include side ports
which allow electrodes 18 to be deployed at a selectable angle with
respect to the longitudinal axis 12al of introducer 12, including
about 45 and 90.degree.. The use of such side ports is described in
U.S. Pat. No. 5,683,384, which is incorporated by reference
herein.
[0075] Referring to FIG. 8, introducer 12 can have a substantially
circular, semicircular, oval or crescent shaped cross section, as
well as combinations thereof along its lengths. Similarly, lumens
13 can have a circular, semicircular, oval or crescent shaped cross
section for all or a portion of the length 12'' of introducer
12.
[0076] A variety of energy delivery devices and power sources can
be utilized by embodiments of the invention. Specific energy
delivery devices 18 and power sources 20 that can be employed in
one or more embodiments include, but are not limited to, the
following: (i) a microwave power source coupled to a microwave
antenna providing microwave energy in the frequency range from
about 915 MHz to about 2.45 GHz (ii) a radio-frequency (RF) power
source coupled to an RF electrode, (iii) a coherent light source
coupled to an optical fiber or light pipe, (iv) an incoherent light
source coupled to an optical fiber, (v) a heated fluid coupled to a
catheter with a closed or at least partially open lumen configured
to receive the heated fluid, (vi) a cooled fluid coupled to a
catheter with a closed or at least partially open lumen configured
to receive the cooled fluid (viii) a cryogenic fluid, (ix) a
resistive heating source coupled to a conductive wire, (x) an
ultrasound power source coupled to an ultrasound emitter, wherein
the ultrasound power source produces ultrasound energy in the range
of about 300 KHZ to about 3 GHz, (xi) and combinations thereof.
[0077] For ease of discussion for the remainder of this
application, the energy delivery device includes a plurality of RF
electrodes 18 and the power source utilized is an RF power supply.
For these and related embodiments RF power supply delivers 5 to 200
watts, preferably 5 to 100, and still more preferably 5 to 50 watts
of electromagnetic energy is to the electrodes of energy delivery
device 18 without impeding out. The electrodes 18 are electrically
coupled to energy source 20. The coupling can be direct from energy
source 20 to each electrode 18 respectively, or indirect by using a
collet, sleeve, connector, cable and the like which couples one or
more electrodes to energy source 20. Delivered energies can be in
the range of 1 to 100,000 joules, more preferably in the range 100
to 50000 joules, still more preferably in the range of 100 to 5000
and still yet more preferably in the range 100 to 1000 joules.
Lower amounts of energy can be delivered for the ablation of
smaller structures such as nerves and small tumors with higher
amounts of energy for larger tumors. Also delivered energies can be
modified (by virtue of the signal modulation and frequency) to
ablate or coagulate blood vessels vascularizing the tumor. This
provides the benefit of providing a higher degree of assurance of
destroying other otherwise occluding the blood supply of the
tumor.
[0078] Turning now to a discussion of the fabrication and
configuration of the RF electrodes, in various embodiments
electrode 18 can be made of a variety of conductive materials, both
metallic and non-metallic. Suitable materials for electrode 18
include, steel such as 304 stainless steel of hypodermic quality,
platinum, gold, silver and alloys and combinations thereof. Also,
electrode 18 can be made of conductive solid or hollow straight
wires of various shapes such as round, flat, triangular,
rectangular, hexagonal, elliptical and the like. In a specific
embodiment all or portions of electrodes 18 can be made of a shaped
memory metal, such as NiTi, commercially available from Raychem
Corporation, Menlo Park, Calif.
[0079] Referring back to FIGS. 1-2, the plurality electrodes 18 are
carried in the device for movement between retracted positions at
which the electrodes are disposed within the device's lumen, and
deployed positions at which the electrodes are deployed from the
distal end, preferably at a plurality of arcuate, laterally
extending, angularly spaced positions, as illustrated in FIGS. 2
and 22-24 in particular. By arcuate is meant the electrodes fan out
away from the device distal tip in a curved fashion with one or
more radii of curvature. By laterally extending is meant that the
electrodes in their deployed positions extend radially outwardly
away from the device distal tip. By angularly spaced is meant that
the electrodes, when viewed from the top as in FIG. 23, are spaced
from one another with an angle typically between 20-120 degrees,
depending on the number of electrodes in the electrode set. `As
will be discussed below, each deployed electrode defines an
individual-electrode ablation volume, such as a spherical volume,
which is proximate to that electrode when an RF current is applied
to that electrode, with such deployed in tissue. Also as discussed
below, where continued application of RF current (which may be
measured as power) to the electrodes causes the
individual-electrode ablation volumes to grow and merge with each
other to form a combined-electrode ablation volume.
[0080] The electrodes are typically ganged together at their
proximal ends for movement as a unit between the retracted and
deployed positions (which can include partially deployed
positions). A handle or other actuator is carried on or otherwise
functions with the device to allow the user to move the electrodes
from their retracted positions to various deployed (partially or
fully deployed) positions. Such electrode construction is
known.
[0081] Electrodes, such as electrode 18, can include one or more
coupled sensors 22 to measure temperature and impedance (both of
the electrode and surrounding tissue), voltage and current other
physical properties of the electrode and adjacent tissue. Sensors
22 can be positioned on the exterior or interior surfaces of
electrodes 18 at their distal ends or intermediate sections. A
radiopaque marker 11 can be attached, soldered or coated on
electrodes 18 for visualization purposes. Referring now to FIGS.
9-11 in various embodiments electrodes 18 can have variety of
shapes and geometries including but not limited to ring-like, ball,
hemispherical, cylindrical, conical or needle-like as illustrated
in FIG. 9. In an embodiment shown in FIG. 10, electrode 18 can be a
needle with sufficient sharpness to penetrate tissue including
bone, cartilage and fibrous tissue and encapsulated tumors. The
distal end of electrode 18 can have a cut angle 68 that ranges from
1 to 60.degree., with preferred ranges of at least 25.degree. or,
at least 30.degree. and specific embodiment of 25.degree. and
30.degree.. The surface electrode 18 can be smooth or textured and
concave or convex. The conductive surface area 38' of electrode 18
can range from 0.05 mm.sup.2 to 100 cm.sup.2. Referring to FIG. 11,
electrode 18 can also be configured to be flexible and or
deflectable having one or more radii of curvature 70 which can
exceed 180.degree. of curvature. In use, electrode 18 can be
configured and positioned to heat, necrose or ablate any selected
target tissue volume 5'.
[0082] Electrode 18 can have selectable lengths 38 that are
advanced from distal end 16 of introducer 12. The lengths can be
determined by the actual physical length of electrode(s) 18, the
length of an energy delivery surface 38' of electrode 18 and the
length, 38'' of electrode 18 that is covered by an insulator.
Suitable lengths 38 include but are not limited to a range from
1-30 cm with specific embodiments of 0.5, 1, 3, 5, 10, 15 and 25.0
cm. The actual lengths of electrode 18 depends on the location of
tissue site 5' to be ablated, its distance from the site, its
accessibility as well as whether or not the physician chooses a
endoscopic, percutaneous, surgical or other procedure.
[0083] Referring now to FIG. 12, in various embodiments electrode
18 can include one or more lumens 72 (which can be contiguous with
or the same as lumen 13) coupled to a plurality of fluid
distribution ports 23 or apertures 23. Fluid distribution ports 23
can be evenly formed around all or only a portion of electrode 18
and are configured to permit the introduction or infusion of a
variety of fluids 27 to a selected tissue site as well to the
electrode surface. This can be accomplished by having ports 23
fluidically coupled to lumens 13 (via lumens 72 or fluid channel)
that are in turn fluidically coupled to fluid reservoir 30 and/or
fluid delivery device 28. Ports 23 can configured to delivery
fluids at both low flow rates and Reynolds numbers (e.g. wicking)
to high flow rates a (e.g., jetting) and levels there between as
well as low and high viscosity fluids with a viscosity range
including but not limited to 1 to 100 centipoise with specific
embodiments of 1, 3, 5, 10 and 20 centipoise. This can be achieved
by controlling diameter 23d, number and location of ports 23 on one
or more electrodes 23.
[0084] Suitable fluids 27 that can infused or introduced via ports
23 include but are not limited to liquids, pastes, gels emulsions,
conductivity enhancing fluids, electrolytic solutions, saline
solutions, cooling fluids, cryogenic fluids, gases,
chemotherapeutic agents, medicaments, gene therapy agents,
photo-therapeutic agents, contrast agents, infusion media and
combinations thereof. Examples of suitable conductive gels are
carboxymethylcellulose gels made from aqueous electrolyte solutions
such as physiological saline solutions, and the like.
[0085] In various embodiments the size and diameter of ports 23 can
vary depending upon their position on the electrode as well as the
size and shape of the electrode. Preferably at least a portion of
apertures 23 are positioned and even more preferably concentrated
near the distal ends 18de of electrodes 18. In various embodiments
1 to 10 side apertures 23 are positioned near distal end 18de, with
specific embodiments of 2, 3 and five apertures. These and related
configurations allow for the infusion of an conductivity enhancing
solution 27 at a location where current density in around the
electrode is greatest, allowing the electrode and tissue adjacent
the electrode to carry increased current density without
desiccation, charring and appreciable impedance rises causing
impedance shut downs of power supply 20. This in turn permits
larger and faster ablation volumes to be performed without
appreciable risk of impedance shut down. Apertures 23 are also
configured to wet the surface 18s of electrode 18 (as is more fully
described herein) to cool it, increase conductivity and prevent
tissue adhesion and charring.
[0086] In an embodiment shown in FIG. 13, ports 23 can be
configured to have an increasing diameter 23d moving in a distal
direction so as to maintain the flow rate out of each port 23
approximately constant and/or prevent significant decreases due to
pressure decreases. The relationship of increasing diameter to
distance can linear, parabolic or logarithmic. In a preferred
embodiment, the apertures 23 are configured to have increasing
diameters going in a distal direction with respect to electrode 18o
as to provide a substantially constant flow rate over the apertured
portion 18ap of the electrode by decreasing the fluid resistance
moving in the distal direction according to Poiseuille's law (F=DP
p r 4/8 h l). This is achieved by increasing the aperture diameter
23d about 0.0625% (e.g. about 1:16 ratio) of the increase in
lateral distance of placement of the aperture.
[0087] Referring now to FIG. 14a, in another related embodiment all
or a portion of apertures 23 are substantially positioned on a
neutral force axis 18nfa of one or more electrodes 18. In these and
related embodiments electrodes 18 can be configured to be bendable
and/or deflectable. This can be achieved through the selection of
the material properties for electrodes as well as its construction
and the use off a deflection mechanism described herein. Suitable
bendable embodiments of electrodes 18 include electrodes fabricated
from spring steel, 304 stainless steel, shape memory metals, nickel
titanium alloys (NITINOL), articulated metal, flexible wire, 0.018
flexible wire, high strength polymers, and the like. Positioning
apertures 23 along force neutral axis 18fna provides the benefit of
an electrode that can deflected or bent omni-directional, without
appreciable loss of structural integrity and hence reduced
probability of failure. Also the use of apertures 23 infusion holes
in electrodes provides the benefit stop crack propagation.
[0088] In these and related embodiments apertures 23 can be
fabricated using laser drilling or micro-machining or drilling
techniques known in the art. The position of force neutral axis
18nfa can be determined from the geometric centerline of electrode
18, calculated using mechanical engineering methods known in the
art or identified real time using analytical optical techniques
including but not limited to photo-elastic optical methods known in
the art including but not limited to moire interferometry, digital
speckle pattern interferometry (DSPI) and computer analysis of the
fine grid technique. In one embodiment, apertures 23 can be drilled
while the optical measurement of lines of stress or strain is being
made to obtain a more accurate placement of the apertures along the
force neutral line of the electrode. In these and related
embodiments drilling of apertures 23 can be facilitated by the use
of one or more fixtures known in the art.
[0089] In a related embodiment shown in FIG. 14b, apertures 23 can
also be positioned on opposite lateral sides 18ls of electrodes 18
and offset a distance 23ad to preserve the structural integrity of
electrode while reducing the likelihood of plugging on both side of
the electrodes. In a specific embodiment one aperture can be
positioned 4 mm (distance 23ld1) from electrode distal end 18de and
second apertures can be positioned on the opposite side of the
electrode at distance 6 mm (distance 23ld2) from distal end
18de.
[0090] In an embodiment shown in FIG. 15, apertures 23 can be
configured to provide cooling of one or more electrodes 18 and
surrounding tissue to prevent tissue from the development of
excessive impedance at electrode 18 from the deposition of charred
tissue on the surface of electrode 18. The cooling is accomplished
by both the use of a cooled solution to cool the electrodes by
convection, conduction and a combination thereof. The amount of
cooling can be controlled by control of one or more of the
following parameters (i) temperature of the cooling solution, (ii)
flow rates of the cooling solution, and/or (iii) heat capacity
(e.g. specific heat) of the cooling solution. Examples of cooling
solutions include, water, saline solution and ethanol and
combinations thereof. Other embodiments can utilize a cooling fluid
or gas 27gwhich serves to cool electrodes 18 by ebullient cooling
or Joule Thomson Effect cooling as well as the mechanisms described
above. Embodiments utilizing Joule-Thomson Effect cooling can have
a nozzle-shaped aperture 27n to provide for expansion of a cooling
fluid 27g. Examples of cooling fluid 27g include, but are not
limited to, freon, CO.sub.2, and liquid nitrogen.
[0091] Referring now to FIGS. 12 and 15, various embodiment
apparatus can be configured to infuse or deliver a conductivity
enhancing solution 27 or other solution into target tissue site 5'
including tissue mass 5''. The solution can be infused before
during or after the delivery of energy to the tissue site by the
energy delivery device. The infusion of a conductivity enhancing
solution 27 into the target tissue 5' creates an infused tissue
area 5i that has an increased electrical conductivity (verses
uninfused tissue) so as to act as an enhanced electrode 40. During
RF energy delivery the current densities in enhanced electrode 40
are greatly lowered allowing the delivery of greater amounts of RF
power into electrode 40 and target tissue 5' without impedance
failures. In use, the infusion of the target tissue site with
conductivity enhancing solution provides two important benefits:
(i) faster ablation times; and (ii) the creation of larger lesions;
both without impedance-related shut downs of the RF power supply.
This is due to the fact that the conductivity enhancing solution
reduces current densities and prevents desiccation of tissue
adjacent the electrode that would otherwise result in increases in
tissue impedance. An example of a conductivity enhancing solution
includes saline solution, including hypotonic or hypertonic
solution. Other examples include halide salt solutions, and
colloidal-ferro solutions and colloidal silver solutions. The
conductivity of enhanced electrode 40 can be increased by control
of the rate and amount of infusion and the use of solutions with
greater concentrations of electrolytes (e.g. saline) and hence
greater conductivity.
[0092] In various embodiments the use of conductivity enhancing
solution 27 allows the delivery of up to 2000 watts of power into
the tissue site impedance shut down, with specific embodiments of
50, 100, 150, 250, 500, 1000 and 1500 watts achieved by varying the
flow, amount and concentration of infusion solution 27. The
infusion of solution 27 can be continuous, pulsed or combinations
thereof and can be controlled by a feedback control system
described herein. In a specific embodiment a bolus of infusion
solution 27 is delivered prior to energy delivery followed by a
continuous delivery initiated before or during energy delivery with
energy delivery device 18 or other means. In another embodiment
feedback control is used to prevent impedance rises and failures by
monitoring impedance at the electrode-tissue interface and
increasing the flow rate of cooling and/or conductive fluid 27 in
response to impedance increase using PID or other control
algorithms known in the art. In related embodiment feedback control
could also incorporate sensor input on the deployed length (e.g.
deployment depth) of one or more electrodes and incorporate this
into an algorithm to regulate fluid flow, energy delivery power
level, duty cycle, duration and other ablation related parameters
described herein.
[0093] In related embodiments, the conductivity of the tumor mass
5' can be enhanced so as to preferentially increase the rate and
total amount of energy delivery of energy to the tumor mass 5'
relative to healthy tissue. This can be achieved by infusing
solution 27 directly into the tumor mass 5' through the use of a
needle electrode 18 placed within the tumor mass only. In related
embodiments infusion solution 27 can be configured to remain or be
preferentially absorbed or otherwise taken up by tumor mass 5''.
This can be achieved by controlling by one or more of the
osmolality, viscosity and concentration of solution 27.
[0094] Embodiments of the invention utilizing infusion of a
conductivity enhancing solution 27 provide several important
benefits including more consistent and homogeneous ablation volumes
as well as faster ablation times. This is achieved by infusing
conductivity enhancing solution 27 into the desired ablation volume
or target tissue site to both increase and homogenize tissue
conductivities throughout the desired ablation volume. This in turn
significantly reduces the incidence of tissue desiccation, charring
as well as the size zones of higher impedance any of which can slow
or prevent the delivery of ablative RF or thermal energy.
[0095] Referring now to FIG. 16, in various embodiments all or a
portion of infusion ports 23 can be configured as side holes in the
wall 18w of electrode 18 offset a minimum longitudinal distance
23ld from the distal tip 18de of electrode 18. These and other
embodiments solve the problem of tissue plugging or blocking of
fluid delivery lumens 72 which may occur as the electrode is
advanced into tissue by position aperture 23 proximally enough such
that it is not obstructed by the tissue plug 23tp. Distal end 18de
can include an axial aperture 23de or in a preferred embodiment
does not to eliminate any tissue coring effect of the electrode. In
various embodiments distance 23ld can be in the range of 0.010 to 1
inches, more preferably 0.05 to 0.5 inches and still more
preferably 0.1 to 0.25 inches. Specific embodiments can include
0.05, 0.1, 0.15 and 0.16 inches.
[0096] In an embodiment shown in FIG. 17, tissue plugging can be
overcome through the use of a lubricous or non-stick coating 18c
positioned over all or a portion of the surface 18s of electrode 18
including within lumens 72. Coating 18c prevents tissue, including
burnt or charred tissue and other biological material from
coagulating, adhering or otherwise sticking onto electrode surface
18s, apertures 23 or within lumens 72. In specific embodiments
coating 18c is configured to be thermally and/or electrically
insulative to prevent any partially adhered tissue from cooking or
coagulating onto the surface 18s of electrode 18 reducing the
probability of permanent tissue plugging and making partially
adherent tissue readily removable by flushing or increase flow
rates or pressure of fluid 27. Coating 18c can also be configured
to have a sufficiently low surface tension such that tissue and
other biological tissue do not stick to it. In various embodiments
the surface tension can be below 50 dynes/cm, preferably in the
range of 50 to 10 dynes/cm and more preferably in the range 40 to
18 dynes/cm, with specific embodiments of 25, 23, 19, 18.5, 18, 17
and 15 dynes/cm. Suitable coatings 18c can include but are not
limited to including, polyamide, polyamide fluoro, PTFE, TEFLON,
other fluoro-carbon polymers, silicones, paralene and other low
surface tension non-stick coatings known in the art. Such coatings
can range in thickness 18ct from 0.0001 to 0.1 inches with a
preferred embodiment of 0.001 to 0.003 inches. Coatings 18c can be
applied using co-extrusion dip coating, spray coating,
co-extrusion, electro-deposition, plasma coating, lithographic and
other coating methods known in the art.
[0097] Referring now to FIGS. 18a-18c, in various embodiments
electrode 18 can include a fixed or movable sleeve or sheath 31s
which covers a selectable portion of apertures 23 preventing them
from being blocked or plugged by tissue during either electrode
insertion and/or during or after the delivery of RF or other
thermally ablative energy. For movable embodiments, sheath 31s can
be configured to slide over the outer portion of the electrode or
slide through the inner lumen 72 while still not appreciably
obstructing fluid flow through the lumen. In an embodiment of a
method of the invention sheath 31s can be positioned over all or
portion of electrode 18 so as to cover and protect one or more
apertures 23 during insertion of electrode into tissue and then
subsequently pulled back to allow fluid infusion from uncovered
aperture 23 before, during or after the delivery of ablative
energy. In a related embodiment sheath 31 s can also be configured
to be used to control the flow rate of infusion media 27, as well
as the total area of electrode 18 available for infusion by
uncovering selected segments of apertured electrode 18 which are
used for infusion.
[0098] Positioning of the slidable sheath 31s can be controlled by
configuring the sheath to be directly coupled to an actuator 24''
on handpiece 24. In alternative embodiments positioning of sheath
31s can be controlled by the use of a positioning wire, cam, rocker
switch, ratchet mechanism, micropositioner, or servomechanism and
the like which is mechanically or electrically coupled to the
sheath an actuable by an actuator 24'' on handpiece 24.
[0099] As discussed herein, sheath 31s can be pulled back (e.g.
proximally) once electrodes 18 are positioned at the desired tissue
site or in an alternative embodiment sheath 31s can have a
sufficient inner diameter 31sid to provide enough of an annular
channel or thickness 31at to allow fluid 27 to flow out in annular
fashion from apertures 23 (either in a proximal or distal
direction) to the desired tissue site. In an embodiment sheath 31s
can have diameter 1-5 mm greater than of electrode 18 providing an
annular channel with a thickness between 0.5 to 2.5 mm Sheath 31s
can be actuated at handle 24 by the physician, and its position
along electrode 18 is controlled. The sheath 31s can be made from a
variety of polymers including, but not limited to resilient
polymers, elastomers, polyesters, polyimides, polyurethanes,
silicicones, PARALENE, flouropolymers, TEFLON and the like. Also in
various embodiments, slidable sheath 31s can be configured to be
electrically and/or thermally insulative or can be electrically and
thermally conductive using conductive polymers known in the art. An
example of a conductive polymer includes Durethane C manufactured
by the Mearthane Products Corporation (Cranston, R.I.). Also, all
or a portion of the sheath 31s can have radio-opaque, magno-opaque,
or echogenic markers to facilitate viewing and placement of the
sheath using X-ray, CAT scans, nmr ultrasound and the like.
[0100] Referring now to FIG. 19, in another embodiment of an
electrode configured to reduce plugging of apertures comprises a
needle configured to have a needle bevel angle 68 that minimizes
tissue coring and hence plugging of lumen 72. In various
embodiments the needle angle 68 can be in the range of 5 to
30.degree., preferably 10 to 20.degree. and still more preferably
12.degree..
[0101] Referring now to FIGS. 20a and 20b, in various embodiments
introducer 12 or electrode 18 can include a porous distal section
12pds or 18pds. Porous distal section 12pds or 18pds is configured
to allow fluid to diffuse out of the pore and or interstitial
spaces 12pds' between braids 12pds''. In various embodiments
section 12pds can comprise a braided section which has sufficient
rigidity or column strength to penetrate tissue, but still porous
enough to allow the passage of fluid. Braided section 12pds can be
made from braid material known in the art including high strength
material and can be wound or woven using methods known in the art
including filament winding techniques and carbon fiber filament
winding techniques. Suitable braid materials include metal braids
such as stainless steel that can be hardened to increase stiffness
or high strength polymer braids such as Nylon.RTM., polyester and
Kevlar.RTM. fibers, examples including Kevlar 29 and Kevlar 49
manufactured by the Dupont Corporation. Other suitable braid
materials can include but are not limited to fiberglass, graphite
or carbon fibers including Pitch and Pan based carbon fibers.
Examples of fiberglass material include ASTROQUARTZ II, ASTROQUARTZ
III and styles 106, 108, 7628 and 7637 manufactured by JPS
Industries (Greenville, S.C.). The rigidity of braided or porous
section 12pds or 18pds can be achieved through the use of a
structural or stiffening member 12sm positionable within all or a
portion of porous section 12pds. In various embodiments, member
12sm can be a metal mandrel, such as stainless steel mandrel, a
hardened steel mandrel or rigid polymer member made from
polycarbonate or other thermoset polymer.
[0102] The packing or weave of braids or fibers 12pds or 18pds can
be varied to control the fluid porosity of section 12pds that is
amount of fluid that diffuses or wicks through the fibers. In
various embodiments the porosity of section 12pds can be in the
range of 1-2000 cc/min/cm.sup.2, preferably in the range of 10 to
1000 cc/min/cm.sup.2, with specific embodiments of 20, 50, 100, 250
and 500 cc/min/cm.sup.2.
[0103] In related embodiments all or portions of sections 12pds or
18pds can be fabricated from heat resistant materials and polymers
such that the strength, stiffness or shape of section 12pds or
18pds is not appreciably degraded or altered during the delivery of
RF or other thermal ablative energy. Such embodiments solve the
problem of softening or deformation of a porous or fluid delivery
section 12pds or other section of elongate member 12 that can occur
during delivery of thermally ablative energy to a tissue site.
Suitable heat resistant polymers and materials include
polyetherimide available from the General Electric Company under
the trademark ULTEM.RTM. and polyetheretherketone available from
the General Electric Company under the trademark UNITREX.RTM.). In
other embodiments all or portions of section 12pds can fabricated
from electrically conductive or electrically dissipative polymers.
Examples of electrically dissipative polymers include acetals such
as UNITAL ESD available from the General Electric Company. In still
other embodiments a braided porous section 12pds is configured to
increase the surface area for conductive heat transfer from section
12pds and/or energy delivery device 18 to either fluid 27 or the
surrounding tissue. These embodiments enhance the heat transfer
from energy delivery device 18 and/or section 12pds reducing the
likelihood of tissue desiccation and charring on or near the energy
delivery device in turn reducing impedance of the energy delivery
device and impedance caused shut downs (i.e. called impeding out)
of power supply 20.
[0104] In another embodiment porous section 12pds including
electrode 18 can comprise a porous, microporous or liquid permeable
material 12pm fluidically coupled to lumen 13 or 72 and configured
to uniformly effuse or diffuse fluid through itself, onto its
surface and into tissue. Suitable porous materials include polymer
foam, polyester foam, OPCELL foam, ceramic, polyester, polyester
membrane, Nylon membrane, glass fiber membranes DACRON, expanded
PTFE membranes and porous ceramics known in the art. The pore sizes
of porous material 12pm can be in range from 5 to 1000 microns,
preferably 40 to 500 microns and more preferably 50 to 150 microns.
In these and related embodiments porous section 12pds can be
configured to wick, effuse, spray or jet fluid to wet, irrigate and
cool the electrode by a combination of one or more of conductive,
convective and evaporative cooling. Irrigating the electrodes
provides the benefit of preventing and/or reducing an impedance
rise at the electrode tissue interface. In embodiment the electrode
can be coated with a hydrophilic coating or texture to facilitate
wetting of the electrode surface. Examples of hydrophilic surfaces
include metal, glass, and plasma treated polymers and metals,
whereby the plasma treatment increases the surface tension of the
substrate surface via chemical reaction and/or deposition with the
surface. The plasma treatment can be a variety of plasma treatment
known in the art such as argon plasma treatment.
[0105] In an embodiment of a method of the invention, tissue
plugging can be prevented or reduced by infusing fluid through one
or more electrode lumens 72 when the electrode is inserted into
tissue and/or during the delivery of RF or other thermally ablative
energy. In various embodiments the infusion rate can be in the
range between 0.1 to 2 ml with specific embodiments of 0.2, 0.5,
1.0 and 1.5 ml/min. Tissue infusion flow via a fluid delivery
device 28 such as an infusion or syringe pump can be initiated
before or during insertion of apparatus 10 into tissue, or before
or during deployment of needles 18 into tissue. Also in a related
embodiment flow to one or more electrodes 18 can be monitored using
sensors 22 to detect developing plugs and using feedback control
(described herein) can be increased or otherwise modified to push
out the plug or otherwise prevent plug formation. In specific
embodiments feedback control can used to initiate a pressure or
flow pulse or a series of pulses or related waveforms by the fluid
delivery device (e.g. square waves, sinusoidal, step function,
etc.) to push out a developing or existing plug. The pressure pulse
can be in the range of 0.05 to 5 atm, preferably 0.1 to 2 atm and
still more preferably 0.3 to 1 atm.
[0106] Turning now to a discussion of the use of infusion with RF
energy delivery. While such a combination present advantages during
ablative treatment there are also technical challenges as well. Two
such challenges are (i) inconstant flow and (ii) inability to
achieve a homogenous level of infusion, and or inability to infuse
the entire volume of a target tissue volume particularly with only
one infusion port or channel of infusion. Referring now to FIGS.
1-2 and 12-15, various embodiments of the invention solve these
problems by providing an apparatus configured to infuse fluid
through multiple electrodes 18 or other infusion channels so as to
collectively define a larger, more predictable and homogenous or
complete infusion volume than would be possible by infusing from a
single electrode 18 or channel. Such embodiments solve the problem
of inconstant flow or incomplete, uneven or otherwise
non-homogenous ablation volumes that may result without infusion or
with only a single infusion channel. Uneven ablations can occur
with a single infusion channel due to uneven or incomplete infusion
volumes and/or zones within the desired infusion volume receiving
differing amounts of infusion fluid.
[0107] In various embodiments feedback control described herein can
also be employed to improve the uniformity of infusion volumes as
well as better control the infusion process. This can be achieved
by utilizing feedback control to monitor and control flow rates
through each electrode 18 or infusion channels 72 to compensate for
flow variation in any one channel and ensure more uniform volume of
infusion and subsequent ablation volumes. Embodiments of the
invention configured to infuse through multiple electrodes provide
the advantage of reducing collective back pressure that results
from a single infusion channel from fluidic pressure at the target
tissue site 5'' due to tissue resistance, obstruction or plugging
of a single electrode. Consequently, by distributing infusion over
multiple electrodes and multiple apertures at multiple site overall
flow rates, infusion rates and infusion volumes can be increased
and more uniform infusion can be achieved for a selected target
tissue site than via use of a single point of infusion. In
particular, by controlling infusion of liquid to the individual
electrodes, liquid can be supplied through each electrode at a
desired flow rate, independent of the resistance to flow of other
individual electrodes, allowing, for example, equal flow rates to
be applied to the electrodes.
[0108] Referring now to FIG. 21, in an embodiment of a method of
the invention fluid is infused through one or more electrodes 18 or
infusion channels such that the individual volumes or zones of
local tissue infusion 5ivl surrounding each electrode grow or
coalesce to form one large infusion volume 5iv. This can be
achieved by controlling the flow rate through the electrodes or
infusion channels and monitoring the amount infused analytically or
visually. The progression of the growth of the infusion volume 5iv
can be monitored using imaging methods including but not limited to
ultrasound, CT scan, MRI, and x-ray. In various embodiments of
methods of the invention, the monitoring process can be facilitated
by the use of X-ray or flouroscopic contrast agents, echogenic
contrast agents, or MRI contrast agents known in the art which are
added to infusion media 27. The delivery of ablative energy can be
initiated before during or after the completion of the infusion
process. In one embodiment, the delivery of ablative energy such as
RF energy is initiated only after the collective large infusion
volume has formed or substantially about the same time. In another
embodiment the delivery of RF energy is initiated before infusion,
at it onset or as the local infusion volumes are growing.
[0109] In alternative embodiments the delivery of an infusing
solution 27 can be enhanced by several means. In one embodiment,
ultrasound energy can be delivered to the selected target tissue
site 5'' during or post infusion to increase the diffusion and
permeation of fluid 27 into tissue site 5'' including the
interstitial space of tissue site 5' via a combination of fluid
sonication, agitation (fluid and tissue and/or brownian motion,
this analogous to shaking up a bottle containing a dissolvable
solid in a liquid to get the solid to dissolve. Further the energy
can be configured to cause cell lysis, enabling fluid 27 to diffuse
into cells. The ultrasound energy can be delivered by a
piezoelectric transducer known in the art that is coupled to one or
more electrodes or to a separate catheter/probe in turn coupled to
an ultrasound energy source. In various embodiments ultrasound
energy can be delivered in the frequency range from 0.5 to 30 MHz,
more preferably from 1 to 10 MHz, with specific embodiments of 2,
3, 5 and 8 Mhz.
[0110] In another embodiment fluid delivery device 28 can be
configured to produce pressure pulses in flow and/or pulsed flow to
enhance diffusion. Still another embodiment employs the use of RF
or DC voltage to create an electroporation effect known in the art.
The DC voltage can be delivered by a separate probe coupled to a DC
power source with a voltage known in the art to produce an
electroporation affect. Such a voltage source can be in the range
of 0.1 to 10 volts.
[0111] Referring now to FIG. 22, during the delivery of RF each RF
electrode 18 is configured to generate an ablation volume 5ave
proximate each electrode 18. This volume, which may be spherical or
columnar, depending on the length of active region(s) is also
referred to herein as an individual-electrode ablation volume, and
corresponds to the ablation volume produced by applying an RF
current (RF power) to that electrode during the initial phase of RF
ablation. When multiple electrode are used, and optionally,
electrolyte solution is infused into tissue from the electrodes,
application of RF energy to the multiple ablation volumes, e.g.,
spherical ablation volumes, will result in each ablation volume
expanding and eventually merging and overlapping to form a single
combined-electrode ablation volume 5avc, also referred to herein as
a meta volume.
[0112] Depending on the size and shape of the of the desired
combined-electrode ablation volume 5av, different number of
electrodes 18 can be used to create the meta ablation volume 5avce
whose shape a volume approximates that of the desired ablation
volume. In various embodiments a range of 2-12, typically 3-10,
electrodes are employed to create a corresponding number of
individual-electrode ablation volumes. In a specific embodiments
four electrodes used to create four ablation volumes 5ave which can
have an approximately a tetrahedral orientation.
[0113] In a related embodiment platonic solids 5ps (described
herein) can be used as a positioning geometric template for
individual electrode ablation volumes 5ave to create the desired
collective or meta ablation volume size 5avc using the fewest
number of individual ablation volumes 5ave. In a specific
embodiment each individual electrode ablation volumes 5ave is
positioned such that it is bisected by a single face or surface 5pf
of the respective platonic solid, with one ablation volume 5ave
positioned as such on all faces of the chosen platonic solid.
Examples of suitable platonic solids include, but are not limited
to a cube, tetrahedron and dodecahedron, as discussed below.
[0114] In accordance with one aspect of the invention, the
progression of the ablation volumes 5av is monitored using one or
more passive (non ablating) sensor elements. Referring now to FIG.
23, apparatus 10 includes one or more passive (non ablating) sensor
elements or monitoring members 18pm advanceable from device 12 and
positionable within a target tissue site 5' concurrently or
independently of the positioning of electrodes 18. As will be
appreciated, the sensor elements are carried on the delivery device
for movement with respect therein between retracted positions, in
which the sensor elements are carried within the lumen of the
device, and deployed (including partially deployed) positions in
which the sensor elements (or at least their distal ends) are
deployed outside of and away from the distal end of the delivery
device.
[0115] Typically, the sensor elements, when deployed, are arrayed
in an arcuate, laterally extending, angularly spaced configuration,
with the sensor elements being positioned within the volume
corresponding to the combined-electrode ablation volume, and with
the individual sensor elements being disposed between adjacent
electrodes, as detailed below. Specifically, the sensor elements
are typically arrayed outside of the individual-electrode ablation
volume in the region of coalescence of ablation volumes of two
adjacent electrodes. In this configuration, in the early phases of
RF ablation, the sensor elements are located outside of the
individual-electrode ablation volumes. As the individual volumes
expand and begin to coalesce, the regions of ablation begin to
overlap with the sensor elements positions. By placing the sensor
elements outside of the initial ablation volumes, the spread of the
ablation volume, and ultimately, the desired extent of ablation
throughout the combined-electrode ablation volume can be monitored
and controlled, as detailed herein.
[0116] As will be appreciated, the plural sensor elements may be
ganged together for movement as a unit between retracted and
deployed positions, as described above for the electrodes, or they
may be individually movable to place the sensor elements at
different extended positions in the combined-electrode ablation
volume. When ganged together, the sensor elements and electrodes
and be moved independently of one another or moved as a combined
electrode/sensor unit between retracted and deployed positions.
[0117] The sensor elements are designed to sense tissue properties
rather than deliver ablative energy and accordingly can include one
or more sensors 22 or alternatively, all or portion of passive
members can be sensing elements 22. Preferably members 18pm are
configured to be non conductive and/or to not delivery appreciable
amounts of RF or other electromagnetic energy. In various
embodiments this can be accomplished by coating all or portions of
members 18m with an electrically insulative coating or layer 18ic
that can also be thermally insulative as well. Suitable insulative
coatings 18ic include, but are not limited to insulative polymers,
PARALENE, polyimide, polyamide, TEFLON, NYLON, flouropolymers and
other high dielectric materials and insulators known in the art.
The coating can be applied using spray coating, dip-coating methods
known in the art to produce a uniform coating thickness and
consistency. The use of higher dielectric strength materials
provides the benefit of thinner coatings which reduces the diameter
of passive elements 18mp in turn providing the benefit of making
members 18mp more flexible or maneuverable as well as allowing for
the positioning and deployment of a greater number of members 18mp
from introducer 12. In various embodiments the thickness 18ict of
coating 18ic can be in the range of 0.001 to 0.006 inches with
specific embodiments of 0.002 and 0.003 inches.
[0118] Alternatively, all or portions of passive members 18pm can
be fabricated from nonconductive materials such as resilient
polymers tubing including not limited to polyethylene, PEBAX,
polyimide and other polymers known in the catheter arts.
[0119] Passive members 18pm can be made of similar materials and/or
have similar properties to electrodes 18, e.g. tissue penetrating
ends, bendability, resiliency, memory, spring memory, etc. which
enable members 18pm to be deployed from introducer 12 and
positioned at selectable locations within a target tissue site 5'',
with the exceptions that members 18pm are configured either to not
be conductive and or not deliver ablative amounts of RF or other
electromagnetic energy. In an embodiment passive member can made
from 304v steel or spring steel which has an insulative coating
18ic and also includes a lumen 72 for the passage of both fluids 27
and also electrical wires 15 for coupling to sensors 22.
[0120] Referring now to FIG. 24, sensors 22 can be positioned in
one or more locations along the length of one or more members 18pm.
Also in various embodiments, sensors 22 can be positioned on or
flush with the surface of members 18pm, in the interior of members
18pm including within lumens 72 or can be integral to members 18pm
including the wall 18pmw of member 18pm. Further sensor 22 can
positioned using soldering or adhesive bonding methods known in the
medical device arts. Sensors 22 can be electrically coupled
directly to members 18pm (whereby an insulted conductive member
18mp provides an electrically coupling of the sensor to monitoring
resources describe herein) or can be electrically coupled to one or
more insulated wires 15 positioned within lumens 72 and
electrically coupled to sensing resources. Suitable sensors 22 for
use with members 18pm include but are not limited to temperature,
chemical, optical and other sensors described herein.
[0121] In embodiment sensors 22 and/or passive members 18pm can be
coupled to monitoring resources 20mr directly or via a multiplexing
device allowing selective polling and signaling of one or more
selected passive elements 18pm and or sensors 22. In various
embodiments, monitoring resources 20mr can comprise monitoring
circuitry such as temperature or impedance monitoring circuitry or
a monitoring unit 20mu comprising monitoring circuitry, a
microprocessor/controller, a visual display known in the art and
alarm circuitry. In an embodiment, the monitoring unit 20mu can be
integral to or otherwise electronically or optically coupled to
power source 20.
[0122] Referring now to FIG. 25, in an embodiment the plurality
20pmp of passive members 18pm can be positioned to define a
sampling volume 5sv either by circumscribing the volume and/or
positioning within the interior of the sampling volume. Passive
members can be manipulated to increase, decrease or change the
shape of sample volume 5sv being monitored. In various embodiments
sample volume 5sv can include all or a portion of ablation volume
5av, can larger than the ablation volume so as to include all or
portion of the ablation volume, define substantially the same
volume as ablation volume 5sv or be smaller than ablation volume
5av to be completely or partially bounded by ablation volume 5av.
In a related embodiment volume 5sv can be configured or manipulated
to be substantially separate or distinct from the ablation volume
5av. Passive members can be manipulate to define sample volumes
having a variety of geometric shapes including but not limited to
substantially spherical, hemispherical, oval, pyramidal,
tetrahdreral, rectangular, pentagonal, hexagonal, or another
selectable platonic solid.
[0123] Referring to FIG. 26, in an embodiment the passive arrays
are positioned to define a tetrahedron or pyramid 5tv which is
approximately circumscribed by a sphere which can approximately
correspond to the ablation volume 5av. In this and other
embodiments the ends 18de of the active array or electrodes 18 can
be positioned approximately on the plane of 5eqp of the equator 5eq
of the selected ablation volume. Preferably, the distal ends 18pmd
of passive members 18pm are positioned above and below this plane.
In related embodiments the central electrode 18ce can be positioned
above plane 5eqp while in other embodiments one or more electrodes
18 can be positioned above or below plane 5eqp. Further in other
related embodiments, the ends 18pmd of the passive members 18pm can
configured to define another geometric shape also circumscribed by
a sphere including but not limited to a cube, rectangle, or
oval.
[0124] Referring to FIG. 23 in preferred embodiments the deployed
length 38p of passive elements 18pm are longer than the active
elements or electrodes 18 such that they can be positioned more
distally than the electrodes and define a larger volume than the
electrodes and that larger volume substantially contains the
ablation volume 5av. In various embodiments, the length 38p of the
passive elements can be 0.1 to 5 cm longer than the deployed length
38 of the electrodes, preferably 0.5 to 2 cm longer and still more
preferably 1 cm longer. In a specific embodiment the electrode or
active array elements are approximately 2.5 cm in length and the
passive array elements are approximately 3.5 cm in length. Use of
passive arrays 18pma, with one or more passive elements 18pm longer
than electrodes 18 provides the novel benefit of being able to
monitor in real time the development and progression of the
ablation volume allowing for more complete, faster and controlled
ablations and in turn, a more successful clinical outcome for the
patient.
[0125] Referring now to FIGS. 23 and 26, in these and related
embodiments the passive elements 18pm can be positioned in the
spaces between the electrodes or active elements so as to sample
tissue volumes or zones 5vz at the farthest point or otherwise
equidistant from any two electrodes or active elements. Referring
now to FIG. 27, in an embodiment this can be optimally achieved by
configuring passive arrays 18pma and active arrays 18a with an
equal number of equally spaced elements and positioning the passive
elements 18pm approximately at a point which bisects the angle 18ba
formed between any two active elements in a plane approximately
perpendicular to the longitudinal axis 12al of introducer 12. For
example, for an embodiment having three electrodes and three
passive elements the passive elements would be positioned at an
angle 18ba of approximately 600 with respect to each of the three
electrodes. Similarly for an embodiment having four passive
elements and four electrodes angle 18ba would be approximately
450.
[0126] Use of passive arrays positioned in zones 5vz provides the
benefit of a higher confidence of a complete and uniform ablation
in that zones 5vz are typically the last to reach a temperature
necessary to cause ablation and/or cell necrosis and as such are
the most difficult or challenging areas to ablate using RF energy.
Further, the use of passive elements 18pm eliminates any signal
artifacts and/or hysteresis that might occur as result of
positioning sensors 22 on the electrodes 18 or other active
elements 18. Accordingly, by using passive arrays to sample
ablation volume 5av, embodiments of the invention provide the
benefit of a more representative and/or accurate sampling of tissue
temperature (or other tissue property indicative of ablation) of
the entire desired ablation volume and in turn a higher confidence
(including a higher statistical confidence) of achieving a complete
ablation. More specifically, such embodiments provide a higher
statistical correlation of measured temperature to actual tissue
temperature throughout a desired tissue volume and thus a higher
confidence of achieving a desired treatment endpoint (as indicated
by temperature or other measured tissue property).
[0127] In an embodiment of a method of the invention, passive
arrays can be used to measure a temperature at the outermost
portions of the ablation volume or other zones 5vz such that a
clinical endpoint is established and energy is stopped or decreased
once a selectable temperature is reached at or near those zones.
Such embodiments provide the benefits of faster ablation times as
well a decreased risk of damage to healthy surrounding tissue and
structures including critical anatomical structures such as organs,
nerves, blood vessels etc. In various embodiments the endpoint
temperature can be in the range of 38 to 75.degree. C., preferably
40 to 70.degree. C. and still more preferably 50 to 70.degree. C.,
with specific embodiments of 40, 41, 45, 50, 55, 60 and 65.degree.
C. In a related embodiment, temperature can continued to be
monitored for a period of time after energy delivery is stopped and
endpoint assessed by the time decay in tissue temperatures with a
relatively constant post ablation tissue temperature or slower
decay being indicative of endpoint.
[0128] In an embodiment the apparatus can include three or more
power arrays or electrodes and three or more passive arrays.
However other embodiment can comprise any number or combination of
active electrodes and passive elements including, but not limited
to (i) two or more electrodes and two or more passive elements;
(ii) three or more electrodes and two or more passive elements;
(iii) two or more electrodes and three or more passive elements;
(iv) two or more electrodes and one or more passive elements; (v)
one or more electrode and two or more passive elements; (vi) more
electrodes than passive elements; (vii) more passive elements than
electrodes; and (viii) and an equal number of passive elements and
active elements. Further in various embodiments the exact number of
the electrodes and passive elements as well as their defined volume
(e.g. spherical, oval,) can be selectable by the physician
depending upon factors such as the size and shape of the tumor,
consistency and type of tumor (e.g. fibrous, degree of vascularity,
necrotic, etc.), location of the tumor (e.g. liver vs. bone) and
proximity of adjacent anatomical structures (e.g. blood vessels,
organs etc.). This can be achieved though the use of a multiplexing
device described herein, coupled to one or more electrodes and
passive elements (so as to be able to switch them on or off) or
advancing or withdrawing additional electrodes and passive elements
through elongated member 12 and/or through electrodes or passive
elements in place at the tissue site. Also the respective ablation
or sample volume defined by the plurality of electrodes and passive
elements can be adjusted by the physician by advancing or
retracting one or more electrodes or passive elements or rotating
one or more electrodes or passive elements or a combination of both
techniques.
[0129] For ease of discussion introducer 12 will now be referred to
as trocar 12; however all other embodiments discussed herein are
equally applicable. Turning now to a discussion of trocar 12 and it
use with passive arrays 18pmp, one of the potential problems in
using a sharpened trocar 12 with insulative passive arrays is the
scraping or braiding of the insulation 18ic on passive elements
18pm. Referring now to FIGS. 28a-28c, various embodiments of the
invention provide solutions to this problem. As shown in FIG. 28a a
standard trocar 12 has a tissue penetrating distal end 16 with a
sharpened leading edge 16le. This sharpened leading edge can cause
scraping or scything of the insulation layer of one or more passive
member 18pm as the passive member pass over it during deployment to
the tissue site 5''.
[0130] In various embodiments all or a portion of leading edge 16le
can be smoothed so as reduce or eliminate its propensity to abrade
or cut insulation layer 18ic. In an embodiment shown in FIG. 28b,
the leading edge 16le is only smoothed over all or a portion of its
inner surface 16lei still leaving a sharpened outer surface 16leo.
This embodiment provides the benefit of allowing passive member
18pm to pass over and through leading edge 16le without being
abraded or cut and still permits trocar tip 16 to be tissue
penetrating (e.g. the cutting edge 16leo is substantially
preserved). In one embodiment inner leading 16lei is radiused using
machining casting, molding or EDM methods known in the art. In
another embodiment it can be polished smooth using metal polishing
methods known in the art or EDM methods known in the art. The edge
16le can also be deburred using deburring methods known in the
art.
[0131] In various embodiments, the inner leading edge 16lei can
have a radius of curvature in the range of 0.0001 to 0.2 inches
with specific embodiments of 0.0005, 0.001, 0.005, 0.0.01, 0.05 and
0.1 inches. In another embodiment shown in FIG. 28c, inner leading
edge 16lei can be smoothed or otherwise made non-scything by virtue
of an applied coating 16c which can be a lubricous polymer coating
known in the art such as TEFLON and the like or a hard smooth
coating such as polycarbonate, acrylic and the like. Coating 16c
can be applied to all or a portion of leading edge 16le as well as
distal tip area 16 but is preferably only substantially applied to
inner leading edge 16lei. In still another alternative embodiment,
the problem of insulating scything can be solved using a hardened
or high strength insulative coating known in the art such as
polycarbonate, LUCITE, acrylic or high strength polyimide. In a
related embodiment, all or a portion of trocar distal end 16 can
fabricated from molded or machined plastic or elastomer that is
configured to have sufficient rigidity, column strength and related
material properties to penetrate and be advanced into tissue, but
is also configured to have a radiused or smooth inner leading edge
16lei that is substantially non-scything. Plastic distal end 16pl
can be attached to the body of introducer 12 using adhesive
bonding, ultrasonic welding, butt joining, crimping or other tube
joining method known in the medical device arts. Suitable materials
for plastic distal end 16pl include polycarbonate, high-density
polyethylene, acrylic and other rigid medical plastics known in the
arts.
[0132] In other embodiments, insulative scything can be reduced or
prevented via the geometric arrangement of the passive member and
electrodes as they exit the trocar tip 16. Referring now to FIG.
29, in an embodiment the passive members 18pmand electrodes 18 can
be packed or otherwise arranged such that the passive members 18pm
do not pass over leading edge 16le as they exit trocar tip 16. In
this and related embodiments the passive members 18pm and
electrodes 18 can be packed or bundled in a substantially circular
arrangement 50 approximating the arrangement of a multiwire cable
with passive members 18pm placed within the interior 50i of the
arrangement surrounded by active members or electrodes 18 such that
the passive members do not pass do not contact in the interior
surface 16is of distal end 16 including leading edge 16le. In
various embodiments the packing of electrodes around passive
members 18mpm can be substantially hexagonal in order to maximize
packing density. In another embodiment the packing arrangement can
be octagonal. In one embodiment three passive members 18pm are
surrounded by eight or more electrodes 18. The maintenance of
passive members 18pm within the interior 50i of packing 50 can
facilitated by joining passive members 18pm and electrodes 18 at
proximal locations that remain within introducer 12 using
soldering, adhesive bonding or other wire bundling method known in
the art.
[0133] Referring now to FIGS. 30 and 31, in various embodiments
trocar 12 has electrically insulated and non-insulated sections 12i
and 12ni. Non-insulated section 12ni is conductive and tissue
ablation can occur proximate to this section. However as shown in
FIG. 30, the transition 12t from section 12i to 12ni can be abrupt
due to the stepdown decrease in trocar outer diameter (going from
12di to 12dni) resulting from the end of the insulation layer 12il.
Such an abrupt transition 12t can increase axial resistance or
force necessary to insert and position trocar 12 into tissue
position distal end 16 at the target tissue site. In an embodiment
shown in FIG. 31, the transition 12t can be eliminated or
substantially reduced by configuring a distal section 16ds of
trocar 12 to have a larger diameter 16d than the remainder of
trocar 12 such that distal section 16ds is substantially flush with
the insulative layer 12il on the body of trocar 12 (e.g., distal
end diameter 16d is substantially equivalent to diameter 12di of
section 12i).
[0134] Distal section 16ds can be made of the same material as
trocar 12 (e.g., stainless steel, 304 steel and the like) and
fabricated using metal, machining, molding or forging methods known
in the art. Section 16ds can be integral with trocar section 12i or
alternatively can be joined to section 12i using soldering,
brazing, crimping or other metal joining methods known in the art.
Configuring distal section 16ds flush with trocar section 12i
reduces the force necessary to insert the trocar into tissue and
also smoothes out the insertion process giving the physician a
better tactile feel for properly positioning the trocar at the
target tissue site. Further these and related embodiments of a
stepped trocar distal end provide the benefit of facilitating
insertion and positioning of trocar 12 and distal section 16ds to
the target tissue site, increasing the placement accuracy of distal
section 16ds, reducing procedure time and increasing procedure
efficacy. In an embodiment, distal section 16ds can have an outer
diameter 16dsod of 0.087 to 0.089 inches while the outer diameter
12iod of the non-insulated trocar is 0.080 to 0.082 inches, and
insulation layer 12il thickness of between 0.0025 to 0.0045 inches.
The length 16dsl of distal section 16ds can be in the range of 6.5
to 8.5 mm.
[0135] Referring now to FIG. 32, in an embodiment, all or a portion
of one or more of the energy delivery devices 18 can include a
radioactive portion 18r. Radioactive portion 18r is fabricated from
a radioactive material having sufficient radioactive strength
(e.g., curies) to necrose, ablate, ionize or otherwise kill
tumorous tissue 5'' at tissue site 5'. In related embodiments, a
radioactive absorbing sheath 18s can be configured to be slidably
positioned over radioactive portion 18r so as to control the
exposed length 18r' of radioactive portion 18r and thus the dose of
radioactivity delivered to the tumor mass 5''.
[0136] The radioactive material in section 18r can include gamma,
alfa- or beta- emitting materials. Suitable gamma emitters include,
but are not limited to Cobalt-60, Iodine-131, Iodine-123,
Indium-111, Gallium-67 and Technetium-99 m. Suitable beta emitting
particles include tritium. The amount of radioactive material in
portion 18r can be configured to deliver 0.01 to 100 rads of
radiation with specific embodiments of 0.1, 0.25, 0.5, 1, 10 and 50
rads. The amount of radiation delivered can measure using a
radiation sensor 22 coupled to energy delivery device 18 or
introducer 12. Radioactive absorbing sheath 18s can include one or
more radioactive absorbing materials known in the art that are
impregnated or otherwise integral to a flexible metal or polymer
layer. Such radioactive absorbing materials include but are not
limited to lead, iron or graphite. In an embodiment, the
radioactive absorbing material can be fabricated into a braided
wire or sheath incorporated into the wall of sheath 18s using
catheter production methods known in the art.
[0137] In use, radioactive section 18r provides the patient with
the benefit of radiation therapy having a highly targeted delivery
of radioactivity to the tumor mass while minimizing injury to
surrounding tissue. The radiation can be delivered alone or as an
adjunct to another ablative treatment describe herein (before
during or after such treatment) to sensitize cancer cells to other
forms of necrotic therapy or otherwise increase the probability of
killing cancerous tissue. The dose of radiation can at such level
for example below 1 rad that it has no affect on healthy or
untreated tissue but when combined with another energetic therapy
serves to surpass a lethal threshold for the selected tumorous
tissue. Such therapy provides the benefit of an increased
probability of killing all the cancer cells at the tumor site and
thus an improved clinical outcome for the patient.
[0138] Other embodiments of the invention can employ photodynamic
therapy described herein to treat tumors. Referring to FIG. 33 (a
perspective view illustrating an embodiment employing photo
activated agents), in such embodiments apparatus 10 can be
configured to deliver a phototherapeutic agent 27pa also known as a
photodynamic agent 27pa to the target tissue site. Agent 27a can be
configured to selectively be taken up and/or otherwise selectively
bind to tumor mass 5''. Once the agent is delivered and taken up by
the tumor 5'' an optical embodiment of the energy delivery device
is used to delivery optical radiation to activate therapeutic agent
5'' and cause the necrosis or ablation of tumor mass 5''. However,
prior to photo-activation agent 27pa remains in an inert or
nontoxic state. Examples of optical energy delivery devices 18
include optical fibers, light pipes, wave-guides and the like.
Examples of photo-therapeutic agents include chlorophyll-based
compounds such as Bacteriochlorophyll-Serine and texaphyrin based
compounds such as lutetium texaphyrin manufactured by
Pharmacyclics, Inc. (Sunnyvale, Calif.). Examples of activating
radiation include radiation in the infrared, near infrared and
ultraviolet range of the spectrum. Such radiation can be delivered
by the optical energy delivery devices described herein as well as
other optical delivery devices known in the art. In an embodiment,
agent 27pa can be delivered as a fluid through a bone access device
or bone biopsy needle directly to the tumor site 5'' or through the
Haversian canals.
[0139] In various embodiments, photo-dynamic therapy can be
conducted prior, concurrently or after with thermal ablative
therapy such as RF ablative therapy. In a related embodiment,
photo-agent 27pa can also be configured to increase the
hyperthermic affect of RF or other electromagnetic energy delivered
to tumor mass 5'' or otherwise selectively sensitize tumor tissue
to the necrotic affects of hyperthermic tumor treatment such as RF
ablative treatment. In a specific embodiment photo-agent 27pa is
configured to be repelled by bone tissue including calcium-based
tissue or collagen-based tissue and thus increase the agents
specificity for tumorous tissue. In another embodiment the
photosentisizing agent 27pa can be configured to be activated by a
wavelength of light that is reflected by bone tissue yet absorbed
darker tumorous tissue. This and related embodiments provide the
benefit of an agent 27pa that is highly specific to tumor tissue
yet has little or no affect on healthy bone. Further, the use of
agent 27pa allows the level of hypothermic treatment to be titrated
to the size and type of tumor tissue. This can be accomplished by
using a spectrum of agent's 27pa that increases or decreases the
level of tumor sensitization as needed.
[0140] Other embodiments of the invention can combine thermal or
other ablative therapy described herein with chemotherapy or other
medicinal based therapy. Apparatus 10 can be used to deliver
various chemotherapeutic or medicinal agents along or in
combination before, during or post ablation. One such family of
agent includes antisense-based compounds configured to inhibit the
metabolism by the liver (by inhibition of liver enzymes) of various
chemotherapeutic agents and thus extend their biological half-life
(e.g. effectiveness) while minimizing side-affects. An example of
such a compound includes NEUGENE.RTM.) antisense compound
manufacture by AVI BioPharma Inc (Portland Oreg.). Such compounds
can be delivered directly to the liver using apparatus 10 or other
drug delivery device described herein or known in the art.
[0141] Referring now to FIGS. 34 and 35, a feedback control system
329 can be connected to energy source 320, sensors 324 and energy
delivery devices 314 and 316. Feedback control system 329 receives
temperature or impedance data from sensors 324 and the amount of
electromagnetic energy received by energy delivery devices 314 and
316 is modified from an initial setting of ablation energy output,
ablation time, temperature, and current density (the "Four
Parameters"). Feedback control system 329 can automatically change
any of the Four Parameters. Feedback control system 329 can detect
impedance or temperature and change any of the Four Parameters.
Feedback control system 329 can include a multiplexer to multiplex
different antennas, a temperature detection circuit that provides a
control signal representative of temperature or impedance detected
at one or more sensors 324. A microprocessor can be connected to
the temperature control circuit.
[0142] The following discussion pertains particularly to the use of
an RF energy source and lung treatment/ablation apparatus 10. For
purposes of this discussion, energy delivery devices 314 and 316
will now be referred to as RF electrodes/antennas 314 and 316 and
energy source 320 will now be an RF energy source. However it will
be appreciated that all other energy delivery devices and sources
discussed herein are equally applicable and devices similar to
those associated with lung treatment/ablation apparatus 10 can be
utilized with laser optical fibers, microwave devices and the like.
The temperature of the tissue, or of RF electrodes 314 and 316 is
monitored, and the output power of energy source 320 adjusted
accordingly. The physician can, if desired, override the closed or
open loop system.
[0143] The user of apparatus 10 can input an impedance value that
corresponds to a setting position located at apparatus 10. Based on
this value, along with measured impedance values, feedback control
system 329 determines an optimal power and time needed in the
delivery of RF energy. Temperature is also sensed for monitoring
and feedback purposes. Temperature can be maintained to a certain
level by having feedback control system 329 adjust the power output
automatically to maintain that level.
[0144] In another embodiment, feedback control system 329
determines an optimal power and time for a baseline setting.
Ablation volumes or lesions are formed at the baseline first.
Larger lesions can be obtained by extending the time of ablation
after a center core is formed at the baseline. The completion of
lesion creation can be checked by advancing energy delivery device
316 from distal end 16' of introducer 12 to a position
corresponding to a desired lesion size and monitoring the
temperature at the periphery of the lesion such that a temperature
sufficient to produce a lesion is attained.
[0145] The dosed loop system 329 can also utilize a controller 338
to monitor the temperature, adjust the RF power, analyze the
result, and then modulate the power. More specifically, controller
338 governs the power levels, cycles, and duration that the RF
energy is distributed to electrodes 314 and 316 to achieve and
maintain power levels appropriate to achieve the desired treatment
objectives and clinical endpoints. Controller 338 can also in
tandem govern the delivery of electrolytic, cooling fluid and, the
removal of aspirated tissue. Controller 338 can also in tandem
monitor for pressure leaks (via pressure flow sensors 324') through
introducer 312 tending to cause pneumothorax and actuate coupled
control valves to block the fluid path causing the leak and/or
initiate the delivery of sealant and/or energy at the target tissue
site to seal the leak. Controller 338 can be integral to or
otherwise coupled to power source 320. The controller 338 can be
also be coupled to an input/output (I/O) device such as a keyboard,
touchpad, PDA, microphone (coupled to speech recognition software
resident in controller 338 or other computer) and the like.
[0146] Referring now to FIG. 34, all or portions of feedback
control system 329 are illustrated. Current delivered through RF
electrodes 314 and 316 (also called primary and secondary RF
electrodes/antennas 314 and 316) is measured by a current sensor
330. Voltage is measured by voltage sensor 332. Impedance and power
are then calculated at power and impedance calculation device 334.
These values can then be displayed at a user interface and display
336. Signals representative of power and impedance values are
received by controller 338 which can be a microprocessor 339.
[0147] A control signal is generated by controller 338 that is
proportional to the difference between an actual measured value,
and a desired value. The control signal is used by power circuits
340 to adjust the power output in an appropriate amount in order to
maintain the desired power delivered at the respective primary
and/or secondary antennas 314 and 316. In a similar manner,
temperatures detected at sensors 324 provide feedback for
maintaining a selected power. The actual temperatures are measured
at temperature measurement device 342, and the temperatures are
displayed at user interface and display 336. A control signal is
generated by controller 338 that is proportional to the difference
between an actual measured temperature, and a desired temperature.
The control signal is used by power circuits 340 to adjust the
power output in an appropriate amount in order to maintain the
desired temperature delivered at the respective sensor 324. A
multiplexer 346 can be included to measure current, voltage and
temperature, at the numerous sensors 324 as well as deliver and
distribute energy between primary electrodes 314 and secondary
electrodes 316.
[0148] Controller 338 can be a digital or analog controller, or a
computer with embedded, resident or otherwise coupled software. In
an embodiment controller 338 can be a Pentium.RTM.) family
microprocessor manufacture by the Intel.RTM. Corporation (Santa
Clara, Calif.). When controller 338 is a computer it can include a
CPU coupled through a system bus. On this system can be a keyboard,
a disk drive, or other non-volatile memory systems, a display, and
other peripherals, as are known in the art. Also coupled to the bus
are a program memory and a data memory. In various embodiments
controller 338 can be coupled to imaging systems, including but not
limited to ultrasound, CT scanners (including fast CT scanners such
as those manufacture by the Imatron Corporation (South San
Francisco, Calif.), X-ray, MRI, mammographic X-ray and the like.
Further, direct visualization and tactile imaging can be
utilized.
[0149] User interface and display 336 can include operator controls
and a display. In an embodiment user interface 336 can be a PDA
device known in the art such as a Palm.RTM. family computer
manufactured by Palm.RTM. Computing (Santa Clara, Calif.).
Interface 336 can be configured to allow the user to input control
and processing variables, to enable the controller to generate
appropriate command signals. Interface 336 can also receives real
time processing feedback information from one or more sensors 324
for processing by controller 338, to govern the delivery and
distribution of energy, fluid etc.
[0150] The output of current sensor 330 and voltage sensor 332 is
used by controller 338 to maintain a selected power level at
primary and secondary antennas 314 and 316. The amount of RF energy
delivered controls the amount of power. A profile of power
delivered can be incorporated in controller 338, and a preset
amount of energy to be delivered can also be profiled.
[0151] Circuitry, software and feedback to controller 338 results
in process control, and the maintenance of the selected power, and
are used to change, (i) the selected power, including RF,
microwave, laser and the like, (ii) the duty cycle (on-off and
wattage), (iii) bipolar or monopolar energy delivery and (iv)
infusion medium delivery, including flow rate and pressure. These
process variables are controlled and varied, while maintaining the
desired delivery of power independent of changes in voltage or
current, based on temperatures monitored at sensors 324. A
controller 338 can be incorporated into feedback control system 329
to switch power on and off, as well as modulate the power. Also,
with the use of sensor 324 and feedback control system 329, tissue
adjacent to RF electrodes 314 and 316 can be maintained at a
desired temperature for a selected period of time without causing a
shut down of the power circuit to electrode 314 due to the
development of excessive electrical impedance at electrode 314 or
adjacent tissue.
[0152] Referring now to FIG. 35, current sensor 330 and voltage
sensor 332 are connected to the input of an analog amplifier 344.
Analog amplifier 344 can be a conventional differential amplifier
circuit for use with sensors 324. The output of analog amplifier
344 is sequentially connected by an analog multiplexer 346 to the
input of A/D converter 348. The output of analog amplifier 344 is a
voltage that represents the respective sensed temperatures.
Digitized amplifier output voltages are supplied by A/D converter
348 to a microprocessor 350. Microprocessor 350 may be Model No.
68HCII available from Motorola. However, it will be appreciated
that any suitable microprocessor or general purpose digital or
analog computer can be used to calculate impedance or
temperature.
[0153] Microprocessor 350 sequentially receives and stores digital
representations of impedance and temperature. Each digital value
received by microprocessor 350 corresponds to different
temperatures and impedances. Calculated power and impedance values
can be indicated on user interface and display 336. Alternatively,
or in addition to the numerical indication of power or impedance,
calculated impedance and power values can be compared by
microprocessor 350 with power and impedance limits. When the values
exceed predetermined power or impedance values, a warning can be
given on user interface and display 336, and additionally, the
delivery of RF energy can be reduced, modified or interrupted. A
control signal from microprocessor 350 can modify the power level
supplied by energy source 320 to RF electrodes 314 and 316. In a
similar manner, temperatures detected at sensors 324 provide
feedback for determining the extent and rate of (i) tissue
hyperthermia, (ii) cell necrosis, and (iii) when a boundary of
desired cell necrosis has reached the physical location of sensors
324.
[0154] Platonic Solid Embodiments: An embodiment of a method of the
invention provides a method to utilize platonic solid geometry to
minimize the number of individual ablations required to produce a
collective ablation volume larger than any single ablation volume.
More specifically the embodiment provides a method to maximize the
effect of overlapping ablations to treat tumors larger than the
capabilities of current commercially available products. This and
related embodiments are also applicable to the design of a
multi-electrode device where each electrode will create a
sub-lesion in order to create a meta-lesion that is the combination
of the smaller lesions.
[0155] Specific embodiments provide method for using one or more of
a series of optimal geometries used as a template for positioning
overlapping ablations to create a meta-ablation volume. In order to
find the most efficient geometry for the placement of the
sub-lesions it is obvious that the more symmetric the pattern the
larger the meta-lesion will be for a given number of sub-lesions at
a given size.
[0156] Platonic solids are composed of regular convex polygons that
have the same number of polygons meeting at each corner. In all
Platonic solids the number of sides is equal to or less than the
number of vertices. Because the goal is to reduce the number of
sub-lesions required, the sub-lesions will be placed on each face
of the platonic solid and not at the vertices.
[0157] Referring now to FIG. 36 in an embodiment a platonic solid
5ps is used as a template or reference volume 5rv with which to
place individual or sublesions 5ave in order to create a larger
collective lesion or meta-lesion 5avc. With the center of the
sub-lesion 5ave on the center of the face of the platonic solid 5ps
and the diameter of the sub-lesion circumscribing the vertices of
the face of the platonic solid, a meta-lesion is formed that is
defined by the diameter of the platonic solid, as measured between
opposite corners. Referring to FIGS. 37a-37e example platonic
solids 5ps which can be used as the template or reference volume
5rv include, but are not limited to, Tetrahedron, Cube, Octahedron,
Dodecahedron, and Icosahedron.
[0158] For platonic solids with 8 or fewer faces the sub-lesions
overlap in the center of the meta-lesion. For platonic solids with
12 or more sides an additional sub-lesion in the center of the
meta-lesion is required for a complete volumetric coverage. Using
this concept and geometry it is possible to construct a table
outlining the minimum number of ablations required to create a
meta-lesion. TABLE-US-00001 Number Size 4 6 8 12* 20* 1 1.06 1.23
1.23 1.65 1.9 3 3.18 3.69 3.69 4.95 5.7 5 5.3 6.15 6.15 8.25 9.5
*One additional ablation required in the center to cause complete
volumetric coverage
[0159] The apparatus and method of this invention are particularly
useful for o benign and cancerous tumors using of RF energy and
infused fluids. It will be readily apparent to a person skilled in
the art that various embodiments and combinations of embodiments of
the device and method can be used to sample or ablate/destroy body
tissues, tissue locations that are accessible by percutaneous or
endoscopic catheters, and is not limited to the bone in the liver,
lung, bone, brain and breast. Such tissue locations and organs
include, but are not limited to, the heart and cardiovascular
system, upper respiratory tract and gastrointestinal system as well
as the bone in the liver, lung, bone, brain and breast. Application
of the apparatus and method in all of these organs and tissues are
intended to be included within the scope of this invention.
[0160] Also this specification discloses various catheter-based
systems and methods for treating the bone and adjoining tissue
regions in the body. The systems and methods that embody features
of the invention are also adaptable for use with systems and
surgical techniques both in the bone and other areas of the body
that are not necessarily catheter-based. Furthermore, this
specification is not intended to be exhaustive or to limit the
invention to the precise forms disclosed. It will be apparent that
various modifications, applications, and different combinations of
embodiments can be made without departing from the invention as
claimed.
* * * * *