U.S. patent application number 11/259763 was filed with the patent office on 2006-09-07 for surgical file instrument.
Invention is credited to Richard J. Harp.
Application Number | 20060200155 11/259763 |
Document ID | / |
Family ID | 37441028 |
Filed Date | 2006-09-07 |
United States Patent
Application |
20060200155 |
Kind Code |
A1 |
Harp; Richard J. |
September 7, 2006 |
Surgical file instrument
Abstract
A reciprocating surgical file system for precisely removing bone
and/or other tissue is described. The system allows a user to
maneuver the system and navigate into hard-to-access sites under a
direct vision mechanism. A transmission mechanism converts rotary
motion from a motor into reciprocating motion and provides it to
the surgical file for precision removal of bone or other tissue. A
pulsatile pump mechanism is operatively coupled with the
transmission mechanism and provides irrigating fluid to the
surgical site.
Inventors: |
Harp; Richard J.; (Carlsbad,
CA) |
Correspondence
Address: |
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE
CA
92614
US
|
Family ID: |
37441028 |
Appl. No.: |
11/259763 |
Filed: |
October 25, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10675068 |
Sep 29, 2003 |
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11259763 |
Oct 25, 2005 |
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60414690 |
Sep 27, 2002 |
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60621843 |
Oct 25, 2004 |
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60621853 |
Oct 25, 2004 |
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60701727 |
Jul 22, 2005 |
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Current U.S.
Class: |
606/85 |
Current CPC
Class: |
A61B 17/32002 20130101;
A61B 2017/00544 20130101; A61B 2017/00553 20130101; A61B 2017/1653
20130101; A61B 17/320016 20130101; A61B 2217/005 20130101; A61B
17/1659 20130101; A61B 2017/1651 20130101; A61B 2017/00477
20130101; A61B 17/1624 20130101; A61B 2017/320084 20130101; A61B
2017/320008 20130101; A61B 2217/007 20130101; A61B 2017/0046
20130101; A61B 17/1671 20130101; A61B 17/1644 20130101 |
Class at
Publication: |
606/085 |
International
Class: |
A61B 17/00 20060101
A61B017/00 |
Claims
1. A surgical instrument comprising: a handle assembly; and a
distal assembly connected to said handle assembly, said distal
assembly comprising: a blade having a first width; a lower blade
structure having an upper face which has a second width extending
between a first lateral side and a second lateral side, said blade
being slidably coupled to said lower blade structure, wherein said
first width is equal to or less than said second width.
2. The surgical instrument of claim 1, wherein said first width is
at least about 95% of said second width.
3. The surgical instrument of claim 1, wherein said first width is
at least about 80% of said second width.
4. The surgical instrument of claim 1, wherein said blade comprises
an exposed cutting surface, said cutting surface configured to
perform at least one of grinding, filing, and cutting of
tissue.
5. The surgical instrument of claim 1, wherein said blade is
axially movable along said lower blade structure.
6. The surgical instrument of claim 1, wherein at least a portion
of said lower blade structure is tapered in said distal
direction.
7. The surgical instrument of claim 1, wherein said distal assembly
forms a minimally traumatic tip that is dimensioned so as to fit
into a neuroforamen without appreciable trauma to a nerve extending
through said neuroforamen.
8. The surgical instrument of claim 7, wherein said lower blade
structure defines a shield on one side of said distal assembly, and
said blade is disposed on another side of said distal assembly.
9. The surgical instrument of claim 1, wherein said blade and said
upper face are curved about a long axis of said lower blade
structure.
10. The surgical instrument of claim 1, wherein said lower blade
structure defines a fluid delivery channel, said blade is axially
moveable between a proximal position and a distal position, a
window for expelling fluid at a distal end of said fluid delivery
channel, wherein said window is defined between said blade and said
lower blade structure when said blade occupies a proximal
position.
11. A surgical instrument having a distal assembly, said distal
assembly comprising: a blade having a first blade edge and a second
blade edge; and a lower blade structure comprising an upper face
between a first structure edge and a second structure edge, said
blade being positioned upon said upper face and movable relative to
said lower blade structure, and said first blade edge proximate to
said first structure edge and said second blade edge proximate to
said second structure edge.
12. The surgical instrument of claim 11, wherein said first blade
edge and said second blade edge are opposing, longitudinally
extending lateral edges of said blade, said first and second blade
edges define a blade width, wherein said first structure edge and
said second structure edge are opposing, longitudinally extending
lateral edges of said lower blade structure, said first and second
structure edges define a lower blade structure width; and wherein
said blade width is equal to or greater than said lower blade
width.
13. The surgical instrument of claim 11, wherein a blade width is
defined between said first blade edge and said second blade edge, a
lower blade structure width is defined between said first structure
edge and said second structure edge, wherein said blade width is
substantially similar to said lower blade structure width.
14. The surgical instrument of claim 11, wherein a periphery of at
least a portion of said blade has a similar shape to a periphery of
at least a portion of said lower blade structure.
15. The surgical instrument of claim 11, wherein at least a portion
of a surface of said blade conforms to a periphery of at least a
portion of said lower blade structure.
16. The surgical instrument of claim 11, wherein said lower blade
structure has a shield surface opposing said upper face, and said
shield surface forms a tip that curves towards said blade.
17. The surgical instrument of claim 11, wherein said lower blade
structure has a shield surface opposing said upper face, and at
least a portion of said shield surface is convex towards said
blade.
18. The surgical instrument of claim 11, wherein said lower blade
structure has a shield surface opposing said upper face, and at
least a portion of said shield surface is concave towards a nerve
extending through a neuroforamen, when said lower blade structure
is positioned at least partially in said neuroforamen.
19. The surgical instrument of claim 11, wherein said lower blade
structure has a shield surface opposing said upper face, and at
least a portion of said shield surface is concave about a
longitudinal axis of said lower blade structure.
20. The surgical instrument of claim 11, wherein said lower blade
structure has a longitudinally extending fluid delivery channel
disposed along said lower blade structure and a plurality of
channels in communication with said fluid delivery channel.
21. The surgical instrument of claim 11, wherein said blade further
comprises a plurality of throughholes, said blade and is movable
between a proximal position and a distal position, at least one of
said throughholes is positioned near said first structure edge and
at least one of said throughholes is positioned near said second
structure edge.
22. The surgical instrument of claim 21, wherein said lower blade
structure further comprises an elongate delivery channel and a
plurality of side channels, said elongate delivery channel
extending along said lower blade structure, said plurality of side
channels in communication with said delivery channel, wherein at
least one of said side channels is aligned with at least one of
said throughholes in the blade.
23. The surgical instrument of claim 11, wherein said distal
assembly forms a tip that is dimensioned so as to fit into a
neuroforamen without producing appreciable trauma to a nerve
extending through said neuroforamen.
24. An instrument, comprising: a blade having an upper filing
surface; and a lower blade structure, wherein said blade slidably
couples with said lower blade structure, wherein said blade and
said lower blade structure are each convex away from said upper
filing surface.
25. The instrument of claim 24, wherein said distal assembly
further comprises a tip, said tip dimensioned so as to fit into a
neuroforamen without producing appreciable trauma to a nerve
extending through said neuroforamen.
26. The instrument of claim 24, wherein said blade has a first
transverse width and said lower blade structure has a second
transverse width, wherein said first transverse width is about the
same as said second transverse width.
27. The instrument of claim 24, wherein said blade has a first
transverse width and said lower blade structure has a second
transverse width, wherein said first transverse width is less than
said second transverse width.
28. The instrument of claim 24, wherein said blade has a first
transverse width and said lower blade structure has a second
transverse width, wherein said first transverse width is greater
than said second transverse width.
29. The instrument of claim 24, wherein said blade has a first
transverse width and said lower blade structure has a second
transverse width, wherein said first transverse width is less than
about 95% of said second transverse width.
30. A surgical instrument comprising: a filing surface configured
to cut, grind, and/or file tissue; a shield surface coupled to said
filing surface; wherein said instrument is configured to be
positioned at least partially in a neuroforamen having a nerve
extending therethrough; and wherein at least a portion of said
shield surface is concave towards said nerve when said instrument
is positioned at least partially in said neuroforamen.
31. A surgical instrument comprising: a filing surface configured
to cut, grind, and/or file tissue; and a shield surface coupled to
said filing surface; wherein at least a portion of said shield
surface is convex towards said filing surface.
32. The instrument of claim 31, wherein said instrument is
configured to be positioned at least partially in a mammalian
neuroforamen having a nerve extending therethrough.
33. A surgical instrument comprising: means for grinding a first
tissue; and means for shielding a second tissue from said means for
grinding when said second tissue is in proximity to said first
tissue; wherein at least part of said means for shielding is convex
towards said means for grinding.
34. A method of treating a patient comprising: placing a distal
assembly of an instrument at least partially in a neuroforamen
having a nerve extending therethrough; wherein at least a portion
of said distal assembly is concave towards said nerve; and removing
tissue from said patient by operating said distal assembly.
35. The method of claim 34, wherein said removing of tissue
comprises at least one of cutting, filing, and grinding.
36. The method of claim 34, further comprising oscillating a blade
of said distal assembly to remove said tissue.
37. The method of claim 34, further comprising coupling a powered
handpiece to said distal assembly of said instrument, and said
powered handpiece has a drive system for driving a movable blade of
said distal assembly.
38. The method of claim 37, wherein said powered handpiece is a
rotary handpiece and said instrument further comprises a mechanical
transmission that converts rotary motion of said powered handpiece
to reciprocating, linear motion.
39. The method of claim 34, further comprising positioning an
access device in a patient's body, and advancing said distal
assembly through said access device until said distal assembly
reaches a target location for tissue removal.
40. The method of claim 34, wherein tissue is removed by
reciprocating a blade while at least a portion of said distal
assembly remains in said neuroforamen.
41. A method of treating a patient, said method comprising: placing
a distal assembly of an instrument at least partially into a
neuroforamen between target tissue and a nerve; removing said
target tissue from surrounding tissue with said distal assembly;
after removing said target tissue, drawing said target tissue into
said distal assembly; and moving said target tissue through said
distal assembly.
42. The method of claim 41, wherein drawing said target tissue into
said distal assembly comprises drawing said target tissue through
an inlet port of said distal assembly and through a lumen extending
from said inlet port through said distal assembly.
43. The method of claim 41, further comprising: delivering
irrigation fluid out of said distal assembly as said distal
assembly removes said target tissue such that said irrigation fluid
is mixed with said target tissue; and drawing said mixture of
target tissue and irrigation fluid into and through said distal
assembly.
44. The method of claim 41, wherein said distal assembly is
substantially L-shaped and has a cutting blade for removing tissue.
Description
RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S.
application Ser. No. 10/675,068, entitled SHIELDED RECIPROCATING
SURGICAL FILE, filed Sep. 29, 2003, which claims the benefit of
U.S. Provisional Application No. 60/414,690, filed Sep. 27, 2002,
and this application also claims the priority benefit under 35
U.S.C. .sctn.119(e) of U.S. Provisional Application No. 60/621,843,
filed Oct. 25, 2004, U.S. Provisional Application No. 60/621,853,
filed Oct. 25, 2004, and U.S. Provisional Application No.
60/701,727, filed Jul. 22, 2005, all of which are hereby
incorporated by reference in their entireties.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The invention relates generally to systems and methods for
tissue cutting and removal. More particularly, the invention
relates to a reciprocating surgical file system for cutting,
removing, grinding, shaping and sculpturing bone and/or tissue
material under direct vision.
[0004] 2. Description of the Related Art
[0005] Adjacent spinal vertebrae are spaced by intervertebral discs
that are tough and semi-elastic. The discs act as a flexible spacer
between the vertebrae that makeup the backbone. Vertebrae are
shaped to provide a bony tubular shaped tunnel between upper and
lower pairs of vertebrae and this tunnel is made-up in part by the
spacing disc. These tubular shaped tunnels are called neuroforamen
and serve as a passageway foSSr nerve roots. The size of the
neuroforamen tubular shaped tunnels is a close fit for the nerve
roots that pass through these tunnels on their way from the spinal
cord to the arms, legs and other muscles.
[0006] Each year millions of people encounter neck and back
injuries. Many million suffer from truly problematic back pain that
either keeps them out of work or debilitates them in some way. Many
vertebral and disc injuries result in pain from nerve irritation
and compression.
[0007] When an intervertebral disc is damaged, often it is because
of a physical overrotation between two vertebrae and normal wear
and tear. When a vertebra is overrotated, small facet joints called
the zygopophyseal capsules that are located to the left and right
sides of the disc are damaged. When the body incurs damage to these
small joints, unwanted osteophytes and bony overgrowths frequently
occur at the edges of these tiny joints. The unwanted bony
overgrowth restricts the neuroforamen and pinches the delicate and
sensitive nerve roots.
[0008] Also, with age, for many people, the sensation of thirst is
somewhat reduced. As a result, sometimes less water is consumed
than needed by the body. The intervertebral discs depend on water
as well as other materials to maintain a healthy function. When a
disc looses a part of its fluid mass it is the to desiccate. When a
disc is desiccated it reduces in height and reduces the space
between the two vertebras it is connected to, that is, the
neuroforamen becomes constricted and pinches nerve roots.
[0009] Pinched nerves that are constrained in between vertebras can
cause neck and back pain. The bony overgrowth and a reduction in
the space between vertebras pinch the nerves causing irritation,
pain and numbness. The pinching can potentially result in a loss of
use of the limbs controlled by the affected nerve.
[0010] Thus, when intervertebral discs are damaged from accident,
age and/or general wear and tear the intervertebral nerve roots in
the neuroforamen are irritated and pinched and can cause unwanted
involuntary muscular contractions. The muscle contractions can come
in the form of a continuous low-grade ache or become more severe as
a spasm. The muscle contractions can act to further compress the
space between the vertebras, which further pinches the nerve. This
becomes a severely painful, self-destructive and self-feeding
problem.
[0011] One current technology to treat a patient with nerve
compression that causes pain and numbness involves the removal of
the disc and fusion of the vertebra below with the vertebra above
it. Vertebral fusion removes a disc that was flexible and fuses one
vertebra together with the adjacent vertebra resulting in a rigid
joint between two vertebrae. This causes added strain on the disc
above and below the now rigid bone fusion. Sometimes the attempted
fusion of one vertebra onto another vertebra is unsuccessful and
does not provide the intended fusion.
[0012] Disadvantageously, the intervertebral fusion is an invasive
and relatively complicated procedure. In addition, and undesirably,
the fusion process can result in a long hospital stay for the
patient, a long recuperation and rehabilitation period and high
costs for both the patient and care providers.
SUMMARY OF THE INVENTION
[0013] Embodiments of the invention overcome some or all of the
above disadvantages by providing systems and methods for tissue
cutting and removal including a reciprocating surgical file and a
direct vision apparatus. Some embodiments provide surgical
instrumentation that allows a surgeon to navigate into small
neuroforamina-next to delicate nerves under direct or indirect
vision, and locate and remove obstructions of tissue that can cause
nerve compression and irritation. Advantageously, this offers many
patients a minimally invasive surgical option that can result in
shorter hospital stays and lower cost.
[0014] In some embodiments, a surgical instrument comprises a
handle assembly and a distal assembly connected to the handle
assembly. The distal assembly comprises: a blade having a first
width, a lower blade structure having an upper face which has a
second width extending between a first lateral side and a second
lateral side, the blade being movably mounted to the lower blade
structure and slidably coupling with the lower blade structure,
wherein the first width is equal to or less than the second width.
In some embodiments, the first width is at least about 95% of the
second width. In some embodiments, the first width is at least
about 80% of the second width. In some embodiments, the blade
comprises an exposed cutting surface, the cutting surface
configured to perform at least one of grinding, filing, and cutting
of tissue. In some embodiments, the blade is axially movable along
the lower blade structure. In some embodiments, at least a portion
of the lower blade structure is tapered in the distal direction. In
some embodiments, the distal assembly forms an minimally traumatic
tip that is dimensioned so as to fit into a neuroforamen without
appreciable trauma to a nerve extending through the neuroforamen.
In some embodiments, the lower blade structure defines a shield on
one side of the distal assembly, and the blade is disposed on
another side of the distal assembly. In some embodiments, the blade
and the upper face are curved about a long axis of the lower blade
structure. In some embodiments, the lower blade structure defines a
fluid delivery channel, the blade is axially moveable between a
proximal position and a distal position. A window for expelling
fluid is at a distal end of the fluid delivery channel which is
defined between the blade and the lower blade structure when the
occupies a proximal position.
[0015] In some embodiments, the blade has a cutting zone comprising
a cutting surface. The cutting surface can be convex. In some
embodiments, the cutting zone comprises cutting elements configured
to remove tissue. In some variations, the cutting elements are
self-sharpening. The cutting elements can be spaced evenly or
unevenly along the cutting zone.
[0016] In some embodiments, a surgical instrument has a distal
assembly comprising a blade and a lower blade structure. The blade
can have a first blade edge and a second blade edge. The lower
blade structure comprises an upper face between a first structure
edge and a second structure edge. The blade is positioned upon the
upper face and is movable relative to a lower blade structure. The
first blade edge is proximate to the first structure edge and the
second blade edge is proximate to the second structure edge. In
some embodiments, the first blade edge and the second blade edge
are opposing, longitudinally extending lateral edges of the blade.
The first and second blade edges define a blade width. The first
structure edge and the second structure edge are opposing,
longitudinally extending lateral edges of the lower blade
structure. The first and second structure edges define a lower
blade structure width. The blade width is equal to or greater than
the lower blade width. A blade width is defined between the first
blade edge and the second blade edge, a lower blade structure width
is defined between the first structure edge and the second
structure edge. The blade width is substantially similar to the
lower blade structure width. The periphery of at least a portion of
the blade has a similar shape to a periphery of at least a portion
of the lower blade structure. In some embodiments, at least a
portion of a surface of the blade conforms to a periphery of at
least a portion of the lower blade structure. In some embodiments,
the lower blade structure has a shield surface opposing the upper
face, and the shield surface forms a tip that curves towards the
blade. The lower blade structure has a shield surface opposing the
upper face, and at least a portion of the shield surface is convex
towards the blade. In some embodiments, the lower blade structure
has a shield surface opposing the upper face, and at least a
portion of the shield surface is concave towards a nerve extending
through a neuroforamen, when the lower blade structure is
positioned at least partially in the neuroforamen. In some
embodiments, the lower blade structure has a shield surface
opposing the upper face, and at least a portion of the shield
surface is concave about a longitudinal axis of the lower blade
structure. In some embodiments, the lower blade structure has a
longitudinally extending fluid delivery channel disposed along the
lower blade structure and a plurality of channels in communication
with the delivery channel. In some embodiments, the blade further
comprises a plurality of throughholes, the blade is movable between
a proximal position and a distal position, at least one throughhole
is positioned near the first structure edge and at least one
throughhole is positioned near the second structure edge. In some
embodiments, the lower blade structure further comprises an
elongate delivery channel and a plurality of channels. The elongate
delivery channel extends along the lower blade structure. The
plurality of channels are in communication with the delivery
channel. At least one of the delivery channels is aligned with at
least one of the throughhole blade. In some embodiments, the distal
assembly forms a tip that is dimensioned so as to fit into a
neuroforamen without producing appreciable trauma to a nerve
extending through the neuroforamen.
[0017] In some embodiments, an instrument comprises a blade and a
lower blade structure. The blade has an upper filing surface. The
blade is slidably coupled with the lower blade structure. The blade
and the lower blade structure are each convexed away from the upper
filing surface. In some embodiments, the distal assembly further
comprises a tip. The tip is dimensioned so as to fit into a
neuroforamen without producing appreciable trauma to a nerve
extending through the neuroforamen. In some embodiments, the blade
has a first transverse width and the lower blade structure has a
second transverse width. The first transverse width is about the
same as the second transverse width. In some embodiments, the blade
has a first transverse width and the lower blade structure has a
second transverse width. The first transverse width is less than
the second transverse width. In some embodiments, the blade has a
first transverse width and the lower blade structure has a second
transverse width. The first transverse width is greater than the
second transverse width. In some embodiments, the blade has a first
transverse width and the lower blade structure has a second
transverse width. The first transverse width is less than about 95%
of the second transverse width.
[0018] In some embodiments, the blade has a cutting zone having a
transverse width that is generally similar to a transverse width of
the blade. In some embodiments, the cutting zone has a transverse
width that is generally similar to a transverse width of a lower
blade structure. In some embodiments, the cutting zone comprises
one or more of the following: cutting teeth, filing elements,
sharpened edges, and the like. In some embodiments, the cutting
zone has a generally rectangular shape. In some embodiments, the
cutting zone is an array of cutting elements positioned evenly or
unevenly through the cutting zone. In some embodiments, the cutting
zone is an array of cutting elements forming throughholes. The
cutting elements can be positioned evenly or unevenly through the
cutting zone.
[0019] In some embodiments, an instrument has a distal assembly for
removing tissue. The distal assembly forms an atraumatic tip that
is dimensioned so as to fit into a neuroforamen without appreciable
trauma to the nerve extending through the neuroforamen. In some
variations, the distal assembly has a movable blade configured to
remove tissue.
[0020] In some embodiments, a surgical instrument comprises a
filing surface configured to cut, grind, and/or file tissue. A
shield surface is coupled to the filing surface. The instrument is
configured to be positioned at least partially in a neuroforamen
having a nerve extending therethrough. At least a portion of the
shield surface is concave towards the nerve when the instrument is
positioned at least partially in the neuroforamen. In some
variations, the neuroforamen is a vertebral foramen.
[0021] In some embodiments, a surgical instrument comprises a
filing surface configured to cut, grind, and/or file tissue. A
shield surface is coupled to the filing surface. At least a portion
of the shield surface is convex towards the filing surface. In some
variations, the instrument is configured to be positioned at least
partially in a mammalian neuroforamen having a nerve extending
therethrough.
[0022] In some embodiments, a surgical instrument comprises means
for grinding a first tissue, means for shielding a second tissue
from the means for grinding when the second tissue is in proximity
to the first tissue, and at least part of the means for shielding
is convex towards the means for grinding.
[0023] In some embodiments, an instrument has a distal assembly
that forms an atraumatic tip. The atraumatic tip is dimensioned so
as to fit into a vertebral foramen, having nerve extending through
the vertebral foremen, without appreciable trauma to the nerve. The
distal tip can have an actuatable member for cutting, filing,
and/or grinding tissue. The tissue can be bone tissue.
[0024] In some embodiments, a method of treating a patient is
provided. The method comprises placing a distal assembly of an
instrument at least partially in a neuroforamen having a nerve
extending therethrough. At least a portion of the distal assembly
is concave towards the nerve. Tissue is removed from the patient by
operating the distal assembly. In some variations, the removing of
tissue comprises at least one of cutting, filing, and grinding. In
some embodiments, the removing of tissue comprises at least one of
cutting, filing, and grinding. In some embodiments, the method
further comprises oscillating a blade of the distal assembly to
remove the tissue. In some embodiments, the method further
comprises coupling a powered handpiece to the distal assembly of
the instrument, and the powered handpiece has a drive system for
driving a movable blade of the distal assembly. In some
embodiments, the powered handpiece is a rotary handpiece and the
instrument further comprises a mechanical transmission that
converts rotary motion of the powered handpiece to reciprocating,
linear motion. In some embodiments, the method further comprises
positioning an access device in a patient's body, and advancing the
distal assembly through the access device until the distal assembly
reaches a target location for tissue removal. In some embodiments,
the tissue is removed by reciprocating a blade while at least a
portion of the distal assembly remains in the neuroforamen.
[0025] In some embodiments, method of treating a patient comprises:
placing a distal assembly of an instrument at least partially into
a neuroforamen between target tissue and a nerve; removing the
target tissue from surrounding tissue with the distal assembly;
after removing the target tissue, drawing the target tissue into
the distal assembly; and moving the target tissue through the
distal assembly. In some embodiments, the drawing the target tissue
into the distal assembly comprises drawing the target tissue
through an inlet port of the distal assembly and through a lumen
extending from the inlet port through the distal assembly. In some
embodiments, the method further comprises: delivering irrigation
fluid out of the distal assembly as the distal assembly removes the
target tissue such that the irrigation fluid is mixed with the
target tissue; and drawing the mixture of target tissue and
irrigation fluid into and through the distal assembly. In some
embodiments, the distal assembly is substantially L-shaped and has
a cutting blade for removing tissue.
[0026] In some embodiments, a surgical instrument comprises a
housing that contains a drive system. A distal assembly has a
distal tip configured to perform at least one of grinding tissue,
filing tissue, and cutting tissue. The distal assembly extends from
the housing and engages the drive system of the housing. A lumen
extends through the housing and the distal assembly. The lumen is
configured to receive at least a portion of an endoscope such that
an optical element of the endoscope is positioned to provide
endoscopic viewing of the distal tip. In some embodiments, the
instrument is further configured to permit releasable engagement of
the endoscope to the housing. In some embodiments, the distal tip
is curved and comprises a blade and a lower blade structure. The
blade is slidably disposed on the lower blade structure. In some
embodiments, the distal assembly has a longitudinal axis, wherein
the endoscope provides viewing of the distal tip when the distal
tip is offset from the longitudinal axis.
[0027] In some embodiments, a surgical instrument comprises a body
assembly that has a distal tip configured to remove bone from a
mammal. The body assembly is configured to hold releasably an
endoscope such that the endoscope is positioned to provide viewing
of the distal tip when the distal tip removes bone. In some
embodiments, the surgical instrument further comprises a passageway
extending through the body assembly, wherein the passageway is
sized to receive the endoscope. In some embodiments, the distal
assembly has a curved distal tip that comprises a movable blade
coupled to a lower blade structure. In some embodiments, the body
assembly has a longitudinal axis, wherein the endoscope provides
viewing of the distal tip when the distal tip is offset from the
longitudinal axis. In some embodiments, the surgical instrument
further comprises the endoscope.
[0028] In some embodiments, a method of assembling an instrument is
provided. The method comprises placing a distal end of a
visualization instrument into a body assembly. The body assembly
has an outwardly extending distal assembly which is configured to
remove bone from a mammal. The distal end of the visualization
instrument is advanced through a lumen extending through the distal
assembly. The distal end of the visualization instrument is
positioned so that the visualization instrument is capable of
providing viewing of at least a portion of the distal assembly. In
some embodiments, the method further comprises locking the
visualization instrument to the body assembly. In some embodiments,
the body assembly has a longitudinal axis. The visualization
instrument is configured to provide viewing of a distal tip of the
distal assembly when the distal tip is offset from the longitudinal
axis. In some embodiments, the distal assembly is configured to
perform at least one of grinding tissue, filing tissue, cutting
tissue, when driven by a drive system of the housing. In some
embodiments, the method further comprising removing the
visualization instrument out of the lumen after performing a
surgical procedure. In some embodiments, the visualization
instrument is an endoscope.
[0029] In some embodiments, a surgical distal module comprises a
distal body configured to attach to a handle assembly. The surgical
distal module further comprises a blade coupled to the distal body.
The blade is configured to be slidably moved in a reciprocating
linear way by rotary motion emanating from the handle assembly. The
module is further configured to remove bone from a mammal. In some
variations, the module further comprises a protrusion extending
from the distal body. The protrusion is configured to be gripped by
a clinician while the blade removes the bone. The protrusion can be
dimensioned so as to be gripped between a thumb and a finger of a
user. In some embodiments, the module further comprising a
protrusion extending from the distal body, wherein the protrusion
is configured to be gripped by a clinician while the blade removes
the bone. In some embodiments, the protrusion is dimensioned so as
to be gripped between a thumb and a finger of a user. In some
embodiments, further comprising a transmission that converts the
rotary motion to linear reciprocating motion. The transmission can
be a toroidal drive system. In some embodiments, the blade and the
protrusion are on substantially opposite sides of the distal tip
body. In some embodiments, the module comprises a coupling assembly
at a proximal end of the distal body. The coupling assembly is
configured to releasably couple to the handle assembly. In some
embodiments, the blade has a convex surface. In some embodiments,
the convex surface is configured to perform at least one of
grinding, cutting, or filing the bone. In some embodiments, the
blade has a concave surface configured to perform at least one of
grinding, filing, and cutting the bone.
[0030] In some embodiments, a blade for removing tissue comprises
an elongated blade body having an upper surface and an opposing
lower surface. A plurality of raised cutting elements extends from
the upper surface, each of the cutting elements defining a cutting
edge for removing tissue. The cutting edge is substantially
parallel to at least one of the upper surface and lower surface. In
some embodiments, the cutting elements are adapted to remove bone
by at least one of grinding, cutting, and filing. In some
embodiments, the raised cutting elements each have a throughhole
extending through the elongated blade body. In some embodiments,
the elongated blade body has an arcuate transverse axis. In some
embodiments, the cutting edge is substantially flat. In some
embodiments, the cutting edge is substantially parallel to the
transverse axis. In some embodiments, the cutting edge is arcuate.
In some embodiments, the raised cutting elements each have a
substantially frusto-conical shape. In some embodiments, the raised
cutting elements are substantially self-sharpening. In some
embodiments, the blade is movably coupled to a lower blade
structure of a surgical instrument. In some embodiments, the blade
is dimensioned so as to fit at least partially within a
neuroforamen.
[0031] In some embodiments, a blade for removing tissue comprises a
blade body having an upper face and a lower face. The upper face
and the lower face extend between a first edge and a second edge. A
plurality of raised elements for removing tissue is provided. The
raised elements extend from the upper face. Each of the raised
elements has a cutting edge that is substantially concentric to an
arcuate transverse axis of the blade body. In some embodiments, the
blade body is dimensioned so as to fit at least partially within a
neuroforamen. In some embodiments, the raised elements form an
array of cutting elements that effectively remove tissue when the
blade is actuated. In some embodiments, the raised elements each
have a throughhole extending through the blade body. In some
embodiments, the cutting edge is substantially flat. In some
embodiments, the raised elements are substantially frusto-conical
in shape. In some embodiments, the cutting edge is defined at a
junction of an outer surface and an inner surface of the cutting
element. In some embodiments, the raised elements are substantially
self-sharpening.
[0032] In some embodiments, a blade for removing tissue comprises a
blade body that has an upper face and a lower face. The upper face
and the lower face extend between a first edge and a second edge. A
plurality of cutting elements for removing tissue extend from the
upper face. Each of the raised elements has a cutting edge that is
substantially concentric to an curved transverse axis of the blade
body.
[0033] In some embodiments, a surgical instrument comprises a blade
for removing tissue. The blade has a plurality of throughholes. A
lower blade structure couples to the blade. The lower blade
structure comprises a fluid delivery channel that extends
substantially along a long axis of the lower blade structure. At
least a portion of the fluid delivery channel is aligned with at
least one of the throughholes in the blade so as to permit flow
through the at least one of the throughholes. The blade is
configured to move along the long axis with respect to the lower
blade structure. In some embodiments, the instrument is configured
to produce pulsatile flow of fluid when the blade is moved
reciprocally along the long axis. In some embodiments, the
instrument is configured to produce a substantially pulsatile flow
of fluid when the blade is moved reciprocally along the long axis,
and while the fluid is supplied to the fluid delivery channel at a
substantially constant pressure. In some embodiments, at least one
of the throughholes is adjacent to the fluid delivery channel such
that fluid can flow substantially continuously through the at least
one of the throughholes. In some embodiments, at least one of the
throughholes is aligned with the fluid delivery channel to permit
fluid through the at least one of the throughholes when the blade
is in a first position with respect to the lower blade structure,
and wherein the at least one of the throughholes is not aligned
with the fluid delivery channel when the blade is in a second
position with respect to the lower blade structure. In some
embodiments, the fluid delivery channel comprises a elongate
portion extending along the long axis and a plurality of side
channels extending from the elongate portion. In some embodiments,
the instrument is configured to permit fluid flow from at least one
side channel through at least one of the throughholes when the at
least one throughhole is aligned with the at least one side
channel. In some embodiments, the instrument is configured to
substantially obstruct fluid flow from the at least one side
channel through the at least one of the throughholes when the at
least of the one throughholes is not aligned with the at least one
side channel. In some embodiments, the blade is configured to move
reciprocally such that the at least one of the throughholes and at
least one of the side channels are alternatingly aligned and not
aligned.
[0034] In some embodiments, a surgical instrument comprises means
for removing tissue from a mammal and means for delivering fluid
through the means of removing tissue. Movement of the means for
removing tissue produces substantially pulsatile flow.
[0035] In some embodiments, a surgical instrument comprises a blade
configured to remove tissue from a patient. A lower blade structure
couples with the blade. Reciprocating motion of the blade with
respect to the lower blade structure generates substantially
pulsatile flow of fluid through the blade when the fluid is
supplied to the lower blade structure at a substantially constant
pressure.
[0036] In some embodiments, the tissue is bone. In some
embodiments, the lower blade structure comprises a fluid delivery
channel configured to permit fluid flow therethrough. In some
embodiments, the blade comprises at least one throughhole that is
adjacent to the fluid delivery channel such that fluid can flow
substantially continuously through the at least one throughhole. In
some embodiments, the blade comprises at least one throughhole that
is aligned with the fluid delivery channel to permit fluid through
the at least one throughhole when the blade is in a first position
with respect to the lower blade structure, and wherein the at least
one throughhole is not aligned with the fluid delivery channel when
the blade is in a second position with respect to the lower blade
structure. In some embodiments, the fluid delivery channel
comprises an elongate portion extending along a long axis of the
lower blade structure and a plurality of side channels extending
from the elongate portion. In some embodiments, the blade comprises
at least one throughhole, wherein the instrument is configured to
obstruct substantially fluid flow from the at least one of the
plurality of side channels through the at least one throughhole
when the at least one throughhole is not aligned with the at least
one of the plurality of side channels. In some embodiments, the
blade is configured to move reciprocally such that the at least one
throughhole and at least one of the plurality of side channels are
alternatingly aligned and not aligned.
[0037] Kits can be provided that include at least one of the
components, devices, or assemblies disclosed herein. The kits can
include instructions for using the components, devices, or
assemblies in a procedure. The instructions can be recorded on a
suitable recording medium. For example, the instructions may be
printed on a substrate, such as paper, plastic, packaging, etc. As
such, the instructions may be present in the kits as a package
insert, in the labeling of the container of the kit or components
thereof (e.g., packaging, sub-packaging, etc.). In other
embodiments, the instructions are present as an electronic storage
data file present on a suitable computer readable storage medium.
The instructions may take any form, including complete instructions
for how to use, assemble, or perform other methods described
herein.
[0038] Embodiments of the invention can desirably be adapted and
tailored to serve at least three surgical fields. These include,
but are not limited to, neurosurgery, orthopaedic surgery and
plastic surgery. The neurosurgical embodiments enable surgeons to
safely enlarge the constricted neuroforamen and provide more space
for the nerve roots to pass through the rigid bony vertebral
structure, thereby relieving the nerve pinching and
compression.
[0039] The orthopaedic embodiments provide improved bone and/or
tissue removal instrumentation and methodology, for example, for
orthopaedic surgical procedures such as knee surgery. The plastic
surgery embodiments provide improved bone and/or tissue sculpturing
instrumentation and methodology, for example, for cosmetic surgical
procedures such as nose reshaping or rhinoplasty.
[0040] Some embodiments include a surgical instrument comprising a
blade; a housing in which the blade moves, the housing having a
long axis; a transmission that converts rotary motion to
reciprocating, linear motion, wherein the transmission is coupled
to the blade such that the blade moves reciprocally in the housing;
a first opening in the housing through which a portion of the blade
is exposed; and a cutting surface on the exposed portion of the
blade, the surface configured to perform at least one of grinding,
filing, and cutting of tissue.
[0041] In some embodiments the housing is concave about at least a
portion of its long axis, such as at least a distal portion of its
long axis. In some embodiments, the housing is convex about at
least a portion of its long axis, such as at least a distal portion
of its long axis. In some embodiments, the first opening is in an
opening surface on the housing. In some embodiments, the housing is
curved along its long axis, to assist in placing the surgical
instrument in the body of a patient. In some embodiments the blade
is substantially flat.
[0042] In some embodiments, the housing is curved along its long
axis in a direction toward the opening surface. Some embodiments
further comprise at least one bearing retainer for reducing
friction. In some embodiments the at least one bearing retainer has
at least one slot configured to transmit fluid toward a distal end
of the instrument. Some embodiments further comprise at least one
fiberoptic in or on the housing, for transmission of at least one
of a video signal and illumination light. In some embodiments the
housing has at least a second opening at a distal end of the
housing.
[0043] Some embodiments further comprise at least two lenses
coupled to the at least one fiberoptic. In some embodiments, at
least one of the at least two lenses is disposed at a distal end of
the housing, and another of the at least two lenses is disposed in
proximity to the first opening in the housing. Some embodiments
further comprise a pump for pumping fluid through the surgical
instrument. In some embodiments the pump is mechanically coupled to
the transmission. In some embodiments, the transmission comprises:
two surfaces that are a substantially fixed distance apart; a cam
that rotates about a central axis, the central axis being at an
angle to a plane extending between the two surfaces; and the cam
having a curvilinear body, the body having a nonuniform thickness,
wherein the body continuously contacts the two surfaces as the cam
rotates about the central axis, such that the two surfaces remain
at the substantially fixed distance apart as they move linearly in
response to the cam's rotation about the central axis.
[0044] In some embodiments, the cam's central axis is substantially
parallel to a direction of the linear motion of the two surfaces.
In some embodiments, the central axis is substantially
perpendicular to the plane extending between the two surfaces. In
some embodiments the two surfaces move linearly back and forth in
reciprocating motion in response to the cam's rotation about the
central axis. In some embodiments the curvilinear body has a shape
comprising at least two toruses, the at least two toruses being
partially superimposed, and each of the at least two toruses has a
central axis, wherein the central axes of the at least two toruses
are at an angle to each other. In some embodiments at least one
bearing comprises the two surfaces. In some embodiments two
bearings respectively comprise the two surfaces.
[0045] In some embodiments the curvilinear body is disposed at an
angle to the central axis of the cam. Some embodiments include an
apparatus for translating a rotary motion to a linear motion, the
apparatus comprising: two surfaces that are a substantially fixed
distance apart; and a cam that rotates about a central axis, the
central axis being at an angle to a plane extending between the two
surfaces; the cam having a curvilinear body, the body having a
nonuniform thickness, wherein the body continuously contacts the
two surfaces as the cam rotates about the central axis, such that
the two surfaces remain at the substantially fixed distance apart
as they move linearly in response to the cam's rotation about the
central axis.
[0046] In some embodiments, the cam's central axis is substantially
parallel to a direction of the linear motion of the two surfaces.
In some embodiments the central axis is substantially perpendicular
to the plane extending between the two surfaces. In some
embodiments the two surfaces move linearly back and forth in
reciprocating motion in response to the cam's rotation about the
central axis. In some embodiments the curvilinear body has a shape
comprising at least two toruses, the at least two toruses being
partially superimposed, and each of the at least two toruses has a
central axis, wherein the central axes of the at least two toruses
are at an angle to each other.
[0047] In some embodiments at least one bearing comprises the two
surfaces. In some embodiments two bearings respectively comprise
the two surfaces. In some embodiments the curvilinear body is
disposed at an angle to the central axis of the cam. In some
embodiments a pump comprises: a fluid path; two plungers configured
to at least partially occlude the fluid path; a cam configured to
cause the two plungers to at least partially occlude the fluid path
alternatingly; and at least one check valve along the fluid path
for reducing backflow of fluid within the fluid path.
[0048] In some embodiments the cam translates in a direction that
is substantially perpendicular to a long axis of at least one of
the two plungers. In some embodiments the cam translates in a
direction that is substantially perpendicular to a long axis of
each of the two plungers. In some embodiments, the pump comprises:
a fluid path; two plungers configured to at least partially occlude
the fluid path; a cam configured to cause the two plungers to at
least partially occlude the fluid path alternatingly; and at least
one check valve along the fluid path for reducing backflow of fluid
within the fluid path.
[0049] In some embodiments the cam translates in a direction that
is substantially perpendicular to a long axis of at least one of
the two plungers. In some embodiments the cam translates in a
direction that is substantially perpendicular to a long axis of
each of the two plungers. Some embodiments of the instrument
further comprise at least one opening in the exposed portion of the
blade, for transmitting fluid. In some embodiments the cutting
surface comprises an abrasive material. In some embodiments the
cutting surfaces comprises diamond. In some embodiments the blade
comprises stainless steel.
[0050] In some embodiments, a blade may have one or more
throughholes. As used herein, the term "throughholes" has a broad
meaning that includes, but is not limited to, any channel or
passageway that permits fluid flow from one side of structure to
another.
[0051] Some embodiments further comprise a handpiece coupled to the
housing. Some embodiments further comprise a video camera. In some
embodiments the camera is configured to couple with a fiberoptic
that extends to a distal end of the housing. In some embodiments a
video camera is located in the handpiece. Some embodiments further
comprise a watertight seal in the handpiece. In some embodiments
the handpiece is configured to contain the video camera in a
chamber such that the watertight seal reduces or prevents ingress
of at least one of water and bacteria from outside the handpiece
into the chamber containing the video camera in the handpiece.
[0052] Some embodiments further comprise a motor in the handpiece,
the motor configured to power the rotary motion. In some
embodiments the motor comprises a gas turbine. Some embodiments
further comprise a cord configured to couple to a proximal end of
the surgical instrument, the cord comprising at least one of a
fiberoptic, an electrical line, an irrigation channel, a suction
line, and a gas tube for powering a gas turbine motor in the
surgical instrument.
[0053] For purposes of summarizing the invention, certain aspects,
advantages and novel features of the invention have been described
herein above. Of course, it is to be understood that not
necessarily all such advantages may be achieved in accordance with
any particular embodiment of the invention. Thus, the invention may
be embodied or carried out in a manner that achieves or optimizes
one advantage or group of advantages as taught or suggested herein
without necessarily achieving other advantages as may be taught or
suggested herein.
[0054] All of these embodiments are intended to be within the scope
of the invention herein disclosed. These and other embodiments of
the invention will become readily apparent to those skilled in the
art from the following detailed description of the preferred
embodiments having reference to the attached figures, the invention
not being limited to any particular preferred embodiment(s)
disclosed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0055] Having thus summarized the general nature of the invention
and some of its features and advantages, certain preferred
embodiments and modifications thereof will become apparent to those
skilled in the art from the detailed description herein having
reference to the figures that follow, of which:
[0056] FIG. 1 is a schematic view of a surgical file system
illustrating features and advantages in accordance with an
embodiment of the invention.
[0057] FIG. 2 is a perspective view of the surgical file system of
FIG. 1.
[0058] FIG. 3 is a perspective view of a surgical file device with
a curved distal tip configuration illustrating features and
advantages in accordance with an embodiment of the invention.
[0059] FIG. 4 is a perspective view of a surgical file device with
a straight distal tip configuration illustrating features and
advantages in accordance with another embodiment of the
invention.
[0060] FIG. 5 is a side view of a surgical file device illustrating
features and advantages in accordance with an embodiment of the
invention.
[0061] FIG. 6 is a partially exploded view of the surgical file
device of FIG. 5.
[0062] FIG. 7 is a perspective view of the surgical file device of
FIG. 5 with the distal cover removed illustrating features and
advantages in accordance with an embodiment of the invention.
[0063] FIG. 8 is a perspective view of a distal tip assembly of the
surgical file device of FIG. 5.
[0064] FIG. 9 is a simplified exploded perspective view of the
distal tip assembly of FIG. 8 illustrating features and advantages
in accordance with an embodiment of the invention.
[0065] FIG. 10 is a sectional view along line 10-10 of FIG. 5
illustrating features and advantages in accordance with an
embodiment of the invention.
[0066] FIG. 11 is a sectional view along line 11-11 of FIG. 5
illustrating features and advantages in accordance with an
embodiment of the invention.
[0067] FIG. 12 is a simplified perspective view of a surgical
cutting blade illustrating features and advantages in accordance
with an embodiment of the invention.
[0068] FIG. 13 is a simplified schematic cross-section view of a
convex surgical file cutting surface illustrating features and
advantages in accordance with an embodiment of the invention.
[0069] FIG. 14 is a schematic cross-section view of a concave
surgical file cutting surface illustrating features and advantages
in accordance with another embodiment of the invention.
[0070] FIG. 15 is a schematic side view sectional view of surgical
file distal tip with a top cutting surface illustrating features
and advantages in accordance with an embodiment of the
invention.
[0071] FIG. 16 is a schematic side sectional view of a surgical
file distal tip with a top cutting surface illustrating features
and advantages in accordance with another embodiment of the
invention.
[0072] FIG. 17 is a perspective view of a surgical file cutting
surface with abrasives illustrating features and advantages in
accordance with an embodiment of the invention.
[0073] FIG. 18 is a perspective view of a surgical file cutting
surface with irrigation fluid openings illustrating features and
advantages in accordance with an embodiment of the invention.
[0074] FIG. 19 is a schematic view of a surgical file cutting blade
with irrigation fluid flow therethrough illustrating features and
advantages in accordance with an embodiment of the invention.
[0075] FIG. 20 is a cross-section view of a surgical file distal
cutting tip with irrigation fluid passageways illustrating features
and advantages in accordance with an embodiment of the
invention.
[0076] FIG. 21 is a side sectional view of a surgical file distal
cutting tip with a linear reciprocation stroke illustrating
features and advantages in accordance with an embodiment of the
invention.
[0077] FIG. 22 is a side sectional view of a surgical file distal
cutting tip with fiber optic probes illustrating features and
advantages in accordance with an embodiment of the invention.
[0078] FIG. 23 is a sectional view along line 23-23 of FIG. 22
illustrating features and advantages in accordance with an
embodiment of the invention.
[0079] FIG. 24 is a simplified side sectional view of a surgical
file distal cutting tip with an illumination and vision system
illustrating features and advantages in accordance with an
embodiment of the invention.
[0080] FIG. 25 is a schematic view of an arrangement of lenses of a
surgical file illumination and vision system illustrating features
and advantages in accordance with an embodiment of the
invention.
[0081] FIG. 26 is a schematic view of display images provided by a
surgical file illumination and vision system illustrating features
and advantages in accordance with an embodiment of the
invention.
[0082] FIG. 27 is a simplified perspective view of a dual torus and
drive shaft illustrating features and advantages in accordance with
an embodiment of the invention.
[0083] FIG. 28 is a simplified side view of the dual torus and
drive shaft of FIG. 27.
[0084] FIG. 29 is a simplified schematic view of a dual torus
partial superposition illustrating features and advantages in
accordance with an embodiment of the invention.
[0085] FIG. 30 is a schematic graphical representation of variation
in outer rim thickness of a dual torus or toroid illustrating
features and advantages in accordance with an embodiment of the
invention.
[0086] FIG. 31A is a sectional view along line 31-31 of FIG. 28
illustrating features and advantages in accordance with an
embodiment of the invention.
[0087] FIG. 31B is a sectional view along line 31-31 of FIG. 28
illustrating features and advantages in accordance with another
embodiment of the invention.
[0088] FIG. 31C is a sectional view along line 31-31 of FIG. 28
illustrating features and advantages in accordance with yet another
embodiment of the invention.
[0089] FIG. 32 is a perspective view of a distal cutting blade and
a reciprocating slide plate that connects to the blade illustrating
features and advantages in accordance with an embodiment of the
invention.
[0090] FIG. 33 is a schematic side view of a distal cutting blade
connected to a slide blade illustrating features and advantages in
accordance with an embodiment of the invention.
[0091] FIG. 34 is a schematic view of toroid drive and associated
bearings illustrating features and advantages in accordance with an
embodiment of the invention.
[0092] FIG. 35 is a schematic view of toroid drive and associated
bearings illustrating features and advantages in accordance with
another embodiment of the invention.
[0093] FIG. 36 is a perspective view of a surgical file
transmission system in a test set-up illustrating features and
advantages in accordance with an embodiment of the invention.
[0094] FIG. 37 is a side cross-sectional view of a surgical file
pulsatile pump system illustrating features and advantages in
accordance with an embodiment of the invention.
[0095] FIG. 38 is a side cross-sectional view of a surgical file
pulsatile pump system illustrating features and advantages in
accordance with another embodiment of the invention.
[0096] FIG. 39 is an exploded perspective view of a surgical file
powered handpiece illustrating features and advantages in
accordance with another embodiment of the invention.
[0097] FIG. 40A is a sectional view along line 40-40 of FIG. 39
illustrating features and advantages in accordance with an
embodiment of the invention.
[0098] FIG. 40B is a sectional view along line 40-40 of FIG. 39
illustrating features and advantages in accordance with another
embodiment of the invention.
[0099] FIG. 40C is a sectional view along line 40-40 of FIG. 39
illustrating features and advantages in accordance with yet another
embodiment of the invention.
[0100] FIG. 41 is a schematic view of a bone and/or tissue removal
procedure illustrating features and advantages in accordance with
an embodiment of the invention.
[0101] FIG. 42 is a simplified perspective view of a bone and/or
tissue removal procedure on a plastic anatomical model of the human
spine illustrating features and advantages in accordance with an
embodiment of the invention.
[0102] FIG. 43 simplified side view of an orthopaedic surgical file
instrument illustrating features and advantages in accordance with
an embodiment of the invention.
[0103] FIG. 44 is a simplified front view of a distal cutting
assembly of the surgical file instrument of FIG. 43.
[0104] FIG. 45 is a simplified bottom view of the distal cutting
assembly of FIG. 44.
[0105] FIG. 46 is a perspective view of a surgical instrument in
accordance with another embodiment.
[0106] FIG. 47 is an exploded view of the surgical instrument of
FIG. 46.
[0107] FIG. 48 is a perspective view of the surgical instrument of
FIG. 46 being assembled.
[0108] FIG. 49 is a partial cross-sectional view of the surgical
instrument of FIG. 46. A portion of the surgical instrument is
positioned through an access device.
[0109] FIG. 50 is a cross-sectional side view of a body assembly of
the surgical instrument of FIG. 49.
[0110] FIG. 50A is an enlarged cross-sectional side view of the
surgical instrument of FIG. 49 taken along 50A-50A.
[0111] FIG. 51 is a cross-sectional side view of a distal end of
the surgical instrument of FIG. 49 performing a procedure.
[0112] FIG. 52 is a perspective view of the distal end of the
surgical instrument of FIG. 51.
[0113] FIG. 53 is a longitudinal cross-sectional view of the distal
end of the surgical instrument of FIG. 51.
[0114] FIG. 54 is a simplified side view of a bone and/or tissue
removal procedure on a human spine.
[0115] FIG. 55 is a side view of a bone and/or tissue removal
procedure on a human spine in accordance with another
embodiment.
[0116] FIG. 56 is a partial cross-sectional view of a surgical
instrument having a drive system in accordance with another
embodiment.
[0117] FIG. 57 is a front view of a slide plate connector of a
drive member of the drive system of FIG. 56.
[0118] FIG. 58 is a side view of the slide plate connector of FIG.
57.
[0119] FIG. 59 is a front view of a slide plate of the drive system
of FIG. 56.
[0120] FIG. 60 is a perspective view of a surgical instrument in
accordance with another embodiment. The surgical instrument has a
removable distal tip assembly attached to a handle assembly.
[0121] FIG. 61A is a cross-sectional view of a distal tip assembly
that is attached to a handle assembly.
[0122] FIG. 61B is a cross-sectional view of the distal tip
assembly of FIG. 61A having a blade assembly removed.
[0123] FIG. 62 is a cross-sectional view of a distal tip assembly
in accordance with another embodiment.
[0124] FIG. 63 is a perspective cross-sectional view of the distal
tip assembly of FIG. 62.
[0125] FIG. 63A is a perspective cross-sectional view of the distal
tip assembly of FIG. 62 outputting a fluid.
[0126] FIG. 64 is another perspective cross-sectional view of the
distal tip assembly of FIG. 62.
[0127] FIG. 65 is a perspective view of a distal tip assembly in
accordance with another embodiment.
[0128] FIG. 66 is another perspective view of the distal tip
assembly of FIG. 65.
[0129] FIG. 67 is a side view of the distal tip assembly of FIG.
65.
[0130] FIG. 68 is a perspective view of a distal tip assembly in
accordance with another embodiment.
[0131] FIG. 69 is a perspective view of a surgical instrument in
accordance with another embodiment.
[0132] FIG. 70 is an elevation view of the surgical instrument of
FIG. 69.
[0133] FIG. 71 is an enlarged top view of the surgical instrument
of FIG. 70 taken along 71-71.
[0134] FIG. 72A is a cross-sectional view of the surgical
instrument of FIG. 71 taken along the line 72A-72A.
[0135] FIG. 72B is a cross-sectional view of the surgical
instrument of FIG. 71 taken along the line 72B-72B.
[0136] FIG. 73 is a perspective view of the surgical instrument of
FIG. 69. A blade of the instrument has been removed.
[0137] FIG. 74 is a perspective view of a distal end of the
surgical instrument of FIG. 73.
[0138] FIG. 75 is a perspective view of a blade assembly of the
surgical instrument of FIG. 69.
[0139] FIG. 76 is a longitudinal cross-sectional view of the blade
assembly of FIG. 75.
[0140] FIG. 77 is a longitudinal cross-sectional view of the distal
end of the surgical instrument of FIG. 69.
[0141] FIG. 78 is a perspective view of the distal end of the
surgical instrument of FIG. 69 having a blade in a distal
position.
[0142] FIG. 79 is a perspective view of the distal end of the
surgical instrument of FIG. 69 having the blade in a proximal
position.
[0143] FIG. 80 is a perspective view of internal components of the
surgical instrument of FIG. 69.
[0144] FIG. 81 is a longitudinal cross-sectional view of a portion
of the surgical instrument of FIG. 69.
[0145] FIG. 82 is a longitudinal cross-sectional view of a portion
of the surgical instrument of FIG. 69, wherein components have been
removed.
[0146] FIG. 83 is a longitudinal cross-sectional view of a portion
of the surgical instrument of FIG. 69 delivering out a fluid.
[0147] FIG. 84 is another perspective view of the surgical
instrument of FIG. 69.
[0148] FIG. 85 is perspective view of a power device attached to
the surgical instrument of FIG. 84.
[0149] FIG. 86 is a perspective view of the assembled instrument of
FIG. 85 held in a clinician's hand.
[0150] FIG. 87 is a perspective view of a blade for a surgical
instrument.
[0151] FIG. 88 is a cross-sectional view of the blade of FIG. 87
taken along the line 88-88.
[0152] FIG. 89 is a cross-sectional view of a distal tip assembly
of a surgical file instrument, the distal tip assembly is
positioned between vertebral bone and a nerve.
[0153] FIG. 90 is a perspective view of another embodiment of a
surgical instrument.
[0154] FIG. 91 is a perspective view of a distal tip of the
surgical instrument of FIG. 90 taken along 91-91.
[0155] FIG. 92 is a side elevational view of the surgical
instrument of FIG.. 90.
[0156] FIG. 93 is an enlarged side view of a distal tip of the
surgical instrument of FIG. 92 taken along 93-93.
[0157] FIG. 94 is a longitudinal cross-sectional view of the distal
tip of the surgical instrument of FIG. 90.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0158] The preferred embodiments of the invention described herein
relate generally to systems and methods for tissue cutting and
removal and, in particular, to a reciprocating surgical file system
for cutting, removing, shaping and sculpturing bone and/or tissue
material under direct vision.
[0159] While the description sets forth various embodiment specific
details, it will be appreciated that the description is
illustrative only and should not be construed in any way as
limiting the invention. Furthermore, various applications of the
invention, and modifications thereto, which may occur to those who
are skilled in the art, are also encompassed by the general
concepts described herein.
[0160] FIGS. 1 and 2 show a surgical file system 10 generally
comprising a motorized reciprocating surgical file instrument,
apparatus, assembly or device 12 and a mobile portable control
system 14 connected via a flexible umbilical cable 16. The surgical
file device 12 generally comprises a distal tip assembly 18 and a
powered handpiece 20. Reciprocating as used herein generally
includes back and forth motion and to and from motion.
[0161] The system 14 generally comprises a mobile portable stand,
cabinet or trolley 22 that supports a controller or control unit or
box 24 and a computer system 26. In on embodiment, the system 14
has a footprint of about 0.2 m.sup.2 (2 square feet (ft.sup.2)) and
a height of about 1.8 m (6 feet (ft)). In modified embodiments,
other suitable dimensions may be efficaciously used, as needed or
desired. The system 14 may also utilize wireless communication.
[0162] The cabinet 22 has a plurality of drawers or compartments 28
to store system parts, including spare parts, such as cables,
connection lines, powered hand piece 20 and an array of various
disposable distal cutting tip assemblies, for example, for
neurosurgery, orthopaedic surgery and plastic surgery. The storage
drawers 28 also serve to store instructions.
[0163] The cabinet 22 has a plurality of wheels 30 such as caster
wheels to enable movement of the system 14. In the illustrated
embodiment, the cabinet 22 has four wheels 30. The caster wheels 30
have wheel locks or other suitable fastening mechanisms to enable
stationarily locking the unit at the desired position in the
operating room or other area.
[0164] The computer system 26 comprises a central processing unit
(CPU) 32, a monitor 34, a keyboard 36 including a mouse and a color
printer to produce color pictures. The CPU 32 may be supported on
(see, for example, FIG. 1) or within (see, for example, FIG. 2) the
movable cabinet 22. The CPU 32 includes a video processing system,
such as but not limited to a data acquisition board and the like,
to process video signals from the surgical file device 12 and
supply the signals to the monitor or video display 34. The CPU 32
has a printer port to interface it with the color printer.
[0165] The display monitor 34 can comprise any one of a number of
suitable commercially available monitors. In one embodiment, the
display 34 is a 17-inch (43 cm) liquid crystal display (LCD)
monitor.
[0166] The storage cabinet 22 includes a substantially vertical
pole or rod 38 to support the monitor 34. The height and tilt angle
of the display 34 is adjustable to allow suitable viewing for the
operating surgeons. In one embodiment, the monitor 34 is positioned
at a height of about 1.5 meters (5 feet). As discussed further
below, the monitor 34 can display a magnified visual picture of the
view from the distal end of the cutting tip assembly 18.
[0167] The cabinet 22 includes one or more hooks or supports 42 for
mounting of an irrigation fluid bag, container or pouch 44. The
hooks 42 can be positioned at a suitable position, for example, on
the pole 38. The irrigation bag 44 is provided sterile irrigation
water from a source 46 through a feedline 48. The sterile water is
transported to the distal cutting tip assembly 18 during device
operation through feed line 50.
[0168] In one embodiment, sterile water is provided to the distal
cutting tip assembly 18 through the control unit 24 via feedline
50a. In a modified embodiment, the sterile water is provided
directly to the distal cutting tip assembly 18 via feedline
50b.
[0169] The control unit 24 is supported at a suitable working
height by the cabinet structure 22. The control unit 24 is
operatively interfaced or connected the cable 16 at its proximal
end 40. In the illustrated embodiment, the cable 16 connects to a
front face 52 of the control box 24. The control box 24 and the CPU
32 can be housed in a single unit.
[0170] The control unit 24 and the computer system 26 are powered
by a conventional 115-Volt AC electrical power supply 54, for
example, by connecting a male plug to a wall receptacle. In
modified embodiments, the system may be powered by a portable power
supply such as a generator and the like.
[0171] In one embodiment, the control unit 24 connects to a
pressurized gas or air source supply 56 via feedline 58. As
discussed further below, the pressurized gas is used to power an
air turbine motor of the powered handpiece 20. The pressurized gas
is supplied by the hospital or house supply. In modified
embodiments, a portable pressurized gas source such a cylinder may
be efficaciously used, as needed or desired.
[0172] In one embodiment, the pressurized gas and the irrigation
water are supplied from the control unit 24 and through the
umbilical cable 16 to the surgical file device 12. In addition, the
cable 16 provides video signals from the surgical file device 12 to
the control unit 24 and computer system 26. The umbilical cable 16
provides a mechanical and waterproof connection for electrical,
video, pressurized gas and irrigation water supply. In modified
embodiments, one or more of the electrical and video signals, gas
and water may be transmitted through separate cables with efficacy,
as needed or desired.
[0173] The cable 16 can be any suitable length, for example, about
16 feet long. The cable 16 is sterilizable. The cable 16 may also
be used to provide a suction line, as needed or desired.
[0174] The control box 24 houses switches and valves to control the
flow of the pressurized gas and irrigation water. The control unit
24 has electrical controls for the handpiece 20 and video signals
for the computer system 26. The control unit 24 may also include
sensors such as pressure sensors, flow rate sensors and the like to
monitor the flow of the pressurized gas and irrigation water.
[0175] Software is provided that interfaces with the control unit
24 to monitor and control system operation and perform various
other related functions. For example, the software allows the
operating room personnel to enter the patient identification and
date and other pertinent data into the computer for record
reference.
[0176] The software also allows operating room personnel to change
video picture zoom ratios and to control and modify details of the
picture for clarity. The computer-based system enables the
operating personnel to save pictures of the patient's anatomy,
including before and after pictures, to a computer file and to
print out color pictures in seconds.
[0177] The software is used to control the pressurized gas and
irrigation liquid flow to the surgical file device 12. The software
can also be used to turn the device 12 on and off and control the
frequency of cutting blade reciprocation during filing
procedures.
[0178] The control unit 24 accommodates connection to existing
cauterizing equipment. As discussed further below, and as shown in
phantom in FIG. 1, the control unit 24 can be connected to a
cauterizing system 60 through connection line 61 to stop or prevent
undesirable bleeding during surgery.
[0179] In brief, to enable the surgeon to stop the bleeding of
freshly cut bone tissue, the cutting blade surface can feature an
electrically conductive surface that is operatively connected to an
electric circuit, for example, 60. This allows a controlled pulse
of electricity to generate a small amount of heat applied directly
onto the bone surface to coagulate the blood and stop the bleeding
at the freshly cut bone surface only, while insufating delicate
nerve roots from unwanted heat damage. The irrigation water also
works in conjunction to assist in keeping heat precisely localized
and preventing heat injury to the nearby delicate nerve roots and
spinal cord.
[0180] FIG. 3 shows the surgical file device 12 with a distal tip
assembly 18 having a generally curved and/or angled configuration.
FIG. 4 shows the surgical file device 12 with a distal tip assembly
18' having a generally straight configuration. The powered
handpiece 20 has at its proximal end 62 a quick connect docking
feature 64 to enable connection to the umbilical cable 16 that
provides a mechanical and waterproof connection for electrical,
pressurized gas and irrigation water supply.
[0181] FIG. 5 shows the surgical file device 12 connected to the
umbilical cable 16 at its distal end 66. The interface or
connection between a proximal end 330 of the powered handpiece 18
and the cable 16 includes a cover or housing 68. In the illustrated
embodiment, the cover 68 is generally frusto-conical in shape,
though in modified embodiments other suitable shapes such as
cylindrical and the like may be efficaciously utilized, as needed
or desired.
[0182] The distal tip assembly 18 at its proximal portion or end 70
includes a cover or housing 72. In the illustrated embodiment, the
cover 72 is generally frusto-conical in shape, though in modified
embodiments other suitable shapes such as cylindrical and the like
may be efficaciously utilized, as needed or desired.
[0183] The powered handpiece 20 includes a cover 74 intermediate
the front and back covers 68 and 72. In the illustrated embodiment,
the cover 74 is generally cylindrical in shape and can include a
longitudinally extending bulging portion 76 for housing a video
camera. In other embodiments, the cover 74 may be efficaciously
contoured in suitable ergonomic shapes that facilitate operation by
a surgeon or other operator.
[0184] The covers 68, 72, 74 can be formed from a number of
suitably durable materials. In one embodiment, the covers 68, 72,
74 are formed from a suitable plastic such as a thermoplastic. In
another embodiment, the covers 68, 72, 74 are formed from a
suitable metal such as stainless steel. In modified embodiments,
other suitable plastics, metals, alloys, ceramics, combinations
thereof, among others, may be efficaciously utilized, as needed or
desired. Suitable surface coatings or finishes may be applied, as
required or desired.
[0185] The covers 68, 72, 74 can be fabricated by using a number of
manufacturing techniques. These include, but are not limited to,
molding, machining, casting, forging, laser cutting and/or
processing, laminating, adhesively fixing, welding, combinations
thereof, among others, with efficacy, as needed or desired.
[0186] FIG. 6 shows a partially exploded view of the surgical file
device 12. As discussed further below, the powered handpiece 20
includes a video camera 78 and a micro-motor 80 that provides
rotary motion which is converted to linear reciprocating motion
within the distal tip assembly 18. FIG. 7 shows another perspective
view of the surgical file device 12 with the distal cover 72
removed illustrating some of the features of the distal tip
assembly.
Distal Tip Assembly
[0187] FIGS. 8 and 9 show the distal tip assembly 18 in greater
detail. In one embodiment, the composite tip 18 has a length of
about 10 cm (4 inches) to about 15 cm (6 inches), including all
values and sub-ranges therebetween. In one embodiment, the
composite tip 18 has a length of about 5 cm (2 inches) to about 30
cm (12 inches), including all values and sub-ranges therebetween.
In modified embodiments, other suitable lengths may be
efficaciously utilized, as needed or desired.
[0188] The distal tip assembly 18 is sterile to maintain
appropriate surgical standards and is provided in a sterile
packaging. In one embodiment, the distal tip assembly 18 is for one
time use and is disposable thereafter. As described further below,
embodiments of the distal tip assembly 18 include a cartilage or
other tissue and bone removal file with vision, illumination,
irrigation and cauterization features.
[0189] The distal tip assembly 18 generally comprises a distal tip
portion 92 that has a distal-most end 94 and a proximal portion
extending into the cover 72 that encloses a housing 96 that
receives a toroidal power converter system 98 and a water pump
system. The distal tip assembly 18 further includes an interface
member 102 and a coupling 104 that facilitate connection between
the distal tip assembly 18 and the powered handpiece 20.
[0190] In some embodiments, the distal tip portion 92 generally
comprises a reciprocating cutting or filing blade 106 that is
enclosed in a protective case or shield 108. The shield 108 has an
aperture, window, opening 112 to expose a cutting surface 114 of
the filing blade 106 proximate the distal end 94. Desirably, the
shielded blade 106 permits surgical bone and/or tissue removal
substantially without risk of damage to nearby delicate tissues
such as nerve tissue.
[0191] The distal tip portion 92 can be configured to be small and
thin so it is minimally intrusive and can go around corners and
into any small inaccessible blind channels where nerves are
located. The distal tip portion 92 can be configured to fit any
desired cavity or contoured shape. The tip portion 92 can be
supplied in a variety of sizes and shapes to suit a particular
application such as, but not limited to, neurosurgery, orthopaedic
surgery and plastic surgery.
[0192] The blade cutting surface 114 can be located on the end of
an extension with a bend 116 of any desired angle. In the
illustrated embodiment of FIGS. 8 and 9, the tip portion 92 has a
curved, angled or bent configuration with the bend 116. In another
embodiment, the distal tip portion 92 has a substantially straight
and/or planar (flat) configuration.
[0193] The tip portion 92 further includes a linear bearing
retainer 118 within the shield 108. The reciprocating blade 106 is
precision fitted within the bearing retainer 118 that allows free
linear motion of the reciprocation blade stroke. Advantageously,
the bearing retainer 118 provides low friction bearing surfaces for
the reciprocating motion of the blade 106.
[0194] The bearing retainer 118 comprises a plurality of stationary
linear bearings 120 which are positioned on the top, bottom and
both sides of the reciprocation blade. The top linear bearing 120
has an aperture, opening or window 122 that is substantially
aligned with the shield aperture 112 to expose the blade-cutting
surface 114. In one embodiment, the tip portion 92 (and hence the
lengths of the blade cutting surface 114 and the apertures 112,
122) are configured so that substantially the entire blade cutting
surface 114 is exposed during the full blade reciprocation
cycle.
[0195] The bearing retainer 118 can be formed from a number of
suitably durable materials. In one embodiment, the bearing retainer
118 is formed from a suitable plastic such as a thermoplastic. In
modified embodiments, other suitable plastics, metals, alloys,
ceramics, combinations thereof, among others, may be efficaciously
utilized, as needed or desired. Suitable surface coatings or
finishes may be applied, as required or desired.
[0196] The bearing retainer 118 can be fabricated by using a number
of manufacturing techniques. These include, but are not limited to,
molding, machining, casting, forging, laser cutting and/or
processing, laminating, adhesively fixing, welding, combinations
thereof, among others, with efficacy, as needed or desired.
[0197] As described in more detail below, the distal tip portion 92
further includes a pair of fiber optic probes 124, 126 that are
part of an on-board optical illumination and vision system. The
fiber optic probes 124, 126 optically connect or interface at their
proximal ends to the video camera 78.
[0198] The bottom or lower fiber optic probe 124 is below the lower
bearing 120. The fiber optic probe 124 may be housed within the
shield 108 or it may have its independent protective jacket below
the shield 108. The fiber optic probe 124 has a distal end 128 at
about the distal-most end 94 of the tip portion 92.
[0199] The top or lower fiber optic probe 126 is above the upper
bearing 120. The fiber optic probe 126 may be housed within the
shield 108 or it may have its independent protective jacket above
the shield 108. The fiber optic probe 126 has a distal end 130
proximal to a proximal end 132 of the aperture 112 and/or the
cutting surface 114.
[0200] The shield 108 can include the aperture 112 on any one of
its sides depending on the positioning of the cutting surface 114.
This includes the top (as shown in, for example, FIGS. 8 and 9),
the bottom and the sides of the shield 108 and even its distal end
134. The shield 108 has a longitudinally extending cavity that
houses the blade 106, the bearing retainer 118 and in some
embodiments the fiber optic probes 124, 126. In the illustrated
embodiment, the distal end 134 closes the longitudinal shield
cavity.
[0201] In one embodiment, the shield 108 is capable of deflecting
and bends at predetermined and/or low loads (for example about 2
lbs.) in order to prevent injury or damage to tissue, such as nerve
tissue, engaged by the shield 108. The shield 108 has a
predetermined stress-strain curve and spring constant to provide
the desired deflection and can comprise, for example, a suitable
polymer and the like. The shield 108 may bend at the bend location
116 or at a location proximate to the contact with the tissue. One
or more of the associated tip portion 92 components such as the
blade 106, bearings 120 and the fiber optic probes 124, 126 can
also bend with the shield 108, as needed or desired.
[0202] The shield 108 can be formed from a number of suitably
durable materials. In one embodiment, the shield 108 is formed from
a suitable plastic such as a thermoplastic. In another embodiment,
the shield 108 is formed from a polymer that is flexible or can
bend under a predetermined load. In modified embodiments, other
suitable plastics, metals, alloys, ceramics, combinations thereof,
among others, may be efficaciously utilized, as needed or desired.
Suitable surface coatings or finishes may be applied, as required
or desired.
[0203] The shield 108 can be fabricated by using a number of
manufacturing techniques. These include, but are not limited to,
molding, machining, casting, forging, laser cutting and/or
processing, laminating, adhesively fixing, welding, combinations
thereof, among others, with efficacy, as needed or desired.
[0204] The shield 108, the bearing retainer 118 and the fiber optic
probes 124, 126 generally conform in shape to the longitudinal
profile of the blade 106. In the illustrated embodiment of FIGS. 8
and 9, this is a curved, angled or bent profile with a bend at
around 116.
[0205] FIG. 10 shows a cross-sectional view of the distal tip
portion 92 at a location proximal to the aperture 112 and the bend
116. The blade 106 is substantially centrally located within the
shield or outer jacket 108. The blade 106 is precision fitted
within the bearing retainer 118 including the linear bearings 120.
The respective lower and upper fiber optic probes 124, 126 are
buffered from the blade 106 by the stationary bearings 120.
[0206] The cutting blade linear bearing 120 has a series of shallow
slots 190 running substantially longitudinally in line with the
proximal to distal axis. The slots 190 serve as water passageways
to enable irrigation water to be transported from a proximal to a
distal location. The irrigation water serves several functions and
provides several advantages.
[0207] The water is a lubricant for the interface between the
moving blade 106 and the stationary linear bearings 120, which in
one embodiment are positioned on the top and bottom and both sides
of the reciprocation blade 106. The water cools the blade and
bearing material, and in the embodiment the bearing material is
plastic, prevents the plastic bearing material from getting hot and
softening. The water also serves to wet the cutting blade surface.
The water is also used to clean tissue and transport the cut tissue
away from the cutting blade 106. Additionally, water transported
across the linear blade 106 intimately irrigates the volume of
water in the distal blade area to clear the optical vision field
for clear viewing.
[0208] FIG. 11 shows a cross-sectional view of the distal tip
portion 92 at the shield aperture 112. The cutting surface 114 of
the blade 106 is exposed and is above the lower bearing 120, the
lower fiber optic probe 124 and a lower portion 192 of the shield
108. The drawing also shows portions of the shield 108 and the
upper bearing 120 at the tip distal end 94. In this embodiment, the
cross-sectional profile of the cutting surface 114 is convex and
the associated portions of the shield 108, bearings 120 and lower
fiber optic probe 124 generally conform to this shape.
[0209] In one embodiment, and as described further below, the
toroidal drive system 98 is substantially mounted within the
housing 96 and generally comprises a rotatable toroid drive 136 and
a drive slide 138. A drive shaft 140 is connected to the handpiece
motor 80 and transfers rotary motion to the toroid drive 136 which
engages the linear slider 138 to convert rotary motion into
reciprocating motion that is provided to the blade 106 for
performing bone and/or tissue removal operations. In modified
embodiments, other suitable rotary to reciprocating motion
mechanisms or devices may be used, as needed or desired, to
reciprocatingly drive the blade 106.
[0210] As discussed further below, the drive shaft 140 is connected
to the toroid drive 136 and has a specially designed female
receptor hole. The receptor hole allows the drive shaft 140 to
substantially irrotationally mate with a power drive shaft of the
motor 80.
[0211] The housing 96 has a distal end 142 and a proximal end 144
and a generally flat recessed surface 146 extending from the distal
end 142 towards the proximal end 144. The linear slide 138 is
reciprocatingly seated on or within the recessed surface 146. The
housing 96 includes a cavity 148 intermediate the recessed surface
146 and the housing proximal end 144 that receives the rotatable
toroid drive 136. The housing proximal end 144 has an opening 149
that receives a power shaft of the handpiece motor 80 that connects
to the drive shaft 140.
[0212] The housing 96 can be formed from a number of suitably
durable materials. In one embodiment, the housing 96 is formed from
a suitable plastic such as a thermoplastic. In modified
embodiments, other suitable plastics, metals, alloys, ceramics,
combinations thereof, among others, may be efficaciously utilized,
as needed or desired. Suitable surface coatings or finishes may be
applied, as required or desired.
[0213] The housing 96 can be fabricated by using a number of
manufacturing techniques. These include, but are not limited to,
molding, machining, casting, forging, laser cutting and/or
processing, laminating, adhesively fixing, welding, combinations
thereof, among others, with efficacy, as needed or desired. The
housing 96 and bearing retainer 118 may comprise an integral unit,
for example, they may be formed by molding and the like.
[0214] The toroid drive 136 is connected with the drive shaft 140.
The toroid drive 136 has an outer rim 150 that is engaged with the
slider 138 and transmits rotary motion that is converted into
reciprocating motion by the slider 138.
[0215] The slide plate 138 has a distal end 152, a proximal end 154
and a specially contoured slot 156 proximate to the proximal end
152 with a pair of generally opposed bearing surfaces 164, 166. As
described in greater detail below, the slot 156 receives the
rotating outer rim 150 of the toroid drive 136.
[0216] The blade 106 is connected to the slide 138. As described in
greater detail below, this connection utilizes shear pins to
provide a safety mechanism against blade buckling.
[0217] The slide 138 can be formed from a number of suitably
durable materials. In one embodiment, the slide 138 is formed from
a suitable plastic such as a thermoplastic. In modified
embodiments, other suitable plastics, metals, alloys, ceramics,
combinations thereof, among others, may be efficaciously utilized,
as needed or desired. Suitable surface coatings or finishes may be
applied, as required or desired.
[0218] The slide 138 can be fabricated by using a number of
manufacturing techniques. These include, but are not limited to,
molding, machining, casting, forging, laser cutting and/or
processing, laminating, adhesively fixing, welding, combinations
thereof, among others, with efficacy, as needed or desired.
[0219] The interface member 102 has an opening 158 which allows
passage of the fiber optic probes 124, 126 for connection to the
camera 78. The interface member 102 has an opening 160 that
receives that receives a power shaft of the handpiece motor 80 that
connects to the drive shaft 140.
[0220] The coupling 104 has an opening 162 that receives that
receives a power shaft of the handpiece motor 80 that connects to
the drive shaft 140. The openings 149, 160 and 162 are
substantially aligned with one another.
[0221] The interface member 102 and coupling 104 can be formed from
a number of suitably durable materials. In one embodiment, the
interface member 102 and coupling 104 are formed from a suitable
plastic such as a thermoplastic. In modified embodiments, other
suitable plastics, metals, alloys, ceramics, combinations thereof,
among others, may be efficaciously utilized, as needed or desired.
Suitable surface coatings or finishes may be applied, as required
or desired.
[0222] The interface member 102 and coupling 104 can be fabricated
by using a number of manufacturing techniques. These include, but
are not limited to, molding, machining, casting, forging, laser
cutting and/or processing, laminating, adhesively fixing, welding,
combinations thereof, among others, with efficacy, as needed or
desired.
Blade Embodiments
[0223] Embodiments of the invention provide reciprocating cutting
blade for precision bone and/or tissue removal. In one embodiment,
the reciprocating cutting blade is shielded or covered or guarded
on five sides to provide a shielded surgical file. As used herein,
the term "blade" is a broad term and includes, without limitation,
any of various grinders, filers, cutters, surfaces that are
configured to grind, file, and/or cut tissue.
[0224] The shielded file can be flat, planar, convex or concave in
its cross-section. The shielded file can extend generally straight
or be curved, angled or bent along its longitudinal axis.
Advantageously, the angled configuration allows the cutting surface
to travel around a corner to reach into usually inaccessible body
cavities. Desirably, this provides the ability to remove unwanted
tissue in a blind tunnel or body cavity while enabling direct
vision through the illumination and vision probes.
[0225] The shielded file can be dimensioned in a number of manners.
The shielded file can be any length or width suitable for the human
or mammalian anatomy proportions. For other non-medical
applications, the shielded file can be of any length or width to
suit the material removal application.
[0226] The thickness of the shielded file can be varied to be very
thin. In one embodiment, the thickness can be of the order of
1/10.sup.th of an inch. Advantageously, this enables the shielded
file to fit into small spaces such as between a nerve and the
foramen opening that it is passing through. In other embodiments,
the thickness of the shielded file can be greater, as needed or
desired.
[0227] The cutting blade can be shaped and contoured in several
configurations. In one embodiment, the reciprocating cutting blade
is straight and planer (in one flat plane). In another embodiment
the reciprocating cutting blade that is curved convex or concave in
its cross sectional shape. In yet another embodiment, the
reciprocating cutting blade that is substantially straight in its
longitudinal axis. In still another embodiment, the reciprocating
cutting blade is curved in its longitudinal axis.
[0228] The thickness of the cutting blade drive 106 can be varied.
In one embodiment, the cutting blade thickness is in the range from
about 100 microns or .mu.m (0.004 inches) to about 300 .mu.m (0.012
inches). In another embodiment, the cutting blade thickness is in
the range from about 50 .mu.m (0.002 inches) to about 600 .mu.m
(0.024 inches). In yet another embodiment, the cutting blade
thickness is in the range from about 25 .mu.m (0.001 inches) to
about 2.5 mm (0.1 inches). In modified embodiments, other suitable
dimensions may be efficaciously utilized, as needed or desired.
[0229] The cutting blade 106 can be formed from a number of
suitably durable materials. In one embodiment, the cutting blade
106 is formed from steel. In another embodiment, the cutting blade
106 comprises spring stainless steel. In modified embodiments,
other suitable metals, alloys, plastics, ceramics, hard carbon
(e.g., graphite, diamond, etc.), composites, laminates,
combinations thereof, among others, may be efficaciously utilized,
as needed or desired. Suitable surface coatings or finishes may be
applied, as required or desired.
[0230] The cutting blade 106 can be fabricated by using a number of
manufacturing techniques. These include, but are not limited to,
molding, machining, casting, forging, laser cutting and/or
processing, laminating, adhesively fixing, welding, combinations
thereof, among others, with efficacy, as needed or desired.
[0231] In one embodiment, the cutting blade 106 is flexible.
Advantageously, this allows the cutting blade to be easily bent,
angled or curved along its length as it is enclosed in a bent,
angled or curved outer shield 108. In another embodiment, the
cutting blade is substantially rigid. This can be suitable for
blade configurations that are generally straight. The rigid blade
may also be bent by suitable techniques, as needed or desired. In
modified embodiments, the cutting blade 106 may efficaciously
comprise one or more flexible portions and one or more rigid
portions, as needed or desired.
[0232] FIG. 12 shows an embodiment of the cutting blade 106. The
blade 106 comprises a thin flexible material that is capable of
bending along its length. The blade 106 includes a distal section
or, portion 194 with the cutting surface 114, a medial section or
portion 196 and a proximal section or portion 198. When enclosed
within the curved, angled or bent shield 108 the blade 106 flexes
like a thin spring to conform to the shape of the shield or guide
cover 108. Thus, the medial section 196 is curved, angled or bent
while the respective distal and proximal sections 194, 198 extend
generally straight.
[0233] FIG. 13 shows a cross-section of a cutting surface 114a and
an associated portion 202a of the shield 108a having a generally
convex configuration suited for some particular bone and/or tissue
removal applications. The convex curvature of the cutting surface
114a can also be advantageous in providing enhanced rigidity to the
thin cutting surface 114a and/or the associated blade 106.
[0234] FIG. 14 shows a cross-section of a cutting surface 114b and
an associated portion 202b of the shield 108b having a generally
concave configuration suited for particular bone and/or tissue
removal applications. The concave curvature of the cutting surface
114b can also be advantageous in providing enhanced rigidity to the
thin cutting surface 114b and/or the associated blade 106.
[0235] FIG. 15 shows a lengthwise-section of the distal tip portion
92 having a cutting surface 114c on the top or upper side of the
reciprocating blade 106 within the non-moving shield 108. This
configuration is suited for some particular bone and/or tissue
removal applications. The bend 116 allows the cutting surface 114c
to pass into a cavity that involves traveling around a corner. The
direction of blade travel is generally denoted by arrows 204.
[0236] FIG. 16 shows a lengthwise-section of the distal tip portion
92 having a cutting surface 114d on the bottom or lower side of the
reciprocating blade 106 within the non-moving shield 108. This
configuration is suited for some particular bone and/or tissue
removal applications. The bend 116 allows the cutting surface 114d
to pass into a cavity that involves traveling around a corner. The
direction of blade travel is generally denoted by arrows 204.
[0237] FIG. 17 shows the cutting surface 114 including an abrasive
material or abrasives 206 for cutting, removing, filing or grinding
bone and/or tissue materials. For clarity, one side of the shield
108 has been removed in the drawing. Any one of a number of
suitable abrasives may be used that are safe to use within a
patient's body or are biocompatible and hard. In one embodiment,
the abrasives 206 comprise embedded diamonds or diamond
particles.
[0238] Also shown in FIG. 17 is a lateral slot or opening at the
tip portion distal end 94. Advantageously, the distal opening 208
allows the removal of any bone and/or tissue debris that may
collect within the distal and provides for flushing out of the
debris as the blade cutting surface 114 reciprocates and the
irrigation fluid flows out of the instrument.
[0239] FIG. 18 shows the blade cutting surface 114 including a
plurality of micro holes or openings 212 for the flow of irrigation
fluid therethrough. For clarity the abrasives are not shown in the
drawing. The holes 212 are in fluid, liquid or hydraulic
communication with the longitudinal slots 190 of the lower linear
bearing 120. The slots 190 of the upper linear bearing 120 also
provide irrigation water to the cutting area.
[0240] FIG. 19 schematically depicts the fluid, liquid or hydraulic
communication between the bearing slot(s) 190 and the cutting
surface holes 212. The flow of water from the bearing slots(s) 190
and the micro hole openings 212 is generally indicated by arrows
214. The water is forced to flow up, down or out through the
openings 212 in the cutting blade surface 114 and away from the
blade cutting surface 114. The water washes away cut material and
keeps debris from clogging the cutting surface 114 to maintain
optimum cutting and material removal performance, and to keep the
cutting area cool to prevent tissue necrosis damage.
[0241] The water also flows over the moving (reciprocating) cutting
blade 106 and drive mechanism or bearings 120 to provide cooling
and lubrication. The water can be forced into the cutting cavity
112 to flush away micro cutting debris and maintain a clear field
of view for video navigation and visualization. The water can be
forced into the cutting area cavity 112 to clean and remove freshly
cut bone cells and bone fragments to prevent repopulation and
unwanted bone growth in the area.
[0242] FIG. 20 is another schematic depiction showing the fluid,
liquid or hydraulic communication between the irrigation fluid
holes 212 and the bearing irrigation passageways 190. The drawing
also shows the abrasive material or abrasives 206 of the blade
cutting surface 114.
[0243] FIG. 21 shows the reciprocation blade stroke direction as
generally indicated by arrows 216. The free linear motion of the
reciprocation blade stroke is a linear stroke. In one embodiment,
for applications within the human body, the linear stroke is in the
range from about 2.5 mm (0.1 inches) to about 7.6 mm (0.3 inches),
including all values and sub-ranges therebetween. In another
embodiment, the linear stroke is in the range from about 1.3 mm
(0.05 inches) to about 12.7 mm (0.5 inches), including all values
and sub-ranges therebetween. In yet another embodiment, the linear
stroke is in the range from about 0.25 mm (0.01 inches) to about
25.4 mm (1 inch), including all values and sub-ranges therebetween.
In modified embodiments, the linear stroke may efficaciously be
lower or higher depending on the particular application, as needed
or desired.
Cauterization
[0244] In accordance with one embodiment, the surgical file
instrument 12 can stop the small amount of bleeding of freshly cut
or sculpture shaped bone or other tissue by accommodating
connection to existing cauterizing equipment 60. In this
embodiment, the special feature the system has is a
non-electrically conductive shield 108, which is covering an
electrically conductive metal file blade 106.
[0245] When bleeding of the freshly cut bone is detected, the file
cutting blade 106 can be brought back into contact with the freshly
shaped bone that may be bleeding slightly. A pulse of electricity
can be momentarily applied that will flow from the metal blade file
surface into the bleeding bone or other tissue surfaces. This will
heat the bleeding bone or other tissue surfaces, coagulate the
blood flow and advantageously stop the bleeding of the bone and/or
tissue surface. Desirably, the irrigation flow facilitates
localizing the heat and cooling while the shield 108 protects the
adjacent nerves and spine from heat.
Illumination and Vision Probes
[0246] FIG. 22 shows a fiber optic vision system 218 including the
fiber optic probes 124 and 126. The fiber optic vision system 218,
in some surgical embodiments, enables surgeons to visually see and
verify the presence of unwanted bone and cartilage buildup that is
causing nerve root compression and damage to normal body functions.
This information on the unwanted material can be documented and
recorded by saving visual pictures into a computer database and
printing color pictures immediately for reference and record.
[0247] The lower fiber optic probe 124 includes a plurality of
optical fibers 220a that optically terminates at a distal lens
array or arrangement 222a. The lens array 222a is positioned at
substantially the tip distal end 94. The fiber optic probe 124 may
be placed within the shield 108 or it may have a separate housing.
The lower fiber optic probe 124 generally follows the longitudinal
profile of the distal tip portion 92, the blade 106 and/or the
shield 108.
[0248] The upper fiber optic probe 126 includes a plurality of
optical fibers 220b that optically terminates at a distal lens
array or arrangement 222b. The lens array 222b is positioned
proximal to the blade cutting surface 114. The fiber optic probe
126 may be placed within the shield 108 or it may have a separate
housing. The upper fiber optic probe 126 generally follows the
longitudinal profile of the distal tip portion 92, the blade 106
and/or the shield 108.
[0249] Advantageously, the fiber optic vision system 218 enables
visual viewing of the patient's body cavities all during insertion
and placement of the cutting blade. This is intended to enable the
surgeon to safely navigate the tiny body cavities such as
neuroforamina and other tubular canals, and avoid damage to fragile
nerve roots.
[0250] FIG. 23 shows the optical fibers 220a in more detail. The
upper optical fibers 220b (220b', 220b'') have a similar
configuration and functioning though they may have a different
curvature or be flat and planar. The optical fibers 220a comprise a
central plurality of optical vision fibers 220a' flanked by light
or illumination fibers 220a''. The optical vision fibers 220a' are
connected at their proximal end to the video camera 78.
[0251] The fiber optical illumination fibers 220a'' illuminate the
body cavity and enable video visualization. An LED located at the
proximal end of the fiber optics illumination fibers 220a'' is used
transmit light to the distal end of the illumination fibers 220a''
to provide illuminating light. Advantageously, the direct vision
optical system 218 enables surgeons to safely navigate into blind
cavities of the human body and to illuminate and see specific body
anatomy such as nerves and bony buildups that could be irritating
and pressing against nerves causing nerve compression.
[0252] In the illustrated embodiment, the direct vision optical
system 218 desirably provides an integrated illumination and
optical vision system. The optics for vision and illumination are
included within the distal tip assembly 18 which in some
embodiments is a docking sterile one time use assembly.
[0253] Referring in particular to FIG. 24, the distal optical
system lenses arrangements 222a and 222b are each arrayed in three
segments. The lower optical segments 222a are arranged with a video
imaging lens 222a' centered medially and with illuminating lenses
222a'' positioned on the right and left lateral sides. The upper
optical segments 222b are arranged with a video imaging lens 222b'
centered medially and with illuminating lenses 222b'' positioned on
the right and left lateral sides.
[0254] FIG. 25 shows the lens arrays 222a, 222b in more detail. The
lateral sides of the central lenses 222a', 222b' have a respective
semi-arc male shape 224a', 224b' to each of their left and right
sides. The illuminating lenses 222a'', 222b'' are shaped to have
mating female semi-arc medial sides 226a'', 226b'' on there medial
sides which mate into the male mating features 224a', 224b' of the
central lens sides.
[0255] Advantageously, such mating lens arrays 222a, 222b can
accommodate a wide range of instrument sizes while using
substantially the same basic lens assembly design. Different lenses
may be used in the design and the curvature of the lens array
adjusted and changed to provide the desired illumination and/or
field of view. For example, for a particular medial video imaging
lens 222a', 222b' the curvature of the side illuminating lenses
222a'', 222b'' can be adjusted or changed to illuminate the desired
field of view. This desirably saves on cost since micro lenses are
very expensive to tool up and make. The distal tip assembly 18 can
have numerous sizes with varying cross sections of the distal tip
portion 92 depending on the particular application and
advantageously substantially the same basic lens assembly design
222a, 222b can be utilized with the different sizes.
[0256] Additionally the mating lenses 222a', 222b' and 222a'',
222b'' allow the black out of the respective mating surfaces 224a',
224b' and 226a'' and 226b'' to substantially prevent illumination
light from passing laterally into the imaging lens 222a', 222b' and
degrading the optical quality of the resulting picture. A lens set
comprising the central imaging lens 222a', 222b' and one each right
and left illuminating lenses 222a'', 222b'' can be assembled onto a
wide range of instrument disposable cutting tips 18 in an assembly
that has an optical distal lens system which is very thin in cross
section and that the lenses follow the instrument cross sectional
curve. Advantageously, for embodiments of the invention and in
particular the neurosurgery embodiments, having a very thin cross
section enables the instruments distal tip to fit into the tiny
space between a nerve root and its neuroforamen opening.
[0257] As shown in FIG. 26 the images from the direct vision
optical system 218 can be viewed on the LCD monitor 34. The drawing
shows an example of the display with a view 228 from the upper
fiberoptic 126 looking onto the blade 106 and a view 230 from the
lower fiberoptic 124 looking out from the instrument distal end
92.
Toroidal Transmission System
[0258] The toroidal transmission or power conversion system 98 is a
mechanical conversion device that converts rotary to reciprocating
motion or action. The powered handpiece 20 houses a rotating motor
80 to power the cutting action of the tissue removal instrument or
blade 106. The rotating mechanical action of the motor 80 is
converted into reciprocating mechanical motion of a suitable
reciprocal stroke length. It is desirable that the mechanical
motion conversion device be simple and have few parts.
[0259] Having a video camera system mounted directly into a
reciprocating motion mechanical device can create a stability
problem with respect to inherent vibration that is usually inherent
in all reciprocating motion mechanical devices. Advantageously, the
toroidal drive system 98 of embodiments of the invention provides a
desirable solution for the vibration problem since it has low or
minimum levels of associated vibration. This advantageously
provides a stable platform for the capture of high quality pictures
by the video system including the camera 78 housed in the handpiece
20.
[0260] The toroidal drive system 98 inherently has few parts and
can be built to be very low vibration due to low mass of the
reciprocating components. Thus, the toroidal drive system 98 can
provide the powered handpiece 20 with a stable platform and a
smooth running mechanical action. The transmission system of
embodiments of the invention has utility in a number of fields and
applications where conversion of rotary motion to reciprocating
motion is desired.
[0261] FIGS. 27 and 28 show the toroid drive 136 and the female
receptor drive shaft 140. In one embodiment, the toroid drive 136
and the drive shaft 140 comprise an integral unit and are formed as
a single piece. In another embodiment, the toroid drive 136 and the
drive shaft 140 can be rigidly connected to one another.
[0262] The toroid drive 136 and the drive shaft 140 can be formed
from a number of suitably durable materials. In one embodiment, the
toroid drive 136 and the drive shaft 140 are formed from a suitable
plastic by molding. The plastic material may comprise a suitable
thermoplastic. In modified embodiments, other suitable plastics,
metals, alloys, ceramics, combinations thereof, among others, may
be efficaciously utilized, as needed or desired. Suitable surface
coatings or finishes may be applied, as required or desired.
[0263] The toroid drive 136 and the drive shaft 140 can be
fabricated by using a number of manufacturing techniques. These
include, but are not limited to, molding, machining, casting,
forging, laser cutting and/or processing, laminating, adhesively
fixing, welding, combinations thereof, among others, with efficacy,
as needed or desired.
[0264] The toroid drive 136 and the drive shaft 140 are rotatable
about a substantially central rotation axis 232. The toroid drive
136 has a generally circular or curvilinear cam portion 234 and a
generally central shank portion 236. As discussed further below,
the cam 234 has a specially designed generally circular or
curvilinear outer rim 150 with a varying or non-uniform
thickness.
[0265] The cam 234 and/or the outer rim 150 have a substantially
central side view plane 238. The cam 234 and/or the outer rim 150
are tilted relative to a vertical plane or axis 240 by a
predetermined angle .alpha. and hence to the rotation axis by an
angle .beta. where .beta.=90.degree.-.alpha.. Thus, typically
.beta. and .alpha. are less than 90.degree..
[0266] In one embodiment, .alpha. is about 20.degree. and .beta. is
about 70.degree.. In another embodiment, .alpha. is in the range
from about 10.degree. to about 40.degree. and .beta. is in the
range from about 50.degree. to about 80.degree., including all
values and sub-ranges therebetween. In yet another embodiment,
.alpha. is in the range from about 5.degree. to about 80.degree.
and .beta. is in the range from about 10.degree. to about
85.degree., including all values and sub-ranges therebetween. In
modified embodiments, .alpha. and .beta. may be lower or higher, as
needed or desired.
[0267] As schematically illustrated in FIG. 29, in one embodiment,
the cam 234 and/or the outer rim 150 are designed to provide a
variable thickness for the outer rim 150 by the partial
superimposition of two toruses or toroids 242, 244 of substantially
uniform rim thickness with respective central axes 246, 248. By
controlling the degree of superposition, the rim 150 of variable
and controlled thickness is created. Thus, the transmission or
power conversion system 98 is also referred to as a "hybrid dual or
twin toroid" system.
[0268] Advantageously, the outer rim 150 thickness is varied such
that the rim 150 substantially continuously contacts the bearing
surfaces 164 and 166 as the cam 234 rotates about the central axis
232. Thus, desirably the two surfaces 164 and 166 can remain at a
substantially fixed distance apart as they move linearly back and
forth in reciprocating motion in response to the cam's rotation
about the central axis 232.
[0269] In the illustrated embodiment, the torus central axes 246,
248 are at an offset angle .theta. to produce the desired variable
thickness rim 150. The slightly dimpled or grooved surface 250 is
indicative of the partial superposition of the two toruses or
toroids 242, 244. In modified embodiments, more than two toruses
and/or toruses with variable rim thickness may be utilized to
create the desired outer rim profile.
[0270] Advantageously, the dual torus or toroid (one toroid
partially inside another) configuration provides an elegant
solution of for maintaining a uniform distance between the bearing
surfaces 164, 166 or driven rollers. The rotation of the toroid or
torus cam 234 moves the outer rim 150 in a reciprocating motion
with the motion being generally parallel to the rotary axis 232.
The reciprocating motion of the slide plate 138 is also generally
parallel to the rotary axis 232 which is then transmitted to the
blade 106.
[0271] FIG. 30 shows the thickness profile of the outer rim 150 in
accordance with one embodiment. The thickness varies across the rim
150 in a generally offset sinusoidal profile with a minimum
thickness T.sub.min and a maximum thickness T.sub.max. In modified
embodiments, other suitable rim thickness profiles may be
efficaciously utilized, as needed or desired.
[0272] The disposable cutting blade assembly 18 includes the
integrated transmission system 98 within the distal cover 72. The
transmission system 98 converts the rotary motion of the drive
motor 80 into the reciprocating motion of the tissue-cutting blade
106. The transmission system 98 is a sterile assembly of the
disposable cutting blade assembly 18 that is sterile packaged.
[0273] The transmission system 98 is an internal mechanism and is
generally housed within the housing 96. This is important in that
the "one time use disposable" tip assembly 18 embodiments because
easy separation from the re-sterilizable motor drive portion of the
powered handpiece 20. In theses embodiments, the powered handpiece
20 with its rotary motor 80 comprises an independent assembly from
the disposable distal cutting tip assembly 18. Numerous sizes and
shapes of distal cutting tip portion 92 are available to be
connected onto the motor drive powered handpiece 20.
[0274] Since the disposable distal cutting tip assembly 18 has an
internal mechanism to convert rotary motion into reciprocating
motion, it advantageously enables a simple and cost effective means
of disconnecting the two assemblies 18 and 20. The drive shaft 140
at its proximal end 253 includes a female receptor hole 254 that is
configured to substantially irrotationally mate with a matching
male distal shaft drive protruding out of the motor drive 80.
[0275] FIG. 31A shows a simple female triangular hole 254a in the
drive shaft 140 that can engage a triangular shaped distal shaft
drive protruding out of the motor drive assembly. When the distal
tip assembly 18 and the powered handpiece 20 are connected both the
female triangular receptor hole 254a and the motor's male
triangular drive shaft can rotate in tandem. The male and female
features are free to mesh and align during the axial motion of
connecting the disposable cutting tip assembly 18 onto the reusable
sterilizable motor handpiece 20.
[0276] A triangular shaped male mating drive is desirable because
it facilitates sterilization of the male triangular shaft. The
surfaces that are steam sterilized and reused are desirably simple
surfaces that are easy to wash and clean. The surfaces should also
enable reliable cleaning prior to sterilization. A triangular male
shaft has three flat surfaces that are both easy to see and
clean.
[0277] In modified embodiments, other suitable male-female mating
drive polygonal or non-polygonal interlocking configurations may be
utilized with efficacy, as needed or desired. For example, FIG. 31B
shows a generally square or rectangular female receptor hole 254b
and FIG. 31C shows a generally hexagonal female receptor hole
254c.
[0278] FIG. 32 and 33 show the cutting blade 106 and the drive
slide 138. The outer rim 150 of the toroid drive 136 engages the
slide slot 156 and abuts against the bearing surfaces 164, 166 as
it rotates to reciprocatingly displace the slide 138 connected to
the blade 106. The slide 138 can be generally above the toroid
drive 136 or it can be generally below the toroid drive 136. In
modified embodiments, the slide 138 can be to the sides of the
toroid drive 136 as long as the outer rim 150 rotates within the
slide slot 156 and causes the slide to move in a reciprocating
motion.
[0279] It is important that the distal filing blade 106 maintain
its structural rigidity and not to fail in a buckling mode that
would cause the file blade 106 to become bent or distorted into a
shape that may result in an undesirable thicker profile. To
safeguard against this, in one embodiment, a safety shear system is
provided.
[0280] The slide 138 includes a pair of posts or pins 260, 262 that
engage respective blade holes 256, 258. In one embodiment, the
posts 260, 262 are formed from a molding process in which the slide
138 including the posts 260, 262 comprises a plastic. The posts
260, 262 in one embodiment are heat staked and the like to mushroom
and form respective heads 264, 266 to affix the blade 106 and the
slide 138. The mushroomed pins 260, 262 prevent undesirable blade
buckling by being configured to shear at a force much lower than
the force that could potentially buckle the file blade 106.
[0281] Thus, advantageously, the file blade 106 is driven by a
structure that has an intentional weak point that will shear away
the driving reciprocating action of the blade drive 106 to prevent
a potential distal blade 106 buckling. The configuration of the
shear pins 260, 262 is tailored to the specific file blade
configuration (which varies in width and length and cross sectional
curve). Thus, the shear pin connection including the diameter
and/or cross-section of the mushroomed heads 264, 266 and/or the
shank portions of the pins 260, 262 is configured such that the
mushroomed pins 260, 262 shear at a force lower than a force that
would buckle the specific distal cutting blade 106 and allow safe
disengagement and disconnection of the blade 106 from the slide
138.
[0282] Advantageously, the diameter(s) of the pins 260, 262
provides a desirable shear pin safety mechanism. The pins 260, 262
allow the connection between the drive slide 138 and the blade 106
to shear at a predetermined force. This force can be determined for
a particular cutting blade configuration by a number of methods
including modeling, numerical analysis, computer simulation,
experimental and empirical testing and the like, among others.
Accordingly, each differing cutting blade 106 is provided with a
shear connection feature to shear and stop the blade driving action
before the blade could conceivably buckle. A clearance space 268 in
the slide 138 is provided in the proximal direction behind a blade
proximal end 270 to allow the blade 106 to move proximally in the
slide part 138 when shear disconnection occurs so that the blade
106 is substantially decoupled from the reciprocating motion.
[0283] The safety shear force F.sub.shear can be calculated as a
function of the blade buckling force F.sub.buckle in a number of
ways to provide suitable protection. In one embodiment, the shear
force F.sub.shear is about 1/3.sup.rd of the blade buckle force
F.sub.buckle. In another embodiment, the shear force F.sub.shear is
in the range from about 0.25F.sub.buckle to about 0.75F.sub.buckle,
including all values and sub-ranges therebetween. In yet another
embodiment, the shear force F.sub.shear is in the range from about
0.1F.sub.buckle to about 0.9F.sub.buckle, including all values and
sub-ranges therebetween. In modified embodiments, the shear force
F.sub.shear may be lower or higher, as needed or desired.
[0284] FIGS. 32 and 33 illustrate a connection between the blade
106 and the slide plate 138 in accordance with an embodiment that
provides a safety shear decoupling between the 106 and the slide
plate 138. In modified embodiments, as the skilled artisan will
appreciate, the blade 106 and the slide 138 may be connected
utilizing other suitable techniques, as needed or desired.
[0285] FIG. 34 shows the hybrid dual toroid drive 136 with a pair
of associated bearings 272, 274 operatively mounted on the slide
plate 138. The bearings 272, 274 and their toroid abutting surfaces
276, 278 are spaced by a predetermined distance that allows the
variable thickness cam outer rim 150 to be in substantially
continuous contact while rotating. In this embodiment, the rotation
axis 232 is substantially perpendicular to a plane 280 between the
bearing surfaces 276, 278.
[0286] The specially configured bearing abutting surfaces 282, 284
of the outer rim 150 advantageously provide an increased surface
contact area with respective bearing surfaces 276, 278. This
desirably decreases the pressure load between driving toroidal
surfaces 282, 284 and the driven linear slide follower bearings
272, 274 and their respective surfaces 276, 278. The bearings 272,
274 also provide for a low friction contact with the driving
toroidal surfaces 282, 284 and advantageously improve
wear-resistant properties.
[0287] FIG. 35 shows a modified embodiment wherein the toroid drive
136 has an outer rim 150a that substantially contacts the bearing
surfaces 276, 278 mounted on the slide 138 in a low surface area or
point contact arrangement. In further embodiments, the cam outer
rim 150 can directly contact the slide bearing surfaces 164 and
166, as needed or desired.
[0288] FIG. 36 shows the operation of the toroidal transmission and
power converter system 98 in a laboratory system set-up. Rotation
of the toroid drive 136 is about the central rotary axis 232 is
converted into linear reciprocating motion of the slide 138 as
generally indicated by arrows 204. The slide is connected to the
cutting blade 106. Also shown are the slide bearings 272 and
274.
Irrigation Pump System
[0289] A pulsatile water pump system 290 is incorporated into the
disposable cutting blade assembly 18 and is housed within the
distal cover 72. The pulsating water pump 290 supplies sterile
water into a patient and in one embodiment is disposed after one
use to insure no "patient to patient" bio-contamination. The
pulsatile pump system of embodiments of the invention has utility
in a number of fields and applications where fluid transport is
desired. In one embodiment, a pulse of water is provided after each
linear motion stroke.
[0290] The integrated cutting blade water pump system 290 is
advantageously driven by blade motion and insures that the blade
106 will automatically be cooled and lubricated whenever the
cutting blade 106 is in reciprocating motion. In modified
embodiments, an external pump system may be utilized, as needed or
desired.
[0291] The water pump system 290 lubricates the reciprocating blade
moving parts. The water pump system 290 cools the reciprocating
blade moving parts. The water pump system 290 provides clear water
for optical vision capability.
[0292] The pulsating water pump system 290 more effectively clears
debris from the cutting blade surface for better cutting
performance by providing pulsed jets of irrigation fluid. The
pulsatile water pump system 290 is driven by reciprocating cutting
blade motion pumps water whenever reciprocating blade 106 is
driven. In modified embodiments, the system may have a manual
override feature for pump operation.
[0293] FIG. 37 shows the pulsatile dual direction water pump system
290 in accordance with an embodiment. The pump system 290 has a
stationary pump body 292 that includes an inlet 294, a flow chamber
296 and an outlet 298. The inlet 294 is fed water from the
umbilical cord 16 or through another feedline. The outlet 298
provides water to the bearing retainer 118 within the blade shield
108. The general direction of flow or the fluid path through the
pump 290 is generally indicated by arrows 302.
[0294] The inlet 294 has a one-way or check valve 304 and the
outlet 298 has a one-way or check valve 306 to prevent undesired
back-flow. Any one of a number of suitable valves may be used such
as, but not limited to, pressure relief valves, ball-spring devices
and the like.
[0295] The pump system 290 includes a pair of spaced spring-biased
or -loaded plungers 308, 312. In modified embodiments, other
suitable resilient biasing or loading mechanisms may be
efficaciously utilized, as needed or desired. The plungers 308, 312
can move back and forth into the pump chamber 296 to selectively
occlude the pump chamber 296 and/or fluid path 302 to displace
fluid and pulsatingly pump it to the desired site. Water is drawn
in from the inlet 294 through the valve 304 as the plungers 308,
312 move back towards their undepressed position.
[0296] The slide 138 has a lower surface 314 with a pair of
specially contoured and spaced cam surfaces 316, 318 that
operatively couple the slide 138 with the pump plungers 308, 312.
During a forward linear stroke motion the distal cam surface 316
contacts or abuts the distal plunger 308 and depresses it to pump
water out of the outlet 298. During a backward linear stroke motion
the proximal cam surface 318 contacts or abuts the proximal plunger
312 and depresses it to pump water out of the outlet 298.
[0297] Thus, the reciprocating linear stroke blade drive motion
moves cam surfaces 316, 318 to alternatingly depress pump plungers
and thereby pump water in a pulsing modality whenever the driven
cutting blade 106 is moved through a linear stroke by the
transmission system 98. Desirably, the transmission system 98
provides the motion, force or energy to substantially
simultaneously and synchronously drive the reciprocating blade 106
and the pulsatile pump system 290.
[0298] In embodiments of the invention, the water pump 290 is
integrated into the reciprocating blade mechanism. The pulsatile
(pulsating with each linear stroke) water pump feature pulses a jet
of water out through the cutting blade irrigation holes 212 to keep
the cutting surface 114 clean for optimum cutting action. The pulse
powered pump 290 is powered by the reciprocating action of the
cutting blade 106. Advantageously, this direct drive eliminates a
separate pump drive source. This desirably saves parts and cost by
eliminating a separate water pump.
[0299] The disposable cutting tip assembly 18 is sterile. It
incorporates the water pump 290 which is also sterile. The pump 290
is very close or proximate to the site where the pressurized water
is provided. Advantageously, this reduces pressure losses that
would be incurred if the pump is at a distance from the point of
use. It desirably also solves the problem of sterilizing a far away
water pump.
[0300] When the reciprocating blade device 106 is cutting it should
be provided lubrication and cooling and the cutting surface 114
should desirably also remain clean and clear of tissue debris. The
water pump 290 pumps water when the cutting surface 114 is
activated as the same drive mechanism drives both. Thus, an
operator need not remember to activate the pump 290 since its
operation is automatically actuated with cutting blade 106.
Desirably, this provides a safety feature to prevent damage,
galling, a freeze up and also prevents cutting debris buildup and
thermal glazing.
[0301] The pump system 290 can be formed from a number of suitably
durable materials. In one embodiment, the pump system 290 is formed
from a suitable plastic. The plastic material may comprise a
suitable thermoplastic. In modified embodiments, other suitable
plastics, metals, alloys, ceramics, combinations thereof, among
others, may be efficaciously utilized, as needed or desired.
Suitable surface coatings or finishes may be applied, as required
or desired.
[0302] The pump system 290 can be fabricated by using a number of
manufacturing techniques. These include, but are not limited to,
molding, machining, casting, forging, laser cutting and/or
processing, laminating, adhesively fixing, welding, combinations
thereof, among others, with efficacy, as needed or desired.
[0303] FIG. 38 shows a pulsatile single direction eater pump system
290a in accordance with another embodiment. The pump system 290a
includes a plunger 320 connected to the slide 138. During forward
linear stroke motion the plunger 320 occludes the pump cavity 296
to displace water form the outlet 298 to the desired site. During
backward linear stroke motion the plunger 320 moves in an outward
direction from the pump cavity 296 and water is drawn into the
cavity 296 through the inlet 294.
Powered Handpiece
[0304] FIG. 39 shows the powered handpiece 20 including the cover
or housing 74, the video camera 78, the motor assembly 80 and a
distal interface member 322 for connecting to the interface member
102 and coupling 104 of the distal tip assembly 18. The interface
member 322 has an opening 324 substantially aligned with the
interface opening 158 which allow passage of the fiber optic probes
124, 126 for connection to the camera 78.
[0305] The proximal end 70 of the distal tip assembly 18 and the
handpiece's distal end or portion 326 are configured and adapted to
provide a quick and reliable connection or mating. This includes,
but is not limited to, mechanical docking, electrical docking,
optical docking and hydraulic docking.
[0306] The housing 74 and motor assembly 80 are steam sterilizable.
The steam sterilization process involves the application of hot
water and steam under pressure to kill germs followed by a partial
drying process. The drying process is not always fully complete in
that the instruments and parts processed, often come back partially
wet. Usually there are small pockets of standing water trapped in
small pools created by part shapes with water-titer pockets that
end up facing upward due to there placement in the holding trays
used to contain the parts and instruments to be steam
sterilized.
[0307] With the routine use of steam sterilization it is desirable
that any optical or electronic parts that are used with the steam
sterilized instruments be designed to provide solutions to residual
water and the problems it can create with electromechanical and
opto-mechanical components. As discussed further below, the motor
housing also houses the video camera module, which in inserted into
the freshly sterilized motor housing. The hermetically sealed video
camera module is designed to specifically address the specialized
problems of residual water in a freshly steam sterilized surgical
instrument in a sterile surgical setup environment.
[0308] The handpiece housing 74 has a motor housing 328 that
receives the motor assembly 80 and the video housing 76 that
receives the video camera 78. The video camera 78 is contained in
the video housing 76 which provides a hermetically sealed housing.
The video housing 76 desirably provides a water and gas sealed
environmentally protective housing. The video camera 78 optically
connects to the proximal end 70 of the distal tip assembly 18 and
interfaces with the imaging fiberoptics.
[0309] The cable 16, the cover 68 and the components of the
handpiece 20 are sterilizable except for the video camera 78 that
is hard to sterilize. During assembly in a sterile field operating
room, the non-sterile video camera 78 is inserted into a freshly
sterilized handpiece housing 74. A hermetic (gas and liquid) seal
is created by O-ring seals or the like. The O-rings are part of the
interface at the handpiece's proximal end 330 and the distal end
interface 322. Advantageously, this hardware and procedure combined
together enables a non-sterile delicate electronic video camera to
be made bacteriologically safe inside the sterile outer housing 74
of the sterilized handpiece 20.
[0310] The housing 74 also contains an LED illuminator 332 that
connects to the illumination fiberoptics of the distal tip assembly
18. The LED (Light Emitting Diode) 332 is also mounted into the
video housing 74 in a waterproof and gas-tight method to prevent
intrusion and damage from water or water vapor accumulation. In one
embodiment, a distal video imaging lens 334 is recessed to help
prevent accidental damage.
[0311] The camera 78 can be provided in a mount 336 with an outer
shape that is designed to prevent the incorrect insertion into the
housing 74. The mount 336 has a male structure 338 that is received
within a mating female receptor opening 340 within the housing 74.
The male structure 338 provides the mount 336 with an asymmetrical
cross sectional shape that is intended to create a visually obvious
shape that can be readily inserted into its mating female receptor
opening 340 in the correct or desired orientation.
[0312] In one embodiment, the camera 78 and the mount 336 comprise
a video module 342 with the camera 78 housed in a waterproof and
air-tight manner as discussed above in connection with the video
housing 74. The hermetically sealed video module 342 can then be
fitted within in the housing 74. The LED 332 can also be
hermetically sealed within the module 342, for example, in an
opening 344.
[0313] The camera 78 can comprise any one of a number of suitable
video or digital devices. In one embodiment, the video camera 78
comprises a device as available from Toshiba. Advantageously, the
integration of the video camera 78 within the handpiece 20 greatly
enhances the capability, compactness, utility and versatility of
the system.
[0314] As discussed above, the sterilizable powered handpiece 20
contains a non-sterile non-sterilizable video camera 78 contained
inside the sterile hand piece assembly. Advantageously, the sterile
powered handpiece 20 hermetically seals the non-sterile video
camera 78 in a sterile housing 74 or 336, which permits safely
using the sealed assembly in the sterile field and inside a
patient's body.
[0315] The handpiece 20 can include one or more switches or buttons
that allows the user to operably control the surgical file
operation. Alternatively, or in addition, the controls can be
provided on a separate platform and/or on the control system
14.
[0316] The precision motor 80 can comprise any one of a number of
suitable rotary motion creating devices such as, but not limited
to, gas turbines and electric motors and the like. In one
embodiment, the motor 80 comprises a gas or air turbine rotary
motor that is fed pressurized air or gas through the umbilical cord
16.
[0317] In one embodiment, the gas turbine motor 80 is provided air
or gas at about 80 psi to run the device. In another embodiment,
air or gas is provided at a pressure in the range from about 50 psi
to about 100 psi, including all values and sub-ranges therebetween.
In modified embodiments, the pressure can be lower or higher, as
needed or desired.
[0318] The motor assembly 80 at its distal end or portion 342
includes a rotatable power shaft 344 connected to a rotatable drive
shaft 346. The motor distal end 342 docks with the proximal end 70
of the distal tip assembly 18. The power shaft 344 is generally
received in the distal tip assembly holes 162, 160 and 149.
[0319] The motor 80 powers the reciprocating blade 106. The male
drive shaft 346 is substantially irrotationally received within the
matching female receptor hole of the drive shaft 140 to provide
rotary motion to the transmission system 98 that converts it into
linear reciprocating motion.
[0320] FIG. 40A shows a simple triangular shaft 346a that can
engage the triangular receptor hole 254a. When the distal tip
assembly 18 and the powered handpiece 20 are connected both the
female triangular receptor hole 254a and the motor's male
triangular drive shaft 346a can rotate in tandem. The male and
female features are free to mesh and align during the axial motion
of connecting the disposable cutting tip assembly 18 onto the
reusable sterilizable motor handpiece 20. This docking feature has
a simplified rotary triangular shaped drive shaft, even though it
drives a reciprocating (push-pull) motion-cutting blade.
[0321] A triangular shaped male mating drive 346a is desirable
because it facilitates sterilization of the male triangular shaft
346a. The surfaces that are steam sterilized and reused are
desirably simple surfaces that are easy to wash and clean. The
surfaces should also enable reliable cleaning prior to
sterilization. The triangular male shaft 346a has three flat
surfaces that are both easy to see and clean.
[0322] In modified embodiments, other suitable male-female mating
drive polygonal or non-polygonal interlocking configurations may be
utilized with efficacy, as needed or desired. For example, FIG. 40B
shows a generally square or rectangular male shaft 346b and FIG.
31C shows a generally hexagonal male shaft 346c.
Surgical Methods
[0323] The methods which are described and illustrated herein are
not limited to the sequence of acts described, nor are they
necessarily limited to the practice of all of the acts set forth.
Other sequences of acts, or less than all of the acts, or
simultaneous occurrence of the acts, may be utilized in practicing
embodiments of the invention.
[0324] The surgical instrument of embodiments of the invention
enable the removal of obstructions in the tubular spaces
(neuroforamen) between the vertebras of the neck and back.
Desirably, this allows surgeons to navigate into the tiny
(neuroforamen) canals between delicate nerve roots and remove small
amounts of bony overgrowth (osteophytes) under direct vision.
[0325] Embodiments of the invention allow a surgeon to safely
navigate down into the neuroforamen canal next to the nerve roots
and see and remove obstructions that cause nerve compression with
direct vision. The surgeons can perform a new surgical procedure, a
"micro foramentomy" through as small as about a 1/2 inch to about 1
inch incision. This advantageously represents a truly minimally
invasive surgical procedure which would serve to benefit patients
and surgeons.
[0326] FIGS. 41 and 42 show a bone and/or tissue cutting procedure
using the surgical instrument 12. The shielded cutting blade 106 is
inserted into a neuroforamen 348 between a vertebra 350, unwanted
bone and/or tissue 352 and a nerve root 354. The shield 108
protects the nerve root 354 while the blade cutting surface 114
removes the bone and/or tissue 354 to relieve nerve compression by
enlarging the neuroforamen 348.
[0327] Advantageously, embodiments of the invention provide a high
level of cutting blade control and enable surgeons to reach into
previously inaccessible areas to remove unwanted bone with
precision, sensitivity and complete safety and confidence. The
shielded cross sectional profile of embodiments of the cutting tip
permit protection of delicate nerves during the neuroforamen
enlargement process to relieve nerve compression.
[0328] As seen in FIG. 42, the shielded portion 108 of the file is
facing the delicate nerve 354 and the opposite cutting surface 114
is facing the bone that is to be removed 352 to enlarge the bony
and cartilage structural opening. Advantageously, the surgical
instrument of embodiments of the invention has a cutting surface
114 that can travel around corners. A direct vision system allows
surgeons to safely navigate into blind cavities of the patient's
body and also assists visualization of the actual tissue cutting
action and its results.
[0329] In the embodiments of a sterile disposable (one time use)
cutting tip assembly 18, the cutting tip assembly 18 is used
typically, in one embodiment, for about three minutes in a two-hour
surgical procedure. The tip of the distal assembly 18 can provide
the surgeon with a picture of the area, and enable the doctor to
see the cavity and its anatomical features.
[0330] The view is magnified so the user sees a full screen image
of the small tunnel, which is typically, in one embodiment, about
one quarter of an inch in diameter. The enlarged view of the area
allows surgeons to inspect and find the exact location and size of
nerve irritation and compression, and determine where and how much
bone and cartilage to remove to eliminate the nerve compression and
relieve the pain.
Orthopaedic File Embodiments, Components, and Procedures
[0331] FIGS. 43-45 show different views of an orthopaedic shielded
reciprocating surgical file instrument or apparatus 12a. The
surgical file instrument 12a generally comprises a distal tip
assembly 18a docked to and powered by a handpiece 20a.
[0332] The distal blade assembly 18a generally comprises a
reciprocating blade 106a with a cutting surface 114a and a shield
or guard 108a. The cutting surface 114 has an abrasive material or
abrasives 206a.
[0333] The distal blade assembly 18a further includes a handle 356
above the blade 106a. The handle 356 is used by a surgeon to press
against or down on the bone and/or tissue material to be removed.
The handle 356 is shaped to facilitate manipulation and has a
suitable ergonomic shape or the like. The handle 356 further
includes an opening 358 to facilitate operation.
[0334] FIGS. 46-48 illustrate a surgical instrument 400 in
accordance with another embodiment. The illustrated surgical
instrument 400 is a surgical file device that includes a handle
assembly 403 and a distal tip assembly 405. The handle assembly 403
has a powered handpiece 410 that is connected to a modular body
assembly 416. The modular body assembly 416 comprises a housing 418
that is connected to the distal tip assembly 405. The distal tip
assembly 405 includes a distal tip portion 420 that has a somewhat
L-shaped distal tip 422. The surgical file device 400 also includes
a visualization system 430 that provides viewing of a target
surgical area. When the distal tip 422 is used to perform a
surgical procedure, the visualization system 430 provides viewing,
preferably direct viewing, of the surgical site. The illustrated
visualization system 430 includes an endoscope 432 that can be
connected to an imaging capturing device 434. The endoscope 432 can
extend through the modular body assembly 416 such that a viewing
element 470 is positioned to provide viewing of the distal tip
422.
[0335] FIG. 47 illustrates the surgical file device 400 when
unassembled. The powered handpiece 410 is a powered device that can
be used to operate the body assembly 416. The illustrated powered
handpiece 410 is in the form of a standard motorized rotary
handpiece that can be pneumatically powered, electricity powered,
and/or mechanically powered. Other types of handpieces can also be
used to drive the body assembly 416.
[0336] The handpiece 410 has a distal handpiece connector 440 and a
proximal handpiece connector 442. A body 446 of the handpiece 410
extends between the connectors 440, 442. The distal handpiece
connector 440 is configured to mate with a handpiece docketing
assembly 446 of the body assembly 416. Preferably, the distal
handpiece connector 440 is in the form of a quick connector that
can be easily coupled to and removed from the handpiece docketing
assembly 446. Various types of connectors can be utilized depending
on the configuration of the body assembly 416 and the handpiece
410.
[0337] To switch handpieces, the illustrated handpiece 410 can be
decoupled from the handpiece docketing assembly 446. Another
handpiece can then be coupled to the handpiece docketing assembly
446. The quick connection thus allows a user to quickly change
between any number of handpieces. A single handpiece can be used
with more than one body assembly.
[0338] With reference again to FIGS. 46-48, the proximal handpiece
connector 442 is configured to be connected to an umbilical cord
447 that can deliver power to the handpiece 410. Non-limiting
exemplary umbilical cords can be pressurized air lines, electrical
lines, and other types of lines that are used for effectively
powering surgical devices. The illustrated umbilical cord 447 of
FIG. 48 has an umbilical cord connector 444 for coupling to the
proximal handpiece connector 442. To couple the line 447 to the
handpiece 410, the connector 444 can be inserted over the proximal
handpiece connector 442.
[0339] As shown in FIG. 49, the distal handpiece connector 440
includes a drive shaft 448 that can be coupled to a proximal end of
a drive system 480. The illustrated drive shaft 448 can be moved
distally until it is coupled to the drive system 480. The drive
shaft 448 can be rotated by a drive motor 450. The motor 450 is
surrounded and protected by a housing 452. The housing 452 provides
a comfortable gripping surface for the user. The housing 452 can
advantageously provide a thermal barrier to limit heating of an
outer gripping surface of the handpiece 410. As such, the housing
452 can form a surface that is maintained at a suitable temperature
for gripping, even when the motor 450 reaches elevated
temperatures. In some cases, the handpiece 410 can drive a
disposable distal tip assembly 405. After the distal tip assembly
405 is spent, the distal tip assembly 405 can be discarded and
replaced with another distal tip assembly. If desired, the
handpiece can be a standard handpiece. These types of powered
handpieces are often found in hospital surgical rooms. Accordingly,
the modular body 416 can be used with standard power devices
without the need of additional tools or power sources.
[0340] With reference again to FIG. 46, the modular body assembly
416 is configured to receive the endoscope 432. The endoscope 432
extends through the housing 418 and the distal tip portion 420 so
that the viewing element 470 is positioned near the distal tip 422.
When the endoscope 432 is in the illustrated position, the body
assembly 416 can securely hold the endoscope 432. If desired, the
endoscope 432 can be retracted and pulled out of the body assembly
416 to perform maintenance on the endoscope, replace the endoscope,
or for any other reason.
[0341] To position the endoscope 432, the housing 418 has a pair of
guides 476 (see FIG. 47) configured to receive an illumination
light port 481 of the endoscope 432. The illumination light port
481 of the endoscope 432 can extend outwardly between the guides
476 such that the guides 476 inhibit rotation of the endoscope 432
with respect to the housing 418. The guides 476 can advantageously
maintain proper alignment of the endoscope 432 during a surgical
procedure, even if the surgical file device 400 is subjected to
external forces or sudden acceleration, for example. The
illustrated guides 476 are protrusions that define a U-shaped
channel that is sized to receive the light port 481. Other types of
guides can also be used to position the endoscope 432. One or more
clamps, pins, ties, brackets, or other suitable structures can be
used to position the endoscope 432. Thus, various types of
arrangements can be used to lock an endoscope to body assembly
416.
[0342] With respect to FIG. 49, the body assembly 416 includes the
drive system 480 for drivingly connecting the powered handpiece 410
to a cutting blade at the distal tip 422. The drive assembly 480 is
a mechanical transmission that converts rotary motion of the
powered handpiece 410 to reciprocating, linear motion for driving
the cutting blade.
[0343] FIG. 50 illustrates the drive system 480 disposed in the
housing 418. The drive system 480 comprises a toroidal drive 500
that is driven by the motor 450 of the handpiece 410. A drive shaft
502 of the toroidal drive 500 can be permanently or temporarily
coupled to the drive shaft 448 of the handpiece 410. A rim cam 504
of the toroidal drive 500 is interposed between and contacts
follower bearings 510 of a slide plate 512. When the toroidal drive
500 rotates about its longitudinal axis, the cam 504 pushes and
pulls on the bearings 510 because the slide plate 512 is restrained
so that it slides linearly along the housing 418.
[0344] The drive system 480 also includes a drive member 516
extending through a drive member passageway 530 formed in the
housing 418. The drive member 516 connects the slide plate 512 to
the drive ribbon 600. Alternatively, the drive member 516 can be
directly connected to the blade.
[0345] A sealing member 522 can surround the drive member 516 to
inhibit fluid flow past the drive member 516 through the drive
member passageway 530. The drive member 516 and sealing member 522
cooperate to isolate fluid in the body assembly 416 in order to
avoid damage to components of the surgical file device 400.
[0346] The drive member 516 can have any suitable configuration to
engage the sealing member 522. Non-limiting exemplary drive members
516 can have a polygonal, elliptical, circular, or any other
suitable axial cross-section depending on the intended application.
The drive member 516 can be a tube, plate, rod, and the like. The
drive member 516 is preferably securely coupled to the slide plate
512. As the toroidal drive 500 rotates, the slide plate 512 and the
drive member 516 are actuated together in a linear direction.
[0347] The sealing member 522 can be disposed in a recess formed in
the drive member passageway 530. The sealing member 522 is somewhat
compressed against the outer surface of the drive member 516 and
the wall of the passageway 530. In such a configuration, the
sealing member 522 can effectively inhibit fluid flow along the
drive member passageway 530 past the sealing member 522. Other
sealing arrangements can also be employed to seal portions of the
body assembly 416.
[0348] With respect again to FIG. 49, the body assembly 416 can
have a fluid system 550 for providing fluid irrigation and/or fluid
removal at the surgical site. When the distal tip 422 is positioned
at a surgical site, the fluid system 550 can deliver irrigation
fluid (preferably sterile irrigation fluid) to the surgical site to
enhance tissue removal. Alternatively, or in addition, the fluid
system 550 can remove substances, such as irrigation fluid, tissue
(including detached tissue, particulate, debris, contaminants) and
the like, from the surgical site.
[0349] The body assembly 416 has an inlet connector 560 and an
outlet connector 562 that are configured to connect to an input
fluid line 571 and an output fluid line 573, respectively. See FIG.
48. Fluid delivered into the inlet connector 560 can be circulated
through the body assembly 416 and is eventually expelled out of the
distal tip 422 at the surgical site.
[0350] In some embodiments, material at the surgical site (e.g.,
tissue and the irrigation fluid) can be sucked into the distal tip
422 and is eventually drawn through the surgical file device 400
until it reaches the outlet connector 562. The fluid can then be
delivered out of the outlet connector 562 and into the outlet line
573. Thus, fluid can flow continuously into and out of the surgical
file device 400 to irrigate a surgical site and/or remove
undesirable substances at the surgical site.
[0351] The irrigation fluid can be delivered by any suitable means
to the inlet connector 560. To aid fluid flow through the fluid
system 550, one or more pressurization devices can be employed to
pressurize the irrigation fluid. For example, pumps, such as a
parastolic pump, can be connected to the fluid line. The pump can
pressurize the irrigation fluid to enhance fluid flow through the
fluid system 550.
[0352] The inlet connector 560 and the outlet connector 562 can
have various configurations as are known in the art. Preferably,
the connectors 560, 562 are quick connectors configured to couple
to standard fluid lines. In some embodiments, the connectors 560,
562 have a different configuration from each other so that a
clinician can visually distinguish between the connectors. This can
help the clinician determine which line should be attached to a
particular connector. The inlet connector 560 of FIG. 48 can be
specifically designed to receive the inlet fluid line 571 but not
the outlet fluid line 573. Similarly, the outlet connector 562 can
be specifically designed to receive the outlet fluid line 573 but
not the inlet fluid line 571. Accordingly, the connectors 560, 562
may reduce the likelihood that an improper line is connected to the
corresponding connector. Alternatively, the connectors 560, 562 can
have similar or identical configurations, if desired.
[0353] With reference to FIG. 50, an irrigation system 551 includes
an inlet connector passageway 570 of that extends to a valve system
574. The valve system 574 of the irrigation system 551 regulates
fluid flow through the body assembly 416. The valve system 574 is
in the form of a check valve that permits one way flow
therethrough. The illustrated valve system 574 comprises a movable
valve member 580 and a biasing member 582. A valve member chamber
584 houses the members 580, 582. The movable valve member 580 bears
against a narrowing portion 569 of the valve member chamber 584.
The biasing member 582 is interposed between the valve member 580
and an upper end of the valve member chamber 584. Fluid can flow
through the valve system 574 by lifting the valve member 580 away
from the surface of the narrowing portion 569, but pressure in the
opposite direction will force the valve member 580 against the
narrowing portion 569 inhibit fluid flow in the reverse
direction.
[0354] The illustrated biasing member 582 permits fluid flow
through the valve system 574 when a relatively low pressure
differential exists. For example, when the upstream pressure is
equal to or greater than 3 psi greater than the downstream
pressure, the valve system 574 can open. The pressure differential
moves the valve member 580 thereby compressing the biasing member
582 to open the valve system 574. Once the pressure differential
drops to less than 3 psi, the biasing member 582 moves the valve
member 580 to the closed position. The stiffness of the biasing
member 582 can be chosen based on the desired actuation pressure
for opening and closing of the valve system 574. Other types of
check valves, gate valves, flow regulators, and the like can be
used to control fluid flow through the device 400.
[0355] The fluid system 550 can also have a pumping chamber 590
that is in fluid communication with the valve system 574 and the
distal tip 422 illustrated in FIG. 46. The pumping chamber 590 is
configured to contain fluid that can be pressurized to a
sufficiently high pressure such that the fluid flows through a
delivery lumen 614 that extends along the length of the distal tip
portion 420. The pressurized fluid ultimately can be expelled out
of the distal tip 422.
[0356] To pressurize fluid in the pumping chamber 590, the drive
member 516 can be actuated between a first position and a second
position. In some embodiments, including the illustrated embodiment
of FIG. 50, the drive member 516 reciprocates in a forward and
backward motion.
[0357] The pressure in the pumping chamber 590 is increased or
decreased as the drive member 516 is moved distally or proximally,
respectively. When the drive member 516 is displaced proximally,
the pressure in the pumping chamber 590 can be sufficiently reduced
so that fluid flows through the valve system 574 and into the
pumping chamber 590. When the drive member 516 moves distally
through the pumping chamber 590, the pressure within the chamber
590 is increased. The increased pressure causes the valve system
574 to close. Additionally, the pressurized fluid flows from the
pump chamber 590 through a ribbon passage 602 and the delivery
lumen 614.
[0358] With reference to FIGS. 50 and 50A, the delivery lumen 614
of the distal tip portion 420 extends from the ribbon passage 602
to the distal tip 422. Fluid flowing distally through the delivery
lumen 614 can proceed along the distal tip portion 420 until it is
ultimately expelled out of the distal tip 422. One of ordinary
skill in the art can select the size of the delivery lumen 614 to
achieve a desired fluid flow through the distal tip portion
420.
[0359] As shown in FIG. 51, the distal tip 422 outputs irrigation
fluid, F, to irrigate a surgical site. In the illustrated
embodiment, the irrigation fluid F flows out of a blade 592 mounted
to a lower blade structure 593. To remove the freshly cut tissue
and expelled irrigation fluid, the fluid system 550 can also
comprise an optional removal system 594. The removal system 594 can
draw in the mixture of freshly cut tissue and irrigation fluid to
improve visibility of the surgical site.
[0360] The removal system 594 includes an inlet -port 595
positioned so that material at the surgical site can be drawn into
the distal tip 422. The position and configuration of the inlet
port 595 can be chosen based on the flow dynamics of the irrigation
fluid. The illustrated inlet port 595 is position at the
distal-most portion of the lower blade structure 593 of the distal
tip 422. A distal face 597 of the lower blade structure 593 can
define the inlet portion 595. Irrigation fluid can flow distally
along the blade 592. Once the fluid reaches the end of the distal
tip 422, the fluid flows around the distal tip 422 towards the
inlet port 595. As shown in FIG. 51, the mixture of solids (e.g.,
particulate, contaminates, tissue, etc.) and irrigation fluid can
be pulled into the inlet port 595 and then flows proximally along a
return lumen 620 towards the housing 418.
[0361] The illustrated inlet port 595 is a single aperture.
However, the inlet port 595 can include a plurality of apertures
for receiving material at the surgical site. The positions and the
sizes of the apertures can be selected to achieve the desired flow
dynamics for effective irrigation of the surgical site. In some
embodiments, the distal tip 422 can have a plurality of inlet ports
positioned along the lateral sides and/or the front surface of the
distal tip 422.
[0362] With reference to FIGS. 50 and 51, the return lumen 620
provides fluid communication between the inlet port 595 and the
outlet connector 562 (see FIG. 49) of the removal system 594. In
some embodiments, the return lumen 620 extends through the distal
tip portion 420, the housing 418, and the handpiece 410. Suction or
aspiration can be provided by the fluid line 573 attached to the
outlet connector 562. Thus, the removal system 594 and the outlet
line 573 can cooperate to remove material from the surgical site
that may undesirably obstruct a physician's viewing. As such, the
visual sight field can remain substantially free of debris for a
clear line of sight for enhanced viewing of the cutting blade and
the tissue removal process. The removal system 594 can also remove
contaminates, debris, detached tissue, and the like. Alternatively,
or in addition, the surgical file device 400 can have one or more
pumps for drawing fluid through the return lumen 620.
[0363] With reference again to FIG. 50, the reciprocating drive
ribbon 600 couples the drive member 516 to the cutting blade 592.
In some embodiments, the reciprocating drive ribbon 600 can be a
somewhat thin, flexible band that is sized to fit within a ribbon
passageway 602. In some non-limiting embodiments, the drive ribbon
600 is constructed of metal (e.g., stainless steel) and has a
thickness of about 0.004 to 0.008 inches. In such an embodiment,
the drive ribbon 600 can bend easily through the curved ribbon
passageway 602. Other materials can also be used to form the drive
ribbon 600. The drive ribbon 600 can preferably flex and assume a
curved shape, even when drive ribbon 600 is reciprocated. As used
herein, the term "reciprocate" is a broad term and includes, but is
not limited to, the concept of moving an object alternatingly in
substantially opposite directions. If the drive ribbon 600 is made
of a stainless steel, the ribbon 660 can be flexible with high
deflection limits. In alternative embodiments, the drive member 516
can be connected to the blade 592 by a flexible rod or other
suitable structure. The rod can comprise a flexible material so
that it can assume various curved configurations. The rod can be a
single element or may comprise multiple elements. Alternatively,
the drive member 516 can be directly coupled to the proximal end of
the cutting blade 592.
[0364] Because the drive ribbon 600 of FIG. 50 can assume a curved
configuration, the toroidal drive 500 can be positioned away from
the longitudinal axis of the distal tip portion 420. The toroidal
drive 500 can thus be spaced from the endoscope 432 extending
through the housing 418. Accordingly, the housing 418 can have a
somewhat compact configuration.
[0365] The distal tip portion 420 of FIGS. 50 and 50A has a body
598 that has a working lumen 610 extending the entire length of a
body 598. The delivery lumen 614 and the return lumen 620 also
extend axially through the body 598. The upper portion of the blade
590 may or may not be disposed within the delivery lumen 614 or the
working lumen 610. The illustrated working lumen 610 extends
axially along the distal tip portion 420 to a distal tip portion
opening 614 of FIG. 51. During a surgical procedure, irrigation
fluid can flow through the body 598 via the delivery lumen 614..
The irrigation can flow out into the surgical site. Fluid and cut
tissue can be sucked in the distal tip 422 and can flow proximally
through the the return lumen 620. As detailed above, the fluid can
then flow through the housing 418 and through the powered handpiece
410 until it eventually flows out of the fluid outlet connector 562
and into the outlet line 573.
[0366] The body 598 can be constructed of metal, polymers,
plastics, combinations thereof, or any other suitable material
having appropriate structural properties for the intended
application of the device 400. Additionally, the body 598 can have
any number of lumens. The illustrated body 598 has four lumens, but
the body can have any number of lumens nding on the application.
The lumens of the body 598 can have polygonal (including rounded
polygonal), elliptical, circular, or any other cross-section as
desired.
[0367] FIG. 47 illustrates a receptor port 618 of the housing 418
that is configured to receive a distal end 620 of the endoscope
432. To assemble the modular body assembly 416 and the endoscope
432, the distal end 620 of the endoscope 432 can be inserted into
the receptor port 618. The endoscope 432 can then be advanced along
the instrument lumen 610, until an enlarged proximal portion 619 of
the endoscope 432 contacts a seat 622 of the housing 418, as shown
in FIG. 50. The enlarged portion 619 and the seat 622 can have a
similar shape. When the endoscope 432 is assembled with the body
assembly 416, the guides 476 and seat 622 cooperate to hold
securely the endoscope 432.
[0368] An elongated body 640 of the endoscope 432 can have such a
length that the endoscope 432 extends through the housing 418 and
the distal tip portion 420. The distal end 620 of the endoscope 432
preferably extends out of the distal portion opening 614 (see FIG.
51). The illustrated elongated body 640 is a cylindrical body sized
to fit within the working lumen 610 of the distal tip portion
420.
[0369] As shown in FIG. 48, the endoscope 432 can be inserted into
the receptor 618 in the direction indicated by the arrow 483. The
endoscope 432 can be inserted into the body assembly 418 until the
enlarged portion 619 of the endoscope 432 rests against the seat
622 of the housing 418.
[0370] FIG. 52 illustrates the distal tip 422 of the surgical file
device 400. The distal end 620 of the endoscope 432 extends out of
the distal portion opening 614 and is near the cutting surfaces of
the cutting blade 592. The illustrated endoscope 432 of FIG. 53 is
aligned to provide a field of vision for direct visualization of a
surgical site. The line of sight of the endoscope 432 can be
generally aligned with the longitudinal axis of the blade 592. If
the endoscope is in such a position, the user can view the cutting
blade 592 cutting tissue during a surgical procedure. However, the
endoscope 432 can be at other orientations depending on the
surgical procedure. For example, the endoscope 432 can have a line
of sight that is offset or angled from the centerline of the
cutting blade 592. In the illustrated embodiment, the distal tip
portion 420 has a longitudinal axis 453. The endoscope 432 provides
viewing of a distal tip 422 when the distal tip 422 is offset from
the longitudinal axis 453.
[0371] In the illustrated embodiment of FIG. 53, the distal end 620
of the endoscope 432 defines the viewing element 470 in the form of
optical prism. The configuration of the prism can be chosen based
on the desired range of viewing. The illustrated viewing element
470 is in a 70 degree prism (i.e., .delta. is about 70 degrees)
that defines a field of vision having an angle .alpha.. The
illustrated viewing element 470 has a 50 degree field of vision,
although the viewing element 470 can have any desire field of
vision. For example, field of vision can have an angle a that is
about 40 degrees, 50 degrees, 60 degrees, or any other angle
suitable for providing adequate visualization to an operator. This
viewing element 470 provides direct visualization during navigation
of the surgical file device 400 and positioning of the distal tip
422. This enables an operator to navigate in areas of the body
having sensitive nerve roots, blood vessels, or other delicate
structures under direct vision.
[0372] Various types of diagnostic tests can be performed to
evaluate and determine an appropriate treatment for a patient. A
patient may have a disorder (e.g., facet joint disorder) that
adversely affects the patient. The surgical file device 400 can be
used to perform a procedure that may alleviate discomfort, improve
spine functioning, or otherwise improve functioning or health of a
patient.
[0373] The distal tip portion 420 extends away from the housing 418
and terminates at a distal tip 422 that is curved away from the
longitudinal axis of the distal tip portion 420. The illustrated
distal tip 422 has a somewhat L-shape. However, the distal tip 422
can have other configurations depending on the intended use of the
surgical file device 400. For example, the distal tip 422 can have
a somewhat J-shaped configuration. The blade 592 is positioned
above the lower blade structure 543. The lower blade structure 543
supports the blade 592 when the blade 592 is actuated. The
illustrated lower blade structure 543 is wider then the blade
592.
[0374] FIG. 54 illustrates the cutting blade 592 of the distal tip
422 engaging tissue 630 on a facet joint 629. The upwardly facing
cutting surface of the cutting blade 592 can cut off tissue 630
(e.g., boney overgrowth). In some instances, the tissue 630 can be
a bone spur or a portion of an enlarged region of the joint 629.
The cutting blade 592 can be actuated to remove (e.g., grind, cut,
file, etc.) a desired amount of tissue 630. The physician can view
the surgical procedure using the visualization instrument 430 to
ensure accuracy of the treatment. In the illustrated procedure, the
viewing element 470 of the endoscope 432 is proximate to the
surgical site for viewing the cutting blade 592 and the tissue
630.
[0375] The illustrated distal tip 422 is interposed between the
facet joint 629 and a nerve root 631. The distal tip 422 can be
slid between the facet joint 629 and the nerve root 631 without
injuring the sensitive nerve root 631. The blunt, atraumatic tip
422 has a shield 641 that protects the nerve root 631. Thus, the
distal tip 422 can be configured to fit safely between the anterior
portion of the facet joint 629 and nerves (e.g., nerve roots 631 or
ganglion) for safely removing a portion of the facet joint 629. The
curve and angle of the distal tip portion 420 can be chosen such
that the distal tip 422 can be easily inserted between the facet
joint 629 and an adjacent vertebral body 643. In some embodiments,
the distal tip 422 is shaped to match the angle of a neural foramen
canal. For example, if the neural foramen canal is angled at 20
degrees sloping down from horizontal when a patient is positioned
face down, the distal dip 422 can also have a 20 degree angle. As
such, the configuration of the tip 422 can be selected to match the
patient's physiology. The surgical instrument described herein can
be used in neuroforamina anywhere in the body, including the spine,
skull, and other bones through which nerves extend.
[0376] As tissue is removed from the facet joint 629, the
irrigation system 551 and removal system 594 can be used for
continuously (or intermittently) irrigating and cleaning the
surgical site thereby avoiding debris buildup and improving viewing
of the surgical site. The distal tip 422 can be moved along the
facet joint 629 as the blade 592 reciprocates to remove target
tissue. The distal tip 422 can also be used for general bone
sculpturing, if desired.
[0377] The distal tip 422 can also have other configurations to
treat other portions of a patient's body. FIG. 55 illustrates
another distal tip 644 that is positioned to remove tissue from a
vertebral body 643. The distal tip 644 is generally similar to the
distal tip 422, except as detailed below.
[0378] The distal tip 644 has a downwardly facing cutting blade 690
and an opposing shield 692. To remove tissue 642 from the vertebral
body 643, the distal tip 644 can be inserted between the nerve root
631 and the vertebral body 643. The shield 692 can contact and
protect the nerve 631. The distal tip 644 can be utilized to remove
tissue from the posterior portion of the vertebral body 643 in the
neural foramen area. To move the distal tip 644 to the illustrated
position, the distal tip 644 can be slid over the dura mater and
then between the nerve 631 and the vertebral body. The dura mater
is a tough fibrous membrane that envelopes the spinal nerves that
can be navigated through to remove tissue from the spine. The
distal tip 644 can be delivered to the target site with or without
using an access device, such as the introducer discussed above.
Additionally, the distal tip 644 may or may not have an irrigation
system and/or removal system.
[0379] An access device can optionally be used for positioning a
surgical instrument, such as the file device 400. FIG. 49
illustrates the distal tip portion 420 extending through an access
device 638 in accordance with one embodiment. In some embodiments,
including the illustrated embodiment, the access device 638 is an
introducer. A standard tubular introducer for lumber spine surgery
has an inner diameter of about 22 mm. If such an introducer is
used, the distal tip portion 420 can have a spin diameter that is
less than 22 mm. However, the distal tip portion 420 can have other
spin diameters, if desired. The spin diameter can be selected based
on the surgical procedure and/or the type and size of introducer
utilized.
[0380] After the introducer 638 is positioned in the patient, the
distal tip 422 can be inserted through an upper end 639 of the
introducer 638 and then advanced through the introducer 638. The
distal tip portion 420 can be advanced distally until the distal
tip 422 is exposed from lower end 651 the introducer 638 and is
positioned at the target surgical site. The introducer 638 provides
a delivery path to the target surgical site. Non-limiting exemplary
access devices can be a tube, sleeve, or other device capable of
providing a delivery path for insertion of a surgical instrument to
a target surgical site.
[0381] In some embodiments, one or more of the components of the
surgical file device 400 are disposable. As used herein, the term
"disposable" when applied to a component, such as a body assembly
(e.g., the body assembly 416, distal tip assembly, etc.) is a broad
term and means, without limitation, that the component in question
is used a finite number of times and then discarded. Some
disposable components are used only once and then discarded. Other
disposable components are used more than once and then discarded.
In some embodiments, the body assembly of the surgical file device
is a single-use component. Such body assemblies assures that
sterile irrigation fluid is delivered to a surgical site, if the
surgical file device has a fluid system. In alternative
embodiments, the body assembly of the surgical device 400 is a
multiuse component that may or may not be sterilized after each
use.
[0382] FIG. 56 illustrates a drive system 700 of a surgical
instrument for actuating a cutting blade. The surgical instrument
699 can be similar to the surgical instrument 400, except as
detailed below. In FIG. 56, many of the internal components of the
instrument have been removed to more clearly illustrate the drive
system 700.
[0383] The drive system 700 translates rotary motion to linear
motion. The illustrated drive system 700 comprises a drive member
702 that has a drive connector 706, a slide plate connector 708,
and a drive member body 710 therebetween.
[0384] The drive connector 706 is configured to engage a portion of
a powered handpiece, such as the handpiece 410 of FIG. 46. The
drive connector 706 can be coupled to a rotatable output shaft of a
handpiece. If the handpiece 410 of FIG. 46 powers the body assembly
416 of FIG. 56, the drive connector 706 can be adapted to mate and
lock with the receptor shaft 448 of the handpiece 410.
Alternatively, the drive connector 706 can be adapted to mate with
other output structures based on the design of the powered
handpiece. The drive connector 706 is preferably coupled to a
structure that imparts rotary motion to the drive member 702.
[0385] The drive member body 710 extends between the drive
connector 706 and the slide plate connector 708. The drive member
body 710 can be a shaft, rod, tubular member, or other suitable
member for imparting rotary motion. The body assembly 416 can have
brackets, a drive member passageway, or other structure for
pivotally holding the drive member 710. As such, the body assembly
416 and drive member body 710 are arranged so that the drive member
702 is rotatable about its longitudinal axis.
[0386] The slide plate connector 708 is connected to an axially
movable slide plate 716. As shown in FIGS. 56-59, the slide plate
connector 708 can have a pin 722 that extends through a slot 726 of
the slide plate 716. The pin 722 extends outwardly from a distal
face 727 of the slide plate connector 708. As the drive member 702
rotates, the pin 722 travels along a somewhat circular path about
the longitudinal axis 713 of the drive member 702. The traverse
dimension of the travel path of the pin 722 determines the axial
travel stroke of the slide plate 716. The pin 722 slides back and
forth in the slot 726 when the drive member 702 rotates about its
longitudinal axis. The rotating pin 722 also axially displaces the
slide plate 716 towards or away from the elongate distal tip
portion 420 as indicated by the arrows 732. Hence, the slide plate
716 is reciprocated as the drive member 702 is rotated.
[0387] The slide plate 716 of FIGS. 56 and 59 has the elongated
slot 726 that is sized to receive the pin 722. The longitudinal
axis of the slot 726 is somewhat perpendicular to the direction of
travel of the slide plate 716. The length of the slot 726 is
preferably greater than the diameter of the travel path of the pin
722. The slide plate 716 is connected to the upper end 738 of the
cutting blade. In such embodiments, the slide plate 716 and cutting
blade can be reciprocated together.
[0388] With continued reference to FIG. 56, the instrument 699 also
includes a working lumen for receiving a visualization instrument.
The illustrated instrument 699 has a working lumen 721 configured
to receive a visualization instrument, such as an endoscope,
although other visualization instruments can be employed.
[0389] FIGS. 60-64 illustrate another embodiment of a surgical
instrument. In the illustrated embodiment, the surgical instrument
800 comprises a straight distal tip cutting blade, straight ribbon
drive or tube drive, with suction and irrigation. This design can
be powered by a standard specialized power handpiece. This
illustrated distal tip assembly 802 is configured to be mated to an
existing rotary motor powered handpiece 816.
[0390] The distal tip assembly 802 can have a relatively simple
design and can be mounted onto a standard powered surgical hand
piece. These standard powered surgical hand pieces are often built
to drive rotary cutting tools. The distal tip assembly 802 converts
the rotary handpiece into a reciprocating cutting instrument.
Rotary instruments may often have a rotating cutter. Unfortunately,
these rotating cutters skip sideways, especially when the rotating
cutter touches hard to cut tissue, such as bone. Additionally,
rotary cutting tools may not be suitable for forming a smooth or
flat sculptured surface. By comparison, the illustrated
reciprocating cutting instrument 800 can avoid sideways skipping.
The distal tip assembly 802 cuts an inherently smoother and flatter
surface with dramatically improved control, and therefore reduces
fatigue of the surgeon's hands. Thus, the surgical file system 800
is easier to operate and can be safer for the patient than systems
employing rotary cutting instruments.
[0391] As shown in FIGS. 60 and 61A, the distal tip assembly 802 is
coupled to a distal end 812 of a handle assembly 816. A quick
connect docking mechanism 822 connects the distal tip assembly 802
to the handpiece or handle assembly 816. In some embodiments, the
distal tip assembly 802 is removably coupled to the handle assembly
816. Threads of the distal tip assembly 802 can engage threads of
the handle assembly 816. For example, the mechanism 822 can have
internal threads that mate with external threads of the distal tip
assembly 802. Alternatively, pins, screws, snap structures, or the
like can be utilized to temporarily couple the distal tip assembly
802 to the handle assembly 816. If desired, the distal tip assembly
802 can also be permanently coupled to the handle assembly 816
[0392] The distal tip assembly 802 has a drive system 826 and a
housing 830 that surrounds the drive system 826. An inlet connector
836 of FIG. 60 of a fluid system extends outwardly from the housing
830. The modified distal tip assembly 802 of FIGS. 61A and 61B does
not have an inlet connector. The distal tip assembly 802 tapers
distally and has a substantially straight distal tip 840.
[0393] In the illustrated embodiment, the distal tip assembly 802
is in the form of a removal, disposable tip. As such, the distal
tip assembly 802 can be conveniently removed from the handle
assembly 816 when desired. Accordingly, one or more distal tip
assemblies can be used to perform a surgical procedure. The
embodiment of FIG. 61 is illustrated without an irrigation system.
However, the distal tip assembly 802 can have an irrigation system
and/or a removal system, as shown in FIGS. 62-64.
[0394] With respect to FIGS. 62-63, a coupling assembly 817 is
configured to be coupled to a handle assembly. The coupling
assembly 817 is operatively connected to a shaft 844 of the drive
system 821. The illustrated coupling assembly 817 is rotatable
about its longitudinal axis and one or more ports 831 in fluid
communication with the shaft 844. That is, the coupling assembly
817 is fixedly attached to the shaft 844. In such an arrangement,
the coupling assembly 817 and the shaft 844 can rotate together.
The coupling assembly design can be selected based on the
handpiece.
[0395] The shaft 844 can form part of the fluid system 838. The
illustrated shaft 844 has a shaft passageway 846 that permits
transportation of waste fluids from the distal tip assembly 802
into the handle assembly 816. A shown in FIG. 62, the shaft 844 can
be a hollow or tubular shaft that is suitable for transporting
fluids while also being capable of transmitting rotational forces.
If the distal tip assembly 802 does not have the fluid system 838,
the shaft 844 can be a solid shaft that extends between the drive
motor of the handle assembly 816 and the distal tip assembly 802.
Thus, various types of shafts can be used for operatively coupling
the distal tip assembly 802 to the handle assembly 816. Of course,
other types of coupling structures can also be utilized.
[0396] The drive system 821 includes the shaft 844, a toroidal
drive 850, and a slide plate 852 operatively connected to a cutting
blade. The drive system 821 preferably converts rotary motion into
linear motion. The toroidal drive 850 is rotatably mounted to a
face plate 862 and a toroidal holder 864. In some embodiments, the
toroidal drive 850 is supported by a pair of bearings.
[0397] In the illustrated embodiment of FIG. 62, the toroidal drive
850 and the rotating shaft 844 are supported by two bearings 853,
856, respectively. The shaft passageway 846 extends proximally from
the bearing 856 through the face plate 862 and into the handle
assembly 816. To seal the fluid from the toroidal drive, a sealing
member 867 (e.g., an O-ring) is positioned between the housing 810
and the shaft 844. In such an embodiment, the drive system 821 can
remain dry during operation to avoid contamination and damage of
its components.
[0398] An outer rim 857 of the toroidal drive 850 is positioned
somewhat midway between the face plate 862 and the holder 864. The
toroid outer rim 857 warbles as the toroidal drive 850 rotates. The
toroid rim 857 drives a pair of follower bearings 861 that are
connected to the slide plate 852. Rotation of the toroidal drive
850 causes liner movement of the slide plate 852.
[0399] The slide plate 852 can be guided in its linear travel by
one or more linear guides 870 as shown in FIGS. 63 and 64. The
slide plate 852 is preferably connected to a blade assembly 880.
The slide plate 852 drives the cutting assembly 880 as the toroidal
drive 850 rotates. The cutting assembly 880 extends distally from
the slide plate 852 through the distal tip assembly 802. The
cutting assembly 880 includes an elongated body 882 and a cutting
blade 884 at the distal end 886 of the body 882. The illustrated
cutting assembly can be a multi-piece structure that has a movable
upper cutting surface 885 mounted to slidable plate 887.
Alternatively, the cutting assembly can be similar to blade
assembly of the instrument illustrated in FIG. 69.
[0400] The elongated body 882 has an elongated body passageway 891
for transporting fluids. The illustrated elongated body 882 is a
tubular body that defines the elongated passageway 891 extending
between the passageway 846 and the cutting blade 884. Fluid
(including irrigation fluid, tissue, etc.) can flow proximally from
the distal end of distal tip assembly 802 through the elongated
body 882 via the passageway 891. The fluid then proceeds along the
passageway 891 and into the passageway 846.
[0401] Because the elongated body 882 is subjected to axial loads
during operation, its axial cross section can be chosen to avoid
buckling or other failure modes. The elongated body 882 can be
comprised of metal, such as steel (including stainless steel),
titanium, or other suitable material. For example, the elongated
body 882 can be comprised of a high strength plastic.
[0402] The elongated body passageway 891 of the housing 810
surrounds at least a portion of the elongated body 882, and can
limit flexing of the elongated body 882. Hence, the elongated body
passageway 891 can inhibit buckling of the elongated body 882.
[0403] With reference again to FIG. 62, the fluid system 838 has an
inlet connector 836 in communication with a delivery passageway
910. The delivery passageway 910 extends through the housing 810. A
tapered or narrowing portion of the housing 810 defines the
elongated passageway 891 that cooperates with the outer surface of
the elongated body 882 of the blade assembly 880 to form a distal
portion 908 of the delivery passageway 910.
[0404] Irrigation fluid 922 can be introduced through the inlet
connector 836 into the housing 810. The fluid proceeds through the
delivery passageway 910 until it reaches the distal portion 908.
The fluid then flows through the distal portion 908 of the delivery
passageway 910. In some embodiments, the irrigation fluid acts as a
lubricant to the cutting blade guides and also cleanses the cutting
blade 884 by exhausting out cutting holes 920.
[0405] The irrigation fluid can clean the surgical site. As shown
in FIG. 63A the cleansing fluid and the freshly cut bone and tissue
debris 926 are hydrodynamically drawn along a flow path 927 away
from the cutting surface and into the lower blade structure 921. In
particular, the tissue and fluid are drawn into the inlet port 928.
The mixture then flows proximally through the elongated body
passageway 891. After the mixture exits the elongated body
passageway 891, it flows through the drive system 821, and is
ultimately removed from the distal tip assembly 802.
[0406] FIGS. 65-67 illustrate another distal tip assembly 950 in
accordance with another embodiment. The distal tip assembly 950 has
a distal tip body 951 and a handle 960 connected to the distal tip
body 951. The handle 960 is used to help a user control the
movement of the distal tip assembly 950. Additionally, the handle
960 can be used for pressing an actuatable cutting blade 964
against tissue.
[0407] The cutting blade 964 and the handle 960 are on opposing
sides of a distal end 970 of the distal tip assembly 950. The
cutting blade 964 protrudes out of an aperture 974. The illustrated
cutting blade 964 has a somewhat concave cutting surface 970 as
shown in FIG. 65. In some embodiments, the cutting surface 970 is
concave along the length of the cutting blade 964. However, the
cutting surface 970 can have other shapes, if needed or desired.
For example, the cutting blade 964 can have a generally flat
cutting surface for preparing a flat surface. Alternatively, the
cutting blade 964 can have a convex cutting surface 970.
[0408] As shown in FIG. 67, the portion 966 of the cutting blade
964 extending out of the aperture 974 has a height, H, of about 1
mm, 2 mm, 3 mm, 5 mm, and ranges encompassing such distances. In
some non-limiting embodiments, the portion 966 has a height H of
more than about 5 mm. In some non-limiting embodiments, the portion
966 has a height H of more than about 8 mm, 10 mm, and 20 mm. The
portion 966 can have other heights also. In other embodiments, the
cutting blade 964 is generally flush with the aperture 974. The
cutting blade 964 can also be similar to the cutting blades
described above.
[0409] The handle 960 is designed to be comfortably gripped between
a user's thumb and index finger while the user's other hand holds
an handle assembly to which the distal tip assembly is attached.
The operator can use the handle 960 to provide a mechanical
advantage in order to remove tissue at a desired rate. As the
cutting blade 964 cuts tissue, for example, the handle 960 can be
used to press the cutting blade 964 against the tissue. As such,
the applied pressure and rate of tissue cutting can be accurately
controlled. Thus, the handle 960 can be used for accurately
positioning the cutting blade 964 and/or controlling the rate of
cutting.
[0410] The illustrated handle 960 has depressions to enhance
traction. The illustrated handle 960 has depressions 963 on either
side for receiving a finger or thumb of a user. Surface texturing,
protrusions, or other structures can be used to help a user grip
the handle 960. The illustrated handle 960 extends longitudinally
along the distal tip assembly 950. However, the handle 960 can be
at other orientations, if desired.
[0411] The illustrated distal tip assembly 950 has a single handle
960. Other distal tip assemblies can have a plurality of handles.
The configurations and positions of the handles can be selected
based on the intended use of the surgical file device. In
alternative embodiments, the structure 960 can be a guide that
assists in positioning of the cutting blade 964. The guide 960 can
be positioned against tissue to help align the distal tip 950.
[0412] FIG. 68 illustrated another distal tip assembly. The
illustrated distal tip assembly 990 has a cutting blade 992 that is
somewhat recessed. The distal tip assembly 990 may or may not have
a handle depending on its intended use. The illustrated distal tip
assembly 990 does not have a handle and has a low profile
configuration.
[0413] Advantageously, a single handpiece or handle assembly can be
used with more than one distal tip assembly. During a single
surgical procedure, the surgeon can use a plurality of distal tip
assemblies to perform specific procedures. Thus, various portions
of a patient's body can be treated without the need of several
handpieces.
[0414] FIG. 69 shows another embodiment of a surgical instrument.
The surgical instrument 1400 can be generally similar to the
embodiments described above, except as detailed below. Generally,
the surgical instrument 1400 can be used to remove tissue, such as
unwanted bony overgrowth of the spine. Bony overgrowths can affect
the neural foramen and can cause nerve root compression. The
illustrated instrument 1400 is well suited for treating this type
of nerve compression, although the instrument can be used to treat
other conditions.
[0415] The distal tip assembly 1402 extends from a handle assembly
1403 and has a long axis 1401. Generally, the distal tip assembly
1402 comprises a distal tip portion 1404 that includes a cutting
implement or filing blade 1412 (e.g., the blade of the blade
assembly shown in FIG. 48).
[0416] The distal tip portion 1404 preferably comprises the blade
1412 that overlays at least a portion of a lower blade structure
1420. The blade 1412 is preferably slidably coupled with the lower
blade structure 1420. The illustrated distal tip portion 1404
preferably forms an atraumatic tip. In some embodiments, the
atraumatic tip is configured to engage a patient's body without
causing traumatic injury. Such atraumatic tip can be a generally
blunt tip, although the atraumatic tip can have any suitable design
for minimizing trauma to a patient. The shape and configuration of
the atraumatic distal tip portion 1404 can be chosen based on the
application of the surgical file instrument 1400. In some
embodiments, however, the distal tip portion may not comprise an
atraumatic tip. For example, the distal tip portion may form a
cutting edge for severing tissue. Thus, both sides of the distal
tip portion 1404 can be used to perform a procedure on a
patient.
[0417] A shield 1408 can be formed by a lower portion of the lower
blade structure 1420. The blade 1412 can be positioned on one side
of the distal tip portion 1404 and the shield 1408 can be
positioned on the opposing side of the distal tip portion 1404. The
blade 1412 can be movably mounted to the lower blade structure 1420
to provide cutting action. The exposed portion of the blade 1412 is
unrestrained by the lower blade structure 1420. Irrigation of a
surgical site can be provided via the distal tip portion 1404, as
detailed below. Additionally, the distal tip portion 1404 can also
have one or more inlet ports for tissue removal, although not
illustrated.
[0418] FIGS. 70-71 are elevation views of the instrument 1400 that
has the blade 1412 having a similar shape to the lower blade
structures 1420. The lower blade structure 1420 can have an average
width that is similar to the average width of the blade 1412. An
outer periphery 1493 of the blade 1412 can have a similar shape as
a periphery 1405 of the lower blade structure 1420. Thus, the
overall shapes of the blade 1412 and lower blade structure 1420 can
be similar to one another, as viewed from above.
[0419] FIG. 72A is a cross-sectional view of the instrument 1400
taken along the line 72A-72A of FIG. 71. A lower surface 1415 of
the blade 1412 can mate with an upper face 1416 of the lower blade
structure 1420. The blade 1412 preferably extends longitudinally
along the upper face 1416.
[0420] The blade 1412 can extend laterally across a substantial
portion of the distal tip portion 1404. In some embodiments, the
average width, Wb, of the blade 1412 is at least 50%, 60%, 70%,
80%, 90%, or 95% of the average width, Wdt, of the shield 1408,
lower blade structure 1420, and/or upper face 1416. In the
illustrated embodiments, the blade 1412 has a width that is
substantially similar to the width of the lower blade structure
1420. The lower blade structure 1420 has the upper face 1416 (see
FIGS. 73 and 74) that mates with the blade 1412. In non-limiting
embodiments, the width of the blade 1412 is equal to or less than
the width of the upper face 1416. In some embodiments, the width of
the blade 1412 is at least about 95%, 90%, 85%, 85%, and ranges
encompassing such percentages of the width of the upper face 1416.
In one exemplary non-limiting embodiment, the width of the blade
1412 is at least about 95% of the width of the upper face 1416. In
another exemplary non-limiting embodiment, the width of the blade
1412 is at least about 80% of the width of the upper face 1416.
[0421] The blade 1412 can have a shape that is generally similar to
the shape of the upper face 1416 of the lower blade structure 1420.
In the illustrated embodiment, the blade 1412 and the upper face
1416 of the lower blade structure 1420 have a curved shape.
However, the blade 1412 can have other suitable shapes for cutting
tissue. For example, the blade 1412 can have a substantially
arcuate, U-shaped, V-shaped, curved, linear, polygonal,
combinations thereof, or any other suitable cross-sectional
profile. Although not illustrated, the blade 1412 can have a
generally U-shaped cross-sectional profile and can extend
vertically along both sides of the lower blade structure 1420.
[0422] When the blade 1412 is utilized to treat tissue, the lower
blade structure 1420 may not limit cutting of the blade 1412. That
is, the lower blade structure 1420 preferably does not extend
laterally from the blade 1412 to limit appreciably the vertical
movement of the blade 1412 into tissue. Of course, the lower blade
structure 1420 can extend slightly from the blade 1412 without
appreciably limiting the vertical cutting ability of the blade
1412. Additionally, if the lower blade structure 1420 extends
laterally from the blade 1412, the blade 1412 can be moved
horizontally (e.g., the blade 1412 can be slid across tissue) for
effective cutting action of the surgical file instrument 1400.
[0423] FIGS. 73 and 74 illustrated the distal tip assembly 1402
with the blade 1412 removed. The lower blade structure 1420 has a
long axis 1401 and the upper face 1416 extending between a first
lateral side 1417 and an opposing second lateral side 1419 (see
FIG. 72). The device 1400 has an irrigation system 1417 having a
fluid delivery channel system 1423 of the lower blade structure
1420. The delivery channel system 1423 extends longitudinally along
the upper face 1416.
[0424] The delivery channel system 1423 can cooperate with the
blade 1412 to expel irrigation fluid. The delivery channel system
1423 includes an elongate delivery channel 1424 and a plurality of
side delivery channels 1422. The elongate delivery channel 1424 can
be in communication with an irrigation fluid source via an inlet
connector 1480 of an adapter 1652 (see FIG. 71). Irrigation fluid
can flow through the handle assembly 1403, the delivery channel
system 1423, and ultimately out of the distal tip portion 1404.
[0425] With respect to FIG. 74, the elongate delivery channel 1424
can be sloped in the distal direction. In the illustrated
embodiment, a bottom surface 1440 of the elongate delivery channel
1424 is sloped towards the upper surface 1416 in the distal
direction. The elongate delivery channel 1424 can have a generally
uniform or varying width along its length. The illustrated elongate
delivery channel 1424 has a generally constant width and has a
generally flat bottom surface 1440, although the bottom surface
1440 can have other configurations. Although not illustrated, the
elongate delivery channel 1424 can have a generally uniform height
and can have any suitable cross-section for delivering fluid to the
channels 1422. For example, the elongate delivery channel 1424 can
have a generally U-shaped, V-shaped, semi-circular, or curved axial
cross-section.
[0426] The channels 1422 are spaced along a portion of the lower
blade structure 1420 and are in fluid communication with the
elongate delivery channel 1424. The elongate delivery channel 1424
is interposed between two rows of channels 1422. Any suitable
number of channels 1422 can be positioned along the distal tip
portion 1404. In the illustrated embodiment, eight channels 1422
are positioned on either side of the elongate delivery channel
1424. Each channel 1422 can have a generally semi-circular shape,
polygonal shape (including rounded polygonal), or other shape
suitable for delivering fluid out of the distal tip portion 1404.
The channels 1422 can be depressions formed in the lower blade
structure 1420. The number, sizes, and configurations of the
channels 1422 can be selected to achieve the desired fluid flow out
of the distal tip portion 1404. When the blade 1412 mates with the
upper surface 1416, at least one of the channels 1422 can be
covered by the blade 1412. The side delivery channels 1422 can be
formed by any suitable process, such as by a molding process (e.g.,
an injection molding process), cutting or machining process, or
other suitable manufacturing process.
[0427] FIG. 75 illustrates the blade assembly 1413 having the blade
1412 connected to an elongated body 1460. The blade 1412 can
comprise a cutting zone or cutting surface 1432 configured to
remove tissue as the blade 1412 is actuated. In some embodiments,
the cutting zone 1432 comprises a plurality of cutting members,
cutting teeth, sharp edges, and combinations thereof. The blade
1412 can have a first blade edge 1428 and a second blade edge 1430.
The illustrated the first blade edge 1428 and the second blade edge
1430 are free edges that are not restrained by the lower blade
structure 1420. The cutting zone 1432 can be positioned between the
blade edges 1428, 1430. The blade 1412 can be perforated for
providing fluid flow therethrough. The illustrated cutting zone
1432 comprises an array of throughholes 1434. In some embodiments,
at least one throughhole 1434 is positioned near the first blade
edge 1428 and at least one throughhole 1434 is positioned near the
second blade edge 1430. The throughholes 1434 can be positioned
near the sides of the cutting zone 1432. Any number of throughholes
1434 can be positioned along the cutting zone 1432. The cutting
zone 1432 can have a transverse width that is similar to, less
than, or greater than a transverse width of the blade 1412.
[0428] In some embodiments, a plurality of throughholes 1434 is
positioned near the first blade edge 1428 and a plurality of
throughholes 1434 is positioned near the second blade edge 1430. In
some embodiments, at least one throughhole 1434 is positioned near
the first lateral side 1417 and at least one throughhole 1434 is
positioned near the second lateral side 1419 of the lower blade
structure 1420. For example, in the embodiment of FIG. 72A, the
plurality of throughholes (e.g., cutting elements having a
throughhole) is positioned near the first lateral side 1417 and a
plurality of throughholes is positioned near the second lateral
side 1419 of the lower blade structure 1420. The throughholes 1434
can be evenly or unevenly spaced along the cutting zone 1432.
[0429] With respect to FIG. 76, the blade assembly 1413 can be
actuated linearly by the elongated body 1460 in the form of a drive
member. The drive member 1460 can be temporarily or permanently
coupled to the blade 1412. The blade 1412 can be used for a single
procedure, or a plurality of procedures. In some embodiments, the
blade assembly 1413 is disposable and can be easily replaced with a
new blade assembly after use. Alternatively, the blade assembly
1413 can be a non-disposable component configured for one or more
procedures. Any suitable attachment means, such as welding,
mechanical fasteners, adhesives, or the like can be used to attach
the blade 1412 to the drive member 1460.
[0430] In some embodiments, the drive member 1460 is operatively
coupled to the blade 1412 by a plurality of welds. The welds can
have significant structure integrity and reliability. The blade
assembly 1413 can comprise one or more of the following: metals
(e.g., titanium, aluminum, steel and its alloys, such as stainless
steel), plastics, polymers, ceramics, composites, and combinations
thereof. Alternatively, the blade assembly 1413 can have a
one-piece construction. For example, the blade assembly 1413 can be
monolithically formed through a machining or molding process. Thus,
the blade assembly 1413 can have a one-piece or multi-piece
construction.
[0431] The blade 1412 is preferably movable between a distal
position (FIGS. 77-78) and a proximal position (FIG. 79). The blade
1412 can be rapidly reciprocated between the distal position and
the proximal position to remove tissue. In non-limiting
embodiments, the blade 1412 can be actuated 1,000 times/min., 2,000
times/min., 3,000 times/min., or 4,000 times/min. The blade 1412
can also be actuated at other rates. As the blade 1412 slides along
the lower blade structure 1420, at least some of the throughholes
1434 of the blade 1412 can be matched and unmatched with the
channels 1422 to provide pulse irrigation. In some embodiments, a
substantial number or all of the throughholes 1434 can cooperate
with the elongate delivery channel 1424 to provide pulse
irrigation. The illustrated blade 1412 and the lower blade
structure 1420 can cooperate to provide pulsatile flow even if the
fluid is delivered to the distal tip at a constant or varying
pressure.
[0432] Any number of the throughholes 1434 can be positioned over
the elongate delivery channel 1424. As shown in FIG. 77, a series
of throughholes 1434 is adjacent the elongate delivery channel
1424. Thus, some of the throughholes 1434 can be periodically
aligned with the channels 1422 while at least some of the
throughholes 1434 can be disposed over the elongate delivery
channel 1424. As such, some of the throughholes 1434 can provide
pulse irrigation while other throughholes 1434 can provided
somewhat continuous irrigation.
[0433] In the illustrated embodiment of FIG. 77, a center row of
throughholes 1434 is constantly fed irrigation fluid. The fluid can
be provided at a generally constant or varying pressure, although
the irrigation fluid can be provided at any pressure depending on
the application. In some embodiments, the center row of
throughholes 1434 is fed irrigation fluid at varying pressures,
preferably delivered in synchronization with the reciprocating rate
of the blade 1412. However, the irrigation fluid can be delivered
in other relationships with the movement of the blade 1412. The
pressurized irrigation fluid can be delivered at varying rates to
create an enhanced cleaning action to keep the cutting zone 1432
clean and to remove tissue debris.
[0434] The centrally disposed throughholes 1434 can remove a
substantial portion or most of the debris material and therefore
may need constant fluid flushing. The flushing can be accomplished
by variations in the pressure and flow rate of the irrigation
fluid. The laterally offset throughholes 1434 may remove less
material during operation and can also benefit from variations in
irrigation flow. In some embodiments, the nearly on and nearly off
flow of the irrigation fluid effectively cleans the laterally
offset throughholes 1434. The variations in irrigation fluid
temperature, flow rates, and pressure can be chosen to clean
effectively tissue debris from the blade 1412.
[0435] The irrigation fluid can also be used to control the
temperature of at least a portion of the distal tip portion 1404.
For example, the frictional interaction between the blade 1412 and
the lower blade structure 1420 can cause localized heating at the
interface of the blade 1412 and the upper surface 1416. During
operation, the irrigation fluid can be at a relatively low
temperature and used to absorb heat generated by the frictional
interaction. Accordingly, heat can be transferred to the irrigation
fluid which then carries the heat away from the distal tip portion
1404 to cool the components of the distal tip portion 1404. In some
cases, the irrigation fluid can be a chilled fluid to ensure that
the distal tip portion 1404 is maintained below a target
temperature. The irrigation fluid can be heated/cooled as
desired.
[0436] Irrigation fluid can function as a lubricant for the
interface between the moving blade 1412 and the stationary lower
blade structure 1420. The irrigation fluid can thus be used to
clean the blade 1412 and transport the cut tissue away while also
lubricating the distal tip portion 1404. The lubricant irrigation
fluid can minimize wear of one or more components of the surgical
file instrument 1400.
[0437] FIG. 78 illustrates the blade 1412 in a distal position.
When the blade 1412 occupies the distal position, the distal end
1444 of the blade 1412 is preferably proximate to a distal end 1446
of the lower blade structure 1420. The blade 1412 can be actuated
proximally along the lower blade structure 1420 to a proximal
position shown in FIG. 79. When the blade 1412 occupies the
proximal position, the distal end 1444 is preferably distanced from
the distal end 1446 such that at least a portion of the delivery
channel system 1423 is exposed. In some embodiments, the blade 1412
is moved laterally and/or longitudinally between two or more
positions, if needed or desired.
[0438] With respect to FIG. 79, when the blade 1412 occupies a
proximal position, the blade 1412 and the lower blade structure
1420 cooperate to define a window 1450. A fluid can be expelled
through the window 1450. The irrigation fluid delivered from the
window 1450 can be used to dislodge and flush tissue debris from
the distal tip portion 1404, as well as for irrigating the surgical
site. As the blade 1412 moves in the distal direction, the window
1450 is reduced in size. In some embodiments, when the blade 1412
reaches its distal position (FIGS. 77 and 78), the blade 1412
completely covers the elongate delivery channel 1424 thereby
completely closing the window 1450. In the illustrated embodiment,
the blade 1412 and the lower blade structure 1420 are configured to
open and close the window 1450 repeatedly for a somewhat on and off
fluid flow. The pulsing fluid flow from the window 1450 can aid in
breaking up of clots and tissue debris. However, in other
embodiments, the blade 1412 and the lower blade structure 1420 can
be configured to provide continuous fluid flow out of the window
1450. For example, the distal end 1444 of the blade 1412 can be
positioned at some point above the delivery channel system 1423
when the blade 1412 occupies its distal-most position and its
proximal-most position. In such an embodiment, fluid can be
continuously delivered during reciprocation of the blade 1412.
[0439] The cyclic nature of the pertubated irrigation fluid can
enhance cleaning and debris removal. The frequency and magnitude of
the pulsed irrigation fluid flow can be selected to achieve the
desired cleaning and debris removal effect. In some embodiments,
the fluid perturbations can hold the tissue debris (e.g., bone
particles, cartilage, and other debris material) in suspension. The
suspension can be easily removed from the surgical site. For
example, the suspension can be sucked out of the surgical area by a
surgical suction wand, suction tube, or other tissue or removal
device. Alternatively, or in addition, the device 1400 can have a
removal system for waste fluid removal. In some embodiments, for
example, the device 1400 can have a removal system similar to the
removal system illustrated in FIG. 51.
[0440] FIG. 80 illustrates the blade assembly 1413 connected to
internal components of the handle assembly 1403. The drive member
1460 extends from the handle assembly 1403. As shown in FIG. 77,
the drive member 1460 can be a generally tubular member that
defines at least one lumen 1476. As such, the drive member 1460 can
have a reduced weight to therefore reduce the overall weight of the
surgical file instrument 1400. The drive member 1460 can have any
suitable cross-section. Exemplary drive members 1460 can have a
generally circular cross-section, elliptical cross-section,
polygonal (including rounded polygonal) cross-section, although the
drive members 1460 can have other cross-sections depending on the
application. The size and configuration of the drive member 1460
can be selected to minimize or avoid buckling, deflection, bending,
and/or fatigue failure.
[0441] In some embodiments, the lumen 1476 can be in communication
with the distal tip portion 1404. The lumen 1476 can be used to
transport water to and/or from the distal tip portion 1404.
Alternatively, the lumen 1476 can be used to provide suction to
draw in material (e.g., debris and suspension) from the surgical
area through the distal tip portion 1404. Any fluid (e.g.,
lubricants, medicants, irrigation fluid, or combinations thereof)
or material can be passed through the lumen 1476 depending on the
application.
[0442] With respect to FIG. 81, to deliver fluid F (e.g.,
irrigation fluid) through the distal tip portion 1404, fluid can be
delivered to the inlet port 1480 of a fluid delivery system 1482.
The fluid delivery system 1482 also comprises an adapter 1652 and a
fluid supply tube 1488 that connects the inlet port 1480 to the
drive member 1460. The irrigation fluid can pass through the inlet
port 1480 and the adapter 1652. The irrigation fluid then flows
through the supply tube 1488 and eventually through the distal tip
portion 1404.
[0443] The fluid F can flow distally along the supply tube 1488 and
eventually to a junction 1490. The fluid F can then flow distally
between a delivery tube 1492 and the drive member 1460. The drive
member 1460 extends through the length of the delivery tube 1492.
In some embodiments, the drive member 1460 and the delivery tube
1492 are generally concentric and define a fluid channel. The fluid
channel can be defined by the outer surface of the drive member
1460 and the inner surface of the delivery tube 1492. The fluid F
can flow distally through the fluid channel.
[0444] The supply tube 1488 can be made of a flexible material,
such as silicon, rubber, or other suitable flexible material.
However, the supply tube 1488 can also be made of generally rigid
materials, such as metals or hard plastics. In the illustrated
embodiment, the supply tube 1488 is connected to a coupler 1502. A
distal end 1504 of the supply tube 1488 is received by a female
receptor hole 1506 of the connector 1502. Preferably, a water-tight
seal is accomplished by coating the supply tube 1488 with a sealant
(e.g., silicon rubber sealant, gels, and the like) and inserting
the distal end 1504 into the female receptor hole 1506.
Additionally, one or more sealing members (e.g., annular sealing
members) can be used to further seal in irrigation fluid. It is
contemplated that other arrangements can be employed to connect the
supply tube 1488 to the junction 1490.
[0445] In operation, as shown in FIG. 82, the fluid F flows through
the junction 1490 and through a flow chamber defined by the drive
member 1460 and the delivery tube 1492. The fluid F flows distally
along the fluid chamber until it reaches the distal tip portion
1404 and is eventually expelled out of the surgical file instrument
1400. In some embodiments, however, the fluid F can be delivered
through a lumen within the drive member 1460. For example, the
fluid F can be delivered through the lumen 1476 of the drive member
1460 illustrated in FIG. 77. The drive member 1460 can be disposed
in the elongated channel 1424.
[0446] With reference again to FIGS. 81 and 82, the connector
assembly 1510 can hold the distal end 1504 of the tube 1488 and
both the delivery tube 1492 and the drive member 1460. The
connector assembly 1510 surrounds both the delivery tube 1492 and
the drive member 1460. In some embodiments, the drive member 1460
extends all the way through the connector assembly 1510. The distal
end 1504 of the tube 1488 is positioned within the connector
assembly 1510.
[0447] The connector assembly 1510 can include a connector housing
1512 that can define a connector chamber 1514. The delivery tube
1492 and the drive member 1460 can extend centrally through the
chamber 1514. In the illustrated embodiment, the chamber 1514 is
tapered in the proximal direction. However, the connector chamber
1514 can have any other suitable shape and configuration depending
on the application.
[0448] As shown in FIG. 81, the connector housing 1512 is
configured to receive a distal tip structure proximal end 1520 of
the distal tip 1522. The distal tip structure proximal end 1520 is
configured to fit within the connector chamber 1514. As such, the
connector chamber 1514 and the distal tip structure proximal end
1520 can have a similar shape so that the distal tip structure
proximal end 1520 is tightly held by the connector housing 1512.
The illustrated distal tip structure proximal end 1520 has a
generally frusto-conical shape, although the distal tip can have
other configurations.
[0449] The connector system 1510 can comprise a sealing system 1511
used to seal the fluid within the surgical file instrument 1400.
The sealing system 1511 can comprise a plurality of sealing members
that are strategically positioned at various points throughout the
surgical file system 1400 to inhibit or prevent fluid from leaking.
In the illustrated embodiment, the sealing system 1511 comprises a
first O-ring 1530 that is positioned between the distal tip
structure proximal end 1520 and the connector housing 1512. The
sealing member 1530 surrounds the tube 1492 and substantially
prevents fluid flow from escaping between the tube 1492 and the end
1520 and the connector housing 1512.
[0450] A second sealing member 1532 can be positioned proximal of
the junction 1490. The illustrated sealing member 1532 surrounds
the drive member 1460 and prevents fluid flow proximally past the
sealing member 1532. The sealing members 1530, 1532 can be any
suitable sealing members for containing the fluid F. For example,
the sealing members can comprise one or more O-rings, gaskets,
sealing gels, or other suitable sealing structures and can comprise
plastic, polymers, rubber, and the like.
[0451] The connector housing 1512 can comprise one or more ribs
extending along its side. In the illustrated embodiment of FIG. 80,
the connector housing 1512 comprises a pair of diametrically
opposed longitudinally extending ribs 1533a, 1533b. The
longitudinal ribs 1533a, 1533b can lock the connector assembly 1510
into position relative to the distal tip 1522. The ribs 1533a,
1533b can be spaced at any location along the periphery of the
housing 1512. Any number of longitudinally extending ribs can be
used to orient the connector assembly 1510 with the distal tip
1522. Exemplary ribs can have generally U-shaped, V-shaped,
semi-circular, polygonal, or any other shaped cross-sections.
[0452] The connector housing 1512 can comprise a cylindrical collar
1551 that engages the tip 1522. The cylindrical collar 1551 can be
positioned somewhat proximally along the connector housing 1512.
The cylindrical collar 1551 can engage sealing members to absorb
excessive linear forces, which may be due to reciprocation of the
blade assembly 1413.
[0453] With reference again to FIG. 81, the surgical file
instrument 1400 can comprise a drive assembly 1540. The drive
assembly 1540 can comprise a shear pin 1546. The pin 1546 is
configured to shear by linear forces caused by the drive plate or
sled 1557 and the linear cylindrical drive shaft. The illustrated
shear pin 1546 has a plurality of elements extending through the
drive member 1460. The elements are movably retained in a retainer
member 1544. Other retaining means can be employed to connect the
drive member 1460 to the drive assembly 1540. The drive assembly
1540 can comprise a toroidal drive system or transmission, or other
type of drive system. The illustrated assembly has a toroidal drive
system 1541.
[0454] FIG. 83 illustrates the instrument 1400 outputting
irrigation fluid F (preferably a sterile fluid). An inlet line 1651
delivers the fluid to the surgical file instrument 1400. The fluid
is transported by means of the adapter 1652 via the inlet port
1480. The adapter 1652 extends into the body housing and is in
communication with the supply tube 1488. The adapter 1652 can be
attached to various types of conduits or supply systems. In view of
the present disclosure, the adapter 1652 can be designed to couple
temporarily or permanently to the inlet line 1651. One end of the
adapter 1652 is connected to the distal end 1631 of the conduit
1651. The other end of adapter 1652 is connected to a proximal end
1621 of the supply tube 1488.
[0455] Relatively large axial compressive forces can be applied to
the adapter 1652, especially because of its relatively small size,
when conduits are connected and disconnected. The adapter 1652 can
have a fitting structure to locate the adapter 1652 relative to the
outer housing 1670. The illustrated fitting feature is in the form
of a cylindrical ring 1653 configured to fit within a corresponding
annular recess in the outer housing 1670. The fitting structure can
comprise one or more of the following: a ring, flange, recess, pin,
and adhesives. The fitting structure can be positioned at any point
between the ends of the adapter 1652.
[0456] The adapter 1652 operatively connects to the supply tube
1488. The fluid path continues running distally into the delivery
lumen between the drive member 1460 and the delivery tube 1492. The
fluid continues to flow distally until it is expelled out of the
instrument 1400 at the distal tip portion 1404 and thru the tissue
cutting holes. The pulsatile nature of the exiting fluid that is
expelled directly thru the actual cutting teeth has several
advantages. As detailed above, the fluid can cool the device
mechanism or other moving components. The fluid can also lubricate
the moving components of the instrument 1400. The fluid suspends
the bone debris so it can be safely extracted from the tissue
removal site by a surgical wand vacuum.
[0457] With respect to FIGS. 84 and 85, a power device 1650 is
connected to a proximal adapter 1641 of the surgical file
instrument 1400. The surgical file instrument 1400 can be driven by
various types of electrical motors, power devices and other motor
systems known in the art. Power devices can be rotary devices for
driving the surgical file instrument 1400. The power device 1650
can be small and light. In some cases, the small motors that can be
used to power the surgical file instrument 1400 may become very hot
to the touch. The surgeon can advantageously grip the surgical file
instrument 1400 without touching the hot motor housing.
[0458] The overall geometric shape of the surgical file instrument
1400 provides for comfortable gripping. As shown above in FIG. 86,
surgical file instrument 1400 can be designed to fit the human hand
by a natural grip between the thumb 1643 and an index finger
1644.
[0459] The illustrated surgical file instrument 1400 has a body
shape that is somewhat similar to the shape of a radish. The
relaxed human hand generally features a curved opening between the
thumb and index finger that fits the general shape and curve of an
outer body handle grip area 1645 of the surgical file instrument
1400.
[0460] The outer body of the surgical file instrument 1400 features
finger grip depressions 1646 (on both sides) that assist in adding
hand traction without the tiring of a hard grip. This enables a
surgeon to relax their grip and work in more comfort, and with
better hand control and long term stamina. Indicia (e.g., the
instrument name, trademark, etc.) can be featured in raised letters
1647 (see FIG. 85) in an area of the finger grip areas to improve
grip traction. The illustrated instrument has raised indicia
comprising SURGIFILE.TM. to improve traction. The superior grip and
hand traction can be achieved even if the surgeon wears a glove. A
wet surgical gloved hand can engage the indicia to enable the
surgeon to have a good grip.
[0461] FIG. 87 illustrates one embodiment of a blade of a surgical
file instrument. The blade 1700 is perforated and comprises a
cutting zone 1719. The illustrated cutting zone 1719 comprises a
plurality of cutting elements 1702. The cutting elements 1702 also
define throughholes extending through the blade 1700. As shown in
FIG. 88, the cutting elements 1702 extend outwardly from an upper
face 1706 of the blade 1700. The cutting elements 1702 can have any
configuration suitable for grinding, cutting, filing, or otherwise
removing tissue. A blade body 1747 of the blade 1700 is defined
between the upper face 1706 and a lower face 1741.
[0462] The illustrated cutting elements 1702 are raised elements
that are somewhat conical in shape and define throughholes 1710. In
some embodiments, an irrigation fluid can pass through the
throughholes 1710 as discussed in detail above. Each of the cutting
elements 1702 can comprise one or more cutting edges for engaging
tissue. In the illustrated embodiment of FIG. 88, each of the
cutting elements 1702 comprises a tip 1733 that defines an outer
cutting surface 1720 and an inner cutting surface 1722. As the
cutting surfaces 1720, 1722 move along tissue, the cutting elements
1702 remove tissue.
[0463] Tips 1733 of the cutting elements 1702 can have cutting
edges 1742 for engaging tissue. The cutting edges 1742 define upper
ends 1751 of the throughholes 1710. The cutting edges 1742 can be
general parallel to the upper face 1706 and/or the lower face 1741
of the blade 1700. The illustrated body 1747 has a somewhat arcuate
transverse axis 1759, as shown in FIG. 88. The cutting edges 1742
can be somewhat arcuate to match the curvature of the body 1747. In
some embodiments, the cutting edges 1742 are substantially
concentric to the arcuate transverse axis 1759 of the blade 1700.
In alternative embodiments, the cutting edges 1742 are
substantially flat. Thus, the cutting edges 1742 can be curved,
flat, or combinations thereof. The cutting edges 1742 are
preferably capable of grinding, cutting, or filing tissue (e.g.,
bone or other somewhat hard tissue).
[0464] The cutting edges 1742 can be formed at the junction of the
surfaces 1702, 1722. In the illustrated embodiment, the tips 1733
have a substantially V-shaped portion forming the cutting edges
1742. However, the tips 1733 can have other configurations. The
cutting edges 1742 can form substantially contiguous cutting
edges.
[0465] In alternatively embodiments, the cutting zone 1719 does not
comprise throughholes corresponding to each cutting element. For
example, cutting elements, without throughholes, can extend from a
substantial planar surface.
[0466] The blade 1700 can be self-sharpening to retain
effectiveness over extended periods of use. As the cutting elements
1702 treat tissue (e.g., remove tissue), the cutting elements 1702
generally do not become dull. In the illustrate embodiment, the
cutting elements 1702 are generally circular as view from above.
However, in exemplary embodiments, the cutting elements 1702 can be
ellipsoidal, polygonal, or having any other shape and size suitable
for treating tissue. The cutting elements may or may not define
throughholes. For example, the blade may have throughholes spaced
from the cutting elements.
[0467] The blade 1700 can be formed by a punching process to form
the cutting elements 1702. Etching processes (e.g., chemical
etching), machining, molding, or other manufacturing techniques can
be employed to form the cutting elements 1702.
[0468] FIG. 89 is a cross-sectional view of the distal tip assembly
of a surgical file instrument positioned to treat tissue of a
patient. The distal tip assembly can be similar to the distal tip
assembly of FIGS. 69-72B.
[0469] A distal tip assembly 1800 of the surgical file instrument
comprises a blade 1802 and a lower blade structure 1810. The
illustrated distal tip assembly 1800 is positioned between a nerve
1812 and tissue 1814, although the distal tip assembly 1800 can be
positioned at other treatment sites in a patient's body.
[0470] In some embodiments, the distal tip assembly 1800 can be
used to remove tissue 1814 in a form of vertebral bone made up of
one or more facets. In the illustrated embodiment, the distal tip
assembly 1800 is positioned to remove material from the inner
periphery 1816 of the vertebral bone.
[0471] The blade 1802 can comprise an upper filing surface 1820
configured to engage the tissue 1814. The blade 1802 is configured
to mate with the lower blade structure 1810. The blade 1802 and the
lower blade structure 1810 can be configured to promote and guide
movement of the blade 1802. In some embodiments, including the
illustrated embodiment, the blade 1802 is slideably coupled to the
lower blade structure 1810. The blade 1802 and the lower blade
structure 1810 are convexed away from the filing surface 1820.
[0472] The lower blade structure 1810 can be configured to reduce
or minimize trauma to the nerve 1812. The lower blade structure
1810 can define an atraumatic surface 1830 suitable for contacting
the tissue 1812. In some embodiments, the atraumatic surface 1830
is concaved towards the nerve 1812. As such, the distal tip
assembly 1800 can be positioned between the bone 1814 and the nerve
1812 without substantially traumatizing the nerve 1812. That is,
this atraumatic distal tip assembly 1800 is dimensioned so as to
fit into a neuroforamen without appreciable trauma to a nerve
extending through the neuroforamen. In some embodiments, the distal
tip assembly 1800 can have a shape similar to the shape of the
opening defined between the bone 1814 and the nerve 1812. The
target tissue is removed by reciprocating the blade 1802 while the
distal tip assembly 1800 remains in the neuroforamen.
[0473] The blade 1802 can have a transverse width that is generally
similar to a transverse width of the lower blade structure 1810. In
some embodiments, the blade 1802 has a transverse width that is
greater than the transverse width of the lower blade structure
1810. In some embodiments, the blade 1802 has a width that is
generally similar to the transverse width of the lower blade
structure 1810. In some embodiments, the blade 1802 has a
transverse width that is less than the transverse width of the
lower blade structure. In some embodiments, the blade 1802 can
overhang or extend vertically along the edges of the lower blade
structure 1810.
[0474] The blade 1802 can have a cutting zone. A plurality of
cutting elements can define the zone which has a width that is
generally similar to the transverse width of the blade 1802. That
is, the lateral most cutting elements on either side of the blade
1802 can define a width that is substantially similar to the width
of the lower blade structure 1810. In some embodiments, the lateral
most cutting elements of the blade 1802 can define a width that is
about 95%, 90%, 85%, 80%, 70%, 60%, or other percentages of the
width of the lower blade structure 1810. The cutting elements can
therefore define an enlarged cutting zone for effectively and
rapidly removing tissue from the bone 1814.
[0475] FIGS. 90 and 91 illustrate a surgical instrument 2000 in
accordance with another embodiment. The surgical instrument 2000
has a curved distal tip assembly 2010 and is generally similar to
the surgical instrument 1400, except as detailed below.
[0476] The distal tip assembly 2010 has a blade 2014 positioned
above a lower blade structure 2016. The distal tip assembly 2010
has an angled section 2020. As shown in FIG. 92, the angle section
2020 defines an angle .theta.. The angle .theta. is the angle
between the longitudinal axis 2040 of the upper portion of the
distal tip assembly 2010 and the distal tip 2050. The angle .theta.
can be about 110 degrees, 120 degrees, 130 degrees, 140 degrees, or
ranges encompassing such angles. Distal tip assemblies can also be
at other angles or orientations. Such distal tip assemblies can be
used for general bone sculpturing, for example. The illustrated
instrument 2000 can be used to remove tissue from the spine or any
other region of the body, such as a shoulder. For example, the
instrument 2000 can be used remove tissue from the scapula,
humerus, clavicle, cartilage or any other tissue. The instrument
2000 can also be used in neuroforamina anywhere in the body,
including the spine, skull, and other bones through which nerves
extend. The shape and size of the distal tip assembly 2010 can be
chosen based on the surgical procedures.
[0477] Except as further described herein, the embodiments,
features, systems, devices, materials, methods and techniques
described herein may, in some embodiments, be similar to any one or
more of the embodiments, features, systems, devices, materials,
methods and techniques described in U.S. application Ser. No.
10/675,068 (U.S. Publication No. 2004-0122459) entitled SHIELDED
RECIPROCATING SURGICAL FILE, filed Sep. 29, 2003.
[0478] From the foregoing description, it will be appreciated that
a novel approach for precision bone and/or tissue removal surgery
has been disclosed. While the components, techniques and aspects of
the invention have been described with a certain degree of
particularity, it is manifest that many changes may be made in the
specific designs, constructions and methodology herein above
described without departing from the spirit and scope of this
disclosure.
[0479] Various modifications and applications of the invention may
occur to those who are skilled in the art, without departing from
the true spirit or scope of the invention. It should be understood
that the invention is not limited to the embodiments set forth
herein for purposes of exemplification, but is to be defined only
by a fair reading of the appended claims, including the full range
of equivalency to which each element thereof is entitled.
* * * * *