U.S. patent application number 13/597951 was filed with the patent office on 2012-12-20 for needle device.
This patent application is currently assigned to BOSTON SCIENTIFIC SCIMED, INC.. Invention is credited to Barry N. Gellman.
Application Number | 20120323071 13/597951 |
Document ID | / |
Family ID | 27610305 |
Filed Date | 2012-12-20 |
United States Patent
Application |
20120323071 |
Kind Code |
A1 |
Gellman; Barry N. |
December 20, 2012 |
NEEDLE DEVICE
Abstract
A needle device for penetrating body tissues while substantially
reducing the risk of damage to blood vessels and body organs by
using visual control of the operative tip during insertion and the
procedure, is disclosed herein. The needle device of the present
invention has a large and diverse applicability to a number of
medical procedures by enabling internal visual inspection of body
tissues and cavities during treatment without open surgery or
supplemental penetrating or visualization devices.
Inventors: |
Gellman; Barry N.; (North
Easton, MA) |
Assignee: |
BOSTON SCIENTIFIC SCIMED,
INC.
Maple Grove
MN
|
Family ID: |
27610305 |
Appl. No.: |
13/597951 |
Filed: |
August 29, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10062357 |
Jan 31, 2002 |
8277411 |
|
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13597951 |
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Current U.S.
Class: |
600/104 |
Current CPC
Class: |
A61B 2090/3614 20160201;
A61B 5/6848 20130101; A61M 5/1582 20130101; A61B 1/313 20130101;
A61B 1/015 20130101; A61B 2090/306 20160201; A61B 1/00167
20130101 |
Class at
Publication: |
600/104 |
International
Class: |
A61B 1/06 20060101
A61B001/06; A61B 1/012 20060101 A61B001/012 |
Claims
1. (canceled)
2. A needle device comprising: a nozzle defining a first lumen and
a second lumen, the first and second lumens extending adjacently
through the nozzle, the nozzle comprising a first portion
terminating in a distal end and a second portion extending distally
from the distal end of the first portion, the first lumen defining
a first opening on the distal end of the first portion, the second
lumen defining a second opening on the second portion, an optical
element disposed with in the first lumen for transmitting and
receiving optical radiation; and a supply tube configured to
deliver a component into the second lumen, out of the second
opening and into a body of a patient.
3. The needle device of claim 2, wherein the first portion is
cylindrical member.
4. The needle device of claim 2, wherein the second portion is
cylindrical member.
5. The needle device of claim 2, wherein a diameter of the first
portion is larger than a diameter of the second portion.
6. The needle device of claim 2, wherein the first portion has a
longitudinal axis and a face of the distal end of the first portion
is substantially perpendicular to the longitudinal axis.
7. The needle device of claim 2, wherein the second portion
comprises a tissue penetrating tip.
8. The needle device of claim 7, wherein a bevel forms the tissue
penetrating tip.
9. The needle device of claim 8, wherein the second lumen defines
the second opening on the bevel.
10. The needle device of claim 2, wherein a pressurizer is operably
associated with the supply tube to transport the component.
11. The needle device of claim 2, wherein the component is selected
from the group consisting of a fluid, a medication, a bulking
implant, and combinations thereof.
12. The needle device of claim 11, wherein the bulking implant is
selected from the group consisting of collagen, silicon particles,
ceramic balls, and fluoropolymer particles.
13. The needle device of claim 2, wherein the optical element
comprises a bundle of fiber-optic rods.
14. The needle device of claim 13, wherein further comprises a lens
system coupled to the fiber-optic rods and positioned to obtain
images out of the second opening.
15. A needle device comprising: a nozzle including a distal end and
defining a first lumen and a second lumen adjacent to the first
lumen, the distal end of the nozzle comprising a bevel tip
configured to penetrate tissue, the bevel tip comprising a first
opening of the first lumen and a second opening of the second
lumen; a supply tube configured to deliver a component into the
first lumen, out of the first opening and into a body of a patient;
and an optical element disposed with in the second lumen for
transmitting and receiving optical radiation.
16. The needle device of claim 15, wherein a pressurizer operably
associated with the supply tube to transport the component.
17. The needle device of claim 15, wherein the component is
selected from the group consisting of a fluid, a medication, a
bulking component, and combinations thereof.
18. The needle device of claim 17, wherein the bulking implant is
selected from the group consisting of collagen, silicon particles,
ceramic balls, and fluoropolymer particles.
19. The needle device of claim 15, wherein the optical element
comprises a bundle of fiber-optic rods.
20. The needle device of claim 19, wherein the optical element
further comprises a lens system coupled to the fiber-optic rods and
positioned to obtain images out of the second opening.
Description
RELATED APPLICATION
[0001] The present application claims the benefit of and priority
to U.S. patent application Ser. No. 10/062,357, filed on Jan. 31,
2002, the entirety of which is incorporated by reference.
TECHNICAL FIELD
[0002] The present invention generally relates to devices for
percutaneous diagnostic and therapeutic procedures, and, more
particularly, to a multi-lumen needle device incorporating an
optical element for continuously visualizing placement of the
operative tip of the device during the procedure.
BACKGROUND INFORMATION
[0003] Percutaneous needle devices are used in a number of medical
procedures, where access to body cavities or organs is desired.
Such needle devices typically have a hollow shaft ending in a
point, which serves to pierce the body tissue. After inserting the
device to the target body cavity or organ, the hollow shaft may be
used as a channel to take a fluid sample from the target site,
aspirate, irrigate or deliver medicaments and other materials to
the target site.
[0004] Despite the use of preliminary exploratory measuring
procedures such as ultrasound and X-ray, it is extremely difficult
for a medical professional to determine the positional relationship
of the tip of the needle to an internal organ or body cavity to be
treated. Moreover, blind percutaneous insertion of the needle
device entails the risk of damaging blood vessels, puncturing
organs, or tearing tissue as the needle is directed toward the
target.
[0005] Typically, when percutaneous insertion of the treating
instrument is desired, a puncture needle and a stylet are inserted
in the target area without visualization of the piercing tip.
Subsequently, the stylet is withdrawn and a multi-lumen endoscope
or catherer are inserted. This may prolong and complicate the
procedure, as well as cause inconvenience to a patient.
Furthermore, as described above, initial unguided insertion of a
puncture needle increases a risk of damaging blood vessels and
internal organs.
[0006] While it is desirable that surgical instruments have a
minimum diameter, the small diameter of instruments heretofore
resulted in functional limitations. To overcome this deficiency,
additional viewing instruments are often inserted to the target
site. Such additional instruments, however, are typically too large
to be successfully used in many medical procedures involving
percutaneous devices.
[0007] It is, thus, desirable to provide a penetrating needle
device that allows visualization of the target tissue simultaneous
with application of diagnostic and treatment procedures. Thus,
there is a need in the art for a low profile needle device capable
of penetrating body tissues and enabling a medical professional to
perform a number of diagnostic and therapeutic procedures
percutaneously with a precise degree of control without resort to
essentially blind approaches to the target tissue.
SUMMARY OF THE INVENTION
[0008] It is an object of the present invention to provide a
versatile diagnostic and treatment needle device useful for
inspection and treatment of internal body tissues, including
removing material within a body such as calculi, hydrodissection of
tissue planes, tissue cutting, flushing and debridement, and
percutaneous injection of bulking materials, while substantially
reducing the risk of damage to blood vessels and body organs.
[0009] Further, it is an object of the present invention to provide
a versatile diagnostic and treatment needle device capable of
percutaneous approaches to body cavities while providing continuous
visual supervision of the surgical field, control of the insertion
of the device, and performance of a therapeutic procedure through
an operative channel of the device.
[0010] Finally, it is an object of the present invention to provide
a versatile diagnostic and treatment needle device which is
miniature enough to be acceptable for introduction into and
visualization of tissue areas, which are difficult to otherwise
access without resorting to open surgery techniques or to
essentially blind guidance techniques.
[0011] Accordingly, a low profile needle device for penetrating
body tissues while substantially reducing the risk of damage to
blood vessels, nerves, and body organs by enabling the
visualization and control of the operative tip during insertion and
the procedure, is disclosed herein. The needle device of the
present invention has a large and diverse applicability to a number
of medical procedures because it enables internal visual inspection
of body tissues and cavities at the treatment site without
resorting to open surgery or to the simultaneous introduction or
supplemental penetrating of visualization devices at the treatment
site.
[0012] The needle device is adapted for applying hydrodynamic spray
to the inside surface of the kidney or other tissue such as
peri-prostatic tissue to irrigate the surface or debride tissue
therefrom, or in between body organs or tissue to dissect the
tissue planes. The needle device of the present invention is also
useful for efficient percutaneous injections of bulking material
into the urinary bladder wall, urethral wall or tissues surrounding
the bladder or urethra.
[0013] The present invention enables the physician to observe the
advance of the operative pointed tip of the device, thereby
assisting the physician in controlling the path of the needle
device and rate of its advance, as well as permits the physician to
observe the tissues in front of the tip in order to avoid damage to
vessels, nerves, and organs. In addition, the invention permits the
physician to visualize the opening of the operative channel during
the procedure. Because of its convenient size and low profile, the
device of the present invention performs the above-described
functions without compromising maneuverability and ease of use.
[0014] In general, in one aspect, the invention features a needle
device, consisting of a supply tube and a nozzle with a tissue
piercing point at its distal end. The tissue-piercing point of the
nozzle may be adapted to penetrate skin, rectus, bladder wall and
bladder neck of a patient. In one embodiment, the tissue piercing
point may be reinforced.
[0015] A first lumen, axially formed in the nozzle, is connected to
the distal end of the supply tube and has a first opening at the
distal end of the nozzle. A second lumen axially formed in the
nozzle has a second opening near the distal end of the nozzle. The
second opening is positioned proximal to the tissue piercing point
of the nozzle and proximal to the first opening. At least one
optical element is axially positioned in the second lumen for
transmitting and receiving optical radiation through the second
opening in the nozzle.
[0016] Embodiments of this aspect of the invention include the
following features. In one embodiment, the nozzle is a hollow
tubular member having a first tube and a second tube axially
disposed therein defining the first lumen and the second lumen
respectively. In another embodiment, the nozzle consists of a base
cylindrical member and a auxiliary cylindrical member, axially
extending from the base cylindrical member at the distal end of the
nozzle. The first lumen is axially formed in and extends through
the base cylindrical member and the auxiliary cylindrical member.
The second lumen is axially formed in and extends through the base
cylindrical member.
[0017] In one embodiment, the needle device may also include a
suction apparatus. The needle device may contain a handle at the
proximal end of the nozzle. In one embodiment, the needle device
may include a pressurizer for transporting fluids under pressure
through the tube, the nozzle and through the first opening. The
pressurizer may be pneumatic or hydraulic, for example, a bladder
pump, a piston pump, and an impeller pump. In another embodiment,
the pressurizer intermittently pressurizes the fluid delivered
through the first opening. In yet another embodiment, the
pressurizer delivers pressurized fluid through the first opening at
a rate sufficient to dissect tissue planes.
[0018] In one embodiment, the second opening is substantially
perpendicular to the longitudinal axis of the nozzle and proximal
to the distal end of the nozzle. In a particular embodiment, the
auxiliary cylindrical member curves inward at its distal end so
that the first opening of the first lumen of the nozzle is
substantially parallel to the longitudinal axis of the nozzle and
the tissue piercing point is adjacent and distal to said first
opening.
[0019] In one embodiment, the optical element positioned in the
second lumen of the nozzle may be an image transmitting bundle of
fiber-optic rods. The optical element may also include a fish-eye
lens positioned at the second opening. Further, the needle device
may include a plurality of illumination transmitting fiber-optics
rods. In one embodiment, the illumination transmitting fiber-optics
rods may be disposed in the second lumen. In another embodiment,
the illumination transmitting fiber-optics rods may be positioned
in the space between the hollow tubular member of the nozzle and
the first and the second tubes.
[0020] In one embodiment, the device further consists of a syringe
for holding bulking material. Non-limiting examples of such bulking
material include collagen, silicone particles, ceramic balls, and
fluoropolymer particles. In use, the pressurizer transports the
bulking implant material under pressure from the reservoir through
the nozzle and the first opening.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] In the drawings like reference characters generally refer to
the same parts throughout the different views. The drawings are not
necessarily to scale, emphasis instead generally being placed upon
illustrating the principles of the invention.
[0022] FIG. 1 illustrates a schematic view of the needle device
according to one embodiment of the present invention.
[0023] FIG. 2 illustrates a schematic view of the needle device
according to another embodiment of the present invention.
[0024] FIG. 3 illustrates a longitudinal cross-sectional view of
the nozzle and its attachment to the handle according to the one
embodiment of the present invention.
[0025] FIG. 4 illustrates an enlarged longitudinal cross-sectional
view of the distal end of the nozzle according to the embodiment
the present invention shown in FIG. 3.
[0026] FIG. 5 illustrates a cross-sectional view along the line 5-5
of FIG. 4 according to one embodiment of the present invention.
[0027] FIG. 6 illustrates a cross-sectional view along the line 5-5
of FIG. 4 according to another embodiment of the invention.
[0028] FIG. 7 illustrates a perspective view of the distal end of
the nozzle according to another embodiment of the present
invention.
[0029] FIG. 8 illustrates an enlarged longitudinal cross-sectional
view of the distal end of the nozzle according to the embodiment of
the present invention shown in FIG. 7
[0030] FIG. 9 illustrates a cross-sectional view along the line 9-9
of FIG. 8 according to another embodiment of the invention.
[0031] FIG. 10A illustrates an enlarged longitudinal
cross-sectional view of the distal end of the nozzle according to
yet another embodiment of the present invention.
[0032] FIG. 10B illustrates an enlarged longitudinal
cross-sectional view of the distal end of the nozzle according to
still another embodiment of the present invention.
[0033] FIG. 11 illustrates a top view of the distal end of the
nozzle according to the embodiments of the present invention shown
in FIGS. 10A and 10B.
[0034] FIG. 12A illustrates positioning of the nozzle in a method
for removing calculi from a kidney using the needle device of the
present invention.
[0035] FIG. 12B illustrates positioning of the nozzle in a method
for injecting bulking material using the needle device of the
present invention
[0036] FIG. 13 illustrates positioning of the nozzle in a method
for separating tissue planes using the needle device of the present
invention.
DETAILED DESCRIPTION
[0037] A feature common to each of the embodiments of the needle
device according to the invention described below is a multi-lumen
nozzle with a tissue-piercing point. At least one lumen in the
nozzle is a working channel, for example, for aspiration, flushing
or introduction of a surgical instrument. At least one other lumen
has an optical system. The optical system is positioned in the
nozzle to enable an operator to view the tissue piercing point
during a surgical procedure.
[0038] Referring to FIG. 1, a needle device 10 includes a
multi-lumen nozzle 30 connected to a reservoir 60 by a supply tube
40. The reservoir 60 supplies fluid 100 under pressure through the
supply tube 40 to the nozzle 30, which directs the pressurized
fluid 100 onto a target body site in the patient. In one embodiment
of the present invention, the needle device 10 also includes a
suction apparatus 70 connected to the nozzle 30, for example,
through the supply tube 40 to enable aspiration through the nozzle
30. In this embodiment of the invention the supply tube 40 may have
two lumens 42 and 44 where one lumen 42 is used for flushing, and
the other lumen 44 for aspiration of the target body site.
[0039] In one embodiment, according to the invention, the reservoir
60 contains fluid 100, for example, water, Ringer's solution, or a
balanced salt solution such as saline solution. The fluid 100 may
contain medications 105, for example, antibiotics. In one
embodiment, medications 105 are added to the reservoir 60. In
another embodiment, the needle device 10 includes a container 46
with medications 105 connected to the nozzle 30 through the supply
tube 40. In this embodiment, medications 105 are supplied to the
flow of the fluid 100 in the lumen 42 of the supply tube 40 from
the container 46. In another embodiment, the fluid 100 contains
bulking material such as collagen, silicone particles, ceramic
balls, or fluoropolymer particles, for example,
polytetrafluoroethylene particles sold under the trademark
TEFLON.RTM. by E.I. du Pont de Nemours and Company of Wilmington,
Del.
[0040] Referring still to FIG. 1, in another embodiment of the
needle device 10 according to the invention, a pressurizer 65 is
submerged in the reservoir 60. The pressurizer 65 transfers fluid
100 from the reservoir 60 under pressure and delivers fluid 100 to
the nozzle 30 through the lumen 42 in the supply tube 40. In one
embodiment of the invention, the pressurizer 65 is an electric
multi-stage rotary hydraulic pump, for example, a bladder pump,
piston pump, or impeller pump. Other hydraulic pumps known in the
art can also be used. In another embodiment, the pressurizer 65 is
a pneumatic pump. In yet another embodiment, the reservoir 60 is
pressurized by a pressurizer external to the reservoir 60. In yet
another embodiment of the invention, the reservoir 60 is an
intravenous fluid bag. Pressure may be applied to the intravenous
fluid bag manually, by gravity, a pressure cuff, or by means of a
pressurized chamber. In still another embodiment, a gas, for
example, oxygen, carbon dioxide, or nitrogen, may be used in place
of fluid 100.
[0041] With continued reference to FIG. 1, in one embodiment of the
invention, the pressurizer 65 may include a pulsatile flow
generator 67 to intermittently change the pressure of the flow of
fluid 100 delivered to the nozzle 30. Suitable pulsatile flow
generators may include, but are not limited to, for example, an
ultrasonic vibrator, valving system, gas-assist system, and
piezoelectric actuator. In one embodiment, the pulsatile flow
generator 67 is flutter valve, activated by the fluid flow that
rhythmically opens and closes to intermittently change the pressure
of the flow of fluid 100.
[0042] Referring still to FIG. 1, in one embodiment, a handle 50
having a lumen 51 therein is attached to the supply tube 40 to
enable manipulation of the nozzle 30 inside the patient's body. A
proximal end 315 of the nozzle 30 is in fluid communication with at
least one lumen 42 of the supply tube 40. The handle 50 may also
contain or be connected to a control system (not shown) to control
the pressurizer 65, pulsatile flow generator 67 and suction
apparatus 70 to manage the pressure and direction of fluid 100, as
well as pulsation and aeration of the flow. The control system of
the handle 50 may also permit switching between flushing and
aspiration modes.
[0043] As illustrated in FIG. 1, the handle 50 includes a port 55
for introducing optical elements. Attached to the port 55 are a
light source 57 and an ocular system 59. Suitable light sources may
include, but are not limited to, for example, a high-intensity
tungsten filament lamp with fan cooling, or a halogen lamp. The
light source 57 is in optical communication with a distal end 316
of the nozzle 30 through illumination fiber-optics rods, to be
described below, axially positioned in a connecting tube 570, the
lumen 51 in the handle 50, and the nozzle 30. The light source 57
provides illumination to the target site inside the patient's body.
The ocular system 59, which includes an objective 592 and a
focusing system 593, is in optical communication with the distal
end 316 of the nozzle 30 through the image-transmitting
fiber-optics bundle, to be described below, in a connecting tube
590, the lumen 51 in the handle 50, and the nozzle 30. The ocular
system 59 permits an operator to visualize the distal end 316 of
the nozzle 30 when the nozzle 30 is positioned inside the patient's
body during a surgical procedure as will later be described.
[0044] Referring to FIG. 2, in another embodiment of the invention,
a needle device 10, according to the invention, includes a syringe
80 containing fluid 100. In one embodiment, the syringe 80 is
affixed to the handle 50 through a port 75 having a lumen 77, such
as a Luer port. The barrel of the syringe 80 is in fluid
communication with the lumen 51 in the handle 50 and the nozzle 30.
In one embodiment of the invention, the fluid 100 is preferably a
bulking material to be injected, for example, into the submucosal
tissues of the urethra and/or the bladder neck and into tissues
adjacent to the urethra for treatment of, for example, intrinsic
sphincter deficiency. In this embodiment of the invention, a
control system of the handle 50 includes a flow control subsystem,
for example, a three-way valve (not shown), which allows the
operator to switch between reservoir 60 and syringe 80 as sources
of fluid 100.
[0045] In another embodiment of the invention, referring to FIG. 3,
the nozzle 30 has a proximal end 315, which is secured to the
handle 50, for example, by means of a mounting member 52 disposed
in the distal end 53 of the handle 50. In one embodiment, the
nozzle 30 has a hollow tubular member 33. The tubular member 33 is
formed from, for example, a stainless steel tube, having an outside
diameter from 0.050 to 0.275 inches, preferably 0.100 inches, an
inside diameter from 0.033 to 0.175 inches, preferably 0.085
inches, and a wall thickness from 0.0035 to 0.010 inches,
preferably 0.006 inches. The nozzle 30 has a bevel 312 ranging from
0.degree. to 45.degree. angle .alpha.. from the plane of the
longitudinal axis 300 of the nozzle 30. The bevel 312 forms a
tissue piercing point 310 at the distal end 316 of the nozzle 30.
The tissue piercing point 310 is adapted to penetrate body tissues,
including skin, rectus, bladder wall and bladder neck. In one
embodiment of the invention, the tissue piercing point 310 is
reinforced by, for example, a cobalt-chromium alloy to improve, for
example, edge holding, durability and strength of the tissue
piercing point 310.
[0046] Referring still to FIG. 3, in one embodiment according to
the invention, disposed within the nozzle 30 are the second tube
329 defining an axially disposed second lumen 330, and an operative
channel comprising a first tube 319 defining an axially disposed
first lumen 320. In the preferred embodiment, the first tube 319
and the second tube 329 are substantially parallel and
substantially adjacent to each other. The second tube 329 is made
of any suitable material, for example, stainless steel or
polyimide, and has an outside diameter from 0.020 to 0.100 inches,
preferably 0.050 inches, an inside diameter from 0.015 to 0.090
inches, preferably 0.040 inches, and a wall thickness from 0.003 to
0.010 inches, preferably 0.005 inches. The first tube 319 is also
made from any suitable material, for example, stainless steel or
polymide, and has an outside diameter of from 0.050 to 0.150
inches, preferably 0.100 inches, an inside diameter from 0.040 to
0.140 inches, preferably 0.090 inches, and a wall thickness from
0.002 to 0.010 inches, preferably 0.005 inches. The first tube 319
and the second tube 329 extend proximal to the proximal end 315 of
the nozzle to a connector 54 in the distal end of the handle 50 as
will be described below. In another embodiment, the first lumen 320
and the second lumen 330 may be formed as an integral part of the
nozzle, for example, by an extrusion process.
[0047] Referring to FIG. 4, the first lumen 320 of the first tube
319 has a first opening 340 at the distal end 316 of the nozzle 30
substantially adjacent to the tissue piercing point 310. The second
lumen 330 has a second opening 350 proximal to the tissue piercing
point 310 and proximal to the first opening 340 so that the first
opening 340 is positioned distal to the second opening 350 and the
tissue piercing point 310. The openings 340 and 350 are disposed in
the bevel 312 at the distal end 316 of the nozzle 30.
[0048] Referring still to FIG. 4, a lens system 360 is joined to
the distal end of the tube 329 at the second opening 350. In a
particular embodiment, the lens system 360 includes a wide-angle
plano-convex lens, also known as a "fish-eye" lens, made from any
suitable material, such as glass having, for example, a glass index
of 1.62.
[0049] Referring still to FIG. 4, in one embodiment, an image
transmitting bundle 370 of fiber-optic rods or fibers is disposed
within the second lumen 330. In order to provide a high quality
resolution for viewed objects, the smallest flexible fiber-optic
fibers available in the making of the bundle 370 are used. Such
bundles are usually produced by a drawing technique where a bundle
of fibers is heated and the fibers are drawn at a specific drawing
pressure and rate so that the bundle is elongated and the diameter
of the fibers is reduced to achieve a predetermined diameter. In a
particular embodiment, each of the individual fibers of the bundle
370 is approximately 6 microns in diameter. The preferred diameter
of individual fiber rods in the bundle 370 is in the range from
approximately 4 microns to about 10 microns. Additionally, the
fibers in the bundle 370 can be made from any suitable material,
including glass or plastic. The diameter of the fiber-optic bundle
370 is in the range from about 200 microns to 600 microns,
preferably from about 300 microns to 500 microns. For descriptive
purposes in this application, the term "rods" is used to define
optic fibers of the type referred to herein, for example, flexible
optic fibers.
[0050] Further, referring now to FIG. 5, a cross-section of an
embodiment of the nozzle 30, illustrated in FIG. 4, is shown. A
plurality of illumination transmitting fiber-optic rods or fibers
380 is axially disposed in the nozzle 30. There are typically about
6,000 fiber-optic rods in the fiber-optic bundle. In a particular
embodiment, the rods 380 are positioned within the second lumen 330
and extend from the second opening 350 of the nozzle 30 to the
light source 57 (shown in FIGS. 1-2). In one embodiment of the
invention, the nominal diameter of the bundle 370 is 375 microns.
In another embodiment, the rods 380 having diameters ranging from
0.003 to 0.008 inch are bundled in a plurality of bundles 370
having diameters ranging from 0.020 to 0.030 inches.
[0051] Referring now to FIG. 6, another embodiment of the
illumination transmitting fiber-optic rods 380 is illustrated. A
plurality of rods 380 is axially disposed within the nozzle 30
outside of and parallel to the lumens 320 and 330 of the tubes 319
and 329 respectively. The rods 380 extend from the distal end 316
of the nozzle 30 to the light source 57 (shown in FIGS. 1-2).
[0052] Referring again to FIG. 3, the fiber-optic bundle 370 and
the plurality of rods 380 exit from the proximal end 315 of the
nozzle 30 into the connector 54 and then into the port 55 through
the connecting tubes 570 and 590. The proximal ends of the rods 380
pass through port 55 and are in optical communication with the
light source 57 shown on FIGS. 1-2. Light is transmitted from the
light source 57 through the distal end 316 of the nozzle 30 onto
the target body site. The proximal end of the fiber optic bundle
370 is in optical communication with the ocular system 59 shown in
FIGS. 1-2 to permit visualization of an image, such as a composite
image, transmitted by the lens system 360 to the proximal end of
the bundle 370. In order that the image transmitted by the lens
system 360 is precisely focused on the proximal end of the bundle
370, the bundle 370 can be reciprocated axially within the lumen
330 to compensate for objects viewed at varying distances from the
second opening 350 of the nozzle 30.
[0053] Referring to FIG. 4, in one embodiment of the invention, the
first opening 340 is positioned distal to the second opening 350
between the second opening 350 and the tissue piercing point 310.
Such configuration of the tissue piercing point 310, and the
opening 350 enables an operator to observe the tissue piercing
point 310 as it advances in the patient's body, as well as to
observe the first opening 340.
[0054] Referring again to FIGS. 1-2, the fluid 100 may be held in
the reservoir 60 or the syringe 80. Referring again to FIG. 3, in
one embodiment, the lumen 320 of the nozzle 30 is in fluid
communication with the reservoir 60 shown in FIG. 1 through the
supply tube 40 and the connector 54 in the handle 50. In another
embodiment, the lumen 320 of the nozzle 30 is in fluid
communication with the syringe 80, through a connecting tube 810,
axially disposed in the lumen 77 of the port 75, and the connector
54. In one embodiment, the connector 54 contains a flow control
system (not shown), which allows an operator to connect the first
lumen 320 alternatively to the supply tube 40 or to the syringe 80
as needed.
[0055] Referring to FIG. 7, in another embodiment of the needle
device 10 according to the present invention, the nozzle 30
consists of a base member 31, such as a cylindrical member, having
a base longitudinal axis 735 axially disposed through the center of
the base member 31, a proximal end 733 and a distal end face 731;
and an auxiliary cylindrical member 32, having an auxiliary
longitudinal axis 736 axially disposed through the center of the
auxiliary member 32, a proximal end 734 and a distal end face 732.
The diameter of the base cylindrical member 31 is in the range from
about 0.050 inches to 0.275 inches, preferably from about 0.100
inches to 0.120 inches. The diameter of the auxiliary cylindrical
member 32 in the range from about 0.050 inches to 0.090 inches,
preferably from about 0.060 inches to 0.080 inches. The auxiliary
cylindrical member 32 extends axially from the distal end face 731
of the base cylindrical member 31. The length of the auxiliary
cylindrical member 32 is in the range from about 0 inches to 0.100
inches, preferably from about 0.125 inches to 0.500 inches. In one
embodiment of the nozzle 30, the center auxiliary axis 736 is
substantially parallel to and offset from the central base axis
735.
[0056] Referring still to FIG. 7, in a particular embodiment, the
distal end face 731 of the base cylindrical member 31 is
substantially perpendicular to the central base axis 735. The
distal end face 732 of the auxiliary cylindrical member 32 is
positioned at an angle .beta. between 0.degree.. and 90.degree.
clockwise from the auxiliary axis 736, preferably between
15.degree. and 30.degree., thereby forming a tissue piercing point
310 at the distal end 316 of the nozzle 30.
[0057] The tissue piercing point 310 is adapted to penetrate body
tissues, including skin, rectus, bladder wall and bladder neck. In
one embodiment of the invention, the tissue piercing point 310 is
reinforced to improve, for example, edge holding, durability and
strength of the tissue piercing point 310.
[0058] With continued reference to FIG. 7, the first lumen 320 and
the second lumen 330 are disposed axially in the nozzle 30. The
first lumen 320 extends from the proximal end 733 of the base
cylindrical member 31 to the distal end face 732 of the auxiliary
cylindrical member 32. The second lumen 330 extends from the
proximal end 733 of the base cylindrical member 31 to the distal
end face 731 of the base cylindrical member 31. In a particular
embodiment, the first lumen 320 and the second lumen 330 are
substantially parallel to the central base axis 735 and to the
auxiliary axis 736 of the nozzle 30. As described above in the
embodiment of the needle device depicted in FIG. 1 and FIG. 3, the
lumen 320 of the nozzle 30 illustrated in FIG. 7 is in fluid
communication with the reservoir 60 through the supply tube 40 and
the connector 54 in the handle 50. In another embodiment, the lumen
320 of the nozzle 30 illustrated in FIG. 7 is in fluid
communication with the syringe 80 shown in FIG. 2 and described in
the corresponding text, through a connecting tube 810, axially
disposed in the port 75, and the connector 54.
[0059] Referring now to FIGS. 7 and 8, in this embodiment of the
invention, the first lumen 320 has a first opening 340 in the
distal end face 732 of the auxiliary cylindrical member 32 proximal
and adjacent to the tissue piercing point 310. The second lumen 330
has a second opening 350 at the distal end face 731 of the base
cylindrical member 31 and adjacent to the proximal end 734 of the
auxiliary cylindrical member 32. In one embodiment of the
invention, the second opening 350 is substantially perpendicular to
the central base axis 735 of the base cylindrical member 31 of the
nozzle 30.
[0060] As described above in the embodiment of the needle device
depicted in FIGS. 3 and 4, the plurality of
illumination-transmitting rods 380 and the image transmitting
fiber-optic bundle 370, having an axis 376 axially disposed through
the center thereof, are disposed within the second lumen 330. In a
particular embodiment illustrated in FIGS. 7 and 8, the tissue
piercing point 310 lies in the cross-sectional plane of the nozzle
30, defined by the central base axis 735 of the base cylindrical
member 31 and the auxiliary axis 736 of the auxiliary member 32,
and is positioned in that plane between the auxiliary axis 736 and
the axis 376.
[0061] Referring to FIG. 8, the lens system 360 is joined to the
distal end face 731 of the base cylindrical member 31 at the second
opening 350. As described above, the lens system 360 includes, for
example, a wide-angle plano-convex lens made from any suitable
material, such as glass.
[0062] Referring to FIG. 9, the image transmitting bundle 370 of
fiber-optic fibers and a plurality of illumination transmitting
fiber-optic fibers 380 are disposed within the second lumen 330. As
described above with regard to the embodiment illustrated in FIGS.
3-5, the image transmitting fiber-optic bundle 370 and illumination
transmitting fiber-optic fibers 380 are connected to the light
source 57 and the ocular system 59 shown in FIG. 1, respectively,
to enable visualization of the tissue piercing point 310 through
the ocular system 59.
[0063] Referring to FIG. 10a, in yet another embodiment of the
nozzle 30 according to the invention, a distal end portion 180 of
the auxiliary cylindrical member 32 forms a curve with the convex
surface of the curve disposed on the side of the auxiliary
cylindrical member 32 furthest from the central base axis 735. The
distal end face 732 of the auxiliary cylindrical member 32 and the
first opening 340 are substantially parallel to the center base
axis 735 of the nozzle 30. The tissue piercing point 310 is located
at the distal end of the distal end face 732 of the auxiliary
cylindrical member 32. In the embodiment illustrated in FIG. 10a,
the second opening 350 is substantially perpendicular to the center
base axis 735 of the base cylindrical member 31 of the nozzle 30
and substantially perpendicular to the first opening 340.
[0064] As illustrated in FIG. 10B, in another embodiment of the
invention, the distal end face 732 may be positioned at an angle
.gamma. to a perpendicular 738 from the center base axis 735 drawn
from the tissue piercing point 310 between 0.degree. and 90.degree.
In one embodiment, the angle .gamma. equals 90.degree. In another
embodiment, the angle .gamma. equals 60.degree. In yet another
embodiment, the angle .gamma. equals 45.degree.
[0065] Referring to FIG. 11, in the embodiments of the nozzle 30
described above and illustrated in FIGS. 10a and 10b, the position
of the lens 360 relative to the tissue piercing point 310 and the
first opening 340 permits an operator to observe both the tissue
piercing point 310 as it advances in the patient's body, and the
first opening 340.
[0066] The needle device 10 of the present invention can be useful
in a variety of medical procedures. For example, staghorn calculi
trapped in the renal pelvis of a patient may become infected and
may reform if all remnants of the stone are not removed during
surgery. It is desirable to flush the renal pelvis to remove all of
the stone fragments.
[0067] Referring now to FIG. 12A, in another aspect the invention
includes a method for removing material from the body, for example,
for removing calculi 1220 from a kidney 1200. In one embodiment of
the invention, the method includes the steps of providing the
needle device 10 described above with the nozzle 30 dimensioned to
fit within a renal calyx 1210. The nozzle 30 of the needle device
10 is inserted by an operator through a flank incision into the
abdomen, and then into the renal pelvis 1205 of the kidney 1200 of
a patient. The distal end of the nozzle 30 is visualized through
the ocular system 59. After the needle device 10 is inserted into
the renal pelvis 1205, the operator visualizes the renal calyx 1210
and advances the distal end 316 of the nozzle 30 in close proximity
to the calculi 1220 in the renal calyx 1210. The operator activates
the pressurizer 65, which transports fluid 100 from reservoir 60
under pressure through the supply tube 40 and the lumen 320, and
directs the pressurized fluid 100 through the first opening 340
onto the calculi 1220. The calculi 1220 are flushed from the renal
calyx 1210 into the renal pelvis 1205 where the calculi 1220 are
aspirated or pass freely from the kidney 1200 to the urethra 1230,
and out of the patient's body.
[0068] In another embodiment, the needle device 10 can be used to
treat intrinsic sphincter deficiency ("ISD"), which is a medical
condition that is characterized by stress incontinence and has been
associated with a weak urethral sphincter that is unable at rest to
adequately close the urethra. Treatment of this condition typically
entails injection of a bulking material, such as, for example,
collagen, silicone particles, ceramic balls, or fluoropolymer
particles, for example, polytetrafluoroethylene particles sold
under the trademark TEFLON.RTM.. by E. I. du Pont de Nemours and
Company of Wilmington, Del., to obstruct the lumen of the urethra
to prevent urine outflow.
[0069] Referring to FIG. 12B, the method for injecting a bulking
material 110 includes providing a needle device 10 having a syringe
80 containing the bulking material 110. The operator inserts the
tissue piercing point 310 of the nozzle 30 using handle 50 through
a flank incision into the abdomen of a patient, and then into the
bladder 1260, while visualizing the distal end 316 of the nozzle 30
through the ocular system 59. After the needle device 10 is
inserted into the bladder 1260, the operator locates the bladder
neck 1270 visually and inserts the tissue piercing point 310 at the
distal end 316 of the nozzle 30 through the wall of the bladder
neck 1270 until the tissue piercing point 310 is in the submucosal
tissues as determined visually via optical system 59. The operator
activates the syringe 80 containing bulking material 110, and
injects bulking material 110 from the barrel of the syringe 80
through the connecting tube 810, into the lumen 320 of the nozzle
30, and through the first opening 340 near the tissue piercing
point 310 into the submucosal tissues of the urethra, the bladder
neck, and/or into peri-urethral tissues proximal to the urethra.
Bulking material 110 is injected into the tissue until the operator
determines visually that the urethral sphincter muscle is coapted
and able to maintain sufficient resting closing pressure to prevent
urine from involuntarily leaking from the distal urethral orifice
of the patient.
[0070] It can be appreciated that this method of the invention is
not limited to the embodiments described above and shown in FIGS.
12A-12B. The method according to the invention can also be applied
to other internal surfaces in the body to flush, irrigate, cut, or
debride tissue, such as diverticular or fistular tissue, or to
inject fluids into tissues in the patient's body.
[0071] The needle device of the present invention can also be used
in the course of retropubic radical laparoscopic prostatectomy, a
standard surgical procedure for patients with organ confined
prostate cancer. During this procedure, it is highly desirable to
maintain the neuro-vascular bundle of the prostate intact to
preserve sexual function. The nerve sparing technique is difficult
because this bundle is located under the prostate and out of the
field of vision of the laparoscope. Referring to FIG. 13, in one
embodiment of the invention, the method for hydrodissecting tissue
planes, more particularly, for example, for separating the prostate
1310 from the ventral surface of the rectum 1320, includes the
steps of providing the needle device 10 described herein, inserting
the nozzle 30 using the handle 50 until the tissue piercing point
310 is in the biplane fascial layer 1330, known as Denonvillers
fascia and located between the dorsal surface of the prostate 1310
and the ventral surface of the rectum 1320, and, as described
above, injecting a fluid or a gas at a sufficient force into
Denonvillers fascia to generate a fluid-filled or gas-filled space
1340 to physically separate the prostate 1310 and the rectum 1320.
This method can be practiced by a variety of surgical approaches,
such as, for example, transperineally, transrectally, or
suprapubically, and avoids substantially traumatizing the prostate
neurovascular bundle
[0072] It can be appreciated that the method of hydrodissecting is
not limited to separating the prostate from the rectum, and may
also be used separate muscle planes or to hydrodissect other tissue
planes in the body, such as strictures or adhesions.
[0073] It will be apparent to those skilled in the art of medical
devices that various modifications and variations can be made to
the above-described structure and methodology without departing
from the scope or spirit of the invention.
* * * * *