U.S. patent application number 10/782377 was filed with the patent office on 2005-01-06 for prostate visualization device and methods of use.
This patent application is currently assigned to NeoSeed Technology LLC.. Invention is credited to Belman, Yuri, Boucher, Ryan P., Gandionco, Isidro M., Green, Thomas C., Hogendijk, Michael.
Application Number | 20050004471 10/782377 |
Document ID | / |
Family ID | 26969102 |
Filed Date | 2005-01-06 |
United States Patent
Application |
20050004471 |
Kind Code |
A1 |
Hogendijk, Michael ; et
al. |
January 6, 2005 |
Prostate visualization device and methods of use
Abstract
Methods and apparatus are provided for improved administration
of brachytherapy in the treatment of prostate disease. More
particularly, a prostate visualization device is provided
comprising a catheter coupled to at least one deployable member at
the distal end of the catheter. The deployable member is preferably
manufactured from a shape memory alloy having a petal-shaped
configuration suitable for engaging and defining the proximal
region of a patient's bladder. The deployable member may comprise
tubing filled with air or other radiopaque agents to facilitate
ultrasonic imaging of the deployable members near the
bladder/prostate junction.
Inventors: |
Hogendijk, Michael; (Palo
Alto, CA) ; Green, Thomas C.; (S. W. Seattle, WA)
; Gandionco, Isidro M.; (Fremont, CA) ; Boucher,
Ryan P.; (San Francisco, CA) ; Belman, Yuri;
(Sunnyvale, CA) |
Correspondence
Address: |
FISH & NEAVE LLP
1251 AVENUE OF THE AMERICAS
50TH FLOOR
NEW YORK
NY
10020-1105
US
|
Assignee: |
NeoSeed Technology LLC.
San Francisco
CA
|
Family ID: |
26969102 |
Appl. No.: |
10/782377 |
Filed: |
February 18, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10782377 |
Feb 18, 2004 |
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10160341 |
May 31, 2002 |
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6695787 |
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10160341 |
May 31, 2002 |
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09648319 |
Aug 25, 2000 |
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6422997 |
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60295408 |
May 31, 2001 |
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Current U.S.
Class: |
600/463 ;
600/7 |
Current CPC
Class: |
A61B 8/12 20130101; A61B
8/481 20130101; A61B 8/0833 20130101; A61M 2210/1085 20130101; A61N
2005/1011 20130101; A61M 25/1011 20130101; A61M 25/1002 20130101;
A61N 5/1014 20130101; A61B 8/0841 20130101; A61N 5/1001
20130101 |
Class at
Publication: |
600/463 ;
600/007 |
International
Class: |
A61B 008/14; A61M
036/12 |
Claims
1. Apparatus for facilitating visualization of a patient's
prostate/bladder junction, comprising: a catheter having proximal
and distal ends, a proximal deployment port at the proximal end, a
first outlet port at the distal end, and a first lumen extending
therebetween; a plunger having proximal and distal ends, the distal
end of the plunger configured to slidably pass through the proximal
deployment port; and at least one deployable member coupled to the
distal end of the plunger, wherein the deployable member is
expandable from a delivery configuration adapted for transurethral
insertion, to a deployed configuration adapted for engagement of a
proximal portion of the patient's bladder.
2. The apparatus of claim 1 wherein the catheter further comprises
a second inlet port, a second outlet port and a second lumen
extending therebetween.
3. The apparatus of claim 2 wherein the catheter further comprises
a third inlet port, a third outlet port and a third lumen extending
therebetween.
4. The apparatus of claim 1 wherein the deployable member comprises
at least one wire loop.
5. The apparatus of claim 4 wherein the wire loop has a roughened
exterior surface, the roughened exterior surface adapted to entrap
gas bubbles to facilitate ultrasonic imaging.
6. The apparatus of claim 4 wherein the wire loop comprises a shape
memory material.
7. The apparatus of claim 6 wherein the wire loop consists of a
Nickel Titanium alloy.
8. The apparatus of claim 1 wherein the deployable member comprises
a petal-shape in the deployed configuration.
9. The apparatus of claim 1 wherein the deployable member comprises
a plurality of petal-shaped members that at least partially overlap
in the deployed configuration.
10. The apparatus of claim 1 wherein the elasticity of the
deployable member enables the deployable member to conform to the
proximal wall of the bladder without displacing the bladder
wall.
11. The apparatus of claim 1 wherein the deployable member is
concave with respect to the proximal wall of the bladder in the
deployed configuration.
12. The apparatus of claim 1 further comprising brachytherapy
apparatus configured for delivery of radioactive seeds to the
patient's prostate, wherein delivery of the seeds is facilitated by
ultrasonic imaging of a junction of the patient's prostate and
bladder.
13. The apparatus of claim 1 wherein the plunger further comprises
a handle affixed to the proximal end of the plunger.
14. The apparatus of claim 1 wherein the plunger comprises a rigid
material.
15. The apparatus of claim 1 wherein the plunger comprises a rigid
proximal section and an elastic distal section, the elastic distal
section suitable for conforming to the curvature of the
catheter.
16. The apparatus of claim 1 further comprising a connector having
proximal and distal ends, wherein the proximal end of the connector
is affixed to the distal end of the plunger, and the distal end of
the connector is affixed to the deployable member.
17. The apparatus of claim 16 wherein the connector is a plastic
rod.
18. The apparatus of claim 16 wherein the connector has a coiled
configuration.
19. The apparatus of claim 16 wherein the connector has a flexible
wire configuration.
20. The apparatus of claim 1 wherein the catheter has a length of
between 30 cm and 50 cm.
21. The apparatus of claim 1 further comprising a piece of tubing
at least partially covering the deployable member, the tubing
suitable for confining gas pockets to enhance ultrasonic imaging
around the deployable member.
22. The apparatus of claim 21 further comprising adhesives suitable
for affixing the deployable members to the tubing to confine the
gas pockets within the tubing.
23. The apparatus of claim 21 wherein a plurality of spaced apart
pieces of tubing are spaced along the deployable member.
24. The apparatus of claim 1 wherein the deployable member further
comprises a hinging member suitable for rotating the deployable
member to a predetermined configuration upon deployment.
25. The apparatus of claim 1 wherein the deployable members
comprise a plurality of interwoven wires.
26. A method of facilitating visualization of a patient's
prostate/bladder junction, the method comprising: providing
apparatus comprising a catheter having proximal and distal ends, a
proximal deployment port at the proximal end, a first outlet port
at the distal end, a first lumen extending therebetween, a plunger
having proximal and distal ends, and at least one deployable member
affixed to the distal end of the plunger; advancing the apparatus
through the patient's urethra; distally advancing the deployable
member beyond the distal outlet port to deploy the deployable
member to a predetermined configuration within the patient's
bladder; and proximally retracting the deployable member such that
it engages a proximal portion of the patient's bladder.
27. The method of claim 26 further comprising injecting an
echo-contrast agent to facilitate visualization of the patient's
prostate/bladder junction.
28. The method of claim 26 further comprising ultrasonically
imaging a junction between the patient's bladder and the patient's
prostate.
29. The method of claim 26 further comprising performing
brachytherapy on the patient's prostate.
Description
REFERENCE TO RELATED APPLICATION
[0001] The present application is a continuation-in-part of U.S.
patent application Ser. No. 09/648,319, filed Aug. 25, 2000, and
claims the benefit of the filing date of U.S. provisional
application Ser. No. 60/295,408, filed May 31, 2001, the disclosure
of which is incorporated herein by reference in its entirety.
FIELD OF THE INVENTION
[0002] This invention relates to improved apparatus and methods for
the treatment of prostate cancer. More particularly, the present
invention provides a prostate visualization device having at least
one deployable member suitable for imaging the bladder/prostate
junction, and methods of use.
BACKGROUND OF THE INVENTION
[0003] Excluding nonmelanoma skin cancers, prostate cancer is the
most common cancer afflicting American men. The American Cancer
Society estimates that over 180,00 new cases will be diagnosed in
the U.S. in the year 2000 alone, and that nearly 32,000 people will
die from the disease. Prostate cancer is second only to lung cancer
as the leading cause of cancer death in men, accounting for roughly
11%.
[0004] Prostate cancer is defined as malignant tumor growth within
the prostate gland. Its cause is unknown, although high dietary fat
intake and increased testosterone levels are believed to be
contributory factors. A letter scale ("A" through "D"), which
accounts for the location of the cancer, is commonly used to
classify the stage of disease. In Stage A, the tumor is not
palpable but is detectable in microscopic biopsy. Stage B is
characterized by a palpable tumor confined to the prostate. By
Stage C, the tumor extends locally beyond the prostate with no
distant metastasis. By Stage D, cancer has spread to the regional
lymph nodes or has produced distant metastasis.
[0005] In the early stages, prostate cancer is most commonly
treated by either prostate removal or by brachytherapy. More
advanced cases are treated by hormonal manipulation or orchiectomy
to reduce testosterone levels and curb spreading of the disease, by
chemotherapy, or by external beam radiation therapy.
[0006] With regard to treatment of early stage prostate cancer, the
state of the art has several drawbacks. Radical prostatectomy is
often recommended for treatment of localized stage A and B prostate
cancers. Under general or spinal anesthesia, an incision is made
through a patient's abdomen or perineal area, and the diseased
prostate is removed. The procedure is lengthy, especially if a
lymph node dissection is simultaneously performed, and requires a
hospital stay of 2-5 days. Possible complications include impotence
and urinary incontinence.
[0007] Internal radiation therapy or brachytherapy has recently
been developed and holds great promise for the treatment of early
stage prostate cancer. Radioactive pellets or seeds of, for
example, iodine-125, palladium-103, or iridium-192, are deposited
directly into the prostate through needle placement. U.S. Pat. No.
5,928,130 to Schmidt provides a slightly modified example of such a
needle device. Imaging techniques, such as transrectal ultrasound,
CT scans, or MRI, are used to accurately guide placement of the
radioactive material. Advantageously, radiation from the
brachytherapy seeds is administered directly to the prostate with
less damage to surrounding tissues, delivering a substantially
higher radiation dosage to the prostate than to the surrounding
tissues, as compared to external beam radiation therapy. The
procedure need only be performed once, and impotence and urinary
incontinence complications are significantly reduced, as compared
to prostate removal procedures.
[0008] The seeds, which are permanently implanted, give off
radiation for weeks or months. Their presence causes little
discomfort, and they remain in the prostate after decay of the
radioactivity. For several weeks following needle insertion,
patients may experience pain in the perineal area, and urine may
have a red-brown discoloration.
[0009] Although, when performed correctly, brachytherapy may
provide several benefits when compared to prostate removal and
other techniques, current apparatus and methods for delivering the
seeds to target locations within the prostate are somewhat crude
and are subject to practitioner error. The current method of
identifying the depth of needle insertion is by ultrasound imaging.
The junction of the base of the prostate and the bladder provides a
common reference plane for needle insertion. Identifying this
critical reference "base" plane is critical to proper needle and
seed placement.
[0010] One previously known technique for imaging the base plane is
to visualize the plane in either transverse or sagittal ultrasound
imaging. Injection of contrast agent may facilitate imaging. A
catheter, such as a standard Foley catheter, may be inserted into
the patient's urethra proximal of the junction. Contrast agent
comprising aerated K-Y jelly and water, may then be injected
through an end port of the catheter. The agent moves distally
towards the patient's bladder and is visible to an ultrasound
probe, positioned in the patient's rectum, thereby facilitating
imaging.
[0011] Attempts have been made to improve Foley catheters, as well
as to facilitate improved imaging within a body lumen. For example,
U.S. Pat. No. 5,715,825 to Crowley provides an acoustic imaging
catheter with an inflatable dilation balloon and an ultrasound
transducer. However, while Crowley may provide improved imaging,
the device is mechanically and electrically complex, and is
therefore costly. U.S. Pat. No. 5,916,153 to Rhea, Jr. provides a
multifunction, modified Foley catheter. The device described in
that patent, however, does not improve on current junction imaging
techniques.
[0012] In view of the drawbacks associated with previously-known
methods and apparatus for bladder/prostate junction imaging, it
would be desirable to provide methods and apparatus that overcome
such drawbacks.
[0013] It further would be desirable to provide methods and
apparatus that provide reliable imaging of the bladder/prostate
junction.
[0014] It still further would be desirable to provide methods and
apparatus that may be used in conjunction with standard
brachytherapy apparatus.
SUMMARY OF THE INVENTION
[0015] In view of the foregoing, it is an object of the present
invention to provide methods and apparatus for bladder/prostate
junction imaging that overcome drawbacks associated with
previously-known methods and apparatus.
[0016] It is also an object of the present invention to provide
methods and apparatus that provide reliable imaging of the
bladder/prostate junction.
[0017] It still further is an object to provide methods and
apparatus that may be used in conjunction with standard
brachytherapy apparatus.
[0018] These and other objects of the present invention are
accomplished by providing methods and apparatus for
bladder/prostate junction imaging comprising a catheter having at
least one distally deployable member that engages and defines the
proximal region of the bladder. The deployable member is preferably
constructed from a shape memory material that forms a petal-shaped
configuration upon deployment. The deployable member is deployed
within the patient's bladder, and may be retracted proximally to
conform to the proximal wall of a patient's bladder. Gas pockets
may be provided around the deployable member to enhance visibility
with an ultrasound probe. Additionally, echo-contrast agent may be
injected to the region to facilitate reliable imaging.
[0019] In a preferred embodiment, the deployable member comprises a
plurality of petal-shaped Nitinol wires affixed to the distal end
of a plunger that is coupled to a multi-lumen catheter. The
catheter may include a deployment lumen, a bladder drainage lumen,
a contrast injection lumen, and a prostatic therapy lumen. The
catheter is advanced through a patient's urethra into the patient's
bladder. The deployable member is deployed by advancing the plunger
distally within the deployment lumen. Upon deployment within the
bladder, the plunger is proximally retracted until the deployable
member engages the proximal wall of the bladder. Echo-contrast
agent then may be injected into a space near the bladder/prostate
junction. Ultrasonic imaging may then proceed, often with an
ultrasound probe positioned in the patient's rectum. Urine also may
be emptied from the bladder via the bladder drainage lumen, and the
patient's prostate may be accessed via the prostatic therapy
lumen.
[0020] The deployment lumen may be used in combination with any of
the drainage, contrast, and prostatic therapy lumens. In
alternative embodiments, one or more catheter lumens may be
configured to serve more than one function. For example, a single
lumen catheter having only one distal outlet port may be provided
whereby one or more proximal ports are in communication with the
outlet port via the single lumen. In this embodiment, the single
lumen of the catheter allows for passage of the deployable member,
fluid injection, fluid drainage and delivery of prostatic therapy
devices or therapeutic agents.
[0021] Additionally, tubing may cover the deployable member to form
gas pockets around the deployable member such that the gas enhances
ultrasonic imaging of the bladder/prostate junction. The tubing may
comprise a variety of shapes and sizes to facilitate imaging of the
deployable member.
[0022] Methods of using the present invention are also
provided.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] Additional objects and advantages of the invention will be
apparent from the following description, the appended claims, and
the accompanying drawings, in which like reference characters refer
to like parts throughout, and in which:
[0024] FIG. 1 is a schematic view of a prior art method of
performing brachytherapy;
[0025] FIG. 2 is a schematic view detailing the prior art method of
imaging the bladder/prostate junction in greater detail;
[0026] FIGS. 3A-3C are, respectively, a side view of apparatus
constructed in accordance with the present invention in a collapsed
delivery state, a sectional view of the apparatus through section
line A--A of FIG. 3A, and a side view, partly in section, of the
apparatus in an expanded deployed state;
[0027] FIG. 4 is a schematic view, partly in cross-section,
demonstrating a method of using the apparatus of FIG. 3 to image a
patient's bladder/prostate junction;
[0028] FIG. 5 illustrates an actuation mechanism for the deployable
member;
[0029] FIG. 6 illustrate alternative embodiments for enhancing
ultrasonic imaging of the deployable member;
[0030] FIG. 7 illustrates an alternative mechanism for actuating
the deployable member;
[0031] FIGS. 8A-8B are, respectively, a side view of an alternative
apparatus constructed in accordance with the present invention in a
collapsed delivery state, and a sectional view of the apparatus
through section line B-B of FIG. 8A; and
[0032] FIGS. 9A-9B are, respectively, a side view of a further
alternative embodiment constructed in accordance with the present
invention in a deployed state, and a cross-sectional view through
line C-C of FIG. 9A.
DETAILED DESCRIPTION OF THE INVENTION
[0033] The present invention provides methods and apparatus for
improved administration of brachytherapy. More particularly, the
present invention provides a prostate visualization device
comprising at least one distally deployable member that engages and
defines the proximal wall of a patient's bladder. The device is
preferably coupled to a catheter to facilitate imaging of the
patient's bladder/prostate junction.
[0034] Referring to FIGS. 1 and 2, a prior art method of performing
brachytherapy is described. The method and apparatus are as taught
by Peter Grimm, DO, in a pamphlet entitled, "Ultrasound Guided
Implantation of the Prostate: A Practical Review Course." As seen
in FIG. 1, brachytherapy apparatus 10 comprises transrectal
ultrasound probe 12, guide block 14, needle 16, plunger 18, and
radioactive seeds 20. Ultrasound probe 12 is advanced through a
patient's rectum R to facilitate imaging of the patient's prostate
P. Prostate P surrounds urethra U and is just proximal of bladder
B. An ultrasonic image of a junction between the prostate and the
bladder is acquired, as described hereinbelow with respect to FIG.
2. Needle 16, loaded with seeds 20 and plunger 18, is then advanced
through guide block 14, through the patient's perineum Pe, and into
prostate P, where needle 16 is retracted while plunger 18 is held
stationary to sew the seeds in a line within prostate P.
[0035] With reference to FIG. 2, the imaging aspect of the
apparatus and method of FIG. 1 is described in greater detail. A
catheter, such as a standard Foley catheter, is inserted into the
patient's urethra proximal of the patient's bladder/prostate
junction. A combination of water and KY jelly is then injected
through an end port of the catheter. The combination moves distally
towards the patient's bladder and appears to ultrasound probe 12 as
contrast agent. Ultrasound probe 12 then provides signals that are
converted by a previously known ultrasound system to display
ultrasonic image 22 of base plane BP, which is located tangent to
the distal surface of prostate P, i.e. at the prostate/bladder
junction. All positions within the prostate are determined relative
to base plane BP during the brachytherapy procedure.
[0036] Ultrasonic imaging and location determination of base plane
BP may be unreliable due to irregular ultrasonic images dependent
on a density of the water/KY jelly combination at a given location,
as well as flow conditions within the bladder and urethra. Thus,
there exists a need for reliable apparatus and methods for
bladder/prostate junction imaging.
[0037] Referring now to FIG. 3, a first embodiment of apparatus
constructed in accordance with the present invention is described.
Apparatus 30 comprises catheter 32 and plunger 42 having handle 36.
Plunger 42 may span the approximate length of catheter 32 such that
it is directly affixed to deployable member 44 of FIG. 3C.
Alternatively, plunger 42 may be affixed to the proximal end of a
connector, and the distal end of the connector may be affixed to
deployable member 44, as described in FIG. 5 hereinbelow.
[0038] Catheter 32 further comprises deployment lumen 33 and
contrast lumen 35. A second contrast lumen 37 may be provided, and
contrast lumens 35 and 37 may be separated by optional dividing
wall 39 to enhance catheter stability during injection of the
contrast agent.
[0039] Deployment lumen 33 extends between proximal deployment port
46 and distal deployment port 38. Proximal deployment port 46 is
preferably a hemostatic port, e.g., a Touhy-Borst connector, that
enables plunger 42 to slide longitudinally through the port while
inhibiting fluid transfer. Contrast lumens 35 and 37 extend between
proximal contrast port 34 and distal contrast port 40, which is
located proximal of distal deployment port 38. Catheter 32,
excluding plunger 42 and handle 36, preferably comprises a total
length of 30-50 cm.
[0040] Deployable member 44 is expandable from a collapsed delivery
configuration within deployment lumen 33, to an expanded deployed
configuration, as shown in FIG. 3C. In the deployed configuration,
deployable member 44 is suitable for engaging and defining the
proximal wall of a patient's bladder. Deployment member 44
preferably is provided in a petal or hoop shape, and may comprise a
shape memory material, e.g., a Nickel-Titanium alloy (commonly
known in the art as Nitinol). The predetermined shape is set by
constraining the Nitinol element on a mandrel or fixture of the
desired shape, then applying an appropriate heat treatment.
[0041] Deployable member 44 preferably is provided in a concave
configuration with respect to the bladder/prostate junction. The
member is flexible such that it may automatically conform to the
shape of the proximal wall of the bladder, without imposing
excessive pressure on the prostate or bladder upon retraction of
the member against the proximal wall of the bladder. In a preferred
embodiment, deployable member 44 comprises twelve petal-shaped
members, although greater or fewer numbers of petal-shaped members
may be used. The petal-shaped members may either overlap
circumferentially or be spaced apart circumferentially when
deployed.
[0042] Referring now to FIG. 4, a method of using apparatus 30 in
accordance with the principles of the present invention is
described. Catheter 32 is advanced through a patient's urethra U
into bladder B, with deployable member 44 in a collapsed delivery
configuration. Plunger 42 then is advanced distally, e.g., by
pushing handle 36 of plunger 42 distally while retaining catheter
32 stationary, such that deployable member 44 extends beyond distal
deployment port 38 of catheter 32. Deployable member 44 then
self-expands to a predetermined, deployed configuration, as shown
in FIG. 4.
[0043] Catheter 32 then is retracted out of bladder B to a desired
position within urethra U. Alternatively, catheter 32 first may be
placed at the desired position within the urethra and plunger 42
then is advanced distally to push deployable member 44 through the
remaining portion of the urethra and into the bladder. With
deployable member 44 in the expanded configuration, plunger 42 is
retracted proximally until deployable member 44 engages a proximal
region of bladder B.
[0044] Echo-contrast agent then may be injected through proximal
contrast port 34 so that it exits distal contrast port 40. Contrast
lumens 35 and 37, and ports 34 and 40, are preferably dimensioned
in a manner that accounts for the viscosity of the agent. Once the
contrast agent has been injected, apparatus 30 facilitates reliable
ultrasonic imaging with ultrasound probe 12 inserted through the
patient's rectum R, as shown in FIG. 1, and enables determination
of a reliable reference plane, as depicted in FIG. 2. The reference
plane may be used to conduct or to prepare for brachytherapy
treatment of prostate cancer, in the manner discussed
hereinabove.
[0045] With respect to FIG. 5, a mechanism for actuating the
deployable member is described. Plunger 42 of FIG. 3 may be affixed
to connector 50 via adhesive 52. Plunger 42 preferably comprises a
relatively rigid material suitable for longitudinally sliding
though proximal deployment port 46. Connector 50 preferably
comprises a relatively elastic material that may adapt to the
curvature of catheter 32, i.e., during transurethral insertion of
catheter 32. Connector 50 may, for example, comprise a coil, a
straight wire, a plastic rod, or any other configuration having
elastic properties.
[0046] Connector 50 may be affixed to deployable member 44 via
adhesive 54. Alternatively, connector 50 may be omitted and plunger
42 may span the approximate length of catheter 32 such that it is
directly affixed to deployable member 44. In this embodiment,
plunger 42 may comprise a relatively rigid proximal section and a
more elastic distal section that spans the majority of the length
of catheter 32.
[0047] Referring now to FIG. 6, alternative embodiments for
enhancing ultrasonic imaging of the deployable member are
described. In FIG. 6A, deployable member 81 is preferably
constructed from shape memory wire 80 that expands to the deployed,
petal-shape illustrated. Shape memory wire 80 may be covered with
biocompatible tubing 82.
[0048] Biocompatible tubing 82 may be affixed to wire 80 by a
biocompatible adhesive 84. The inner diameter of tubing 82 is sized
to form gas pocket G around wire 80. Gas pocket G may comprise air,
or any other radiopaque material, to enhance radiopaque imaging of
deployable member 81 within the body.
[0049] Alternatively, tubing 92 may completely surround deployable
member 91 and may extend toward the proximal end of catheter 32, as
shown in FIG. 6B. In this embodiment, tubing 92 surrounds wire 90
and plunger 93 such that gas pocket G is visible along the length
of catheter 32. An optional inflation port (not shown) may be added
to the apparatus of FIG. 3, and the inflation port may be coupled
to the tubing such that additional gas G may be added to or removed
from within the tubing.
[0050] FIG. 6C illustrates deployable member 101 comprising various
tubing configurations that are intermittently spaced around
deployable member 101. Tubing pieces 102 are affixed at spaced
increments around wire 100, each piece of tubing being suitable for
housing gas pockets G to facilitate ultrasonic imaging of
deployable member 101. Intermittently spacing the tubing around
wire 100 may provide less resistance as wire 100 deploys to its
predetermined configuration. Similarly, smaller tubing pieces 106
or rounded tubing pieces 104 may be intermittently spaced around
deployable member 101.
[0051] In FIG. 6D, deployable member 111 comprises plurality of
interwoven wires 112. Plurality of interwoven wires 112 are loosely
wrapped such that gaps exist between the wires. Advantageously,
these gaps may trap gas bubbles G to facilitate ultrasonic imaging
of deployable member 111 near the bladder/prostate junction.
[0052] In FIG. 6E, deployable member 121 comprises a single piece
of tubing 122 configured to deploy to a predetermined shape. In
this embodiment, the proximal end of tubing 122 is sealed by plug
124 to confine contrast gas G. Alternatively, plug 124 may be
omitted and tubing 122 may be coupled to a proximal inflation port
(not shown) such that a radiopaque contrast agent may be injected
into or removed from tubing 122.
[0053] In FIG. 7, an alternative mode of actuating deployable
member 131 is depicted. Deployable member 131 comprises wire 130
having hinging member 134. Hinging member 134 is initially
constrained within catheter 132 during transurethral insertion of
the device, as illustrated by the dotted line outline of position
X. Upon positioning, wire 130 is advanced distally, e.g., by
distally advancing plunger 42 of FIG. 1, such that hinging member
134 is advanced distal to port 138. Hinges 136 provide torsional
rotation that allow hinging member 134 to expand to a curved
configuration, as illustrated by position Y, suitable for
conforming to the proximal wall of the patient's bladder.
[0054] Referring now to FIG. 8, a further alternative embodiment of
the catheter of the present invention is described. Catheter 152
comprises deployment lumen 153, prostatic therapy lumen 155,
contrast lumen 157, and bladder drainage lumen 159. Deployment
lumen 153 extends between proximal deployment port 158, e.g., a
Touhy-Borst connector, and distal deployment port 170. Contrast
lumen 157 extends between proximal contrast port 160 and distal
contrast port 166, which is located proximal of distal deployment
port 170. Prostatic therapy lumen 155 extends between proximal
prostate port 164 and distal prostate port 165, which is located
proximal of distal contrast port 166. Bladder drainage lumen 159
extends between proximal drainage port 162 and distal drainage port
168, which is located adjacent to distal deployment port 170.
[0055] Urine and other fluids may be emptied from the patient's
bladder B of FIG. 8 during and after imaging via bladder drainage
lumen 168. Urine enters distal drainage port 168, passes through
drainage lumen 159 and exits the patient's body through proximal
drainage port 162.
[0056] Prostatic therapy lumen 155 provides access to the patient's
prostate P of FIG. 8. Therapeutic agents or interventional devices
may be inserted into lumen 155 through proximal prostate port 164,
and deposited into the patient's prostate P via distal prostate
port 165. Apparatus 150 thus may be used for a variety of
procedures which will be apparent to those of skill in the art and
of which brachytherapy is only one example. Furthermore, it should
be appreciated that deployment lumen 153 and its respective ports
may be used in conjunction with any of the other three lumens
described hereinabove, and their respective ports.
[0057] Referring now to FIGS. 9A-9B, a further alternative
embodiment of a catheter of the present invention is described. In
FIG. 9A, apparatus 230 comprises catheter 232 having plunger 242
disposed within lumen 233 thereof. Plunger 242 includes handle 236
and is coupled to deployable member 244, for example, via
connecting rod 250, as described hereinabove with respect to FIG.
5. In this embodiment, catheter 232 comprises single lumen 233, as
shown in FIG. 9B, that is configured to be used as a deployment
lumen, contrast lumen, bladder drainage lumen and, optionally, as a
prostatic therapy lumen. This configuration eliminates the need for
two or more separate lumens, and reduces the overall profile of
catheter 232.
[0058] In the embodiment of FIG. 9A, proximal deployment port 246
and proximal contrast port 234 preferably are similar to ports 46
and 34 of FIG. 3A, respectively, except that each of ports 246 and
234 communicate with lumen 233. Accordingly, contrast may be
injected into proximal contrast port 234, flow through lumen 233
alongside connecting rod 250, and exit through distal outlet port
240, which forms as an opening at the distalmost end of catheter
232. In this embodiment, distal outlet port 240 also serves as the
deployment port through which deployable member 244 is extended to
self-deploy.
[0059] In the embodiment of FIG. 9, the wire loops forming the
petal-shaped members at least partially overlap, thereby enhancing
the structural rigidity of the petal-shaped members when deployed.
As in the embodiment of FIG. 5, the petal-shaped members preferably
comprise a shape-memory biocompatible alloy, such as
nickel-titanium.
[0060] Although particular embodiments of the present invention
have been described above in detail, it will be understood that
this description is merely for purposes of illustration. Specific
features of the invention are shown in some drawings and not in
others; this is for convenience only, and any feature may be
combined with another in accordance with the invention. Further
variations will be apparent to one skilled in the art in light of
this disclosure and are intended to fall within the scope of the
appended claims.
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