U.S. patent application number 11/777931 was filed with the patent office on 2008-01-24 for method and apparatus for tissue resection.
This patent application is currently assigned to BOSTON SCIENTIFIC SCIMED, INC.. Invention is credited to Marcia Buiser, Paul DiCarlo, Arnold E. Oyola.
Application Number | 20080021486 11/777931 |
Document ID | / |
Family ID | 38750822 |
Filed Date | 2008-01-24 |
United States Patent
Application |
20080021486 |
Kind Code |
A1 |
Oyola; Arnold E. ; et
al. |
January 24, 2008 |
METHOD AND APPARATUS FOR TISSUE RESECTION
Abstract
A resection device includes an elongated probe shaft and a
tissue resection member disposed at a distal end of the elongated
probe shaft. The tissue resection member has a cutting surface
configured for being placed in contact with tissue. In one aspect
of the invention, at least one ejection port is located adjacent to
the cutting surface of the tissue resection member, wherein the at
least one ejection port is coupled to a source of a polymerizable
hemostasis-promoting material that is delivered to the resection
site of interest. In certain embodiments, polymerization of the
hemostasis-promoting material may be accelerated by application of
heat, radiofrequency energy, or ultra violet light.
Inventors: |
Oyola; Arnold E.;
(Northborough, MA) ; Buiser; Marcia; (Watertown,
MA) ; DiCarlo; Paul; (Middleboro, MA) |
Correspondence
Address: |
Vista IP Law Group LLP
2040 MAIN STREET, 9TH FLOOR
IRVINE
CA
92614
US
|
Assignee: |
BOSTON SCIENTIFIC SCIMED,
INC.
Maple Grove
MN
|
Family ID: |
38750822 |
Appl. No.: |
11/777931 |
Filed: |
July 13, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60807815 |
Jul 19, 2006 |
|
|
|
Current U.S.
Class: |
606/169 ; 604/73;
606/170; 607/3; 607/89; 607/92 |
Current CPC
Class: |
A61B 2017/320069
20170801; A61B 17/3211 20130101; A61B 18/20 20130101; A61B
2017/00495 20130101; A61B 17/00491 20130101; A61B 18/1482
20130101 |
Class at
Publication: |
606/169 ; 604/73;
606/170; 607/3; 607/89; 607/92 |
International
Class: |
A61B 17/32 20060101
A61B017/32 |
Claims
1. A resection device comprising: an elongated probe shaft; a
tissue resection member disposed at a distal end of the elongated
probe shaft, the tissue resection member having a cutting surface
configured for being placed in contact with tissue; and at least
one ejection port located adjacent to the cutting surface of the
tissue resection member, the at least one ejection port configured
for being coupled to a source of a polymerizable
hemostasis-promoting material.
2. The resection device of claim 1, wherein the
hemostasis-promoting material comprises a thermally-activated
polymer.
3. The resection device of claim 1, wherein the
hemostasis-promoting material comprises a light-activated
polymer.
4. The resection device of claim 3, wherein the
hemostasis-promoting material is activated upon exposure to
ultraviolet light.
5. The resection device of claim 1, wherein the
hemostasis-promoting material comprises energy-activated
polymer.
6. The resection device of claim 5, wherein hemostasis-promoting
material is activated upon exposure to radiofrequency (RF)
energy.
7. The resection device of claim 1, wherein the tissue resection
member comprises a resection electrode.
8. The resection device of claim 1, wherein the tissue resection
member comprises a mechanical resection member.
9. The resection device of claim 8, wherein the mechanical
resection member comprises a blade.
10. The resection device of claim 8, wherein the tissue resection
member comprises a vibrational cutting member.
11. The resection device of claim 1, wherein the tissue resection
member comprises a laser.
12. The resection device of claim 11, wherein the source of
polymerizable hemostasis-promoting material is pressurized.
13. A resection device comprising: an elongated probe shaft; a
tissue resection member disposed at a distal end of the elongated
probe shaft, the tissue resection member having a cutting surface
configured for being placed in contact with tissue; and a porous
delivery member disposed at the distal end of the elongated probe
shaft, the porous delivery member configured for being coupled to a
source of a polymerizable hemostasis-promoting material.
14. The resection device of claim 13, wherein the
hemostasis-promoting material comprises a thermally-activated
polymer.
15. The resection device of claim 13, wherein the
hemostasis-promoting material comprises a light-activated
polymer.
16. The resection device of claim 15, wherein the
hemostasis-promoting material is activated upon exposure to
ultraviolet light.
17. The resection device of claim 13, wherein the
hemostasis-promoting material comprises energy-activated
polymer.
18. The resection device of claim 17, wherein hemostasis-promoting
material is activated upon exposure to radiofrequency (RF)
energy.
19. The resection device of claim 13, wherein the tissue resection
member comprises a resection electrode.
20. The resection device of claim 13, wherein the tissue resection
member comprises a mechanical resection member.
21. The resection device of claim 20, wherein the mechanical
resection member comprises a blade.
22. The resection device of claim 13, wherein the tissue resection
member comprises a vibrational cutting member.
23. The resection device of claim 13, wherein the tissue resection
member comprises a laser.
24. The resection device of claim 13, wherein the porous delivery
member comprises a sponge.
25. The resection device of claim 19, further comprising an
insulating member interposed between the resection electrode and
the porous delivery member.
26. The resection device of claim 19, wherein the resection
electrode and porous delivery member are in electrical contact in a
bipolar arrangement.
27. The resection device of claim 19, wherein the resection device
is configured in a monopolar arrangement.
28. The resection device of claim 13, wherein the source of
polymerizable hemostasis-promoting material is pressurized.
29. A resection device comprising: an elongated probe shaft; a
tissue resection member disposed at a distal end of the elongated
probe shaft, the tissue resection member having a cutting surface
configured for being placed in contact with tissue; a porous
delivery member disposed at the distal end of the elongated probe
shaft, the porous delivery member configured for being coupled to a
source of a polymerizable hemostasis-promoting material; and an
ultra violet light emitter located adjacent to the porous delivery
member.
30. The resection device of claim 29, further comprising an ultra
violet light shield interposed between the porous delivery member
and the ultra violet light emitter.
31. The resection device of claim 29, wherein the source of
polymerizable hemostasis-promoting material is pressurized.
32. The resection device of claim 29, wherein the
hemostasis-promoting material is activated upon exposure to
ultraviolet light.
33. The resection device of claim 29, wherein the tissue resection
member comprises a resection electrode.
34. The resection device of claim 29, wherein the tissue resection
member comprises a mechanical resection member.
35. The resection device of claim 29, wherein the mechanical
resection member comprises a blade.
36. The resection device of claim 29, wherein the tissue resection
member comprises a vibrational cutting member.
37. The resection device of claim 29, wherein the tissue resection
member comprises a laser.
38. A method of resecting tissue using the resection device of
claim 1.
39. A method of resecting tissue comprising: providing a resection
device; cutting the tissue with a distal end of the resection
device; and ejecting the polymerizable hemostasis-promoting
material from at least one ejection port in the resection device to
contact at least a portion of the cut tissue.
40. The method of claim 39, further comprising the step of curing
the polymerizable hemostasis-promoting material contacting the
portion of cut tissue.
41. The method of claim 40, wherein the curing process is
accelerated by application of heat to the cut tissue using the
resection device.
42. The method of claim 40, wherein the curing process is
accelerated by application of ultra violet radiation to the cut
tissue using the resection device.
43. The method of claim 42, wherein the resection device includes a
porous delivery member disposed at the distal end thereof, the
porous delivery member configured for being coupled to a source of
a polymerizable hemostasis-promoting material, the resection device
including an ultra violet light emitter located adjacent to the
porous delivery member, and an ultra violet light shield interposed
between the porous delivery member and the ultra violet light
emitter.
44. The method of claim 40, wherein the curing process is
accelerated by application of radiofrequency energy to the cut
tissue using the resection device.
45. The method of claim 39, wherein the polymerizable
hemostasis-promoting material is ejected from the at least one
ejection port at substantially the same time the tissue is cut.
46. The method of claim 39, wherein the polymerizable
hemostasis-promoting material is ejected from the at least one
ejection port after the tissue is cut.
47. The method of claim 39, wherein the polymerizable
hemostasis-promoting material is ejected from the at least one
ejection port under pressure.
Description
RELATED APPLICATION DATA
[0001] The present application claims the benefit under 35 U.S.C.
.sctn. 119 to U.S. provisional patent application Ser. No.
60/807,815 filed Jul. 19, 2006. The foregoing application is hereby
incorporated by reference into the present application in its
entirety.
FIELD OF THE INVENTION
[0002] The field of the invention generally relates to tissue
resection devices and methods. More particularly, the field of the
invention pertains to devices and methods for use in resecting
tissue such as, for example, diseased organ tissue.
BACKGROUND OF THE INVENTION
[0003] Electrosurgery is now a widely used surgical method for
treating tissue abnormalities. One class of electrosurgical
abalation devices are so-called monopolar electrosurgical devices.
Typically such ablation devices include an electrosurgical probe
having a first or "active" electrode extending from one end. The
electrosurgical probe is electrically coupled to an electrosurgical
generator, which provides a high frequency electric current. A
remote control or hand-activated switch is attached to the
generator and commonly extends to a foot switch located in
proximity to the operating theater. During an operation, a second
or "return" electrode, having a much larger surface area than the
active electrode, is positioned in contact with the skin of the
patient (e.g., a patch). The surgeon may then bring the active
electrode in close proximity to the tissue and activate the foot
control switch, which causes electrical current to arc from the
distal portion of the active electrode and flow through tissue to
the larger return electrode.
[0004] Still other electrosurgical abalation devices are classified
as bipolar-based. In these devices no return electrode is used.
Instead, a second electrode is closely positioned adjacent to the
first electrode, with both electrodes being attached to an
electrosurgical probe. As with the monopolar-based devices, the
electrosurgical probe is electrically coupled to an electrosurgical
generator. When this generator is activated, electrical current
arcs from the end of the first electrode to the end of the second
electrode, flowing through the intervening tissue. In practice,
several electrodes may be employed, and depending on the relative
size or locality of the electrodes, one or more electrodes may be
active.
[0005] Whether arranged in a monopolar or bipolar fashion, the
active electrode may be operated to either cut tissue or coagulate
tissue. When used to cut tissue, the electrical arcing and
corresponding current flow results in a highly intense, but
localized heating, sufficient enough to break intercellular bonds,
cellular membranes, and cellular contents, resulting in tissue
severance. When used to coagulate tissue, the electrical arcing
results in a low level current that denatures cells to a sufficient
depth without significant breakage of intercellular bonds, i.e.,
without cutting the tissue.
[0006] There are many medical procedures in which tissue is cut or
carved away for diagnostic or therapeutic reasons. For example,
during hepatic transection, one or more lobes of a liver containing
abnormal tissue, such as malignant tissue or fibrous tissue caused
by cirrhosis, are cut away. There exists various modalities,
including mechanical, ultrasonic, and electrical (which includes RF
energy), that can be used to effect the resection of abnormal
tissue. Regardless of which modality is used, however, extensive
bleeding can occur, which can obstruct the surgeon's view and lead
to dangerous blood loss levels, requiring transfusion of blood,
which increases the complexity, time, and expense of the resection
procedure. To prevent extensive bleeding, hemostatic mechanisms,
such as blood inflow occlusion, coagulants (e.g., Surgicel.TM. or
Tisseel.TM.), and energy coagulation (e.g., electrosurgical
coagulation or argon-beam coagulation), can be used.
[0007] In the case where an electrosurgical coagulation means is
used, the bleeding can be treated or avoided by coagulating the
tissue in the treatment areas with an electro-coagulator that
applies a low level current to denature cells to a sufficient depth
without breaking intercellular bonds, i.e., without cutting the
tissue. Because of their natural coagulation capability, ease of
use, and ubiquity, electrosurgical modalities are often used to
resect tissue.
[0008] During a typical electrosurgical resection procedure,
electrical energy can be conveyed from an electrode along a
resection line in the tissue. The electrode may be operated in a
manner that incises the tissue along the resection line, or
coagulates the tissue along the resection line, which can then be
subsequently dissected using the same coagulation electrode or a
separate tissue dissector to gradually separate the tissue. In the
case where an organ is resected, application of RF energy divides
the parenchyma, thereby skeletonizing the organ, i.e., leaving
vascular tissue that is typically more difficult to cut or dissect
relative to the parenchyma.
[0009] When a blood vessel is encountered, RF energy can be applied
to shrink the collagen contained in the blood vessel walls, thereby
closing the blood lumen and achieving hemostasis. The blood vessel
can then be mechanically transected using a scalpel or scissors
without fear of blood loss. In general, for smaller blood vessels
less than 3 mm in diameter, hemostasis may be achieved within 10
seconds, whereas for larger blood vessels up to 5 mm in diameter,
the time required for hemostasis may increase to 15-20 seconds.
During or after resection of the tissue, RF energy can be applied
to any "bleeders" (i.e., vessels from which blood flows or oozes)
to provide complete hemostasis for the resected organ. This may be
accomplished by employing the same device used for cutting.
[0010] When electrosurgically resecting tissue, care must be taken
to prevent the heat generated by the electrode from charring the
tissue, which generates an undesirable odor, results in tissue
becoming stuck on the electrosurgical probe, and most importantly,
increases tissue resistance, thereby reducing the efficiency of the
procedure. Adding an electrically conductive fluid, such as saline,
to the electrosurgery site reduces the temperature of the electrode
and keeps the tissue temperature below the water boiling point
(100.degree. C.), thereby avoiding smoke and reducing the amount of
charring. The electrically conductive fluid can be provided through
the probe that carries the active electrode or by another separate
device.
[0011] Although the application of electrically conductive fluid to
the electrosurgery site generally increases the efficiency of the
RF energy application, energy applied to an electrode may rapidly
diffuse into fluid that has accumulated and into tissue that has
already been removed. As a result, if the fluid and removed tissue
is not effectively aspirated from the tissue site, the
electrosurgery may either be inadequately carried out, or a greater
than necessary amount of energy must be applied to the electrode to
perform the surgery. Increasing the energy used during
electrosurgery increases the chance that adjacent healthy tissues
may be damaged. At the same time that fluid accumulation is
avoided, care must be taken to ensure that fluid is continuously
flowed to the tissue site to ensure that tissue charring does not
take place. For example, if flow of the fluid is momentarily
stopped, e.g., if the tube supplying the fluid is kinked or stepped
on, or the port on the fluid delivery device becomes clogged or
otherwise occluded, RF energy may continue to be conveyed from the
electrode, thereby resulting in a condition where tissue charring
may occur.
[0012] A related concern with existing electrosurgical ablation
devices is that heat generated at the application site rapidly
dissipates away from the treated area of interest. It is
preferable, however to localize the elevated temperatures (and
coagulation effect) to the application site. Heat energy that is
dissipated away from the application site has the potential to
damage or destroy healthy tissue. In addition, heat dissipation
requires that additional energy be applied to the electrode which,
as stated above, increases the probability that adjacent healthy
tissues may be damaged or destroyed.
[0013] While electrosurgical resection of tissue reduces the amount
of blood loss, as compared to other tissue resection modalities, it
still involves a tedious process that includes painstakingly
cutting/dissecting through the parenchyma and ligating and cutting
though blood vessels. Moreover, because time is of the essence in
such procedures there is a need to reduce the amount of time wasted
in manipulating and switching between multiple instruments. It is
generally desirable to provide as much functionality in a single
device to avoid the use of multiple devices having separate
functions. Similarly, the use of multiple devices often requires
one or more surgeons or other trained personnel to assist.
[0014] There remains a need for resection devices and methods that
can be used to efficiently resect vascularized tissue. Similarly,
there is a need for such devices and methods to effectuate and
maintain hemostasis at the treatment site. There is also a need for
resection methods and devices that reduce or eliminate the need for
a physician to switch between different surgical instruments.
SUMMARY OF THE INVENTION
[0015] In one embodiment of the invention, a resection probe is
provided that includes cutting capability as well as the means to
effectuate or maintain hemostasis at the cut site. Hemostasis may
be maintained or otherwise controlled by the use of polymerizable
hemostasis-promoting material that is delivered at or near a distal
end of the resection probe. Polymerization of the
hemostasis-promoting material may be initiated or accelerated by
application of heat, radiofrequency energy, or ultra violet light
delivered in situ by the probe.
[0016] In one particular aspect of the invention, the resection
device includes an elongated shaft and a tissue resection member
disposed at a distal end of the elongated probe shaft that includes
a cutting surface configured for being placed in contact with
tissue. At least one ejection port is located adjacent to the
cutting surface of the tissue resection member and is coupled to a
source of polymerizable hemostasis-promoting material.
[0017] The polymerizable hemostasis-promoting material may be
formed from a thermally-activated polymer, a light-activated
polymer (e.g., ultra violet light), or energy-activated polymer
(e.g., radiofrequency (RF) energy).
[0018] In certain embodiments, the tissue resection member may take
the form of a resection electrode that cuts tissue in response to
an applied RF signal. In still other embodiments, the tissue
resection member may be formed from a mechanical resection member.
As one example, the mechanical resection member may be formed as a
blade or knife. In still another aspect of the invention, the
tissue resection member may be formed from a vibrational cutting
member. In still another aspect, the tissue resection member is
formed from a laser.
[0019] In still another aspect of the invention, the polymerizable
hemostasis-promoting material may be under pressure when delivered
via the one or more ejection ports. A valving mechanism or the like
may be used to selectively dispense the material to the site of
interest. In certain embodiments, the dispensing of the
hemostasis-promoting material to the site of interest may be
synchronized with the cutting operation of the tissue resection
member. For example, the hemostasis-promoting material may be
dispensed to the site of interest when the tissue resection member
cuts or touches the tissue.
[0020] In yet another embodiment of the invention, an elongated
surgical probe is provided that includes an elongated probe shaft
and a tissue resection member disposed at a distal end of the
elongated probe shaft, the tissue resection member having a cutting
surface configured for being placed into contact with the tissue.
In this embodiment, a porous delivery member is disposed at the
distal end of the elongated probe shaft and is coupled to a source
of polymerizable hemostasis-promoting material. In one exemplary
embodiment, the porous delivery member may be formed from a
medical-grade sponge.
[0021] As in the embodiments described above, various activating
mechanisms may be employed to activate the hemostasis-promoting
material. These include, by way of example, thermally-activated,
light-activated, and energy-activated compounds. Similarly, various
tissue resection members may be used to cut the tissue site of
interest.
[0022] According to some embodiments of the invention, the tissue
resection member is formed as a resection electrode. In such an
embodiment, an insulating member may be interposed between the
resection electrode and the porous delivery member. In addition,
the resection electrode and the porous delivery member may be in
electrical contact with one another in either a monopolar or
bipolar arrangement.
[0023] In still another aspect of the invention, a resection device
includes an elongated probe shaft and a tissue resection member
disposed at a distal end of the elongated probe shaft. The tissue
resection member includes a cutting surface configured for being
placed into contact with tissue. A porous delivery member is
disposed at the distal end of the elongated probe shaft and is
coupled to a source of polymerizable hemostasis-promoting material.
An ultra violet light emitter is located adjacent to the porous
delivery member. In order to prevent polymerization of the
hemostasis-promoting material within porous delivery member, a
light shield is interposed between the porous delivery member and
the ultra violet light emitter.
[0024] In yet another aspect of the invention, a method of
resecting tissue includes providing a resection device of the type
described above. Using the probe, the tissue is cut with the
cutting surface of the tissue resection member. In addition, the
polymerizable hemostasis-promoting material is ejected or otherwise
delivered from the one or more ejection ports and comes into
contact with at least a portion of the cut tissue. In an
alternative aspect of the invention, the polymerizable
hemostasis-promoting material is delivered to the resection site
via the porous delivery member.
[0025] In one aspect of the invention, the polymerizable
hemostasis-promoting material that is located on the cut tissue is
then activated or cured. The curing or activation process may be
accelerated or initiated by the application of heat, ultra violet
radiation, or RF energy from the resection device. In certain
embodiments of the invention, the polymerizable
hemostasis-promoting material is ejected or effused from the at
least one ejection port at substantially the same time the tissue
is cut by the resection device. In an alternative aspect of the
invention, the polymerizable hemostasis-promoting material is
ejected or effused from the at least one ejection port after the
tissue is cut.
[0026] It is thus one object of the invention to provide a
resection device that is capable of resecting tissue while
minimizing or preventing the bleeding from the cut tissue. It is
another object of the invention to provide a device is able to
localize coagulative heating to a relatively small site of
interest. Related to this, it is a further object of the invention
to provide a resection device that reduces heat dissipation into
tissue surrounding a cut region. It is yet another object of the
invention to provide a single device that is capable of cutting
tissue and promoting hemostasis at the same time. Further features
and advantages will become apparent upon review of the following
drawings and description of the preferred embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] The drawings illustrate the design and utility of preferred
embodiments of the present invention, in which similar elements are
referred to by common reference numerals. In order to better
appreciate how the above-recited and other advantages and objects
of the present inventions are obtained, a more particular
description of the present inventions briefly described above will
be rendered by reference to specific embodiments thereof, which are
illustrated in the accompanying drawings. Understanding that these
drawings depict only typical embodiments of the invention and are
not therefore to be considered limiting of its scope, the invention
will be described and explained with additional specificity and
detail through the use of the accompanying drawings in which:
[0028] FIG. 1 is a plan view of a resection device according to one
preferred aspect of the invention.
[0029] FIG. 1A is plan view of the distal end of the resection
device illustrated in FIG. 1. FIG. 1A illustrates a lumen in
phantom (dashed lines) that is coupled to the ejection ports of the
probe.
[0030] FIG. 1B is a plan view of a distal end of a resection device
according to another aspect of the invention. FIG. 1B illustrates a
single ejection port in the form of a slit. Also shown in FIG. 1B
in phantom is a lumen coupled to the single ejection port.
[0031] FIG. 2 is a plan view of a resection device according to
another preferred aspect of the invention.
[0032] FIG. 2A is plan view of the distal end of the resection
device illustrated in FIG. 2. FIG. 2A illustrates a lumen in
phantom (dashed lines) that is coupled to the ejection ports of the
probe.
[0033] FIG. 2B is a plan view of a distal end of a resection device
according to another aspect of the invention. FIG. 2B illustrates a
single ejection port in the form of a slit. Also shown in FIG. 2B
in phantom is a lumen coupled to the single ejection port.
[0034] FIG. 2C illustrates a dual-chamber syringe according to one
embodiment of the invention.
[0035] FIG. 2D illustrates a resection device according to one
embodiment of the invention. FIG. 2D illustrates a dual-chambered
syringe coupled to the probe device. A portion of the shaft is
shown in cross-section to illustrate the multiple conduits or
lumens. A mixing port is located just proximal of the ejection
ports.
[0036] FIG. 3 is a plan view of a resection device according to
another preferred aspect of the invention.
[0037] FIG. 3A is a magnified plan view of the distal end of the
resection device illustrated in FIG. 3.
[0038] FIG. 3B is a cross-sectional view of the distal end of the
resection device taken along the line A-A in FIG. 3A.
[0039] FIG. 4 is a plan view of a resection device according to
another preferred aspect of the invention.
[0040] FIG. 4A is a magnified plan view of the distal end of the
resection device illustrated in FIG. 4.
[0041] FIG. 4B is a cross-sectional view of the distal end of the
resection device taken along the line A-A in FIG. 4A.
[0042] FIG. 5A is a perspective view of tissue having an unhealthy
tissue portion that is shown being resected from a healthy tissue
portion through use of a resection device of the type disclosed
herein.
[0043] FIG. 5B is a perspective view of the tissue of FIG. 5A
showing a partially-cut tissue. As seen in FIG. 5A, the tissue is
cut generally along a resection line.
[0044] FIG. 5C is a perspective view of the tissues of FIGS. 5A and
5B showing fully-cut tissue. As seen in FIG. 5C, the tissue has
been resected into a healthy portion (left) and an unhealthy
portion (right).
[0045] FIG. 6A is a cross-sectional view of a portion of tissue
being resected using a resection probe according to one embodiment
of the invention.
[0046] FIG. 6B is a cross-sectional view of a portion of tissue
being resected using a resection probe according to another
embodiment of the invention.
[0047] FIG. 6C is a cross-sectional view of a portion of tissue
being resected using a resection probe according to another
embodiment of the invention.
[0048] FIG. 6D is a cross-sectional view of a portion of tissue
being resected using a resection probe according to another
embodiment of the invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0049] FIG. 1 illustrates a tissue resection device 10 constructed
in accordance with one embodiment of the present invention. In this
embodiment, the tissue resection device 10 generally includes a
resection device or probe 12 configured for resecting and
coagulating tissue and a syringe 17 or other pumping source
configured for delivering a polymerizable hemostasis-promoting
material 16 to the resection site. The resection probe 12 includes
a tissue resection member 18 disposed on a distal end of the
resection probe 12 that is configured for being placed into contact
with tissue.
[0050] In the embodiment illustrated in FIG. 1, tissue resection
member 18 is formed as a resection electrode 19. Accordingly, the
device 10 further includes an ablation energy source, and in
particular a radio frequency (RF) or microwave generator 14,
configured for supplying RF energy or microwave energy to the
resection electrode 19 in a controlled manner.
[0051] The resection probe 12 generally comprises an elongated
probe shaft 20 having a proximal end 22, a distal end 24, a handle
assembly 26 mounted to the proximal shaft end 22, a tissue
resection member 18 mounted to the distal shaft end 24, one or more
ejection ports 28 formed in the distal end 24 of the probe shaft
20, and a fluid conduit 30 (shown in phantom in FIGS. 1A, 1B)
extending through the probe shaft 20 between the proximal shaft end
22 and terminating at the one or more ejection ports 28. In the
illustrated embodiment, the probe shaft 20 is rigid, thereby
providing maximum control at the distal end 24 of the probe shaft
20. The probe shaft 20 is composed of a suitable material, such as
plastic, metal or the like, and has a suitable length, typically in
the range from about 2 cm to about 30 cm, and preferably from about
10 cm to about 20 cm.
[0052] In certain embodiments, the probe shaft 20 may be formed
from an electrically conductive material, in which case, the probe
shaft 20 is preferably covered with an insulative material (not
shown). In certain embodiments where the tissue resection member 18
may be selectively activated or energized (e.g., a resection
electrode), the handle assembly 26 may include one or more
activating switches or buttons 32 which can be used to selectively
energize the tissue resection member 18. In still other
embodiments, the handle assembly 26 may include another switch or
button 34 that controls or modulates the dispensing of the
polymerizable hemostasis-promoting material 16 from the syringe 17.
For example, the syringe 17 or other pumping device may be coupled
to a pumping source that may be selectively activated via the
button 34. In still another embodiment, the button 34 may be
operably connected to a valve or the like (not shown) that opens
upon actuation.
[0053] The tissue resection member 18 has a cutting surface 18a,
which is straight or rectilinear, so that it can be placed along a
resection line. The tissue resection member 18 may be formed as a
resection electrode 19 as is shown, for example, in FIGS. 1, 1A,
1B, 3, 3A, 3B, 4, 4A, and 4B. In embodiments utilizing a resection
electrode 19 as the tissue resection member 18, tissue separation
may be achieved by conveying electrical energy to or from the
resection member 18 to either cut the tissue or coagulate the
tissue. If the resection member 18 operates to coagulate the
tissue, the mechanical pressure applied by the resection member 18
may naturally separate the tissue as it is coagulated. As will be
described in further detail below, electrical energy can either be
conveyed from the resection electrode 19 in a monopolar mode or a
bipolar mode.
[0054] With reference to FIGS. 2, 2A, 2B, in an alternative
configuration, the tissue resection member 18 may be formed from a
mechanical resection member 21, which means that tissue separation
may be achieved by mechanically manipulating the tissue with the
resection member 18. For example, FIGS. 2, 2A, and 2B illustrate an
embodiment of a device 15 in which the tissue resection member 18
is formed as a mechanical resection member 21. The mechanical
resection member 21 may be formed as a blade, as is shown in FIGS.
2, 2A, and 2B. In still other embodiments, the mechanical resection
member 21 may be formed as a vibrational cutting member such as,
for instance, an ultrasonic knife or the like.
[0055] In this embodiment, the one or more ejection ports 28 are
located adjacent to the mechanical resection member 21. FIGS. 2A
and 2B illustrate the ejection ports 28 being located proximal with
respect to the cutting surface 18a of the blade. The ejection ports
28 may be dimensioned so as to allow the hemostasis-promoting
material 16 to weep onto the cut or resected tissue. Depending on
the orientation of the device 15, the hemostasis-promoting material
16 may weep or eject first onto the cutting surface 18a of the
blade and then transfer to the resected tissue.
[0056] The tissue resection member 18 may optionally comprise a
radiation source such as, for example, a laser (not shown). In this
regard, a directed beam of radiation capable of ablating or
destroying tissue may be used to resect the tissue of interest.
[0057] Referring back to FIGS. 1, 1A, and 1B, one or more ejection
ports 28 are disposed adjacent to the cutting surface 18a of the
tissue resection member 18. In the embodiment illustrated in FIG.
1A, the one or more ejection ports 28 are located proximal to the
cutting surface 18a on the probe shaft 20. It is possible, however,
to integrate the ejection ports 28 directly into the tissue
resection member 18 as is shown, for example, in FIG. 1B. As best
seen in FIGS. 1A and 1B, a fluid conduit 30 is disposed along at
least a portion of the length of the probe shaft 20 and provides a
lumen or passage through which the polymerizable
hemostasis-promoting material 16 passes. The fluid conduit 30 is
coupled at a proximal end to a port 36 or the like which can be
coupled to the syringe 17 via tubing 38 or the like. The distal end
of the fluid conduit 30 terminates at the one or more ejection
ports 28. In this regard, the polymerizable hemostasis-promoting
material 16 can flow from the syringe 17, down through the probe
shaft 20, and be delivered in situ adjacent to the site of
resection.
[0058] The polymerizable hemostasis-promoting material 16 may be
formed as a one-component material or, alternatively, as a
multi-component material. For example, in certain embodiments, the
hemostasis-promoting material 16 begins to polymerize in response
to outside stimulus. For instance, the hemostasis-promoting
material 16 may polymerize upon application of heat (e.g.,
thermally-activated polymer), upon application of radiation or
light (e.g., light-activated polymer), or upon application of
energy such as radiofrequency (RF) or microwave energy. In another
embodiment, an applied external stimulus (e.g., heat, light, RF or
microwave energy) may be used to accelerate the rate of
polymerization.
[0059] Alternatively, the hemostasis-promoting material 16 may be
formed from multiple pre-polymer components that are mixed
immediately before delivery to the resection site. For instance, as
seen in FIGS. 2C and 2D, a two-component pre-polymer solution may
be loaded into the syringe 17a, 17b just prior to the resection
procedure. The material 16 has a set or cure rate that is
slow-enough such that the material 16 does not solidify and occlude
the conduit 30 and/or tubing 38. In one embodiment, as illustrated
in FIG. 2C, a two-chamber chamber syringe 17a is provided with each
chamber containing one of the two pre-polymer components. The
pre-polymers are mixed together upon exit from the syringe 17a and
passage into the tubing 38.
[0060] FIG. 2D illustrates another embodiment wherein a two-chamber
syringe 17b is coupled at an outlet to two separate tubing conduits
38a, 38b. The two tubing conduits 38a, 38b then connect to two
separate ports 36a, 36b on the probe 12. Of course a single piece
tubing 38 with dual lumens may also be used. Each port 36a, 36b is
coupled to a separate fluid conduits 30a, 30b traversing the length
of the probe shaft 20 until terminating at or proximal to the
ejection ports 28. The separate fluid conduits may be coupled to
separate ejection ports 28. In this regard, the mixing of the
pre-polymer components occurs external to the probe 12.
Alternatively, as shown in FIG. 2D, the fluid conduits may
terminate just prior to the ejection ports 28 into a mixing chamber
29 located within the probe shaft 20. The mixing chamber 29 may be
formed from a common chamber or reservoir that is used to mix the
pre-polymer components just prior to ejection from the probe 12.
The mixing chamber 29 may be constructed of a geometry or include
tortuous pathways to promote mixing of the pre-polymer
components.
[0061] The hemostasis-promoting material 16 may be formed from a
biocompatible or biodegradable material. As one example, the
hemostasis-promoting material 16 may be formed as a polymerizable
hydrogel. The hemostasis-promoting material 16 may also be formed
as a curable glue or epoxy that is biocompatible or biodegradable.
In embodiments where radiation such as UV light is used to initiate
or accelerate polymerization, the hemostasis-promoting material 16
may be formed from a photosensitive glue or adhesive. The
photosensitive glue or adhesive may also require the addition of
one or more photoinitiators which may be included or loaded into
the syringe 17.
[0062] As one exemplary hemostasis-promoting material 16, a
photoreactive gelatin and a water-soluble difunctional macromer
(poly(ethylene glycol) diacrylate: PEGDA) may be irradiated by UV
light (or even visible light) to form a gel or glue-like
consistency that strongly adheres to tissue (e.g., to walls 104a,
104b as shown in FIGS. 5A-5C). The hemostasis-promoting material 16
referred to above is described in detail in Nakayama et al.,
Photocurable Surgical Tissue Adhesive Glues Composed of
Photoreactive Gelatin and Poly(ethylene glycol) Diacrylate, J.
Biomed Mater Res. 1999; 48(4):511-521 which is incorporated by
reference as if set forth fully herein. Another exemplar
hemostasis-promoting material 16 may be a photocrosslinkable
chitosan molecule that is curable in the presence of UV radiation.
For example, the chitosan-based hydrogel disclosed in Ono et al.,
Experimental Evaluation of Photocrosslinkable Chitosan as a
Biologic Adhesive With Surgical Applications, Surgery, 2001
November; 130(5):844-850 may be used. The above-identified
publication is incorporated by reference as if set forth fully
herein.
[0063] In one embodiment, the hemostasis-promoting material 16 is
delivered as a viscous or semi-viscous solution such that the
material 16 readily adheres to the exposed or cut surface of
tissue. Alternatively, the hemostasis-promoting material 16 may be
delivered in a non-viscous state that rapidly turns viscous or
semi-viscous, for example, after application of heat, light, or RF
or microwave energy. The hemostasis-promoting material 16, when
delivered to the resection site, advantageously forms a film or
barrier on the exposed or cut surface of tissue.
[0064] In one embodiment, the hemostasis-promoting material 16 has
the ability to retain heat to promote the local coagulation of
tissue. For example, when used in connection with applied RF
energy, the hemostasis-promoting material 16 retains heat at or
adjacent to the resection site to promote localized coagulation of
tissue. In this regard, dissipation of heat energy into surrounding
healthy tissue is reduced. This also advantageously reduces the
amount the energy needed to achieve tissue coagulation.
[0065] Referring back to FIGS. 1, 1A, and 1B, the resection probe
12 may operate in either a monopolar mode or a bipolar mode. In the
monopolar mode, RF current is delivered from the RF generator 14 to
the resection electrode 19, which means that current will pass from
the respective electrode 19, which is configured to concentrate the
energy flux in order to have an injurious effect on the surrounding
tissue, and a dispersive electrode (not shown), which is located
remotely from the electrode and has a sufficiently large area
(typically 130 cm.sup.2 for an adult), so that the current density
is low and non-injurious to surrounding tissue. In the illustrated
embodiment, the dispersive electrode may be attached externally to
the patient, e.g., using a contact.
[0066] In a bipolar mode, the RF current is delivered between two
electrodes, with one of the electrodes being the "positive"
electrode element and the other of the electrodes being the
"negative" electrode element. One of the electrodes may be formed
from the resection electrode 19. Bipolar arrangements, which
require the RF energy to traverse through a relatively small amount
of tissue between the tightly spaced electrodes, are more efficient
than monopolar arrangements, which require the RF energy to
traverse through the thickness of the patient's body. As a result,
bipolar electrode arrangements are generally more efficient than
monopolar electrode arrangements.
[0067] Additionally, bipolar arrangements are generally safer for
the physician and patient, since there is an ever-present danger
that the physician and patient may become a ground in the monopolar
arrangement, resulting in painful burns. The embodiment illustrated
in FIGS. 3, 3A, and 3B, for instance, may be implemented in either
a monopolar or bipolar arrangement.
[0068] Referring back to FIGS. 1, 1A, and 1B, the handle assembly
26 is composed of any suitable rigid material, such as, e.g.,
metal, plastic, or the like. The handle assembly 26 carries a port
36, which is in fluid communication with the fluid delivery conduit
30. In embodiments where the tissue resection member 18 is formed
as a resection electrode 19, the handle assembly 26 further carries
an electrical connector 40 that is electrically coupled to the
resection electrode 19 via the probe shaft 20. In this case, the
core of the probe shaft 20 is composed of an electrically
conductive material, such as stainless steel, and the exterior of
the probe shaft 20 is coated with an electrically insulative
material (not shown).
[0069] Alternatively, the electrical connector 40 may be
electrically coupled to the resection electrode 19 via wires (not
shown) extending through the probe shaft 20 and terminating within
the resection electrode 19 or in the shaft distal end 24 (which
will be electrically conductive in this case) on which the
resection electrode 19 is directly mounted.
[0070] The RF generator 14 is electrically connected to the
electrical connector 40 on the probe 12 via a cable 42. The RF
generator 14 may be a conventional RF power supply that operates at
a frequency in the range from 200 KHz to 9.5 MHz, with a
conventional sinusoidal or non-sinusoidal wave form. Such power
supplies are available from many commercial suppliers, such as
Valleylab, Aspen, Bovie, and Ellman. Most general purpose
electrosurgical power supplies, however, operate at higher voltages
and powers than would normally be necessary or suitable for tissue
coagulation and/or cutting. Thus, such power supplies would usually
be operated at the lower ends of their voltage and power
capabilities. More suitable power supplies will be capable of
supplying an ablation current at a relatively low voltage,
typically below 150V (peak-to-peak), usually being from 50V to
100V. The power will usually be from 20 W to 200 W, usually having
a sine wave form, although other wave forms would also be
acceptable. Power supplies capable of operating within these ranges
are available from commercial vendors, such as Boston Scientific
Corporation of San Jose, Calif., who markets these power supplies
under the trademarks RF2000 (100 W) and RF3000 (200 W). Optionally,
the RF generator 14 may include means for conveying the RF energy
in a "coagulation mode" or a "cutting mode." As previously
described, operating an RF generator in a coagulation mode will
tend to create a tissue coagulation effect, while operating an RF
generator in a cutting mode will tend to create a tissue cutting
effect, although tissue coagulation or cutting will ultimately
depend, to a greater extent, on the structure of the electrode to
or from which the electrical energy is conveyed.
[0071] FIGS. 3, 3A, and 3B illustrate a resection probe 50
according to an alternative aspect of the invention. Those features
of the resection probe 50 that are common with the embodiment
illustrated in FIGS. 1, 1A, and 1B retain the same element number
for sake of clarity. In this embodiment, the distal end 24 of the
probe shaft 20 terminates in a tissue resection assembly 52. The
assembly 52 includes a resection electrode 19 and a porous delivery
member 54 separated from one another via an insulating member 56.
The insulating member 56 is formed from an electrically
non-conductive material and acts to electrically isolate the
resection electrode 19 from the porous delivery member 54.
[0072] As best seen in FIG. 3A, the porous delivery member 54 is
coupled at a proximal end to the fluid conduit 30. The porous
delivery member 54 is thus in fluidic contact with the
hemostasis-promoting material 16 during operation of the device 50.
Suitable materials that can be used to construct the porous
delivery member 54 include open-cell foam (such as polyethylene
foam, polyurethane foam, polyvinylchloride foam) and medical-grade
sponges. Polyvinyl alcohol (PVOH) sponges, such as Merocel.TM.,
marketed by Medtronic, Inc., and cellulose sponges, such as
Weckcel.TM. are also suitable. It should be appreciated that
material, other than foam or sponges, may be used for the porous
delivery member 54 as long as it is capable of deploying a
sufficient amount of hemostasis-promoting material 16. For example,
spun-laced polyester, cotton, gauze, cellulose fiber, ceramic,
metal (e.g., compressive metal) or the like can be used.
[0073] In one aspect of the invention, the porous delivery member
54 is used to apply or "paint" a film of hemostasis-promoting
material 16 on resected tissue. For example, the porous delivery
member 54 may be sized such that the stroking motion utilized in
resection operations causes the porous delivery member 54 to
physically contact resected tissue (e.g., as shown in FIG. 6C).
Physical contact between the tissue and the porous delivery member
54 causes a layer or film to be applied to the contacted
surface.
[0074] The device 50 illustrated in FIGS. 3, 3A, and 3B may be
configured in either a monopolar or bipolar configuration. In the
monopolar configuration, the resection electrode 19 acts as one
electrode while a second or "return" electrode having a much larger
surface area than the active electrode, is positioned in contact
with the skin of the patient. Alternatively, in the bipolar
configuration, the resection electrode 19 acts as one electrode
while the porous delivery member 54 acts as the second
electrode.
[0075] In the bipolar configuration, both the resection electrode
19 and the porous delivery member 54 (the second electrode) need to
be in contact with tissue to complete the circuit. Gentle downward
pressure placed on the probe 12, however, will cause a depression
(or cut) in the tissue to enable the porous delivery member 54 and
resection electrode to contact the tissue. Once tissue is cut or
resected, as seen in FIG. 6C, the porous delivery member 54 may
contact the exposed inner walls 104a, 104b of the tissue 100.
[0076] FIGS. 4, 4A, and 4B illustrate yet another embodiment of a
resection probe 60 according to an alternative aspect of the
invention. Those features of the resection probe 60 that are common
with the embodiment illustrated in FIGS. 1, 1A, and 1B retain the
same element number for sake of clarity. In the resection probe 60
of this embodiment, ultra-violet light is used to initiate or
accelerate polymerization of the hemostasis-promoting material 16.
The distal end 24 of the probe shaft 20 terminates in a tissue
resection assembly 62. The assembly includes a resection electrode
19, a porous delivery member 64, an ultra-violet (UV) light emitter
66, and an ultra-violet light shield 68 interposed between the UV
light emitter 66 and the porous delivery member 64.
[0077] The resection electrode 19 is RF-powered as described in
detail herein. The porous delivery member 64 is fluidically coupled
with conduit 30 in the probe shaft 20 as best seen in FIG. 4A. In
this regard, the hemostasis-promoting material 16 is able to pass
from conduit 30, into the porous delivery member 64, and onto the
resected tissue. The porous delivery member 64 may be formed from a
solid, porous material that is capable of weeping
hemostasis-promoting material 16 on resected tissue. The porous
delivery member 64 may also be formed from the same material used
to form the porous delivery member 54 shown in FIGS. 3, 3A, and
3B.
[0078] The ultra violet light emitter 66 may be formed as a light
pipe or other structure capable of emitting light in the radial
direction (with respect to the long axis of probe 12). One or more
reflective or refractive surfaces may be needed to alter the path
of the light from a generally axial path (e.g., along the length of
the probe shaft 20) to a direction that is generally perpendicular
to the long axis of the probe 12. Alternatively, the ultra violet
light emitter 66 may be formed from a fiber optic cable or bundle
(not shown) that terminates in a mirrored or refractive surface to
bend the light generally perpendicular to the long axis of the
probe 12.
[0079] UV light may be emitted from the entire length of the light
emitter 66. Alternatively, UV light may be directed radially
outward at one or more points along the length of the light emitter
66. The UV light emitter 66 is coupled, for example, via fiber
optic cables 69 or the like to a UV light source 70. The UV light
source 70 may emit light over a range of UV wavelengths (e.g., a
broadband source) or, alternatively, emit light at one or more
discrete or predominant wavelengths.
[0080] The UV light shield 68 may be formed from any material
impermeable to ultra-violet radiation. For example, an opaque
material impermeable to all forms of light may be used.
Alternatively, the light shield 68 may specifically prevent
transmission of radiation in the UV wavelength range.
[0081] In one embodiment, the porous delivery member 64 may be
formed having a generally triangular cross-sectional shape. For
example, the resection electrode 19 may be formed at one apex of
the porous delivery member 64 as is shown in FIG. 4B. In this
orientation, the chance that stray UV light may enter the porous
delivery member 64 is reduced or eliminated. If UV light entered
the porous delivery member 64, then the hemostasis-promoting
material 16 could potentially cure within the device 60 thereby
occluding further flow. The outer or exposed surface of the porous
delivery member 64 may optionally be coated with a UV-resistant
coating to prevent UV light from penetrating deep within the porous
delivery member 64.
[0082] Referring to FIG. 4, the handle assembly 26 may include an
actuator 35 such as a button or the like that permits the selective
release of UV light via the UV light emitter 66. In certain
situations, the operator may want to apply or irradiate the cut
tissue with UV light after performing a cutting or resection
operation. In this case, a separate actuator 35 may be provided to
trigger delivery of UV light. Alternatively, the same actuator or
button 32 used to energize the resection electrode 19 may be used
to trigger UV light. In this regard, UV light is delivered
simultaneously with activation of the resection electrode 19. In
yet another alternative, the actuator or button 34 used to deliver
the polymerizable hemostasis-promoting material 16 may also be used
to control or modulate UV light delivery.
[0083] Having described the general structure and function of the
tissue resection devices (10, 15, 50, 60), their operation in
resecting tissue will be described. As best seen in FIGS. 5A-5C the
tissue 100 may be located anywhere in the body where resection may
be beneficial. Most commonly, the tissue 100 will contain a solid
tumor within an organ of the body, such as the liver, kidney,
pancreas, breast, prostrate (not accessed via the urethra), and the
like. In this case, an unhealthy tissue portion 100a, e.g., a
cancerous portion containing a tumor, e.g., a lobe of a liver, may
be resected from the healthy portion of the tissue 10b. It should
be understood that the tissue resection devices (10, 15, 50, 60)
may also be used to resect donor organ tissue such as, for example,
the resection of donor liver tissue in a liver transplant
surgery.
[0084] In the preferred method, access to the tissue 100 may be
accomplished through a surgical opening to facilitate movement of
the resection probe within the patient as well as to facilitate
removal of the resected tissue 100a from the patient. However,
access to the tissue 100 may alternatively be provided through a
percutaneous opening, e.g., laparoscopically, in which case, the
tissue resection probe 12 can be introduced into the patient
through a cannula, and the removed tissue 100a may be minsilated
and aspirated from the patient through the cannula.
[0085] The operation of the RF-based tissue resection device (10,
50, 60) is now described in resecting unhealthy portion of tissue
100a to be removed from a patient, which has a tumor, from a
healthy portion of tissue 100b to be retained within the patient.
First, the RF generator 14 and associated cable 42 are connected to
the electrical connector 40 on the handle 26, and the syringe 17
and associated tubing 38 are connected to the port 36 on the handle
26.
[0086] Next, the resection probe 12 is manipulated, such that the
resection electrode 19 is moved in proximity to the tissue 100
along a resection line 102, and RF energy is conveyed between the
RF generator 14 and the resection electrode 19. At the same time or
prior to when RF energy is conveyed to the resection electrode 19,
the syringe 17 is then operated such that the hemostasis-promoting
material 16 is conveyed under positive pressure, through the tubing
38, and into the port 36. The hemostasis-promoting material 16
travels through the fluid conduit 30 within the probe shaft 20 and
out the one or more ejection ports 28 (in the embodiments shown in
FIGS. 1, 1A, 1B) or out the porous delivery members 54, 64 (in the
embodiments shown in FIGS. 3, 3A, 3B, 4, 4A, and 4B).
[0087] In one method, the hemostasis-promoting material 16 travels
onto the tissue resection member 18 where it then is passed or
transferred to the tissue 100 in a subsequent cutting operation
(described in more detail below). Alternatively, the
hemostasis-promoting material 16 may pass directly from the
resection probe 12 to the tissue 100.
[0088] As best seen in FIG. 5A, to resect or cut the tissue 100,
electrical energy is conveyed from the resection electrode 19
through the tissue 100 along the resection line 102, thereby
cutting or separating a portion of the tissue 100 that straddles
the resection line 102. The probe 12 is typically moved along the
resection line 102 in one or more strokes with each stroke cutting
deeper within the tissue 100. The now formed cut may take the
general cross-sectional shape of a "V" wherein the tissue 100
includes exposed walls or sides 104a, 104b that are formed as a
result of the resecting operation.
[0089] As seen in FIG. 5A, the exposed walls or sides 104a, 104b of
the tissue 100 are coated with a polymerizable hemostasis-promoting
material 16. The hemostasis-promoting material 16 may be deposited
onto the walls 104a, 104b at substantially the same time as the
cutting or resecting operation is performed.
[0090] In one embodiment, the polymerizable hemostasis-promoting
material 16 may be dispensed by a activation of a heat and/or
current sensitive valve (not shown) that operates by the principle
of thermal expansion, such as a concentric nozzle assembly made of
dissimilar metals that is heated with the RF power on its way to
the distal end 24 of the device 10. By heating the concentric
assembly, and by virtue of differing thermal expansion of the
metals, a gap may be generated in the concentric assembly. The
pressurized polymer material 16 would then flow from the distal end
24.
[0091] Alternatively, the syringe 17 or other pumping mechanism may
be engaged to coat the newly formed tissue walls 104a, 104b with
the hemostasis-promoting material 16 after a cutting stroke or
operation has taken place. After application of the
hemostasis-promoting material 16, the material 16 cures or
polymerizes. While the resecting electrode 19 has the ability to
partially or even fully seal lumens via collagen shrinkage, there
may be additional areas of tissue bleeding. These areas of
bleeding, however, are rapidly sealed by the polymerizable
hemostasis-promoting material 16.
[0092] The resection of the tissue 100 continues as is shown in
FIGS. 5B and 5C. In FIG. 5B, a V-shaped groove or cut is shown
fully across the resection line 102. As seen in FIG. 5B, the walls
of the exposed tissue contains a film or is otherwise substantially
coated with the polymerizable hemostasis-promoting material 16. As
seen in FIGS. 5A, 5B, and 5C, a localized region 106 adjacent to
the resected tissue 100 undergoes coagulation in response to the
energy supplied via the resection electrode 19. The probe 12
continues to cut the tissue 100 deeper along the resection line 102
until the unhealthy portion of tissue 100a is completely separated
from the healthy portion of tissue 100b. The unhealthy portion of
tissue 100a can then be removed.
[0093] The curing of the hemostasis-promoting material 16 may be
initiated or accelerated by application of heat and/or RF energy
from the resection electrode 19. The heat may be applied directly
to the hemostasis-promoting material 16 from the probe 12.
Alternatively, in embodiments where the hemostasis-promoting
material 16 is ejected along a trailing or lagging edge, heat
retained in the cut tissue aids in initiating and/or accelerating
polymerization. In still another alternative, curing of the
hemostasis-promoting material 16 may be initiated or accelerated by
application of radiation such as UV light from a probe 60 of the
type illustrated in FIGS. 4, 4A, and 4B.
[0094] FIGS. 6A-6D illustrate cross-sectional views of the various
resection probes (10, 15, 50, 60) resecting tissue 100. FIG. 6A
illustrates the resection probe device 10, wherein the resection
electrode 19 is used to resect tissue 100. FIG. 6A illustrates a
layer or film of hemostasis-promoting material 16 disposed on the
exposed walls 104a, 104b of the now-cut tissue 100. Also
illustrated is a localized region of coagulated tissue 106 just
underlying the layer or film of hemostasis-promoting material 16.
FIG. 6B illustrates the resection probe device 15, wherein the
mechanical resection member 21 is used to resect tissue 100.
[0095] FIG. 6C illustrates the resection probe 50 used to resect
tissue 100. As seen in FIG. 6C, in certain embodiments of the
invention, the porous delivery member 54 may be sized such that an
exterior surface is able to directly contact the exposed walls
104a, 104b of the cut tissue 100. In this regard, the porous
delivery member 54 is able to paint or apply hemostasis-promoting
material 16 directly to the exposed tissue 104a, 104b. During
delivery, the hemostasis-promoting material 16 may flow or even
pool at the apex region where tissue cutting takes place. In this
manner, the hemostasis-promoting material 16 is able to cover
substantially all of the exposed tissue regions 104a, 104b.
[0096] FIG. 6D illustrates the resection probe 60 used to resect
tissue 100. The resection probe 60 in this embodiment uses UV light
to initiate or accelerate the polymerization of the
hemostasis-promoting material 16.
[0097] In another embodiment, the hemostasis-promoting material 16
may be dispensed from a forceps-type device (not shown) such as
those used for open surgery or endoscopic surgery used for
nodulectomies, lobectomy or volume reduction surgeries of the lung.
The hemostasis-promoting material 16 will aid in hemostasis and
air-leak sealing of the lung. The hemostasis-promoting material 16
may also be dispensed from a stapling device, and be activated by
any of the means mentioned above.
[0098] While embodiments of the present invention have been shown
and described, various modifications may be made without departing
from the scope of the present invention. The invention, therefore,
should not be limited, except to the following claims, and their
equivalents.
* * * * *