U.S. patent application number 17/456108 was filed with the patent office on 2022-03-17 for stiff sheath for image guided tissue resection.
This patent application is currently assigned to PROCEPT BioRobotics Corporation. The applicant listed for this patent is PROCEPT BioRobotics Corporation. Invention is credited to Nikolai ALJURI, Luis BAEZ, Jonathan FOOTE, Surag MANTRI, Michael W. SASNETT, George SURJAN.
Application Number | 20220079613 17/456108 |
Document ID | / |
Family ID | |
Filed Date | 2022-03-17 |
United States Patent
Application |
20220079613 |
Kind Code |
A1 |
ALJURI; Nikolai ; et
al. |
March 17, 2022 |
STIFF SHEATH FOR IMAGE GUIDED TISSUE RESECTION
Abstract
A fluid stream is directed toward tissue to generate a plurality
of shedding clouds. The fluid stream can be scanned such that the
plurality of shedding clouds arrive a different overlapping
locations. Each of the plurality of shedding clouds can remove a
portion of the tissue. In many embodiments, an apparatus to ablate
tissue comprises a source of pressurized fluid, and a nozzle
coupled to the source of pressurized fluid to release a fluid
stream, in which the fluid stream generates a plurality of shedding
clouds.
Inventors: |
ALJURI; Nikolai;
(Hillsborough, CA) ; MANTRI; Surag; (East Palo
Alto, CA) ; BAEZ; Luis; (Mountain View, CA) ;
SURJAN; George; (Redwood City, CA) ; SASNETT; Michael
W.; (Los Altos, CA) ; FOOTE; Jonathan; (San
Francisco, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
PROCEPT BioRobotics Corporation |
Redwood City |
CA |
US |
|
|
Assignee: |
PROCEPT BioRobotics
Corporation
Redwood City
CA
|
Appl. No.: |
17/456108 |
Filed: |
November 22, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15825040 |
Nov 28, 2017 |
11213313 |
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17456108 |
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14708910 |
May 11, 2015 |
9848904 |
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15825040 |
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PCT/US2014/054412 |
Sep 5, 2014 |
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14708910 |
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62019305 |
Jun 30, 2014 |
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61972730 |
Mar 31, 2014 |
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61874849 |
Sep 6, 2013 |
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International
Class: |
A61B 17/3203 20060101
A61B017/3203; A61B 18/14 20060101 A61B018/14; A61B 8/12 20060101
A61B008/12; A61B 34/10 20060101 A61B034/10; A61B 18/12 20060101
A61B018/12 |
Claims
1. A method for tissue resection, said method comprising:
positioning a nozzle at a surgical site within tissue; pressurizing
the surgical site with a liquid; directing a fluid stream outwardly
from the nozzle at the surgical site; and moving the fluid stream
such that a plurality of shedding clouds arrive at different
overlapping locations and remove a volume of the tissue.
2. The method of claim 1, wherein the plurality of shedding clouds
is shed from the fluid stream at a characteristic shedding
frequency.
3. The method of claim 2, wherein the characteristic length of each
of the plurality of shedding clouds is related to the
characteristic shedding frequency and a velocity of said plurality
of shedding clouds.
4. The method of claim 3, wherein the nozzle is positioned at the
distance from said tissue, in order to allow the plurality of
shedding clouds to substantially form prior to said plurality of
shedding clouds striking the tissue.
5. The method of claim 4, wherein the distance is adjustable to
distribute the plurality of shedding clouds over a desired region
of said tissue.
6. The method of claim 5, wherein the distance is adjustable to a
greater height from said tissue to distribute the plurality of
shedding clouds over a larger region of said tissue, or adjustable
to a lower height from said tissue to distribute the plurality of
shedding clouds over a smaller region of said tissue.
7. The method of claim 1, wherein the fluid stream comprises a
cavitating jet.
8. The method of claim 7, wherein the cavitating jet comprises a
pulsed energy stream comprising a plurality of sequential
pulses.
9. The method of claim 8, wherein the plurality of shedding clouds
is provided for each of said plurality of sequential pulses.
10. The method of claim 8, wherein the plurality of shedding clouds
is configured to overlap with the plurality of sequential pulses.
Description
CROSS-REFERENCE
[0001] This application is a continuation of U.S. patent
application Ser. No. 15/825,040, filed Nov. 28, 2017, which is a
continuation of U.S. patent application Ser. No. 14/708,910, filed
May 11, 2016, now U.S. Pat. No. 9,848,904, issued Dec. 26, 2017,
which is a bypass continuation of International Patent Application
No. PCT/US2014/054412, filed Sep. 5, 2014, published as WO
2015/035249 on Mar. 12, 2015, and claims the benefit under 35
U.S.C. .sctn. 119(e) of U.S. Provisional Patent Application No.
62/019,305, filed Jun. 30, 2014, U.S. Provisional Patent
Application No. 61/972,730, filed Mar. 31, 2014, and U.S.
Provisional Patent Application No. 61/874,849, filed Sep. 6, 2013,
the entire disclosures of which are incorporated herein by
reference.
[0002] The subject matter of this application is related to
International Application No. PCT/US2013/028441, filed on Feb. 28,
2013, published as WO 2013/130895 on Sep. 6, 2013; U.S. Provisional
Patent Application No. 61/604,932, filed Feb. 29, 2021; U.S. patent
application Ser. No. 12/399,585, filed Mar. 6, 2009, now U.S. Pat.
No. 8,814,921, issued Aug. 26, 2014; U.S. patent application Ser.
No. 12/700,568, filed Feb. 4, 2010, now U.S. Pat. No. 9,232,959,
issued Jan. 12, 2016; U.S. patent application Ser. No. 11/968,445,
filed Jan. 2, 2008, now U.S. Pat. No. 7,882,841, issued Feb. 8,
2011; and International Application No. PCT/US2011/023781, filed
Apr. 8, 2007, published as WO 2011/097505 on Nov. 8, 2011, the full
disclosures of which are incorporated herein by reference.
BACKGROUND
[0003] The field of the present invention is related to the
treatment of tissue with energy, and more specifically to the
treatment of an organ such as the prostate with fluid stream
energy.
[0004] Prior methods and apparatus of treating subjects such as
patients can result in less than ideal removal in at least some
instances. For example, prior methods of prostate surgery can
result in longer healing time and less than desirable outcome than
would be ideal in at least some instances.
[0005] Prior methods and apparatus of imaging tissue can be less
than ideal for imaging a treated tissue. For example, prior
ultrasound methods and apparatus may not be well suited to view the
treatment sight during treatment, and alignment of diagnostic
images with treatment images can be less than ideal. Also, at least
some of the prior treatment methods and apparatus of treating
tissue may not be well suited from combination with imaging systems
of the prior art. In at least some instances, it would be helpful
to provide improved imaging of tissue during surgery, for example
to provide real time imaging of tissue that would allow a user to
adjust the treatment based on real time images of the tissue. At
least some of the prior methods and apparatus to image tissue
during surgery can be somewhat cumbersome to use, and can result in
delays in the patient treatment.
[0006] Prior methods and apparatus to treat an organ such as the
prostate may provide a user interface that is somewhat cumbersome
for the user, and can provide less than ideal planning of the
surgery. Also, at least some of the prior methods and apparatus to
treat tissue such as the prostate tissue can be somewhat less
accurate than would be ideal. In at least some instances, the prior
methods and apparatus may provide a less than ideal user
experience. Also, at least some of the prior interfaces may provide
less than ideal coupling of the treatment apparatus with tissue
structures.
[0007] Improved methods for tissue resection are described in U.S.
Pat. No. 7,882,841 and pending applications U.S. Ser. No.
12/700,568 and U.S. Ser. No. 12/399,585. The methods and systems
described in this patent and these patent applications rely on the
positioning of a probe such as a urethral probe, which directs a
fluid stream radially outwardly for controlled resection of tissue
such as the prostate and luminal tissues. Optionally, the fluid
stream may be used to deliver light, electrical, heat or other
energy sources to aid in resection and/or to cauterize the treated
tissue.
[0008] Work in relation to embodiments suggest that in at least
some instances treatment of diseased tissue can be less than ideal.
For example, diseased tissue may not provide fluid flow similar to
healthy tissue, and work in relation to embodiments suggest that
diseased tissue can be related to distension and stretching with
small variations in fluid delivery and removal. Consequently,
recovery and healing, while an improvement over the prior art, can
take somewhat longer than would be ideal in at least some
instances.
[0009] In addition, it would be helpful to have improved monitoring
of surgical procedures that could be readily implemented in a cost
effective manner so that many people could benefit from the
advances in surgical robotics. In at least some instances it would
be helpful to have improved imaging of the surgical site. Also, it
would be helpful to determine when treatment may exceed a desired
limit, such as the capsule of the prostate, and to provide
measurement apparatus with the treatment device to inhibit cutting
tissue too deeply and perforation of tissue such as the capsule of
the prostate, for example. Although ultrasound imaging can be
helpful, it would be desirable to have improved alignment of
ultrasound probes with treatment probes.
[0010] While these methods are very effective and represent a
significant advance over prior luminal tissue treatment protocols,
it would be desirable to provide improvements to assist in more
accurate tissue removal in both fully automated and physician
assisted operating modes. At least some of these objectives will be
met by the inventions described hereinafter.
SUMMARY
[0011] Embodiments of the present invention provide improved
methods and apparatus for performing tissue resection, such as
prostate tissue resection, by positioning an energy source within a
urethra.
[0012] Embodiments of the present invention provide improved
methods and apparatus for performing tissue resection, such as
prostate tissue resection, by positioning an energy source within a
urethra. In many embodiments, a fluid stream is directed toward
tissue to generate a plurality of shedding clouds. The fluid stream
can be scanned such that the plurality of shedding clouds arrive a
different overlapping locations. Each of the plurality of shedding
clouds can remove a portion of the tissue. In many embodiments, an
apparatus to ablate tissue comprises a source of pressurized fluid,
and a nozzle coupled to the source of pressurized fluid to release
a fluid stream, in which the fluid stream generates a plurality of
shedding clouds.
[0013] In a first aspect, embodiments provide a method of ablating
tissue. A fluid stream is directed toward the tissue to generate a
plurality of shedding clouds. The fluid stream is scanned such that
the plurality of shedding clouds arrives at different overlapping
locations.
[0014] In many embodiments, each of the plurality of shedding
clouds removes a portion of the tissue.
[0015] In many embodiments, the shedding clouds comprise
cavitations visible to a user.
[0016] In many embodiments, the fluid stream comprises a first
liquid released into a second liquid to generate the shedding
clouds.
[0017] In many embodiments, the first liquid comprises saline and
the second liquid comprises saline.
[0018] In many embodiments, the fluid stream is scanned with one or
more of a hand held probe or a probe coupled to a linkage.
[0019] In another aspect, embodiments provide an apparatus to
ablate tissue. The apparatus comprises a source of pressurized
fluid, and a nozzle coupled to the source of pressurized fluid to
release a fluid stream. The fluid stream generates a plurality of
shedding clouds, wherein each of the plurality of shedding clouds
removes a portion of the tissue.
[0020] In many embodiments, a scanner is coupled to the nozzle to
ablate each portion of the tissue with partially overlapping
shedding clouds.
[0021] In many embodiments, the fluid stream comprises a liquid,
the apparatus further comprising an irrigation opening to irrigate
the tissue with a second liquid.
[0022] In many embodiments, the first liquid comprises saline and
the second liquid comprises saline.
[0023] In many embodiments, the nozzle comprises a Strouhal number
within a range from about 0.02 to about 0.03.
[0024] In many embodiments, fluid source comprises a pump having a
frequency less than a frequency of the shedding pulses.
[0025] In many embodiments, the shedding pulses comprise a
frequency within a range from about 1 k Hz to about 10 kHz.
[0026] In many embodiments, tissue resection is performed with an
opening to aspirate ablated material on the distal end of the probe
in order to promote removal of fluid from the bladder neck and
inhibit excessive amounts of fluid from accumulating in the
bladder. The opening on the distal end of the probe can be
fluidically coupled to the surgical site. In many embodiments, the
probe can be provided without a distal anchor on the treatment
probe, and improved methods and apparatus are provided for aligning
the treatment with the target tissue structure. The probe inserted
into the urethra can be provided without an anchor in order to
promote movement of fluid from the surgical site toward the bladder
neck. A distal opening of the probe can be configured to aspirate
fluid with suction from the distal end of the probe toward a source
of suction such as a gravity flow line of a siphon or suction pump.
The opening on the distal end of the probe can be fluidically
coupled to the surgical site, such that fluid can be drawn from the
surgical site when the distal end of the probe is placed in the
bladder neck during at least an initial portion of the procedure.
In many embodiments, the aspiration opening on the distal end of
the probe is coupled to a fluid pump configured to remove fluid at
a rate determined by the user. The fluid pump may comprise a
peristaltic pump, or pump with a diaphragm such that fluid can be
accurately removed from the surgical site to inhibit distension of
tissue. In many embodiments, the probe can be aligned with
reference to anatomical structures of the patient such as the
bladder neck and verumontanum, which can be readily viewed with
endoscopic visualization. In many embodiments, the display screen
visible to the user comprises a reference, and a tissue marker such
as the bladder neck is aligned with internal visualization of the
patient in order to align a reference structure shown on the
display with the anatomical marker of the patient. When the probe
is aligned, an arm coupled to the probe can be locked to inhibit
unintended movement of the probe.
[0027] While embodiments of the present invention are specifically
directed at transurethral treatment of the prostate, certain
aspects of the invention may also be used to treat and modify other
organs such as brain, heart, lungs, intestines, eyes, skin, kidney,
liver, pancreas, stomach, uterus, ovaries, testicles, bladder, ear,
nose, mouth, soft tissues such as bone marrow, adipose tissue,
muscle, glandular and mucosal tissue, spinal and nerve tissue,
cartilage, hard biological tissues such as teeth, bone, as well as
body lumens and passages such as the sinuses, ureter, colon,
esophagus, lung passages, blood vessels, and throat. The devices
disclosed herein may be inserted through an existing body lumen, or
inserted through an opening created in body tissue.
BRIEF DESCRIPTION OF THE DRAWINGS
[0028] A better understanding of the features and advantages of the
present disclosure will be obtained by reference to the following
detailed description that sets forth illustrative embodiments, in
which the principles of the disclosure are utilized, and the
accompanying drawings of which:
[0029] FIG. 1 is a schematic illustration of a device suitable for
performing intraurethral prostatic tissue debulking in accordance
with the principles of the present invention;
[0030] FIGS. 2A, 2B, 2C and 2D illustrate use of the device of FIG.
1 in performing prostatic tissue debulking;
[0031] FIG. 3 illustrates a specific prostatic tissue treatment
device incorporating the use of a radiofrequency saline plasma for
performing prostatic tissue debulking;
[0032] FIG. 4 illustrates an energy source suitable for use in the
devices of the present invention, wherein the energy source
delivers a fluid stream for tissue resection;
[0033] FIG. 5 illustrates an energy source suitable for use in
devices of the present invention, wherein the energy source
comprises a deflected optical waveguide for delivering laser energy
to the prostatic tissue;
[0034] FIG. 6 illustrates a device similar to that shown in FIG. 5,
except the optical waveguide directs laser energy at a mirror which
laterally deflects the laser energy;
[0035] FIG. 7 illustrates an energy source suitable for use in the
devices of the present invention, wherein the energy source
comprises a laterally projecting electrode which can engage the
urethral wall and prostatic tissue to deliver radiofrequency energy
for tissue ablation;
[0036] FIG. 8 is a graph of tissue resection rates demonstrating
critical pressures;
[0037] FIG. 9a is a flow diagram illustrating selective and
controlled resection;
[0038] FIG. 9b is a flow diagram illustrating selective resection,
wherein the fluid stream is configured to penetrate the urethral
wall and resect the prostate tissue;
[0039] FIG. 10a illustrates a columnar fluid stream and a diverging
fluid stream;
[0040] FIG. 10b illustrates a cross-sectional view of a tissue
modification device configured to emit a columnar fluid stream;
[0041] FIG. 10c illustrates a cross-sectional view of a tissue
modification device configured to emit a diverging fluid
stream;
[0042] FIG. 11 illustrates a tissue modification device that uses a
fluid stream for tissue resection, wherein the fluid stream may
optionally act as a conduit for electromagnetic energy;
[0043] FIG. 12 shows a component of the treatment probe in
accordance with embodiments;
[0044] FIGS. 13A and 13B show a system that treat a patient in
accordance with embodiments;
[0045] FIG. 14A shows a multipurpose sheath and manifold in
accordance with embodiments;
[0046] FIG. 14B shows manifold conduits of the manifold as in FIG.
14A configured for transmit and reception of multiple fluids while
the manifold remains coupled to the patient in accordance with
embodiments;
[0047] FIG. 14C shows components of treatment probe and linkage in
accordance with embodiments;
[0048] FIG. 14D1 shows rapid exchange of a carrier when the linkage
is coupled to the elongate element anchored to a target location of
an organ, in accordance with embodiments;
[0049] FIG. 14D2 shows alignment of the distal tip of the carrier
with the proximal end of the linkage to insert the carrier tube as
in FIG. 14D1;
[0050] FIG. 14D3 shows the carrier advanced toward a locking
structure on the proximal end of the linkage as in FIG. 14D1;
[0051] FIG. 14D4 shows the carrier locked to the linkage as in
FIGS. 14D1 and 14D2;
[0052] FIG. 14E shows a cytoscope inserted at least partially into
an elongate element for advancement toward a bladder neck to view
tissue of an organ such as the prostate, in accordance with
embodiments;
[0053] FIG. 14F shows advancement of an elongate element into a
sheath;
[0054] FIG. 14G shows a linkage coupled to an elongate element
comprising a spine in accordance with embodiments;
[0055] FIG. 14H shows a carrier tube and carrier inserted into the
linkage tube in accordance with embodiments;
[0056] FIGS. 15 and 16 show self cleaning with a fluid jet in
accordance with embodiments;
[0057] FIG. 17A shows components of user interface on the display
of the patient treatment system as in FIG. 13 in accordance with
embodiments;
[0058] FIGS. 17B and 17C show a marker moving on a plurality of
images in which movement of the marker corresponds to the position
and orientation of an energy stream in accordance with
embodiments;
[0059] FIG. 17D shows a user defined cut profile in accordance with
embodiments;
[0060] FIGS. 17E and 17F show a user interface to define a
plurality of curved portions of a cut profile in accordance with
embodiments;
[0061] FIG. 18 shows a system configuration mode for the cutting
mode input of the user interface as in FIG. 17A;
[0062] FIG. 19 shows a coagulation mode selected with input of the
user interface as in FIG. 17A;
[0063] FIG. 20A shows mapping and alignment of an image of the
patient with the treatment coordinate reference frame in accordance
with embodiments;
[0064] FIGS. 20B and 20C show a method of treating a patient in
accordance with embodiments;
[0065] FIGS. 21A and 21B show screenshots of a 3d segmentation
image used in accordance with the systems and methods of
embodiments;
[0066] FIGS. 21C, 21D, 21E and 21F show a plurality of sagittal
images of a target tissue to define a three dimensional treatment
plan and a user defined treatment profile in each of the plurality
of images;
[0067] FIG. 21G shows a transverse view of the target tissue and
planes of the axial images of FIGS. 21C to 21F;
[0068] FIG. 21H shows a three dimensional treatment plan based on
the plurality of images of FIGS. 21A to 21F;
[0069] FIG. 21I shows a user input treatment profile of an image
among a plurality of images;
[0070] FIG. 21J shows scan patterns of the fluid stream, in
accordance with embodiments;
[0071] FIG. 21K shows a bag over a fluid stream comprising a water
hammer in accordance with embodiments;
[0072] FIGS. 22A and 22B show schematic illustrations of a probe
being operated in accordance with the principles of
embodiments;
[0073] FIG. 22C shows an endoscope placed in the working channel of
elongate element with carrier to image tissue when the patient is
treated in accordance with embodiments;
[0074] FIGS. 23A and 23B show a carrier configured to provide
integrated jet delivery in accordance with embodiments;
[0075] FIG. 24 shows carrier comprising a fluid delivery element
and design considerations of the fluid delivery element, in
accordance with embodiments;
[0076] FIGS. 25A, 25B and 25C show jet deflection in accordance
with embodiments;
[0077] FIGS. 26A, 26B and 26C show jet masking in accordance with
embodiments;
[0078] FIGS. 27A and 27B show variation of jet angle in accordance
with embodiments;
[0079] FIG. 28 shows multiple jets delivered simultaneously in
accordance with embodiments;
[0080] FIG. 29 shows morcellation in accordance with
embodiments;
[0081] FIGS. 30, 31A and 31B show single tube designs in accordance
with embodiments;
[0082] FIG. 32 shows means of registering and locating the
treatment system with respect to the human anatomy in accordance
with embodiments;
[0083] FIG. 33 shows a plurality of expandable structures
comprising a first expandable basket and a second expandable basket
in accordance with embodiments;
[0084] FIG. 34 shows means of registering the system with respect
to the human anatomy in accordance with embodiments;
[0085] FIG. 35 shows a disposable balloon in accordance with
embodiments;
[0086] FIG. 36 shows tissue resection and depth control in
accordance with embodiments;
[0087] FIG. 37 shows the visible entrainment region at a first size
as is shown in FIG. 36;
[0088] FIG. 38 shows tissue resection depth control in accordance
with embodiments;
[0089] FIG. 39 shows an optical image of the entrainment region
"flame" in saline as shown in FIG. 38 with a different pressure
than is shown in FIGS. 36 and 37, in accordance with
embodiments;
[0090] FIG. 40 shows nozzle flow rate versus maximum penetration
depth for a plurality of pressures and nozzles in accordance with
embodiments;
[0091] FIG. 41 shows nozzle back pressure versus maximum depth of
penetration in accordance with embodiments;
[0092] FIG. 42 shows nozzle flow rate versus back pressure for 130
micron nozzle and 150 micron nozzle in accordance with
embodiments;
[0093] FIG. 43 shows a frequency spectrum of a jet configured to
cut tissue in saline without striking tissue, in accordance with
embodiments;
[0094] FIG. 44 shows a frequency spectrum of the jet as in FIG. 43
ablating tissue, in which the frequency spectrum has an increase in
high frequency components corresponding to the ablation of tissue,
in accordance with embodiments;
[0095] FIG. 45 shows pressure regulation of the surgical site with
a substantially constant pressure and variable flow, in accordance
with embodiments;
[0096] FIG. 46 shows flow regulation of the surgical site with a
pump providing a substantially fixed fluidic flow and a
substantially constant pressure, in accordance with
embodiments;
[0097] FIGS. 47A and 47B show a transurethral treatment probe
having an ultrasound array located near the fluid release element
to image the treatment site;
[0098] FIG. 48A shows a user interface screen with treatment input
parameters and treatment monitoring parameters, in accordance with
embodiments;
[0099] FIG. 48B shows a user interface as in FIG. 48A with a
real-time ultrasound image of the treatment site, in accordance
with embodiments;
[0100] FIGS. 49 and 50 show a side view and an isometric view,
respectively, of a stiff sheath over a transrectal ultrasound probe
to inhibit changes in tissue shape as the elongate ultrasound probe
moves along an elongate axis of the ultrasound probe, in accordance
with embodiments;
[0101] FIG. 51A shows a docking structure configured to engage a
protrusion of a stiff sheath to hold the stiff sheath in place for
the surgery, in accordance with embodiments;
[0102] FIG. 51B shows the docking structure engaging the stiff
sheath with the docking structure in order to support and inhibit
movement of the stiff sheath during treatment, in which the docking
structure is coupled to a lockable arm;
[0103] FIGS. 52A and 52B show isometric and cross-sectional views,
respectively, of a treatment probe comprising a support structure
having a dynamic tip, in accordance with embodiments;
[0104] FIG. 53 shows venturi aspiration into the probe with a
channel configured to receive fluid located on the moving probe
near the nozzle of the ablative jet;
[0105] FIG. 54 shows a radio frequency (hereinafter "RF") electrode
on a cautery probe configured to rotate around an elongate axis of
the probe in order to cauterize tissue, in accordance with
embodiments;
[0106] FIG. 55 shows a bipolar electrode configured to rotate
around an elongate axis of a cautery probe in order to cauterize
tissue, in accordance with embodiments;
[0107] FIG. 56 shows an integrated tissue treatment probe having
aspiration an irrigation integrated into the probe, in accordance
with embodiments;
[0108] FIG. 57 shows an integrated treatment probe with an opening
for fluid suction on a distal end, in which the probe has been
place in a stiff sheath with an endoscope to view the
treatment;
[0109] FIG. 58 shows an integrated treatment probe having an
aspiration opening and an irrigation opening on a distal end to
aspirate through the aspiration opening and irrigate through the
irrigation opening, in which the probe has been placed in a stiff
sheath with an endoscope to view the treatment, in accordance with
embodiments;
[0110] FIGS. 59A, 59B and 60 show nozzle angles of the probe, in
accordance with embodiments;
[0111] FIGS. 61, 62 and 63 show isometric, side and cross-sectional
views, respectively of a treatment probe having a viewing path
substantially concentric with rotation of a nozzle of a treatment
jet, in accordance with embodiments;
[0112] FIGS. 64 and 65 show an endoscope and a sliding telescopic
structure to add stiffness and guide the endoscope into the stiff
sheath, in accordance with embodiments;
[0113] FIG. 66 shows a treatment probe configured for at least
partially manual treatment of an electrode and at least partially
automated treatment with a water jet, in accordance with
embodiments;
[0114] FIG. 67 shows a treatment probe configured for at least
partially manual treatment with bipolar electrodes and at least
partially automated treatment with the liquid jet, in accordance
with embodiments;
[0115] FIG. 68 shows a handpiece of the treatment probe as in FIGS.
66 and 67;
[0116] FIG. 69 shows an ablative flame visible to the human eye, in
accordance with embodiments;
[0117] FIG. 70 shows a high speed image of the ablative flame as in
FIG. 69;
[0118] FIG. 71 shows a plurality of shedding pulses and sweeping of
the ablative jet to provide smooth and controlled tissue erosion at
a plurality of overlapping locations in accordance with
embodiments;
[0119] FIG. 72 shows a catheter 950 to treat a patient in
accordance with embodiments;
[0120] FIG. 73 shows the distal end of the catheter as in FIG. 72
in accordance with embodiments;
[0121] FIG. 74 shows a catheter placed in a working channel of a
commercially available endoscope in accordance with
embodiments;
[0122] FIG. 75 shows a catheter as in FIGS. 72 and 73 placed an
endoscope as in FIG. 74 and deflection of the distal end of the
endoscope and catheter, in accordance with embodiments;
[0123] FIG. 76 shows maximum tissue penetration depth of cutting
and flow rate through a nozzle in accordance with embodiments;
and
[0124] FIG. 77 shows selective removal of potato with a blood
vessel positioned over the incision of the potato as a model for
selective removal of tissue.
DETAILED DESCRIPTION
[0125] A better understanding of the features and advantages of the
present disclosure will be obtained by reference to the following
detailed description that sets forth illustrative embodiments, in
which the principles of embodiments of the invention are utilized,
and the accompanying drawings.
[0126] Although the detailed description contains many specifics,
these should not be construed as limiting the scope of the
invention but merely as illustrating different examples and aspects
of the invention. It should be appreciated that the scope of the
invention includes other embodiments not discussed in detail above.
Various other modifications, changes and variations which will be
apparent to those skilled in the art may be made in the
arrangement, operation and details of the method and apparatus of
the present invention disclosed herein without departing from the
spirit and scope of the invention as described herein.
[0127] The embodiments disclosed herein can be combined in one or
more of many ways to provide improved therapy to a patient. The
disclosed embodiments can be combined with prior methods and
apparatus to provide improved treatment, such as combination with
known methods of prostate surgery and surgery of other tissues and
organs, for example. It is to be understood that any one or more of
the structures and steps as described herein can be combined with
any one or more additional structures and steps of the methods and
apparatus as described herein, the drawings and supporting text
provide descriptions in accordance with embodiments.
[0128] Although the treatment planning and definition of treatment
profiles and volumes as described herein are presented in the
context of prostate surgery, the methods and apparatus as described
herein can be used to treat any tissue of the body and any organ
and vessel of the body such as brain, heart, lungs, intestines,
eyes, skin, kidney, liver, pancreas, stomach, uterus, ovaries,
testicles, bladder, ear, nose, mouth, soft tissues such as bone
marrow, adipose tissue, muscle, glandular and mucosal tissue,
spinal and nerve tissue, cartilage, hard biological tissues such as
teeth, bone, etc. as well as body lumens and passages such as the
sinuses, ureter, colon, esophagus, lung passages, blood vessels and
throat.
[0129] As used herein, the term Aquablation.TM. encompasses
ablation with water.
[0130] As used herein, the words telescope, endoscope and cytoscope
are used interchangeably.
[0131] As used herein, the terms entrainment region and cavitation
region are used interchangeably.
[0132] The imaging and treatment probes as described herein can be
combined in one or more of many ways, and in many embodiments the
images of the patient can be used to define a target volume and a
target profile of the volume of tissue removed. The profile of
tissue removed can be planned to efficaciously remove tissue. The
methods and apparatus for imaging as described herein can be used
to beneficially plan for treatment. Alternatively or in
combination, the imaging methods and apparatus as described herein
can be used to modify the treatment in real time as the patient is
treated, for example.
[0133] The visible entrainment and cavitation region can be
combined with the images of tissue and treatment regions shown on
the display, so as to provide confirmation that the correct amount
of tissue will be resected. In many embodiments, the distance of
the visible entrainment region corresponds to a maximum cut depth,
such that the surgeon can select the depth of the cut based on
images and with adjustment of treatment parameters such as one or
more of flow rate, nozzle diameter, or pressure.
[0134] The visible entrainment region as described herein comprises
region of cavitation of the fluid stream emitted from the energy
source such as a nozzle, and the maximum resection depth
corresponds to the distance of the visible entrainment region. By
visible entrainment region, it is meant that the user can visualize
the entrainment region with imaging sensitive to formation of
cavitation pockets, such as visible and ultrasound imaging which
scatter waves in response to cavitation pockets being formed.
[0135] A plurality of carrier probes can be provided to allow the
user to treat one or more of many tissues in a variety of ways. An
elongate structural element having a working channel such as a
shaft remains positioned in the patient when a first carrier probe
is exchanged with one or more carrier probes. In many embodiments,
the carrier probes can be rapidly exchanged while a linkage remains
fixedly attached to the elongate element anchored to an internal
structure of the patient. Each of the carrier probes inserted into
the patient can be identified based on a treatment plan, for
example.
[0136] As used herein a processor encompasses one or more
processors, for example a single processor, or a plurality of
processors of a distributed processing system for example. A
controller or processor as described herein generally comprises a
tangible medium to store instructions to implement a steps of a
process, and the processor may comprise one or more of a central
processing unit, programmable array logic, gate array logic, or a
field programmable gate array, for example.
[0137] As used herein, the transverse plane of an image may be
referred to as the horizontal plane of the image, the axial plane
of the image, or transaxial plane of the image. An image along an
axial plane may be referred to as an axial image.
[0138] As used herein, a probe encompasses an object inserted into
a subject such as a patient.
[0139] As used herein like characters and numerals identify like
elements.
[0140] As used herein, real-time a real time image shown on a
display encompasses an image shown within a few seconds of the
event shown. For example, real time imaging of a tissue structure
encompasses providing the real time image on a display within about
ten seconds of the image being acquired.
[0141] As used herein, the terms distal and proximal refer to
locations referenced from the apparatus, and can be opposite of
anatomical references. For example a distal location of a probe may
correspond to a proximal location of an elongate member of the
patient, and a proximal location of the probe may correspond to a
distal location of the elongate member of the patient.
[0142] Automated robotic control--where movement of the water jet
is motorized and under computer control with preselected
routines--allows accurate and finely detailed resections not
possible with manual control. Advantages include reduced time
required for procedures, fewer complications, improved outcomes and
less training time needed for surgeons. Many of these improvements
arise from reducing or eliminating the need for manual dexterity of
the treating physician. Automatic control further allows the
cutting power of the nozzle to be increased to levels not
achievable with full manual control. The system may be manually
controlled during less critical portions of the procedure, e.g.
during initial selection of an area to operate on and for touch-ups
in cutting and cautery. Even during these less critical phases of
the protocols, the increased precision and smoothness provided by
the automated control can provide reduction and filtering of hand
jitter. Another significant advantage is that automation allows for
pretesting or "dry runs" of a procedure. When a cutting routine is
selected, the limits of area can be selected using a joystick or
other control element to position the laser during a mock the
procedure without cutting. Changes can be made before cutting
commences, so that errors can be corrected before beginning the
actual procedure.
[0143] Closed-loop and real-time automation are new capabilities
provided by robotic automation include resection volume
registration within the organ and in-situ depth and volume
measurement. With the ability to input organ geometry data into the
control system, e.g., from an ultrasound or other pre-operative or
real time image, the cutting region can be precisely registered
within the organ. This eliminates the imprecision of manual
procedures with respect to important tolerances, such as to how
close the resection is to the surface of the capsule and/or to the
neurovascular bundle in the prostate. Additionally, the shape of
the resected volume itself may be selectable and adjustable from a
set of preprogrammed routines, where the details of how to control
the cutting motion and pressure have been worked out in advance
with extensive engineering knowledge that is then stored in the
robotic surgical tool, ready for access at the push of a button by
the surgeon. For example, the resected shape of tissue may comprise
a pre-defined treatment profile such as one or more of domed,
cubic, tear-drop, or directly from a 3D rendering of the target
volume as described herein and illustrated below in the two
screenshots of FIGS. 21A and 21B, for example. In addition, the
surgeon can adjust the cutting parameters in real-time based on the
feedback provided by the ultrasound images, which adds another
layer of safety to the system.
INCORPORATION BY REFERENCE
[0144] The subject matter of FIGS. 1 to 11 and the corresponding
text have been incorporated by reference as described in: U.S.
patent application Ser. No. 12/700,568, filed Feb. 4, 2010, now
U.S. Pat. No. 9,232,959, issued Jan. 12, 2016; and International
Application PCT/US2011/023781, filed Apr. 8, 2007, published as WO
2011/097505 on Nov. 8, 2011; the full disclosures of which have
been previously incorporated herein by reference.
[0145] Referring to FIG. 1, an exemplary prostatic tissue debulking
device 10 constructed in accordance with the principles of the
present invention comprises a catheter assembly generally including
a shaft 12 having a distal end 14 and a proximal end 16. The shaft
12 will typically be a polymeric extrusion including one, two,
three, four, or more axial lumens extending from a hub 18 at the
proximal end 16 to locations near the distal end 14. The shaft 12
will generally have a length in the range from 15 cm to 25 cm and a
diameter in the range from 1 mm to 10 mm, usually from 2 mm to 6
mm. The shaft will have sufficient column strength so that it may
be introduced upwardly through the male urethra, as described in
more detail below.
[0146] The shaft will include an energy source positioned in the
energy delivery region 20, where the energy source can be any one
of a number of specific components as discussed in more detail
below. Distal to the energy delivery region, an inflatable
anchoring balloon 24 will be positioned at or very close to the
distal end 14 of the shaft. The balloon will be connected through
one of the axial lumens to a balloon inflation source 26 connected
through the hub 18. In addition to the energy source 22 and the
balloon inflation source 26, the hub will optionally further
include connections for an infusion/flushing source 28, an
aspiration (a vacuum) source 30, and/or an insufflation
(pressurized C02 or other gas) source 32. In the exemplary
embodiment, the infusion or flushing source 28 can be connected
through an axial lumen (not shown) to one or more delivery ports 34
proximal to the balloon anchor 24 and distal to the energy delivery
region 20. The aspiration source 30 can be connected to a second
port or opening 36, usually positioned proximally of the energy
delivery region 20, while the insufflation source 32 can be
connected to an additional port 38, also usually located proximal
of the energy delivery region. It will be appreciated that the
locations of the ports 34, 36, and 38 are not critical, although
certain positions may result in particular advantages described
herein, and that the lumens and delivery means could be provided by
additional catheters, tubes, and the like, for example including
coaxial sleeves, sheathes, and the like which could be positioned
over the shaft 12.
[0147] While the present embodiments are described with reference
to the human prostate, it is understood that they may be used to
treat mammal prostates in general. Referring now to FIGS. 2A-2D,
the prostatic tissue debulking device 10 is introduced through the
male urethra U to a region within the prostate P which is located
immediately distal to the bladder B. The anatomy is shown in FIG.
2A. Once the catheter 10 has been positioned so that the anchoring
balloon 24 is located just distal of the bladder neck BN (FIG. 2B)
the balloon can be inflated, preferably to occupy substantially the
entire interior of the bladder, as shown in FIG. 2C. Once the
anchoring balloon 24 is inflated, the position of the prostatic
tissue debulking device 10 will be fixed and stabilized within the
urethra U so that the energy delivery region 20 is positioned
within the prostate P. It will be appreciated that proper
positioning of the energy delivery region 20 depends only on the
inflation of the anchoring balloon 24 within the bladder. As the
prostate is located immediately proximal to the bladder neck BN, by
spacing the distal end of the energy delivery region very close to
the proximal end of the balloon, typically within the range from 0
mm to 5 mm, preferably from 1 mm to 3 mm, the delivery region can
be properly located. After the anchoring balloon 24 has been
inflated, energy can be delivered into the prostate for debulking,
as shown by the arrows in FIG. 2. Once the energy has been
delivered for a time and over a desired surface region, the energy
region can be stopped and the prostate will be debulked to relieve
pressure on the urethra, as shown in FIG. 2D. At that time, a
flushing fluid may be delivered through port 34 and aspirated into
port 36, as shown in FIG. 2D. Optionally, after the treatment, the
area could be cauterized using a cauterizing balloon and/or stent
which could be placed using a modified or separate catheter
device.
[0148] Referring now to FIGS. 3-7, a number of representative
energy delivery regions will be described. Referring now to FIG. 3,
a first exemplary prostate resection device 110 constructed in
accordance with the principles of the present invention comprises a
shaft 112 having a proximal end 114 and a distal end 116. A
plurality of nozzles 118 are mounted on the shaft 112 at a location
spaced proximally from the distal end 116 by distance in the range
from 1 cm to 5 cm. The nozzles, which are typically ceramic cores
capable of generating a plasma or ports capable of directing a
radially outward stream of electrically conductive fluid, may be
mounted on structure 120, which allows the nozzles 118 to be moved
radially outwardly, as shown in broken line in FIG. 3. An anchor
122, shown as an inflatable balloon is mounted on the distal end
116 of the shaft 112 at a location between the nozzles 118 and the
distal tip 124. The expandable structure 122 will be capable of
being expanded within the bladder to anchor the shaft 112 so that
the nozzle array 118 lies within the prostate, as described in more
detail below. The shaft 112 will include lumens, passages,
electrically conductive wires, and the like, in order to deliver
energy and materials from the proximal end 114 to the distal end
116 of the shaft. For example, an RF energy source 126 will be
connected to the shaft 112, usually to the nozzles 118, in order to
deliver RF energy to an electrically conductive fluid delivered
from source 128 to the nozzles 118, typically through a lumen
within the shaft 112. Other lumens, channels, or conduits will be
provided in order to allow aspiration to a vacuum source 130 which
is typically connected to one or more aspiration ports 132. Other
conduits may be provided within the shaft 112 in order to permit
introduction of a flushing fluid, such as saline, from a source 134
to ports 136. In other instances, it will be possible to connect
the aspiration and flushing sources 130 and 134 to a common port so
that aspiration and flushing may be conducted sequentially rather
than simultaneously. Further optionally, internal lumens, conduits,
or the like, may be provided in order to connect a source of
insufflation 140 to one or more insufflation ports 142 on the shaft
in the region of the array 118. Finally, internal lumens, conduits,
or the like, may be provided for connecting balloon 122 to a
balloon inflation source 144.
[0149] As shown in FIG. 4, an exemplary energy delivery region 20
can be formed by a high pressure nozzle 200 which is carried on a
delivery tube 380 which is disposed within the shaft 12. Carrier
tube 380 may be axially translated as shown by arrow 204 and/or
rotated as shown by arrow 206 so that the fluid stream 208
emanating from the nozzle 200 can be scanned or rastered over all
or a selected portion of the urethra within the prostate. Specific
pressures and other details for such high pressure water treatment
are described, for example, in Jian and Jiajun, supra.
[0150] Referring now to FIG. 5, the energy source within the energy
delivery region 20 may comprise a fiber-optic waveguide or fiber
bundle 220 carried on the rotating and translating shaft 380. The
optical waveguide 220 transmits laser or other coherent optical
energy in a beam 222 which may be scanned or rastered over the
urethral wall and prostatic tissue by rotating and/or translating
the carrier tube 380.
[0151] As shown in FIG. 6, laser energy from an optical waveguide
or fiber bundle 230 may be directed axially against a mirror 232,
where the waveguide and mirror are both carried on the rotating and
axially translating carrier tube 380. Again, by rotating and/or
translating the carrier tube 380, the emanating beam 234 can be
scanned or rastered over the urethral wall.
[0152] Referring now to FIG. 7, in yet another embodiment, the
rotating and axially translating tube 380 may carry an electrode
240 which projects laterally from the tube. The electrode 240 will
be adapted for connection to a radiofrequency energy source so
that, when the electrode contacts the urethral wall and prostatic
tissue, radiofrequency energy can be delivered, either in a
monopolar or bipolar mode. The radiofrequency energy can thus
ablate the tissue over selected volumes and regions of the
prostatic tissue. Optionally, by changing the nature of the
radiofrequency energy, the electrode 240 could also be used to
cauterize the tissue after it has been treated.
[0153] In one embodiment of the present invention, the device is
configured to selectively resect tissue, causing the removal of
some tissue compositions while leaving other tissue compositions
intact. For example, the prostate and nearby regions comprise a
variety of tissue compositions, including glandular prostate
tissue, intra-prostate vessels, fibromuscular stroma, capsular
tissue, sphincter muscles, seminal vesicles, etc. When treating BPH
or other prostate conditions, it is desirable to remove glandular
prostate tissue and leave other tissues, such as vessels and
capsular tissue, substantially undamaged.
[0154] As referred to herein, the term resection is meant to
include any removal of tissue, including removal of one or more
conglomerates of tissue cells, removal of fractions of tissue
cells, etc.
[0155] One advantage of treating BPH by selective tissue resection
is the reduced need (or no need) for cauterization, since there is
little or no damage to intra-prostate blood vessels and as a result
there is limited bleeding. Another advantage is a decreased chance
of incontinence or impotence, since selective resection decreases
the risk of perforating or otherwise damaging surrounding tissues,
such as the prostate capsule, sphincter muscles, seminal vesicles,
etc.
[0156] When using a fluid stream to resect tissue, selective tissue
resection may be accomplished by varying one or more parameters of
the fluid stream, such as the pressure within a nozzle or other
fluid delivery element, or the flow rate of the fluid in the
stream, so that it resects some tissue compositions while leaving
other tissue compositions substantially undamaged.
[0157] In one embodiment, the fluid stream parameters may be
configured to leave non-target tissues substantially undamaged even
when those tissues are exposed to the fluid stream for an extended
period of time, i.e., typically a period of time that is sufficient
to achieve the desired resection. In another embodiment, the fluid
stream parameters may be configured to resect the target tissue at
a substantially higher rate than the non-target tissue, thereby
limiting damage to non-target tissue. Such parameters may be
adjusted, depending on the target tissue that is to be selectively
resected.
[0158] In one embodiment, the rate of resection is configured to be
higher for glandular tissue than for non-glandular tissue. The rate
of resection may be configured by altering the pressure of the
fluid, or by adjusting other fluid parameters, as described above.
In particular, the rate of resection for glandular tissue may be
configured to be significantly higher than that for non-glandular
tissue, such that during the treatment period non-glandular tissue
remains effectively undamaged. For example, the rate of resection
of glandular tissue may be configured to be at least twice as high
as that for non-glandular tissue. As another example, the rate of
resection for glandular tissue may be configured to be at least 10
times as high as that for non-glandular tissue.
[0159] It is noted that tissue resection has a critical pressure
(which is a pressure below which tissue does not resect and above
which tissue can be resected) because the removal process involves
tearing of the tissue, wherein tissue is stretched on a micro scale
to the point where the tissue matrix ruptures or tears. Since
tissue is elastic, there will be a critical breaking point.
Different types of tissue will have different critical breaking
points, and hence different critical pressures associated with
them.
[0160] Indeed, given a particular fluid delivery element size (such
as nozzle diameter), each tissue type typically has a critical
pressure of the fluid stream source (hereinafter also referred to
as Pcrit) below which the rate of resection approaches zero, and
above which the rate of resection generally increases
monotonically, and possibly exponentially. Specifically, due to
differences in tissue composition, the pressure of the fluid stream
source may be configured to selectively resect a particular type of
tissue while leaving other tissue types with higher critical
pressures generally undamaged.
[0161] An important aspect of resecting tissue in a multi-tissue
environment according to the present embodiments is that it is
possible to operate in a regime where one tissue type is resected
and another tissue type remains substantially undamaged. This
happens most strongly when operating at a pressure between the
critical pressures of the two tissue types. As seen in FIG. 8, the
operating pressure p0 of the fluid stream may be configured to be
greater than the critical pressure of tissue 1 (/>,,>pcriti)
so that tissue 1 experiences a resection rate that is greater than
zero, while keeping the pressure p0 less than the critical pressure
of tissue 2 (p0<pcrit2) so that tissue 2 experiences a rate of
resection that is substantially near zero. In such a configuration,
the fluid stream is said to be configured to selectively resect
tissue 1 but not tissue 2.
[0162] In one embodiment configured to treat BPH, the fluid stream
source pressure is configured to be above the critical pressure of
glandular prostate tissue but below the critical pressure of
non-glandular prostate tissue. In such an embodiment, the pressure
is sufficiently high to resect glandular tissue, but too low to
substantially resect or damage non-glandular tissue such as
intra-prostate blood vessels, fibromuscular stroma, capsular
tissue, etc. In one embodiment, the fluid is pressurized to a
pressure within the range of about 1-30,000 psi before leaving the
fluid delivery element, more preferably to a pressure within the
range of about 50-1,500 psi, and most preferably to a pressure
within the range of about 100-1,000 psi.
[0163] The following example illustrates some tissue critical
pressures for fluid stream resection. It is noted that the
following configurations are provided as an example and should not
be construed as limiting.
[0164] EXAMPLE 1: Exemplary critical pressures of different kidney
tissue compositions. Tissue critical pressures were measured in pig
kidneys. Kidney tissue was chosen because its composition is
similar to that of the prostate tissue. A columnar fluid stream of
approximately 200 microns in diameter was used for tissue
resection. The glandular tissue (the pink outer portion of the
kidney) is very soft, and easily tears with finger pressure, while
the inside of the kidney comprises tougher vascular tissue. The
critical pressure for the glandular tissue with this fluid stream
was found to be about 80 psi, and about 500 psi for the vascular
tissue, as seen in Table 1 below.
TABLE-US-00001 TABLE 1 of Different critical pressures of glandular
and vascular tissues in pig kidney. Tissue P .sub.crit (psi)
Glandular 80 Vascular 500
[0165] For example, experiments show that when resecting pig kidney
using a nozzle of approximately 200 microns in diameter with liquid
source pressure of about 500 psi, the rate of resection over a 10
cm area is about 1 cm per 30 sec for glandular tissue (i.e.,
removal of 10 cc per 30 sec), and less than about 0.1 cm per 180
sec for vascular tissue, which is about a sixty-fold difference in
resection rates. Thus, within the same resection time period, more
glandular tissue will be resected than vascular tissue. Thereby,
the resection time period can be configured to allow resection of
glandular tissue without substantial damage to vascular tissue. The
rate of resection may be adjusted by varying the fluid source
pressure and/or the size of the nozzle. For example, the rate of
resection for glandular tissue may be adjusted to about 1 cc per
min, 5 cc per min, 10 cc per min, 30 cc per min, or other rates. As
noted above, it is understood herein that varying the size of the
nozzle may necessitate varying the fluid source pressure in order
to cause the fluid stream to impinge with sufficient force upon
tissue to achieve desired resection rates.
[0166] FIG. 9a is a flow diagram illustrating a method for
selective prostate resection, according to one embodiment. At step
700, the device is positioned and anchored in the urethra, as
described above. At step 701, various fluid parameters such as the
pressure of the fluid source, shape of the fluid stream, etc., are
configured to resect a specific tissue type, such as glandular
prostate tissue. By configuring the fluid parameters one can
control fluid force, rate of resection, treatment time, area of
tissue to be resected, etc., in order to achieve controlled and
selective resection. After the parameters are configured, at step
702, the device is configured to discharge a fluid stream to resect
the target tissue. At step 703, if it is determined that the
treatment is complete, the device is withdrawn from the urethra U
at step 704.
[0167] However, if at step 703 it is determined that the treatment
is not yet complete, then the fluid parameters may be re-configured
as needed, as described in step 701, and the cycle of steps repeats
until treatment is complete. In particular, re-configuration of the
fluid parameters is advantageous in an embodiment where it is
desired to resect two different types of tissues for a complete
treatment. In such an embodiment, the fluid parameters may be
adjusted to take into account the change in the type of target
tissue that is to be resected.
[0168] Typically, after some or all of the glandular tissue has
been resected, other tissue types such as vascular or capsular
tissue will be exposed to the fluid stream. While the fluid stream
parameters are configured to selectively resect glandular tissue,
it is also contemplated that the fluid parameters may be
dynamically adjusted during the resection procedure to take into
account the gradual exposure of non-glandular tissue and to
fine-tune the resection selectivity as needed. After the fluid
parameters are thusly re-configured at step 701, then at step 702
the re-configured fluid stream is emitted to continue tissue
resection, and the operation continues until the treatment is
complete.
[0169] Specifically, it is noted that when treating the prostate
from within the urethra, the urethral wall is interposed between
the source of the fluid stream (such as a nozzle or other fluid
delivery element) and the target glandular prostate tissue that is
to be resected.
[0170] Therefore, in one embodiment, the fluid stream parameters
are initially configured to resect and penetrate a portion of
urethral tissue (e.g., the urethral wall). However, since the
composition of glandular prostate tissue is weaker than that of the
urethral tissue, it is desirable to avoid resecting glandular
tissue with the same fluid stream force as that used to resect the
urethral wall. To accomplish this, the fluid stream may be used for
a period of time that is sufficient to resect and penetrate the
urethral wall, and not longer. Thereafter, a fluid stream of
reduced strength may be used to resect glandular prostate
tissue.
[0171] FIG. 9b is a flow diagram illustrating a method for
selective prostate resection, wherein the fluid stream is
configured to first penetrate and resect the urethral wall,
according to one embodiment. At step 801, the device is positioned
and anchored in the urethra, as described above. At step 802, the
device is configured to discharge a fluid stream of sufficient
force to resect and penetrate the urethral wall. At step 803, after
the fluid stream has penetrated the urethral wall, the fluid stream
is adjusted to a level that selectively resects the desired
prostate tissue while leaving intra-pro state blood vessels,
capsules, and other non-glandular tissue substantially
undamaged.
[0172] In addition, it is contemplated that the shape of the fluid
stream also affects selective resection. While the fluid stream is
exemplarily shown in FIG. 10a as a columnar fluid stream 333 or
diverging fluid stream 334, it is contemplated that the fluid
stream may be of any shape or configuration that allows resection
according to the present embodiments. In particular, there are
numerous advantages to both the columnar fluid stream configuration
and the diverging fluid stream configuration, as will be described
further below.
[0173] In a columnar fluid stream configuration 333, the device
emits the fluid stream as a substantially focused rod-like fluid
column that has a substantially zero divergence angle. In one
embodiment, the columnar fluid stream is configured as a generally
straight or non-diverging fluid stream. In such configuration, the
device emits the fluid stream substantially as a cylinder or other
non-diverging shape, thereby transmitting energy to the tissue over
an area or spot size that is largely independent of the tissue
distance from the fluid delivery element. Optionally, the fluid
stream may be adjusted to converge, for example if the fluid
delivery element comprises multiple nozzles or if the fluid
contains bubbles, in order to focus the energy delivered to
tissue.
[0174] FIG. 10b shows a cross-sectional view of the device emitting
a columnar fluid stream to modify a tissue such as the prostate. An
elongate element 310 (such as a shaft, as described above) of the
device is disposed within the urethra U. A fluid delivery element
320 disposed on the carrier tube (not shown) within the elongate
element 310 is configured to emit a columnar fluid stream 333. As
understood herein, the fluid delivery element 320 may comprise a
nozzle, as described above, or any other element configured to emit
fluid. The columnar fluid stream 333 is configured to resect
tissue, such as the urethral wall UW and the prostate tissue P,
within a resection area RA.
[0175] One characteristic of the columnar fluid stream
configuration is that the resection area RA remains substantially
constant for some distance from the fluid delivery element 320,
since the width of the resection area RA is substantially
independent of the fluid distance from the fluid delivery element
320. This is advantageous because the resection area RA remains
focused and constant as the fluid stream 333 travels away from the
fluid delivery element 320, thereby transmitting energy to the
tissue at a focal area. The concentration of energy within a
focused resection area RA is particularly advantageous when
resecting or penetrating tough tissue, such as the urethral wall
UW. In one embodiment, the columnarity of the fluid stream may be
varied by introducing pressure fluctuations in the fluid delivery.
For example, the columnarity of the fluid stream may be varied by
mechanically and controllably introducing a generally solid object
in the fluid delivery path, such as behind an aperture of the fluid
delivery element 320 or in the path of the fluid stream after it
exits an aperture of the fluid delivery element 320. In another
example, the columnarity of the fluid stream may be varied by
introducing a vibrating element in the fluid pathway, such as a
piezoelectric element or the like, to create pressure
fluctuations.
[0176] In another embodiment, the fluid stream is configured as a
diverging fluid stream 334, as seen in FIG. 10a. A diverging fluid
stream 334 is one in which the fluid exits a fluid stream source,
such as the fluid delivery element 320, and diverges substantially
in a cone, wherein the tip of the cone is at the fluid stream
source. The rate of resection of a diverging fluid stream 334 can
be represented as a function of the distance z from the fluid
emitting fluid delivery element 320 to the tissue that is to be
resected. As shown in FIG. 10a, z{circumflex over ( )} is further
away from the orifice than z/, and accordingly the rate of
resection at z{circumflex over ( )} is higher than the rate of
resection at z{circumflex over ( )}.
[0177] The diverging fluid stream 334 may be characterized by the
angle of divergence of the fluid stream. In one embodiment, the
angle of divergence is configured to be about 0-90 degrees, more
preferably about 2-45 degrees, more preferably about 4-20 degrees,
and most preferably about 7 degrees, while it is also contemplated
that the angle of divergence may be varied as needed.
[0178] Additionally, the diverging fluid stream 334 may be
characterized by the cross-sectional shape of the fluid stream.
Generally, the diverging fluid stream 334 has a cross-sectional
area, or spot-size, that increases at distances further from the
fluid stream source (e.g., fluid delivery element 320), thereby
proportionally reducing the force of the fluid stream per unit
area. This increase of spot-size generally results in greater
resection rates of tissue closer to the fluid stream source.
[0179] In one embodiment, the cross-sectional shape of the
diverging fluid stream 334 is configured as a generally narrow
rectangle (for a fan-shaped fluid stream). In another embodiment,
the cross-sectional shape of the diverging fluid stream 334 is
configured as generally a circle (for a conical-shaped fluid
stream), wherein the smallest cross-sectional area is at the fluid
stream source. It is noted that the cross-sectional shape of the
diverging fluid stream 334 may be configured as any shape that
encloses a non-zero area (e.g., an ellipse, or an irregular
shape).
[0180] FIG. 10c shows a cross-sectional view of the device emitting
a diverging fluid stream to modify tissue such as the prostate. An
elongate element 310 of the device is disposed within the urethra
U. A fluid delivery element 320 disposed on the carrier tube (not
shown) within the elongate element 310 is configured to emit a
diverging fluid stream 334. The diverging fluid stream 334 is
configured to resect tissue such as the urethral wall UW and the
prostate tissue P within a resection area RA. The resection area RA
covered by the diverging fluid stream 334 increases as the fluid
stream travels away from the fluid delivery element 320, thereby
proportionally reducing the strength of the fluid stream per unit
area.
[0181] A characteristic of the diverging fluid stream 334 is that
the resection width increases as a function of distance from the
fluid delivery element 320, while the rate of resection per unit
area decreases as a function of distance from the fluid delivery
element 320. This is because the total energy delivered in the
fluid stream is generally constant (not taking into account any
decrease in fluid speed), yet the energy is delivered over a larger
area. Thus, the energy delivered per area decreases, which is a key
parameter upon which the rate of resection depends. Therefore, the
rate of resection per unit area decreases as a function of
distance.
[0182] Furthermore, in a diverging fluid stream 334 the volumetric
rate of resection may be substantially constant as a function of
distance. That is, while the rate of resection per unit area
decreases, the total area resected increases proportionately, and
hence the total resected volume remains substantially constant. It
is noted that if the areal rate of resection as a function of areal
energy density is non-linear and monotonically increasing with
energy, then the volumetric rate of resection will decrease as
function of distance from the fluid delivery element 320. It is
further noted that any slowing of the fluid stream particles (for
example, liquid droplets) will also decrease the volumetric
resection rate as a function of distance.
[0183] Referring now to FIG. 11, the device comprises an elongate
element 310, such as a shaft, configured to be inserted into a body
region. The elongate element 310 comprises a window exposing a
carrier tube 380 and other components described below. The window
reveals a carrier tube 380 and a high pressure fluid delivery
element 320 disposed on the carrier tube 380. The fluid delivery
element 320 is connected to a fluid source (not shown) via a fluid
lumen 390 which delivers fluid from the source to the fluid
delivery element 320.
[0184] Optionally, when the elongate element 310 is introduced
through the urethra, the elongate element 310 may be covered by a
sheath or other cover (not shown). When fully covered with the
sheath, the window is protected so that it reduces scraping and
injury to the urethra as the elongate element 310 is advanced. Once
in place, the sheath is retracted, exposing the window. The carrier
tube 380 may then be rotated and advanced and/or retracted so that
the fluid is delivered through the fluid delivery element 320.
[0185] Additionally and optionally, the device may comprise a
shield element (not shown) that is positioned to substantially
cover the fluid delivery element 320 while maintaining a space
between the fluid delivery element 320 and the shield element. This
in return effectively maintains that space between the fluid
delivery element 320 and any tissue that might impinge on the
shield element. In one embodiment, the shield element is a
substantially flat sheet-like element positioned over the fluid
delivery element 320. The shield element is positioned or shaped
such that it allows the carrier tube 380 to move within the
elongate element 310 as needed. For example, the shield element may
be curved to follow a curvature of the carrier tube 380. The shield
element comprises an opening to allow the fluid stream emitted by
the fluid delivery element 320 to travel unobstructed through the
opening and impinge on the tissue. The opening may be circular, or
it may comprise other shapes. One advantage of such a shield
element is that it protects the fluid delivery element 320 from
being damaged during insertion or removal procedures and/or during
treatment. Another advantage of the shield element is that, during
or after fluid emission, fluids that are returning back towards the
fluid delivery element 320 may travel through the shield element
opening (or through other paths around the shield element) and into
the space between the shield element and the fluid delivery element
320. Such returned fluids may then be channeled out of that space
such that fluid emission is not obstructed or hindered by such
returned fluids.
[0186] The shield element may further be configured such that the
space between the shield element and the fluid delivery element 320
is in continuous communication with a waste disposal lumen via a
low-flow-resistance fluid path. This creates a low-flow-resistance
path between the fluid delivery element 320 and an external
destination of such waste, such that waste and fluids leaving the
fluid delivery element 320 may easily leave the region surrounding
the fluid delivery element 320. Low resistance in this case is
understood to mean a flow resistance that is lower in comparison
with a flow resistance of the fluid delivery element 320. This
configuration advantageously prevents back-pressure at the fluid
delivery element 320, which would otherwise reduce flow, and
thereby allows the fluid stream emitted by the fluid delivery
element 320 to travel substantially undisturbed by waste and return
fluids.
[0187] The fluid delivery element 320 may be a single nozzle, a
plurality of nozzles, or an array of nozzles of various
configurations. The fluid delivery element 320 is configured to
emit a fluid radially outwardly as a fluid stream 331, with
sufficient force so that upon contact with the tissue the fluid
stream 331 resects the tissue. The fluid stream 331 may be
perpendicular to the elongate element 310, or it may be configured
to be at various angles relative to the elongate element 310.
[0188] The carrier tube 380 may be axially translated, rotated,
oscillated, or rotationally oscillated relative to the elongate
element 310 so that the fluid stream 331 can be scanned or rastered
to resect a desired area or volume of the tissue. The desired area
or volume may be spherical, cylindrical, or any other predetermined
area or volume of arbitrary shape and dimension.
[0189] Additionally and optionally, when the device is not being
used to resect tissue, the carrier tube 380 may be positioned so
that the fluid delivery element 320 and/or any other elements (such
as visualization or cauterization elements) are positioned away
from the window, thereby reducing the risk of damage to such
elements, as well as reducing any risk of unintentional resection
of the tissue.
[0190] The device further comprises at least one insufflation port
340 disposed on the elongate element 310. The insufflation port 340
is connected via one or more lumens to an insufflation source (not
shown), wherein the insufflation source delivers a fluid 330 into
the body region through the insufflation port 340 in order to
expand the surrounding tissue and create a working space. The
device further comprises at least one removal port 360 for the
removal of debris products, such as resection products, resection
fluid, other waste products, or a mixture thereof. The elongate
element 310 may include lumens, passages, electrically conductive
wires, and the like, configured to deliver energy and/or materials
from the proximal end to the distal end of the elongate element 310
and/or to remove debris and waste products, details of which are
described above.
[0191] Optionally, in addition to the fluid delivery element 320,
the device may comprise an electromagnetic energy delivery port 350
disposed on the carrier tube 380 and positioned near or within the
fluid delivery element 320. Electromagnetic energy 332 is delivered
to the energy delivery port 350 by means of one or more conduits
351, such as optical fibers or other waveguides within the carrier
tube 380 and the elongate element 310, as also described in greater
detail above. The electromagnetic energy 332 may be radiofrequency
energy, coherent or non-coherent light, or any other modality of
electromagnetic energy. The energy delivery port 350 is configured
to deliver the energy 332 through the interior of the fluid stream
331 so that the electromagnetic energy 332 may resect the tissue in
lieu of, or in combination with, the fluid resection.
[0192] Additionally and optionally, the various electromagnetic
energy modalities described above may be configured to cauterize
the tissue, in combination with tissue resection, or independently
thereof. Since selective tissue resection as disclosed herein
generally causes little or no damage to remaining tissue such as
vascular tissue and therefore causes limited or no bleeding, such
cauterization need only be used on a limited basis, if at all. It
is contemplated that when electromagnetic energy is delivered to
the tissue by the fluid stream 331 for cauterization, the fluid
source pressure may be adjusted to be generally below the critical
pressure for tissue resection such that no additional tissue is
resected.
[0193] Alternatively or additionally, cauterization may be achieved
using other means, for example using a cauterizing balloon and/or
stent placed in contact with tissue using a catheter device, as
described above.
[0194] Furthermore, the device may comprise optional deflective
elements, for example positioned within the interior or the
elongate element 310 and away from the window, configured to
deflect fluid, emitted by the fluid delivery element 320, back
towards the fluid delivery element 320, thereby removing any debris
that may have accumulated on the fluid delivery element 320 and/or
energy delivery port 350 during tissue resection. Furthermore, the
fluid delivery element 320 in combination with the deflective
elements may be configured to clean a part of, or substantially the
entirety of, the fluid delivery element 320, any visualization or
cauterization elements, and/or carrier tube 380. The deflective
element may be configured to be substantially flat or concave.
Alternatively the deflective element may be configured as any shape
or design.
[0195] Additionally, the deflective element may act be configured
as a protective element for the fluid delivery element. The fluid
delivery element may be positioned at a specific location relative
to the protective element that protects the prostate from
unexpected fluid emissions and protects the fluid delivery element
320 from, for example, clogging or obstruction by tissue,
especially during insertion and removal from the body.
[0196] The carrier tube 380 comprises a carrier. The carrier may
optionally comprise a tubular structure. Although reference is made
to a carrier tube 380 in accordance with embodiments, the carrier
may comprise a substantially non-tubular cross-section, for example
a rectangular cross section, extending along a substantial portion
of the carrier as described herein. Therefore, it is to be
understood that although the carrier tube shown and described in
the drawings, the carrier may comprise a non-circular carrier in
each of the drawings and supporting text as described herein.
[0197] FIG. 12 shows a component of treatment probe 350 in
accordance with embodiments. A carrier tube 380 comprises a
concentric configuration of a first fluid delivery port and a
second fluid delivery port. Fluid delivery element 320 releases
fluid stream 331. Fluid stream 331 defines an axis extending from
the fluid delivery element 320 outward. The fluid stream 331 may
comprise a diverging stream 334 or a columnar stream 333 as
described herein. Fluid delivery element 320 comprises a nozzle
322. Nozzle 322 may comprise a substantially circular cross
section. The nozzle 322 may comprise an internal channel having the
circular cross section in which the internal channel extends
cylindrically. The internal channel extends along an axis
corresponding to the axis of the fluid stream 331.
[0198] Concentrically disposed around the fluid delivery element
320 is a port 340. The port 340 comprises a substantially annular
channel extending circumferentially around fluid delivery element
320 and nozzle 322. Port 340 may comprise an insufflation port as
described herein. Port 340 releases fluid 330 in a substantially
concentric arrangement with fluid stream 331. The substantially
concentric arrangement has the advantage of providing a protective
jacket around fluid stream 331 with first fluid 330 extending
outward from port 340 so as to beneficially direct the treatment
stream toward the tissue. Energy conduit 351 extends from a source
of energy such as a laser toward fluid delivery element 320. The
energy conduit may comprise an optical fiber or a plurality of
optical fibers coupled to a laser, for example. The optical fiber
can extend toward nozzle 322 and can be concentrically aligned with
the axis defined by nozzle 322 so as to provide efficient energy
transmission of the light energy emitted from the optical fiber
through the nozzle 322. A structure can be provided near the distal
end of the optical fiber in order to align the optical fiber with
the channel of nozzle 322. The concentric alignment of the optical
fiber, the nozzle and the port 340 can provide therapeutic
treatment of the patient that allows visualization and treatment of
the patient. The fluid release from port 340 may comprise a liquid,
for example saline, or a gas, for example CO2. The fluid delivered
through port 340 can be user selectable with the interface as
described herein.
[0199] The fluid stream 331 can provide an optical wave guide
directed toward the tissue. In many embodiments the fluid stream
331 comprises an index of refraction greater than the fluid
released through port 340. The wave guide media can be a liquid or
gas and the jacketing media released from port 340 can be a liquid
or gas. An intermediate media can be located between the probe and
the target tissue. The intermediate media can be a liquid or gas,
for example, one or more of saline, air or carbon dioxide. In many
embodiments the intermediate media comprises a fluid release from
nozzle 322 and a fluid release from annular port 340.
[0200] FIGS. 13A and 13B show a system that treat a patient in
accordance with embodiments. The system 400 comprises a treatment
probe 450 and may optionally comprise an imaging probe 460. The
treatment probe 450 is coupled to a console 420 and a linkage 430.
The imaging probe 460 is coupled to an imaging console 490. The
patient treatment probe 450 and the imaging probe 460 can be
coupled to a common base 440. The patient is supported with the
patient support 449. The treatment probe 450 is coupled to the base
440 with an arm 442. The imaging probe 460 is coupled to the base
440 with an arm 444.
[0201] The patient is placed on the patient support 449, such that
the treatment probe 450 and ultrasound probe 460 can be inserted
into the patient. The patient can be placed in one or more of many
positions such as prone, supine, upright, or inclined, for example.
In many embodiments, the patient is placed in a lithotomy position,
and stirrups may be used, for example. In many embodiments, the
treatment probe 450 is inserted into the patient in a first
direction on a first side of the patient, and the imaging probe is
inserted into to the patient in a second direction on a second side
of the patient. For example, the treatment probe can be inserted
from an anterior side of the patient into a urethra of the patient,
and the imaging probe can be inserted trans-rectally from a
posterior side of the patient into the intestine of the patient.
The treatment probe and imaging probe can be placed in the patient
with one or more of urethral tissue, urethral wall tissue, prostate
tissue, intestinal tissue, or intestinal wall tissue extending
therebetween.
[0202] The treatment probe 450 and the imaging probe 460 can be
inserted into the patient in one or more of many ways. During
insertion, each arm may comprise a substantially unlocked
configuration such the probe can be desirably rotated and
translated in order to insert the probe into to the patient. When a
probe has been inserted to a desired location, the arm can be
locked. In the locked configuration, the probes can be oriented in
relation to each other in one or more of many ways, such as
parallel, skew, horizontal, oblique, or non-parallel, for example.
It can be helpful to determine the orientation of the probes with
angle sensors as described herein, in order to map the image date
of the imaging probe to treatment probe coordinate references.
Having the tissue image data mapped to treatment probe coordinate
reference space can allow accurate targeting and treatment of
tissue identified for treatment by an operator such as the
physician.
[0203] In many embodiments, the treatment probe 450 is coupled to
the imaging probe 460. In order to align the treatment with probe
450 based on images from imaging probe 460. The coupling can be
achieved with the common base 440 as shown. Alternatively or in
combination, the treatment probe and/or the imaging probe may
comprise magnets to hold the probes in alignment through tissue of
the patient. In many embodiments, the arm 442 is a movable and
lockable arm such that the treatment probe 450 can be positioned in
a desired location in a patient. When the probe 450 has been
positioned in the desired location of the patient, the arm 442 can
be locked with an arm lock 427. The imaging probe can be coupled to
base 440 with arm 444, can be used to adjust the alignment of the
probe when the treatment probe is locked in position. The arm 444
may comprise a lockable and movable probe under control of the
imaging system or of the console and of the user interface, for
example. The movable arm 444 may be micro-actuable so that the
imaging probe 440 can be adjusted with small movements, for example
a millimeter or so in relation to the treatment probe 450.
[0204] In many embodiments the treatment probe 450 and the imaging
probe 460 are coupled to angle sensors so that the treatment can be
controlled based on the alignment of the imaging probe 460 and the
treatment probe 450. An angle sensor 495 is coupled to the imaging
probe 450 with a support 438. An angle sensor 497 is coupled to the
imaging probe 460. The angle sensors may comprise one or more of
many types of angle sensors. For example, the angle sensors may
comprise goniometers, accelerometers and combinations thereof. In
many embodiments, angle sensor 495 comprises a 3-dimensional
accelerometer to determine an orientation of the treatment probe
450 in three dimensions. In many embodiments, the angle sensor 497
comprises a 3-dimensional accelerometer to determine an orientation
of the imaging probe 460 in three dimensions. Alternatively or in
combination, the angle sensor 495 may comprise a goniometer to
determine an angle of treatment probe 450 along an elongate axis of
the treatment probe. Angle sensor 497 may comprise a goniometer to
determine an angle of the imaging probe 460 along an elongate axis
of the imaging probe 460. The angle sensor 495 is coupled to a
controller 424. The angle sensor 497 of the imaging probe is
coupled to a processor 492 of the imaging system 490.
Alternatively, the angle sensor 497 can be coupled to the
controller 424 and also in combination.
[0205] The console 420 comprises a display 425 coupled to a
processor system in components that are used to control treatment
probe 450. The console 420 comprises a processor 423 having a
memory 421. Communication circuitry 422 is coupled to processor 423
and controller 422. Communication circuitry 422 is coupled to the
imaging system 490. The console 420 comprises components of an
endoscope 35 is coupled to anchor 24. Infusion flashing control 28
is coupled to probe 450 to control infusion and flushing.
Aspiration control 30 is coupled to probe 450 to control
aspiration. Endoscope 426 can be components of console 420 and an
endoscope insertable with probe 450 to treat the patient. Arm lock
427 of console 420 is coupled to arm 422 to lock the arm 422 or to
allow the arm 422 to be freely movable to insert probe 450 into the
patient.
[0206] The console 420 may comprise a pump 419 coupled to the
carrier and nozzle as described herein.
[0207] The processor, controller and control electronics and
circuitry can include one or more of many suitable components, such
as one or more processor, one or more field-programmable gate array
(FPGA), and one or more memory storage devices. In many
embodiments, the control electronics controls the control panel of
the graphic user interface (hereinafter "GUI") to provide for
pre-procedure planning according to user specified treatment
parameters as well as to provide user control over the surgery
procedure.
[0208] The treatment probe 450 comprises an anchor 24. The anchor
24 anchors the distal end of the probe 450 while energy is
delivered to energy delivery region 20 with the probe 450. The
probe 450 may comprise a nozzle 200 as described herein. The probe
450 is coupled to the arm 422 with a linkage 430.
[0209] The linkage 430 comprises components to move energy delivery
region 20 to a desired target location of the patient, for example,
based on images of the patient. The linkage 430 comprises a first
portion 432 and a second portion 434 and a third portion 436. The
first portion 432 comprises a substantially fixed anchoring
portion. The substantially fixed anchoring portion 432 is fixed to
support 438. Support 438 may comprise a reference frame of linkage
430. Support 438 may comprise a rigid chassis or frame or housing
to rigidly and stiffly couple arm 442 to treatment probe 450. The
first portion 432 remains substantially fixed, while the second
portion 434 and third portion 436 move to direct energy from the
probe 450 to the patient. The first portion 432 is fixed to the
substantially constant distance 438 to the anchor 434. The
substantially fixed distance 438 between the anchor 24 and the
fixed first portion 432 of the linkage allows the treatment to be
accurately placed. The first portion 434 may comprise the linear
actuator to accurately position the high pressure nozzle in
treatment region 20 at a desired axial position along an elongate
axis of probe 450.
[0210] The elongate axis of probe 450 generally extends between a
proximal portion of probe 450 near linkage 430 to a distal end
having anchor 24 attached thereto. The third portion 436 controls a
rotation angle around the elongate axis. During treatment of the
patient, a distance 439 between the treatment region 20 and the
fixed portion of the linkage varies with a reference distance 439.
The distance 439 adjusts in response to computer control to set a
target location along the elongate axis of the treatment probe
referenced to anchor 24. The first portion of the linkage remains
fixed, while the second portion 434 adjust the position of the
treatment region along the axis. The third portion of the linkage
436 adjusts the angle around the axis in response to controller 424
such that the distance along the axis at an angle of the treatment
can be controlled very accurately with reference to anchor 24. The
probe 450 may comprise a stiff member such as a spine extending
between support 438 and anchor 24 such that the distance from
linkage 430 to anchor 24 remains substantially constant during the
treatment. The treatment probe 450 is coupled to treatment
components as described herein to allow treatment with one or more
forms of energy such as mechanical energy from a jet, electrical
energy from electrodes or optical energy from a light source such
as a laser source. The light source may comprise infrared, visible
light or ultraviolet light. The energy delivery region 20 can be
moved under control of linkage 430 such as to deliver an intended
form of energy to a target tissue of the patient.
[0211] The imaging system 490, a memory 493, communication
circuitry 494 and processor 492. The processor 492 in corresponding
circuitry is coupled to the imaging probe 460. An arm controller
491 is coupled to arm 444 to precisely position imaging probe
460.
[0212] FIG. 14A shows a multipurpose sheath and manifold in
accordance with embodiments. A manifold 468 is configured to
transmit a plurality of fluids to and from the working site.
Manifold 468 is rigidly coupled, for example affixed, to the spine
452. A sheath 458 is located around spine 452 and can extend inward
toward the manifold 468. The manifold 468 is coupled with a locking
element 460 to support 438 in linkage 430. Manifold 468 can be
decoupled from the linkage 430 and the support 438 so as to remove
the linkage 430 and support 438 to permit additional components to
be inserted into the working channel. For example, an endoscope can
be inserted into the working channel to extend toward the working
area of the organ, for example, the prostate. A structure 462
comprising a nose portion extends toward manifold 468. Structure
462 is shaped to engage manifold 468 and allow removal of structure
462, linkage 430 and support 438 when locking element 460 is
disengaged. Manifold 468 comprises a structure 464 to engage in
nose portion of structure 462. A plurality of seals are arranged on
manifold 468 to allow removal of structure 462. When structure 462
has been removed an endoscope or other surgical tool can be
inserted into the working space and advance toward the treatment
site. For example an endoscope can be advanced toward the treatment
site to be the treatment area. The manifold comprises a plurality
of ports that are coupled to the treatment site to allow fluid to
be transmitted and removed from the treatment site. For example
when an endoscope has been placed at the treatment site. The
locking element and manifold allow for removal of the linkage and
treatment probes such that the manifold 468 remains coupled to
sheath 458 and spine 452 within the patient.
[0213] In many embodiments treatment probes and carriers as
described herein, for example tubular carriers, can be inserted and
removed while the locking element 460 engages the linkage 430 and
support 438. This configuration of the linkage, locking element and
support allow probes to be rapidly and easily removed and
reinserted to provide beneficial treatments.
[0214] The multipurpose sheath and manifold as described herein has
the benefit of allowing the sheath, manifold, spine and anchor to
remain attached to the patient while additional surgical tools are
employed. The locking element interfaces with multiple instruments
allowing for placement, visualization, and Aquablation.TM. and
aquabeam operations, without reintroduction or movement with
respect to the tissue. Multiple sealed conduits allow for sheath
ports to be used to transmit flow or pressure of varying fluids
within or parallel to the working channel. The working channel may
be used for visualization access to anatomy via existing rigid or
flexible endoscope technology. The working channel has a large bore
to accommodate many types of tools and allow for free flow of
tissue and fluids. Alternate energy delivery devices may be used
within the sheath or working channel as described herein.
[0215] In many embodiments the working channel is sized to allow a
plurality of carriers within the working channel. For example, an
endoscope carrier within the working channel and a treatment probe
carrier as described herein within the working channel so as to
allow visualization of the treatment site while the treatment probe
performs Aquablation.TM. and aqua beam operations as described
herein.
[0216] FIG. 14B shows manifold conduits of the manifold configured
for transmitting and receiving multiple fluids while the manifold
remains coupled to the patient. The manifold is coupled to a
plurality of ports 456. The plurality of ports 456 may comprise an
auxiliary fluid port 456A, a balloon pressure port 456B and a
tissue removal port 456C. A sheath 458 extends circumferentially
around spine 452. The spine 452 and sheath 458 can be rigidly
coupled to the manifold portion and provide connections and
channels coupled to the manifold portion. A channel 467, for
example a tubular channel, is connected to port 456B to allow for
inflation of the balloon. A channel 469 can be defined with sheath
458. Channel 469 can be coupled to port 456A to provide an
auxiliary fluid to the treatment site. Port 456C to allow removal
of tissue can be coupled to the main working channel 465. The main
working channel 465 can extend from port 456C to the treatment
site. A plurality of seals 466 are arranged to separate the
treatment ports and channels as described herein. The manifold 468
can be decoupled from the linkage 430 and support 438 and allow
balloon inflation pressure to be applied through port 456B. An
auxiliary fluid can be provided through port 456A, for example, so
as to flush the working channel 465. This configuration of the
manifold allows the spine 452 and anchor 24 to remain in place when
other instruments have been inserted into the working channel.
[0217] The plurality of manifold conduits as described herein allow
tissue collection to be routed through the large bore working
channel 469 to reduce flow obstructions. Balloon pressure can be
transmitted from a lure fitting to the distal tip of the anchor
with small diameter tubing, for example, tubing defining channel
467. An auxiliary fluid is transmitted between the sheath and spine
to the treatment area with channel 469.
[0218] FIG. 14C shows components of treatment probe and linkage
disassembled prior to use. The linkage 430 comprises a casing 410
and a cover 412. The cover 412 can be placed on the lower portion
of the casing 410. The cover and casing may comprise rigid
materials to add stiffness. The casing and cover can be sized so as
to comprise a handpiece containing the linkage 430. The linkage 430
comprises an elongate tubular structure comprising a gear 433 to
engage another gear 434 of the linkage. The gear 434 can be
positioned on a movable carriage 413. The elongate tubular
structure may comprise second movable portion 436 of the linkage.
The casing 410 may comprise the support 438 of the linkage. The
gear 433 remains connected to the elongate tubular structure 431
when the linkage is disassembled. The movables portion of the
linkage 430 may comprise gear 433, gear 434 and movable carriage
413 so as to advance the elongate structure 431 distally when
connected to the second movable portion 436 as shown with arrows
418. The cover 412 comprises flanges 416. When the cover is placed
on the casing, the elongate structure can be locked into position
431 on the linkage.
[0219] The elongate element 310 comprises a spine 452 as described
herein and is shown covered with a sheath 458. The sheath 458
comprises a channel to receive the elongate element 310. The
elongate element 310 comprises the working channel and can inserted
into the sheath 458 such that the elongate element is covered with
sheath 458. The sheath 458 and elongate element 310 are shown
connected to manifold 468 as described herein.
[0220] The sheath 458 can be inserted into the patient prior to
insertion of elongate element 310. In many embodiments, sheath 458
is coupled to manifold 468 when inserted into the patient.
[0221] The elongate element 310 is configured to slide into the
sheath 458 such that the elongate element 310 and sheath comprise a
locked configuration. The elongate element 310 comprises structure
411 configured to engage the housing 410 of the linkage, such that
the elongate element 310 and housing 410 remain substantially fixed
when the elongate structure 431 moves as described herein.
[0222] In many embodiments, casing 410 comprises support 438. The
support 438 may comprise a substantially non-moving portion of the
linkage 430 as described herein. The linkage 430 may comprise
moving carriage 433 to move the carrier 382 when the casing 410
comprising support 438 remains locked to the arm and substantially
non-moving as described herein.
[0223] In many embodiments, the structure 411 of the elongate
element 310 comprises locking structure to form a locked joint with
the casing 410 and cover 412.
[0224] In many embodiments, manifold 468 is connected to the sheath
458 and can be affixed to the sheath to inset the sheath 458 into
the patient and inflate the balloon anchor 24 with the manifold 468
as described herein. The elongate element 310 comprising spine 452
may then be inserted into sheath 458. The manifold 468 and
structure 411 comprises locking structures 417 to lock the manifold
to the elongate element 310 when the elongate element 310 has been
inserted into the manifold 468 and sheath 458. A release 415 can be
pressed by the user to unlock the manifold 468 from the elongate
element 310.
[0225] The elongate tubular structure 431 of the linkage 430
comprises structures to receive the carrier tube 380. An opening
409 of the elongate tubular structure 431 is sized to receive the
carrier tube 380. A connection structure 408 is shown on the
proximal end of the linkage, and comprises a locking structure 406
to receive a protrusion 404 of the connection structure 405 of
carrier tube 308.
[0226] FIG. 14D1 shows rapid exchange of a carrier tube 380 when
the linkage 430 is coupled to the elongate element 310 anchored to
a target location of an organ. The elongate element 410 can be
inserted or removed from the linkage by the user. The elongate
element 380 can be advanced into opening 409 near connection
structure 405 of the elongate tubular structure 431.
[0227] The imaging probe 460 can be mounted on a second linkage and
configured to move with the nozzle of carrier 382, so as to image
interaction of the energy stream from carrier 382 when tissue is
treated. The images of the treatment may comprise axial images and
sagittal images from the imaging probe 460. The linkage can be
coupled to the controller or processor (or both) as described
herein to move the imaging probe 460 synchronously along the axis
with the carrier 382 and nozzle of the carrier, for example. The
imaging probe 460 may comprise a trans-rectal ultrasound probe and
the carrier 482 may comprise a component of the treatment probe 450
as described herein.
[0228] FIG. 14D2 shows alignment of the distal tip of the carrier
382 with the opening 409 of proximal end of the elongate tubular
structure 431 to insert the carrier tube 380 as in FIG. 14D1.
[0229] FIG. 14D3 shows the carrier advanced toward a locking
structure 406 on the proximal end of the linkage as in FIG. 14D1.
The locking structure 406 is sized to receive protrusion 404 so as
to form a locked joint 402.
[0230] FIG. 14D4 shows the carrier tube 380 locked to the linkage
430 as in FIGS. 14D1 and 14D2. The protrusion 404 has been inserted
into an opening of locking structure 406 so as to form the locked
joint. The joint can be unlocked by user manipulation.
[0231] FIG. 14E shows a cytoscope inserted at least partially into
a sheath 458 for advancement toward an anchoring location of an
organ. The anchoring location may comprise a bladder neck to view
tissue of an organ such as the prostate. The sheath 458 as
described herein can be advanced to a target location with
visualization from the cytoscope placed within the working channel
of the elongate element 310. When positioned, the anchor 24 such as
a balloon can be inflated with a port of manifold 468 coupled to
the sheath as described herein.
[0232] There are at least two forms of visualization possible with
the embodiments as described herein. 1) The cystoscope is locked
within the sheath 458. The purpose can be to view the prostate and
then eventually leave the sheath as a safe channel to guide the
elongate element 310 comprising spine 452 into the patient, in many
embodiments without having direct visualization. The distal end of
the sheath lines up near bladder neck. 2.) Once the elongate
element 310 is locked into the sheath 458, ureteroscope can be used
to view the patient. The ureteroscope can be inserted inside the
same channel that carrier 380 goes into, for example shared
channel.
[0233] FIG. 14F shows advancement of an elongate element 310 into a
sheath 458. The manifold 468 on the proximal end of the sheath 458
may comprise a locking structure to receive a locking structure on
the proximal end of elongate element 310. The elongate element 310
can be advanced into sheath 458 such that the locking elements on
the sheath 458 and elongate element 310 engage.
[0234] FIG. 14G shows a linkage 430 coupled to an elongate element
310 comprising a spine 452. The linkage is configured to receive
carrier 382 and carrier tube 380 as described herein.
[0235] FIG. 14H shows a carrier tube and carrier inserted into the
linkage tube in a locked configuration as described herein.
[0236] FIGS. 14A to 14H show a method of treating a patient in
accordance with embodiments, and each of these figures shows one or
more optional steps of the method.
[0237] FIGS. 15 and 16 show self cleaning with a fluid jet as
described herein. The fluid jet, for example fluid stream, as
described herein, can be utilized to clean the working channel and
clear tissue or other ports within the multifunction sheath. The
self cleaning can be automated or performed manually. Additionally,
water jet intensity can be reduced to clean laser cameras or other
accessory devices without having to remove the devices from the
working channel. For example an endoscope can be sized to fit
within the working channel or alternatively an endoscope can be
sized to fit within the working channel with the linkage decoupled
and to allow flushing and cleaning of the working channel.
Alternatively or in combination the carrier 382 that may comprise
carrier tube 380 can be sized to fit within the working channel
alongside an endoscope so as to allow cleaning of the
endoscope.
[0238] In many embodiments the self cleaning can be employed with
the probe comprising carrier 382 that may comprise carrier tube 380
positioned within the working channel. The elongated element 310
comprising the sheath and spine can contain the carrier 382 that
may comprise carrier tube 380 along a substantial portion of the
carrier. The carrier 382 may comprise a rectangular end portion or
a tubular end portion and may comprise a portion having a
cylindrical and tubular geometry, for example. The fluid stream
released from carrier 382 can extend to distance 457 with
divergence, for example. Alternatively the fluid stream may
comprise a columnar fluid stream. An angle of the fluid stream 453
can be controlled with the linkage so as to rotate the fluid stream
during cleaning. The fluid stream can be increased or decreased in
terms of pressure.
[0239] The fluid jet can be utilized to clean the working channel
and clear tissue or other parts within the multifunction sheath.
This can be automated or performed manually. Additionally water jet
intensity can be reduced to clean the laser camera or other
accessory devices without having to remove the devices from the
working channel.
[0240] FIG. 17A shows components of user interface 500 on the
display 425 of the system 400. The display 425 may comprise a touch
screen display, for example, alternatively or in combination, the
display 425 can be coupled with a pointing device, a keyboard, and
other known user input devices to work with processor systems. The
interface 500 comprises an operation tab 502, a CO2 monitor tab
504, and a system configuration tab 506. The user interface 500
includes buttons 507 on the display to adjust up or down values
entered into the computer system. An abort button 503 is provided
on the user interface for the user to stop treatment of the
patient. A start button 501 is provided for the user to initiate
treatment of the patient. The user interface 500 comprises an image
510 of an organ such as a prostate. The image 510 shown can be an
image of one or more of many organs as described herein. The image
510 may comprise, for example, an image of a prostate from an
anatomical image corresponding to a prostate of a patient. The
image 510 is shown in an axial transaxial cross-sectional view
having an anterior and a posterior orientation, the image 510 is
also shown along the longitudinal axis. The sagittal view of the
image 510 along the longitudinal axis shows anchor 24 and a lumen
such as the urethra. The image 510 may comprise an image of the
patient to be treated, for example, an ultrasonic image of the
patient. The image 510 can be shown in axial and sagittal views
with the ultrasonic image sized so as to correspond with the
treatment profiles shown on the display 425.
[0241] A treatment profile 520 is shown in the axial and sagittal
views. The treatment profile 520 corresponds to a profile of tissue
to be removed in the surface remaining subsequent to removal. The
treatment profile 520 comprises a radius 522 extending from a
central reference location to an outer portion of the cut tissue
boundary. The treatment profile 520 comprises an outer component
524 extending circumferentially around an axis of the treatment.
The treatment profile 520 extends from a first end 526 proximate
the bladder and the anchor to a second end 528 toward the urethra.
The treatment profile images shown on the display comprise a
plurality of references to align the treatment with the anatomy of
the patient. An axis 530 corresponds to a central location of the
treatment and extends axially along a lumen of the patient such as
the urethra. The treatment axis 530 may correspond to an anatomical
reference of the patient such as the urethra or path with which the
instrument is introduced to the patient. An angular reference 532
is shown extending from the central axis of the treatment profile
to an outer radial boundary of the treatment profile 534. The
angular component 532 corresponds to an anterior posterior location
on the component of the patient and extends from the anterior to
the posterior to location 534 to provide and permit alignment with
the patient. As can be seen in the sagittal view, a treatment
reference location 536 corresponds to a location adjacent the
inflatable anchor such as a balloon 24. Reference location 536
corresponding to the expandable anchor is shown aligned with the
end 526 of the treatment profile 20 in which the treatment profile
is shown aligned with the axis 451 of the treatment probe.
[0242] The user interface 500 comprises a plurality of inputs. The
plurality of input may comprise one or more of the following inputs
as described herein.
[0243] A plurality of angular input parameters 550 may comprise
input 552 and input 554, for example. The angular orientation can
be set so as to align with an anterior posterior direction of the
patient extending between axis 530 and marker 534. The input 552
can be used to adjust the angular orientation of the treatment
around the axis 530, for example, when the patient and probe are
aligned at slightly different angles. An input 552 aligns the
center of the treatment profile in degrees rotationally around the
axis. An input 554 provides a sweep angle from one angular extreme
to another, for example, a sweep angle may comprise an angle less
than 360.degree., for example, 240.degree.. The sweep angle
generally extends around the anterior-posterior treatment axis and
extends from the anterior end treatment posterior treatment axis by
a distance of approximately half the sweep angle, for example,
sweeping 120.degree. in the first direction and sweeping
120.degree. in an opposite direction from the anterior posterior
treatment axis. In many embodiments, the sweep angle is limited to
less than 360 degrees to avoid sweeping the fluid stream into the
spine.
[0244] The angular position of the stream can be shown in real time
on the display with an output 556 of the angular position in
degrees. The output angle can be shown on the display as a moving
colored line, for example green, which sweeps around the axis
530.
[0245] A plurality of input parameters 560 can be used to determine
the extent of the treatment along axis 451 and axis 530. An input
562 determines a location of the treatment profile in relation to
expandable anchor 24. An input 564 determines a length of treatment
along axis 451 and axis 530. Input 564 may comprise a longitudinal
distance of the treatment extending from a first end 524 to a
second end 528. An input 570 can determine a radius of the
treatment profile around axis 530. Input 570, a radial distance
from axis 530 radially outward to an outer boundary of the
treatment profile 524. The radius may comprise a radial distance in
millimeters such as the distance of 10 mm for example.
Alternatively, the radius can be determined with power of a pump
which can be set with arbitrary values from 1 to 10, for
example.
[0246] A select mode input 508 can allow the user to set the
interface from a cut mode to a coagulation mode, for example. In
the cut mode, many of the inputs for the treatment can be provided
so as to determine and align the treatment with the patient. In the
cut mode as shown the user is able to visualize the extent of
treatment with respect to the anatomy of the patient and to
formulate and improve treatment strategy. The user can establish a
cut profile having a predetermined profile surface and a
predetermined removal volume.
[0247] The patient interface comprises additional outputs for the
user to determine appropriate treatment, for example, a time
remaining in the treatment can allow the user to determine the time
of treatment and the time remaining in the treatment, for example,
an output 580 shows the time remaining in seconds. An output 582
comprises an estimated volume of tissue removal, the estimated
volume of tissue removed can be determined based on the treatment
profile. An estimated radial depth of the removal can also be
determined and an output 584 can show the estimated radial depth of
removal. The estimated depth of removal may comprise the input
radius from input 570 alternatively the estimated depth may
correspond to an estimated depth from a pump power of input 570. A
start button input 501 allows a user to start treatment when the
physician is satisfied with the patient treatment. When
insufflation is used, for example insufflation with a gas such as
CO2 an insufflation pressure can be set with an input 586.
Alternatively, if liquid is used as described herein as a second or
first fluid in combination with another liquid insufflation
pressure may be set to zero or disabled. In many embodiments the
insufflation may be set to zero in a first mode such as the cut
mode and set to an appropriate value in a second mode such as the
coagulation mode.
[0248] FIGS. 17B and 17C show a marker moving on a plurality of
images in which movement of the marker corresponds to the position
and orientation of an energy stream. The energy steam may comprise
a fluidic stream from the nozzle as described herein. A radial
marker 557 is shown on the axial image in relation to the resection
profile 520. A longitudinal marker 559 is shown on the sagittal
image in relation to resection profile 520. The radial marker 557
is shown at a first angle in FIG. 17B and a second angle in FIG.
17C so as to indicate the angle of the fluid stream from the
carrier as described herein, for example. As the treatment
progresses, the longitudinal maker 559 can move along the treatment
axis of the sagittal image to indicate the longitudinal position of
the nozzle on the carrier as the radial marker 557 sweeps
rotationally around the axis on the axial image.
[0249] FIG. 17D shows a user defined resection profile 520. The
user interface can be configured with instructions of the processor
to allow the user to define a plurality of points of the treatment
profile, and interpolate among the points as described herein.
[0250] FIGS. 17E and 17F show a user interface to define a
plurality of curved portions of a cut profile. A first user movable
input 551 can be configured to move along the display to define a
first curved portion of the profile 520, and a second user movable
input 553 can be configured to move along the display to define a
second curved portion of the profile 520, and the instructions of
the processor can be configured to interpolate among the first
curved portion and the second curved portion to define the profile
529 extending between the first curved portion and the second
curved portion, for example. A first end 526 of the treatment
profile can be set based on user input and a second end 528 can be
set based on user input as described herein. The user can slide the
first movable input 551 to determine the curved shape of the first
portion based on anchoring of the cut profile with the end 526 and
the location of the movable input 551 on the display. For example,
the first curved shape may be determined with a spline fit
extending from the first input to the end 526 constrained with
angles at the end 526 and the movable input 551. The second movable
input 553 can be moved similarly to define the second curved shape
of the second portion, for example.
[0251] FIG. 18 shows a system configuration mode 506 for the
cutting mode input 508. When the system configuration is set the
user can set several parameters for the treatment prior to the
treatment or during the treatment so as to align the treatment
profile with a patient and to insure that the treatment probe 450
cuts tissue as intended. One or more inputs 590 allows the user to
align intended treatment with the probe placed in the patient. One
or more inputs 590 may comprise an input 591 to zero the treatment
and align the treatment axis with an axis of the patient, for
example the intended anterior posterior treatment profile can be
aligned in an anterior posterior direction of the patient such that
an anterior posterior axis of the treatment profile is aligned with
an anterior posterior axis of the patient. Input 591 can be set
based on one or more measurements for example an ultrasonic imaging
measurement to determine that the probe is properly aligned with
the patient. Alternatively or in combination, input 591 can be set
based on angle sensors as described herein. One or more inputs 590
may comprise an input 592 to zero the treatment in the axially
direction and align the treatment probe with an intended anatomic
target of the patient. Input 592 allows alignment of the
longitudinal axis with the intended target location of the patient,
for example if treatment probe 450 has been placed insufficiently
far or too deep the zero z button can be pressed such that input
592 zeros the treatment at the correct anatomical location.
[0252] The system configuration mode can also be used to set and
calibrate the system. For example, an input 598 can allow the zero
angle of a first angle sensor, for example, an angle sensor of the
treatment probe 450 to be set to zero and properly aligned. An
input 599 can be used to set the imaging probe sensor to an
appropriate angle, for example, to calibrate the imaging probe.
[0253] An input 595 can allow a user to select a probe type from
among a plurality of probe types, for example the probe type may
comprise a plurality of nozzle types, for example, a fourth nozzle
type may comprise a narrower nozzle diameter to allow treatment at
a greater distance radially from the axis of the treatment probe
450. In the system configuration mode for a given profile a user
can select a plurality of probe types so as to determine a time
remaining, an estimated volume and an estimated depth based on the
probe identified and, for example, the size of the nozzle of the
probe selected.
[0254] By way of example, the input screens and parameters shown in
FIGS. 17A and 18 may refer to a divergent cutting screen in which a
first fluid comprises a liquid and the second fluid comprises a
liquid. Alternatively a gas can be used to provide a protective
jacket around a treatment beam in a treatment stream so as to
extend the effective cutting distance of the treatment probe 450.
The system may comprise instructions so as to perform a portion of
the treatment with one configuration of the first fluid and the
second fluid and a second configuration of the first fluid and
second fluid so as to cut a second portion of the treatment with a
gas protecting the treatment stream.
[0255] In many embodiments in which the sweep angle is limited to
less than 360 degrees to avoid the spine as described herein, a
first treatment can be performed at a first angular orientation of
the probe about the axis, the probe rotated to move the spine out
of the way in order to expose the untreated portion with the
stream, and a second treatment performed. The angle of the probe
for the first treatment can be measured, and the angle of the probe
for the second treatment measured, and the treatment rotated to
treat the untreated portion based on the first and second angles.
For example, the first treatment may comprise a sweep of 240
degrees, and the second treatment may comprise a sweep of 120
degrees, such that the total treatment extends substantially around
the axis of the probe and to a greater angle than would be provided
if the spine were not rotated to expose the untreated portion. The
probe may be rotated to a second measured angle, for example 70
degrees, and the second treatment performed with a sweep of 120
degrees. The center location can be adjusted with input 552 or
software, such that the second treatment is aligned with the
untreated portion.
[0256] FIG. 19 shows a coagulation mode selected with input 508.
With the operation tab selected with input 502, the treatment for
coagulation can be set. The coagulation can be provided in many
ways, for example, with a divergent stream or a columnar stream and
combinations thereof. In many embodiments it may be desirable to
treat only a portion of the treatment profile with coagulation. For
example, a posterior portion of an organ, for example, the prostate
can be selectively treated with coagulation. Work in relation to
embodiments suggest that posterior treatment may result in slightly
more bleeding potentially and it can be advantageous in some
embodiments to selectively treat a posterior portion of a patient's
anatomy, for example, the prostate. In the coagulation mode with a
laser beam, the treatment input parameters are similar to those
described above with respect to cutting. The sweep angle can be set
with input 554, for example, to a value of 100.degree. in which the
sweep angle for coagulation is less than a sweep angle for cutting.
The time of treatment remaining 580 can be shown and the user may
also see a volume of treatment, for example, a coagulation volume.
The user is allowed to select laser power with an input 575 and
also to position the treatment similarly to what was done with the
cutting and the angular extent can be lesser and the longitudinal
extent can be lesser or greater, for example.
[0257] The input treatment profile can be input in one or more of
many ways, for example, the image of the organ to be treated, for
example, the prostate, can be provided and the user can draw an
intended treatment profile on an axial view and a sagittal view of
the patient. The image shown may comprise an anatomical image
corresponding to anatomy of a generalized population or
alternatively the images shown may comprise images of the patient.
The processor system comprises instructions to map and transform
the reference treatment profile on the image of the patient to the
machine coordinate references of the treatment probe 450 and
linkage 430 and anchor 24 as described herein. In many embodiments
the images shown to the user are scaled to correspond to the
treatment profile so that the treatment profile shown on the image
of the anatomical organ treated corresponds to and aligns with the
treatment dimensions of the image. This allows the user to
accurately determine and place the intended treatment profile on
the patient.
[0258] FIG. 20A shows mapping and alignment of an image of the
patient with the treatment coordinate reference frame. The image
510 of the organ can be obtained in one or more of many ways as
described herein. The image may comprise an image reference frame,
for example comprising X, Y and Z coordinate references. The
treatment probe 450 comprises a treatment reference frame, for
example cylindrical coordinate references R, Z, theta. The
orientation of the axes of the probes can be determined as
described herein. A marker reference 536, such as the anchor of the
treatment probe can be identified from the image, in order to align
the two images with a common known reference point. The points of
the image from the image reference frame can be mapped to the
coordinate reference frame and shown on the display, based on the
location of the identified reference point and the orientation of
the probes. A point in the image having an image coordinate
reference of (X1, Y1, Z1) can be mapped to the treatment reference
frame to provide treatment reference location (R1, Z1, T1). A three
dimensional mapping of the patient tissue can be similarly
performed, for example.
[0259] Three dimensional mapping of the tissue of the target organ
can be performed, and the three dimensional mapping used to provide
a three dimensional profile of the target organ. For example, a
plurality of sagittal views and plurality of axial views can be
provided of the three dimensional profile of the organ, and the
user can draw the target treatment profile on each of the plurality
of sagittal views and each of the plurality of axial views in order
to provide a customized treatment of the patient. In many
embodiments, the processor comprises instructions to interpolate
the treatment profile among the sagittal an axial views, so as to
provide a mapped three dimensional treatment profile. In many
embodiments, providing additional treatment of the prostate
medially may provide additional tissue removal, and the mapping as
described herein can be used to provide additional removal of
medial portions of the prostate tissue.
[0260] In many embodiments, the user can identify a plurality of
points of a treatment profile on the image of the tissue of the
patient, and the plurality of points are mapped to the treatment
coordinate reference, and shown on the display so that the user can
verify that the treatment coordinates of the treatment profile
shown on the display treat the targeted tissue as intended by the
user.
[0261] FIGS. 20B and 20C show a method 600 of treating a
patient.
[0262] At a step 602, a calibrated treatment probe as described
herein is provided.
[0263] At a step 605, an image of an organ (e.g. prostate) as
described herein is provided.
[0264] At a step 607, a reference structure of a treatment probe as
described herein is provided.
[0265] At a step 610, the reference structure is aligned with the
image of the organ as described herein.
[0266] At a step 612, organ image coordinates are mapped to
treatment reference coordinates as described herein.
[0267] At a step 615, image coordinates are scaled to match
treatment reference coordinates as described herein.
[0268] At a step 617, images of the organ aligned with reference
structure are displayed as described herein.
[0269] At a step 620, treatment input parameters are received as
described herein.
[0270] At a step 622, the tissue resection profile is determined
based on the input parameters as described herein.
[0271] At a step 625, the tissue resection profile is displayed on
views of the organ as described herein.
[0272] At a step 627, the tissue resection profile and location are
adjusted based on the images as described herein.
[0273] At a step 630, resection parameters are determined as
described herein.
[0274] At a step 632, a treatment nozzle is identified from among a
plurality of treatment nozzles as described herein.
[0275] At a step 633, a carrier is identified from among a
plurality of carriers as described herein.
[0276] At a step 635, a fluid stream type is selected as columnar
or divergent as described herein.
[0277] At a step 637, a first fluid and a second fluid are selected
as described herein.
[0278] At a step 640, a treatment probe is inserted into the
patient as described herein.
[0279] At a step 642, a treatment probe arm is locked as described
herein.
[0280] At a step 645, an imaging probe is inserted into the patient
as described herein.
[0281] At a step 650, an imaging probe is locked as described
herein.
[0282] At a step 657, an imaging probe is moved in relation to the
treatment probe as described herein.
[0283] At a step 660, alignment of the treatment probe with the
patient is determined as described herein.
[0284] At a step 662, orientation of treatment probe is measured as
described herein.
[0285] At a step 665, orientation of a treatment probe is measured
as described herein.
[0286] At a step 667, the planned treatment is adjusted based on
patient alignment as described herein.
[0287] At a step 668, the patient is treated as described
herein.
[0288] At a step 670, tissue treated with the planned treatment is
imaged and viewed as described herein.
[0289] At a step 672, the jet entrainment "fluid flame" is viewed
as described herein.
[0290] At a step 675, interaction of the jet entrainment "fluid
flame" is viewed as described herein.
[0291] At a step 677, additional tissue is resected based on the
viewed images as described herein.
[0292] At a step 680, treatment is adjusted as described
herein.
[0293] At a step 682, the elongate element and sheath are rotated
amount the elongate axis to rotate the spine as described
herein.
[0294] At a step 685, an angle of rotation of the elongate element
and spine are measured as described herein.
[0295] At a step 687, the treatment profile is rotated around the
axis based on measured angle. For example, the treatment profile
can be rotate around the elongate axis of the treatment profile
corresponding to the elongate axis of the elongate element and
spine and sheath as described herein as described herein.
[0296] At a step 690, a portion of the organ blocked as described
herein by the spine is treated.
[0297] At a step 695, treatment is completed as described
herein.
[0298] Although the above steps show method 600 of treating a
patient in accordance with embodiments, a person of ordinary skill
in the art will recognize many variations based on the teaching
described herein. The steps may be completed in a different order.
Steps may be added or deleted. Some of the steps may comprise
sub-steps. Many of the steps may be repeated as often as if
beneficial to the treatment.
[0299] One or more of the steps of the method 600 may be performed
with the circuitry as described herein, for example one or more of
the processor or logic circuitry such as the programmable array
logic for field programmable gate array. The circuitry may be
programmed to provide one or more of the steps of method 600, and
the program may comprise program instructions stored on a computer
readable memory or programmed steps of the logic circuitry such as
the programmable array logic or the field programmable gate array,
for example.
[0300] FIGS. 21A and 21B show screenshots of organ images, for
example trans-rectal ultrasound prostate images, from 3D
segmentation software according to embodiments of the present
invention. The two dimensional images shown on the right side of
FIGS. 21A and 21B, respectively. Three dimensional images of the
prostate are shown on the right left of FIGS. 21A and 21B,
respectively. The two dimensional images on the right side of FIGS.
21A and 21B show examples of transverse and sagittal planes,
respectively, of the three dimensional prostate representations
shown with the images on the left of FIGS. 21A and 21B. The
transverse image may also be referred to as horizontal image, axial
image, or transaxial image as described herein. Note segmentation
of the sagittal plane of the prostate is depicted in light gray
color, and the segmentation of the axial plane of the prostate is
depicted in light gray color.
[0301] These segmented images can be provided on the display for
the user to plan the treatment of the organ with images of
treatment overlaid on the image of the organ as described herein,
such as the treatment profiles overlaid on the image of the
prostate.
[0302] The images shown in FIGS. 21A and 21B can be provided on the
display 425 of interface 500. For example the axial and sagittal
images can be provided on the display as described herein.
[0303] FIGS. 21C to 21F show a plurality of axial images 525 of a
target tissue to define a three dimensional treatment plan and a
user defined treatment profile in each of the plurality of images.
The user interface comprises a first tab 527 to select a Z-slice
view and a second tab 529 to select a Y-view, of a three
dimensional representation of a target tissue such as an organ that
may comprise the prostate. The Z-slice view may correspond to a
sagittal image of the target tissue and the Y-slice view may
correspond to an axial view of the target tissue. The plurality of
axial images comprises a first image 525A at a first z-frame 523.
The z-frame 523 may correspond to a location along an axis of the
traversed by the y-slice view, and each z-frame may correspond to a
location of the axial image along the z-axis. The first z-frame can
be one or more of many frames.
[0304] Each image 510 comprises a user input treatment profile 520.
The user input treatment profile may comprise a plurality of points
that are user adjustable on the image to define the treatment
profile. The first plurality of images 525A shows the treatment
profile partially positioned by the user, and a plurality of
treatment profile marker points 521 have yet to be placed on the
target tissue location by the user. The user can adjust the
location of the points with the user interface, for example with a
pointing device or touch screen display. The processor as described
herein comprises instructions to receive the plurality of points
input by the user. The plurality of points may comprise small user
movable markers such as circles, dots or X's, and the plurality of
points can be connected with lines in one or more of many ways,
such as with a linear interpolation corresponding to straight lines
on the display or splines corresponding to curved lines shown on
the display so as to connect the markers, for example.
[0305] A second image 525B of the plurality of images at a second
depth is shown on the display as described herein. The second image
525B comprises points 521 aligned with the image by the user so as
to define the treatment profile 520 at the second location along
the z-axis corresponding to the treatment.
[0306] A third image 525C of the plurality of images at a third
depth is shown on the display as described herein. The third image
525C comprises points 521 aligned with the image by the user so as
to define the treatment profile 520 at the third location along the
z-axis corresponding to the treatment.
[0307] A fourth image 525D of the plurality of images at a fourth
depth is shown on the display as described herein. The fourth image
525C comprises points 521 aligned with the image by the user so as
to define the treatment profile 520 at the fourth location along
the z-axis corresponding to the treatment.
[0308] FIG. 21G shows a sagittal view of the target tissue and
planes of the axial images of FIGS. 21C to 21F. The z-slice view
can be selected with tab 527, so as to show a sagittal view of the
target tissue. The plurality of images 525 are shown as lines
extending through the sagittal view.
[0309] FIG. 21H shows a three dimensional treatment profile based
on the plurality of images of FIGS. 21A to 21F. The three
dimensional treatment plan may comprise a three dimensional
representation of the three dimensional treatment profile 520. The
three dimensional treatment profile 520 can be determined in one or
more of many ways. The three dimensional treatment profile may be
obtained by interpolation among the plurality of points 521 that
define the treatment profile of each image, for example by linear
interpolation of splines. Alternatively or in combination, the
three dimensional treatment profile can be determined based on
polynomial fitting to the surface points 521, for example.
[0310] FIG. 21I shows a user input treatment profile of an image
among a plurality of images as described herein. The user can
adjust the plurality of points 521 in one or more of many ways, and
the user can determine the treatment profile based on patient need.
The treatment profile can be selected so as not to extend to an
outer boundary of a tissue structure, for example an outer
structure of an organ such as a prostate as shown in FIG. 21I.
[0311] FIG. 21J shows scan patterns of the fluid stream as
described herein. The fluid stream may comprise a pulsed or
continuous fluid stream. The scan pattern can be based on critical
pressures as described herein so as to remove a first tissue and
inhibit removal of a second tissue. In many embodiments, the fluid
stream comprises a plurality of pulses 810 from a pump such as a
piston pump, and the pulses comprise a frequency and duty cycle. In
many embodiments, the duty cycle correspond to no more than about
50%. The plurality of pulses 810 comprises a first pulse 812 and a
second pulse 814. The fluid flame may comprise an approximate cross
sectional size at the location of tissue being scanned. Based on
the teachings described herein, a person of ordinary skill in the
art will recognize that the fluid flame comprises a maximum cross
sectional width at about 1/2 the length of the fluid flame. At the
location where the fluid flame impinges upon tissue, the fluid
flame comprises a cross sectional size 848.
[0312] The scanning pattern of the fluid stream comprising the
fluid flame are along a Z-axis and angle 844. The angle 844 may
correspond to time 845, for example when the angular sweep rate
remains substantially constant. The fluid flame is scanned along a
scan path 846. The scan path 846 may correspond to the velocity of
the carrier 382 along the Z-axis and the rotation of the carrier
382 around the Z-axis, for example.
[0313] The pulses can be spaced apart such that a plurality of
sequential pulses strike a location 830 of tissue. The plurality of
sequential pulses can be effective in removing a first type of
tissue when removal of a second type of tissue is inhibited.
[0314] Alternatively or in combination with the critical pressures
as described herein, work in relation to embodiments suggests that
the rate of removal can be related to a relaxation time of a
targeted tissue. The fluid flame can be configured to dwell on a
point 830 of tissue for a duration longer than the relaxation time
of the tissue, such that the tissue can be deformed beyond a
threshold and removed.
[0315] In many embodiments, the plurality of pulses 820 impinge
upon the tissue location 830 with a duration between pulses that is
less than a tissue relaxation time of elastic deformation of the
tissue so as to remove the tissue. In many embodiments, a first
tissue to be removed comprises a first relaxation time greater than
the time between pulses, and the second tissue for which removal is
to be inhibited comprises a second tissue relaxation time less than
the time between pulses, so as to inhibit removal of the second
tissue.
[0316] As the tissue is removed toward the final desired treatment
profile, the size of the fluid flame may decrease substantially
near the distal tip of the flame, such that the size of the pulsed
fluid flame impinging upon the resected profile is decreased
substantially tissue removal decreased substantially.
[0317] Based on the teachings described herein, a person of
ordinary skill in the art can determine the scanning movement of
the carrier 382 and nozzle to resect tissue to a target profile
with the fluid flame as described herein.
[0318] FIG. 21K shows a bag over a fluid stream. The fluid stream
may comprise the columnar stream or divergent stream as described
herein. In many embodiments the bag is placed over a fluid stream
comprising a pulsed stream so as to comprise a water hammer. The
bag can be made of one or more of many materials and may comprise
an elastomer, for example. The interior of the bag can be coupled
to the carrier 382, and the exterior of the bag can be coupled to
the working channel to remove material. The bag has the advantage
of protecting the tissue from the high fluid flow rate and can
provide more even pressure. The fragmented tissue can be collect
through passive or active means, for example through an outer
collection tube or the working channel.
[0319] FIGS. 22A and 22B show schematic illustrations of a probe
being operated in accordance with the principles of embodiments as
described herein, so as to provide a real time determination of the
tissue removal profile 520. FIG. 22A shows columnar fluid stream
331 and FIG. 22B shows diverging stream 334, each of which is
suitable for combination with the image guided tissue resection as
described herein.
[0320] Interstitial laser-guided 3D imaging (inside tissue and/or
inside an organ with or without fluid and with or without a water
jet): employ the spot from the laser on the inner surface of the
prostate to determine the depth of a cut. That is, knowing the
axial and rotational position of the nozzle, and given that the
spot lies on a radius from the nozzle, locating the spot in the
image from the camera gives a unique spot-to-nozzle distance.
Scanning the laser, and using image processing to find the spot, a
full image of the volume inside the prostate can be produced.
Combining this with the organ geometrical data, the volume resected
can be displayed within the organ in 3D. Alternatively, using the
laser to measure the distance between itself and the target
surface, an exact three-dimensional replica of the area it has
scanned can be recreated.
[0321] Acoustic Distance Measurement.
[0322] By placing an acoustic transducer in the assembly near the
water jet it will be possible to measure distance along the water
jet to the tissue plane struck by the jet. Scanning the jet then
allows three-dimensional mapping of the cavity. At least one
transducer 392 can be provided on the carrier tube 380.
Interstitial sound-guided tissue differentiation (inside tissue
and/or inside an organ in fluid/gas environments): the audible
frequencies produced by the jet-tissue interface can allow for
differentiation of tissue. Monitoring the acoustic behavior at this
interface may add a depth monitoring feature to the system; this
can enhance safety as to prevent the jet from penetrating the
prostate's capsule. The sensor could be attached to the tip or
anywhere along the probe/sheath's shaft.
[0323] Pulse width modulation of the water column: modulating the
frequency at which the water is on and off can allow the user to
estimate the distance of nozzle to tissue under camera
visualization. The frequency can be fixed to a predetermined column
size (e.g. 5 mm) or user could adjust it to match the height
between the nozzle and tissue, as shown in FIG. 22A. Alternatively,
the diameter of the jet at the jet-tissue interface can determine
distance from nozzle assuming the high pressure divergence
characteristics of the nozzle is defined as shown in FIG. 22B.
[0324] The at least one transducer 392 may comprise an acoustic
transducer to receive acoustic signals from the tissue. In some
embodiments, at least one transducer 392 transmits acoustic signals
for ultrasound imaging. The at least one transducer may comprise a
plurality of transducers. A second acoustic transducer can be
provided on carrier tube 380 to one or more of receive or transmit
acoustic signals for ultrasound imaging from the probe to the
tissue. The at least one transducer 392 may comprise an ultrasound
array to provide axial and transverse imaging as described herein,
for example.
[0325] FIG. 22C shows an endoscope 394 placed in the working
channel of elongate element 310 with carrier 382 to image tissue.
The endoscope 394 can be used to image the tissue profile as
described herein. For example, a fluid stream can be used to
illuminate the tissue with laser pointing with the fluid stream,
for example columnar fluid stream 331. The known angle and axial
location of the fluid stream can be used with the location of the
image from the endoscope to determine the surface profile of the
tissue.
[0326] FIGS. 23A and 23B show a carrier configured to provide
integrated jet delivery. The carrier 382 that may comprise carrier
tube 380 comprises an energy delivery conduit 351, such as an
optical fiber. An alignment block is provided to align the optical
fiber with the fluid delivery element. The optical fiber can be
bent to provide a bend angle suitable for delivery of optical
energy to the end of the optical fiber.
[0327] The configuration of the optical fiber, jet orifice and
alignment orifice provide the integrated jet capability. The jet
orifice can be formed in a nozzle that comprises an inverted solid
conic section that defines a conic channel to receive the fluid to
form the fluid stream and to receive light from the optical fiber.
The alignment orifice can be formed in an alignment structure and
comprises an inverted solid conic section that defines a conic
channel to receive the fiber and the conic channel extends to a
cylindrical channel having a diameter sized to receive the optical
fiber. In many embodiments, the conic channel comprises of the
alignment orifice comprises an angle to receive the fiber such that
the fiber can be advanced along the conic channel and through the
cylindrical channel without damaging the optical fiber. In many
embodiments, the optical fiber, including the cladding, comprises a
diameter less than the cylindrical channel of the alignment
orifice, such that the optical fiber can be advanced along the
cylindrical section without damaging the fiber. The flat section of
the alignment block can hold the fiber to inhibit movement of the
fiber along the longitudinal axis of the fiber when the tip of the
fiber is held in alignment with the cylindrical portion of the jet
orifice channel.
[0328] The nozzle comprising the jet orifice and the alignment
structure comprising the alignment orifice may each comprise a
jewel having the conic section and cylindrical section as described
herein.
[0329] In many embodiments, the cylindrical channel portion of the
alignment orifice holds the optical fiber in alignment with a gap
extending around at least a portion of the optical fiber. The
cylindrical channel portion of the alignment orifice extends along
an axis a sufficient distance so as to align the optical fiber with
the jet orifice with the gap extending between the fiber and the
cylindrical channel portion of the alignment orifice along at least
a portion of the fiber and the cylindrical channel portion.
[0330] The jet orifice and alignment orifice are spaced apart
axially a sufficient distance such that the fluid that passes
through the jet orifice can deliver a fluidic stream of energy with
predictable flow, for example so as to form the columnar stream
with low pressure and the divergent cutting stream with high
pressure. In many embodiments, a distance 351D extends between an
upper surface of the structure defining the cylindrical channel
portion of the alignment orifice and the lower end of the
cylindrical channel of the jet orifice. Distance 351D is
dimensioned such that the light beam emitted from the optical fiber
diverges so as to allow energy transmission of at least about 80%
through the jet orifice, for example at least about 90% through the
alignment orifice, and such that the predictable flow can be
provided. In many embodiments, the distance 351D is within a range
from about 200 um to about 2.5 mm, for example within a range from
about 0.5 mm to about 2 mm, for example.
[0331] An alignment block is coupled to the optical fiber, and the
alignment block comprises a surface to engage the optical fiber in
which the fiber engaging surface comprises a radius of curvature
which can be less than 5 mm, for example no more than 2 mm, so as
to allow the cross sectional dimensions of the tip of the carrier
382 to be sized to pass through the working channel with rapid
exchange as described herein.
[0332] The alignment block can engage the optical fiber so as to
retain the optical fiber. The curved engagement surface of the
alignment block engages the optical fiber and retains the optical
fiber in position. The lower engagement surface of the block also
comprises a substantially non-curved elongate channel portion
proximal to the curved portion to engage the fiber and fix the
location of the fiber within the probe, for example by holding the
fiber between the block and an upper surface of the lower portion
of the carrier 382.
[0333] The fluid jet can be used at high pressure for ablation, for
example, a fluid jet, or low pressure, for example, columnar for
transmitting an optical beam. The optical fiber can be bent, guided
and aligned by positioning the alignment block and alignment
orifice to achieve a desired alignment. A short and tight bend
radius can be achieved by positioning and fixing the optical fiber
in this manner. Cavitation and other fluid jet effects can be
altered by varying the relative position and orientation of the jet
alignment orifices.
[0334] The fluid stream released from the fluid delivery element
may comprise a diverging stream 334 as shown in FIG. 23A or a
columnar stream 333 as shown in FIG. 23B. The diverging stream 334
can be provided by providing a higher pressure to the delivery
element. At high pressure the fluid jet will diverge, for example
when the first fluid is a liquid and the second fluid is a liquid.
Alternatively a low pressure can be provided to provide the
columnar stream 333 as shown. The columnar stream 333 can be
provided when the fluid released is a liquid and the liquid is
released into a gas, and the liquid can be released with a low
pressure within a range from 2 to 100 psi, for example within a
range from 5 to 25 psi. At the low pressure the columnar fluid
comprising the columnar stream 333 can be used as a pointing device
to point the laser beam for alignment. Alternatively or in
combination the columnar fluid stream can be used to heat tissue,
for example, to heat with one or more of ablation, vaporization, or
coagulation, for example.
[0335] The diverging stream 334 can be provided by increasing the
pressure to the nozzle for tissue removal with the divergent stream
as described herein. The optical fiber of the carrier 382 that may
comprise carrier tube 380 can be bent to provide a narrow profile
configuration of the carrier 382. For example, the optical fiber
can be bent with a radius within a range from about 1 to 10 mm, for
example, within a range from about 2 to 5 mm. This bending of the
optical fiber can allow the light energy to be released and
transmitted with high efficiency from a light source to the desired
tissue target. Also the terminal end of the optical fiber can be
aligned such that light emitted from the optical fiber is
substantially directed through the channel defined with the nozzle
that delivers the fluid stream. An alignment structure comprising
an alignment orifice can be used to align the optical fiber with
the jet orifice of the fluid delivery element.
[0336] FIG. 24 shows carrier 382 comprising a fluid delivery
element and design considerations of the fluid delivery element.
The jet orifice design of the fluid delivery element can be
configured in one or more of many ways. Fluid jet ablation
characteristics can be varied by varying the jet orifice geometry.
For example cone angle variation will result in an increase or
decrease in cavitation occurring at the nozzle exit. The jet
orifice design may comprise a cone at one or more of the entrance
or the exit of the orifice. The cone angle can vary from 0 to 180
degrees, for example. The orifice diameter and orifice length
variation can result in a variation in nozzle back pressure and
exit speed of the fluid stream. The resulting entrainment region
varies with each of these parameters. The entrainment region may
comprise a cloud of cavitation bubbles generated by the nozzle. The
depth of tissue penetration can be predicted and controlled based
on the entrainment region length. In many embodiments the
entrainment region can be visualized with ultrasound imaging or
optical imaging in combinations thereof. The entrainment region
corresponds to a region where cavitation occurs, which allows the
entrainment region to be visualized and can be referred to as a
fluid flame. The cool cutting of the entrainment region can allow
for tissue removal with minimal tissue damage. In many embodiments
the cone angles within a range from about 40 degrees to about 80
degrees. A ratio of the orifice length to the inner diameter of the
orifice can be within a range from about 1 to 10, for example,
within a range from about 4 to 7. A person of ordinary skill in the
art can design a jet orifice to treat tissue as described herein
based on the teachings provided herein.
[0337] FIGS. 25A through 25C show jet deflection in accordance with
embodiments. A deflector 710 can be provided on the distal end of
carrier 382. The jet deflection can be achieved in one or more of
many ways. The fluid jet can be deflected to achieve different
cutting angles, for example. Alternatively or in combination,
deflected or diverted fluid jets can be utilized to clean the
working channel and auxiliary devices, for example. Deflection of
the fluid stream can be actuated manually or robotically via pull
wires, pneumatics, hydraulics, mechanical links and other means,
for example. The deflector can be moveable under computer control
and the deflector may comprise a gimbal to vary deflection of the
fluid stream with respect to the longitudinal axis of the carrier
382. FIG. 25A shows deflection of the fluid stream to a first angle
in relation to the longitudinal axis. And FIG. 25B shows deflection
of the fluid stream at a second angle to the longitudinal axis.
FIG. 25C shows rotation of the fluid stream around the longitudinal
axis with the fluid stream deflected at the second angle.
[0338] FIGS. 26A through 26C show jet masking in accordance with
embodiments. Fluid jet masking can be used to achieve different
cutting areas, for example in a single location or multiple
locations. A masking mechanism can be actuated manually or by
robotically via pull wires, pneumatics, hydraulics, mechanical
links and other means, for example. In many embodiments a hypo tube
extends along carrier 382 so as to allow shaping of the mask on the
distal end of the carrier 382. A mask 720 comprises a first
configuration 722 as shown in FIG. 26A. As shown in FIG. 26B, mask
720 comprises a second configuration in which the mask has been
adjusted to provide a wider angle of the release fluid stream. FIG.
26C shows a third configuration 726 of the mask.
[0339] The mask embodiments as described herein can allow rotation
of the mask around the longitudinal axis for angles of rotation
greater than 360 degrees. For example, a plurality of rotations can
be used. The plurality of mask configurations can allow sculpting
of the target tissue to a desired intended profile and can allow
rapid removal of the tissue with sweep rates that allow a smooth
profile to be provided. The shape of the mask can allow for bulk
tissue removal with a large divergence angle for tissue proximate
to the mask. For tissue farther from the mask the angle may be
decreased so as to provide decreased divergence of the jet to reach
tissue at a location farther from the mask.
[0340] FIGS. 27A and 27B show variation of jet angle in accordance
with embodiments. The fluid jet angle and the laser beam can be
fixed at different angles to achieve cutting or coagulation. The
one or more of cutting or coagulation can be directed to a single
location or multiple locations, for example. Angling can assist in
targeting tissue near an expandable anchor such as a balloon or
reduce risk of incidental contact with unintended tissue. The jet
angle can be varied in one or more of many ways. For example, a
plurality of carriers 730 can be provided, and each of the carriers
may comprise carrier 382 having structures and components for
treatment as described herein. Each of the plurality of carriers
730 can provide a different fluid stream angle. For example, a
first carrier can provide a first fluid stream at a first angle
732. A second carrier can provide a second fluid stream at second
angle 734, and a third carrier can provide a fluid stream at a
third angle 736 as shown. The plurality of probes may comprise a
set of probes, for example, three or more probes in which each
probe is configured to direct one or more of the jet angle or the
laser beam at an angle. For example, first angle 732 can extend
substantially perpendicular to the elongate axis and third angle
736 can be directed toward a distal end of the probe in order to
resect medial tissue, for example tissue of the prostate.
[0341] In many embodiments, a plurality of probes can be provided
in which one or more jets exits the device axially to target tissue
immediately distal of the device.
[0342] FIG. 28 shows a plurality of jets delivered simultaneously
in accordance with embodiments. The plurality of jets of carrier
382 may comprise a primary jet 740 and a secondary jet 744
connected with the supply channel 742. The supply channel 742 may
comprise a common supply channel.
[0343] Multiple jets can be employed to achieve concurrent ablation
and coagulation. This can be achieved through the use of a single
supply channel or multiple supply channels. In the case of a single
supply channel, a small amount of pressure can be bled off to feed
the secondary jet. Additionally, a low power source laser pointer
can be utilized for the secondary jet to assist in tissue targeting
while using the primary jet for ablation.
[0344] In many embodiments, the secondary jet can be used to direct
a light beam to coagulate tissue and the primary jet can be used to
clear tissue away while the secondary jet is utilized as a wave
guide.
[0345] In many embodiments, the primary jet can be used to debride
tissue while secondary jet is used to coagulate tissue.
[0346] FIG. 29 shows morcellation in accordance with embodiments.
In many embodiments, morcellation can be achieved concurrently with
ablation with structural features such as blades on the probe or
spine for example. If integrated to the probe, morcellation can be
automatically driven by the movement of the probe. Vacuum suction
can be used alongside or independently with physical morcellation
to increase collection flow. The combination of physical
morcellation for example with an auger structure and vacuum can be
utilized to regulate intraorgan pressure.
[0347] Carrier 382 can extend to a distal end portion having one or
more jets as described herein. Morcellating features can be
provided proximately with respect to the jets and the morcellating
features may be contained within the working channel, for example,
with an auger shaped structure to remove tissue.
[0348] FIG. 30 shows a single tube design in accordance with
embodiments. The single tube design may comprise a fluid delivery
element such as an orifice jewel 762. A variable bend 760 allows a
radius to bend, for example, when the carrier 382 is advanced
within the working channels. A fluid is coupled to the orifice on
the end of the carrier 382. The fluid may comprise liquid or gas
and the orifice on the distal end can be configured in one or more
of many ways as described herein. FIGS. 31A and 31B show a single
tube design in accordance with embodiments. A fluid such as a
liquid or gas can be coupled with a laser as described herein. The
laser can emit electromagnetic energy transmitted along an energy
conduit 351 such as an optical fiber as described herein. A
variable bend 760 can be provided near the fluid delivery element
such as an orifice jewel 762 on the distal end. The optical fiber
can be aligned with structures as shown in FIG. 31B. For example, a
fiber guide can be used to locate the optical fiber coaxially with
the orifice of the fluid jet.
[0349] The single tube design in accordance with the embodiments of
FIGS. 30, 31A and 31B can provide many advantages. For example,
package size and complexity can be greatly reduced when utilizing a
single tube design. Internal laminar flow characteristics can be
improved with a single tube design as the fluid path can be more
continuous than with other designs, for example. The orifice jewel
can be swaged in place or a small cover can be laser welded to
retain the jewel. Optical fiber integration can be achieved through
the use of an internal fiber alignment structure. The bend angle
and radius can be varied so as to allow for alternate tissue
targeting or for manufacturing. Multiple jets can be employed to
balance jet reaction courses and cut more than one location
concurrently. For example, opposing jets can be used. An additional
jet may be added to power rotational motion of the catheter for
example.
[0350] The small package size can allow the implementation to take
the form of a small catheter. This can allow for use with prior
commercially available rigid and flexible introducers and scopes.
The distal tip shapes can be preformed with a given bend angle to
access a tissue volume.
[0351] FIG. 32 shows means of registering and locating the
treatment system with respect to the human anatomy in accordance
with embodiments. A plurality of expandable anchor 770 comprises a
first expandable anchor 772 and a second expandable anchor 774. The
first expandable anchor 772 may comprise a balloon, for example,
and the second expandable anchor 774 may comprise a second balloon,
for example. The first expandable structure can be configured to
expand in the bladder neck, and the second expandable structure can
be configured to expand within the urethra so as to contain
movement of the device.
[0352] FIG. 33 shows a plurality of expandable structures
comprising a first expandable basket 776 and a second expandable
basket 778. The expandable basket can be permeable or nonpermeable
and can be expanded to allow anchoring. The nonpermeable basket can
inhibit fluid flow through the urethra, while the permeable
expandable basket can allow fluid flow through the urethra and
between the urethra and the bladder.
[0353] The plurality of expandable structures can have the benefit
of limiting movement of the probe, both from the bladder toward the
urethra and also movement from the urethra toward the bladder neck,
so as to effectively lock the anchor in place.
[0354] FIG. 34 shows means of registering the system with respect
to the human anatomy. For example, a plurality of expandable
anchors 770 may comprise a first expandable anchor 777 and a second
expandable anchor 779. The first expandable anchor 777 may comprise
a balloon or a basket, for example. The expandable anchor 777 is
used to position against a posterior wall of the bladder. The
second expandable anchor is positioned in the bladder neck. The
first expandable anchor and the second expandable anchor can lock
the position of the probe so as to inhibit movement. Opposing
forces can be applied manually or via robotic control.
[0355] In some embodiments, an opposing force can be applied
between the first expandable anchor and the second expandable
anchor, so as to urge the first expandable anchor toward the
bladder wall and the second expandable anchor toward the neck of
the bladder.
[0356] Additional anchoring op embodiments can be provided in
accordance with the teachings described herein. For example, a
suction means can be used for anchoring. Alternatively, sensors for
patient movement can be used. An arm can be used for anchoring.
Clamps can be provided on the groin for anchoring. Magnetic forces
can be used to hold the system in place. An attachment to tissue
can be provided with suction. Each of these provide nonlimiting
examples of anchoring means in accordance with the embodiments
described herein.
[0357] FIG. 35 shows a disposable balloon in accordance with
embodiments. The disposable balloon 780 can be threaded onto a
distal end of the carrier 382. The disposable balloon may comprise
internal threads in the tip of the balloon. Internal thread 782 can
engage external thread 784. Threaded engagement between the balloon
and the carrier can allow the balloon to be removed subsequent to
treatment and the carrier 382 can be sterilized. An inflation hole
can be provided. The inflation hole 786 allows inflation of the
balloon 780 when the balloon 780 has been threadedly engaged on the
distal tip. The disposable balloon can be sterilized individually.
The threaded attachment of the balloon can be provided to a hand
piece or to the carrier as described herein. Sealing can be
achieved with the o ring and threaded engagement. A balloon capable
of achieving a 1 to 7 collapsed to inflated ratio can be
provided.
[0358] FIG. 36 shows tissue resection and depth control in
accordance with embodiments. A live patient ultrasound image is
shown. FIG. 37 shows a visible fluid flame in saline. The visible
fluid flame in saline corresponds to the entrainment region of the
jet as described herein. The visibility of the fluid flame of the
entrainment region is provided with cavitation of small bubbles
that can produce light scattering or acoustic scattering, so as to
make the fluid flame of the entrainment region visible with imaging
by ultrasound or optical imaging, for example. The benefit of the
visible entrainment region can be for a physician to visualize the
distance of the treatment and to compare this distance with
ultrasound. FIG. 37 shows the visible entrainment region at 11
millimeters, the same size as is shown in FIG. 36. The substantial
similarity of the distance of the entrainment region corresponds to
the distance of tissue resection and removal. This experimental
result showing the visualization of the entrainment region can
provide for a safer treatment. Merely by way of example, the flow
parameters used with the images shown in FIGS. 36 and 37 comprise a
flow rate of approximately 130 milliliters per minute and a nozzle
back pressure of approximately 2700 psi. The configuration of the
nozzle on the carrier comprise a first liquid emitted with a
divergent stream as described herein into a second fluid so as to
provide the divergent stream. The second fluid comprises a
liquid.
[0359] A physician when treating a patient, can use a live patient
ultrasounds, for example, transrectal ultrasound (hereinafter
"TRUS") as described herein. The physician can do the ultrasound in
the entrainment region from the probe tip. This can be used to
determine the appropriate parameters to treat the patient. For
example, the physician can adjust the pressure so as to limit the
depth of penetration of the probe tip such that the probe tip does
not release energy to cause cutting outside of the organ, for
example, beyond the sack of the organ such as the sack of the
prostate. The image of FIG. 36 shows on the left hand side of the
image a structure corresponding to an expandable balloon and the
arrows show the 11 millimeter dimension. FIG. 37 is an optical
image showing a similar distance of the entrainment region. The
sweeping motion of the stream shown in FIG. 36 can be used to
adjust the treatment to be contained within the prostate.
[0360] FIG. 38 shows tissue resection depth control in accordance
with embodiments. Live patient ultrasound from the patient is shown
in FIG. 38 similar to FIG. 37, but with increased back stream
pressure to the nozzle.
[0361] FIG. 39 shows an optical image of the fluid flame in saline
showing the entrainment region with a different pressure. The
pressure flow parameters for FIGS. 38 and 39 comprise an
approximate flow rate of 205 milliliters per minute and the nozzle
back pressure of approximately 5760 psi. The corresponding tissue
resection depth is approximately 16 millimeters. The live patient
ultrasound image shows an entrainment region of 16 millimeters
similar to the entrainment region seen optically. The sweeping
motion of the probe and the fluid stream emitted from the probe as
seen on the left hand side of the image can be used to set the flow
parameters and pressure so as to treat the patient safely with
ultrasound images of the entrainment region.
[0362] FIG. 40 shows nozzle flow rate versus maximum penetration
depth for a plurality of pressures and nozzles. The flow rate in
milliliters per minute is shown. The maximum penetration depth is
also shown as a function of the flow rate. 130 micron nozzle shows
a tissue penetration depth with diamonds and the 150 micron nozzle
is shown with X's. The tissue penetration depth can be used based
on the teachings described herein to set the flow rate parameters
for treatment. For example, for a treatment to a maximum
penetration depth of 12 millimeters or 130 micrometer nozzle, a
flow rate of 150 milliliters per minute is selected. Similarly, for
the 150 micron nozzle, a flow rate of 200 milliliters per minute is
selected. A person of ordinary skill in the art can construct
software to automatically identify a nozzle for treatment based on
depth and also to identify a flow rate suitable for treatment based
on depth. In addition, the flow rate can be varied based on the
tissue profile as described herein. For example, tissue treatment
profiles based on axial and sagittal images as described
herein.
[0363] FIG. 41 shows nozzle back pressure versus maximum depth of
penetration. Maximum penetration in millimeters is shown as a
function of nozzle pressure in psi for both 130 micron nozzle and
150 micron nozzle. Based on the identified nozzle size and tissue
penetration depth, the software or user can identify an appropriate
nozzle pressure to treat the patient.
[0364] FIG. 42 shows nozzle flow rate versus back pressure for 130
micron nozzle and 150 micron nozzle. The pressure and flow rate are
shown. For a flow rate, the flow rate is shown in milliliters per
minute and the pressure is shown in psi. The flow rate can be from
about 100 milliliters per minute to about 250 milliliters per
minute, and the pressure can be from under 1000 psi to as high as
4000 psi or, for example, 8000 psi. In specific embodiments, the
flow rate with a larger diameter nozzle is approximately linear
with the pressure and the flow rate with the 130 micron nozzle is
approximately linear with pressure. These relationships of flow
rate and pressure can be used to appropriately set the pressure for
treatment for desired flow rate. Furthermore, these flow rate
pressure relationships can be non-linear when the range is expanded
to lower values, or higher values, or both. Alternatively or in
combination, the flow rate pressure relationships can be non-linear
when different nozzles with different characteristics are used, for
example.
[0365] A person of ordinary skill in the art can use the one or
more of the nozzle pressure, cut depth and flow rates to resect
tissue to a predefined profile and volume as described herein.
[0366] Ablation Monitoring with Acoustic Measurements
[0367] In many embodiments, an acoustic probe can be used to
monitor the ablation. The probe can be coupled to the patient in
one or more of many ways, for example placed on a limb or body of
the patient and coupled to the skin of the patient with a gel.
[0368] In many embodiments, the ablation monitor comprises an
acoustic sound analyzer. The sound analyze may comprise an acoustic
sensor such as a hydrophone located in one or more of the
Aquablation.TM. probe 450, the handpiece, the rectum of the patient
or external to patient, such that sound emitted by the
Aquablation.TM. system and the corresponding interaction with the
prostate can be measured. The processor system may comprise
instructions to determine one or more the following parameters:
[0369] a. Depth of tissue penetration
[0370] b. Volume removed (with a trend towards lower
frequencies)
[0371] c. Flow rate (cavitation/fluid flame is extremely loud and
can be characterized)
[0372] d. Perforation (a jet that is not contained emits a
different sound)
[0373] e. Tissue densities (cancer, adenomatous tissue, surgical
capsule)
[0374] Examples of actual decibel data are disclosed herein with
reference to the following figures.
[0375] FIG. 43 shows a frequency spectrum of a jet configured to
cut tissue in saline without striking tissue. FIG. 43 shows
frequencies of sound from 25 Hz to 12.5 kHz, and a cumulative
total. The cumulative total is approximately 95 dB. Frequencies up
to the 80 Hz band are below 40 dB. Frequency bands from about 100
to 250 Hz are below 60 dB. Frequency bands of about 315 Hz and
above are at least about 60 dB.
[0376] FIG. 44 shows a frequency spectrum of the jet as in FIG. 43
ablating tissue, in which the frequency spectrum has an increase in
high frequency components corresponding to the ablation of tissue.
The cumulative total is approximately 95 dB. The intensity
increases of the frequency bands show a general trend of increasing
with frequency, with greatest intensity around 4 to 12.5 kHz of
about 85 dB. Frequencies up to the 80 Hz band are below 30 dB.
Frequency bands from about 100 to 250 Hz are below 50 dB. Frequency
bands of about 315 Hz and above are at least about 50 dB. An
acoustic intensity peak is located within a range of frequencies
from about 2 to 5 kHz, for example within a range from about 2.5 to
4 kHz, at about 3.15 kHz.
[0377] These data show trends suitable for incorporation in
accordance with embodiments, which include one or more of: the
intensity peak for tissue ablation located within a range of
frequencies from about 2 to 5 kHz; decreased intensity of low
frequencies near about 100 Hz during ablation; and a peak intensity
over 100 dB, for example.
[0378] The measured frequencies may comprise one or more
frequencies within a range from about 0 to 180 kHz, for example.
The above frequency spectra are provided in accordance with some
embodiments, and a person of ordinary skill in the art will
recognize that many frequencies can be measured and the intensity
of many frequency bins determined, for example for frequencies up
to about 200 kHz.
[0379] The processor system as described herein may comprise one or
more instructions to measure the acoustic signal during treatment.
The processor system may comprise a frequency analyzer to measure
frequency components of the acoustic spectrum. The acoustic signal
comprises several frequencies with greater intensities. For
example, each frequency band from 2 kHz to about 12.5 kHz has an
intensity greater than 90 dB when the jet ablates tissue and each
of these intensities is below 90 dB when the jet having the same
flow parameters is placed in saline with cavitation to provide a
cool flame as described herein. The cumulative acoustic intensity
is about 95 dB when the jet is placed in saline and about 108 dB
when the probe ablates tissue.
[0380] Based on the measurements disclosed herein, a person of
ordinary skill in the art can configure to processor system to
monitor for perforation of tissue based on a decrease in the
intensity of the measured acoustic signal when the flow of the jet
remains substantially constant.
[0381] Work in relation to embodiments suggests that different
tissue types provide different frequency signatures, and a person
of ordinary skill in the art can conduct experiments to determine
the acoustic frequencies of each of a plurality of tissue types in
response to the cutting jet in order to determine the type of
tissue being ablated with real time monitoring. Types of tissue
that can be monitored and for which ablation can be detected
acoustically include one or more of: prostate tissue, benign
prostate hyperplasia tissue, prostate capsule tissue, and carcinoma
prostate tissue. A person of ordinary skill in the art can conduct
experiments to determine the frequency characteristics of tissue as
described herein in order to determine the type of tissue and one
or more tissue removal parameters as described herein, such as:
[0382] a. Depth of tissue penetration
[0383] b. Volume removed (with a trend towards lower
frequencies)
[0384] c. Flow rate (cavitation/fluid flame is extremely loud and
can be characterized)
[0385] d. Perforation (a jet that is not contained emits a
different sound)
[0386] e. Tissue densities (cancer)
[0387] FIG. 45 shows pressure regulation of the surgical site with
a substantially constant pressure and variable flow. The saline bag
is placed at a height to provide substantially constant pressure
regulation. The bag of saline can be placed at a height
corresponding to about 50 to 100 mm of Mercury (hereinafter
"mmHg"). The saline bag is coupled to the irrigation port as
described herein. A collection bag is coupled to one or more of the
irrigation port, the aspiration port, or the suction port as
described herein. The collection bag collects tissue removed with
the water jet ablation probe 450 as described herein.
[0388] FIG. 46 shows flow fluidic regulation of the surgical site
with a pump providing a substantially fixed fluidic flow. A pump
removes fluid from the surgical site at a substantially fixed flow
rate. The pump may comprise a peristaltic pump, for example. The
pump is configured to remove fluid at the substantially the same
rate or greater than Aquablation.TM. saline flow rate, in order to
inhibit pressure build up at the surgical site. The peristaltic
pump can be coupled to the aspiration port of the manifold
comprising tissue removal port 456C as described herein, for
example. Providing the pump having the flow rate that is at least
the flow rate of the tissue ablation jet provides improve suction
as ablated tissue that might otherwise block the tissue removal
openings and channel can be subjected to greater amounts of
pressure when the pump maintains the substantially fixed flow rate
in order to remove the material that would otherwise block the
channel.
[0389] The irrigation flow from the saline bag may remain open in
order to provide at least two functions: 1) maintain pressure based
on the height of the saline bag; and 2) provide a safety check
valve in case the peristaltic pump is not functioning correctly as
visually a person would see flow entering the bag as a pink
color.
[0390] In alternate embodiments, the flow of the pump comprises a
variable rate in order to provide a substantially constant pressure
within the patient near the surgical site. The active sensing of
pressure of the treated organ and variable flow rate of the pump
may comprise a closed loop pressure regulation system. The pump can
be coupled to a sensor such as a pressure sensor, and the flow rate
varied to maintain substantially constant pressure. The pressure
sensor can be located in one or more of many places such as on the
treatment probe, within the aspiration channel of the probe, in a
recess of an outer surface the probe, on an inner surface of the
probe coupled to the surgical site, or near the inlet to the pump
on the console for example.
[0391] Imaging of the Treatment Site
[0392] Transrectal Ultrasound
[0393] Transrectal ultrasound as described herein can be used to
probe images of the target tissue site. The images can be used for
one or more of treatment planning or real time monitoring of the
treatment site as described herein.
[0394] Transurethral Ultrasound
[0395] The transurethral ultrasound probe can be introduced into
the patient through the urethra alongside or within the
Aquablation.TM. treatment probe 450 for one or more of planning or
real-time viewing of treatment as described herein. The ultrasound
probe can be similar commercially available an intravascular
ultrasound (hereinafter "IVUS") probe and an endobronchial
ultrasound (hereinafter "EBUS") probe. The US probe can be placed
in a working channel of the stiff sheath or ultrasound probe, for
example. Alternatively or in combination, the US probe can be
attached to the treatment probe 450 such that the US probe one or
more of translates, rotates, or oscillates with the treatment probe
450, such that synchronous movement of the treatment probe 450 and
US probe can be provided. These embodiments are not dependent on a
separate TRUS probe whose images can be dependent on accurate and
optimal user placement within the rectum. Work in relation to
embodiments suggests that transrectal ultrasound can distorts the
prostate and resulting images, both of which may be related to
compression of tissue as the TRUS probe is advanced into the
patient.
[0396] FIGS. 47A and 47B show a transurethral treatment probe 450
having an ultrasound array 900 located near the fluid release
element 320 to image the treatment site with ultrasound. The
treatment site can be imaged in real time as described herein, for
example. The ultrasound array on carrier 380 moves with the fluid
release element 320 such that the ultrasound image moves with the
fluid release element comprising nozzle 322 as described herein.
The ultrasound array can provide one or more of axial or sagittal
images as described herein. For example, the array 900 may extend
along an elongate axis of the carrier 380 to provide a B-scan slice
radially outward from the probe and extending along the elongate
axis as shown in FIG. 47A. The array 900 can be rotationally
aligned with the fluid release element such that the array 900 is
oriented toward the treatment site when the carrier 380 of probe
450 rotates. The carrier can be rotated around the elongate axis to
provide tomographic images of the treatment site. Alternatively or
in combination, the array 900 can extend circumferentially around
the carrier 380 as shown in FIG. 47B, so as to provide axial images
of the treatment site, and the probe can be translated along the
elongate axis to provide 3D tomographic images of the target tissue
as described herein.
[0397] Doppler Ultrasound
[0398] Doppler ultrasound can be used to provide a velocity
measurement profile of the jet. Doppler ultrasound be could be used
to see where the flow of the jet is slowing down or stopping in
order to determine real-time depth of penetration. The Doppler
ultrasound may comprise a spatially resolved Doppler ultrasound
probe in order to determine the velocity distribution profile at
each of a plurality of locations of the image. For example, the
transaxial images as described herein may comprise two dimensional
Doppler ultrasound images in which the pixels of the ultrasound
image are color coded with the velocity of the jet, for example.
Alternatively or in combination, the longitudinal (sagittal) images
as described herein may comprise two dimensional Doppler ultrasound
images in which the pixels of the ultrasound image are color coded
with the velocity of the jet, for example.
[0399] Fluoroscopy
[0400] Fluoroscopic imaging can be used to visualize one or more
of: the depth, shape of resected volume, or flow rate during
Aquablation.TM. with probe 450, for example. A radiographic dye can
be placed within the fluid jet saline, in order to clearly
visualize depth, shape of resected volume, flow rate during
Aquablation.TM., for example. If there is a perforation, the breach
of the capsular portion of the prostate can be clearly
visualized.
[0401] Thermal Imaging
[0402] Thermal imaging can be used to view the treatment site, as
an alternative or in combination with endoscope viewing as
described herein. During Aquablation.TM., the user may have
difficulty visualizing that jet and the tissue penetration depth,
in part related to the tissue removal of the fluid stream. In many
embodiments, the water jet comprising the entrainment "flame" has a
higher temperature than the surrounding fluid due to the high
friction through the nozzle. Temperatures can range from about 90
to about 100 degrees Fahrenheit. Using thermal imaging, the flame
comprising the entrainment region can be visualized as well as the
tissue depth based on where the flame truncates and disappears upon
contact with the surface of the tissue. As cancerous tissue may
comprise a different tissue perfusion rates than non-cancerous
tissues, cancerous regions of the prostate can be identified based
on the differences in perfusion.
[0403] FIG. 48A shows a user interface 500 shown on a display
screen with treatment input parameters and treatment monitoring
parameters. The user interface 500 comprises one or more components
as described herein, for example as described herein with reference
to FIGS. 17A to 19A. The user interface 500 may provide a real time
user adjustment of angles 593 of the treatment profile. The real
time user adjustment of the treatment profile allows the physician
to adjust the treatment in real time in response to real time
images of the tissue at or near the treatment site. The image 510
of the treated organ such as the prostate may comprise a
representation of the urethra of the patient, and the cross
sectional size such as the diameter can be adjusted to represent
the size of the urethra of the patient. The estimated volume of the
resected tissue can be shown on the display. Alternatively or in
combination, the estimated mass of the tissue to be resected can be
shown on the display. The user interface 500 can be updated in real
time to show the user the amount of tissue resected as the
treatment proceeds and the amount can be expressed a percentage of
the treatment completed. The user interface may comprise a user
selectable input that allows the resection to proceed in reverse,
for example if the treatment has not completed ablated the target
tissue along a portion of the treatment profile, of if the
physician believes additional tissue should be removed, for example
in response to real-time ultrasound images.
[0404] The user interface may comprise a pump input parameter 583
related to the power of the pump that can be used to adjust the
distance of the "cool flame" as described herein, for example. The
pump input parameter may comprise a parameter related to one or
more of a power, a flow rate, a depth (in mm), or a pressure of the
pump, for example. The input may comprise a number, a letter, a
level, a radial button or other input, for example.
[0405] The user interface may comprise a patient identifier
(hereinafter "patient ID") input. The patient ID input can be used
to identify the patient and may comprise data used to identify the
patient, such as a name, hospital ID, or other data, for
example.
[0406] FIG. 48B shows a user interface as in FIG. 48A with a
real-time ultrasound image 510 of the treatment site, in which the
treatment profile 520 is displayed with the real time ultrasound
image. The treatment profile 520 can be aligned with the real time
image 510 as shown on the display, in order to allow the physician
to ensure that the treatment is correctly aligned with the
patient.
[0407] The image 510 shown on the display may comprise a real time
image as described herein, such as a real time ultrasound image as
described herein, for example. The real time ultrasound image may
comprise an image from a TRUS probe, in which the TRUS probe moves
in synchrony with the treatment probe to align the TRUS probe axial
section with the ablation site where the jet contacts tissue.
Alternatively or in combination, the ultrasound probe can be
mounted on the treatment probe and move rotationally and
translationally with the probe.
[0408] The radial marker 557 is shown on the display in alignment
with the location of the jet in real time, such that the position
of radial marker 557 corresponds to the location of the jet shown
in the image. The radial marker 557 can be seen to oscillate on the
screen to and from left and right sides of the patient.
[0409] In many embodiments, the user interface 500 comprises an
angle offset for the physician to align the axial ultrasound image
with an axis of the patient such as a midline of the patient. In
some embodiments, the probe can be inserted into the patient with
an angular mis-alignment of the probe and the patient, and the
angular offset can be adjusted to compensate for the errors in the
angular alignment of the probe with the patient.
[0410] The user interface 500 may comprise a foot pedal assembly
589. The foot pedal assembly 589 comprises one or more foot pedals
and may comprise a plurality of foot pedals. The plurality of foot
pedals may comprise a left foot pedal 589L, a middle foot pedal
589M and right foot pedal 589R, for example. While the foot pedal
assembly can be configured in one or more of many ways, in many
embodiments the foot pedal assembly is configured with the left
pedal to decrease the depth of penetration of the entrainment flame
of the water jet, a right food pedal to increase the depth of
penetration of the entrainment flame of the water jet, and a middle
foot pedal to pause and resume the procedure in a toggle
configuration. In many embodiments, the foot pedal assembly 589
comprises a cord that extends to an input of the processor.
Alternatively or in combination, the foot pedal assembly may
comprise a wireless interface to couple to the processor system as
described herein.
[0411] Alignment of Treatment Probe for Embodiments without a
Distal Anchor
[0412] In many embodiments, the treatment probe 450 can be provided
without a distal anchor such as an anchoring balloon. This
configuration allows fluid to flow into out of the bladder without
increasing pressure and distension of the bladder. In many
embodiments, the treatment reference location 536 corresponds to a
location adjacent the bladder neck Reference location 536
corresponding to an end portion of the prostate adjacent the
bladder neck. The end of the prostate can be aligned with the end
526 of the treatment profile 20, in which the treatment profile is
shown aligned with the axis 451 of the treatment probe as described
herein. Alternatively or in combination, real time imaging of the
prostate can be used to align the treatment reference location with
a reference location of the prostate.
[0413] FIGS. 49 and 50 show a side view and an isometric view,
respectively, of a stiff sheath over a transrectal ultrasound probe
to inhibit changes in tissue shape as the elongate ultrasound probe
moves along an elongate axis of the ultrasound probe. Insertion of
the TRUS probe 460 into the patient can induce changes in the shape
of the tissue when the probe is advanced. A stiff sheath can be
provided on the TRUS probe such that the shape of the prostate and
tissue near the prostate is not altered by axial movement of the
TRUS probe along an elongate axis of the TRUS probe when the sheath
remains substantially fixed. As the TRUS probe can be moved axially
within the stiff sheath that engages the colon of the patient. As
the stiff sheath engages the wall of the colon of the patient and
separates the TRUS probe from the wall of the colon, the TRUS probe
460 can be moved axially without altering the shape of the patient
tissue near the probe, such as the tissue of the prostate, for
example.
[0414] The stiff sheath comprises a rounded distal end portion that
can be spherical or oval in shape for advancement into the patient.
The rounded distal end portion can be stiff, or deflect slightly
when advanced, for example. The stiff sheath may comprise at least
a tubular portion that has stiffness to add rigidity and define a
chamber within the sheath when the distal end of the TRUS probe is
away from the distal end of the sheath. The chamber extends axially
between a distal end of the TRUS probe and a distal end of the
stiff sheath, and radially between the cylindrical side of the
sheath.
[0415] The elongate axis of the stiff sheath and the TRUS probe can
be aligned with the elongate axis of the treatment probe 450. The
stiff sheath can be fixed to a locking arm, and in many embodiments
is provided in an assembly coupled to the transurethral sheath,
such that the elongate axis of the TRUS probe is substantially
parallel to the elongate axis of the treatment probe. The TRUS
probe 460 can be moved axially with the treatment probe 450 such
that the TRUS probe images the treatment site and the water jet
striking tissue as the treatment probe moves along its own elongate
axis. This spaced apart axial configuration of the sheath with the
treatment probe 450 can inhibit changes in the shape of tissue as
the treatment probe 450 and TRUS probe 460 move together axially
and the sheath remains substantially fixed.
[0416] The stiff sheath can be configured to provide ultrasonic
coupling material between the sheath and the TRUS probe to provide
ultrasonic coupling of the TRUS probe to the prostate tissue with
the stiff sheath extending therebetween. The stiff sheath comprises
a closed end to inhibit deposition of fecal material in the chamber
within the stiff sheath. The chamber of the sheath comprises a
container having a variable volume as the TRUS probed is moved
axially. As the TRUS probe is advanced distally, the volume of the
container increases. As the TRUS probe is retracted proximally, the
volume of the container defined with the sheath and the TRUS probe
increases. A fluidic coupling channel is provided to couple fluid
of the container within the sheath to a second container, such that
US coupling fluid can be contained within the sheath as the volume
changes. The second container comprises a sealed container such as
a bag or syringe for example. The second container is configured to
provide a variable volume and remain sealed, for example. The
coupling channel may comprise an external channel outside the
sheath, such as a tube, and an internal channel within the sheath
such as an inner channel defined with an inner wall of the stiff
sheath. The inner wall of the stiff sheath may comprise a stiff
barrier material that defines the coupling channel, for example.
Alternatively or in combination, the inner channel may comprise a
groove on an inner surface of the stiff sheath to allow US coupling
material to flow between the TRUS probe and the stiff sheath. The
coupling channel extends to an opening near the distal end of the
stiff sheath, such that the distal end of the TRUS probe can be
placed near the distal end of the stiff sheath.
[0417] In many embodiments, axial movement of the TRUS probe is
provided by axial movement of the linkage 430 as described herein.
The axial movement of the TRUS probe provided by linkage 430
results in axial movement of the distal end of the TRUS probe in
relation to the distal end of the stiff sheath. The stiff sheath
can be fixedly coupled to a support that is coupled to an arm lock
as described herein, such that the stiff sheath is locked with the
sheath inserted transurethrally into the patient.
[0418] Sheath Docking System
[0419] FIGS. 51A and 51B shows a sheath docking system for
positioning and fixating the sheath, such that a plurality of
instruments and instrument delivery systems can be interchanged
without the frame of reference changing as described herein. The
docking mechanism attaches to commercially available articulating
arm that mounts to a surgical bed rail or other support structure
attached to the patient support.
[0420] FIG. 51A shows a docking structure 467 configured to engage
a protrusion 461 extending from a manifold 468 in order to hold the
stiff sheath 458 in place for the surgery. The protrusion 461
comprises a locking structure 463 on the distal end portion to
engage the docking structure 467 which may comprise a docking
mechanism. The locking structure 463 may comprise an annular
channel extending circumferentially around the distal end portion
of the protrusion. The mechanism of the locking structure 467 may
comprise a ring shaped structure or protrusions to engage the
annular ring of the locking structure 463.
[0421] FIG. 51B shows the docking structure engaging the stiff
sheath 458 with the docking structure in order to support and
inhibit movement of the stiff sheath during treatment, in which the
docking structure is coupled to a lockable arm 442 as described
herein. The lockable arm may comprise an arm lock 427 as described
herein. The arm lock 427 may comprise a manually operated arm that
can be manually locked by the user. Alternatively or in
combination, the arm lock may comprise a computer controlled arm
lock 427 that locks arm 442 in response to user input at user
interface 500 as described herein.
[0422] The manual arm lock may comprise a user manipulated
structure to release the docking structure 467 from the protrusion
461.
[0423] The imaging probe 460 may comprise a similar arm and locking
structure as described herein.
[0424] Dynamic Probe Tip for Support with Tissue
[0425] FIGS. 52A and 52B show isometric and cross-sectional views,
respectively, of a treatment probe 450 comprising an elongate
support structure 840 having a dynamic tip 841. The treatment probe
450 comprises a carrier 380 as described herein contained within
elongate support structure 840. The elongate support 840 is
rotationally coupled to the manifold as described herein so as to
allow rotation around an elongate axis of the support 840. The
carrier 380 as described herein rotates the elongate support 840 in
order to provide 360 degree rotational access while support
structure 840 contacts tissue to support the probe. An aspiration
opening 836 of channel 835 is provided on the tip of the support
840. The cross-sectional shape of support 840 can be one or more of
many shapes and can be tubular, rectangular, square, oval or
elliptical, for example. The lumen comprising channel 835 within
support 840 provides aspiration distal to the jet from within the
bladder, for example. In many embodiments, support 840 is sized to
extend from a distal end of slot 842 to permit placement of the
distal end comprising aspiration opening 836 within the bladder
neck.
[0426] A distance from the distal tip of the support 840 to the
stiff sheath 458 remains substantially constant when the support
840 rotates with rotation of carrier 380 about an elongate axis 848
in response to movement of linkage 430. A key 842 on probe carrier
380 fits within a slot 842 defined with support 840. The key 842 on
the probe carrier 380 drives the dynamic tip of elongate support
840 in rotation around the elongate axis and partially occludes
slot in order to reduce aspiration through the slot. The cross
sectional area of the support 840 probe that defines channel 835
extending to distal opening 836 provides an aspiration path in
order to aspirate material from the treatment site with the distal
end of the probe. The slot 844 is sized to allow translation of
carrier 380 along the elongate axis 848 with movement of linkage
380.
[0427] An irrigation channel can be provided to urge debris away
from the viewing port in order to view the treatment site when
tissue is ablated with the probe. In many embodiments, the
irrigation channel comprises a channel 846 sized to receive a
telescope or endoscope as described herein. The channel 846 can be
coupled to the manifold and locking arm as described herein in
order to fluidically couple the telescope channel with a source of
irrigation fluid such as saline and hold the telescope in a
substantially fixed configuration when the carrier 380 rotates and
translates. In many embodiments, the channel 846 is size to receive
the endoscope and provide a path for fluid. Alternatively or in
combination, one or more channels 849 can be sized to pass
irrigation fluid to an opening near the distal end of the
endoscope.
[0428] Providing irrigation to the endoscope channel has the
advantage of urging ablated material away from the treatment site
toward the opening on the distal end of the support structure. The
ablated material and can decrease visibility of the treatment site,
and urging the material away from the endoscope and treatment site
toward the distal end of the treatment probe 450 can substantially
increase visibility of the treatment site as viewed by an operator
through the endoscope.
[0429] Venturi Aspiration
[0430] FIG. 53 shows venturi aspiration (with arrows) into the
treatment probe 450 with an opening 812 of a venturi channel 810
configured to receive fluid. The venturi channel 810 may comprise
an auxiliary channel located on the moving treatment probe 450
probe near the nozzle 322 of the fluid delivery element 320 that
forms the ablative jet as described herein. High fluid stream
velocity of the waterjet provides a local low pressure zone. The
localized zone of low pressure can be used to provide or enhance
aspiration flow into an opening 812 of an auxiliary channel 810. In
many embodiments, the jet of the fluid stream can be directed
proximally in order to increase effect. For example, with the jet
oriented proximally and the venturi aspiration channel 810
extending proximally from opening 812 located near fluid delivery
element 320 and nozzle 322, substantial amounts of fluid can be
aspirated through venturi channel 810. The venturi channel 810 can
be coupled to a tissue removal port of the manifold such as fluid
removal port 456C as described herein, or another port of the
manifold 468 as described herein, for example.
[0431] Cauterizing Treatment Probes
[0432] The plurality of treatment probes provided with the system
as described herein may comprise one or more cautery probes
configured for insertion along an interior of the sheath 468 as
described herein.
[0433] FIG. 54 shows one or more radio frequency (hereinafter "RF")
electrodes 820 on a cautery probe 825 configured to rotate around
an elongate axis of the probe 825 in order to cauterize tissue. The
one or more electrodes 820 can be connected to a source of
electrical energy with wires extending along the elongate shaft of
probe 825. The one or more RF electrodes can be rotated at least
partially around the elongate axis to cauterize the tissue. The
cautery can be performed subsequent to removal with one or more of
the water jet or the light energy, for example.
[0434] FIG. 55 shows one or more electrodes 820 comprising one or
more bipolar electrodes 824 configured to rotate around an elongate
axis of a cautery probe in order to cauterize tissue.
[0435] The one or more electrodes as described herein comprise a
resiliently deformable conductive material such that the electrodes
can be advanced along the sheath in a narrow profile configuration
and expand to a wide provide configuration when advanced beyond the
distal end of the sheath. The resiliently deformable conductive
material may comprise a metal such as stainless steel or nitinol,
for example. Subsequent to cauterizing the tissue, the electrodes
can be drawn away from the treatment site and urged to the narrow
profile configuration in order to remove the electrodes from the
probe.
[0436] The cautery treatment probe 825 can be coupled to the
linkage 430 and configured to rotate under processor and software
control as described herein, in a manner similar to the water jet
probes, for example. Alternatively, the cautery treatment probe can
be manually advanced and rotated when energized to cauterize tissue
by the user such as a physician.
[0437] Integrated Irrigation and Aspiration Probes
[0438] In many embodiments, one or more of the irrigation or
aspiration can be integrated into the treatment probe 450
comprising carrier 380 and corresponding components as described
herein, for example. In many embodiments, the integrated irrigation
and aspiration probes are used without an anchor, for example.
Alternatively, the integrated probes can be used with an anchor as
described herein.
[0439] FIGS. 56 and 58 show an integrated tissue treatment probe
450 having aspiration and irrigation integrated into the probe.
[0440] FIG. 58 shows an integrated treatment probe having an
aspiration opening and an irrigation opening on a distal end to
aspirate through the aspiration opening and irrigate through the
irrigation opening, in which the probe has been placed in a stiff
sheath with an endoscope to view the treatment, in accordance with
embodiments;
[0441] The treatment probe 450 may comprise an internal aspiration
channel 835 and an internal irrigation channel 831. The internal
irrigation channel 831 can extend to an irrigation opening 832 on
the distal end of the probe 450. The internal aspiration channel
835 can extend to an aspiration opening 836 on the distal end of
the probe 450, for example. The proximal end of treatment probe 450
and the distal end of the treatment probe can be moved with linkage
430 as described herein. The proximal end of the treatment probe
450 comprises an outlet 837 coupled to opening 836 with channel 835
to remove fluid and ablated material. The proximal end of the
treatment probe 450 comprises an inlet 833 coupled to opening 832
with channel 831 to provide irrigation fluid. The proximal end of
the probe comprises a high pressure inlet 830 to receive fluid for
the cutting beam. The inlets, the outlet and the openings on the
distal end and fluid delivery element 320 are driven together with
linkage 430. The treatment probe 450 can be rapidly exchanged as
described herein.
[0442] An irrigation port 830 can be coupled to the working channel
that receives the endoscope as described herein. The irrigation
along the working channel that receives the endoscope has the
advantage of urging ablated material away from the distal end of
the endoscope and away from the treatment site toward the distal
end of the probe to improve visibility of the treatment site. The
irrigation port 830 may comprise a port of manifold 468 as
described herein, for example. The manifold can be fixed with an
arm as described herein.
[0443] One or more optical fibers can extend to the fluid delivery
element to couple light energy as described herein.
[0444] FIG. 57 shows an integrated treatment probe 450 with
aspiration opening 836 for fluid suction on a distal end, in which
the probe has been place in stiff sheath with an endoscope to view
the treatment. The probe comprises one or more components of the
treatment probe 450 as described herein. In many embodiments, the
linkage 430, sheath 458, probe 450, and the endoscope are supported
with a support 839 coupled to the lockable arm as described
herein.
[0445] Plurality of Carriers and Probes Having Different Jet
Angles
[0446] FIGS. 59A, 59B and 60 show nozzle angles of a plurality of
treatment probes. The plurality of probes may comprise a plurality
of carriers 730 as described herein, for example with reference to
FIGS. 27A and 27B. Each of the plurality of carriers comprises a
fluid delivery element 320 with nozzle 322 as described herein and
can be configured to deliver light energy with an optical fiber as
described herein. A first carrier 380 can deliver a first fluid
stream at a first angle 732 to the elongate axis of the carrier 380
as shown in FIG. 59A. A second carrier 380 can deliver a second
fluid stream at a second angle 734 to the elongate axis of the
carrier 380 as shown in FIG. 59B. A third carrier 380 can deliver a
third fluid stream at a third angle 737 to the elongate axis of the
carrier 380, for example at an angle extending along the elongate
axis of the third carrier 380 as shown in FIG. 60. Additional
carriers can be provided having angles as described herein.
[0447] In many embodiments, the sheath 458 and treatment probe 450
are provided without a distal anchor. Each of the plurality of
carriers 730 can be configured to extend from the distal end of the
sheath without anchoring, for example. The treatment probe can be
rotated around the elongate axis and translated as described herein
in order to remove tissue. A probe 450 from among the plurality of
probes comprising the plurality of carriers 730 can be selected by
the treating physician to have an appropriate angle relative to the
elongate axis of the shaft as described herein. The angle of the
nozzle of the fluid delivery element can be oriented with respect
to the elongate axis of the carrier to provide the fluid stream
oriented at the angle with respect to the elongate axis of the
carrier 380 and the elongate axis of the sheath 458.
[0448] Concentric Treatment Probe
[0449] FIGS. 61, 62 and 63 isometric, side and cross-sectional
views, respectively of a treatment probe 450 having a viewing path
substantially concentric with rotation 852 of a nozzle of a
treatment jet. In many embodiments, rotation of the endoscope
viewing path around an elongate axis 848 of the endoscope and probe
450 is substantially inhibited when the jet rotates around the
elongate axis 854 with rotation 852, in order to allow the user to
view the treatment site when the probe rotates. In many
embodiments, a round cross section of sheath 458 allows for full
360 degree viewing and treatment. Irrigation and aspiration can be
incorporated into an intermediate carrier 880 as described herein.
Motion can be provided with intermediate carrier 880 coupled to the
linkage 430 as described herein. The endoscope viewing camera can
be fixed or slidably coupled to the arm or other support structure
to inhibit rotational movement of the endoscope around axis 848.
Alternatively or in combination, the endoscope can be configured to
slide along axis 848 with carrier 880 when rotation 852 about axis
848 is inhibited, for example. In many embodiments, the linkage 430
is decoupled from the endoscope such that the user can slide the
endoscope to a desired location to view the treatment site or an
anatomical landmark, for example.
[0450] The intermediate carrier 880 is configured to provide one or
more of irrigation, aspiration, rotation of the fluid release
element 320 about axis 848, or rotation of an optical fiber coupled
to the fluid release element as described herein. The intermediate
carrier 380 comprises channel 831 extending from inlet 833 to
opening 832 for irrigation, and each of these structures may rotate
about axis 848. The intermediate carrier 380 comprises channel 835
extending from outlet 837 to opening 836 for aspiration of ablated
material from the treatment site, and each of these structures may
rotate about axis 848.
[0451] In many embodiments, the intermediate carrier 880, supports
the carrier 380 as described herein, for example with reference to
FIGS. 30, 31A and 31B. The intermediate carrier 880 may comprise a
longitudinal channel located away from axis 848 in order to hold
the carrier 380 and provide rotation of carrier 380 about axis 848.
In many embodiments, carrier 380 is rotationally fixed to channel
882 such that carrier 380 rotates with intermediate carrier 380,
and the location the fluid release element 320 is maintained
adjacent axis 848 as the intermediate carrier 880 and the carrier
380 rotate, for example.
[0452] The linkage 380 can be configured to move the probe 450 with
rotational and translational motion as described herein. The
linkage 380 can rotate probe 450 about axis 848 with rotation 852,
and translate probe 450 along axis 848 with translation 854. The
movements of the linkage are provided to the distal end of the
probe for 450 and to the proximal components of the probe 450 such
as the high pressure saline inlet 830 from the pump, the irrigation
inlet 833, and the aspiration outlet 837 as described herein.
[0453] In many embodiments, the probe 450 comprises a rotating
probe assembly 850. The rotating probe assembly 850 comprises the
intermediate carrier 880 and corresponding structures as described
herein, the carrier 380 and corresponding structures as described
herein, and the proximal components such as the inlets and outlets
as described herein. The rotating probe assembly 850 can be rapidly
exchange with another probe as describe herein, for example. The
endoscope viewing camera can be removed prior to exchanging the
rotating probe assembly 850, or be removed with rotating probe
assembly, for example.
[0454] Sliding Endoscope Support
[0455] FIGS. 64 and 65 show an endoscope and a sliding support
structure 890 to add stiffness and guide the endoscope into the
stiff sheath. The sliding support structure 890 may comprise one or
more of a sliding telescopic mechanism, a trombone, a rail or a
receptacle 892 sized to receive an elongate structure 894, for
example. In many embodiments, the receptacle 892 comprises a
tubular support structure sized to receive an elongate tubular
structure 894, so as to provide a telescope mechanism. The support
structure 890 can be coupled to the support 839 and protrusion 461
such that the endoscope support structure 890 is coupled to the
lockable arm 422 as described herein.
[0456] In many embodiments, support 890 comprises a telescopic
structure that docks into tube that slides with respect to sheath.
High temperature, autoclaveable seal keep fluids from leaking as
the telescope slides back and forth. The auxiliary support
structure 890 can provides rigidity to the telescope used to view
the interior of the patient. The viewing telescope can be easily
positioned close to cutting jet at any time during treatment by
sliding the endoscope and elongate structure 894 of the support
structure 890.
[0457] Weight Monitoring
[0458] The weight of the fluid removed from the surgical site can
be monitored and compared with the weight of the fluid delivered to
the surgical site. For example, the saline containers for delivery
can be held by scales coupled to the processor system as described
herein, and the containers that collect fluid can be held by scales
coupled to the processor system to monitor the amount of fluid
removed from the patient. The amount of fluid and overall fluid
balance into and out of the surgical site can be shown on the
display as described herein. In many embodiments, the saline bag
for irrigation comprises a clear bag that can be monitored for the
presence of blood if the fluid removal falls below a desired amount
and blood and/or tissue enter the bag.
[0459] Single Use Structures
[0460] In many embodiments, the probe 450 comprises a single use
probe. The probe 450 may comprise one or more structures to limit
use of the probe. For example, the proximal end of the probe may
comprise optically encoded data such a bar code, laser making or
matrix two dimensional bar code such as an Aztec Code. The system
may comprise one or more optical sensors coupled to the processor
system to read the code and determine if the probe has been used
previously, for example with a memory or database of previously
used probes. Alternatively, the probe may comprise a radiofrequency
identification (hereinafter "RFID") tag, and the processor may
comprise an RFID reader to read the RFID tag on the probe. The
processor may store in computer readable memory the amount of time
that the probe has been used, and inhibit use if the probe has been
used more than a predetermined amount of time. The probe 450 may
comprise a breakable tubing where the probe connects to the pump,
such that removal of the probe requires breaking the tubing, for
example.
[0461] Partially Automated Manual Tissue Resection
[0462] In many embodiments, the ablative water jet can be
configured with a combination of at least partially manual and at
least partially automated tissue resection. For example, the
linkage, sheath and probe assembly can be disconnected from the
support arm, such that the user can manually move the probe with
one or more of endoscope visualization or ultrasound visualization
of the treatment site. The user can provide input the processor
system to remove a predefined volume of tissue as described herein,
and manually position and move the probe along the longitudinal
axis in order to treat the target tissue based on visualization of
the target area. Alternatively, the linkage can be configured to
allow the user to manually slide the probe along the longitudinal
axis to move and position the probe along the longitudinal axis in
response to the progress of the treatment as viewed with the
endoscope and/or ultrasound. The user may select this mode with
input to the user interface as described herein. The linkage that
allows the user to slide the probe axially has the advantage that
the carrier probe can remain substantially parallel to the
ultrasound probe as the user slides the probe axially.
[0463] In many embodiments, the longitudinal location of carrier
380 is determined and the TRUS probe moved into alignment with the
carrier 380 in order to view the treatment site with ultrasound. In
many embodiments, the TRUS probe is moved in synchrony with the
carrier 380 such that movement of the TRUS probe tracks movement of
the carrier 380 in order to image the treatment site when the
ablated jet erodes tissue. The encoders or other position sensors
of the linkage coupled to the treatment probe can be used to
determine the location of the treatment jet along the longitudinal
axis and this determine location can be used to drive the TRUS
probe such that the TRUS probe remains substantially aligned with
the longitudinal position of the treatment probe when the user
moves the treatment probe. Alternatively or in combination, a
detectable object such as a magnet can be placed near the end of
the carrier 380 and the location of the detectable objected
measured with a sensor on the TRUS probe such as a coil. In many
embodiments, the carrier 380 comprises a magnet placed near the
distal end of the probe, and the position of the magnet is
determined in three dimensions (3D), and the location of the
carrier 380 transmitted to the processor system. The processor
system comprises instructions to determine the location of the TRUS
probe along the elongate axis of the TRUS probe in order to align
the TRUS probe with the fluid delivery element comprising the
nozzle of the carrier 380 as described herein. While the location
of the tip of the carrier 380 can be determined in one or more of
many ways, in many embodiments the magnetic sensor comprises a
commercially available Hall effect sensor known to persons of
ordinary skill in the art. The components of the Hall effect sensor
can be mounted on the carrier 380 and the TRUS probe, for example.
In many embodiments, the TRUS probe senses the location of the
carrier 380 along the urethra and is driven along the colon of the
patient in order to align the TRUS probe in the colon with the
nozzle of the fluid delivery element on the carrier 380 in the
urethra in order to image the treatment site within the prostate of
the patient. In many embodiments, the at least one transducer 392
as described herein may comprise a magnet on the carrier tube 380
in order to transmit a magnetic field signal to the Hall effect
transducer on the TRUS probe, for example. In many embodiments, the
at least one transducer 392 is located near the tip of the carrier
380 and the Hall effect sensor is located on the tip of the TRUS
probe, for example.
[0464] FIG. 66 shows treatment probe 900 configured for at least
partially manual treatment with one or more electrodes and at least
partially automated treatment with a liquid jet. The probe 900 may
comprise the carrier 380 as described herein, and one or more
electrodes configured to move with the endoscope 394. The one or
more electrodes may comprise a monopolar electrode 912, for
example, and the monopolar electrode 912 may comprise a
radiofrequency (hereinafter "RF") electrode. The carrier 380 can be
configured to rotate with an automated rotation 854 about the
elongate axis of the treatment probe 900 when the one or more
electrodes and endoscope do not rotate, for example. The amount of
rotational movement 852 can be user determined with adjustment of
the user interface. The sheath 458 can be manually positioned in
the patient as described herein, and the sheath 458 and one or more
electrodes 910 manually rotated together and in combination with
the automated rotation of the probe 380. In many embodiments, a
handle is connected to the sheath to allow manual manipulation. The
user can advance the sheath manually or actuate a sliding mechanism
to move the carrier 380 with an axial movement 854. A torque cable
can extend to the handle to automatically rotate the carrier 380
under computer control, for example. Alternatively or in
combination, the user can rotate the sheath 458 in order to rotate
the distal end of the carrier 380 with rotational movement 852.
[0465] FIG. 67 shows treatment probe 900 configured for at least
partially manual treatment and at least partially automated
treatment as described herein. In many embodiments the one or more
electrodes 910 comprise bipolar electrodes 914, such as polar RF
electrodes, for example.
[0466] FIG. 68 shows a proximal handle 930 of treatment probe 900
of the treatment probes as in FIGS. 66 and 67. The handpiece
comprise a handle 930 for the user to grasp. The handpiece
comprises a movable carriage 920 slidable coupled to the handle.
The sheath 458 is coupled to the handle 930 such that the rotation
of the handle 930 results in corresponding rotation of the sheath
458. Alternatively, the handle can be rotated relative to sheath
458, for example with a slidable insert. A torque cable 905 extends
from an actuator to carriage 920. The actuator coupled to the
torque cable 905 may comprise a component of the console or a
linkage as described herein, for example. The carriage 920 is
configured to slide along one or more supports 890 with
longitudinal movement 854. The one or more supports may comprise
two sliding supports extending from the carriage 920 to the handle
930, for example. The sliding of the carriage 920 along one or more
supports 890 results in longitudinal movement 854 of carriage
920.
[0467] The handle 930 combined with the carrier 380 comprising the
fluid delivery element and one or more electrocautery electrodes
910 provides the user with substantial discretion when treating the
patient. For example, the user can view the surgical site with
endoscopy, remove tissue with water jet ablation, and additional
cauterize the tissue where appropriate.
[0468] The one or more electrodes are shaped and arranged to treat
tissue in combination with the jet. In many embodiments, electrical
conductors such as wires extend along the elongate axis of the
probe, and the electrodes are inclined at an angle to the portion
of the conductors extending along the elongate axis in order to
position the electrodes near the treatment site where the jet is
directed to the tissue. In many embodiments, the tissue comprises
invaginations, and the electrodes can be sized to fit in the
invaginations to cauterize tissue. Alternatively or in combination,
the electrodes may comprise a larger surface area such as a roller,
for example.
[0469] The handle 930 and carriage 920 are arranged to advance and
retract the carrier 380 and one or more electrodes 910 with
longitudinal movement 854. The torque cable providing movement 905
can be coupled to the carriage 920 with a rotational bearing, such
that the toque cable moves with the carrier 380 when the carriage
920 is advanced toward handle 930 and moved away from handle 930.
The endoscope 394 can be connected to handle 930 with a retention
structure, such that advancement of carriage 920 does not move the
tip of the endoscope distally when the one or more electrodes 910
and carrier 380 are advanced distally with axial movement 907.
Alternatively, the endoscope 394 can be connected to carriage 920
with a retention structure, such that advancement of carriage 920
moves the tip of the endoscope distally when the one or more
electrodes 910 and carrier 380 are advanced distally with axial
movement 854. A person of ordinary skill in the art will recognize
many variations based on the teachings provided herein.
[0470] A resilient spring 925 can be provided between opposing
surfaces of the handle 930 and carriage 920, such that the carriage
920 is urged away from the handle 930 in an unconstrained
configuration. The resilient spring may comprise a leaf spring
having a U-shape, which can be at least partially covered by the
hand of the user.
[0471] The carriage 920 can be configured in one or more of many
ways, and may comprise an insulating material to insulate the
conductors that are coupled to the probe. In many embodiments, the
cable extending to the handpiece comprises a torque cable and
electrically conducting wires to transmit RF energy to the
treatment site. The insulating material of the carriage can
insulate the conductors to inhibit current leakage. The carriage
930 may comprise an insulated bearing traveler, providing both
insulation and bearing surfaces, for example.
[0472] The handpiece portion may comprise one or more components of
a commercially available device for transurethral resection of the
prostatectomy (hereinafter "TURP"), for example.
[0473] Applicants note that the combination of water tissue
ablation with the cautery can provide substantially improve the
removal of tissue, as compared with removal based on cautery
without water ablation, for example. Work in relation to
embodiments has shown that the water jet can substantially remove a
bulk portion of the tissue, and the remaining fibrous tissue can be
removed with cautery in order to inhibit bleeding, for example.
[0474] FIG. 69 shows an ablative flame visible to the human eye, in
accordance with embodiments.
[0475] FIG. 70 shows a high speed image of the ablative flame as in
FIG. 69. The image was taken at a speed of about 1/400 of a
second.
[0476] The data of FIGS. 69 and 70 show that the ablative flame
comprises a plurality of white clouds generated with the ablative
stream when released from the nozzle. Work in relation to
embodiments has shown that the cavitating cloud can shed from the
jet at a characteristic shedding frequency. A length 992 of each
cloud is related to the shedding frequency and the velocity of the
cloud. The relatively cool ablative flame of the jet comprises a
length 990 corresponding to the cutting length of the jet which can
be adjusted to cut tissue to controlled depth as described herein.
In many embodiments, nozzle of the jet is placed at least about a
quarter of the length 992 of a shed cloud in an non-cutting
configuration as shown in FIG. 70, in order to allow the shedding
cloud to substantially form prior to the cloud striking tissue.
This divergence of the shed cloud to a larger cross sectional size
can also provide improved tissue removal as the cloud can be
distributed to a larger region of tissue and provide improved
overlap among the pulses of the jet.
[0477] In addition to the impact pressure of the jet, the highly
turbulent and aggressive region corresponding to the white cloud of
the image contributes substantially to the ablation of tissue as
described herein. The white cloud comprises a plurality of
cavitation regions. When pressurized water is injected into water,
small cavitations are generated in areas of low pressure in the
shear layer, near the nozzle exit. The small cavitations may
comprise cavitation vortices. The cavitation vortices merge with
one another, forming large discrete cavitation structures that
appear in the high speed images as cavitation clouds. These
cavitation clouds provide effective ablation when interacting with
tissue. Without being bound by any particular theory, it is
believed that the cavitation clouds striking tissue cause
substantial erosion of tissue related to the cavitations in
combination of the high velocity fluid that defines the cavitations
striking tissue.
[0478] The nozzle and pressure as described herein can be
configured to provide the pulsatile clouds, for example with
control of the angle of the nozzle, by a person of ordinary skill
on the art based on the teachings provided herein. In many
embodiments, the nozzle of the fluid delivery element comprises a
cavitating jet in order to improve ablation of tissue.
[0479] The fluid delivery element nozzle and pressure can be
arranged to provide a shedding frequency suitable for removal of
tissue, and can be located on the probe to provide improved tissue
resection.
[0480] In many embodiments, the "white cloud" of "flame" comprises
an "entrainment" region where surrounding water is drawn in or
"entrained" into the jet. Work in relation to embodiments suggests
that the entrainment of fluid can be related to the shedding
frequency.
[0481] The shedding frequency and size of the cloud shed from the
jet can be used to provide tissue ablation in accordance with
embodiments. The shedding frequency can be combined with the
angular sweep rate of the probe around the longitudinal axis to
provide overlap of the locations where each cloud interacts with
the tissue.
[0482] The shedding pulses as described herein can be beneficially
combined with the scanning of the jet as described herein, for
example with reference to FIG. 21J.
[0483] FIG. 71 shows a plurality of shedding pulses 995 and
sweeping of the ablative jet to provide smooth and controlled
tissue erosion at a plurality of overlapping locations 997 in
accordance with embodiments. This shedding frequency can be
substantially faster than the pump frequency, when a pump is used,
such that a plurality of shedding clouds are provided for each
pulse of the pulsatile pump. The sweep rate of the probe can be
related to shedding frequency to provide improved tissue removal,
for example with the shedding clouds configured to provide
overlapping pulses.
[0484] In many embodiments, the system comprises a pump having a
frequency less than a frequency of the shedding pulses, in order to
provide a plurality of shedding pulses for each pulse of the pump.
The pump can have a pulse rate of at least about 50 Hz, for example
within a range of about 50 Hz to about 200 Hz, and the shedding
pulses comprise a frequency of at least about 500 Hz, for example
within a range from about 1 kHz to about 10 kHz.
[0485] Although pulses of a pump are illustrated, similar scanning
of pulsed clouds can be provided with a continuous flow pump.
[0486] While the nozzle can be configured in one or more of many
ways, in many embodiments the nozzle comprises a Strouhal number
(hereinafter "St") within a range from about 0.02 to about 0.3, for
example within a range from about 0.10 to about 0.25, and in many
embodiments within a range from about 0.14 to about 0.2.
[0487] In many embodiments, the Strouhal number is defined by:
St=(Fshed)*(W)/U
[0488] where Fshed is the shedding frequency, W is the width of the
cavitating jet, and U is the velocity of the jet at the exit. A
person of ordinary skill in the art can modify nozzles as described
herein in order to obtain shedding frequencies suitable for
combination in accordance with embodiments described herein, and
experiments can be conducted to determine the cloud lengths and
shedding frequencies suitable for tissue removal.
[0489] The nozzle configurations providing plurality of shedding
clouds are suitable for use with one or more of the treatment
probes as described herein.
[0490] FIG. 72 shows a catheter 950 to treat a patient in
accordance with embodiments as described herein. The catheter 950
comprises an elongate tubular structure comprising a lumen 390 to
pass a fluid from a source of fluidic energy to fluid delivery
element 320 to release a divergent or collimated fluid stream 333
to treat tissue as described herein, for example. The catheter 950
is configured to be received with commercially available rigid or
flexible endoscopes, or both, and may comprise a single tube as
described herein. The catheter 950 can be coupled to console 420
comprising a light source 33 and energy source 22 as described
herein, for example.
[0491] FIG. 73 shows the distal end of the catheter as in FIG. 72
in accordance with embodiments. The elongate tube comprising
catheter 950 comprises fluid delivery element 320 comprising nozzle
322 as described herein. The distal end of the optical fiber is
retained with an alignment structure 960 so as to align the optical
fiber concentrically with the nozzle 322. The alignment structure
may comprise a block, guide, annulus or other structure as
described herein to holds the optical fiber in alignment with an
orifice of the nozzle 322 as described herein. The alignment
structure 960 comprises at least one aperture 962 to allow fluid to
pass from the proximal end of the device to the nozzle. The distal
end of the optical fiber is retained with the alignment structure
960 so as to align the optical fiber concentrically with the nozzle
322.
[0492] In many embodiments, the optical fiber 351 directs a
divergent light beam 964 into the orifice of nozzle 322, so as to
provide transmission of light energy through the nozzle as
described herein. The light beam can be deflected with a mirror or
other optical structure to deflect the divergent light beam into
the nozzle, for example when the stream of energy is directed
transverse to the axis of the carrier tube as described herein.
Alternatively or in combination, the light beam can be focused with
lenses, or mirrors, for example. The light beam can be transmitted
along the fluid stream outside the nozzle with total internal
reflection as described herein.
[0493] In many embodiments, the processor as described herein
comprises instructions configured to provide a two stage
illumination with the light source. With a first stage, the
collimated stream from nozzle 332 comprises enough light energy to
visualize the water jet contacting tissue. When the collimated
light beam contacts tissue or becomes sufficiently proximate to the
tissue, the collimation of the water stream is disrupted such that
light energy scatters from the water stream and is no longer
internally reflected, such that the location of the water stream
contacting tissue is quite visible to the operator. The circuitry
of the light source can be configured to provide a second power
level for treatment. In many embodiments each of the first amount
of light energy and the second amount of light energy is adjustable
by the user. The first amount of light energy may comprise an
amount of optical power of a visible wavelength of light, and the
user can adjust the optical power to visualize the location of
treatment. The second amount of energy may comprise sufficient
optical power to treat the tissue, and may comprise similar
wavelengths of light for the first amount of optical power, or
different wavelengths of light. The light energy may comprise one
or more of ultraviolet, visible, near infrared, mid infrared, or
far infrared light energy, for example. The light source can be
activated in one or more of many ways, for example with one or more
of switches, buttons, dials or a two stage foot pedal of the user
interface.
[0494] The display and endoscope can be configured in one or more
of many ways. In many embodiments the substantially collimated
stream of fluid contacts tissue within the field of view of the
endoscope, such that the user can see the location of the fluid
stream contacting the tissue.
[0495] FIG. 74 shows a catheter 950 placed in a working channel 972
of a commercially available endoscope 970. The commercially
available endoscope may comprise a prior flexible introducer or
scope, for example. The commercially available endoscope can be
configured in one or more of many ways in accordance with the
teachings described herein, and may comprise a viewing channel 974
comprising optics to view tissue of the patient. The endoscope 970
may comprise an additional working channel 972, for example.
[0496] FIG. 75 shows a catheter as in FIGS. 72 and 73 placed an
endoscope as in FIG. 74 and deflection of the distal end of the
endoscope and catheter, in accordance with embodiments. In many
embodiments, the catheter comprising the fiber and water jet nozzle
as described herein is configured to deflect away from an axis, and
can deflect at least about +/-20 degrees, for example at least
about +/-90 degrees, and +/-135 degrees with a total range of
deflection of about 270 degrees. The catheter may comprise an
endoscope viewing channel that allows the optical channel to be
deflected with the catheter comprising the one or more optical
fibers and water nozzle. An additional channel can be used for
biopsy sampling as described herein, for example.
[0497] The steerable catheter can be configured in one or more of
many ways to deflect the distal end relative to the handle, for
example. In many embodiments, the endoscope comprises a built-in
mechanism such as pull wires, for example, and the catheter
comprising the nozzle and optical fiber can be advanced along an
internal channel of the endoscope. IN many embodiments, the
endoscope comprising the optical fiber and water jet nozzle
comprise an elongate flexible member comprising sufficient
flexibility to bend along the internal channel of the endoscope,
and sufficient stiffness to advance along the internal channel.
Alternatively or in combination the catheter comprising the one or
more optical fibers and nozzle for fluid delivery may comprise the
built in steering mechanism and hand held control. The endoscope
may comprise a commercially available endoscope endoscopes have an
articulating distal tip. The user can guide the aquabeam catheter
through the working channel and using one or more of levers or
knobs, for example, and bend the last few centimeters of the scope
in the desired direction. The endoscope scope may also be rotated,
for example, so as to orient the tip at a desired target tissue
when deflected, for example.
[0498] Cavitation
[0499] Cavitation is a phenomenon that occurs when a high pressure
waterjet shoots through a nozzle into a liquid medium. Localized
vapor pockets form as nuclei containing minute amounts of vapor
and/or gas destabilize as they are subjected to drops in pressure
rather than the commonly known method of addition of heat.
Cavitation occurs when the local pressure drops below the vapor
pressure, which occurs when the negative pressure coefficient (-Cp)
is greater than cavitation number (.sigma.), respectively governed
by the equations below
- C p = p ref - p 1 2 .times. .rho. .times. .times. v ref 2 ( 1 )
.sigma. = p ref - p v 1 2 .times. .rho. .times. .times. v ref 2 ( 2
) ##EQU00001##
[0500] where pref is the hydrostatic pressure at the nozzle depth,
p is the local pressure at the jet, .rho. is the fluid density,
vref is the exit velocity of the waterjet at the nozzle, and pv is
the vapor pressure. When a liquid flows through a constricted
region, its velocity increases to maintain continuity and there is
a corresponding drop in pressure, known as the Venturi effect.
Applying this to submerged waterjets, the velocity of water exiting
through a nozzle is increased dramatically due to the constriction
while the pressure of the jet stream is substantially reduced. When
the pressure reduction is significant enough, it can drop below the
vapor pressure, resulting in vapor cavity formation.
[0501] For a given flow dynamic, a cavitation number .sigma. exists
above which cavitation does not occur and below which cavitation
will be present with increased cavitating region size. Several
smaller pockets can combine to form a larger vapor cavity. As the
momentum of the waterjet carries the vapor cloud further away from
the nozzle into surrounding medium, viscous forces cause the jet
velocity to drop and there is a corresponding rise in pressure.
This rise causes the vapor cavity to collapse, resulting in a
pressure pulse which further accelerates nearby water and causes
localized microjets to form. Both the liquid microjets and pressure
pulse can exceed the damage threshold energy of a material and
cause erosion. Due to the rapid loss in velocity as the jet moves
away from the nozzle, beyond a given distance the kinetic energy of
the stream no longer exceeds the threshold energy and pressure
waves and microjets from collapsed cavitation clouds becomes the
primary modality for erosion.
[0502] In many embodiments, cavitation is dependent on local
changes in pressure only, making it an isothermal phenomenon,
meaning no thermal fluctuations are expected. Experimentally, as
the vapor cavitation grows in size, latent heat is drawn from the
surrounding liquid, and a very small drop in temperature
(-0.35.degree. C.) can be observed. Although in many embodiments,
the process is not entirely isothermal, the almost negligible
change in temperature is why waterjet cutting is useful for
machining sensitive parts that demand no heat-affected zones.
[0503] In many embodiments, pressure pulse and microjet erosion
becoming the primary modality of material removal is the limited
erosion radius. Since cavitation occurs due to the pressure
differential of the waterjet relative to the ambient liquid
pressure, vapor cavities can only exist up to a maximum distance
before the cavity collapses as the jet slows down and the pressure
comes to equilibrium with the surrounding liquid. As a result,
submerged waterjet cutting becomes substantially self-limiting due
to the range of pressure pulses and microjets before they dissipate
and is a very safe and high precision tool to cut with. In
alternative embodiments, a gaseous waterjet will have high kinetic
energy levels that exceed the threshold energy at much longer
distances since there are relatively minimal forces acting on the
jet to slow it down.
[0504] Experimental
[0505] FIG. 76 shows maximum tissue penetration depth of cutting
and flow rate through a nozzle in accordance with embodiments. The
maximum penetration depth corresponds substantially to the length
of the cavitation bubbles of the jet comprising the "cold"
aquablation flame. The maximum tissue penetration depth of ablation
corresponds directly to the flow rate and in many embodiments is
linearly related to the flow rate.
[0506] The inset of FIG. 76 shows cut potato as a model of prostate
BPH, in accordance with embodiments. The maximum penetration depth
of potato corresponds closely to the maximum cut depth of BPH. The
potato is shown cut with 10 different flow settings corresponding
to rates within a range from about 50 ml/min to about 250 ml/min
with a nozzle and rotating probe as described herein. The maximum
penetration depth ranges from about 4 mm at 50 ml/min to about 20
mm at about 250 ml/min.
[0507] In many embodiments, the cavitation cloud growth and length
comprises a function of flow rate, which is proportional to the
injection pressure and vice versa, for an appropriately configured
nozzle as described herein. As the pressure increases, the maximum
erosive radius appears to increase linearly, which is shown as the
maximum penetration depth of FIG. 76.
[0508] High velocity cavitating jets can be created by using a
known high pressure pump to force the water through a nozzle in
either a continuous or pulsatile flow. Despite the flow type
produced by a pump, the cavitation phenomenon will be pulsatile due
to the unsteady nature of vapor cavities and the cavity formation
will be pulsatile even in a continuous flow jet as described
herein. Without being bound to a particular theory, it is believed
that both pulsatile and continuous flow waterjets will result in
equivalent amounts of material erosion over a given amount of time.
In many embodiments, nozzle geometry is configured to provide the
flow dynamics and cavitation process as described herein. In many
embodiments, the nozzle is configured to inhibit tight constriction
at the waterjet exit, which can be related to cavitation occurring
inside the nozzle itself. In many embodiments, the sharp corners
cause the water to separate from the wall and converge towards the
nozzle centerline, further constricting the waterjet pathway while
simultaneously reducing frictional effects caused by the nozzle
wall. This results in an increased velocity along with the
corresponding pressure drop and the vapor cavities formation. Vapor
cavity formation will impact the overall flow dynamics as their
eventual collapse results in turbulence and can affect erosion
depth. A person of ordinary skill in the art can conduct
experiments to determine appropriate nozzle geometry and flow rate
to provide tissue removal as described herein without undue
experimentation.
[0509] Aquablation
[0510] Submerged waterjet cutting as described herein has the
capability to take advantage of the cavitation phenomenon to treat
patients with Benign Prostatic Hyperplasia (BPH). The jet removes
the excess soft tissue growth seen in BPH through the pressure
pulses and microjets caused by collapsed vapor cavities. The
waterjet direction can be manipulated by changing the location and
orientation of the devices nozzle, either by translating the nozzle
along the anterior-posterior direction or by rotating the nozzle up
to 180 degrees, for example.
[0511] As vapor cavity formation and its erosive strength is a
function of both injection pressure and the flow dynamics, the
depth of material can be controlled by configuring the pressure as
well as nozzle geometry. A greater injection pressure will result
in a faster exit velocity. As discussed herein, the nozzle geometry
can further increase the velocity depending on the constriction and
will affect the degree of pressure drop as the waterjet exits
through the Venturi effect. These factors can result in longer
distances the cavitation clouds can grow to and travel before
collapsing and releasing pressure pulses and microjets. The nozzle
geometry and pressure settings of the Aquablation system have been
optimized to give the user precise control and ensure the
cavitating jet removes only the desired benign tissue growth.
[0512] The images provided herein show the how tissue erosion depth
is a function of pressure, in accordance with embodiments. The
images show the smaller cavitation cloud length and corresponding
tissue resection depth for a lower injection pressure as compared
with other images.
[0513] In many embodiments, Aquablation as described herein is
capable of removing the excess tissue growth, e.g. BPH, with
inhibited removal and damage of arteries and veins. The pressure
pulses and microjets caused by cavitation exceed the threshold
energy required to erode the soft tissue growth, and may cause
minimal damage to other structures like vessels which have a much
higher threshold energy. Repeated and concentrated pressure pulses
and microjets may cause fatigue stress on the vasculature and
result in bleeding, but the Aquablation system algorithm and
treatment instructions as described herein are configured designed
to inhibit such damage.
[0514] In many embodiments, generation of harmful emboli are
inhibited. Vapor cavity formation may benefit from a minute nucleus
of air already present in the blood stream, for example. Cavitation
can result in the growth of the nucleus without any additional air
being introduced into the system. Furthermore, the cavity will
collapse once the local jet pressure exceeds the vapor pressure,
such that the air pockets may reduce back to their original nucleus
size. In many embodiments, embolus formation is inhibited as
cavitation depends on and can be limited to micro amounts of air
native to the saline solution surrounding the urethra, and the
vapor cavities quickly dissipate as the jet pressure begins to
rise.
[0515] Aquablation as described herein takes advantage of this
phenomenon. The naturally self-limiting erosive radius and unique
ability to precisely ablate tissue with a low damage threshold
energy while minimizing damage to nearby structures with a more
dense cellular structure, such as arteries, make Aquablation as
described herein a useful surgical tool for treating BPH. Coupled
with the nearly isothermal property of cavitation as described
herein, which can mitigate collateral damage and provide improved
healing and an improved safety profile.
[0516] FIG. 77 shows selective removal of potato with a porcine
blood vessel positioned over the incision of the potato as a model
for selective removal of tissue. The porcine blood vessel was
placed on the potato prior to the incision, such that the porcine
blood vessel was exposed to the water jet with cavitation in order
to remove the potato. Aquablation resected the soft potato tissue
model, which is a close proxy for the benign tissue growth seen in
BPH, without causing severe damage to the porcine vessel.
[0517] While preferred embodiments of the present disclosure have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. Numerous variations, changes, and substitutions will
be apparent to those skilled in the art without departing from the
scope of the present disclosure. It should be understood that
various alternatives to the embodiments of the present disclosure
described herein may be employed without departing from the scope
of the present invention. Therefore, the scope of the present
invention shall be defined solely by the scope of the appended
claims and the equivalents thereof.
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