U.S. patent number RE36,473 [Application Number 08/976,528] was granted by the patent office on 1999-12-28 for fiberoptic delivery system and method of use.
This patent grant is currently assigned to Indigo Medical, Inc.. Invention is credited to Victor C. Esch, Kirsten L. Valley.
United States Patent |
RE36,473 |
Esch , et al. |
December 28, 1999 |
Fiberoptic delivery system and method of use
Abstract
A hand held device having an optical fiber with a radiation
emitter carried at a free end, the optical fiber being attached to
a handle that includes a knob which allows movement of a flexible
tubular sleeve from a position covering the fiber and emitter to a
position exposing the emitter and a length of fiber adjacent to it,
the sleeve also having a sharp metal cleat extending from its end,
the cleat being an end of a length of wire which passes through a
separate channel of the sleeve to the knob without being attached
to the sleeve. An application of this device is for inserting the
emitter into a mass of material in order to irradiate the material
from within.
Inventors: |
Esch; Victor C. (San Francisco,
CA), Valley; Kirsten L. (Mountain View, CA) |
Assignee: |
Indigo Medical, Inc. (Palo
Alto, CA)
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Family
ID: |
26934529 |
Appl.
No.: |
08/976,528 |
Filed: |
November 21, 1997 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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Reissue of: |
241735 |
May 12, 1994 |
05469524 |
Nov 21, 1995 |
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Current U.S.
Class: |
385/118; 385/117;
606/15; 606/7 |
Current CPC
Class: |
A61B
1/018 (20130101); A61B 5/1076 (20130101); A61B
18/24 (20130101); G02B 23/2469 (20130101); A61B
90/361 (20160201); A61B 2017/22077 (20130101); A61M
3/0279 (20130101); A61B 2017/22072 (20130101) |
Current International
Class: |
A61B
18/20 (20060101); A61B 18/24 (20060101); A61B
5/107 (20060101); A61B 1/015 (20060101); A61B
1/012 (20060101); A61B 1/018 (20060101); G02B
23/24 (20060101); A61B 17/22 (20060101); A61B
19/00 (20060101); A61M 3/00 (20060101); A61M
3/02 (20060101); G02B 006/06 () |
Field of
Search: |
;385/115,116,117,118,119,120,901 ;606/7,12,15,4,16,9,17,10 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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2-121675 |
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May 1990 |
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JP |
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92/10142 |
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Jun 1992 |
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WO |
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Primary Examiner: Palmer; Phan T. H.
Attorney, Agent or Firm: Shay; Bernard
Claims
It is claimed:
1. A hand held fiber optic delivery system, comprising:
a handle,
a flexible elongated tube carried by the handle in a manner to be
slid in and out thereof for a distance along the length of the
tube, said tube having a free end extending a distance from the
handle,
a knob carried by the handle and attached to said tube therein in a
manner to allow said tube to be slid in and out of the handle along
the length of the tube,
a length of optical fiber positioned within said tube and handle,
said optical fiber being restrained against movement along its
length by attachment to the handle, and
a length of wire extending along the length of said tube, said wire
being attached to said knob and extending a distance away from said
free tube end, whereby said wire and tube are moved together along
their lengths by movement of the knob with respect to the
handle.
2. The system of claim 1 wherein said wire is of an uniform
diameter along its length within the tube and remains unattached to
said tube, thereby allowing the wire to slide along its length with
respect to the tube when the tube is bent.
3. The system of claim 2 wherein the tube includes a first passage
extending along its length in which the optical fiber is carried
and a second passage extending parallel to said first passage in
which the wire is carried, said second passage having a diameter no
more than twice that of said wire.
4. The system of claim 3 wherein the tube is made of a plastic
material and the wire is made of a metallic material.
5. The system of claim 1 which additionally comprises measurement
marks periodically spaced apart on an outside of the tube along its
length adjacent said free end with indicia of a distance of the
marks from said free end of the tube.
6. A method of inserting an end of an optical fiber into biological
tissue through a passage of a body, comprising the steps of:
inserting an endoscope into said passage and positioning a far end
thereof adjacent a surface of the tissue into which the optical
fiber end is desired to be inserted,
feeding through the endoscope an end of a flexible tube containing
an optical fiber by manipulation of a handle to which the tube and
fiber are attached,
piercing the surface of the tissue by first urging thereinto a tip
of a wire that extends along the length of the tube end and beyond
its said one end,
inserting the tube and optical fiber a desired distance within the
tissue as determined by observing measurement markings along a
length of the tube on its outside surface, and
thereafter withdrawing the tube from the tissue while holding the
optical fiber against such withdrawal, whereby the optical fiber
end is positioned within the tissue for treatment thereof.
7. A hand held fiber optic delivery system, comprising:
a handle,
a flexible elongated tube carried by the handle in a manner to be
slid in and out thereof for a distance along the length of the
tube, said tube having a free end extending a distance from the
handle,
a knob carried by the handle and attached to said tube therein in a
manner to allow said tube to be slid in and out of the handle along
the length of the tube,
a length of optical fiber positioned within said tube and handle,
said optical fiber being restrained against movement along its
length by a attachment to the handle,
a length of wire extending along the length of said tube, said wire
being attached to said knob and extending a distance away from said
free tube end, whereby said wire and tube are moved together along
their lengths by movement of the knob with respect to the handle,
and
measurement marks periodically spaced apart on an outside of the
tube along its length adjacent said free end with indicia of a
distance of the marks from said free end of the tube.
8. The system of claim 7 wherein said wire is of a uniform diameter
along its length within the tube and remains unattached to said
tube, thereby allowing the wire to slide along its length with
respect to the tube when the tube is bent.
9. The system of claim 8 wherein the tube includes a first passage
extending along its length in which the optical fiber is carried
and a second passage extending parallel to said first passage in
which the wire is carried, said second passage having a diameter no
more than twice that of said wire.
10. The system of claim 9 wherein the tube is made of a plastic
material and the wire is made of a metallic material. .Iadd.
11. A method of inserting a radiation emitting end of an optical
fiber system into biological tissue through a passage of a body,
comprising:
inserting an endoscope into the passage and positioning a far end
thereof adjacent a surface of the tissue into which the radiation
emitting end is desired to be inserted;
feeding the radiation emitting end through the endoscope by
manipulation of the optical fiber system;
piercing the surface of the tissue using a tip of the optical fiber
system and urging the radiation emitting end of the optical fiber
system into the tissue;
positioning the radiation emitting end a desired distance within
the tissue as determined by observing a measurement marking along a
length of the optical fiber system on an outside surface thereof,
whereby the radiation emitting end is positioned within the tissue;
and
energizing a radiation source connected to the optical fiber system
to provide radiation through the radiation emitting end to the
tissue..Iaddend..Iadd.12. The method according to claim 11 wherein
the optical fiber system further comprises an optical fiber and a
flexible sleeve surrounding at least a portion of the optical
fiber..Iaddend..Iadd.13. The method according to claim 12 wherein
the radiation emitting end of the optical fiber system comprises a
diffusing tip..Iaddend..Iadd.14. The method according to claim 13
wherein the diffusing tip is substantially cylindrical and is
adapted to emit radiation with a substantially uniform intensity
alone a length thereof and around an outer cylindrical surface
thereof..Iaddend..Iadd.15. The method according to claim 14 wherein
the radiation source comprises a diode laser..Iaddend..Iadd.16. The
method according to claim 13 wherein
the radiation source comprises a diode laser..Iaddend..Iadd.17. The
method according to claim 12 wherein the optical fiber system
includes a sharp piercing point..Iaddend..Iadd.18. The method
according to claim 17 wherein the endoscope is tilted with respect
to the passage prior to piercing the surface of the tissue to
increase an angle of incidence of the sleeve with respect to the
surface of the tissue..Iaddend..Iadd.19. The method according to
claim 12 wherein said sleeve is urged into the tissue until a
selected measurement marking is positioned adjacent the surface of
the tissue..Iaddend..Iadd.20. A method of inserting a diffusing
tip, which is positioned at an end of an optical fiber, into a
prostate gland through a urethra for the purpose of treating benign
prostate hyperplasia, comprising:
inserting an endoscope into the urethra and positioning a far end
thereof adjacent a surface of the prostate gland;
feeding the diffusing tip through the endoscope by manipulation of
the optical fiber;
piercing the surface of the prostate gland and urging the diffusing
tip into the prostate gland;
positioning the optical fiber and the diffusing tip a desired
distance within the prostate gland as determined by observing a
measurement marking along an outer surface of a length of a
flexible sleeve positioned around at least a portion of the optical
fiber, whereby the diffusing tip is positioned within the prostate
gland; and
energizing a radiation source connected to the optical fiber to
provide radiation through the diffusing tip to tissue of the
prostate
gland..Iaddend..Iadd.21. The method according to claim 20 wherein
the diffusing tip is substantially cylindrical and is adapted to
emit radiation with a substantially uniform intensity alone a
length thereof and around an outer cylindrical surface
thereof..Iaddend..Iadd.22. The method according to claim 21 wherein
the radiation source comprises a diode laser..Iaddend..Iadd.23. The
method according to claim 20 wherein the endoscope is tilted with
respect to the urethra prior to piercing the prostate gland to
increase an angle of incidence of the sleeve with respect to the
surface of the prostate gland..Iaddend..Iadd.24. The method
according to claim 20 wherein the sleeve is urged into the tissue
of the prostate gland until a selected measurement marking is
positioned adjacent the surface of the prostate
gland..Iaddend..Iadd.25. The method according to claim 20 wherein
the optical fiber and the sleeve are affixed to each other to
prevent significant relative movement
therebetween..Iaddend..Iadd.26. A method of inserting an end of an
optical fiber into tissue of the prostate gland through a urethral
passage of a human body for the purpose of treating benign prostate
hyperplasia, comprising:
inserting an endoscope into the passage and positioning a far end
thereof adjacent a surface of the tissue into which the optical
fiber end is desired to be inserted;
feeding a sleeve through the endoscope by manipulation of the
sleeve wherein at least a portion the optical fiber is enclosed in
the sleeve;
piercing the surface of the tissue by urging thereinto a tip of the
sleeve, wherein the tip extends beyond the optical fiber end;
positioning the sleeve and the optical fiber a desired distance
within the tissue as determined by observing a measurement marking
along a length of the sleeve on an outside surface thereof, whereby
the optical fiber end is positioned within the tissue; and
energizing a radiation source connected to the optical fiber to
provide
radiation through the optical fiber to the
tissue..Iaddend..Iadd.27. The method according to claim 26 wherein
the radiation is emitted from the optical fiber end in a
substantially cylindrical pattern therearound and with a
substantially uniform intensity along a length
thereof..Iaddend..Iadd.28. The method according to claim 27 wherein
the radiation source comprises a diode laser..Iaddend..Iadd.29. The
method according to claim 26 wherein the sleeve includes a sharp
piercing point..Iaddend..Iadd.30. The method according to claim 29
wherein the endoscope is tilted with respect to the passage prior
to piercing the surface of the tissue to increase an angle of
incidence of the sleeve with respect to the surface of the
tissue..Iaddend..Iadd.31. The method according to claim 26 wherein
the radiation source comprises a diode laser..Iaddend..Iadd.32. The
method according to claim 26 wherein the sleeve is urged into the
tissue until a selected measurement marking is positioned adjacent
the surface of the tissue being pierced..Iaddend..Iadd.33. The
method according to claim 26 wherein the sleeve is flexible and the
optical fiber is affixed to the sleeve to prevent relative movement
between the sleeve and the optical
fiber..Iaddend..Iadd.34. A hand-held, fiber optic delivery system
for use with an endoscope, comprising:
a flexible elongated plastic sleeve adapted to be carried by the
endoscope in a manner to be slid in and out of the endoscope and
having a free end extending a distance from the endoscope;
a length of optical fiber positioned within said sleeve; and
measurement marks periodically spaced apart on an outside surface
of said sleeve along the free end thereof..Iaddend..Iadd.35. The
system according to claim 34, further comprising a radiation
emitter at a distal end of said optical fiber..Iaddend..Iadd.36.
The system according to claim 35 wherein said radiation emitter
comprises a diffusing tip..Iaddend..Iadd.37. The system according
to claim 36 wherein said diffusing tip emits radiation with a
substantially uniform intensity along a length thereof and around
an outer cylindrical surface thereof..Iaddend..Iadd.38. The system
according to claim 34, further comprising a radiation source
connected to said optical fiber..Iaddend..Iadd.39. The system
according to claim 38 wherein said radiation source is a diode
laser..Iaddend..Iadd.40. The system according to claim 34 wherein
said measurement marks are indicative of a distance therefrom to
the free end of said sleeve..Iaddend..Iadd.41. The system according
to claim 34 wherein said optical fiber is affixed to said
sleeve
to prevent relative movement therebetween..Iaddend..Iadd.42. A
hand-held, fiber optic delivery system for use with an endoscope,
comprising:
a flexible elongated plastic sleeve adapted to be carried by the
endoscope in a manner to be slid in and out of the endoscope and
having a free end extending a distance from the endoscope;
a length of optical fiber positioned within said sleeve; and
means observable on said sleeve for indicating a distance between
said means and the free end of said sleeve..Iaddend..Iadd.43. The
system according to claim 42, further comprising a radiation source
connected to said optical fiber..Iaddend..Iadd.44. The system
according to claim 43 wherein said radiation source is a diode
laser..Iaddend..Iadd.45. The system according to claim 42, further
comprising means, at a distal end of said optical fiber, for
emitting radiation with a substantially uniform intensity along a
length thereof and around an outer cylindrical surface
thereof..Iaddend..Iadd.46. The system according to claim 42 wherein
said optical fiber is affixed to said sleeve to prevent relative
movement therebetween..Iaddend..Iadd.47. A hand-held, fiber optic
delivery system for inserting an optical fiber into biological
tissue, comprising:
an optical fiber;
an endoscope;
a flexible elongated tube covering at least a portion of said
optical fiber, said tube having a distal end and being positioned
in said endoscope such that the distal end of said tube may be slid
in and out of said endoscope; and
measurement marks periodically spaced apart on an outside of said
tube
along a length thereof adjacent the distal end..Iaddend..Iadd.48.
The system according to claim 47, further comprising a radiation
emitter at a distal end of said optical fiber..Iaddend..Iadd.49.
The system according to claim 48 wherein said radiation emitter
comprises a diffusing tip..Iaddend..Iadd.50. The system according
to claim 49 wherein said diffusing tip emits radiation with a
substantially uniform intensity along a length thereof and around
an outer cylindrical surface thereof..Iaddend..Iadd.51. The system
according to claim 47, further comprising a radiation source
connected to said optical fiber..Iaddend..Iadd.52. The system
according to claim 51 wherein said radiation source is a diode
laser..Iaddend..Iadd.53. The system according to claim 47 wherein
said measurement marks are indicative of a distance therefrom to
the distal end of said tube..Iaddend..Iadd.54. The system according
to claim 47 wherein said optical fiber is affixed to said tube to
prevent relative movement therebetween..Iaddend..Iadd.55. A
hand-held, fiber optic delivery system for inserting an optical
fiber into biological tissue, comprising:
an optical fiber;
an endoscope;
a flexible elongated tube covering at least a portion of said
optical fiber, said tube having a distal end and being positioned
in said endoscope such that the distal end of said tube may be slid
in and out of said endoscope; and
means observable on an outside of said tube along a length thereof
adjacent the distal end for indicating a distance between said
means and the distal
end..Iaddend..Iadd.56. The system according to claim 55, further
comprising a radiation source connected to said optical
fiber..Iaddend..Iadd.57. The system according to claim 56 wherein
said radiation source is a diode laser..Iaddend..Iadd.58. The
system according to claim 55, further comprising means, at a distal
end of said optical fiber, for emitting radiation with a
substantially uniform intensity alone a length thereof and around
an outer cylindrical surface thereof..Iaddend..Iadd.59. The system
according to claim 55 wherein said optical fiber is affixed to said
tube to prevent relative movement therebetween..Iaddend..Iadd.60.
An optical fiber delivery system adapted to irradiate tissue of the
prostate gland, comprising:
an optical fiber;
a flexible outer sleeve of plastic surrounding at least a portion
of said optical fiber;
a radiation emitter located at a distal end of said optical fiber,
said radiation emitter comprising a diffusing tip which emits
radiation with a substantially uniform along a length thereof and
around an outer cylindrical surface thereof;
a measurement scale along an outer surface of said sleeve, said
scale including marks indicating a distance therefrom to an end of
said flexible outer sleeve; and
an electromagnetic radiation source connected to said optical fiber
to supply electromagnetic radiation to said radiation emitter, said
electromagnetic radiation source comprising a diode
laser..Iaddend..Iadd.61. The system according to claim 60, further
comprising an endoscope, said optical fiber and said flexible outer
sleeve being positioned to move within a channel of said
endoscope..Iaddend..Iadd.2. The system according to claim 60
wherein said optical fiber is affixed to said sleeve to prevent
relative movement therebetween..Iaddend..Iadd.63. An optical fiber
delivery system adapted to irradiate tissue of the prostate gland,
comprising:
an optical fiber;
a flexible outer sleeve of plastic surrounding at least a portion
of said optical fiber;
a means at a distal end of said optical fiber for emitting
radiation with a substantially uniform intensity along a length
thereof and around an outer cylindrical surface thereof;
means along an outer surface of said sleeve for indicating a
distance therefrom to an end of said flexible outer sleeve; and
means connected to said optical fiber for supplying electromagnetic
radiation to said radiation emitting means..Iaddend..Iadd.64. The
system according to claim 63 wherein said supplying means is a
diode laser..Iaddend..Iadd.65. The system according to claim 63
wherein said optical fiber is affixed to said sleeve to prevent
relative movement therebetween..Iaddend..Iadd.66. An optical fiber
delivery system for use with an endoscope disposed within a passage
of a body for access to biological tissue, comprising:
an optical fiber having a radiation emitting end at a distal end
thereof;
a sleeve of sufficient flexibility for insertion into a channel of
the endoscope, said sleeve surrounding at least a portion of said
optical fiber;
means at a distal end of said sleeve for piercing a surface of the
tissue;
means surrounding at least a portion of said sleeve for urging the
radiation emitting end and said sleeve together into the tissue a
desired distance; and
means observable on said sleeve for indicating the desired
distance..Iaddend..Iadd.67. The system according to claim 66
wherein the radiation emitting end of said optical fiber comprises
a diffusing tip. .Iadd.68. The system according to claim 67 wherein
the diffusing tip is substantially cylindrical and is adapted to
emit radiation with a substantially uniform intensity along a
length thereof and around an outer cylindrical surface
thereof..Iaddend..Iadd.69. The system according to claim 66 wherein
said piercing means includes a sharp piercing
point..Iaddend..Iadd.70. The system according to claim 69 wherein,
when the endoscope is tilted with respect to the passage, an angle
of incidence between said sleeve and the surface of the tissue is
sufficient for piercing the surface with the piercing
point..Iaddend..Iadd.71. The system according to claim 66, further
comprising a radiation source operably connected to a proximal end
of said optical fiber..Iaddend..Iadd.72. The system according to
claim 71 wherein said radiation source is a diode
laser..Iaddend..Iadd.73. The system according to claim 66 wherein
said indicating means includes a measurement marking on said
sleeve..Iaddend..Iadd.74. The system according to claim 66 wherein
said optical fiber is affixed to said sleeve to prevent relative
movement therebetween..Iaddend.
Description
BACKGROUND OF THE INVENTION
This invention relates to devices used with optical fibers to
assist in inserting optical fiber ends into a mass of material to
be irradiated through the fiber.
Therefore, it is a primary object of the present invention to
provide a hand-held device with improved ease of use to assist
insertion of an optical fiber end into a volume of material to be
irradiated.
It is another object of the present invention to provide a more
precise method, utilizing such a device, of implanting an end of an
optical fiber in such a volume of material.
SUMMARY OF THE INVENTION
According to a primary aspect of the present invention, briefly and
generally, a hand held device, from which an optical fiber extends
with an end carrying a radiation emitter, is provided with a
retractable sleeve normally surrounding the extended fiber and
emitter, and a hand operated knob to allow retraction of the sleeve
into a body of the device. A free end of the sleeve is cut at an
angle to form a point to assist piercing a surface of a mass of
material into which the fiber is implanted. The sleeve is made of
flexible material, preferably a plastic, in order to allow its
insertion through a curved passage of a device that assists guiding
the sleeve and its internal flexible optical fiber into position
for piercing the material surface.
Flexible plastic material suitable for the sleeve will likely lack
the degree of rigidity necessary for its sharp point to adequately
pierce through the material surface at a desired location without
first buckling and then sliding along the outside surface of the
surface to another location. Thus, a small diameter wire is carried
within the sleeve to extend a short distance out of its end to form
a cleat that assists in piercing the material surface at the
location where the user first positions the sleeve tip. This wire
is preferably contained in a separate passage within the sleeve but
is not attached to it. Rather, an end of the wire, opposite to that
of the cleat, is attached to the knob, thereby causing the wire to
move back and forth with respect to the body simultaneously with
the sleeve. This assures that the extended cleat will not be
dislodged in the material and also results in the cleat being
extended an additional distance from the sleeve tip when the sleeve
and fiber are bent during insertion into a curved channel of an
instrument with which the improved device of the present invention
may be utilized. A measurement scale is printed on an outside
surface of the sleeve in order to provide an easy indication of the
distance in which the optical fiber is inserted into the body of
material. Once inserted to a desired depth, the sleeve is withdrawn
by moving the knob with respect to the body of the device, leaving
the optical fiber and emitter within the body of material.
Radiation may then be applied to the emitter through the optical
fiber.
Additional objects, advantages and features of the present
invention will become apparent from the following description of
its preferred embodiments, which description should be taken in
conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 illustrates a use of the improved fiberoptic delivery system
according to the present invention, utilizing an auxiliary
instrument to position it;
FIG. 2 is a view of the right hand end of the auxiliary instrument
of FIG. 1;
FIG. 3 illustrates an embodiment of the improved fiberoptic
delivery system according to the present invention;
FIG. 4 is a sectional view of the system of FIG. 3, taken at
section 4--4 thereof;
FIG. 5 is a view of the fiberoptic delivery system of FIG. 3 with a
sleeve thereof having been repositioned;
FIG. 6 illustrates use of the improved fiberoptic delivery system
of FIGS. 3-5 within a curved passage of the auxiliary instrument
shown in FIG. 1; and
FIGS. 7A, 7B and 7C represent views through the auxiliary
instrument of FIG. 1 that shows different stages in the insertion
therethrough of the improved fiberoptic delivery system of FIGS.
3-5.
DESCRIPTION OF A PREFERRED EMBODIMENT
Although the fiberoptic delivery system according to the present
invention can be used to implant an end of an optical fiber into a
wide variety of types of solid or semi-solid materials, an
application illustrative with respect to FIG. 1 is for insertion of
the optical fiber end into biological tissue of a human or other
body. With reference to FIG. 1, a device 11 according to the
present invention is used with an endoscope 13 of a type commonly
used by physicians for working inside a passage or cavity of a
patient. Such a passage 15 is generically illustrated in FIG. 1 to
pass through a volume of tissue material 17 with a wall formed by a
tissue surface 19. As an example, the tissue 17 can be a male
prostate and the passage 15 can be his urethra or rectum. One very
specific application of the improved fiberoptic delivery system of
the present invention is to treat benign prostate hyperplasia (BPH)
of men. An optical fiber emitter is inserted into one or more lobes
of the prostate to heat a volume therein by application of
electromagnetic radiation within the infra-red range of the
spectrum.
A view of an end 21 of a typical endoscope 13 of FIG. 1 is shown in
FIG. 2. When this end is inserted within a body passage, that
passage is illuminated by light emitted from the ends 23 and 25 of
optical fibers that are connected to an external light source 27. A
lens 29 and other optics within the body of the endoscope 13 allow
a user 31 to view the internal passage through an eye-piece 33. A
channel 35 that is provided in the endoscope 13 for introduction of
fluids or some other instrument into the passage is utilized to
guide and position the improved delivery system 11 of the present
invention.
Referring to FIG. 3, the major components of the delivery system 11
will now be explained. A main body includes a handle 37 having a
slot 39 in which a knob 41 is slidable back and forth. Fixed to
this semi-rigid handle 37 is a semi-rigid, hollow tubular shaft 43.
A flexible plastic sleeve 45 is carried within an opening of the
shaft 43 in a manner to be slidable back and forth within the shaft
43. The sleeve 45 has a free end 47 cut at an angle to create a
point 49 to assist in piercing the surface of material in which an
emitter 51 (FIG. 5) at an end of an optical fiber 53 is to be
inserted. An opposite end of the sleeve 45 is connected to the knob
41 so as to be moveable back and forth with respect to the handle
37 and shaft 43 as the knob 41 is moved. FIG. 3 shows the sleeve 45
being fully extended away from the shaft 43, while FIG. 5 shows the
opposite, namely the sleeve 45 being withdrawn a maximum amount
within the handle 37 and shaft 43 by movement of the knob 41 to an
opposite end of the slot 39.
The optical fiber 53 is fixedly attached to the handle 37 so that
withdrawal of the sleeve 45 into the position shown in FIG. 5
leaves the optical fiber 53 and its radiation emitter 51 fully
extended from the shaft 43. The radiation emitter 51, for the
applications contemplated, will generally be a diffusing tip that
emits radiation with substantially the same intensity along the
length and around its outer cylindrical surface. However, the
improved fiberoptic delivery system according to the present
invention can be used with any type of emitter as is appropriate
for the specific application, including use of a bare fiber end
without any special emitter attached to it.
The tip 49 of the sleeve 45 is used to pierce a surface of the
material into which the optical fiber is to be inserted. A sleeve
45 and the optical fiber 53 are inserted through the surface into
the material without any relative movement between the fiber 53 or
sleeve 45. This manipulation is done by hand by gripping the handle
37. A sleeve 45 and its fiber 53 are then pushed into the material
a desired distance as indicated by a scale 55 printed on an outside
surface of the sleeve 45. This scale, as shown, has a "0" marking
coincident with the position of an exposed end of the emitter 51.
The scale 55 then measures back from that endpoint in some
convenient unit, such as inches or centimeters. Once the sleeve is
inserted into the body of material with the outer surface at the
desired depth marking of the scale 55, the knob 41 is then slid
from the position shown in FIG. 3 to that shown in FIG. 5 in order
to remove the sleeve 45 from the material altogether or at least
well out of the way of the emitter 51. Electromagnetic radiation is
then applied through the optical fiber 53 from a diode laser or
other appropriate source within an instrument 57 (FIG. 1). When the
treatment is completed, the fiber is removed from the material by
gripping the handle 37 and removing the entire device 11 back away
from the material.
The sleeve 45 is made of a flexible material so that it can be
inserted into a curved instrument channel 59 of a typical endoscope
13 or other instrument used in conjunction with the device of the
present invention. The end 49 of the sleeve 45 is inserted into a
port 61 (FIGS. 1 and 6) at an end of the channel 59, and then urged
down along the channel to emerge out of its end illustrated in FIG.
2. Since available optical fibers inserted into the sleeve 45 are
also flexible, the combination may follow the curved path of the
instrument channel 59. The channel 59 is usually formed to have a
circular cross-section with metal walls of a rigid piece 63.
In order to provide the sleeve 45 with this flexibility, the
plastic material that is chosen for it is necessarily relatively
soft, certainly much softer than would be a rigid metal sleeve.
Therefore, the point 49 of the sleeve 45 will not usually be an
effective cutting tool to pierce the surface of the material into
which the sleeve 45 is to be inserted. Especially when the sleeve
is oriented at a small angle with respect to the outer material
surface, a sharp piercing point is important. When so oriented at a
small acute angle with respect to the surface to be pierced, the
tip 49 typically moves around the surface from the position where
the user intends to penetrate the material surface to some other
position removed from it. Therefore, in order to provide for sure
penetration at the location where the user first positions the
sleeve point 49, a metal cleat 65 is extended a short distance from
the free end of the sleeve 45 adjacent to its point 49. The cleat
65 thus immediately penetrates the surface of the material when the
user pushes the end 47 against the surface, even when held at a
small acute angle with respect thereto.
Rather than simply affixing a short metal piercing element to the
end 47 of the sleeve 45, however, the cleat 65 is formed at the end
of a length of stainless steel wire 67 that passes through the
sleeve 45 without attachment to it. The wire 67 is instead attached
at an opposite end 69 thereof to the knob 41. The wire 67 has a
small, uniform cross-section along its length and may tend to bend
when pushed at its cleat end. In order to prevent such bending, the
wire 67 is constrained in a channel 71 (FIG. 4) of the sleeve 43
that has a uniform circular cross-section only slightly larger than
that of the wire 67. As an example, the wire 67 may be less than
one millimeter in diameter, preferably about 0.2 millimeter, and
the passage 71 less than two millimeters in diameter, preferably
about 0.3 millimeter. A secondary purpose of the wire is to
increase the sleeve's rigidity, which is desirable for transmitting
surface piercing force and adding resistance to buckling. The
optical fiber 51 is carried in a separate passage 73 within the
sleeve 45.
By being attached at the end 69 to the knob 41, the wire 67 will
move back and forth with respect to the shaft 43 in the same manner
as the sleeve 45 when the knob 41 is operated within the handle
slot 39. The avoidance of attachment of the wire 67 or cleat 65 to
the sleeve 45 has certain advantages. One advantage is the
reduction of a probability that the cleat 65 will be left behind in
the volume of material after the sleeve 45 is withdrawn from it. A
small piece of wire attached to the end 47 of the sleeve could
suffer from that disadvantage, particularly undesirable if the
material is biological tissue. But another advantage is that the
cleat 65 may be made shorter than desirable for effective
penetration of the material surface when used in the curved
instrument channel 59 (FIG. 6) of a typical endoscope instrument
13. That is because the curvature of the sleeve 45 in that channel
causes the wire 67 to protrude further from the sleeve end 47 than
when the sleeve is straight. Thus, the cleat 45 can be made to be
short enough so that it does not scrape along the interior wall of
the instrument channel 61 as it is being inserted therethrough but
still is long enough when used to pierce a surface of the material
into which the optical fiber emitter 51 is to be implanted for
internal radiation thereof.
FIGS. 7A, 7B and 7C show three views of the user 31 through the
eyepiece 33, lens 29 and other optics of the endoscope 13, when the
optical fiber emitter is being inserted in biological tissue
generally in a manner illustrated in FIG. 1. Once the end 21 of the
endoscope 13 is positioned within the passage 15 so that user 31
can view the region of the surface 19 through which the fiber
emitter is to be implanted, the device 11 of the present invention
is manipulated to insert into the channel port 61 and through the
instrument channel 59 the optical fiber 53 with the sleeve 45
extended to cover it, in the position shown in FIG. 3. The sleeve
45 and fiber 51 are urged through that endoscope channel until the
user sees it within the field of view, the position shown in FIG.
7A. A endoscope 13 is then tilted (not shown) with respect to the
passage 15 in order to increase the angle of incidence of the
sleeve 45 with the surface 19 to be pierced. The sleeve 45 is then
pushed further through the instrument channel 59 of the endoscope
13 to pierce the surface 19. The sleeve 45 and fiber within it are
then urged further until the appropriate marking on the scale 55
appears adjacent the surface 19 being pierced. Such a view is shown
in FIG. 7B. After inserted to the desired depth, the knob 41 of the
device 11 is then moved backwards, from the position shown in FIG.
3 to that shown in FIG. 5, to remove the sleeve from within the
material. FIG. 7C shows the sleeve 45 being removed from within the
volume of material leaving the optical fiber 53 emersed therein.
After the step illustrated in FIG. 7C, the radiation source of the
instrument 57 (FIG. 1) is energized for a time to provide the
desired radiation through the emitter 51 to the interior portion of
the volume.
Although the various aspects of the present invention have been
described with respect to the preferred embodiment thereof, it will
be understood that the invention is entitled to protection within
the full scope of the appended claims.
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