U.S. patent application number 12/856134 was filed with the patent office on 2010-12-09 for resectoscopic device and method.
Invention is credited to Dane M. Larsen.
Application Number | 20100312053 12/856134 |
Document ID | / |
Family ID | 38605698 |
Filed Date | 2010-12-09 |
United States Patent
Application |
20100312053 |
Kind Code |
A1 |
Larsen; Dane M. |
December 9, 2010 |
RESECTOSCOPIC DEVICE AND METHOD
Abstract
A surgical instrument has a channel dimensioned to receive a
viewing instrument and enable the viewing instrument to be moved to
or from a position near an optically transparent portion of a
blunt, enclosed distal end of a shaft to provide unobstructed
viewing through the distal end, and a position to the proximal side
of an enclosed working area to provide viewing of the enclosed
working area. A surgical instrument also or alternatively has a
fluid routing switch within a shaft which can selectively connect a
fluid infusion channel to at least one fluid export pore or a
return channel. A method involves moving a viewing instrument to or
from a position near an optically transparent portion of a blunt,
enclosed distal shaft end and a proximal side of an enclosed
working area. A method also or alternatively involves changing a
position of a fluid routing switch within the shaft.
Inventors: |
Larsen; Dane M.;
(Plattsburgh, NY) |
Correspondence
Address: |
WEITZMAN LAW OFFICES, LLC
425 EAGLE ROCK AVENUE, SUITE 102
ROSELAND
NJ
07068
US
|
Family ID: |
38605698 |
Appl. No.: |
12/856134 |
Filed: |
August 13, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11279665 |
Apr 13, 2006 |
7794393 |
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12856134 |
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Current U.S.
Class: |
600/105 ;
600/104; 600/114; 600/156 |
Current CPC
Class: |
A61B 1/307 20130101;
A61B 18/18 20130101; A61B 1/126 20130101; A61B 1/12 20130101 |
Class at
Publication: |
600/105 ;
600/114; 600/156; 600/104 |
International
Class: |
A61B 1/00 20060101
A61B001/00 |
Claims
1. A surgical instrument comprising: a shaft having a proximal end
and a blunt, enclosed distal end, the blunt, enclosed distal end
being optically transparent over at least a portion of its area,
the shaft further comprising a longitudinally extending fluid
infusion channel, a side wall having an opening therein defining an
enclosed working area within which resection can occur, a
longitudinally extending return channel coupling the working area
to a connection for a tissue collection cavity, a viewing
instrument channel dimensioned to receive a viewing instrument
inserted from the proximal end and being positioned so as to enable
the inserted viewing instrument to be moved to or from i) a
position near the portion of the blunt, enclosed distal end that is
optically transparent to provide unobstructed viewing through the
blunt, enclosed distal end, and ii) a position to the proximal side
of the enclosed working area to provide viewing of the enclosed
working area, and at least one pore through which fluid passing
from the proximal end of the shaft towards the blunt, enclosed
distal end via the fluid infusion channel can exit the shaft.
2. The surgical instrument of claim 1 further comprising: a switch,
within the shaft, coupled to each of the fluid infusion channel,
pore and return channel.
3. The surgical instrument of claim 2 wherein the switch comprises
one of a pivoting switch or a sliding switch.
4. The surgical instrument of claim 1 wherein the optically
transparent portion comprises: a membrane, a plate, a lens, or a
surface of the shaft.
5. The surgical instrument of claim 4 wherein the membrane, plate,
lens or surface of the shaft includes an in-shaft surface
configured as a mirror image of an end surface of a viewing
instrument to facilitate abutting of the end surface against the
in-shaft surface.
6. The surgical instrument of claim 1 wherein the optically
transparent portion comprises: a hole.
7. The surgical instrument of claim 1 further comprising: a handle,
having a tissue receiving cavity therein, coupled to the return
channel.
8. The surgical instrument of claim 1 further comprising: a
reflective surface within the shaft and located relative to the
viewing instrument channel so as to provide a viewing instrument
within the viewing instrument channel with a view that is different
from a view that can be obtained by the viewing instrument
alone.
9. The surgical instrument of claim 1 further comprising: a
trolley, located near the proximal end, and configured to movably
constrain the viewing instrument such that movement of the trolley
will cause the inserted viewing instrument to be moved between the
position near the portion of the blunt, enclosed distal end and the
position to the proximate side of the enclosed working area.
10. The surgical instrument of claim 1 further comprising: at least
one auxiliary channel within the shaft.
11. The surgical instrument of claim 10 wherein the auxiliary
channel extends from near the proximal end to the working area.
12. The surgical instrument of claim 10 wherein the auxiliary
channel extends from near the proximal end to the blunt, enclosed
distal end.
13. The surgical instrument of claim 1 further comprising: a
cutting member within the shaft.
14. The surgical instrument of claim 13 wherein the cutting member
comprises at least one of: a wire loop, a blade, a scissor, a
shutter or a harmonically vibrated cutter.
15. The surgical instrument of claim 13 wherein the cutting member
is moveable solely within the working area.
16. The surgical instrument of claim 13 further comprising: a
cutting member home position and wherein the cutting member is
normally biased to the home position.
17. The surgical instrument of claim 16 wherein the cutting member
home position is to the distal side of the working area.
18. The surgical instrument of claim 16 wherein the cutting member
home position is to the proximal side of the working area.
19. The surgical instrument of claim 1 wherein: the opening in the
side wall defining the enclosed working area comprises a closed
geometric shape.
20. The surgical instrument of claim 19 wherein the closed
geometric shape is one of a circle, a quadrilateral or an
ovoid.
21. (canceled)
22. (canceled)
23. (canceled)
24. (canceled)
25. (canceled)
26. (canceled)
27. (canceled)
28. (canceled)
29. (canceled)
30. (canceled)
31. A surgical instrument comprising: a shaft having a proximal end
and a blunt, enclosed distal end, the blunt, enclosed distal end
being optically transparent over at least a portion of its area, a
scope having a viewing end that is moveable within the shaft
between a first position and a second position such that i) when in
the first position within the shaft, the viewing end will be on a
distal side of a working area within which resection can occur and
proximate to the optically transparent portion of the distal end
and provide an unobstructed view external to the blunt, enclosed
distal end; and ii) when in the second position within the shaft,
the viewing end will be on a proximal side of the working area and
provide a view of the working area.
32. The surgical instrument of claim 31 further comprising: a
trolley.
33. The surgical instrument of claim 32 wherein the trolley
comprises at least two pits, each configured to receive an
orientation pin of the scope.
34. The surgical instrument of claim 31 wherein the viewing end of
the scope comprises a beveled surface.
35. The surgical instrument of claim 34 wherein the portion of the
optically transparent area comprises a section having a bevel that
is configured for mating with the beveled surface.
36. The surgical instrument of claim 31 further comprising a fluid
routing switch configured for actuation by the scope when the scope
is in the first position.
37. (canceled)
38. (canceled)
39. (canceled)
40. (canceled)
41. (canceled)
42. (canceled)
43. (canceled)
44. A method comprising: a) inserting a shaft of a surgical
instrument, having a blunt, enclosed distal end, into a body cavity
while viewing the insertion through the blunt, enclosed distal end
via a viewing element end positioned to the distal side of a
working area near an optically transparent portion of the distal
end; b) establishing a fluid path extending from near a proximal
end of the shaft, through at least a portion of the shaft, to an
export pore; c) withdrawing the viewing element end to a proximal
side of the working area; d) moving the shaft so that tissue to be
resected is within the working area; e) establishing, within the
shaft, a fluid circulation path that will direct fluid along a path
from the proximal side of the working area towards the distal side
of the working area without passing through the working area, then
from the distal side of the working area to the proximal side of
the working area by passing through the working area; and f)
resecting the tissue within the working area such that, once the
tissue is resected, fluid in the fluid circulation path passing
through the working area from the distal to the proximal side will
convey the resected tissue away from the working area.
45. The method of claim 44 wherein step "d)" occurs one of
concurrent with, before or after step "e)".
46. The method of claim 45 wherein, following "f)" the method
comprises: discarding at least the shaft.
47. The method of claim 45 wherein, following "f)" the method
comprises: sterilizing at least the shaft.
48. The method of claim 45 further comprising: establishing, for a
period of time, a rate of fluid flow through the export pore.
49. The method of claim 48 wherein, while the fluid circulation
rate is established, the method further comprises: establishing a
fluid flow rate within at least a portion of the fluid circulation
path that is at least double what the rate of fluid flow was
through the export pore following "b)".
50. The method of claim 48 wherein, while the fluid circulation
rate is established, the method further comprises: establishing a
fluid flow rate within at least a portion of the fluid circulation
path that is at least triple what the rate of fluid flow was
through the export pore following "b)".
51. The method of claim 45 further comprising: causing the fluid in
at least a portion of the fluid circulation path to flow at a rate
of at least 4 liters/min.
52. The method of claim 45 wherein, following "a)" the method
further comprises: cauterizing tissue within the body cavity
without withdrawing the blunt, enclosed distal end from the body
cavity.
53. The method of claim 45 wherein, following "a)" the method
further comprises: deploying a device in the body cavity via an
auxiliary channel within the shaft.
54. A method comprising: viewing insertion of a shaft, having a
blunt, enclosed distal end, into a body cavity through the blunt
distal end via an optical element located proximate to the distal
end; causing a fluid flowing along the shaft from a proximal end to
a distal end to exit the shaft through at least one export pore;
changing a switch setting such that the fluid flowing in the
proximal to distal direction will bypass a working area and, once
past the working area will flow in the distal to proximal direction
and pass through the working area; and causing a discrete piece of
tissue to enter the working area so that it will be conveyed in the
distal to proximal direction by the flow of the fluid.
55. The method of claim 54 further comprising: causing the fluid to
flow through the working area at a rate in excess of 4
liters/min.
56. The method of claim 54 wherein the changing the switch setting
comprises: moving one of a viewing instrument or a cutting
member.
57. The method of claim 54 further comprising: providing a tissue
collector near the proximal end of the shaft that will receive and
retain the discrete piece of tissue.
58. The method of claim 54 wherein the causing the discrete piece
of tissue to enter the working area comprises: moving a cutting
element in a proximal to distal direction.
59. The method of claim 54 wherein the causing the discrete piece
of tissue to enter the working area comprises: moving a cutting
element in a distal to proximal direction.
60. The method of claim 54 wherein, if the discrete piece of tissue
becomes caught on a cutting member, the method comprises: moving at
least one of the cutting member or a viewing instrument relative to
each other to dislodge the discrete piece of tissue.
61. The method of claim 54 wherein, if the discrete piece of tissue
becomes caught on a cutting member, the method comprises: moving
the cutting member within the flowing fluid.
62. The method of claim 54 wherein, if the discrete piece of tissue
becomes caught on a cutting member, the method comprises: inserting
an object through an auxiliary channel in the shaft into the
working area in order to use the object to dislodge the discrete
piece of tissue without withdrawing any of a cutting member,
viewing instrument or a section of the shaft containing the working
area from the body cavity.
63. The method of claim 54 wherein, if the discrete piece of tissue
becomes caught on a cutting member, the method comprises: returning
the cutting member to a home position in order to dislodge the
discrete piece of tissue.
64. A method comprising: providing a switch in a shaft for an
instrument that can be used to resect tissue within a body cavity,
the shaft having a proximal end and a distal end; defining a first
position for the switch which will cause fluid flowing in a channel
in a proximal to distal direction to exit the shaft through at
least one export pore located near the distal end; and defining a
second position for the switch, which will cause fluid flowing in
the channel in the proximal to distal direction to remain within
the shaft and be directed so as to pass through a working area
where resection can occur to cause a piece of resected tissue to
move in a distal to proximal direction within the shaft.
65. The method of claim 64 further comprising: defining at least
one position between the first and second positions wherein at
least some of the fluid flowing in the channel in the proximal to
distal direction will exit the shaft through the at least one
export pore and other of the fluid flowing in the channel in the
proximal to distal direction will remain within the shaft and be
directed so as to pass through the working area and cause the piece
of resected tissue to move in the distal to proximal direction
within the shaft.
66. A method comprising: defining, in a shaft for a resectoscope
having a blunt, enclosed distal end including an optically
transparent area, a first location for a viewing instrument, the
first location being to the distal side of a working area but
proximate to the optically transparent area and the working area
being defined by an opening in the shaft having a closed geometric
shape that is located to the proximal side of the enclosed distal
end in a perimeter surface of the shaft, so that, when the viewing
instrument is in the first position, a user using the viewing
instrument will be able to see an area external to and
longitudinally removed from the distal end of the shaft via the
optically transparent area; defining, in the shaft, a second
location for the viewing instrument, to the proximal side of the
working area, such that, when the viewing instrument is in the
second position the user will be able to see resectable tissue of a
body cavity that is located within the working area; and defining
the placement of the first position relative to the second position
such that, the viewing instrument can be moved back and forth
between the first position to the second position concurrent with
export of tissue within the body cavity.
67. A neurosurgical instrument comprising: a shaft, dimensioned for
insertion through a cranial burr-hole, having a proximal end and a
blunt, enclosed distal end, the blunt, enclosed distal end being
optically transparent over at least a portion of its area, the
shaft further comprising a longitudinally extending fluid infusion
channel, a side wall having an opening therein through which
fluid-induced intracranial pressure caused during insertion of the
shaft can be relieved, the opening further defining an enclosed
working area within which resection can occur, a longitudinally
extending return channel coupling the working area to a connection
for a tissue collection cavity, a viewing instrument channel
dimensioned to receive a viewing instrument inserted from the
proximal end and being positioned so as to enable the inserted
viewing instrument to be moved to or from i) a position near the
portion of the blunt, enclosed distal end that is optically
transparent to provide unobstructed viewing of intracranial tissue
through the blunt, enclosed distal end, and ii) a position to the
proximate side of the enclosed working area to provide viewing of
the enclosed working area, and at least one pore through which
fluid passing from the proximal end of the shaft towards the blunt,
enclosed distal end via the fluid infusion channel can periodically
exit the shaft.
68. The neurosurgical instrument of claim 67 wherein: a portion of
a body of the shaft is curved.
69. The neurosurgical instrument of claim 67 wherein: a portion of
a body of the shaft is flexible.
70. (canceled)
71. A neurosurgical instrument comprising: a shaft, dimensioned for
insertion through a cranial burr-hole, and having a proximal end
and a blunt, enclosed distal end, the blunt, enclosed distal end
being optically transparent over at least a portion of its area, a
scope having a viewing end that is moveable within the shaft
between a first position and a second position such that i) when in
the first position within the shaft, the viewing end will be on a
distal side of a working area within which resection can occur and
proximate to the optically transparent portion of the distal end to
provide an unobstructed view of cranial tissue that is external to
the blunt, enclosed distal end; and ii) when in the second position
within the shaft, the viewing end will be on a proximal side of the
working area and provide a view of the working area.
72. A neurosurgical method comprising: a) inserting a shaft of a
neurosurgical instrument, having a blunt, enclosed distal end,
through a burr-hole in a cranium while viewing the insertion
through the blunt, enclosed distal end via a viewing element end
positioned to the distal side of a working area near an optically
transparent portion of the distal end; b) establishing a fluid path
extending from near a proximal end of the shaft, through at least a
portion of the shaft, to an export pore; c) briefly infusing a
small amount of fluid into the cranium; d) incrementally advancing
the distal end within the cranium to a resection site; e)
withdrawing the viewing element end to a proximal side of the
working area; f) moving the shaft so that tissue at the resection
site that is to be resected is within the working area; g)
establishing, within the shaft, a fluid circulation path that will
direct fluid along a path from the proximal side of the working
area towards the distal side of the working area without passing
through the working area, then from the distal side of the working
area to the proximal side of the working area and passing through
the working area; and h) resecting the tissue within the working
area such that, once the tissue is resected, fluid in the fluid
circulation path passing through the working area from the distal
to the proximal side will convey the resected tissue away from the
working area and towards the proximal end of the shaft.
73. A spinal microdiscectomy instrument comprising: a shaft,
dimensioned for insertion through a paraspinal incision, having a
proximal end and a blunt, enclosed distal end, the blunt, enclosed
distal end being optically transparent over at least a portion of
its area, the shaft further comprising a longitudinally extending
fluid infusion channel, a side wall having an opening therein
defining an enclosed working area within which tissue resection can
occur, a longitudinally extending return channel coupling the
working area to a connection for a tissue collection cavity, a
viewing instrument channel dimensioned to receive a viewing
instrument inserted from the proximal end and being positioned so
as to enable the inserted viewing instrument to be moved to or from
i) a position near the portion of the blunt, enclosed distal end
that is optically transparent to provide unobstructed viewing of
spinal disc tissue through the blunt, enclosed distal end, and ii)
a position to the proximate side of the enclosed working area to
provide viewing of spinal disc tissue that will be resected within
the enclosed working area.
74. (canceled)
75. A spinal microdiscectomy instrument comprising: a shaft,
dimensioned for insertion through a paraspinal incision and having
a proximal end and a blunt, enclosed distal end, the blunt,
enclosed distal end being optically transparent over at least a
portion of its area, a scope having a viewing end that is moveable
within the shaft between a first position and a second position
such that i) when in the first position within the shaft, the
viewing end will be on a distal side of a working area within which
resection can occur and proximate to the optically transparent
portion of the distal end to provide an unobstructed view of spinal
disc tissue external to the blunt, enclosed distal end; and ii)
when in the second position within the shaft, the viewing end will
be on a proximal side of the working area and provide a view of
spinal disc tissue within the working area.
76. A method of performing a surgical procedure on spinal disc
tissue comprising: a) inserting a shaft of an instrument, having a
blunt, enclosed distal end, through a paraspinal incision while
viewing the insertion through the blunt, enclosed distal end via a
viewing element end positioned to the distal side of a working area
near an optically transparent portion of the distal end; b)
establishing a fluid path extending from near a proximal end of the
shaft, through at least a portion of the shaft, to an export pore
to create a minimally inflated cavity; c) withdrawing the viewing
element end to a proximal side of the working area; d) moving the
shaft so that tissue to be resected is within the working area; g)
establishing, within the shaft, a fluid circulation path that will
direct fluid along a path from the proximal side of the working
area towards the distal side of the working area without passing
through the working area, then from the distal side of the working
area to the proximal side of the working area and passing through
the working area; and h) resecting the tissue within the working
area such that, once the tissue is resected, fluid in the fluid
circulation path passing through the working area from the distal
to the proximal side will convey the resected tissue away from the
working area and towards the proximal end of the shaft.
77. An instrument for use in thoracic surgery comprising: an
articulable shaft dimensioned for insertion into the pleural space
and having a proximal end and a blunt, enclosed distal end, the
blunt, enclosed distal end being optically transparent over at
least a portion of its area, the shaft further comprising a
longitudinally extending fluid infusion channel, a side wall having
an opening therein defining an enclosed working area within which
tissue resection can occur, a longitudinally extending return
channel coupling the working area to a connection for a tissue
collection cavity, a viewing instrument channel dimensioned to
receive a viewing instrument inserted from the proximal end and
being positioned so as to enable the inserted viewing instrument to
be moved to or from i) a position near the portion of the blunt,
enclosed distal end that is optically transparent to provide
unobstructed viewing of tissue within the pleural space through the
blunt, enclosed distal end, and ii) a position to the proximate
side of the enclosed working area to provide viewing of tissue that
will be resected within the enclosed working area.
78. The instrument of claim 77 further comprising: a longitudinally
extending auxiliary channel, coupled to an auxiliary port, the
auxiliary port extending the auxiliary channel to a position
external to the distal end, through which fluid external to the
shaft can be drawn into the shaft by vacuum applied to the
auxiliary channel.
79. The instrument of claim 77 wherein: a portion of the shaft
containing the blunt, enclosed distal end is configured for axial
rotation.
80. (canceled)
81. An instrument for use in thoracic surgery comprising: an
articulable shaft, dimensioned for insertion through a chest tube
into a pleural space, and having a proximal end and a blunt,
enclosed distal end, the blunt, enclosed distal end being optically
transparent over at least a portion of its area, an auxiliary
channel within the shaft through which fluid external to the shaft
can be drawn into the shaft by application of a vacuum to the
auxiliary channel; a scope having a viewing end that is moveable
within the shaft between a first position and a second position
such that i) when in the first position within the shaft, the
viewing end will be on a distal side of a working area within which
resection can occur and proximate to the optically transparent
portion of the distal end to provide an unobstructed view of tissue
external to the blunt, enclosed distal end within a pleural space;
and ii) when in the second position within the shaft, the viewing
end will be on a proximal side of the working area and provide a
view of the working area.
82. A method of performing a thoracic surgical procedure
comprising: a) inserting an articulable shaft of an instrument,
having a blunt, enclosed distal end, into the chest cavity while
viewing the insertion through the blunt, enclosed distal end via a
viewing element end positioned to the distal side of a working area
near an optically transparent portion of the distal end; b)
articulating the shaft in order to target tissue for resection; c)
withdrawing the viewing element end to a proximal side of the
working area; d) moving the shaft so that tissue to be resected is
within the working area; e) establishing, within the shaft, a fluid
circulation path that will direct fluid along a path from the
proximal side of the working area towards the distal side of the
working area without passing through the working area, then from
the distal side of the working area to the proximal side of the
working area and passing through the working area; and f) resecting
the tissue within the working area such that, once the tissue is
resected, fluid in the fluid circulation path passing through the
working area from the distal to the proximal side will convey the
resected tissue away from the working area and out of the chest
cavity.
83. An instrument for use in pulmonologic surgery comprising: a
shaft, dimensioned for insertion into one of a human laryngeal,
tracheal or bronchial passage, the shaft having a proximal end and
a blunt, enclosed distal end, the blunt, enclosed distal end being
optically transparent over at least a portion of its area, the
shaft further comprising a longitudinally extending fluid infusion
channel, a side wall having an opening therein defining an enclosed
working area within which resection can occur, a longitudinally
extending return channel coupling the working area to a connection
for a tissue collection cavity, an auxiliary channel coupled to an
opening in a surface of the shaft through which fluid can be moved
from external to the shaft into the shaft by application of a
vacuum to the auxiliary channel; a viewing instrument channel
dimensioned to receive a viewing instrument inserted from the
proximal end and being positioned so as to enable the inserted
viewing instrument to be moved to or from i) a position near the
portion of the blunt, enclosed distal end that is optically
transparent to provide unobstructed viewing through the blunt,
enclosed distal end, and ii) a position to the proximate side of
the enclosed working area to provide viewing of the enclosed
working area.
84. The instrument of claim 83 wherein: the working area is within
a first portion of the shaft, the shaft comprises a second portion
located between the first portion and the proximal end, and the
second portion is flexible.
85. (canceled)
86. A surgical method comprising: a) inserting a shaft of an
instrument, having a blunt, enclosed distal end into one of a
tracheal or bronchial passage of a human while viewing the
insertion through the blunt, enclosed distal end via a viewing
element end positioned to the distal side of a working area near an
optically transparent portion of the distal end; b) visually
locating tissue to be resected; c) withdrawing the viewing element
end to a proximal side of the working area; d) moving the shaft so
that at least a portion of the tissue to be resected is within the
working area; e) viewing the portion via the Original viewing
element end; f) establishing, within the shaft, a fluid circulation
path that will direct fluid along a path from the proximal side of
the working area towards the distal side of the working area
without passing through the working area, then from the distal side
of the working area to the proximal side of the working area and
passing through the working area; and h) resecting the tissue
within the working area such that, once the tissue is resected, the
fluid in the fluid circulation path passing through the working
area from the distal to the proximal side will convey the resected
tissue away from the working area and towards the proximal end of
the shaft.
87. The method of claim 86, wherein, following "a)" the method
further comprises: applying a vacuum to a channel within the shaft
to facilitate movement of a substance from external to the shaft
into a passage within the shaft.
88. The method of claim 86, wherein the fluid circulation path
comprises a fluid infusion channel, the method further comprising:
introducing an oxygenated fluid into a fluid infusion channel.
89. An instrument for use in gastrointestinal surgery comprising: a
shaft, dimensioned for insertion into a section of the
gastrointestinal tract of a human, the shaft having a proximal end
and a blunt, enclosed distal end, the blunt, enclosed distal end
being optically transparent over at least a portion of its area,
the shaft further comprising a longitudinally extending fluid
infusion channel, a side wall having an opening therein defining an
enclosed working area within which resection can occur, a
longitudinally extending return channel coupling the working area
to a connection for a tissue collection cavity, at least one fluid
export pore selectively connectable to the fluid infusion channel;
a viewing instrument channel dimensioned to receive a viewing
instrument inserted from the proximal end and being positioned so
as to enable the inserted viewing instrument to be moved to or from
i) a position near the portion of the blunt, enclosed distal end
that is optically transparent to provide unobstructed viewing
through the blunt, enclosed distal end, and ii) a position to the
proximate side of the enclosed working area to provide viewing of
the enclosed working area.
90. The instrument of claim 89 wherein: the working area and blunt,
enclosed distal end are within a first portion of the shaft, the
shaft comprises a second portion located between the first portion
and the proximal end, and the second portion is flexible.
91. (canceled)
92. A gastrointestinal surgical method comprising: a) inserting a
shaft of an instrument, having a blunt, enclosed distal end into a
portion of the gastrointestinal tract of a human while viewing the
insertion through the blunt, enclosed distal end via a viewing
element end positioned to the distal side of a working area near an
optically transparent portion of the distal end; b) visually
locating tissue that is to be resected; c) withdrawing the viewing
element end to a proximal side of the working area; d) moving the
shaft so that at least some of the tissue to be resected is within
the working area; e) viewing the at least some tissue via the
Original viewing element end; f) establishing, within the shaft, a
fluid circulation path that will direct fluid along a path from the
proximal side of the working area towards the distal side of the
working area without passing through the working area, then from
the distal side of the working area to the proximal side of the
working area and passing through the working area; and h) resecting
the tissue within the working area such that, once the tissue is
resected, the fluid in the fluid circulation path passing through
the working area from the distal to the proximal side will convey
the resected tissue away from the working area and towards the
proximal end of the shaft.
93. The method of claim 92, wherein, following "a)" the method
further comprises: coupling a fluid infusion channel to a fluid
export pore to direct a flow of fluid from the fluid infusion
channel to a location external to the shaft via the fluid export
pore.
94. A gynecological instrument comprising: a shaft, dimensioned for
insertion through the cervix into the uterus, the shaft having a
proximal end and a blunt, enclosed distal end, the blunt, enclosed
distal end being optically transparent over at least a portion of
its area, the shaft further comprising a longitudinally extending
fluid infusion channel, a side wall having an opening therein
defining an enclosed working area within which resection can occur,
a longitudinally extending return channel coupling the working area
to a connection for a tissue collection cavity, a viewing
instrument channel dimensioned to receive a viewing instrument
inserted from the proximal end and being positioned so as to enable
the inserted viewing instrument to be moved to or from i) a
position near the portion of the blunt, enclosed distal end that is
optically transparent to provide unobstructed viewing through the
blunt, enclosed distal end, and ii) a position to the proximate
side of the enclosed working area to provide viewing of the
enclosed working area, and at least one pore through which fluid
passing from the proximal end of the shaft towards the blunt,
enclosed distal end via the fluid infusion channel can exit the
shaft to inflate the uterine cavity.
95. The gynecological instrument of claim 94 wherein: the shaft is
at least 14 cm long.
96. The gynecological instrument of claim 94 further comprising: an
auxiliary channel through which a ureteral stent can be
deployed.
97. The gynecological instrument of claim 94 further comprising: an
auxiliary channel through which a tubal occlusion device for
sterilization can be deployed.
98. (canceled)
99. A gynecological instrument comprising: a shaft, dimensioned for
insertion through the cervix into the uterus, and having a proximal
end and a blunt, enclosed distal end, the blunt, enclosed distal
end being optically transparent over at least a portion of its
area, a scope having a viewing end that is moveable within the
shaft between a first position and a second position such that i)
when in the first position within the shaft, the viewing end will
be on a distal side of a working area within which resection can
occur and proximate to the optically transparent portion of the
distal end to provide an unobstructed view of tissue external to
the blunt, enclosed distal end; and ii) when in the second position
within the shaft, the viewing end will be on a proximal side of the
working area and provide a view of the working area.
100. A gynecological method comprising: a) inserting a shaft of an
instrument, having a blunt, enclosed distal end, into the uterus
via the cervix while viewing the insertion through the blunt,
enclosed distal end via a viewing element end positioned to the
distal side of a working area within the shaft near an optically
transparent portion of the distal end; b) establishing a fluid path
extending from near a proximal end of the shaft, through at least a
portion of the shaft, to an export pore; c) inflating the uterus;
d) withdrawing the viewing element end to a proximal side of the
working area; e) moving the shaft so that tissue to be resected is
within the working area; f) establishing, within the shaft, a fluid
circulation path that will direct fluid along a path from the
proximal side of the working area towards the distal side of the
working area without passing through the working area, then from
the distal side of the working area to the proximal side of the
working area and passing through the working area; and g) resecting
the tissue within the working area such that, once the tissue is
resected, fluid in the fluid circulation path passing through the
working area from the distal to the proximal side will convey the
resected tissue away from the working area and towards the proximal
end of the shaft.
101. The method of claim 100 further comprising: identifying a
cervical polyp during the inserting; causing the cervical polyp to
enter the working area; and resecting the cervical polyp while it
is within the working area.
102. A urological instrument comprising: a shaft, dimensioned for
insertion into the urethra, the shaft having a proximal end and a
blunt, enclosed distal end, the blunt, enclosed distal end being
optically transparent over at least a portion of its area, the
shaft further comprising a longitudinally extending fluid infusion
channel, a side wall having an opening therein defining an enclosed
working area within which resection of tissue from within the
urinary tract can occur, a longitudinally extending return channel
coupling the working area to a connection for a tissue collection
cavity, a viewing instrument channel dimensioned to receive a
viewing instrument inserted from the proximal end and being
positioned so as to enable the inserted viewing instrument to be
moved to or from i) a position near the portion of the blunt,
enclosed distal end that is optically transparent to provide
unobstructed viewing through the blunt, enclosed distal end, and
ii) a position to the proximate side of the enclosed working area
to provide viewing of the enclosed working area, and at least one
pore through which fluid passing from the proximal end of the shaft
towards the blunt, enclosed distal end via the fluid infusion
channel can exit the shaft.
103. The urological instrument of claim 102 further comprising: an
auxiliary channel through which a catheter can be deployed.
104. (canceled)
105. A urological instrument comprising: a shaft, dimensioned for
insertion into the urethra, and having a proximal end and a blunt,
enclosed distal end, the blunt, enclosed distal end being optically
transparent over at least a portion of its area, a scope having a
viewing end that is moveable within the shaft between a first
position and a second position such that i) when in the first
position within the shaft, the viewing end will be on a distal side
of a working area within which resection can occur and proximate to
the optically transparent portion of the distal end to provide an
unobstructed view of tissue external to the blunt, enclosed distal
end; and ii) when in the second position within the shaft, the
viewing end will be on a proximal side of the working area and
provide a view of the working area.
106. A urological method comprising: a) inserting a shaft of an
instrument, having a blunt, enclosed distal end, into a portion of
the urinary tract while viewing the insertion through the blunt,
enclosed distal end via a viewing element end positioned to the
distal side of a working area within the shaft near an optically
transparent portion of the distal end; b) establishing a fluid path
extending from near a proximal end of the shaft, through at least a
portion of the shaft, to an export pore; c) withdrawing the viewing
element end to a proximal side of the working area; d) moving the
shaft so that tissue to be resected is within the working area; e)
establishing, within the shaft, a fluid circulation path that will
direct fluid along a path from the proximal side of the working
area towards the distal side of the working area without passing
through the working area, then from the distal side of the working
area to the proximal side of the working area and passing through
the working area; and f) resecting the tissue within the working
area such that, once the tissue is resected, fluid in the fluid
circulation path passing through the working area from the distal
to the proximal side will convey the resected tissue away from the
working area and towards the proximal end of the shaft.
107. A surgical instrument comprising: a shaft, dimensioned for
insertion into one of a facial, sinus or nasal cavity, the shaft
having a proximal end and a blunt, enclosed distal end, the blunt,
enclosed distal end being optically transparent over at least a
portion of its area, the shaft further comprising a longitudinally
extending fluid infusion channel, a side wall having an opening
therein defining an enclosed working area within which resection of
tissue from the cavity can occur, a longitudinally extending return
channel coupling the working area to a connection for a tissue
collection cavity, a viewing instrument channel dimensioned to
receive a viewing instrument inserted from the proximal end and
being positioned so as to enable the inserted viewing instrument to
be moved to or from i) a position near the portion of the blunt,
enclosed distal end that is optically transparent to provide
unobstructed viewing through the blunt, enclosed distal end, and
ii) a position to the proximate side of the enclosed working area
to provide viewing of the enclosed working area, and at least one
pore through which fluid passing from the proximal end of the shaft
towards the blunt, enclosed distal end via the fluid infusion
channel can exit the shaft.
108. The surgical instrument of claim 107 further comprising: an
auxiliary channel through which the facial cavity can be
aspirated.
109. The surgical instrument of claim 107 wherein the facial cavity
is at least one of: a nasal cavity or a sinus.
110. (canceled)
111. A surgical instrument comprising: a shaft, dimensioned for
insertion into a facial cavity, having a proximal end and a blunt,
enclosed distal end, the blunt, enclosed distal end being optically
transparent over at least a portion of its area, a scope having a
viewing end that is moveable within the shaft between a first
position and a second position such that i) when in the first
position within the shaft, the viewing end will be on a distal side
of a working area within which resection can occur and proximate to
the optically transparent portion of the distal end to provide an
unobstructed view of tissue within the facial cavity external to
the blunt, enclosed distal end; and ii) when in the second position
within the shaft, the viewing end will be on a proximal side of the
working area and provide a view of the working area.
112. A surgical method comprising: a) inserting a shaft of an
instrument, having a blunt, enclosed distal end, into a facial
cavity while viewing the insertion through the blunt, enclosed
distal end via a viewing element end positioned to the distal side
of a working area within the shaft and near an optically
transparent portion of the distal end; b) withdrawing the viewing
element end to a proximal side of the working area; c) moving the
shaft so that tissue to be resected from the facial cavity is
within the working area; d) establishing, within the shaft, a fluid
circulation path that will direct fluid along a path from the
proximal side of the working area towards the distal side of the
working area without passing through the working area, then from
the distal side of the working area to the proximal side of the
working area and passing through the working area; e) resecting the
tissue within the working area such that, once the tissue is
resected, fluid in the fluid circulation path passing through the
working area from the distal to the proximal side will convey the
resected tissue away from the working area and towards the proximal
end of the shaft.
113. The surgical method of claim 112, further comprising:
establishing a fluid path extending from near a proximal end of the
shaft, through at least a portion of the shaft, to an export pore;
and irrigating at least a portion of the facial cavity.
114. An instrument for use in proctological surgery comprising: an
elongated shaft, dimensioned for insertion into the body via the
anus, having a proximal end and a blunt, enclosed distal end, the
blunt, enclosed distal end being optically transparent over at
least a portion of its area, the shaft further comprising a
longitudinally extending fluid infusion channel, a side wall having
an opening therein defining an enclosed working area within which
resection can occur, a longitudinally extending return channel
coupling the working area to a connection for a tissue collection
cavity, at least one fluid export pore selectively connectable to
the fluid infusion channel; a viewing instrument channel
dimensioned to receive a viewing instrument inserted from the
proximal end and being positioned so as to enable the inserted
viewing instrument to be moved to or from i) a position near the
portion of the blunt, enclosed distal end that is optically
transparent to provide unobstructed viewing through the blunt,
enclosed distal end, and ii) a position to the proximate side of
the enclosed working area to provide viewing of the enclosed
working area.
115. The instrument of claim 114 wherein: the working area and
blunt, enclosed distal end are within a first portion of the
elongated shaft, the elongated shaft comprises a second portion
located between the first portion and the proximal end, and the
second portion is flexible.
116. (canceled)
117. A proctological surgical method comprising: a) inserting a
shaft of an instrument, having a blunt, enclosed distal end into a
human via the anus while viewing the insertion through the blunt,
enclosed distal end via a viewing element end positioned to the
distal side of a working area near an optically transparent portion
of the distal end; b) visually locating tissue to be resected from
within at least one of the rectum or colon; c) withdrawing the
viewing element end to a proximal side of the working area; d)
moving the shaft so that at least some of the tissue to be resected
is within the working area; e) viewing the at least some tissue via
the Original viewing element end; f) establishing, within the
shaft, a fluid circulation path that will direct fluid along a path
from the proximal side of the working area towards the distal side
of the working area without passing through the working area, then
from the distal side of the working area to the proximal side of
the working area and passing through the working area; and h)
resecting the tissue within the working area such that, once the
tissue is resected, the fluid in the fluid circulation path passing
through the working area from the distal to the proximal side will
convey the resected tissue away from the working area and towards
the proximal end of the shaft.
118. The method of claim 117, wherein, following "a)" the method
further comprises: coupling a fluid infusion channel to a fluid
export pore to direct a flow of fluid from the fluid infusion
channel to a location external to the shaft via the fluid export
pore.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to surgical devices and, more
particularly, to surgical devices used for resection of tissue from
within a body cavity.
BACKGROUND TO THE INVENTION
[0002] In surgical operations it is often necessary to insert
tubular instruments into small body cavities in order to
manipulate, modify or resect pathological tissues which may
include, for example, lesions, polyps, cysts, fibroids, lymph
nodes, choroid tissues, and other abnormal tissue growths, to name
a few. When an instrument is introduced into a body cavity during
an operative procedure, in some cases, undesired tissue injury can
be expected. However, the risk of significant undesired tissue
injury increases as the ability to view what is happening with the
instrument decreases. In other words, there is significantly
greater risk of injury when an instrument must be inserted and used
"blindly" (i.e. only by feel) than there is when the insertion path
and area of use can be fully viewed.
[0003] While, in some cases, a potential undesirable injury such as
a laceration or perforation may not present a significant risk so
as to require remedial action (i.e. it will heal on its own), in
other cases, such as an injury occurring in an organ like the
uterus, intestine or bowel, a laceration or perforation can be life
threatening--in the former organ due to excessive bleeding and, in
the latter organs, by potentially causing peritonitis.
[0004] In general, the evolution of endoscopic surgical technology
has vastly reduced average morbidities for many operative
procedures, and methods for resection of pathological tissue have
improved over time. However, despite these advances organ
lacerations and perforations still occur. Moreover, currently
available technologies are designed to promote freedom to the
surgeon through a largely exposed cutting member and thus increase,
rather than decrease the possibility of causing undesirable tissue
injury. In addition, current resectoscopic instruments are
generally complicated, balky, and often require multi-component
reconfiguration during use.
[0005] When tissue is removed during a surgical procedure, capture
of the resected tissue is necessary for surgical pathology testing.
Unfortunately, in certain organs, efficient removal of pathological
tissue from an operative site remains problematic. For example,
with respect to removal of pathological tissue from the uterus, the
present practice for hysteroscopy follows a process beset by
multiple task interruptions. The process begins with the trays
containing the hysteroscope and resectosocopic instruments opened
onto the sterile field for assembly into one of two separate
operational modes.
[0006] First, a diagnostic sleeve is usually set up for use with
the hysteroscope to allow the surgeon entry into the uterus. The
surgeon performs an initial diagnostic hysteroscopy to identify the
tissue(s) to be removed and their location.
[0007] After the diagnostic hysteroscopy, the setup is withdrawn
and disassembled with the scope extracted from the assembly. A
separate resectoscopic instrument is then assembled involving
placement and alignment of an electrode upon the scope including
electrode insertion and fixation into a small hole. A bridge piece
is then inserted onto the assembly along with a new sleeve
assembly. A fluid pressure regulator is attached to the inflow port
of the instrument and a power source is connected.
[0008] Now the resectoscopic instrument is carefully entered into
the uterus after further dilation of the cervix to accommodate its
larger diameter and pipe-like tip. Here the surgeon must be very
careful to avoid perforation of the uterus by the cutting tendency
of the resectoscope itself. In addition, the surgeon must avoid
accumulation of endometrium tissues within the tip assembly since
those tissues will obscure the view. If the view becomes too
obscured, removal and cleaning prior to reinsertion is
required.
[0009] Once the resectoscope is within the uterine cavity, the
surgeon employs careful adjustment between the inflow and outflow
valves to infuse fluid into the uterus to open it and to remove
fluid within the uterus which has become tainted with blood from
the abrasion of tissues that is inherent with the insertion. Only
when a balance between the inflow and outflow is obtained such that
where the uterus is opened and inflated and the view is clear can
the actual resection work begin. A typical balanced flow rate is
around 10 cc/min.
[0010] The resectoscope is then maneuvered into position near the
tissue to be resected and, with a clear view for resection, the
loop electrode is extended beyond the distal end of the
resectoscope. The loop is then placed near the tissue to be
resected, the electroloop is activated, and the loop is drawn back
toward the resectoscope itself causing the loop to simultaneously
cut off a piece of the tissue and cauterize the wound in the tissue
left behind. The process of extension and withdrawal would then be
repeated until the full extent of the identified tissue is removed.
However, the process is rarely that straightforward. More
typically, the resection process is repeatedly interrupted by
clogging of the tip assembly by tissue, or by sticking of the
tissue to the loop itself. When this happens, removal, cleaning and
reinsertion of the entire assembly may be necessary.
[0011] In addition, as noted above, each tissue piece must be
captured for surgical pathology. With the present devices, the
resectoscope can be employed to intentionally snare and remove each
tissue piece, but this requires removal of the entire assembly to
remove the individual tissue piece, re-insertion of the
resectoscope, abatement of any new bleeding, re-attaining of the
proper the balance between fluid infusion and removal to gain an
adequate view, and only then, working on the next small tissue
piece to be resected. Alternatively, if the resectoscope is not
used, a tissue forcep may be blindly substituted for the
resectoscope in order to attempt removal of the tissue. In either
case, diagnostically important pieces of tissue may be lost in the
effluvium of uterine deflation, or dropped and lost in the handoff
from surgeon to technician.
[0012] Still further, if cautery needs exceed the ability of the
resection loop during the process, the entire mechanism must be
withdrawn and disassembled to remove the electro-loop and
substitute a roller-ball electrode. Then, re-assembly, and
subsequent re-insertion and fluid flow re-balancing are required in
order to accomplish this phase of cautery. Then, if further
resection is still necessary or desired after the cautery, the
removal, reconfiguration, re-balancing, etc. process must be
repeated.
[0013] Once the procedure is finally complete from the surgeons
perspective, the process must continue for purposes of surgical
pathology. In that regard, the instrument is handed off to a
technician who disassembles it and removes any tissue pieces that
have attached to any of the multiple sleeves, auxiliary
instruments, obturators, stop-cocks, scope, bridge pieces, holes
and grooves. In addition, the electroloop is removed and disposed
of into the sharps container.
[0014] Since the instruments are all reused, after disassembly, the
multiple elements must be transported to the area where final
cleaning is done before sterilization and re-packaging. Thereafter,
at some point a transport is required to return the now cleaned,
sterilized and repacked unassembled kit and tray to the
peri-operative supply area for its next use.
[0015] Some newer systems employ variations on the same basic
free-flow hysteroscopic resectoscope in which an auxiliary
instrument can be inserted through the hysteroscope for the purpose
of tissue capture and removal.
[0016] In some variants tissue morcellation is employed which
requires time. Other variants require a complex opening mechanism
to obliquely pass a small auxiliary tissue cutting and capture
instrument to thereby allow for tissue capture and removal. These
geometric changes increase the size of the instrument and thus
limit the use of the instrument to areas of the body or body cavity
that can accommodate the size change and/or overall increased size.
These methods also involve optically guided capture and
manipulation of tissue morsels in order to accomplish their export
with or without further morcellation. Most of these variant methods
require interruption of cutting to allow for removal of resected
tissue. In addition, none of these variant techniques meaningfully
reduce organ perforation risk. Still further, to avoid removal of
an excessive amount of tissue, resection is typically done in a
series of passes, with every pass involving a "guess" as to the
required (and actual) depth of cut, particularly because gasses
from tissue destruction and heat largely obscure the cutting loop
from precise view during the actual cutting. As a result, surgeons
are forced to weigh and ultimately succumb to the trade-off between
over-removal with its attendant risk of organ perforation or
under-removal with the prospect that a repeat procedure may, at
some point, be necessary.
[0017] Removal of pathological tissue from other organs routinely
involves, to varying degrees, multiple steps of a somewhat
analogous nature (i.e. multiple insertions/removals and issues
relating to capture of resected pathological tissue) and thus
analogous or similar problems exist with those operations as
well.
[0018] As will be appreciated, the above example procedure to
remove pathological tissue from the uterus is time consuming and
typically takes between 30 and 60 minutes to perform. With
operating room costs exceeding several thousand dollars an hour,
this can lead to substantial costs for a patient as well as the
hospital in which the resection is performed.
[0019] Thus, there is a need for a surgical device that does not
suffer from problems attendant with existing devices.
[0020] In addition, there is a need for a surgical device that can
reduce the time required to perform a resection procedure and
thereby, the costs associated with doing so.
SUMMARY OF THE INVENTION
[0021] I have devised an instrument that can be used for resection
of lesions or tissue that significantly reduces the above
problems.
[0022] One example aspect involves a surgical instrument including
a shaft having a proximal end and a blunt, enclosed distal end, the
blunt, enclosed distal end being optically transparent over at
least a portion of its area, a scope having a viewing end that is
moveable within the shaft between a first position and a second
position such that when in the first position within the shaft, the
viewing end will be on a distal side of a working area within which
resection can occur and proximate to the optically transparent
portion of the distal end and provide an unobstructed view external
to the blunt, enclosed distal end and when in the second position
within the shaft, the viewing end will be on a proximal side of the
working area and provide a view of the working area.
[0023] An alternative aspect involves a surgical instrument having
a longitudinal shaft including an enclosed, blunt distal tip, an
internal fluid flow path and an externalizable fluid flow path. The
longitudinal shaft also has a working area defined by an opening in
a side of the longitudinal shaft, located within the internal fluid
flow path, and a switch, coupled to the internal fluid flow path
and the externalizable fluid flow path which will control infusion
fluid flow into the internal fluid flow path and the externalizable
fluid flow path.
[0024] Another alternative aspect involves a method made up of:
viewing insertion of a shaft, having a blunt, enclosed distal end,
into a body cavity through the blunt distal end via an optical
element located proximate to the distal end; causing a fluid
flowing along the shaft from a proximal end to a distal end to exit
the shaft through at least one export pore; changing a switch
setting such that the fluid flowing in the proximal to distal
direction will bypass a working area and, once past the working
area will flow in the distal to proximal direction and pass through
the working area; and causing a discrete piece of tissue to enter
the working area so that it will be conveyed in the distal to
proximal direction by the flow of the fluid.
[0025] Various implementations of my invention can provide one or
more of the following advantages: fully integrated functionality,
reduction in trauma from insertion, reduction in time to perform a
resection procedure, accurate targeting of tissue to be resected,
automatic limiting of cutting depth, and/or capture and export of
all resected tissue and debris. Moreover, certain implementations
can be disposable, in whole or part, resulting in cost savings due
to avoidance of cleaning and re-sterilization issues.
[0026] Variants of the invention are suitable for use in, among
others, gynecological, urological, proctological, thoracic,
neurological, pulmenological, otolaryngological, gastrointestinal
and laparoscopic procedures as well as other procedures in which a
minimally invasive and minimally traumatic tissue resection is
necessary or desirable.
[0027] Variants implementing the invention provide a further
pathological benefit not available with current resection tools
like macerators, morcellators and electrosurgical loops or knives.
One problem with macerators and micro-morcellators is that they
destroy large amounts of tissue, rendering them less suitable for
pathological examination. Electrosurgical loops or knives that
cauterize as they cut create a zone of tissue destruction on the
edges of each side of the cut that is typically about 10 microns
deep. While this zone is considered pathologically acceptable, it
nevertheless represents a zone of pathological uncertainty.
Advantageously, with variants that implement the invention, the
size of the resected tissue pieces can be larger than with
currently available devices resulting in a greater ratio of
undamaged to destroyed tissue and, consequently, a larger volume of
pathologically examinable tissue.
[0028] Moreover, the protected nature of the cutting part of the
device reduces or eliminates the risk of organ perforation,
allowing for performing bi-directional resection--in contrast to
the way surgeons are taught to perform resections with conventional
instruments.
[0029] In addition, different variants can provide one or more of
the following further advantages: quick functional change among
operational modes (i.e. inflation, viewing, resection, irrigation,
etc.); true dual conformation with immediate re-conformation;
single hand manipulation and control; fluid switching and
internalization with vacuum actuated flow boosting for accelerated
tissue export; automatic transfer and capture of resected tissue;
intrinsic depth of cut control; elimination of separate and
discrete insertion or extraction of obturators, tissue choppers;
elimination or reduction in the use of accessory instruments or
undertaking cycles of insertion, cavity infusion, target
acquisition, withdrawal, disassembly, reassembly, reinsertion,
subsequent cavity reinfusion & target reacquisition, etc.
saving effort, time and, consequently, money; unobstructed
panoramic diagnostic viewing pre and post-resection; a protected
resection mechanism; minimally traumatic instrument insertion and
manipulation; and inhibition or prevention of organ perforation by
an activated electrode under proper use.
[0030] The advantages and features described herein are a few of
the many advantages and features available from representative
embodiments and are presented only to assist in understanding the
invention. It should be understood that they are not to be
considered limitations on the invention as defined by the claims,
or limitations on equivalents to the claims. For instance, some of
these advantages are mutually contradictory, in that they cannot be
simultaneously present in a single embodiment. Similarly, some
advantages are applicable to one aspect of the invention, and
inapplicable to others. Thus, this summary of features and
advantages should not be considered dispositive in determining
equivalence. Additional features and advantages of the invention
will become apparent in the following description, from the
drawings, and from the claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0031] FIG. 1 is a simplified side view of one example variant of a
resectoscope incorporating the present invention.
[0032] FIG. 2 is a simplified view of the shaft component of the
resectoscope of FIG. 1;
[0033] FIG. 3 illustrates, in simplified form, the trolley
mechanism for the variant of FIG. 1;
[0034] FIG. 4 illustrates, in simplified form, the example control
mechanism for the instrument of FIG. 1;
[0035] FIG. 5 illustrates, in simplified form, an example handle
102 for the resectoscope variant of FIG. 1;
[0036] FIG. 6 illustrates, in simplified form, a top view of a
portion of the distal end of the shaft;
[0037] FIG. 7 illustrates, in simplified form, an external end view
of the blunt distal end portion of the shaft;
[0038] FIG. 8 illustrates, in simplified faun, a longitudinal cross
section of the portion of the shaft of FIG. 6;
[0039] FIG. 9 illustrates, in simplified form, an alternative
"switchless" variant;
[0040] FIG. 10 illustrates, in simplified form, another alternative
variant;
[0041] FIG. 11 illustrates, in simplified form, a longitudinal,
cross sectional side-view of a further alternative shaft
portion;
[0042] FIG. 12 illustrates, in simplified form, an example sliding
control reed configured for use in conjunction with the shaft
portion of FIG. 10;
[0043] FIG. 13 illustrates, in simplified form, the portion of the
resectoscope of FIG. 8 as it would look during insertion;
[0044] FIG. 14 illustrates, in simplified form, the portion of the
resectoscope of FIG. 8 as it would look during the "working" or
resection process;
[0045] FIG. 15 illustrates, in simplified form, the portion of the
resectoscope of FIG. 8 with the telescope or viewing apparatus
moved ahead of the cutting member;
[0046] FIG. 16 illustrates, in simplified form, the portion of the
resectoscope of FIG. 8 in an optional third configuration; and
[0047] FIGS. 17-20 illustrate, in simplified form, different stages
of tissue resection using the resectoscope.
DETAILED DESCRIPTION
[0048] FIG. 1 is a simplified side view of one example variant of a
resectoscope 100 incorporating the present invention. As shown in
FIG. 1, this example resectoscope 100 is, in summary overview, made
up of a partially hollowed out handle 102 and a control mechanism
104, both of which will be described in greater detail below, a
shaft 106 connected at its proximal end to the handle 102, a port
through which a telescope or other viewing apparatus, which may or
may not involve use of fiber optic technology can be inserted (not
shown), and a finger grip 108 on the shaft 106. The resectoscope
100 further includes a trolley mechanism 110 that facilitates
movement of the telescope or other viewing apparatus that is
contained within the shaft, a stop 112 that acts as a handle to
allow manipulation of the trolley 110 and also limits movement of
the trolley 110 mechanism towards the distal end 114 of the shaft,
a power connector 116, a fluid inlet 118 and a vacuum port/fluid
outlet 120. As can be seen in FIG. 1, the tip 122 of the shaft 106
at the distal end 114 is formed so as to have a physically closed
blunt shape to dramatically reduce, if not eliminate, puncture or
laceration risk. In addition, the shaft includes an opening or
resection port 124 located on a side surface 126 of the shaft 106
near the distal tip 122.
[0049] Depending upon the particular implementation and intended
use, the length of the shaft 106 can be anywhere from relatively
short, for example (i.e. a few centimeters or less) where a shallow
body cavity is involved, relatively long (i.e. in excess of 40
centimeters) where long cavities like the bowel or intestines are
the intended application, or lengths in between, for applications
such as intrauterine resection. Similarly, depending upon the
particular implementation and intended use, the shaft can be rigid
along its entire length, flexible along a portion of its length, or
configured for flexure at only certain specified locations.
[0050] Still further, in some implementation variants, the shaft
can be made up of two or more detachably interlocking segments 128,
130 for purposes of modularization.
[0051] The fluid inlet 118 is configured for connection to an
adjustable pressure fluid infusion line via a stopcock 132 or other
appropriate valve and, in most cases, also having a parallel free
flow one way fluid reservoir to accommodate vacuum boosting.
[0052] The vacuum port/fluid outlet 120 is configured for
attachment to, for example, a foot-pedal actuated boosted vacuum
source via a stopcock 134 or other appropriate valve.
[0053] FIG. 2 is a simplified view of an example shaft 106
component suitable for use as part of the resectoscope of FIG. 1
and further includes cross sectional slices 2A through 2D taken at
the points indicated to illustrate various features of this example
implementation. Moreover, and advantageously, in some variants, the
shaft 106 itself is separable from the non-handle components that
make up the body of the resectoscope 100, for example as in FIG. 2,
and in some cases, made up of two or more discrete modules. Some
shaft variants are also disposable, whereas others can be
sterilized for reuse. In general, the shaft 106 is fanned as a
hollowed multi-channel shaft or cannula, the details of which are
explained with reference to the cross sectional slices of the shaft
shown in FIGS. 2A through 2D taken at 2A-2A, 2B-2B, 2C-2C and
2D-2D. However, it should be understood that the cross sectional
shapes are simply for illustrative purposes, the particular cross
sectional shape being more relevant to the particular application
for which the resectoscope will be used than to the invention.
[0054] Referring now to the cross sectional slice of FIG. 2A taken
at 2A-2A, this variant of resectoscope shaft 106 incorporates a
channel or portal for a telescope or other viewing apparatus 202, a
fluid infusion channel 204 through which fluid can be infused from
the proximal end towards the distal end, a capture or return
channel 206 through which fluid and resected tissue morsels are
conveyed from the distal to the proximal end, one or more optional
auxiliary channels 208 or other arrangement of appropriate size
extending to at least the working area and, if desired, to the
distal tip itself to allow for, for example: further connections to
be made; objects, for example, catheters, drains, ureteral stents
or tubal occlusion devices to be inserted; to provide a brief flow
of liquid nitrogen or other cryo-cautery fluid to accomplish
hemostasis; allow for passage of an auxiliary cauterization element
to perform conventional cautery; or allow for a stylet to be passed
to the vicinity of the working area or beyond the distal tip. In
addition, in this variant, the shaft 106 is of a different modular
configuration from that of FIG. 1, with the grip 108 of this
variant being used as a coupler to couple a main portion 200A of
the shaft from a proximal portion 200B. The shaft 106 also
optionally includes a pair of guides 210 that limit the cutting
member in this variant to longitudinal movement. In this
illustrated variant, the guides are configured for when an
electrosurgical wire loop is illustratively used (not shown in this
FIG.).
[0055] The cross sectional slice of FIG. 2B taken at 2B-2B is
similar to that of cross section 2A-2A except that the guides 210
are not present because, in this variant, they are not needed along
the entire length of the shaft 106.
[0056] The cross sectional slice of FIG. 2C taken at 2C-2C is also
similar to that of cross section 2A-2A except, because this section
is beyond the entry point for the infusion fluid the fluid infusion
channel 204 is no longer present. In addition, this portion of the
shaft will be situated above the handle 102 so, as will be
described later, the return channel 206 is open 212 to the handle
102 for reasons that will become evident below. It also contains a
pair of handle guides 214 that allow for attachment/detachment of
the handle or shaft relative to the other, and guides 210 (similar
to that shown in FIG. 2A) for a proximal portion of the wire loop
apparatus.
[0057] The cross sectional slice of FIG. 2D taken at 2D-2D is
similar to the lower portion of FIG. 2C with respect to the handle
guides 214 and also includes a handle cap portion 216 and a trolley
guide 218 to receive the trolley 110 mechanism.
[0058] FIG. 3 illustrates, in simplified form, the trolley 110
mechanism for the variant of FIG. 1. As shown, the trolley
mechanism may be of solid (FIG. 3A) or hollow (FIG. 3B) cross
sectional configuration (or some combination thereof) and includes
a companion insert port 302 for the port 202 referred to in FIG. 1
through which a telescope or other viewing apparatus can be
inserted, an exit port 304 that will guide and align the telescope
or viewing apparatus for proper engagement with the channel or port
202 of the shaft 106, a pair of rails 306 on each side that
conforms in shape to the trolley guide 218 of the shaft 106, for
example, the sliding "v-groove" arrangement shown, a pair of
stops/handles 310 that can be used to move the trolley 110 through
its range of motion along the longitudinal axis of the shaft 106
and act as a forward-movement limiting element, and a constraining
arrangement 312a, 312b that will clamp, affix or otherwise
constrain the telescope or viewing apparatus (once fully inserted)
in a particular orientation.
[0059] As shown, the telescope or viewing apparatus can be anchored
to the trolley by a grooved nipple-pin pit 312 at the proximal end.
Two grooved pits 312a, 312b are seen on the proximal end, one
above, and one below the channel 314 between the two ports 302,
304. These grooved pits 312a, 312b accept the anchoring pin found
on conventional scopes, and through provision of two such pits
312a, 312b, allow for rotation of the scope through 180.degree. to
allow for viewing in either a downward or upward inclination when,
for example, angled scopes of, for example, common angles such as
12.degree., 30.degree., or 45.degree. are used. This feature aids
in oblique optical targeting through the opening or resection port
124. With and angled scope and the scope attachment pin in the
inferior pit 312a, the scope is thus directed to an upward viewing
angle providing, with those variants, a direct line-of-sight
through resection port 124 to the target area for direct optical
targeting.
[0060] Advantageously, by affixing the telescope or viewing
apparatus to the trolley 110 movement of the trolley 110 along the
guides 218 will effect equal movement of the portion of the
telescope or viewing apparatus in the shaft 106 towards or away
from the distal end 114. In this manner, the trolley 110 provides
an external visual indication of the location of the end of the
telescope or viewing apparatus.
[0061] At this point it should be noted that the telescope or
viewing apparatus per se is conventional in the sense that numerous
types are already well known and regularly used in performing
various types of surgery. The particular type of apparatus, be it a
telescope, fiber optic or other device, is conceptually unimportant
for an understanding of the invention so long as an appropriate one
is selected in terms of size, bevel angle if applicable (i.e.
0.degree., 12.degree., 30.degree., etc.), field of view, type, etc.
so as to be compatible with the concepts described herein.
Moreover, as will be discussed below, in some cases, two or more
different telescopes or viewing apparatus may be used, for example,
to change among different conventional bevel angles. Thus, except
as is specifically pertinent to an understanding of the invention,
particular details regarding the telescope or viewing apparatus are
omitted for both brevity and simplicity.
[0062] FIG. 4 illustrates, in simplified form, the example control
mechanism 104 for the instrument of FIG. 1. As illustrated, the
control mechanism 104 includes a movement ring 402 that is used to
maneuver a cutting member (described below) through its range of
motion via a connection 404 thereto. In addition, the control
mechanism 104 can be arranged to cooperate with or constrain the
trolley mechanism as necessary to effect the desired operation. In
addition, in this particular variant, the control mechanism
optionally includes a power connection 116 through which power can
be supplied to a cauterization element which may or may not be the
cutting member.
[0063] FIG. 5 illustrates, in simplified form, the handle 102 for
the resectoscope variant of FIG. 1. As shown, the handle 102
includes an optional finger hole 502 that facilitates manipulation
of the resectoscope 100 during insertion or while in use. In
addition, the handle 102 has an internal cavity 504 of sufficient
size to enable capture of the resected tissue entering via the
return channel 206 through an opening 506 in the top of the handle
102 while allowing for the unobstructed, filtered exit of the
return fluid via the vacuum port/fluid outlet 120. In addition, as
noted above, the handle 102 also has a pair of rails 508 on each
side of the upper portion that conforms in shape to the handle
guides 214 shown in the cross sections of FIG. 2C and FIG. 2D.
[0064] As shown, the handle 102 for this variant also optionally
includes a fluid inlet hose guide 510 that keeps the fluid inlet
hose out of the way.
[0065] FIG. 6 illustrates, in simplified form, a top view of a
portion 600 of the distal end 114 of the shaft 106 near the tip
602. Note that, for clarity of presentation, internal details have
been omitted from this view. As can again be seen from this view,
the distal end 114 is formed so as to have a physically closed
blunt shape 122. In addition, as shown in more detail in FIG. 6,
the shaft 106 includes an opening or resection port 124 of a
geometrically closed shape that is located on a surface 126 of the
shaft 106 near the distal tip 602. In particular, as illustrated in
this variant, the opening or resection port 124 is located
immediately above, and defines a working area for the underlying
cutting member and has a longitudinal length .lamda. that is
typically equal to or slightly less than the range of movement of
the cutting member, in this case, between its proximal and distal
limits.
[0066] It should be understood that the size, shape and exact
location of the opening or resection port 124 may vary depending
upon the particular implementation or intended use. Similarly, a
sliding shim or cover plate can be incorporated, for example, to
provide size or shape adjustability, and even, in some cases, to
close off the opening or resection port entirely, for example, to
facilitate insertion into body cavities where the opening or
resection port in and of itself could cause trauma during insertion
or withdrawal. Depending upon the particular implementation, in
some variants, the movement of the shim or cover plate can be tied
to that of the telescope so that when the scope is fully extended
the shim or cover plate will close off the opening or resection
port 124 entirely or at least cover the cutting member itself.
Optionally, for some applications, it may be desirable to ensure
that a seal is formed between the periphery of the opening or
resection port and the tissue about the tissue that would be
resected, for example, when used in an application such as removal
of tissue from a sinus or the trachea which are both fairly rigid.
In such cases, this desire can be accommodated in any of multiple
ways. One example approach can involve making some portion of the
shaft about the periphery of the opening or resection port slightly
flexible so that it can conform to the abutting tissue. Another
example approach can involve use of a deformable "gasket" material
606, such as a closed cell foam, putty, gel or other appropriate
non-toxic deformable material. Depending upon the particular use,
such deformable material can be part of the shaft itself or
provided separately, that latter being advantageous for those cases
where a surgeon may wish to have the option to do so up until about
the time that insertion of the shaft begins.
[0067] In addition, and advantageously, some variants may be
implemented in a kit that includes only certain components, for
example, a shaft by itself, a shaft and handle, a shaft and
associated cutting member, different length shafts, or multiple
shafts of different lengths, cross sectional shapes and sizes,
flexibility, curvature, or that each have openings or resection
ports of a different size and/or shape so as to better match or
accommodate the size and shape of the tissue to be resected and
assist in confining the resected tissue within the shaft so that,
it can be conveyed along the shaft 106 for capture in the handle
102.
[0068] Still further, in some cases it may be desirable to have a
more modularized shaft, in that, the shaft itself would be made up
two or more separable pieces, an extension section 608 representing
the bulk of the shaft length, and a shaft module 610 containing
some or all of the shaft components described herein as being
located between the distal end and a location to the proximal side
of the working area. In this manner, a particular shaft module 610
could be used, for example, with different length or flexibility
shaft extensions 608 or different configuration modules 610 could
be used with a common shaft extension 608 in a mix-and-match manner
as needed or desired. In addition, this approach provides further
advantages in terms of the ability to be produced, production cost
and configuration flexibility.
[0069] As illustrated by way of example, the opening or resection
port 124 is of ovoid shape and the shaft is of a length and cross
section appropriate for resection of tissue within the uterus.
Advantageously, and irrespective of the dimensions of the shaft 106
or particular shape of the opening or resection port 124, the
opening or resection port 124 defines the only zone for interaction
between the cutting member and the tissue to be resected while
acting as a passive port for removal of fluid from the tissue area
or body cavity.
[0070] Moreover, depending upon the phase of resectoscope use, the
opening or resection port 124 will create the path for regulation
of the "inflation", if any, of the cavity where the resection will
occur by acting as the outlet (from the perspective of the body
cavity) for excess inflation fluid and/or will serve as a passive
functional portal for fluid and/or tissue. Optionally, one or more
small pore(s) 604 can be provided, that couple to the return
channel 206, to provide an additional or alternative route for
fluid external to the shaft to pass into the return channel 206,
for example, during an inflation phase where it may be difficult or
undesirable to do so through the opening or resection port.
Depending upon the particular implementation, such pores can be
sized small enough so that they do not de-inflate the cavity during
working or, alternatively, can be selectably blocked for example,
by the slidable shim or some other means, so as to only be open at
a particular time, for example, only when, as will be described
below, the telescope or viewing apparatus is in the extreme distal
position or when a switch is in a position where infusion fluid is
routed out of the shaft for purposes of inflation or
irrigation.
[0071] FIG. 7 illustrates, in simplified form, an external end view
of a blunt distal end 122 portion 700 of the shaft 106. As can be
seen from this view, at least a portion 702 of the tip 602 is
optically transparent so as to act like a window and is aligned
with the channel or portal 202 for the telescope or viewing
apparatus so as to provide for forward viewing through the distal
end portion 702 via the telescope or viewing apparatus under the
appropriate conditions.
[0072] Depending upon the particular implementation, the optically
transparent portion 702 can simply be a hole or it can be a
physical element. In the case of a physical element, it can be an
integral part of the shaft, for example, if at least that portion
of the shaft is, or is made, transparent, or it can be a separately
formed and inserted element, like a membrane, a piece of plastic or
glass (whether flat or lens shaped) or other optically transparent
material. Moreover, in some cases, this portion 702 or window area
can be, in whole or part, a lens that can work in conjunction with
the telescope or viewing apparatus to provide a different field of
view than would be provided by the telescope or viewing apparatus
alone. For example, the window area 702 could be an element that is
flat or convex on the external side of the distal end 122, but flat
and beveled at a specified angle on the internal side (i.e. inside
the shaft) so that a comparably opposite beveled end of the
telescope or viewing apparatus can be butted against it to allow
for straight-ahead, angled or wide-field viewing (as determined by
the shape of the external side) when the trolley 110 is in the
extreme forward position.
[0073] Alternatively, by appropriate sizing, the window area 702
can be a hole that, for purposes of insertion, can be filled or
blocked by the end of the telescope or viewing apparatus itself
through maintaining it in a suitably spaced extreme forward
position.
[0074] Optionally, the auxiliary channel 208 can be carried forward
to the distal end 122, such as is shown. Additionally or
alternatively, as shown in this variant, the portion 702 is ringed
with an electrical conductor 704 that can be selectively connected
to a power source to directly effect cauterization while viewing
the tissue to be cauterized through the distal end 122.
[0075] FIG. 8 illustrates, in simplified form, a longitudinal cross
section of the portion 800 of a shaft 106 of one example variant.
In FIG. 8, the longitudinal fluid infusion channel 204 and return
channel 206 can be readily seen as can the blunt nature of the
distal end 122. Although a single fluid infusion channel 204 is
illustrated for simplicity, in some variants, two or more separate
inflow channels with combined or associated individual respective
controls could alternatively be used. In addition, a telescope 802
having a 30.degree. bevel resides in the telescope channel 202, at
a retracted location, and is aligned with the telescope end portal
804. In this variant, the telescope end portal 804 is capped with a
lens 806 that is slightly convex on its outer surface 808 and
beveled 810 at a mirror image 30.degree. bevel so that, at the
extreme extended position, the end of the beveled telescope 802 and
the internal surface if the lens 806 will mate.
[0076] The opening or resection port 124 described in connection
with FIG. 5 is also clearly visible.
[0077] A cutting member 812 also resides within the shaft 106.
Depending upon the particular intended use and implementation, the
cutting member 812 can be a wire loop (such as shown), a sharpened
blade, a rotary cutting implement, a micro-vibrational or harmonic
or shutter-type cutting device, or other cutting implement (each
with or without cauterization capability). Alternatively or
additionally, the particular cutting member 812 can be configured
for movement in an arcuate, axial, rotational, diagonal,
transverse, reciprocating or other manner to effect cutting in a
direction other than through pure longitudinal movement.
[0078] In yet other variants, the cutting member 812 can be
configured so that its orientation within the shaft 106 is
changeable to provide for cutting at two or more different angles.
In such variants, an auxiliary or reconfigurable telescope or
viewing apparatus may be necessary or desirable to allow for
angulation.
[0079] Depending upon the particular implementation, the cutting
member can be supplied with, and integral to, the instrument or
shaft as packaged or it can be of a separately provided snap-in
and/or snap-out design.
[0080] Irrespective of the particular cutting member 812 used, its
mode of integration with the shaft, and its direction of movement
or orientation, the cutting portion of the cutting member 812 is
wholly constrained within the shaft. Moreover, ideally the cutting
member conforms, through at least a part of its range of motion, to
either an inner or outer surface 126 of the shaft 106 and/or an
imaginary surface of the opening or resection port that would be
formed if the shaft contour was continuous across the region of the
opening or resection port. Thus, if the shaft near the opening or
resection port is arched, because the shaft is circular or oval in
cross section, the cutting member will typically have a similar or
lesser arch. If the shaft near the opening or resection port is
flat or near flat, the cutting member can be similarly contoured in
shape.
[0081] However, if a type of cutting member 812 other than a wire
or blade is used, for example a micro-vibrational or harmonic
cutter (i.e. a harmonically vibrated blade), scissor or
shutter-type mechanism, the cutting member may not follow the
contour. This is not a problem, as following the contour is not
critical to implementation of the invention but highly desirable
for some implementations or intended uses. Rather, the important
aspect is that the cutting member 812 remains within the working
area, whether or not the cutting member 812 is a blade, loop,
scissor, shutter, harmonic or other type of cutting mechanism.
[0082] For purposes of illustration, as shown in the variant of
FIG. 8, the cutting member 812 is a wire loop that is moved by
longitudinal movement of the forefinger loop 402 on the control
mechanism 104 near the handle 102 and is constrained against
non-longitudinal movement by the guides 210 of FIG. 2. As should be
understood from FIG. 8, the cutting member has a height "h" that
keeps it wholly within the shaft 106 through its range of motion
from a fully distal position 814 to a fully proximal position 816
and, in this variant, is curved in an arc of approximately a 4 mm
radius so that the telescope or viewing apparatus 802 can pass
through and underneath the cutting loop with minimal to no contact
therewith. In this regard, it should be noted that, at either or
both extremes 814, 816, the cutting member 812 may or may not be
visible through the opening or resection port 124. As a result, the
cutting member 812 can "guarded" by the outer surface 126 of the
shaft 106, thereby preventing it from causing undesirable
laceration or puncture of tissue during insertion or at any point
in the procedure where cutting is not warranted or desired. Still
further, through this configuration, the outer surface 126 of the
shaft 106 limits the depth of cut, again greatly reducing the risk
of undesirable laceration or perforation.
[0083] In addition, in this variant, the shaft 106 includes one or
more fluid export pores 818 and a fluid routing switch 820 with the
fluid export pore(s) 818 being under the fluid routing switch 820
and beyond the termination point 822 of the fluid infusion channel
204. The fluid export pore(s) 818 can be of any geometric shape(s)
or number.
[0084] As shown in FIG. 8, the fluid routing switch 820 is a binary
position pivoting switch that is sized and shaped so that, in one
position (the infusion position), the switch will direct a
substantial portion, if not all, of the fluid passing through the
fluid infusion channel 204, from the proximal end towards the
distal end, and out through the fluid export pore(s) 818, for
example, in the case of a device for intrauterine resection, to
inflate the uterus. In the other position (the circulation
position), the switch 820 will substantially, if not completely,
inhibit fluid flow out of the pore(s) 818 and instead, direct fluid
into the return channel 206 in the vicinity of the opening or
resection port 124. As illustrated in this variant, the switch 820
is normally biased into the circulation position. Advantageously,
this allows the end 824 of the telescope or viewing member 802 to
be used to actuate the switch 820 and divert the infusion fluid out
the pore(s) 818.
[0085] Optionally, in some variants, the internal surface 826 of
the switch 820, about the switch 820, and/or surfaces 828 facing
the return channel 206 (whether or not there is a switch) can be
specifically inclined and polished or otherwise made reflective so
as to act like a mirror and enable a further or additional range of
view through the opening or resection port than could potentially
be available using only the telescope or viewing apparatus (i.e.
provide accessory optical capability for, for example, tissue
targeting or cauterization).
[0086] Alternatively, in other variants, the fluid routing switch
within the shaft 106 can be dispensed with entirely.
[0087] FIG. 9 illustrates, in simplified form, a "switchless" (with
respect to the shaft) variant 900 by employing at least two
separate fluid inflow channels 902, 904 routed to effectively
create the two flow patterns obtained by the switch. In other
words, at least one of the fluid inflow channels 902 is connected
to the export pore(s) (analogous to one of the binary switch
positions) and another of the fluid inflow channels 904 is
configured to cause fluid to remain within the shaft and flow into
and through the working area (analogous to the other binary switch
positions). Such a switchless variant has the advantage that, with
respect to the shaft itself, fluid routing becomes a passive
function, formation of the shaft becomes simpler and a moving part
is eliminated. As a result, it is easier to create an inclined
polished or mirror area within the shaft as described above.
[0088] Of course, such a "switchless" approach would still require
some form of selection element which could be located, for example,
on or adjacent to the handle, the control mechanism, or wholly
external to the resectoscope itself. In addition, this alternative
approach enables specific control of the flows so that a dual or
combination flow can optionally be achieved (i.e. an intermediate
point between full output through the infusion port and full
circulation flow at a desired flow rate).
[0089] FIG. 10 illustrates, in simplified form, an alternative
shaft portion 1000 variant that is similar to that of FIG. 8 except
a portion of the distal end 1002 is itself transparent, so no
separate membrane, lens or other cap is required, there is
specifically one circular infusion pore 1004, and the opening or
resection port 1006 is rectangular. For completeness, FIG. 10A is a
cross sectional slice of the shaft taken at 10A-10A (through the
pivot point of the switch), FIG. 10B is a cross sectional slice of
the shaft taken at 10B-10B (through the infusion pore), and FIG.
10C is a cross sectional slice of the shaft taken at 10C-10C
(through a portion of the opening near the proximal working area
limit for the cutting member). In addition FIG. 10D illustrates a
view of the upper surface of the shaft 1000 taken from above the
opening or resection port 1006.
[0090] FIG. 11 illustrates, in simplified form, a longitudinal,
cross sectional side-view of a further alternative shaft portion
1100 variant that uses a sliding reed as the fluid routing switch.
In addition, in this particular variant the reed also optionally
defines and segregates the fluid infusion channel 1102 from the
return channel 1104. For ease of understanding this variant,
example cross sectional slices, taken at 11A-11A through 11G-11G,
are also provided in FIG. 11A through 11G. For further simplicity,
details such as the cutting member, its constraint and movement
control, as well as any optional additional auxiliary channel(s)
have been omitted but it should be understood that any or all of
them could also be present.
[0091] In this variant, two fluid export pores 1106, 1108 are
provided and are best illustrated in FIG. 11E. As illustrated in
the various cross sectional slices, the fluid infusion channel 1102
splits into a pair of smaller channels 1110, 1112 as it approaches
the distal end 1114 in order to reach the two fluid export pores
1106, 1108. Fluid infusion into the body cavity occurs via fluid
flow from the fluid infusion channel 1102, through the two channels
1110, 1112 to the fluid export pores 1106, 1108. Again, it should
be understood that each individual fluid export pore 1106, 1108
could be readily implemented as two or more individual pores.
Alternatively, fluid circulation occurs via a fluid circulation
channel 1116 that is located between the two smaller infusion
channels 1110, 1112 and is shaped to direct the fluid into the
vicinity of the working area 1120 for return down the return
channel 1104.
[0092] Of course, it should be understood that, in other
implementation variants, the fluid circulation channel could be
split up into the two channels and the fluid infusion channels
could be the central channel, the only differences being a
potential change in relative sizing of the channels, the export
pore(s) would be centrally located and there would be two portions
used to direct the flow into the working area to account for the
split channels.
[0093] The above two variants reflect a desire for longitudinal
symmetry about the vertical. However, it should be understood that
symmetry is not required and, in some variants, asymmetry may
provide advantages for particular uses or applications, for
example, to cause a turbulent or specific pattern of flow near the
distal tip or working area. In such cases, some form of
side-by-side arrangement or other arrangement would likely be
used.
[0094] As noted above, one example variant mechanism for switching
of fluid flow is comprised of a blade-like control reed which spans
the hollowed shaft 106 transversely. The control reed also spans
from proximal to distal within the shaft along the greater length
of the instrument, and is held in place by small lateral grooves
1118 along the inner wall of the shaft. The control reed is capable
of sliding longitudinally distally and proximally along the shaft.
FIG. 12 illustrates, in simplified form, an example sliding control
reed 1200 configured for use in conjunction with the shaft portion
of FIG. 11. As illustrated, when the control reed 1200 is within
the shaft 106, it will create an eccentric partition axially along
said shaft such that the inflow channel 1102 lies beneath, and the
larger outflow/return channel 1104 lies above the control reed 1200
along the length of the shaft 106. Depending upon the particular
implementation, the control reed 1200 may be flat, such as shown,
or may be curved in some manner to, for example, increase the
diameter of the overlying return channel 1104, or contribute to the
overall stiffness of the instrument 100. Similarly, depending upon
the particular design, control reed material or intended use for
the instrument, the control reed 1200 itself can be reinforced, for
example, by fins, ribs, or a differing thickness across its width
or along its length to increase stiffness or create a specific
flexure pattern.
[0095] The control reed 1200 accomplishes its switching task
through use of holes 1202, 1204, 1206 located near its distal end
1208. The holes 1202, 1204, 1206 are placed, sized and shaped to
effect the desired fluid flow control based upon the position of
the control reed 1200 at a particular point in time. As
illustrated, a center hole 1202 is located near the distal end 1208
of the control reed 1200 and provides a flow path up and into the
working area 1120 when the center hole 1202 is aligned, in whole or
part, with the fluid circulation channel 1116. In addition, the
center hole 1202 is located relative to the end of the reed 1200 so
that the control reed 1200 can be placed in a position where an
element 1122 blocks all flow through that hole 1202. As
illustrated, that position is an extreme forward (i.e. distal)
position, but could alternatively be a rearward position or some
position in between.
[0096] In addition, the control reed 1200 contains a pair of
lateral holes 1204, 1206 to either side that can be aligned with
the infusion channels 1110, 1112 to direct fluid flow from the main
fluid infusion channel 1102 to the export pore(s) 1106, 1108. As
with the center hole 1202, the lateral holes 1204, 1206 are located
on the control reed 1200 so that they can, based upon the position
of the control reed 1200, provide a fluid flow path, in this case
between the infusion channel 1102 and export pore(s) 1106, 1108 (in
this variant, in the vicinity of the shaft 106 at the cross section
taken at C-C), or to cut off all flow to the export pore(s) 1106,
1108. As illustrated, in cross section B-B, in this variant, solid
protrusions 1124, 1126 above the control reed groove 1118 are
positioned act so as to block flow through the lateral holes 1204,
1206 when the control reed 1200 is at its most proximal operational
setting. Of course, as with the central hole 1202, this lateral
hole 1204, 1206 blockage could also occur at a forward position or
some position in between.
[0097] For purposes of understanding, in the variant of FIG. 11 and
FIG. 12, the distal end 1208 of the control reed 1200 and distal
end slot 1128 are arranged so that the control reed 1200 can move a
distance essentially equal to, or slightly more than, the diameter
of the central hole 1202. With the control reed 1200 in its
proximal position, the lateral holes 1204, 1206 are blocked and the
central hole 1202 is open to accomplish an internalized fluid
circuit. Thus, with the control reed 1200 in the proximal position,
fluid will be passively directed from the inflow channel 1102 into
the center channel 1116, creating a flow circuit within the
instrument's shaft 106. In the variant illustrated in FIG. 11, when
assembled and in use, fluid flows in the distal direction from the
inflow channel 1202 under the control reed 1200, and then upward
via a curved surface 1130 within the center channel 1116 proceeding
out through the center hole 1202 in the overlying control reed
1200. The fluid then flows or is drawn proximally into the
outflow/return channel 1104 with or without vacuum assist. This is
the typical control reed 1200 position for resection.
[0098] In its distal position, the lateral holes 1204, 1206 of the
control reed 1200 are open while the central hole 1202 is blocked
by the distal end slot 1128 so that fluid will be routed out the
export pore(s) 1106, 1108. Thus, as the control reed 1200 is moved
to block the center hole 1202, the nearest 1206 of two lateral
pores 1204, 1206, one on each side, will move from under the
blocking surface 1124, 1126 and thus allow diversion of flow up and
into the lateral channels 1110, 1112 whose ultimate path leads to
the export pore(s) 1106, 1108.
[0099] Depending upon the particular implementation, movement of
the control reed 1200 can be integral with movement of the
telescope or viewing apparatus 802 or not. As shown, the sliding
control reed 1200, when within the shaft 106, is activated from the
proximal end of the instrument by an open linkage mechanism (not
shown) to the trolley 110, and is automatically activated with full
advancement of the scope/trolley in unison. The control reed 1200
is pushed forward by the trolley 110, or independently by a finger
leaving the trolley 110 in its home/resection position. This
allows, for example, uninterrupted re-inflation of the tissue
cavity while keeping the telescope or viewing apparatus 802 in a
diagnostic or targeting mode or during active resection, as
desired. Alternatively, movement of the control reed 1200 can be
made independent of the other components, for example, the
telescope or viewing apparatus 802. This can be accomplished in a
straightforward manner by providing an element at or near the
proximal end of the shaft 106 that is connected to the control reed
1200 and thus, its movement will move the control reed 1200.
[0100] Advantageously, some variants using the control reed 1200
arrangement for fluid switching will thus, have the ability to
provide variable flow, not readily obtainable via internal
switching alone with the preceding mechanical switch by: a) design,
through placement, sizing and shape of the holes themselves so
that, for example, there is an inverse linear ratio of diversion
between completely internalized and externalized flow as the
control reed is moved, b) movement of the control reed into any of
an infinite number of intermediate positions irrespective of the
particular flow relationship provided by the hole placement, shape
and sizing, or c) both. As a result, finely controlled flow
splitting between internalized and externalized routes can be
achieved, for example, in order to maintain slow balanced cavity
infusion while concurrently performing resection with vacuum
assisted evacuation and/or tissue export.
[0101] In general, the approach to controlling the fluid flow that
is used to convey the resected tissue from the working area towards
the handle 102 will likely vary depending upon the particular
implementation and intended use. For example, in some cases, the
control can be fully manual. In other cases it can be a result of
movement of another element, for example the telescope or viewing
apparatus of FIG. 8 or the movement of the cutting member itself.
In yet other cases, the control can result from a combination of
manual adjustment based upon mechanical, electric or electronic
feedback. In yet other cases, fully automated control is possible
through use of, for example, electrically activated fluid gates,
electromagnetic, mechanical, hydraulic, or other switches. In some
variants that use a distally placed switch that is not directly
manipulable via an external control, the switch can be designed to
be externally controlled through fluid flow itself in conjunction
with vacuum, or through only positive pressure fluid flow (i.e.
without the use of vacuum at all). In addition, and advantageously,
when in the fluid circulation mode or configuration (i.e. fluid
will not flow generally out the export pore(s)) flow rates of 100
cc/min or more can be used and, with vacuum boost, instantaneous
flow rates within the shaft can exceed 4000 cc/min.
[0102] FIG. 13 illustrates, in simplified form, a cutaway view of a
shaft portion 1300 for a resectoscope, that is similar to the shaft
portion 800 of the resectoscope of FIG. 8 except that the distal
end has a window area 702 that is made up of a transparent membrane
1302 instead of a lens 806. As illustrated the shaft portion 1300
is configured as it would look during insertion. In this
configuration, the telescope or viewing apparatus 802 is fully
extended (i.e. the trolley 110 has been moved to its forward limit
position so that viewing out the window area 702 of the shaft 106
is possible using the telescope or viewing apparatus 802. The
cutting member 812 is in its "home" position which, although
illustrated as being at the distal limit 1306 (due to the surgical
convention of preferably only cutting in the distal to proximal
direction due to the puncture risk inherent with conventional
devices) it could alternatively be at a proximal limit or somewhere
in between. In the fully extended position, the telescope or
viewing apparatus 802 impinges against the upper portion 1304 of
the switch 820 thereby opening the fluid export pore(s) 818 to the
fluid input channel 204 to allow fluid to pass out of the shaft 106
while preventing infusion fluid from directly entering the return
channel 206 from inside the shaft 106.
[0103] Advantageously, it should be recognized that variants
configured in this manner can be used in circumstances where organ
"inflation" may or may not be necessary. For uses where inflation
is not necessary, this is accomplished by limiting trolley 110
movement or clamping the telescope or viewing apparatus 802 such
that, when the trolley 110 is in the fully extended position, the
telescope or viewing apparatus 802 will fall just short of the
upper portion 1304 and thus avoid actuating the switch 820.
Although, by doing so, this could result in some minor reduction or
distortion in the forward field of view due to the gap between the
end of the telescope or viewing apparatus 802 and the window area
702, any such reduction or distortion will likely occur, if at all,
at the periphery of the field of view so the reduction will have
minimal to no impact in most cases.
[0104] FIG. 14 illustrates, in simplified form, the portion of the
resectoscope of FIG. 13 as it would look during the "working" or
resection process. As shown, in this configuration, the telescope
or viewing apparatus 802 is at or near its fully retracted position
and, as a result, the switch 820 will block passage of fluid to the
fluid export pore(s) 818 and cause the infusion fluid to circulate
up into the return channel 206 where the applied vacuum will cause
it to traverse towards the proximal end of the shaft 106. Moreover,
the placement of the telescope or viewing apparatus 802 allows for
unobstructed view of the opening or resection port 124 as the
cutting member 812 is moved throughout its range to perform
unidirectional or bi-directional resection. In addition, since they
are independently maneuverable, the end of the telescope or viewing
apparatus 802 can be used to "clear" or dislodge any resected
tissue pieces that may get caught on the cutting member 812 by
simply moving the two with respect to each other so that the
telescope or viewing apparatus 802 passes by the cutting member
812. Still further, should the end of the telescope or viewing
apparatus 802 become partially or totally obstructed by tissue or
clouded by turbid fluid from the resection (if any), the telescope
or viewing apparatus 802 can be moved forward of the cutting member
812 and into the clean flow of infusion fluid, thereby cleaning the
end without the need to withdraw the shaft 106 of the resectoscope
100 or the telescope or viewing apparatus 802 from the body
cavity.
[0105] Alternatively or additionally, in instances where there are
one or more optional auxiliary channels 208 present and a piece of
tissue or debris becomes stuck on the cutting member 812 or
telescope/viewing apparatus 802, a stylet can be passed through an
auxiliary channel 208, in order to bump the cutting member 812 or
piece of stuck tissue or debris and dislodge it from the cutting
member 812 or telescope/viewing apparatus 802. Alternatively, a
home position "groove" or recessed area, configured to closely
conform to and accept the cutting member 812, can be used to aid
clearing of stuck tissue or debris from the cutting member 812
through return to this home position.
[0106] FIG. 15 illustrates, in simplified form, the portion 1300 of
the resectoscope of FIG. 13 wherein the telescope or viewing
apparatus 802 has been moved ahead of the cutting member 812 as
described above.
[0107] FIG. 16 illustrates, in simplified form, the portion 1300 of
the resectoscope of FIG. 13 in an optional third configuration. In
this configuration, the resectoscope is optionally designed to lock
the cutting member 812 at a position within the working
area--illustratively shown in this example for simplicity at the
midpoint of the range of motion. In this position, the cutting
member 812 can be connected to a power source to effect
cauterization or, for example in the case of a cutting loop as
shown in FIGS. 8 and 16, drag cutting of tissue (i.e. along a plane
formed by the cutting member 812 or angled from that plane within
an angle .theta. as necessary. Again, it is worth noting that the
shaft 106 and/or periphery 1604 of the opening or resection port
124 will act to limit the depth of cut and reduce the risk of
unwanted extraneous lacerations.
[0108] Of course, in some variants, the cutting member 812 can
optionally be configured to cauterize throughout all, or in other
variants a limited portion, of the range of movement.
[0109] With respect to the use of the resectoscope, operationally,
there are generally two home positions for the hand to accomplish
the basic movements used to employ many variants of a resectoscope
100 such as described herein.
[0110] The first hand-home position is used to advance/retract the
telescope or viewing apparatus 802 to/from the diagnostic position.
In the diagnostic position, an unobstructed panoramic view beyond
the blunt distal tip 122 is provided. To do so, the index and
middle fingers grasp the shaft 106 via the grip/stop 108 and the
thumb rests on the handle 112 portion of the trolley 110. Movement
of the thumb distally is used to advance the telescope or viewing
apparatus 802 and movement in the opposite direction is used to
retract the telescope or viewing apparatus 802 and, in some
variants, that same movement thereby also controls the switch in
the distal end of the shaft. In the retracted position, a view of
the working area as well as a view external to the shaft 106 via
the opening or resection port 124 is provided.
[0111] The second hand-home position is used to configure the
resectoscope 100 for surgical working (i.e. resection, drag cutting
and/or cauterization as well as targeting). In this position, the
thumb is typically placed in the handle ring 502 and the forefinger
is placed in the ring 402 of the control element 104. Since the
cutting member 812 is connected to the control element 104, the
cutting member 812 is actuated by movement of the control element
104 via its ring 402 while the instrument is stabilized by the
thumb being in the thumb hole 502. Alternatively, in some variants,
the working position can involve placement of the index finger in
the handle ring 502 (with the remaining fingers wrapped around the
back of the handle) and the thumb in the ring 402 of the control
element 104. When used in this manner, movement of the thumb will
move the cutting member.
[0112] Alternatively, the resectoscope 100 is further configured so
that the index and middle fingers can pinch the finger grip 108
while the thumb works the control element 104 or the trolley 110
from a side position.
[0113] Having described aspects of representative example devices
incorporating aspects of the invention, the operation of one
example variant will now be described with reference to FIGS. 17,
18, 19 and 20 to illustrate the operation of a resectoscope 100
using such variant with FIGS. 17-20 specifically illustrating, in
simplified form, different stages of tissue resection. For
simplicity and purposes of contrast with conventional approaches,
the operation of one such device will now be described for the same
procedure as described above in the "Background" section. As
illustrated, the variant of this example employs a hybrid of
adjustable positive pressure infusion into the infusion channel
from a free flow reservoir, and fluid return through the return
channel is vacuum driven with optional boosting.
[0114] Just as in any prior method, the patient is positioned with
adequate analgesia, the cervix sterilized and dilated, except that
here the dilation proceeds directly to the diameter of resection
instrument, in this example, around 10 millimeters.
[0115] Presuming that a fully disposable version or partially
disposable kit version is used, the pre-assembled instrument or the
pertinent kit component(s) is/are removed from one or more sterile
packages, and if in kit form assembled, and if not simply removed
ready for hookup to the telescope 802, power source, and
fluid/vacuum lines. After a quick vacuum driven flush, the
telescope 802 is positioned to provide a view out the distal tip
through the window area (FIG. 13) and the instrument is inserted
into the cervix and directly into the uterine cavity with the aid
of its blunt, enclosed distal tip without significant concern of
laceration or puncture. Advantageously, due to its configuration,
should the surgeon encounter cervical polyps during insertion, they
can be removed as part of the entry process. Upon insertion to the
uterine cavity the usual visual assessments are made with fluid
infusion hydrometra.
[0116] After the surgeon has done the usual photo documentation and
optically identified the areas intended for resection, the
instrument is reconfigured into the resection mode by a single hand
motion to withdraw the telescope 802 back to the resection position
(FIG. 17) and bring the cutting member 812 into position. This also
causes the infusion fluid to begin circulating from the infusion
channel 204 into the return channel 206. Through minor external
adjustment of the infusion fluid flow and return vacuum rates,
fluid flow patterns are actively internalized within the shaft 106
and re-made to serve the purposes of resection with concurrent
tissue exportation.
[0117] Next, the tissue to be resected is brought into proximity of
the resection port (FIG. 18), and with optical guidance and low
pressure vacuum, contact to the intended area is made.
[0118] Now, the protected cutting member is brought into motion
(FIG. 19), in this case removing a slice 1902 of tissue. Depending
upon the particular patient needs and size of the tissue to be
resected, the cutting member 812 may moved through the zone defined
by the resection port multiple times taking multiple slices,
advantageously, without need for re-positioning or reassessment due
to inherent depth control provided by the surface 126 of the shaft
106. The resected tissue slice 1902 passes down the shaft 106
proximally toward the handle assembly via the return channel 206
and, in this implementation, into the handle 102 body through an
opening in the channel floor just past the beginning of the fluid
infusion port 204, for capture and retention either in the handle
102 itself or an auxiliary container inserted in or associated with
the handle 102. In the event a slice of tissue 1902 becomes lodged
on the cutting member 812, the telescope 802 can be independently
moved forward to dislodge it. Similarly, if smaller fragments or
turbid fluid cloud the end of the telescope 802, it can readily be
moved into the clean fluid flow for clearing without withdrawal
from the patient or concern that pathological tissue will be lost.
In addition, a foot pedal actuated vacuum booster can be used in a
pulsed fashion to further augment clearance and export of tissue.
If necessary, with some implementations, the cutting member 812 can
be further cleaned by return to a rest position, for example, if
the rest position is at a location of maximum fluid flow or if a
mechanical element is provided that is designed to clear the
cutting member 812 through relative movement.
[0119] After tissue resection to the flush level, the instrument
100 can again be reconfigured to the diagnostic conformation with a
single hand motion and without withdrawal of the device from the
patient, re-attaining the initial diagnostic conformation,
panoramic view, and fluid flow patterns to support post resection
reassessment or documentation. Advantageously, with some
implementations, if a bleeding vessel is encountered during the
process, it can be treated by cauterization using, for example, the
cutting member 812 itself with optical targeting, or in other
variant implementations where the cutting member 812 can not be
used for cauterization, by an electrode that is passed through the
auxiliary channel 208 without, as would be required with
conventional instruments, disassembly/reassembly to, for example,
substitute a roller-ball electrode.
[0120] Since, in this example, the resected tissue piece 1902 has
been conveyed to and collected in the handle 102, the handle 102
can simply be removed, closed or packaged and the tissue sent for
pathological examination without removal from the handle 102.
Alternatively, if the handle 102 holds or is connected to some
other removable tissue connection receptacle, that receptacle can
be removed from the handle 102 or its connection or, in some other
variants, the tissue 1802 can be removed from the handle 102 or
other collection container and placed in the appropriate receptacle
for transfer to pathology for analysis.
[0121] Note that, throughout the procedure, no components need be
fully withdrawn from the patient and the external shape of the
portion of the device contained within the patient does not
change.
[0122] If all or part of the instrument is disposable, the
disposable elements are now discarded. If the device is not
disposable, it is disassembled, cleaned, sterilized and repackaged
in the conventional manner.
[0123] Based upon the above, it should be understood that different
variants can be used in many different medical disciplines for
different surgical applications. For purposes of understanding, the
following identifies some representative examples of some surgical
applications that can benefit through use of one or more variants,
it being understood that those enumerated are not intended to be
exhaustive with respect to the particular discipline or to the
specific application(s) within any particular medical
discipline.
[0124] In the area of cystoscopic and urologic surgery the
applications are evident from the foregoing description with the
shaft being appropriately sized (length and cross section) for
entry into the particular body cavity.
[0125] In the area of neurosurgery the invention may be used to
enter ventricles, spaces, crevices or between cranial tissue lobes
with visual assistance through the blunt enclosed distal tip and,
with the telescope or viewing apparatus withdrawn to the working
position, to provide for substantially concurrent tissue excision
and export from within the particular area. In practice,
intracranial spaces would be entered and viewed directly, for
example, following a burr-hole craniotomy. Depending upon the
particular circumstances a sealing grommet can be placed to allow
articulation of the instrument shaft around a soft fulcrum like
pivot. For such an application, the shaft would likely be curved or
have at least some flex capability to allow it to be maneuvered
into spaces as needed.
[0126] In order to avoid increased intracranial pressures, where
necessary, a brief fluid infusion via the export port(s) can be
accomplished concurrent with or prior to incremental advancement of
the instrument by using rest phases and fluid pressure
decompression to allow for venous cerebral circulation to resume.
Utilizing the inherent depth of resection control aspect provided
by the resection port, the instrument can biopsy or remove tissues
without the need for concurrent cavity inflation once the targeting
and positioning movements are finished. Brief fluid re-infusion can
then allow for overall assessment of the progress if necessary.
[0127] In a similar fashion, variants can be used in
microdiscectomy of the spine. Here an appropriately shaped and
dimensioned shaft would be passed through a small paraspinal
incision through a ligamentum flavum while viewing through the
blunt, enclosed distal tip. The shaft end would be inserted between
the disc and the nerve accompanied by slight fluid infusion would
then provide additional space for movement. The distal section of
the shaft would then be positioned so that the solid surface would
be positioned away from the disc and used as a retractor. Through
peripheral viewing through the working area upon withdrawal of the
telescope or viewing apparatus to the proximal side of the working
area specific resectable tissue targeting will occur, followed by
switching to the fluid circulation mode and shaving or chipping
away of disc or spinal tissue with an appropriate cutting member
and concurrent tissue export towards the proximal end of the
shaft.
[0128] In the area of chest and pulmonologic surgery variants could
be used in bronchoscopy to enable targeted removal of lesions
ranging from suspected cancer to warty tracheal growths or
laryngeal or vocal chord polyps or nodules. In such a case, the
instrument would be used initially as a bronchoscope viewing
through the blunt, enclosed distal end. Thereafter, targeting
through the working area in conjunction with internalized fluid
circulation would be used to remove multiple lesions quickly with
concurrent cauterization of the base of the cut surface. In such a
variant, an auxiliary port or additional soft and flexible tube
would be included and protrude from the distal tip to vacuum any
fluid that might exit or leak from the resection port during the
actual cutting to avoid any flooding of the lung(s). Optionally or
alternatively, a non-flammable, oxygen carrying fluid can be
utilized as the infusion fluid if necessary or desired.
Advantageously, use of the instant approach provides a speed
advantage over laser ablation.
[0129] In the area of gastrointestinal surgery variants would be
sized and dimensioned to allow for insertion, tissue biopsy and
export with visual targeting. Here the shaft would primarily be a
long and flexible fiberoptic shaft, as in the case of colonoscopic
instruments generally, with only a small, rigid section near the
distal end housing the working area and an intermediate reservoir
piece intervening between the cutting member and the remainder of
the flexible shaft.
[0130] In the area of cardiothoracic surgery variants could be used
for biopsy of mediastinal cavity structures such as lymph nodes, or
pericardial surfaces. Here the variant could incorporate, or be
used in conjunction with, a specialized chest tube to allow for
evaluation and diagnosis within the pleural space. In such
applications, the shaft would be configured to be articulable or of
a pre-specified shape and would be passed through a grommeted chest
tube into the pleural space. Upon doing so, the shaft would be
moved or articulated within the space to view and biopsy pleural
lesion such as mesotheliomas, lymphomas or other lesions.
Optionally, the tip can be configured to rotate axially to allow
for initial drainage of a pyoma or malignant effusion via the chest
tube with immediate rinsing, viewing and possible biopsy without
recourse to standard thoracotomy incisions or multiple instrument
insertion/removals.
[0131] In the area of orthopedic surgery variants can be sized and
dimensioned to allow for passage into compartmental spaces or
articular/joint spaces to allow for single incision joint space
treatments.
[0132] In the area of maxillofacial surgery, variants would likely
be configured to incorporate features applicable to the
pulmonologic variant such as an optional integral inferior
aspirator tube to clear mucous and rinsing fluid. Again, the shaft
would be of appropriate dimensions and likely be at least slightly
flexible along at least a portion of its length. Insertion into the
nasal or sinus cavities, as with the above approaches, would occur
while viewing through the blunt, enclosed distal end followed by
specific targeting of, for example, polyps from the proximal side
of the working area.
[0133] In all of the examples noted above, as well as any other
non-enumerated surgical applications, owing to the tremendous
variances among patients themselves, the numerous types and kinds
of instances (as well as tissues) for which such variants might be
used, it is contemplated that a "one-size fits all" approach may
not be suitable. Advantageously, to accommodate such cases,
variants incorporating the invention can be created in kit form so
that, immediately prior to or during the surgical operation, the
surgeon can have, for example, multiple shafts or other components
available to them each of different configuration in terms of
dimensions, resection ports, cutting members, etc. so that
specialized, multiple different, or initial inspection-discovered
atypical circumstances can be accommodated by, for example, last
minute attachment of a particular shaft or changeover to a
different shaft. While such cases could lead to more than one
insertion, it is to be understood that such a disadvantage relative
to single-insertion cases would still represent a marked
improvement over conventional approaches.
[0134] Moreover, there may be certain instances where a surgeon may
be unable to determine prior to beginning a surgical operation
whether a variant incorporating the invention or a conventional
approach can be used. Advantageously, in such cases, one or more
variants can be kept "on-hand", the procedure can be initiated
using a conventional approach and, should the need arise, the
surgeon can quickly switch over to the variant if necessary or
advantageous.
[0135] As a final note with respect to potential applications,
although all of the above variants have been described with respect
to typical human surgical applications, it is to be understood that
the invention is applicable to use in animals generally (i.e. is by
no means limited solely to use in humans) although human surgical
applications are expected to be the primary use. Thus, it should be
understood that implementations of the invention will have
application in veterinary surgical operations as well.
[0136] Thus, it will be appreciated that, in many of the above
variants, export of resected tissue occurs simply through fluid
flow from the area of the distal tip/working region back towards
the handle at the proximal end. Moreover, due to the unique
configurations of many variants, tissue export can be augmented by
using flow rates well in excess of what can be used with
conventional instruments. This can be illustrated with reference to
a intrauterine hysteroscopic procedure, bearing in mind that,
increased flow rates may not be appropriate for all surgical
procedures (i.e. where the tissue to be resected or the particular
organ involved could be unacceptably damaged by such a flow).
[0137] When performing hysteroscopic surgery, surgeons typically
use a 1.5% glycine solution. This glycine solution is hypotonic
because it only has a 200-210 osmolarity, as compared with human
serum which has better than roughly a 280 osmolarity. As a result,
it is dangerous to absorb because it can cause hyponatremia, a low
sodium condition which can result in coma, brain edema or, if such
a condition occurs and is corrected too rapidly, central pontine
dysmyelinosis. Thus, when performing conventional hysteroscopic
operations, infusion pressures must be maintained during the entire
operation and infusion pressure is intentionally limited in order
to reduce and limit intravasation of the glycine solution. This
limiting function is typically accomplished through use of an
infusion pump operating at a setting derived from the average mean
arterial pressure and abdominal weight of the patient in
conjunction with the general experience of the surgeon. Generally,
the setting is typically on the order of 75-80 mmHg (although the
specific setting will vary depending on the mean arterial pressure
and abdominal weight for a given patient).
[0138] With a conventional 8 mm Olympus resectoscope of 30 cm
length similar to the resectoscope illustrated in U.S. Pat. No.
3,835,842 to Iglesias, a full open (i.e. maximum) infusion flow is
about 1.2 liters per minute.
[0139] Based upon those parameters, it is expected that the same
viscosity 1.5% glycine fluid used in a shaft according one variant
of the invention configured with: a 12 mm external diameter, a 10
mm internal diameter, a length of 30 cm, a 2.7 mm diameter scope in
its channel, a 5 mm diameter inflow tube, and one or more export
pores with a total area equal to that of a single, circular export
pore of 5 mm diameter, would be configured for a fluid infusion
flow rate about equal to that of conventional instruments (i.e.
about 1.2 liters per minute).
[0140] However, in the internal circulation mode (e.g. where
resection and tissue export would occur), an increased fluid
pressure or vacuum assist can readily be used to further advantage.
Specifically, the internalized flow rate could readily be increased
to double, triple or more of the maximum infusion flow rate, in
this example, a rate that would be in excess of 4 liters per minute
or more--a rate dramatically higher than would ever be used with
conventional devices used in present surgical protocols. This is
because, with conventional instruments, to the extent fluid is also
drained by the instrument, the source for fluid is the body cavity
itself. Thus, any removal rate that is greater than the inflow rate
will tend to collapse the cavity and the addition of vacuum would
only accelerate that collapse. In contrast, implementation variants
such as disclosed herein would generally not deflate the cavity at
all in the internal circulation mode because it is a substantially
closed loop system (the possible exceptions being particular
configurations where the window area is a hole that can not be
blocked or where the resection port does not completely seal
against the body cavity surface near an edge). However, even there,
since bursts can be very short, cavity deflation risk is minimized
notwithstanding the high fluid flow rate. In other words, with an
internalized fluid circuit sourced by the inflow channel, a high
flow rate can be used to export resected tissue without appreciably
altering inflation of the cavity.
[0141] Of course, it is to be understood that, irrespective of the
size of the inflow channel, the internal circulation rate will be
limited by the smallest constriction through which the fluid will
have to flow between the source and the infusion channel. Thus, the
limitation will typically be based upon the size of the inflow tube
and source line. In other words, larger flow rates would generally
require a larger diameter inflow tube or source line or both.
However, as will be appreciated, a larger diameter inflow tube can
readily be provided up to, including, and through, one having of a
cross sectional area that is equal to the cross sectional area of
the infusion channel in the shaft. In addition, since it is
expected that vacuum boosted flow rates will occur in bursts--not
continuously--the use of a conventional 3 mm source line is not a
problem if a sufficiently sized reservoir and inflow tube can be
placed between the source line and the infusion channel.
[0142] Thus, it is expected that comparably sized variants can
generally use internal circulation flow rates for tissue export
(with or without vacuum assist) in excess of four times the rate of
fluid infusion, thereby also providing reduced turbidity in the
working area, more efficient cleaning of the scope or viewing
apparatus end and/or reduced risk of a large piece of tissue
becoming lodged within the shaft.
[0143] Although certain materials, features and configurations have
been identified in connection with the above, they should not be
considered literally the only materials, features or configurations
that can be used. Particular materials, features and configurations
will, to some extent, be determined by factors such as
availability, cost, compatibility with the other components being
used, compliance with regulations particular to surgical devices or
manufacturing-related processes not pertinent to the inventive
subject matter herein, only its particular implementation.
Accordingly, it should be understood that those factors may result
in a particular implementation having a configuration, features or
materials that are not specifically described herein but should be
considered as being suitable and within the contemplated scope,
without specific itemization of all possible alternatives
thereof.
[0144] For example, it may be desirable to use different cross
sectional shapes for the shaft or its constituent channels for
different applications. In other words, different configurations of
ovoid, round or other geometric, non-geometric, symmetrical or
non-symmetrical cross-sectional shapes may be desirable. Still
further, the cross sectional shape may vary in different areas of
the instrument. Similarly, different applications may make it
desirable to use different orientations or groupings of channels
due to specific fluid flow, tissue export, or other operational
needs and/or to change parameters of the instrument itself to make
it more suitable for a particular intended use, for example, to
accommodate particular configurations or types of cutting members,
deal with different organ particulars, increase or decrease shaft
stiffness or maintain a given shaft stiffness or flexibility for
different shaft diameters.
[0145] In some variants, tissue export can be augmented through use
of a mechanical conveyor of some form or multiple elements acting
in concert, for example, flexible millipede-like "graspers" or
"pushers" between the working area and the location where the
tissue exits the shaft or some form of "conveyor-belt"-like or
large pitch helical screw arrangement which can be driven, for
example, by the fluid flow in the shaft. Note however, that such an
approach increases the mechanical complexity and consequently the
likelihood of mechanical problems or failure and renders the
instrument more difficult to clean and re-use. Nevertheless, such
alternative approaches can be used from a pathology standpoint due
to the increased size of the resected tissue relative to that
obtained through current macerators or other resection devices used
for similar purposes.
[0146] Still further, with respect to materials, any material that
meets satisfies the intended use can be used in construction of the
various elements, e.g. the shaft, cutting member, distal tip,
handle, etc. For example, if the instrument will be reusable, in
whole or part, in some applications, one or more of those
components can be made from a metal, like stainless steel, or a
polymer or polymer composite of suitable chemical or temperature
resistance to enable it to withstand one or more re-sterilization
cycles. One suitable example polymer is polyamideimide, also known
as "PAI" or under the trade name Torlon.RTM. (a trademark of BP
Amoco), which is commercially available form various suppliers
including Quadrant Engineering Plastics Products of Reading, Pa.
(www.quadrantepp.com). Another suitable example polymer is a
polyethylene terephthalate thermoplastic polyester resin that is
commercially available under the name Rynite.RTM. from E. I. du
Pont de Nemours & Co. or one of its distributors.
[0147] In cases where the instrument or any of its components will
be disposable after a single use, or may be re-usable a very
limited number of times, less expensive materials that still meet
the requirements for the particular component or action can be
used, for example, low temperature plastics or materials that may
only be suitable for a single or limited use because, for example,
they can not stand up to re-sterilization or can only stand up to
limited re-sterilization.
[0148] It should thus be understood that this description
(including the figures) is only representative of some illustrative
embodiments. For the convenience of the reader, the above
description has focused on a representative sample of all possible
embodiments, a sample that teaches the principles of the invention.
The description has not attempted to exhaustively enumerate all
possible variations. That alternate embodiments may not have been
presented for a specific portion of the invention, or that further
undescribed alternate embodiments may be available for a portion,
is not to be considered a disclaimer of those alternate
embodiments. One of ordinary skill will appreciate that many of
those undescribed embodiments incorporate the same principles of
the invention as claimed and others are equivalent.
* * * * *