Note: Descriptions are shown in the official language in which they were submitted.
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DEvicES AND METHODS FOR CUTTING TISSUE
CROSS-REFERENCE TO RELATED APPLICATIONS
100011 This application claims the benefit of priority to U.S. Provisional
Patent
Application No. 61/684,598 filed August17, 2012. and .U.S. Provisional Patent
Application No. 61/707õ800 filed September 28, 2012, the contents of which arc
incorporated herein by reference in their entirety. This application is also a
continuation-
in-part of U.S. Patent Application No. 13/657,773 filed October 22, 2012 which
is a
continuation of U.S. Patent Application No, 13/550,407 filed July 16, 2012,
now U.S.
Patent No. 8,292,909, which is a continuation of U.S. Patent .Application No.
.13/174,416
filed June 30, 2011, now U.S. Patent No. 8,298,254, which claims the benefit
of priority to
U.S. Pmvisional Patent Application No. 61/360,429 filed June 30, 2010 and U.S.
Provisional Patent Application Serial No, 61/377,883 filed August 27, 2010,
the contents
of which are incorporated herein by reference in their entirety.
FIELD OF THE INVENTION
[00021 The present devices and .methods relate generally to medical devices
and
methods for cutting, evacuating andlor performing work on tissue M various
regions of a
patient's body.
BACKGROUND
10003] Many common medical devices perform the function of tesecting
tissue.
Suction, supplied by an external vacuum source is often used. to evacuate
tissue from the:
operative site.
100041 Medical devices which cut and evacuate tissue are used in a variety
of
procedures, including ear, nose, and throat surgery, gynecological surgery,
spinal surg.ery,
ophthalmic surgery, and many other applications. Depending on the procedure,
the
evacuated tissue may be collected. for pathological analysis.
100051 When applied to ear, nose, and throat surgery, tissue resectirg
devices are
commonly referred to as microdebriders.
[0006] Tissue incision may be performed by either a rotating cutter
(unidirectional or
oscillating) or a reciprocating cutter. In the case of a rotating cutter, an
electric motor is
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commonly used as the source of motion. in the case of a reciprocating cutter,
motion may
be produced by manual actuation, through a control such as a button or
trigger, or powered
actuation using pulsed. or valved, compressed air. Each of these power sources
has
distinct disadvantages when used to power a resecting medical device.
100071 For example, when an electric motor is used to provide .rotational
motion of a
cutter, the additional weight of the electric, motor may cause operator
fatigue. Wires from
an external power supply are inconvenient to make the connections and it is
inconvenient
to have the wires attached to the device during use.
100081 An electric motor increases the total cost of a device because of
the relatively
high cost of the motor itself and the cost of a power supply (in the case of
an externally
powered motor) or the cost of a recharging unit (when rechargeable batteries
are used).
The addition of electric motors makes sterilization of the device more
difficult, e.g.,
because of the added mass to the device from the motors. Additionally,. the
presence of
batteries reduces the sterilization options available to the .manufacturer,
due to the heat
generated by certain sterilization techniques. The presence of batteries adds
potentially
toxic chemicals that present additional challenges related to toxicity,
sterilization, and
device disposal.
100091 Medical devices that include electric motors are often made to be re-
usable
which requires a system for reprocessing the device. When using a manually
actuated
cutting device, the operator may experience fatigue from repeated actuations.
Additionally, manual actuations can be performed only as quickly as the
operator can
actuate the cutter via mechanical input through a control and the time
required to perform.
an adequate number of actuations may be excessive.
[00101 Electrically-powered microdebriders typically require an expensive
capital
investment in a power console that is separate from the h.andpiece. The
capital cost of the
power console., handpiece, and disposable blades makes procedures such as a
nasal.
polvpectomy and other procedures cost prohibitive in a doctor's clinic setting
1100111 Existing microdebriders are typically built with a handle of the
device in, line
with the shaft of the device, as a result, the handle and the operator's hand
may interfere
with an endoscope and/or the camera.
10012] Existing microdebriders expose a cutting blade to the end of the
device. This
may be disadvantageous when the operator loses sight of the end of the device
and
accidentally cuts or damages structures that come into contact with it.
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100131 As a result of these limitations, it is impractical for Ear, Nose,
and Throat
physicians or other physicians to remove nasal and sinus polyps or other
polyps or other
tissue in an office or other setting using the current technology. 'Therefore,
patients are left
with the undesirable options of a course of steroid treatments to reduce the
size of the
polyps (with associated steroid side effects), removal of the polyps in an
ambulatory
surgery center (cost prohibitive and therefore rarely performed as a stand-
alone
procedure), or leaving the polyps untreated and dealing with the associated
breathing
obstruction.
BRIEF SUMMARY
100141 'Various medical devices and methods for cutting, evacuating and/or
performing work on tissue in various regions of a patient's body are provided
herein
100151 Various cutting devices driven by various power sources are
described herein.
In certain variations, a vacuum powered tissue cutting device is provided. The
device may
include an elongate shaft having a proximal end, a distal end and a lumen
defined therein.
The distal end may include an opening for receiving tissue. A cutter .may be
positioned
within the elongate shaft., wherein the cutter is configured to be actuated to
cut tissue. A
chamber may be coupled to the proximal end of the elongate shaft. The chamber
may
have a. mechanism positioned therein, wherein the mechanism can be powered by
suction
created by a vacuum source such that the mechanism produces an actuating
motion which
causes the cutter to actuate, e.g.õ to reciprocate. In certain variations, a
cutter positioned
within the elongate shaft may be reciprocated past the opening in the elongate
shaft to cut
tissue in the opening.
10016] in certain variations, a method of cutting and/or removing tissue
from a subject
may include advancing a cutting device next to, near or to a target tissue in
the subject.
The cutting device may have an elongate shaft and a cutter positioned within
the elongate
shaft. The cutting device may be powered using suction created by a vacuum
source such
that the cutting device produces an actuating motion, which causes the cutter
to actuate,
reciprocate, to cut tissue. The cut tissue may be evacuated using the suction
created
by the vacuum source or may be otherwise removed. In certain variations, the
method of
cutting and/or removing tissue may be utilized to perform a polypectomy or a
discectorny.
[00171 In certain variations, an apparatus for cutting or scraping tissue
in a subject
may be provided.. The apparatus may include an end effector, wherein the end
effector
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includes a scraping edge positioned on a distal end of the end effector. One
or more
scraping wings may be positioned at an angle relative to .the scraping edge
such that the.
scraping edge and scraping wings .may be used to provide scraping motions in
different
directions.
100181 In certain variations, devices, systems and methods for excising,
cutting and/or
evacuating tissue are provided. A variation of a device may include a cutter
and a double
action vacuum powered mechanism or motor in which vacuum is used to actively
reciprocate a piston connected to the cutter. The vacuum powered motor may
include a
vacuum port connected to a vacuum source, a shuttle piston, a drive piston
coupled to the
shuttle piston, and a chamber for receiving the drive piston, the chamber
having proximal
and distal sides The drive piston may be set into reciprocating motion through
the
creation of differential pressure on either side of the piston by alternating
evacuation,
through the vacuum port, within the two sides of the piston chamber. The
motion of the
drive piston may effect translation of the shuttle piston, causing the shuttle
piston to
alternate between positions of opening and closing the vacuum port to the
proximal and
distal sides of the piston chamber to alternate evacuation of each side of the
chamber. The
actuating motion., e.g.õ reciprocating motion, of the drive piston may be used
to reciprocate
or rotate the cutter.
[00191 In certain variations, a cutting or scraping component may be
positioned or
at or near a distal end of a. rigid or flexible end effector which may be
utilized to
excise, scrape or cut tissue. The end effector may be curved or straight. The
end effector
may include a shaft, a reciprocating cutter and/or a scraping edge positioned
on the shaft
or on the reciprocating cutter..
[00201 In certain variations, a cutter may be positioned at or near the
distal end of a
malleable shaft that may be shaped by the operator to a curvature suitable to
access the
desired anatomical location.
100211 In certain variations, a medical device driven by a vacuum source
may include
a working end having an operable element. The operable element may be coupled
to a
mechanism, such that when the mechanism is driven by the vacuum source,
movement of
a drive piston actuates the operable element. The drive piston may be located
in a
chamber and may be moveable between a drive stroke and a return stroke. The
device
may include a valve configured to alternately seal and vent at least a portion
of the
chamber. A biasing component may be positioned against the drive piston, where
evacuation of the chamber and movement of the biasing component when the
chamber is
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vented to ambient air causes the drive piston to cycle between a drive stroke
and a return.
stroke,
100221 In certain variations, a medical device driven by a vaCUUM source
may include.
a handle having a linkage support element. A working end may be coupled to the
handle,
where the working end has an operable element and the operable element is
coupled to a
mechanism positioned in the handle. When the mechanism is driven by the vacuum
source, movement of a drive shaft actuates the operable element. The drive
shaft may be
located in a chamber of the mechanism and moveable between a drive stroke and
a return
stroke. A shuttle body may be moveable between a forward and return positions,
wherein
movement between the forward and return positions alternates a fluid path
between the
chamber and vacuum source so that during application of vacuum from the vacuum
source, movement of the shuttle body causes the drive shaft to cycle between
the drive
stroke and the return stroke. A linkage couples the drive shaft to the shuttle
body to assist
in switching the Shuttle body between the forward and return positions and to
prevent
unstable flutter of the shuttle body between the forward and return positions.
:Bre linkage
may be configured such that the linkage is supported by the linkage support
element in a
first position prior to use of the medical device and is unsupported by the
linkage support
element in a second position after use of the medical device.
100231 In certain variations, a vacuum powered tissue cutting device may
include an.
elongate shaft having a proximal end, a distal end and a hunen defined
therein, where the
distal end has an opening for receiving tissue. A cutter is positioned within
the elongate
shaft, wherein the cutter is configured to be actuated to cut tissue. A
chamber is coupled.
to .the proximal end of the elongate shaft, the chamber having a mechanism
positioned
therein and a. linkage support element, wherein the mechanism is powered by
suction
created by a vacuum source such that the mechanism actuates which causes the
cutter to
actuate. The mechanism includes a piston and a valve, wherein the suction is
applied to
both sides of the piston in an alternating manner to cause the piston to
actuate which
causes the cutter to actuate, wherein the piston is coupled. to the valve by a
linkage that
translates motion from the piston to the valve. The linkage may be configured
such that
the linkage is supported by the linkage support element in a first position
prior to use of
the medical device and is unsupported by the linkage support element in a
second position
after use of the medical device_
10024,1 In certain variations, a vacuum powered tissue cutting device may
include one.
or more of the tbllowing elements: an elongate shaft having a proximal end, a
distal end
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and one or more lumens defined therein, wherein the distal end has an opening -
fix
receiving tissue; a cutter positioned within the elongate shaft, wherein the
cutter is
configured to be actuated to cut tissue; and a chamber coupled to the proximal
end of the
elongate shaft, the chamber having a mechanism positioned therein, wherein the
mechanism is powered by suction created by a vacuum source such that the
mechanism.
actuates which causes the cutter to actuate. A malleable outer shaft may be
positioned in a
first lumen of the elongate shaft and an evacuation shaft may be positioned
within the
malleable outer shaft. The evacuation shaft may have a variable diameter to
optimize a
tissue resection rate or tissue evacuation rate,
[00251 In certain variations, a tissue cutting device may include one or
more of the
following: a cutting element; and a tissue filter mechanism having a filter
lid and a filter
body, wherein the filter body has at least one collection chamber for
collecting filtered
tissue and a bypass chamber configured to allow tissue and/or fluid to exit
the tissue filter
mechanism without collection of tissue in the bypass chamber.
100261 In certain variations, a vacuum powered tissue cutting device may
include one.
or more of the following:. an elongate Shaft having a proximal end, a distal
end and one or
more lumens defined therein, wherein the distal end has an opening for
receiving tissue; a
cutter positioned within the elongate Shaft, wherein the cutter is configured
to be actuated
to cut tissue; and a chamber coupled to the proximal end of the elongate
shaft, the chamber
having a mechanism positioned therein, wherein the mechanism is powered by
suction
created by a vacuum source such that the mechanism actuates which causes the
cutter to
actuate; and a tissue filter mechanism coupled to the chamber, the filter
mechanism having
a filter lid and a filter body, .wherein the filter body has at least one
collection chamber for
collecting filtered, tissue and a bypass Chamber configured. to allow tissue
andlor fluid to
exit the tissue filter mechanism without collection of tissue in the bypass
chamber.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
100271 Fig. IA illustrates It side view of a variation of a cutting device.
100281 Fig, LB illustrates a side: view of the cutting device of Fig. A
with the right
hand portion of the chamber hidden.
6.
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100291 Fig. IC illustrates a side view of the cutting device of 1B with
the rigid
sleeve and elongate shaft hidden to show the evacuation shaft.
[00301 Fig,. 11) illustrates a side view of the cutting device of. Fig. I B
with the
manifold of the vacuum powered mechanism hidden.
100311 Fig. ilE illlustrates a side view of the cutting device of Fig. 113
with the
collection chamber hidden to show a filter.
100321 Fig. IF illustrates a magnified view the elongate shaft of the
cutting device of
Fig. 1B having multiple lumens.
100331 Fig, 16. illustrates a magnified view of the cutter of the cutting
device of Fig.
B.
100341 Fig. illustrates a vacuum source coupled to a variation of the
cutting device.
100351 Fig. 2A illustrates a side view of a variation of a vacuum powered
mechanism,
100361 Fig. 2B illustrates a cross sectional view of the vacuum powered
mechanism of
Fig. 2A.
[00371 Fig, 2C illustrates an opposite side view of the vacuum powered
mechanism of
Fir,. 2A.
100381 Fig. 21) illustrates a front view of the vacuum powered mechanism of
Fig. 2A.
[00391 Fig. 2E illustrates a rear view of the Vacuum powered mechanism of
Fig,
100401 Figs. 2F-26 illustrate side and prospective cross sectional views of
the vacuum
powered mechanism of Fig. 2A in a first position.
100411 Fins. 2H-21 illustrate side and prospective cross sectional views of
the vacuum
powered mechanism of Fig. 2A in a second position.
100421 Fig. 3.A illustrates a cross sectional view of a variation of a
double action
vacuum powered mechanism having a bi-stable switch in a proximal position,
100431 Fig,. 313 illustrates a cross sectional view of the double action
vacuum powered
mechanism having a bi-stable switch of Fig, 3A in a distal position.
100441 Fig. 4A illustrates the cross sectional view of a variation of a
double action
vacuum powered mechanism in a proximal position.
[00451 Fig. 413 illustrates a cross sectional view of the double action
vacuum powered
mechanism of Fig. 4A in a distal position.
100461 Fig_ 5A illustrates a cross sectional view of a variation of a
single action
vacuum powered mechanism using a spring return system in a proximal position.
[00471 Fig. 5B illustrates a cross sectional view of a singe action vacuum
powered
mechanisms of Fig. 5A in a distal position,
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100481 no- 6 illustrates a side view of a variation of an end effector:
[00491 Fig 7 illustrates a side view of a variation of an end effector.
[00501 Fig. 8 illustrates a flow chart of a variation of a method for
cutting and
removing tissue using a vacuum powered cutting device.
100511 Fig_ 9 illustrates a flow chart of a variation of a method for
performing a
polypectomy using a vacuum powered cutting device:
[00521 Fig. 10 illustrates a -flow chart of a variation of a method for
performing a
discectomy using a vacuum powered cutting device.
100531 Figs. 11A-11E illustrate across sectional side view of a variation
of a vacuum
powered mechanism utilizing a poppet valve.
100541 Figures 12A-12D illustrate various views of a variation of a vacuum
powered
cutting device utilizing the mechanism of figures 11A-11I2L.
100551 Figures 13A-13D illustrate various views of a variation of a vacuum
powered
cutting device including a mechanism having a deformable linkage.
100561 Figures 14A-14F illustrate various views of a variation of a shaft
for use with a
vacuum powered cutting device.
[00571 Figures 15A-15F illustrate various views of a variation of a filter
mechanism
for integration in a microdebrider or tissue cutting or resection device.
DETAILED DESCRIPTION
[00581 Variations of the devices are best understood from the detailed
description
when read in conjunction with the accompanying drawings. It is emphasized
that,
according to common practice, the various features of the drawings may not be
to-scale.
On the contrary, the dimensions of the various features may be arbitrarily
expanded or
reduced for clarity. The drawings are taken for illustrative purposes only and
are not
intended to define or limit the scope of the claims to that which is shown.
100591 'Various medical devices, including various cutting devices and
methods for
cutting, resecting, incising or excising tissue are described herein. In
certain variations a
medical device may include a mechanism or motor driven or powered by a variety
of
different power sources, e.g., suction from a vacuum source, pneumatic, fluid
pressure
(e.g. hydraulic), compressed air, battery power or electrical power or gas
power or any
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combination thereof. The mechanism or motor may create a reciprocating or
rotational
motion output in any direction which may cause an operable element, such as a
cutter on
or in a cutting device, to actuate, e.g., reciprocate or rotate, to cut
tissue. A cutting device
may be utilized to cut, resect, incise or excise various types of tissue
located in various
regions of a patient's body. For example, the cutting device may be utilized
to perform a
polypectomy in a patient for removal of one or more polyps.
[00601 In certain variations, a cutting device powered by suction from a
vacuum
source (either external or internal.) is provided. The cutting device may
include an
elongate shaft. The elongate shaft may have a. proximal end, a distal end and
one or more,
lumens positioned within or along the elongate shaft. The distal end of the
elongate shaft
may include an opening or window for receiving tissue. The device may include
a cutter
for cutting tissue. A cutter may be positioned within or on the elongate
Shaft. The cutter
may be actuated, reciprocated, e.g., axially along the longitudinal axis of
the elongate
shaft, or rotated to cut tissue. A chamber may be coupled to the proximal end
of the
elongate shaft. Optionally, at least a portion of the elongate shaft may be
coupled to the
chamber such that at least a portion of the elongate shaft or a cannula (or
the entire shaft or
cannula) remains fixed or immovable in one or more direction relative to the
chamber,
e.g., while the cutter, on or in the elongate shaft or cannula, is being
reciprocated or
otherwise motivated or during actuation, reciprocation or rotation of the
cutter.
[00611 A mechanism or motor may be positioned within the chamber. The
mechanism
may be powered by suction created by a vacuum source, which causes the
mechanism to
produce a reciprocating motion. In certain variations, the mechanism may be
powered
solely by suction created by .the vacuum source, .without the use of
electricity or
pressurized air or fluid to power the mechanism. Additional connections for
electrical or
pneumaticihydraulic power may not be required. The mechanism may include a
piston
which is put into reciprocating or reciprocating linear motion by suction from
the vacuum
source. The reciprocating motion output produced by the mechanism causes the
cutter
(connected to the mechanism) to actuate, e.g., to reciprocate or to rotate. In
certain
variations, the cutter may be reciprocated back and forth in a linear motion,
e.g., axially, or
along the longitudinal axis of the elongate shaft. In other variations, linear
reciprocating
motion from the mechanism may be translated into rotational motion of the
cutter. The
cutting device may include a port or valve for connecting the vacuum source to
the cutting
device to provide suction to the cutting device,
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[00621 The suction from 4 vacuurnsource may draw tissue into the opening in
the
elongate shaft. The cutter may be reciprocated or rotated past the opening in
the elongate.
Shaft, thereby cutting the tissue which is drawn into the opening of the
elong.ate shaft. The
cutting device may include an evacuation lumen for evacuating cut tissue using
suction
created by the vacuum source, In certain variations, the tissue may be
otherwise removed
without using evacuation to remove the tissue.
[00631 In certain variations, a Itunen for delivering irrigant or fluid may
be provided.
For example, the elongate shaft may include a lumen for delivering irrigant to
the distal
end of an evacuation lumen in the elongate shaft or to an opening of the
elongate shaft or
to a cutter. The irrigant may flow constantly through the lumen, or it may
flow through
the hit-nen only when suction from the vacuum source is present to draw the
irrigant
through the irrigant lumen. The cutting device may include a reservoir filled
with -water .or
other irrigant positioned with the cutting device or the irrigant may be
provided from an
external supply.. For example, a syringe filled with irrigant, e.g., water,
may be connected
to the cutting device or an elevated container or bag may supply irrigant to
the cutting
device or to the site of treatment. The irrigant may begin to flow through the
cutting
device when suction is present in a lumen within the elongate shaft, at an
irrigant port,
which may be located within the shaft lumen near the opening- of the elongate
shaft. The.
irrigant may be drawn to the distal end of an evacuation lumen in the elongate
shaft or to
the opening of the elongate shaft, where it lubricates tissue and a lumen
within the shaft,
a tissue evacuation lumen, to facilitate evacuation of the cut tissue.
100641 The cutting device rimy include a handle, such that the cutting
device may be
handheld. For example., the chamber of the cutting device may be in the form
of a .handleõ
The handle may be positioned. or set .at an angle relative to the elongate
Shaft. This
arrangement of the handle or chamber relative to the elongate shaft may-
provide a clear or
substantially clear line of site above and/or to the sides of the elongate
shaft. The angled
arrangement may reduce interference with other medical devices or instruments
that a user
may utilize during a tissue cutting procedure, e,g. an endoscope and
associated cables.
This angled arrangement may also provide optimal .user comfort, The handle may
have an
ergonomic design to provide comfort and ease of use. A curved or angled neck
portion
may extend from the chamber or handle, for receiving or holding the elongate
shaft.
100651 A tissue collection chamber may be provided. For example, a tissue
collection
chamber may be integrated in the chamber or handle of the cutting device or
may be
otherwise connected or attached to the cutting device. The tissue collection
chamber may
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be removable from the cutting device.. The removable tissue collection chamber
may.
allow tissue collected therein to be biopsied: studied or a diagnosis of
pathology may be.
performed on the collected tissue_ Removal of the tissue collection chamber
and/or filter
may result in the device being disabled, e.g.., where the tissue collection
chamber may not
be reassembled to the device. This may prevent the device from being reused or
used on
more than one patient to minimize or prevent the associated risks of
transmitting
pathogens from one patient to another or infecting another patient. For
example, the
device may be disabled where the internal vacuum lines are sheered when the
tissue
collection chamber i.s removed from the handle. As a result, the tissue
collection chamber
cannot be reassembled to the device thereby rendering the device useless. The
device
may be .fully or partially disposable.
100661 In other variations, a tissue collection chamber may be reusable,
where the
tissue collection chamber may be removed, sterilized and then reassembled or
reattached
to the cutting device for continued use.
[00671 Various configurations of the elongate shaft are contemplated, in
certain
variations, at least a portion of the .elongate shaft or the entire elongate
shaft may be
malleable or otherwise adjustable. For example, the distal end of the elongate
shaft or the
section oldie elongate shaft where tissue cutting is performed may be
malleable or
flexible such that portion of the elongate shaft may be adjusted or
manipulated by the user,
e.g., hand adjustable. The malleable portion of the elongate shaft may be
manipulated
into a variety of shapes or curves such that the cutting device, e.g., the
cutter or cutter
openingõ niay access or be positioned in a variety of anatomical locations to
cut andior
remove tissue_ The malleable portion of the elongate shalt .may be adjusted or
manipulated before or during operation by the user into various positions or
configurations, ranging from, straight to angled or curved. The shaft may be
manually,
automatically or robotically adjusted. The shaft may be adjusted without the
need for
additional tools or attachments to change or affect the shape or position of
the shaft, such
that the positioning for cutting and cutting may be performed using a single.
device. In
other 'variations, a tool or attachment may optionally be utilized to adjust
or manipulate an
elongate shaft for cutting.
10-068] A cutter may have various shapes and configuration, es., the cutter
may be in
the form of a cutting 'blade or pipe or tube positioned within the elongate
sh.aft. A cutter
may be positioned in the cutting device such that the cutter can reciprocate
past an opening
Of cutting window in the elongate shaft in certain. -variations, the cutter
may be positioned
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svithin or .on the elongate shaft such that the cutting blade is not exposed
on an outside of
the opening or window in the elongate shaft or beyond the distal tip of the
elongate shaft
This arrangement may provide safety to patients and .minimize or prevent the
risk of
inadvertently cutting or puncturing tissue in a patient during the tissue
cutting procedure or
during advancement of the cutting device to the target site in a patient for
treatment In
certain variations, the anvil may protect a cutter such that it is not
exposed, thereby
providing safety to patients,
[0069] A sufficient vacuum source for operating or powering any Of the
cutting
devices described herein may be the vacuum source provided in most standard
operating
rooms, physician's offices, clinics or outpatient surgery centers. For
example, .many
physicians' offices have vacuum pumps capable of generating vacuum in the
ranges of 10
to 25 inches of mercury (in FIG), e.g., about 22 inches of mercury (in Hg)
and/or at about
28 to about 40 liters per minute (LPM) flow rate. The various cutting devices
described
herein may utilize vacuum sources or vacuum pumps operating in the above
performance
ranges to effectively operate and cut tissue without additional power inputs
or supply
requirements needed. For example, suction provided by such vacuum sources may
move,
actuate, reciprocate or otherwise operate the .mechanism of a cutting device
and/or the
cutter at a speed or rate ranging from about 250 to about 2500 cycles/min or
about 500 to
1200 cycles per minute or less than about 1200 cycles per minute. These rates
are slower
than the rates that would be provided by a typical electrically powered motor,
yet provide
the control and power to effectively and safely operate and reciprocate the
cutter of the
cutting devices described herein to cut, resect, and/or excise tissue in
various regions in a
patient, e.g..õ to cut and remove polyps positioned in the nasal or sinus
cavity of a patient in
a safe, controlled and effective manner.
100701 in certain variations, a cutting device may be connected solely- to
a vacuum
source, and optionally, to an irrigant source. The vacuum source may be
connected to the
cutting device such that suction supplied by the vacuum source drives or
powers the
mechanism of the cutting device, draws tissue into the opening in the elongate
shaft or
otherwise into the path of a. cutter, draws irrigant from a reservoir or other
source through
the cutting device or through a lumen in or on the cutting device, Or to the
cutting device
and/or evacuates cut tissue for removal from a patient.
100711 Various vacuum powered mechanism for use in the various cutting
devices
described herein, to drive or actuate a cutter, are also described herein, in
certain
variations, a vacuum powered or vacuum driven mechanism may include one or
more
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pistons, wherein suction is applied to both sides of the piston in an
alternating manner to
cause the piston to reciprocate. The piston is coupled or connected (directly
or indirectly)
to the cutter, thereby causing the cutter to reciprocate. In another
variation, suction may
be applied to one side of the piston and a spring force in a vacuum powered
mechanism
may be applied to the other side of the piston., to cause the piston to
reciprocate. The
reciprocating piston causes the cutter to reciprocate,
100721 In certain variations, a hand-held, fully disposable powered medical
device
capable of resecting tissue in the human body is provided. The device is
powered by an
internal mechanism that is powered by suction from an external vacuum source.
The
mechanism produces reciprocating motion that may be used to move a cutter back-
and-
forth past an opening in a shaft. A portion of the suction from the external
vacuum source
is routed through the shaft and draws tissue into the window where it is
excised by the
cutter. The tissue is then evacuated through the shaft and into a tissue
collection chamber
on the handle of the device The suction in the shaft also draws irrigant into
the lumen of
the shaft, where it lubricates the tissue and shaft lumen to facilitate
evacuation of the
tissue.
[0073] In certain variations, the cutting devices or mechanisms described
herein may
be powered by a vacuum source where the devices have an efficient .use of
supplied
vacuum suction to the device, e.g,, with none of the supplied suction going
unused. In.
certain variations, a. cutting device may be powered by constant delivery of
vacuum or
suction. In certain variations, a cutting device may be manufactured of all or
substantially
all mechanical components reducing costs for manufacturing.
100741 In certain variations, a cutter may be positioned at or near the
distal end of a
flexible shaft that has a preformed or predetermined curvature. The shaft may
be adapted
for insertion into a cannula Where the distal end of the shaft may advance
from the cannula
toward a target site and where the shaft allows its predetermined curvature to
position the
distal end of the shaft near the target site.
10075] Exemplary Cutting Devices
10076] :Figure IA shows one variation of a vacuum powered cutting device.
Referring
to Figures I B-1 E, the cutting device 10 includes an elongate Shaft 11 The
elongate shaft
12 may include a rigid sleeve 14 that provides rigidity to the elongate shaft.
The elongate
shaft may include a window or cutting window or opening 1.6 positioned at or
near a distal
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end of the elongate shaft. An evacuation shaft 17 may be positioned within the
elongate
shaft 12. A cutter 18 may be positioned within the elongate shaft 12 such that
it may be.
reciprocated past the opening 16. In this particular variation, the cutter 18
is formed at the
distal end of the evacuation shaft 17, but other types of cutters are
contemplated, e.g., the
cutter 18 may extend from a wire or blade positioned in the elongate shalt 12.
100771 One or more lumens may be positioned within the elongate shaft 12
(See Fig.
1F). Elongate shaft 12 may include an irrigant lumen, An irrigant line (not
shown) may
connect to the proximal end 13 of the elongate shaft 12, to supply irrigant
from an internal
or external reservoir or irrigant source, through an irrigant lumen in the
elongate shaft 12,
to the distal end of an evacuation lumen in the elongate shaft or to the
opening 16 of the
elongate shaft 12. For example, the irrigant may be drawn to the opening 16 of
the
elongate shaft 12, Where it lubricates tissue and the evacuation lumen, to
facilitate.
evacuation of the cut tissue. Optionally, the elongate shaft 12 may include a
malleable
portion, for example at its distal end, which can be manipulated or adjusted
to provide
various shapes and configurations to the elongate shaft 12 to position a
cutter in various
regions of the body. Optionally, one or more wires 15 may positioned in the
elongate.
shaft 12, which .may serve to hold the malleable portion of the shaft in a
desired position.
A rigid sleeve '14 may be placed over other portions of the elongate Shaft 12
to provide
100781 The elongate shaft 12 may extend from a chamber 20. The chamber 20
may
provide a handle or grip for a user. The chamber 20 may include a tissue
collection
chamber 22. The evacuation shaft 17 may extend into the chamber 20, such that
one or
more lumens of the evacuation shaft 1.7 empties into .the tissue collection
chamber 22
either directly or indirectly, evg., via another tube or pipe (not shown),
connecting the
evacuation shall 12 to a first vacuum chamber port 21. The tissue collection
chamber 22
may include a filter 25 for filtering tissue collected therein. The tissue
collection chamber
22 may be integrated into the chamber 20 such that removal of the tissue
collection
chamber 22 disables the cutting device 10. In certain variations, the elongate
shaft 12
may be coupled or connected to the chamber 20 such that the elongate shaft 12
remains
fixed relative to the chamber 20. For example, the elongate shaft 12 may be
fixed such
that it is not motivated or reciprocated by the mechanism 30 or motor
described below. In
certain variations, the elongate shaft .12 may be coupled or connected to the
chamber 20
such that at least a portion of the elongate shaft 12 or the entire shaft
remains fixed or is
configured to remain stationary in one or more directions relative to the
chamber 20, e.g.,.
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during actuation of the cutter. At least a portion of the elongate. shaft 12
may be coupled
or connected to the chamber such that at least aportion of .the elongate shaft
is not
motivated or reciprocated by the mechanism 30 or motor described below in one
or .more
directions relative to the chamber, e_g., in axial direction along a
longitudinal axis of the
chamber or shaft, and at least a portion of the elongate Shaft may be moveable
or
malleable as described herein. Optionally, at least a portion of the shaft or
the entire shaft
may be or remain movable or not fixed or stationary M one or more directions
relative to
the chamber,
100791 A vacuum powered mechanism 30 is positioned within the chamber 20.
Figures 2A-21 show various views of the vacuum powered mechanism 30. The
mechanism 30 includes a shuttle body or shuttle piston 32 and a drive shall or
drive piston
34. The pistons may be arranged in various configuration, e.g., in parallel to
one another.
A 1A-stable switch 36 may be connected to the shuttle piston 32 and the drive
piston 34.
The bi-stable switch 36 having a switch spring 37 may be connected to the
drive piston 34
and the shuttle piston 32 either directly or via a piston clamp 35 connected
to the switch
spring 37 or bi-stable switch 36_ Actuation of the bi-stable switch 36 by the
drive piston
34, which is .motivated or reciprocated by suction created by the vacuum
source, may
reverse or move the shuttle piston 32 in either the proximal or distal
directions (Le.,
toward the distal end of the cutting device or toward the proximal end of the
cutting
device.) When the shuttle piston 32 moves from one end of its' travel
extremity to the
opposite end of its' travel extremity, the evacuated side of a drive piston
chamber 42 is
vented to allow atmospheric air to flow into the drive piston chamber 42 while
the
opposite side of the drive piston chamber 4.2 is shut off from atmospheric air
and
evacuated. As a result, the drive piston 34 is motivated to move in the
opposite direction
until the bi-stable switch 36 is actuated and the shuttle piston 32 reverses.
The shuttle
piston 32 and the drive piston 34 are positioned in a manifold 38. The
manifold 38
includes a drive piston chamber 44 and a shuttle piston chamber 42. The hi-
stable switch
36 may ensure a reliable transition of the shuttle piston 32 or valve on the
shuffle piston
past. or comple.tely past a shuttle chamber vacuum supply port 47 to prevent
unstable
flutter of the shuttle piston 32 and possible mechanism 30 or motor stall,
100801 As shown in the various cross sectional views of :Future 213 and
Figures 2F-21,
at least a portion of the drive piston 34 i.s positioned in the drive piston
chamber 44 and at
least a portion of the shuttle piston 32 is positioned in shuttle piston
chamber 42. The
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drive piston chamber 44 and the shuffle piston chamber 42 are in fluid
communication
with each other-via first and second vacuum slots 45 and 46.
10081.1 A shuttle chamber vacuum supply port 47 is provided to connect a
vacuum
source, via a tube or line (not shown), to the -mechanism 30 to -provide
suction to the
mechanism 30. Figure 1 U shows a vacuum source coupled to a variation of the
cutting
device 10. The tube or line may be connected to a second vacuum chamber port
28
(shown in 'Figures 1B-1D) andior the shuttle chamber vacuum supply port 47.
The shuttle
chamber vacuum supply port 47 provides entry into the shuttle piston chamber
42, such
that the vacuum source can be in fluid communication with the shuttle piston
chamber 42.
and evacuate the shuttle piston chamber 42 andior the drive piston Chamber 44,
to power
and motivate the drive piston 34 and/or the shuttle piston 32, as described in
further detail
herein. Details of a. vacuum powered mechanism are also provided below with
reference
to Figures 3A-3B,
100821 The mechanism 30 may be activated and the drive piston 34
reciprocated by
suction from the vacuum source as soon as the vacuum source is connected. to
the c.utting.
device 10 and the vacuum source is activated. Referring back to Figs, 1A-1 E,
the .cutting
device 10 may also include a trigger 26 positioned on the chamber 20 in a
location such
that the trigger 26 can be conveniently or ergonomically actuated by a user's
finger as the
user holds the cutting. device 10. When the trigger 26 is in the "on"
position, the trigger 26
is disengaged from the shuttle piston 32õ allowing the Shuttle piston 32 to
reciprocate due
to inotivation of the bi-stable switch 36 which is in turn motivated by the
movement of the
drive piston 34. When the trigger 26 is actuated into an "oft" position, the
trigger 26 may
interact with or engage the shuffle piston 32., which causes the shuffle
piston 32 and drive
piston 34 to stall or stop such that the cutter 18 is stopped in a position
proximal to the
opening 16 thereby leavin,. the opening 16 open. This allows the device 10 to
be used for
suction or evacuation through opening. 16, even when the mechanism 30 and
cutter 18 are
not activated, as the vacuum source may remain activated and connected to the
cutting
device 10, supplyi%,! suction through a lumen of the evacuation shaft 17. In
certain
variations, suction may not be supplied through the lumen of the evacuation
shaft during
cutting.
10083] The vacuum source may be connected to the cutting device 10 at the
.external
vacuum port 29. The external vacuum port 29 is in fluid communication with the
tissue
collection chamber 22 and the first vacuum chamber port 21, supplying suction
to the
lumen of the evacuation. shaft The external vacuum port 29 is in fluid
communication
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svith the second vacuum chamber port 28, supplying suction through the shuttle
chamber
=vacuum supply port 47 to the shuttle piston chamber 42 and the drive piston
chamber 44,
to motivate, reciprocate and/or power drive piston 34, which motivates Or
reciprocates the
hi-stable switch 36 and cutter 18, which is connected to the vacuum powered
mechanism
30 either directly or indirectly.
[00841 In use, the elongate shaft 12 of the cutting device 10 may be
inserted into the
desired location or area in a patient.. The vacuum source is connected to the
cutting device
10, supplying suction to the mechanism 30, causing the drive piston 34 to
reciprocate.
The drive piston 34 causes one side of the hi-stable switch 36 to move either
proximally or
distally which increases the tension on the extension spring 37. The increased
tension on
the extension spring 37 causes the adjacent side of the hi-stable switch 36
and the shuttle
piston to move proximally or distally to decrease the length of the extension
spring 37.
When the seal on the shuttle piston or shuttle piston 32 moves past the
suction port 47, the
vacuum or suction in the shuttle chamber 42 reverses to the opposite side of
the drive
piston 34 while atmospheric air is allowed to flow into the side of the
shuttle chamber 42
that is not evacuated, thereby motivating the drive piston :34 to .move toward
the evacuated
side, (As shown for example in Fig. 213),. The evacuation shaft 17 is
connected to the
drive piston 34. The evacuation shaft 17 may be connected directly to the
drive piston 34
or the evacuation shaft 17 may be connected to sleeves, tubes or other shafts
that are
connected to the drive piston 34. For example, the piston clamp 35 may connect
the,
evacuation shaft 17 to the drive piston 34,
10085] As stated supra, the cutter 18 is formed. at the distal tip of the
evacuation shaft
17. Once the vacuum source is connected to the cutting device 10 and the
trigger 26 is
positioned in the "on' position such that it is disengaged from the shuttle
piston 32,
suction applied to the mechanism 30 causes the drive piston 34 (and
.consequently the
shuttle piston 32 as described above) to reciprocate, which causes the
evacuation shaft 17
and the cutter 18 to reciprocate, driving the cutter 18 back and forth, e.g.,
in a linear or
axial motion along the longitudinal axis of the elongate shaft, past the
opening 16 in the
elongate shaft 12. A close .up of a variation of a cutting window is shown in
Fig. 10õkt
the same time, suction may be supplied from the vacuum source through a lumen
of the
evacuation shaft 17, to draw tissue into the opening 16, where the tissue is
then cut by the
reciprocating cutter 18, Optionally, the suction in the evacuation lumen may
also .evacuate
the cut tissue and deliver it to the tissue collection chamber 22.
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100861 While the reciprocating motion of the drive piston...34 of the
mechanism 30 is
translated to the cutter IS Via the evacuation shaft 17 in .the variation
described above,
other components for translating such reciprocating motion are also
contemplated. For
example a cutter may extend from a wire or blade or any other extension or
member which
is connected to the mechanism 30, e.g., via the drive piston 34 or piston
claim 35. In
certain variations, the cutter 18 may be directly or indirectly connected to
the mechanism
30 or the drive piston 34 or the shuttle piston 32 or the hi-stable switch 36,
10087] In certain variations, a loop or extension may be provided in the
evacuation
shaft 17 or in a tube or pipe connecting the evacuation shaft 17 to the first
vacuum.
chamber port 21, providing extra length that may move or change shape such
that at least a
portion of the evacuation shaft 1.7 or tube or pipe that is connected to the
first vacuum
chamber port 21 does not move or reciprocate or become dislodged when the
evacuation
shaft 17 is being reciprocated or motivated by the mechanism 30,
100881 In certain variations, a method of cutting and removing tissue from
a subject
may include advancing a cutting device at, next to, in or near a target tissue
in the subject.
The cutting device may include an elongate shaft and a cutter positioned
within or on the.
elongate shaft. The elongate shaft may be advanced into the subject to access
the target
tissue and to position the cutter at, next to, in or near the target tissue to
cut and/or remove
the tissue. The cutting device includes a mechanism or motor which is powered
or
driven by suction created by a. vacuum source. The suction from the .vacuum
source
powers the mechanism causing it to produce a reciprocating or rotating motion
which
causes the cutter to reciprocate or rotate to cut tissue. The tissue may
optionally be
evacuated using suction created by the vacuum source_ The cut tissue .may
optionally be
gathered or collected with the cutting device, In certain variations, suction
or vacuum may
be turned off or not supplied to the opening and the tissue may be otherwise
removed. in
certain variations, the suction from the vacuum source may draw tissue into an
opening on
the elongate shaft. The cutter may be reciprocated or rotated past the opening
to cut the
tissue drawn into the opening on the elongate shaft. In certain variations
suction from the
vacuum source may draw an irrigant to the distal end of an evacuation lumen in
the
elongate shaft or to the opening of the elongate shaft, where it lubricates
tissue and/or the
evacuation lumen, to facilitate evacuation of the cut tissue. In certain
variations, the
cutting device may include a chamber in which the mechanism is positioned. The
elongate shaft may be attached to the chamber such that at least a portion of
the shaft or
the entire shaft remains in a fixed position or is configured to remain
stationary in one or
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more directions relative to the chamber, el.., while the mechanism is
producing a
reciprocating motion and/or reciprocating or rotating a cutter., cutter shaft
or evacuation
Shaft positioned within the elongate shaft.
10089] In certain variations, a method of cutting, resecting or excising
tissue in a
patient may include attaching the cutting device to a vacuum source (internal
or external)
and optionally to a source of irrigant. The vacuum source supplies suction
that may power
or motivate the mechanism or motor of the cutting device, draw tissue into the
path of a.
cutter or cutting blade, draw it-rig-ant from an it-rig-ant source to the site
of cutting or
excision or near the cutter, and/or evacuate cut tissue from the patient.
[00901 In certain variations, a method for performing. a polypectomy in a
subject may
include advancing a cutting device at, to, next to, in or near a target polyp.
Polyps may be
located in various regions of a patient. For example, nasal or sinus polyps
may be cut
and/or removed by advancing the cutting device into the nasal cavity and
positioning a
cutter at, .next to, in or near the polyp. The cutting, device .may include an
elongate shaft
and a cutter positioned within or on the elongate shaft. The elongate shaft of
the cutting
device .may he advanced into the nasal or sinus cavity to access the polyp and
position the
cutter near the polyp. The cutting device includes a mechanism or motor which
is.
powered by suction created by a vacuum source. The suction from the .vacuum
source
powers the mechanism causing it to produce a reciprocating or -rotating motion
which
causes the cutter to reciprocate or rotate to cut tissue. The tissue may
optionally be
evacuated using suction created by the vacuum source. The cut tissue may
optionally be
gathered or collected with the cutting. device. In certain variations, suction
or vacuum may
be turned off or not supplied to the opening and the tissue may be otherwise
removed. In
certain variations, the suction from the vacuum source may draw tissue into an
opening on
the elongate Shaft. The cutter .may be reciprocated past the opening to cut
the polyp tissue
drawn into the opening on the elongate shaft. In certain variations, the
mechanism may be
powered solely by suction from a vacuum source, without requiring the use of
compressed
or pressurized air or electric power to supply power.
[00911 In certain variations, a method for perfortning a discectomy in a
subject may
include advancing a cutting device at, to, next to, in or near a disc in a
spine. For example,
a disc annulus or nucleus may be cut by advancing' the cutting device into or
next to the
disc and positioning a cutter at, next to, in or near the disc. The cutting
device may.
include an elongate shaft and a cutter positioned within or on the elongate
shaft. The
elongate shaft of the cutting device may be advanced into or next to the disc
to position the
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cutter. The cutting device includes a mechanism or motor which is powered by
.suction
created by a vacuum source_ The suction from the vacuum source powers the
mechanism.
causing it to produce a reciprocating or rotating motion which causes the
cutter to
reciprocate or rotate to cut tissue. The tissue may optionally be evacuated
using suction
created by the vacuum source. The cut tissue may optionally be gathered or
collected with
the cutting device. In certain variations, suction or vacuum may be turned off
or not
supplied to the opening and the tissue may be otherwise removed_ In certain
variations,
the suction from the vacuum source may draw tissue into an opening on the
elongate shaft.
The cutter may be reciprocated past the opening to cut the disc tissue drawn
into the
opening on the elongate Shaft. In certain variations, the mechanism may be
powered
solely by suction from a vacuum source, 'W thou t requiring the use of
compressed or
pressurized air or electric power to supply power.
E00921 In certain variations, a user may cut tissue by positioning a
cutting window on
an elongate shall against the tissue to be resected and actuate a switch or
trigger to allow
the mechanism to reciprocate. This causes a cutting blade to move back-and-
forth past the.
cutting .window. As tissue is drawn into the cutting window by suction, the
blade shaves
the portion of tissue that is in the path of the cutting blade. The tissue is
then evacuated
through the lumen of the shaft that is connected to the blade and is deposited
in a tissue
collection chamber.
100931 The cutting devices described herein may be utilizing for a variety
of
procedures as described supra. The cutting device may be advanced or inserted
into or
through existing orifices, cavities or passages, e.g., a nasal cavity, airway,
respiratory
passage, reproductive pathways, intestinal pathways or other pathways. The
cutting
devices may be advanced or inserted into a. patient percutaneouslyõ
intraluminally or in
any minimally invasive manner to perform a procedure in or on a subject.
Optionally, a.
cutting device may be utilized through a surgical incision or site.
100941 The various cutting devices described herein, e.g., a handheld
and/or portable
cutting device, allow for cutting and/or removal of tissue, e.g., a nasal
polyp, by providing
a low cost, disposable device that allows the tissue cutting procedure to take
place in a
manner that is safe, quick, and inexpensive. The cutting device does not
require
significant setup time, or the inconvenience and expense associated with
capital.
equipment, in-office tissue removal using a cutting device may be performed
using local
anesthetic as compared to general anesthetic which is used in ambulatory
surgery centers.
For example, a cutting device may be utilized to perform nasal and sinus polyp
removal in
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a doctor's office setting. While the cutting- devices described herein may be
used to
-perform a -polypectomy, they can also be used for tissue resection procedures
it other
locations of the body, eg, including for ear, nose, and throat surgery,
gynecological
surgery, spinal surgery, general surgery and ophthalmic surgery.
100951 A cutting device that uses a vacuum source, e.g.,. an external
vacuum source, to
power an actuating or reciprocating mechanism or motor that is connected to a
cutter,
thereby translating the reciprocating motion to the cutter to cause the cutter
to reciprocate
provides a number of advantages and efficiencies. The cutting device does not
require an
investment in capital equipment, such as electric powered consoles, thus
providing a user
with a substantial cost savings. Capital equipment requires valuable storage
space When
not in use as well as service and maintenance in the facilities where it is
used. The cutting
device also allows a manufacturer to make continuous improvements without
being
constrained by installed capital equipment.
100961 The cutting, devices described herein may be manufactured using tow
cost.
components and assembly techniques, making the cost of the device much lower
than a.
cutting device which utilizes an electric motor. The elongate shaft may be
constructed
from a -variety of materials. For example, a combination of metal and plastic
components
that are not susceptible to heat buildup resulting from friction between
moving
components may be utilized.
100971 Using a -vacuum source as the power source to provide both tissue
evacuation
and mechanical motion to cut tissue eliminates or reduces the number of
additional or
separate connections, wires or tubes that would otherwise be required to
provide electrical.
or other pneumatic power, such as pressurized or compressed air, and
evacuation_ A.
standalone console to transfer the electrical or other pneumatic power may not
be required
to operate the cutting device.
10098] In certain variations, a single tube connects the vacuum source to
the cutting
device to serve the functions of tissue cutting, evacuation, and to power the
mechanism
which actuates the reciprocating cutter_ A single tube simplifies connections
required for
device operation and reduces the number of tubes attached to the device
thereby reducing
the "clutter" and unwieldiness caused by multiple tubes and wire connections
extending
from a device.
100991 In certain .variations, a splitting connection within the handle may
be provided
which connects the vacuum to both a tissue evacuation tube and the vacuum
powered
mechanism. The splitting connection may come in multiple forms such as
multiple,
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connections to the tissue collection chamber where a single connection to-
asource of
.vacuum creates a vacuum, within a Filter Chamber. Another form of a splitting
connection may be a "Y" or "17 shaped junction that joins two fluid paths into
a single
path. As a result of sharing the vacuum source between the mechanism and the
evacuation
tube and cutting window or opening, the vacuum perform several functions
within the
device: powers the mechanism which causes the cutter to reciprocate, draws
tissue into an
opening or cutting window such that it may be excised, evacuates the excised
tissue
through the tissue evacuation shaft to a filter or tissue collection chamber.
101001 Where an external vacuum source is connected to the device to
provide suction
to facilitate tissue cutting and evacuation, an additional power source such
as electricity,
compressed air, or mechanical input by the operator may not be required.
101011 Using vacuum power to actuate the cutter reduces operator fatigue
compared to
a system requiring: the operator to manually actuate the reciprocating
mechanism. The rate
at which the cutter actuates relative to .manual actuation may be
significantly increased,
thereby reducing the time required to complete a tissue resection or excision
procedure.
Also, the control for the rate of actuation of the mechanism or motor may be
moved from
a "-primary" position, such as a trig.ger or button, to a "secondaly"
position, e.g., on the
device handle,. As a result, the "primary control" may be utilized to control
other
parameters, e.g., the rate at which the cutter actuates, the radius of
curvature of the
elongate shaft, or to control an electrocautery system that may be included in
or on the
device. A knob, trigger, roller clamp, or other control interfaces may be used
to control
the rate at which the vacuum driven mechanism or motor actuates or
reciprocates. These
options allow the device to be designed in a variety of configurations to suit
various
surgical specialties or personal preferences.
[0102] The cutting devices described herein may have a relatively- low
mass, providing
ease of use and comfort during short or long procedures. The cutting devices
may be
easily sterilized using commonly used sterilization techniques such as
electron beam
radiation, gamma radiation, or Ethylene Oxide gas.
[01031 in certain variations, a pneumatic logic sequence that maintains
high vacuum
throughout the mechanism, motor or engine cycle by never venting the vacuum
source to
the atmosphere may be provided. As a result, the vacuum suction or pressure
that
facilitates cutting and evacuation does not decrease while the mechanism or
motor
reciprocates.
22.
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101041 In certain variations, the cutting device may include cautety,
electrocautery system or wires heated via monopolar or bipolar radiofrequency,
or by
resistive 'heating. The cautery may be located at or .near the distal
extremity of the device.
to cauterize tissue to control bleeding at the site where tissue has been cut
or excised.
Having a cautery obviates the need to remove the device from an operative site
and.
replace it with a separate electrocautery device, thereby improving speed and
ease-of-use
for the operator while reducing blood loss for the patient. The electrocautery
system may
be powered by wires that run the length of the elongate shaft through an
internal lumen
within the elongate shaft. The wires may be connected to a power console or
optionally
the power source may be located in the handle or chamber of the cutting
device.
i01051 in certain variations, a resistive heating electrocautery system may
be provided
on the distal tip of an elongate shaft. The power source for the
electrocautery system may
be located in the handle of the cutting device and may be connected to the
distal tip of the
shaft by Wires that run the length of the shaft The power source may include
one or more
batteries that provide electrical energy to the distal end of the device. The
electrical.
energy may be converted to heat energy when passed through a heating element
such as a
tungsten wire,
101061 As described supra, in certain variations, a cutting device may
include a.
malleable elongate shaft or at least a partially malleable elongate shaft that
that may be
hand. adjustable. A flexible or malleable shaft provides access to multiple
anatomical
locations using a single device, thereby improving cost efficiency and
convenience for the
operator. One or more annealed wires may be positioned in an elongate shaft or
flexible
shaft to allow the shaft to be .manually shaped by the user intra-
operatively.. ..Alternatively,
malleable tubing may be used to construct the elongate shaft to allow manual
Shaping of
the shaft. Additionally, when the distal end of the elongate shaft is curved
toward the
cutting window, visibility of the cutting window location is improved,
10071 In certain variations, the elongate shaft may be flexible and a semi-
rigid or
rigid outer cannula or sheath may be provided on the shaft to change the
radius of
curvature on the shaft in a. range from substantially straight to curved, in
an arc of about
ISO degrees. The cannula allows the operator to optimize the curvature of the
shaft based
on the patient anatomy, The operator may also increase or decrease the force
between the
elongate shaft or cutter and the target tissue being cut by extending or
retracting the
cannula to increase or decrease the natural radius of curvature of the
elongate shaft.
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101081 in certain variations, a semirigid or rigid outer .sheath or cannula
positioned
over a flexible curved elongate shaft may be used to change the radius of
curvature of the
curved shaft. The radius of curvature may increase when the straight and rigid
sheath is
extended over the curved portion of the shaft, whereas the radius of curvature
returns to its
precurved or predetermined shape when retracted from the curved portion of the
shaft.
1J01091 The radius of curvature of a flexible curved elongate shaft may be
altered in-
vivo by utilizing or advancing or retracting a cannula over the elongate
shaft. This allows
the operator to change the radius of curvature of the elongate shaft in situ
to gain access to
a 'variety of anatomical locations without removing the device or elongate
Shaft from the
operative site to change the radius of curvature.
1011 0 in certain variations, the distal tip of the elongate shaft may be
rounded and
less likely to perforate sensitive structures or other tissue during
advancement to a target
tissue or while cutting is being performed. This reduces susceptibility to
inadvertent.
contact with tissues that .may result in unintended injury to the patient.
[0.1111 Reciprocating a cutter in a back-and-forth motion may shave and cut
tissue by
scissoring it rather than grabbing and ripping tissue as may be the case with
certain rotary
cutters or rotary mechanisms or motors. Back-and-forth cutting action may
shave tissue
with less movement of the tissue, which reduces the tension on the tissue and
consequent
trauma to the tissue thereby reducing the likelihood of bleeding. The excised
tissue may
then be evacuated through an evacuation shaft and into a tissue collection
chamber.
-
10112] An elongate shaft that includes a cutter shaft or an evacuation
shaft with a
cutter at its distal end, which may be reciprocated in a back and forth motion
along the
longitudinal axis of the elongate shaft, .may be positioned in line or at an
angle relative to
the vacuum driven, mechanism or motor and. the handle or chamber in which the
mechanism or motor is positioned,. Positioning at an angle allows the device
handle to be
positioned away from the control surfaces, light cord, and any power cables
for an
endoscope andfor camera that may also be used during the tissue cutting
procedure. The
operator's ease-of-use is improved because the endoscope and the cutting
device are not
interfering with one another,
10113] A cutting device having a handle or hand piece that may be
positioned in line
with an elongate shaft or at an angle to the longitudinal axis of the elongate
shaft may
provide improved ergonomic features for the operator. For example, when the
operator is
using a second device, (e.g., an endoscope as described supra) through the
same orifice or
port that the elongate shaft of the cutting device has entered, the two
devices may interfere
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with one another. However, by positioning the handle or hand piece at an angle
to the
longitudinal axis of the shaft, the top and sides of the cutting device Around
the shaft and
the connection between the handle and the shaft are at a very low profile.
Thus, the.
likelihood of interference is reduced. In certain variations, the elongate
shaft may be
actuatableõ such that the elongate shaft may be moved between a position in
line with a
handle or at an angle to a handle.
[01141 The back and forth reciprocating motion of a cutter shaft or an
evacuation shaft
with a cutter blade at its distal end may be translated along a nonlinear
path. 'Therefore, it
is possible to position the vacuum driven mechanism or motor at an angle
relative to
elongate shaft of the device. Furthermore, the back and forth reciprocating
motion of the.
cutter shaft or an evacuation shaft allows the elongate shaft of the cutting
device to be bent
at the distal portion of the Shaft (e.g., Where the Shaft is malleable) to
allow it to be shaped
to access a variety of locations in the anatomy.
101151 In certain variations, separate conduits may be provided between the
mechanism and evacuation lumen such that vacuum for evacuating tissue is not
interrupted by the mechanism function.
[01161 An anvil component may be located at the distal end of the elongate
shaft An
extension (e.g., a "tail") of the anvil may be provided proximal to the
cutting window.
The extension may improve flexibility of the shaft allowing the shaft to be
malleable
closer to the distal end of the shaft. The anvil and/or extension may maintain
or provide a
guide for the evacuation shaft or the cutter shaft as it translates or
reciprocates axially, in
the absence of an extension, a longer anvil component that may be rigid over
its entire
length or a portion of its length may be provided.
101171 In certain variations, a cutting opening or window may 'be
positioned on the
side of the elongate shaft. The side positioning allows the operator to
maintain -visual
contact or visualization on the position of the opening or window and tissue
that comes
into contact with the opening or window. This visual contact reduces the
likelihood of
unintentionally causing injury to tissue.
[01181 A cutting window may be shaped to prevent the cutter from exiting
the lumen
of the elongate shaft or the anvil component, through the cutting window. The
cutting
window in combination with the cutter may provide a tissue scissoring cutting
action, as
compared to a guillotine cutting action on a straight sided cutting window.
[01191 In certain variations, the distal portion of an elongate shaft may
be plastic, an
indwelling anvil component may be metal, a cutter may be metal and the
evacuation tube
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may be plastic. This arrangement may reduce the likelihood of heat build up
from friction
between moving and/or stationary components of the cutting device. This
arrangement
may create a scissoring cutting action, and/or allow the distal end of the
elongate shaft to
be flexible and malleable. Additionally, the use of plastic components reduces
or
eliminates the possibility that electrical energy may be unintentionally
transmitted through
the shaft thereby injuring the patient,
101201 Optionally, the elongate shaft may be rotatable about the axis of
the shaft
relative to the device handle or chamber, which allows the operator to rotate
the shaft
without rotating the device handle,
[01211 In certain variations, one or more lumens 51, e.g., nonconcentric
lumens may
be positioned in the elongate shaft (As shown in Fig. IF). .Noneoncentric
lumens may
provide advantages compared to single lumen shafts and Shafts having
concentric lumens.
For example, one or more of the lumens may be used for the following purposes:
to
provide a fluid conduit for irrigant; to hold or contain one or more malleable
wire(s) to
maintain the shaft curvature when shaped by the operator,. to contain the
evacuation shaft
or cutter shaft and evacuation lumen; and/or to transmit fluid to treat
bleeding.
10122] In certain variations, an evacuation lumen may be non contiguous
around its
circumference down a portion or the entire length of the evacuation shaft to
improve
flexibility while reducing the likelihood of kinking the evacuation lumen.
[01231 A small gap or a sealing 0-ring between the evacuation shaft and the
inside of
the main lumen of the elongate shaft, may reduce the likelihood of leakage of
suction.
through the proximal end of the elongate shaft, which would reduce the suction
present at
the window,
[01241 Optionally, a ring of material may beprovitied between the outside
diameter of
a noncontiguous evacuation lumen and the inside diameter of a multi-lumen
evacuation
shaft or tubing that seals the air gap between the two structures and thereby
reduces
leakage of air flow in the distal direction from the device handle to the
opening in the
evacuation shaft or lumen, located proximal to the cutting window or opening.
[01251 Optionally, various fluids may be applied or delivered to the distal
end of the
elongate shaft where the cutter and window are positioned. A fluid may be
emitted, via a
lumen in the elongate shaft, from the distal end of an elongate shaft at a
temperature that is
low enough such that the fluid can be used as a bleeding therapy. .A collagen
foam may be
emitted from the distal end of the elongate shaft as a bleeding therapy. These
are
inexpensive, quick, and easy ways to apply a bleeding therapy or anticoagulant
to a
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bleeding site *here tissue is being cut. Anti -coagulant substances emitted
from the distal
end of the elongate shaft as a bleeding therapy may be applied directly and
conveniently TO
the tissue, e.g., without exchanging or removing the cutting device to replace
it with a
separate device intended for applying anticoagulation therapy,
101261 In certain variations, separate fluid conduit paths to the vacuum
source may be
provided to allow the vacuum powered mechanism and cutter to be operated
independently from the tissue evacuation. The independent fluid paths and
operation
capability of the vacuum powered mechanism and evacuation may allow the
opening in
the distal end of the elongate shaft of the cutting device to operate as a
suction port to
evacuate tissue and blood even when the vacuum powered mechanism is .not in
operation
or is stalled or halted, e.g., when the trigger is actuated to engage and hold
the shuttle
piston to prevent its reciprocation,.
[0127] Optionally, a single fluid conduit path between a cutting window and
the
vacuum source that includes an evacuation shaft and vacuum mechanism may be
utilized
to reduce the air flow requirements of the device by using air flow created by
the vacuum
to power both the vacuum .mechanism and the evacuation of tissue..
[0128] Set forth below are additional features or functions that may be
utilized or
included with various cutting devices described herein:
101291 A clear tissue collection chamber may be utilized to allow the
operator to
intraopc.Tatively visualize resected tissue in real time Additionally, the
operator and.
patient are able to see whether the device has been previously used by
inspecting the tissue
collection chamber.
101301 A dual chamber tissue collection system may be provided to separate
.tissue
resected from different locations in the event it is desired to biopsy the
tissue from two
different locations in the body
10131] A hi-stable switch fabricated from plastic, metal or other material
and an elastic.
spring may be utilized in a mechanism to ensure reliable transition of a
Shuttle piston past
a vacuum supply port to prevent unstable flutter of the Shuttle piston and
consequent
mechanism or motor stall. Optionally, a hi-stable switch fabricated using
sheet metal with
two leas that are connected at one end but separated at the opposite end in
their natural
state may be provided. The separate sheet metal legs are then riveted or
otherwise
connected to create a bowed sheet metal component that is stressed and bi-
stable.
Optionally, the separated end may be folded and joined to result in a three
dimensional
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curve that is stable in two positions. These variations may-not require a
separate elastic
spring to be hi-stable.
[0132] Optionally, back-and-forth reciprocating motion from a vacuum
powered
mechanism may be mechanically converted to rotational motion or rotary
oscillation to
provide rotational or rotary oscillation mechanical output by the mechanism.
101331 A tissue evacuation shaft may be routed through the center of the
drive Piston
to provide an efficient method .of transferring the mechanical output of the
mechanism to
the cutter at the window.
101341 To prevent vacuum leakage in the motor, a thin plastic seal may be
molded
integral to a component and plastically deformed by squeezing the thin plastic
seal in a die
to increase its flexibility and conformability. This may reduce the cost of
components and
assembly labor, and it may improve the overall reliability of the mechanism.
Optionally,
flash formed at a parting line of a mold may be used as a seal because it is
very thin and
flexible and conforms to the geometry of mating components while maintaining
minimal
friction between components. An 0-ring may optionally be used to create a seal
between
molded components.
[0135] In certain variations, a. mechanism may include a Shuttle piston
positioned or
arranged adjacent to and/or parallel to the drive Piston such that overall
mechanism and or
device size is reduced, the transfer of mechanical motion between the pistons
is easier and
more efficient and the flow of air through the device is more efficient. This
arrangement
may allow for a smaller, easy to hold and use device. The Shuttle and drive
piston's may
be coupled by a bi-stable switch.
101361 A spring-loaded Trigger may directly or indirectly interact with the
Shuttle
piston or valve to turn the mechanism "ON" and "OFF," This reliably and
consistently
controls the .mechanism function, The trigger may be designed to always stop
the motor
with the Cutter shaft proximal to the opening or cutting window thereby
leaving the
cutting window open such that the device may be used in "suction only" mode
through the
window. Additionally, a device cleaning tool, such as a decloggerõ may be
threaded
through the cutting window and proximally advanced through and/or along the
tissue
evacuation path to clear or remove obstructions in the tissue evacuation path.
101371 A loop of flexible tubing that connects the evacuation shaft to a
stationary
connection on the device, such as a vacuum port, provides a low cost way to
allow back.-
and-forth motion of the evacuation shaft and the mechanism without causing
shaking,
vibration or external motion of other tubing or components in a chamber or
handle, and
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without dislodging the evacuation path connection to the tissue collection
chatriber. The
loop of tubing may change shape to accommodate the back-and-forth motion of
the
evacuation shaft.
10138] The cutting device may be designed such that irrigant does not flow
unless
suction is present at the opening or cutting window to draw the irrigant,
e.g., to provide a
self regulating supply of irrigant. This may be possible by supplying a
reservoir of irrigant
that is not pressurized relative to atmospheric air, however, when suction is
applied to the
reservoir, irrigant flows from the reservoir and toward the source of vacuum.
An example
of this is a syringe filled with irrigant that is connected to tubing; when
suction is applied
to the tubing, irrigant flows from the syringe and through the tubing toward
the source of
vacuum. This will ensure the irrigant does not unintentionally flow out of the
device and
leak into the patient where it may be problematic such as when aspirated by
the patient
(e.g., when the device is used in the respiratory passages), e.g., where a
patient is under
general anesthesia and can't communicate An irrigant reservoir may be located
within
the handle of the device such that it may be tilled by the operator as needed,
thereby
reducing the number of tubes and connections that are tethered to the cutting
device,
[0139] A cutting device or microdebrider having a. reciprocating or back-
and-forth
cutting motion may optionally be powered by an integrated supply of compressed
air such
as a CO2 cartridge or by a battely, e.g., one that supplies electricity to a
DC motor that
actuates a cutter. This would allow the vacuum supply to be used entirely to
draw tissue
into the cutting window and to evacuate excised tissue thereby increasing or
improving a
resection rate. A separate power console is not necessary to provide power to
the device.
Exemplary Vacuum Powered Mechanisms Or Motors
[0140] A vacuum powered or driven mechanism or motor used in -various of
the
cutting devices described herein may be so called because it uses suction from
an internal
or external vacuum source to produce movement. The vacuum mechanism or motor
does
not create suction and is not to be confused with a vacuum pump. The Vacuum is
used to
power a mechanism to power a medical device which cuts and evacuates tissue or
performs other work on tissue. A vacuum-powered mechanism generates the
reciprocating or rotating motion of the cutter or other operable element of
the device, The
mechanism may be powered by the difference in ambient atmospheric air pressure
on one
side of a piston and a vacuum (or partial vacuum) on the opposite side of the
piston in the
chamber or cylinder in which the piston is po.sitioned, in certain
variations:, the
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mechanism may optionally utilize a biasing component, e.gõ a spring, to
motivate a piston
in a direction or cause a drive or return stroke of the piston.
[01411 One vacuum mechanism or motor described herein may be referred to as
a
double action vacuum powered mechanism or double action mechanism because it
uses
suction to move the piston in both directions. Vacuum or suction is
alternately applied to
either sides of a piston to cause the piston to alternately move back and
forth in the
direction of the vacuum (or partial vacuum). Vacuum mechanisms or motors that
use a
spring to return them to their starting position may be referred to as a
spring action or
spring return mechanism.. A single action mechanism or motor may use a vacuum
to
drive the piston in a single direction until the vacuum is vented and the
piston is returned
to its starting position by a spring.
101421 One advantage of using vacuum to move the piston in both directions,
as
compared to using a spring to return the piston to its starting positron, is
that the efficiency
of the motor is nearly doubled. A spring return mechanism must have a piston
size and
cylinder volume that is large enough to generate adequate force both to
perform the work
output required of the .motor as well as to compress the return spring. The
smaller piston
size of a double action mechanism allows the mechanism to be incorporated into
a
handheld device. The spring on a spring-return motor must be adequately sized
to reliably.
return the piston to its starting position with an adequate safety margin to
reliably
overcome friction and external forces on the mechanism.
101431 Exemplary variations of vacuum driven mechanisms are described
herein.
Figures 3A-5B show various mechanisms in distal and proximal positions. The
distal.
position refers to a piston in the mechanism being motivated in a direction
toward the
distal end of the cutting device in which the mechanism would be situated,
Regarding the
figures described below, from a viewer's perspective, the left side of the
figures is the
proximal side and the right side of the futures is the distal side. The
proximal position
refers to a piston in the mechanism being motivated in a direction toward the
proximal end
of the cutting device in which the mechanism would be situated.
[01441 Figure 3A shows a. cross sectional .view of a variation of a double
action
vacuum powered mechanism 310 or motor, similar to the mechanism 30, referred
to
above. The mechanism 310 includes a hi-stable switch. Figure 3A shows the
mechanism
.10 in a proximal position, while Figure 3B shows the double action vacuum
powered
mechanism in the distal position.
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[01451 Referring to Figures 3A-313õ the vacuum powered mechanism 310
includes a
drive piston 301 having a piston shaft 302. The drive piston 301 including at
least a.
portion of the piston shaft 302 are positioned within a drive piston chamber
307. The
drive piston 301 divides or separates the drive piston chamber into a proximal
drive piston
chamber 307a and a distal drive piston chamber 307b. The drive piston 301 may
reciprocate proximally and distally within the drive piston chamber 307 when
Vacuum and
ambient air are alternately applied to .opposite sides of .the drive piston 1
in drive piston
chambers 307a and/or 307b. The piston shaft 302 may reciprocate along with the
drive
piston 301, and the reciprocating piston shaft 302 may conduct reciprocating
motion
output.
101461 A bi-stable switch 303 is connected or coupled to a shuttle piston
314 and a
switch spring, 305. The switch spring, 305 may cause the hi-stable switch 303
to quickly
transition from a distal position to a proximal position and vice versa. The
bi-stable
switch is stabile when it is in either a proximal position (Fig, 3A) or a
distal position (Fig.
3B), but not when .it is in 'between those two positions and therefore the
switch resists
residence in an in-between state. As a result, the mechanism does not
"flutter" or the
mechanism minimizes "flutter" when in transition between states. For example,
the
shuffle valve 31.3 may not nutter or not fail to fully transition from a
proximal to a distal
position or vice versa as the bi-stabl.e switch causes the shuttle piston 314
and a shuttle.
valve 313 to transition or translate in the proximal or distal direction over
and past a.
Shuffle chamber vacuum supply port 308.
10147] The bi-stable switch 303 may be actuated by the drive piston shaft
302 When
the drive piston 1, and therefore the piston shaft 302, move in either the
proximal or distal.
directions. Actuation of the bi-stable switch 303 .results in movement of the
shuttle piston
314 in either the proximal or distal directions. Movement of the drive piston
in the
proximal direction results in movement of the shuttle piston in the proximal
direction via
the hi-stable switch, while movement of the drive piston in the distal
direction results in
movement of the shuffle piston in the distal direction via the 'hi-stable
switch.
[01481 The shuffle piston 314 is positioned within a shuttle piston
chamber. The
shuffle piston 314 includes a shuttle valve 313 or flange which may extend
radially
therefrom, which separates or divides the shuttle -piston chamber into a
proximal shuffle
piston chamber 315 and a distal shuffle piston chamber 316. Proximal shuffle
piston
chamber 315 may be in fluid communication with proximal drive piston chamber
307a via
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proximal vacuum slot 304. Distal shuttle piston chamber 316 may- be in fluid
communication with distal drive piston chamber 307b via distal vacuum slot
306.
[0149] The shuffle piston (314) may also include a proximal ambient air
seal (309), a
proximal cruciform (310), a distal ambient air seal (311), a distal cruciform
(312), and a
central shaft connecting the above components.
[01501 A shuttle piston chamber vacuum supply port (308) may be connected
to an
external or internal vacuum source or supply to evacuate the proximal shuffle
piston
chamber 315 and/or the distal shuttle piston chamber 316. The vacuum port 308
may
allow fir evacuation by vacuum of the proximal drive piston chamber 307a via
the
proximal vacuum slot 304 and the proximal shuffle piston chamber 315. The
vacuum port
308 mar allow for evacuation by vacuum of the distal drive piston chamber 307b
via the
distal vacuum slot 306 and the distal shuttle piston chamber 316.
101511 For example, Proximal drive piston Chamber (307a) may be evacuated
by
vacuum when in fluid communication with the external vacuum source via the
Vacuum
Port (308), Proximal Shuttle piston Chamber (315), and proximal vacuum slot
304. Distal
drive piston Chamber (307b) may be evacuated by vacuum when in communication
with
the external vacuum source via the Vacuum Port (308), Distal Shuffle piston
Chamber
(316), and distal vacuum slot 306. Presence of vacuum in Proximal drive piston
Chamber
307a results in differential pressure between the proximal and distal sides of
the Piston
(301) that results in working force to move the Piston (301) proximally when
ambient air
is in the distal drive piston Chamber (307b). Alternately, ambient air (322)
in proximal
drive piston Chamber 307a applies working force to move the Piston (301)
distally when
the Distal drive piston Chamber (3071) is evacuated.
[01521 The shuffle piston 314 may be translated or positioned in a shuttle
piston
chamber such that Shuffle piston valve 313 can seal against the shuffle block
(321) to the
distal side of the vacuum port (308) to allow the proximal shuffle piston
chamber (315)
andfor proximal drive piston chamber (307a) to be evacuated by communicating
with an
external vacuum supply. Alternatively, the shuttle piston 314 may be
translated or
positioned in a shuffle piston chamber such that the shuttle piston valve 313
may seal
against the shuttle block (321) to the proximal side of the vacuum port (308)
to allow the
distal shuttle piston chamber (316) and/or distal drive piston chamber (307h)
to be
evacuated by communicating with the external vacuum supply.
[01531 The proximal shuttle piston chamber (315) may allow for fluid
communication
between the Vacuum Port (308) and the Proximal drive piston Chamber (307a)
through
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the Proximal Vacuum Slot (1304). The proximal shuttle piston chamber (3315)
may also
allow for fluid communication between the Proximal drive piston Chamber 307a
and
ambient air when the Proximal Shuttle Seal (309) is M the proximal position,
i.e., an open
or unsealed position.
101541 The Distal Shuffle piston Chamber (316) may allow for fluid
communication
between the Vacuum Port (308) and the Distal drive piston Chamber (307b)
through the
Distal Vacuum Slot (306). The Distal Shuttle piston Chamber (316) may allow
for fluid
communication between the Distal drive piston Chamber 307b and ambient air
when the
Distal Shuttle Seal 311 is in the distal position, i.e., an open or unsealed
position.
[01.551 The proximal ambient air seal (309) of the shuttle piston 314 may
se& against
shuttle block (321) to prevent ambient air leakage into proximal shuttle
piston chamber
315 when the proximal shuttle piston chamber (315) is evacuated. Also, the
proximal
cruciform (310) can maintain shuttle piston (314) position concentricity
relative to
proximal shuttle piston chamber (315), e.g.õ when the shuttle piston (314)
moves to a
proximal position and vents ambient air to the proximal shuttle piston chamber
(315).
[01561 The distal ambient air seal (311) of the shuttle piston 314 may seal
against
shuttle block (321) to prevent ambient air leakage into distal shuttle piston
chamber 316
when the distal shuttle piston chamber (316) is evacuated. Also, the distal
cruciform (312)
can maintain shuttle piston (314) position concentricity relative to distal
shuttle piston
chamber (316), e.g., when the shuttle piston (314) moves to a distal position
and vents
ambient air to the distal shuttle piston chamber (316).
10157] The vacuum powered mechanism. 310 may also include a Distal drive
piston
chamber Endcap (317), which may prevent or minimize fluid communication
between
ambient air and the Distal drive piston Chamber (307b) in addition to
providing a sealing
and bearing surface with the drive Piston Shaft (302). The vacuum powered
mechanism
310 may also include a Distal drive piston chamber Endcap Seal (318), which
may prevent
or minimize ambient air leakage between the Distal drive piston chamber
Erid.cap (317)
and the drive piston Shaft (302), e,g., when the Distal drive piston Chamber
(307b) is
evacuated.
101 58] The vacuum powered mechanism. 310 may also include a Proximal drive
piston
Chamber Endcap (319), which may prevent or minimize fluid communication
between
ambient air and the :Proximal drive piston Chamber (37a) in addition to
providing a sealing
and bearing surface with the drive Piston Shaft (302). The vacuum powered
mechanism
Of motor 310 may tits include a Proximal drive piston Chamber Endcap Seal
(320), which
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may prevent or minimize ambient air leakage between the Proximal drive piston
Chamber
Endcap (319) and the drive Piston Shaft (302), e.g..õ when the Proximal drive
piston
Chamber (307a) is evacuated.
10159] The drive piston shaft 302 may seal against the endplates or endcaps
317, 319
or shuttle block 321 to prevent or minimize loss of vacuum to ambient air 322.
Also,
various seals known to person of skill in the art may be utilized to seal the
piston shaft
against the endplates or endcaps 317, 319 or shuttle block. 321,
[0160] A shuttle block 321 or other frame, structure, or casing may provide
an outer
structure for the vacuum powered mechanism 310. Ambient air 322 refers to air
at
atmospheric pressure which is located outside of the vacuum mechanism. Ambient
air
322 may also be allowed to flow inside various chambers of the vacuum powered
mechanism during use of the mechanism as described herein.
101611 in use or in operation, the vacuum powered mechanism 310 operates by
a
pneumatic mechanism, method or logic that utilizes an external or internal
vacuum source
to provide the force to cause reciprocating motion of the drive piston 301 in
both proximal
and distal directions. A hi-stable switch may be utilized to transition the
mechanism as it
reverses or changes direction,
101621 For example, the vacuum port 308 may be opened to the distal drive
piston
chamber 307b to evacuate the distal drive piston chamber 307h and ambient air
is closed
to the distal drive piston chamber 30M, while ambient air is opened to the
proximal drive
piston chamber 307a and the vacuum port is closed to the proximal drive piston
Chamber
307b. The drive Piston advances toward a distal position due to the vacuum
inside the
distal drive piston chamber 307b, on the distal side of the drive piston 301
and the ambient
air pressure in the proximal cylinder chamber, on the proximal side of the
drive piston
301.
101631 As a result of the differential pressure created on opposite sides
of the drive
piston 301, the drive piston Rod or shaft 302 moves through its dwell until it
contacts the
bi-stable switch 303, causing the hi-stable switch 303 to rapidly change
states from a
proximal position to distal position, moving in the distal direction, The hi-
stable switch is
attached to the shuttle piston 314 and rapidly causes the shuttle 314 to move
from a
proximal position to distal position in the shuttle chamber. As a result, the
vacuum seal
313 on the shuttle piston 314 moves from the proximal side of vacuum port 308
to the
distal side of the vacuum port 308, opening the vacuum port 308 to the
proximal drive
piston. chamber 307a to evacuate the proximal .drive piston chamber 307a, and
closing the
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vacuum port 308 to the distal drive pis-toil chamber 307k Also, the distal
seal 311 on the
shuttle piston 314 opens the ambient air 322 to vent the distal drive piston
chamber 30Th
to ambient pressure, and the proximal seal 309 on the shuttle piston 314
closes the ambient
air vent to the proximal drive piston chamber 307a.
101641 The drive piston 301 then reverses direction and moves in the
proximal
direction, due to the vacuum inside the proximal drive piston chamber 307a, on
the.
proximal side of the drive piston and the ambient air pressure in the distal
drive piston
chamber, on the distal side of the drive piston 301.
101651 As a result of the differential pressure created on opposite sides
of the drive
piston 301, drive piston Rod or shaft 302 moves through its dwell until it
contacts the hi-
stable Switch, causing the bi-stable switch to rapidly change states from a
distal position to
a proximal position. The hi-stable switch is attached to the Shuttle 314 and
rapidly causes
the Shuttle 314 to move from its distal position to a proximal position in the
shuttle
chamber_ As a result, the vacuum seal 313 on the shuttle piston 314 moves from
the distal
side of the Vacuum Port 308 to the proximal side of the vacuum port 308,
opening the
vacuum port 308 to the distal drive piston chamber 307b to evacuate the distal
drive piston
chamber 307b, and closing the vacuum port 308 to the proximal drive piston
chamber
307a. Also, the Proximal Seal 309 on the Shuttle piston 314 opens the ambient
air 322 to
vent the proximal drive piston chamber 307a to ambient pressure, and the
Distal Seal 311
on the Shuttle piston 314 closes the ambient air .vent to the distal drive
piston chamber
307k.
101661 Consequently, the mechanism has completed one cycle and is fi7e:e.
to continue
reciprocating as described above by alternating suction or air pressure on
opposite sides of
the piston, as long as adequate vacuum is available to the mechanism. Indeed,
the above
Steps may repeat as necessary such that the vacuum powered mechanism creates a
reciprocating motion until the vacuum source is disconnected, turned oft or if
the vacuum
is inadequate to overcome the force required to move the drive piston 301 or
if the
mechanism 310 is stalled or stopped.
[01671 The reciprocating motion of the mechanism may be .utilized to
actuate a cutting,
device or to operate or actuate another device, eg., another medical device.
In certain.
variations, cutting device may be positioned by maneuvering a flexible or
malleable shaft
of the device e.g., manually or automatically. The shaft may be maneuvered or
positioned
around sensitive tissues or structures in the human body by changing the shape
of the
shaft. For example, extending or retracting an outer sheath or cammia on the
shaft or
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advancing or retracting the shaft "relative to the outer sheath, thereby
allowing improved
maneuverability Of the shaft around structures or within confined spaces may
be
performed, e.g., allowing a shaft's predetermined curvature to position the
distal end of the
shaft near a target site. Such mechanisms, techniques and devices include
those described
in US Patent Application Nos. 11/848,565, 11/848,564, and 11/848,562, each of
which is
incorporated herein by reference in their entirety for all purposes.
[01681 Figure 4A shows a. cross sectional view of another variation of a
double action
vacuum powered mechanism or motor in a proximal position, while Figure 4B
shows the
double action "vacuum powered mechanism or motor in a distal position.
101.691 Referring to Figure 4A-4B, the vacuum powered mechanism 430
includes a
piston 434 having a piston shaft. 432. The piston 431 including at least a
portion of the
piston shaft 432 are positioned within a cylinder chamber 437. The piston 431
divides or
separates the cylinder chamber 437 into a proximal cylinder chamber 437a and a
distal
cylinder Chamber 437b. The piston 431 .may reciprocate proximally and distally
within
the cylinder chamber 437 when vacuum and ambient air are alternately applied
to opposite
sides of the piston 431 in cylinder chambers 437a and/or 437b. The piston 43.1
and piston
shaft 432 may reciprocate, and. the reciprocating piston shaft 432 may conduct
reciprocating motion output.
101701 A proximal shuttle pin 433 is connected to a.shuttle 444. The
shuttle pin 433
may be actuated by the piston 431 when the piston 431 moves in the proximal
direction
and contacts the proximal Shuttle pin 433. Actuation of the proximal Shuttle
pin 433 by
the piston results in movement of the shuttle 444 in the proximal direction.
101.711 A distal shuttle pin 435 is also connected to the shuttle 444. The
distal shuttle
pin 435 may be actuated by the piston 431 When the piston 431 moves in the
distal
direction and contacts the distal shuttle pin 435. Actuation of the distal
shuttle pin 435 by
the piston results in movement of the shuttle 444 in the distal direction.
Indeed,
movement of the piston in the proximal direction results in movement of the
shuttle in the
proximal direction via contact with the proximal shuttle pin 433, while
movement of the.
piston in the distal direction results in movement of the shuttle in the
distal direction via
contact with the distal shuttle pin 435.
101721 The shuttle 444 is positioned within a shuttle chamber. The shuttle
444
includes a shuttle valve 443 or flange which may extend radially therefrom,
which
separates or divides the shuttle chamber into a proximal shuttle chamber 445
and a distal
shuttic chamber 446.
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[01731 Proximal shuffle chamber 445 may be in fluid communication with
proximal
cylinder chamber 437a via proximal shuffle pin slot 434. Proximal shuffle pin
slot 434
also provides an opening in which the proximal shuttle pin 433 may translate
between
proximal and distal positions. Distal shuttle chamber 446 may be in fluid
communication
with distal cylinder chamber 437b via. distal shuttle pin slot 436. Distal
shuttle pin slot
436 also provides an opening in which the distal shuttle pin 435 may translate
between
proximal and distal positions_
[0174] The shuttle (444) may also include a proximal ambient air seal
(439), a
proximal cruciform (440), a distal ambient air seal (441), a distal cruciform
(442), and a
central shaft connecting the above components.
101751 A vacuum port: (438) may be connected to an external or internal
vacuum
source or supply to evacuate the proximal Shuttle chamber 445 and the distal
shuttle
chamber 446. The vacuum port 438 may allow for evacuation by vacuum of the
proximal
cylinder chamber 437a via the proximal shuttle pin slot 434 and the proximal
shuttle
chamber 445. The vacuum port may allow for evacuation by vacuum of the distal
cylinder
chamber 437b via the distal shuttle pin slot 436 and the distal shuttle
chamber 446.
[0176] For example, Proximal Cylinder Chamber (437a) may be evacuated by
vacuum
when in fluid communication with the external vacuum source via the Vacuum
Port (438),
Proximal Shuffle Chamber (445), and Proximal Shuttle Pin Slot 434. Distal
Cylinder
Chamber (437b) may be evacuated by vacuum when in communication with the
external
vacuum source via the Vacuum Port (438), Distal Shuttle Chamber (446), and
Distal
Shuttle Pin Slot (436). Presence of vacuum in Proximal Cylinder Chamber 437a
results
in differential presstue between the proximal and distal sides of the Piston
(431) that
results in working force to move the Piston (431) proximally when ambient air
is in the
distal Cylinder Chamber (437b), Alternately, ambient air (422) in proximal
Cylinder
Chamber 437a applies working force to move the Piston (431) distally when the
Distal
Cylinder Chamber (4rb) is evacuated.
1101771 The shuttle 44 may be translated or positioned in a shuttle chamber
such that
Shuttle valve 443 can, seal against the shuttle block (451) to the distal side
of the vacuum
port (438) to allow the proximal shuffle chamber (445) and proximal cylinder
chamber
(437a) to be evacuated by communicating with an external vacuum supply.
Alternatively,
the shuttle 114 may be translated or positioned in a shuttle chamber such that
the shuttle
valve 443 may seal against the shuttle block (451) to the proximal side of the
vacuum port
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(438) to allow the distal shuttle chamber (446) and distal cylinder chamber
(437b) to be
evacuated by cOrMlltini cati ng with the external vacuum supply,
[01781 'The proximal shuttle chamber (445) may allow for fluid
communication
between the Vacuum Port (438) and the Proximal Cylinder Chamber (437a) through
the
Proximal Shuttle pin Slot (434). The proximal shuttle chamber (445) may also
allow for
fluid communication between the Proximal Cylinder Chamber 437a and ambient air
when
the Proximal Shuttle Seal (439) is in the proximal position. Le., an open or
unsealed
position.
101791 The Distal Shuttle Chamber (446) may allow for fluid communication
between
the Vacuum Port (438) and the :Distal Cylinder Chamber (437h) through the
Distal shuffle
pin Slot (436). The Distal Shuttle Chamber (446) mar allow for fluid
communication
between the Distal Cylinder Chanter 437b and ambient air when the Distal
Shuttle Seal
41 is in the distal position, i.e., an open or unsealed position,
[01801 The proximal ambient air seal (439) of the shuffle 44 may- seal
against shuttle
block (421) to prevent ambient air leakage into proximal shuttle chamber 445
when the
proximal shuttle chamber (445) is evacuated. Also, the proximal cruciform
(440) can
maintain shuffle (444) position concentricity relative to proximal shuttle
chamber (445),
e.g., when the shuttle (444) moves to a proximal position and vents ambient
air to the
proximal shuttle chamber (445).
101811 The distal ambient air seal (441) of the shuttle 444 may seal
against shuttle
block (51) to prevent ambient air leakage into distal shuttle chamber 446 when
the distal
shuffle chamber (446) is evacuated. Also, the distal cruciform (442) can
maintain shuffle
(444) position concentricity relative to distal shuffle chamber (446), e.g.,
when the shuttle
(444) moves to a distal position and vents ambient air to the distal shuffle
chamber (446),
[01821 The vacuum powered mechanism 430 may also include a Distal Cylinder
Endcap (447), which may prevent or minimize fluid communication between
ambient air
and the Distal Cylinder Chamber (437b) in addition to providing a sealing and
bearing
surface with the Piston Shaft (432). The vacuum powered mechanism. 430 may
also
include a Distal Cylinder Endcap Seal (448), which may prevent or minimize
ambient air
leakage between the Distal Cylinder Endcap (447) and the Piston Shaft (432),
e.g., when
the Distal Cylinder Chamber (43 7h) is evacuated.
101831 The vacuum powered mechanism 430 may also include a Proximal
Cylinder
Endcap (449), which may prevent or minimize fluid communication between
ambient air
and the Proximal Cylinder Chamber (437a) in addition to providing a sealing
and bearing
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surface with the Piston Shaft (432). The vacuum powered mechanism .00 may also
include a Proximal Cylinder Endcap Seal (450), which may prevent or minimize
ambient
air leakage between the Proximal Cylinder Endcap (449) and the Piston Shaft
(432), e.g.,
when the Proximal Cylinder Chamber (437a) is evacuated.
101841 The piston shaft 432 may seal against the endplates or endcaps 447,
449 or
shuttle block 451. to prevent or minimize loss of vacuum to ambient air 422.
Also, various
seals known to person of skill in the art may be utilized to seal the piston
shaft against the
endplates or endcaps 447, 449 or shuttle block 451.
101851 A shuttle block 451 or other frame, structure, or casing may provide
an outer
structure for the vacuum powered mechanism 430. Ambient air 422 refers to air
at
atmospheric pressure which is located outside of the vacuum powered
mechanism..
Ambient air 422 may also be allowed to flow inside various chambers of the
vacuum
powered mechanism during use of the mechanism as described herein,
101861 In use or in operation, the vacuum powered mechanism 430 .operates
by a.
pneumatic. mechanism, method or logic that does not require inertial mass to
move the
mechanism through transition (such as a flywheel) and. that uses an external
or internal
vacuum source to provide the force to cause reciprocating motion of the piston
31 in both
proximal and distal directions..
[01871 For example, the vacuum port 438 may be opened to the distal
cylinder
chamber 437b to evacuate the distal cylinder chamber 437h and ambient air is
closed to
the distal cylinder chamber 37b, While ambient air is opened to the proximal
cylinder
chamber 437a and the vacuum port is closed to the proximal cylinder chamber
437b. The
Piston advances toward a distal position due to the vacuum inside the distal
cylinder
chamber 437b, on the distal side of the piston 431 and the ambient air
pressure in the
proximal cylinder chamber, on the proximal side of the piston 431.
10188] As a result of the differential pressure created on opposite sides
of the piston
431, the Piston 431 moves through the chamber and contacts the distal shuttle
pin 435,
causing the shuttle 444 to move from a proximal position to distal position in
the shuttle
chamber. As a result, the vacuum seal 443 on the shuttle 444 moves from the
proximal
side of vacuum port 438 to the distal side of the vacuum port 38, opening the
vacuum port
438 to the proximal cylinder chamber 437a to evacuate the proximal cylinder
chamber
437a, and closing the vacuum port 438 to the distal cylinder chamber 43711.
Also, the
distal seal 441 on the Shuttle 444 opens the ambient air 422 to vent the
distal cylinder
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chamber 437b to ambient pressure, and the proximal seal. 439 on the shuttle
444 closes the
ambient air vent to the proximal cylinder chamber 437a.
[01891 It may be necessary to have adequate evacuated volume in the distal
cylinder
chamber 437b to cause the Piston (431) to continue translating distally after
the Shuttle
Valve (443) shuts off vacuum from vacuum port 438 to the distal cylinder
chamber 437b.
This may ensure that the shuttle 444 continues to translate in the distal
direction as a result
of the moving piston contacting the distal Shuttle pin and thereby moving the
shuttle 444,
such that shuttle valve 443 completely passes vacuum port 438, shutting off
the vacuum to
the distal .cylinder chamber 437b, in manner that avoids or minimizes valve
flutter or
unwanted fluctuation of the valve 443 between proximal and distal positions in
the shuttle
chamber.
101901 'The piston 431 then reverses direction and moves in the proximal
direction,
due to the vacuum inside the proximal cylinder chamber 437a, on the proximal
side of the
Piston and the ambient air pressure in the distal cylinder chamber 437b, on
the distal side.
of the piston 431.
[01911 As a result of the differential pressure created on opposite sides
of the piston
431, the piston 431 moves through its dwell or the cylind.er chamber and
contacts the
proximal shuttle pin 433, causing the Shuttle 444 to move from its distal
position to
proximal position in the shuttle chamber. As a resultõ the vacuum seal 443 on
the shuttle
444 moves from the distal side of the Vacuum Port 438 to the proximal side of
the va.cutun
port 38, opening the vacuum port 438 to the distal cylinder Chamber 37b to
evacuate the
distal cylinder chamber 437h, and closing the vacuum port 38 to the proximal
cylinder
chamber 437b_ Also, the Proximal Seal 439 on the Shuttle 444 opens the ambient
air 422
to vent the proximal Cylinder chamber 437a to ambient pressure, and the Distal
Seal 441
on the Shuttle 444 closes the ambient air vent to the distal cylinder chamber
437b.
10192] Again, it may be necessary to have adequate evacuated volume in the
proximal
cylinder chamber 437a to cause the Piston, (431.) to continue translating
proximally after
the Shuttle Valve (443) shuts off vacuum from vacuum port 438 to the proximal
cylinder
chamber 437a., This may ensure that the shuttle 444 continues to translate in
the proximal
direction as a result of the moving piston contacting. the proximal shuttle
pin and thereby
moving the shuttle 444, such that shuttle valve 443 completely passes vacuum -
port 438,
shutting off the vacuum to the proximal cylMder chamber 437bõ in manner that
avoids or
minimizes valve nutter or unwanted fluctuation of the valve 443 between
proximal and
distal positions in the shuttle chamber.
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[01931 Consequently-, the mechanism has completed one cycle and is free to
continue
reciprocating as described above by alternating air pressure on opposite sides
of the piston,
as long as adequate vacuum is available to the mechanism. Indeed, the above
Steps .may
repeat as necessary such that the vacuum powered mechanism creates a
reciprocating
motion until the vacuum source is disconnected, turned off, or if the vacuum
is inadequate
to overcome the force required to move the Piston 431.
101941 In certain variations of a vacuum powered mechanism, a vacuum may be
created in the "dead space" on the distal or proximal end of the Cylinder that
is adequate
to cause the Piston to continue moving distally or proximally after the
external vacuum
source is shut off from the Cylinder. The "dead space" volume in the proximal
or distal.
end of the Cylinder serves as an "accumulator" that encourages the Piston to
continue
moving distally or proximally thereby eliminating the .need for mass to create
inertia to
move the valve through transitions from one state to another,
[01951 In another variation, a method of reducing pneumatic valve
instability or flutter
caused by the valve or Shuttle attempting to move back and forth between
states includes
exposing one side of the shuttle valve to the vacuum source and the opposite
side of the
shuttle valve to ambient air. This may cause the shuttle valve to move in the
direction of
the vacuum and will more fully open the port connecting the ambient air to the
Cylinder.
[01961 The reciprocating motion of the mechanism may be utilized to actuate
a cutting
device or to operate or actuate another device, e.g,, another medical device,
in certain
variations, cutting device may be positioned by maneuvering a flexible or
malleable shaft
of the device e.g., manually or automatically. The shaft may be maneuvered or
positioned
around sensitive tissues or structures in the human body by changing the shape
of the
shaft. For example, extending or retracting an outer sheath or cannula on the
shaft or
advancing or retracting the shaft relative to the outer sheath, thereby
allowing improved
maneuverability of the shaft around structures or within confined spaces may
be
performed, e.g., allowing a shaft's predetermined curvature to position the
distal end of the
shaft near a target site. Such mechanisms, techniques and devices include
those described
in US Patent Application Nos, 11/848,565,111848,564, and 111848,562, each of
which is
incorporated herein by reference in their entirety for all purposes.
101971 :Further describing operations of a variation of a mechanism as
illustrated in
Figs. 4A-411, the shuttle 444 .may start in the proximal or distal positions.
In certain
variations, a small spring (not shown) may be used to position the piston
and/or the shuttle
component in a particular starting position_
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101981 F. 4A shows the shuttle 444 starting in the proximal position. When
external
vacuum is applied to the mechanism through the Vacuum Port (438), the Shuttle
Valve
(443) is on the proximal side of the Vacuum Port (448) which results in
evacuation of the
air in the Distal Cylinder Chamber (437b), the Distal Shuttle Pin Slot (436),
and the Distal
Shuttle Chamber (446), Consequently, the differential pressure on the proximal
and distal
sides of the Piston (431) causes the piston to move distally.
[01991 The vacuum may apply a force greater than the frictional forces
acting on the
Piston in addition to the forces required by the mechanism to perform work.
102001 As the Piston (431) moves distally, it contacts the Distal Shuttle
Pin (435) and
moves the Shuttle ('114) distally. As a result., the Shuttle Valve ('113)
closes off the
Vacuum Port (438) to the distal side of the mechanism.
102011 It may be necessary to have adequate evacuated volume on the distal
side of
the chamber or in the distal cylinder chamber 437b to cause the Piston (431)
to continue
translating distally after the Shuttle Valve (443) shuts off vacuum to the
distal side of the
mechanism or to the distal cylinder chamber 437b.
[02021 As the Shuttle (444) moves distally, the Distal Ambient Air Seal
(441) opens to
allow ambient air from outside of the mechanism to flow into the distal side
of the
mechanism and fill the evacuated volume including the Distal Cylinder Chamber
(43715),
the Distal Shuttle Pin Slot (436), and the Distal Shuttle Chamber
(446)õAdditionally, the
Proximal Ambient Air Seal (439) closes and the Shuttle Valve (443) opens the
vacuum
port 438 to the proximal side of the mechanism andlor to the proximal cylinder
chamber
437a.
102031 The Shuttle Valve (443) moves to the distal side of the Vacuum Port
(438)
which results in evacuation of the air in the Proximal Cylinder Chamber
(437a), the
Proximal Shuttle Pin Slot (434), and the Proximal Shuttle Chamber (445).
Consequently,
the differential pressure on the proximal and distal sides of the Piston (431)
causes the
piston to move proximally.
1102041 As the Piston (431) moves proximally, it contacts the Proximal
Shuttle Pin
(433) and moves the Shuttle (444) proximally. As a result, the Shuttle Valve
(443) closes
off the Vacuum Port (438) to the proximal side of the mechanism or to the
proximal
cylinder chamber 437a.
102051 it may be necessary to have adequate evacuated volume on the
proximal side of
the chamber or in the proximal cylinder chamber 437a to cause the Piston (431)
to
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continue translating proxnnally after the Shuttle Valve (443) shuts off vacuum
to the
proximal side of the mechanism or to the proximal cylinder chamber 437a.
102061 As the Shuttle (444) moves proximally, the Proximal Ambient Air Seal
(439)
opens to allow ambient air from outside of the mechanism to flow into the
proximal side
of the mechanism and fill the evacuated volume including the Proximal Cylinder
Chamber
(437a), the Proximal Shuttle Pin Slot (434), and the Proximal Shuttle Chamber
(445).
Additionally, the Distal Ambient Air Seal (441) closes and the Shuttle Valve
(443) opens
the vacuum port 8 to the distal side of the mechanism and/or the distal
cylinder chamber
437b.
[02071 The Shuttle Valve (443) is on the proximal side of the Vacuum Port
(438)
which results in the mechanism being returned to the starting position
described above.
Consequently, the mechanism has completed one cycle and is free to continue
reciprocating as described above as long as adequate vacuum is available to
the
mechanism.
[02081 Figures 5A-5B show another variation of a vacuum powered mechanism
560 or
motor including a spring return mechanism. Fig. 5A shows the mechanism with a
Piston
561 in a starting or proximal position, and Fig. 513 shows the mechanism with
a Piston 561
in a distal position.
102091 Referring to Figure 5N-513, the vacuum powered mechanism 560
includes a
piston 561 having a piston shaft 62. The piston 561 including at least a
portion of the,
piston shaft 562 are positioned within a cylinder chamber 581. The piston 561
divides or
separates the cylinder chamber 581 into a proximal cylinder chamber 581a and a
distal
cylinder chamber 581b. The piston 561 may reciprocate distally within the
cylinder
chamber 581 when the distal side of the piston 561 is evacuated or when distal
cylinder
chamber 581b is evacuated. Ambient air may be or may always be present on the
proximal side of the piston 561 or in the proximal cylinder chamber 581a.
Cylinder
chamber 581a may be open to ambient air or may always be open to ambient air.
The
piston shaft 565 may reciprocate along with the piston 561, and the
reciprocating piston
shaft 565 may conduct reciprocating motion output. The piston shaft may serve
to
transmit the motion from the piston as the mechanism output.
102101 A shuttle 562 may be connected to the Piston (561) and the shuttle
562 may
reciprocate along with the Piston 561. The shuttle 562 may be positioned in a
shuttle
chamber. The shuttle includes a proximal seal flange 563 which may be integral
to the
shuttle 562 and/or extend radially therefrom. The seal flange 563 provides a
seal between
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the Ambient Air Conduit (574) and the Distal Cylinder Chamber (581b) when the
Distal
Cylinder Chamber (581b) is evacuated. Proximal Seal Flange 563 may also
contact a
Proximal Stop Pin (580) to stop the proximal movement of the Shuttle (562).
102111 The shuttle may also include a shuttle valve 564, which may be
integral to the
shuttle and/or may extend radially therefrom. The shuttle valve 564 may
separate or
divide the shuttle chamber into a proximal shuttle chamber 588, on the
proximal side of
the valve 564, and a vacuum shuttle chamber 583 on the distal side of the
valve 564, The
Shuttle Valve 564 provides a seal, which may seal, e.g., against the shuttle
block 578, to
the distal or proximal side of the distal conduit 572. The shuttle valve 564
may provide a
seal to the proximal side of the distal conduit 572 to open the distal conduit
572, and the
distal cylinder chamber 58 lb. to a vacuum port 575 to allow the distal
cylinder chamber
58 lb to be evacuated by communicating with an external vacuum supply.
[0212] The shuttle valve 564 may also provide a seal to the distal side of
the distal
conduit 572 to open the distal conduit 572, and the distal cylinder chamber
581b, to an
ambient air conduit 574 to allow the distal cylinder chamber 581b to be open
to ambient
air.
[0213] The piston shaft 565 may be integral to the piston 61 on the
proximal end of
the piston shaft 565 and integral to the distal piston shaft 570 (i.eõ the
external portion of
the piston shaft 565 located at the distal end of the piston shaft 565. A
Shuttle Return
Surface (566) is Integral to the Piston Shaft (565) and serves to contact the
distal end of
the Shuttle (562) to motivate it proximally when the Piston 561 and piston
shaft 565 are
translating in the proximal direction,
102141 The piston shaft 565 may also include a Distal Seal Flange (567),
which may
extend radially therefrom. The distal seal flange 567 may seal ambient air in
the return
spring chamber 584, sealing off the return spring chamber 584 from the shuttle
vacuum
chamber 583. The distal seal flange may also provide a surface for a Return
Spring (568)
to act upon to motivate or translate the Piston Shall (565) proximally or in
the proximal
direction during a return stroke.
[02151 A Return Spring (568), is positioned in the return spring, chamber
584 and
stores mechanical energy by compressing during the distal stroke of the
mechanism. i.e.,
when the piston and piston shaft are moved in the distal direction. The
mechanical energy
is released when the Return Spring 568 motivates the Piston Shaft 565
proximally during
the return stroke of the mechanism.
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102161 The mechanism 560 may include a Distal End Plate (569) which serves
as a
distal stop for the Return Spring (568).
[02171 The mechanism 560 may also include various conduits. A Proximal
Conduit
(571) may provide a connection or conduit for fluid communication between the
Distal
Cylinder Chamber (581b) and a Parallel Conduit (573). A Distal Conduit (572),
as
identified above, may provide a connection or conduit for fluid communication
between
the Proximal Shuttle Chamber (588) and the Parallel Conduit (573). The
Parallel Conduit
(573) may provide a connection or conduit for fluid communication between the
Proximal
Conduit (571) and the Distal Conduit (572), The Ambient Air Conduit (574) may
provide
a conduit to allow ambient air to vent proximal shuttle chamber 588 and Distal
Cylinder
Chamber (581b) depending on the positioning of shuttle valve 564 relative to
the distal
conduit 572.
[02181 The Vacuum Port (575) connects the mechanism to an external vacuum
source
and evacuates Shuttle vacuum chamber 583 and may evacuate distal cylinder
chamber
581b depending on the positioning of shuttle valve 564 relative to the distal
conduit 572.
[02191 The mechanism 560 may also include a. Return Spring Vent (576) which
vents
the Return Spring Chamber (584) to ambient air to maintain ambient air
pressure in the
Return Spring Chamber (584) as the chamber changes volume due to compression
and
extension of the Return Spring (568), The Return spring chamber 84 contains
the return
spring 68. The return spring chamber 84 may be or may always be at ambient
pressure via
the return spring vent 76.
102201 A Distal Parallel Conduit (77) may also be prOvided. The distal
parallel
conduit 77 may be an Artifact from machining the mechanism Block (78) and the
Distal
Parallel Conduit 77 may be plugged at the distal end prior to use.
[0221] A mechanism block 578 or other frame, structure, or casing may
provide an
outer structure for the vacuum powered mechanism 560. Ambient air 522 refers
to air at
atmospheric pressure which is located outside of the. vacuum powered
mechanism.
Ambient air 522 may also be allowed to flow inside various chambers of the
vacuum
powered mechanism during use of the mechanism as described herein.
10222] A Distal Stop Pin (579) provides a distal stop for the Shuttle (562)
by
preventing distal translation of the Shuttle (562) beyond the location of the
distal stop pin
579,
[02231 A Proximal Stop Pin and Ball Plunger (5:80) may provide a proximal
stop for
the Shuttle (562) when in contact with the Proximal Seal Flange (563). The
Ball Plunger
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provides normal. force on the Shuttle to increase the force required to
translate the shuttle
laterally thereby reducing or eliminating the likelihood of valve "flutter" or
unwanted
fluctuation of the valve 564 between proximal and distal positions in the
shuttle chamber
relative to distal conduit 572.
102241 The Distal Cylinder Chamber (581b) alternates between vacuum and
ambient
pressure to motivate the Piston (561) distally when the Distal Cylinder
Chamber (581b) is
in vacuum and to allow the Return Spring (568) to motivate the Piston Shaft
(562) andior
piston 61 proximally when the Distal Cylinder Chamber 58th is at ambient
pressure.
102251 The Proximal Shuttle Chamber (588) may be at ambient pressure or may
always be at ambient pressure. The Shuttle Vacuum Chamber (583) may be
evacuated or
may always be evacuated when an extern& vacuum source is connected to the
Vacuum
Port (575).
102261 hi use or in operation, the vacuum powered mechanism 560 operates by
a
pneumatic mechanism, method or logic *hereby a vacuum mechanism valve sequence
includes. Shutting off the vacuum source from the distal cylinder chamber 8b
or the.
mechanism to allow the piston to return to its home position -without venting
the vacuum
source to ambient pressure. As a result, the vacuum pressure remains
consistent in the.
cutting and evacuation system portion of the device. The pneumatic mechanism,
'method.
or logic for a piston System that does not require inertial mass W move the
mechanism.
through transition (such as a flywheel) and that uses an external or internal
vacuum source
to pro N,ide the force to cause reciprocating motion in one direction and a
return spring to
provide the force to cause reciprocating motion in the reverse direction may
include the
following steps,
[02271 For example, a. vacuum may be open to the distal Cylinder Chamber
581b while
ambient air is closed to that chamber, The Piston 561 advances in the distal
direction,
toward a distal position due to the vacuum inside the distal cylinder chamber
52 lb and
ambient pressure in the proximal cylinder chamber 58.1a, on the proximal side
of the
Piston 561, Distal advancement of the Piston 561 compresses the Compression
Spring
568, where the vacuum force should or may be great enough to overcome friction
in order
to compress the Compression Spring 568.
102281 When the piston 561 moves, the piston 561 contacts Shuttle 562 and
advances
the Shuttle 562 such that the shuttle valve 564 cuts off the vacuum to the
distal Cylinder
chamber 58 1 b and the Compression Spring 568 continues to compress as the
Piston 56i.
advances in the distal direction. Piston 561 may continue to advance distally
(e.g., even
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after the vacuum is cut off to distal cylinder chamber 581.b) due to evacuated
volume on
the distal side of the Cylinder in the distal cylinder chamber 581b, which
should or may be.
great enough to overcome friction and to continue compressing the Compression
Spring
568 and advancing the shuttle 562 to allow ambient air to flow into the distal
cylinder
chamber 581b by opening distal conduit 572 and distal cOinder chamber 581b to
ambient
air conduit 574.
102291 The Piston 561 may retract in the proximal direction to a proximal
position due
to the force of the Compression Spring 568 and a loss of vacuum in the distal
cylinder
chamber 581b resulting from ambient air flowing into the distal cylinder
chamber 581b.
The Piston Shaft 562 contacts the Shuttle and moves the shuttle in a proximal
direction,
thus cutting off ambient air conduit 574 and ambient air flow to the distal
Cylinder
chamber 58 lb. The Piston Shaft :562 continues .moving the Shuttle 562
proximally,
eventually opening the distal conduit 572 and distal cylinder chamber 581b to
vacuum port
575 such that the vacuum connection is open to the distal cylinder chamber 581
b.
102301 The mechanism is free to continue reciprocating as described above
by creating
a pressure differential on opposite sides of the piston as long as adequate
vacuum is
available to the mechanism. The above steps may repeat as necessary such that
the
vacuum powered motor creates a reciprocating, motion unless or until the
vacuum source is
disconnected, turned off, or if the vacuum is inadequate to overcome the force
required to
compress the Compression Spring and overcome the internal friction or if the
mechanism.
is stalled or 'halted.
102311 In certain variations, Pneumatic. valve instability or flutter
caused by the shuffle
or shuttle valve attempting to move back and forth between states, or between
proximal
and distal positions relative to distal conduit 572, may be reduced or
eliminated by
exposing, one side of the shuttle valve 564 to the vacuum source and the
opposite side of
the Shuttle valve 564 to ambient air. This will cause the Shuttle or shuttle
valve to move
in the direction of the vacuum and will more fully open the distal conduit 572
to the
ambient air conduit 574, thereby connecting the ambient air to the distal
Cylinder chamber
58th.
102321 in certain variations, a small normal force may be imparted on the
Shuttle 562
to hold it in place to overcome unintended movement caused by friction against
the Piston
Shaft 565 or valve flutter caused by valve instability. This small normal
force may be
imparted in the form of a ball plunger.
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102331 In certain variations of .a. vacuum powered mechanism, an adequate
volume is
evacuated on the distal end of the Cylinder or from the distal cylinder
chamber to cause.
the Piston to continue .moving distally after the external vacuum source is
shut off from the
distal Cylinder chamber. The evacuated volume in the distal Cylinder chamber
serves to
encourage the Piston to continue moving distally after the external vacuum
source is Shut
off from the volume of the distal cylinder chamber, thereby eliminating the
need for
inertial mass to Move the valve through transitions from one state to another.
10234] The reciprocating motion of the mechanism may be utilized to actuate
a cutting
device or to operate or actuate another device, e.g., another medical device.
In certain
variations, cutting device may be positioned by maneuvering a flexible or
_malleable shaft
of the device e.g., manually or automatically. The shaft may be maneuvered or
positioned
around sensitive tissues or structures in the human body by changing the shape
of the
shaft. For example, extending or retracting an outer sheath or eannula on the
shaft or
advancing or retracting the shaft .relative to the outer sheath, thereby
allowing, improved
maneuverability of the shaft around structures or within confined spaces may
be
performed, e.g., allowing a shaft's predetermined curvature to position the
distal end of the
shaft near a target site. Such mechanisms, techniques and devices include
those described
in US Patent Application Nos. 11/848,565, 11/848,564, and 11/848,562, each of
which is
incorporated herein by reference in their entirety for all purposes.
102351 Further describing operations of a variation of a mechanism as
illustrated in
Figs. 5A-5B, Fig. 5A shows a starting position for the mechanism with the
Piston in a
proximal position due to extension of the Return Spring (568).
102361 When external vacuum is applied -to the mechanism through the Vacuum
Port
(575), the Shuttle Valve (564) is on the proximal side of the Vacuum Port (75)
and on the
proximal side of the Distal Conduit (572). As a result, the vacuum is able to
fluidly
communicate with the Distal Cylinder Chamber (581b) which results in
evacuation of the
air in the Distal Cylinder Chamber (581b). Consequently, the differential
pressure on the
proximal and distal sides of the Piston (561) causes the piston to move
distally,
[02371 As the Piston (561) moves distally, it coinpresses the Return Spring
(568)
thereby storing mechanical energy. The Proximal Shuttle Seal (563) prevents
leakage of
ambient air into the Distal Cylinder Chamber (58 lb). The Shuttle (562)
"dwells" in
position until the Piston (561) contacts the Shuttle (562) and .motivates it
in the distal
direction. The Shuttle Valve (564) then doses off the Vacuum Port (575) to the
_Distal_
Conduit (572) thereby shutting off vacuum to the Distal Cylinder Chamber
(581b).
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102381 It may be necessary to have adequate evacuated volume on the distal
side of
the chamber in the distal cylinder chamber 58 lb to cause the Primary Piston
(561) to
continue translating, distally after the Shuttle Valve (564) shuts off vacuum
to the distal
conduit 572 and the distal cylinder chamber 581b.
102391 As the Distal Cylinder Chamber (581) refills with ambient air, from
ambient air
conduit 574 via distal conduit 572 (which is now open to ambient air conduit
514 as
shown in Fig. 5b), the Return Spring (568) motivates the Piston Shaft (565)
proximally.
The Shuttle "dwells" in position until the Shuttle Return Surface (566) on the
Piston Shaft
(565) contacts the Shuttle (562) and motivates the Shuttle (562) in the
proximal direction,
1102401 The Shuttle Valve (564) moves from the distal side to the proximal
side of the
Distal Conduit (572) thereby opening the distal conduit 572 to the Vacuum Port
(575) to
evacuate the Distal Cylinder Chanter 58 lb).
[02411 The Shuttle (562) and the Piston 561 return to their proximal
(starting) position
and the mechanism has completed one cycle and is free to continue
reciprocating as
described above as long as adequate vacuum is available to the mechanism.
[02421 Mechanism utilizing a Poppet Valve
[02431 in certain variations, a medical device driven or powered by a
vacuum source
may include a working end having an operable element. The operable element may
be
coupled to a mechanism, such that when the mechanism is driven by the vacuum
source
movement of a drive piston or drive shaft of the mechanism results in
actuation of the
operable element. The drive piston or drive shaft may be located at least
partially in a
chamber and may be moveable between a drive stroke and a return stroke. The
mechanism may include a valve configured to alternately seal and vent at least
a portion of
the chamber. The mechanism may also include a biasing component positioned
against
the drive piston or drive shaft. Evacuation of the chamber and movement of the
biasing
component when the chamber is vented to ambient air may cause the drive piston
and/or
drive shaft to cycle between a drive stroke and a return stroke to create a
reciprocating
motion. This reciprocating motion causes actuation of an operable element or
shaft
coupled to the mechanism.
10244] Figures 11A-11E show a variation of a vacuum powered mechanism 600
or
motor which may be used in various medical devices. For example, the mechanism
600
may be utilized in medical devices for cutting tissue or tbr performing other
work on
tissue or on a patient,
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102451 The mechanism 600 includes a Drive piston 601 attached to a drive
piston shaft
602, The drive piston 601 and at least a portion of the drive piston shaft 602
are
positioned in a chamber. The drive piston shaft divides the Chamber into an
evacuation or
suction chamber 611 and a vent chamber 612. The Drive piston 601 translates
proximally
(to the left when referencing figures 11A-11E) when air is evacuated from the
evacuation
or suction chamber 611 and translates distally (to the right when referencing
figures 11A-
11E) when ambient air is vented into the suction chamber 611.
[0246] The Drive piston shaft 602 may be integrated with or otherwise
coupled or
connected to the drive piston 601. The Drive piston shaft 602 reciprocates
along with the
drive piston 601 and conducts linear reciprocating motion to provide output
motion from
the mechanism 600 to an output shaft, elongate shaft, evacuation shaft,
operable element
or tool, e.g., to actuate an operable element coupled to an output or
evacuation shaft or
directly to the mechanism 600. The Drive piston shaft 602 seals against
mechanism body
606 at the mechanism body seal 614 to prevent loss of vacuum or suction from
suction
chamber 611 to ambient air. Drive piston shaft 602 rides or sits on the end
cap bearing
613 to maintain concentricity between the Drive Piston 601 and the mechanism
Body 606,
An airtight seal may be provided between the drive piston shaft 602 and the
end cap
bearing 613, but an airtight seal may not be necessary. Drive Piston Shaft 602
may.
contain a lumen 616 to fluidly connect a source of suction to the Suction
Chamber 611
and/or optionally to a working end of the device to facilitate tissue
evacuation through the
Drive Piston Shaft lumen 616,
10247] Vacuum powered mechanism 600 also ipcludes a valve, e.g., a poppet
valve
603 or similar valve. The poppet Valve 603 alternately seals and vents the
Suction
Chamber 611 by opening and closing the Drive piston Cross-hole 605, The Poppet
Valve
603 is held in place against the Drive Piston Cross-hole 605 by suction in the
Suction
Chamber 611 and ambient air in the Vent Chamber 612. When the Poppet Valve 603
seals
the Drive piston Cross-hole 605 dosed, air is evacuated from the Suction
Chamber 611
and ambient air on the right side of the Drive Piston 601 in the vent chamber
612
translates the drive piston 601 to the left. When the Poppet Valve 603 is not
sealing the
Drive piston Cross-hole 605, ambient air flows through the Drive piston Cross-
hole 605
and into Suction Chamber 611 thereby allowing a biasing component, e.g., a
Return
Spring 609, which may surround at least a portion of the drive piston shaft
602 or be
otherwise positioned against the drive piston 601, to translate the Drive
Piston 601 to the
right such that the Poppet Valve 603 seals against the Drive piston Cross-hole
605.
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102481 The Drive Piston Cross-hole 605 allows ambient air to flow into the
Suction
Chamber 611 to cause the Drive Piston 601 to translate to the right. The drive
piston CMS's
hole 605 seals against the Poppet Valve 603 to allow air within the Suction
Chamber 611
to be evacuated thereby translating the Drive Piston 601 to the left.
102491 The poppet valve 603 may include or be coupled to a Poppet Valve
Spring 604,
which compresses when the Poppet Valve 603 translates to the left along with
the Drive
Piston 601. The poppet valve spring 604 can limit travel or leftward
translation of the
Poppet Valve 603 either by fully compressing or by exerting a force on the
Poppet Valve
603 that is adequate to break the seal between the Poppet Valve 603 and the
Drive Piston
Cross-hole 605. When the seal between the Poppet Valve 603 and the Drive
Piston Cross-
hole 605 is broken the poppet valve spring 604 translates the poppet valve 603
to the right.
102501 The mechanism Body 606 forms the outer shell of the mechanism 600
and
seals the interior components, forming a seal with the Drive Piston 601 to
separate the
Suction Chamber 611 from the Vent Chamber 612. The mechanism body 606 seals
against the Drive Piston Shaft 602 to prevent leakage of air into the Suction
Chamber 61 1
by ambient air outside the mechanism 600,
[0251] The drive piston shaft 602 may include a Drive Piston Shaft Vent
607, which
fluidly connects the Suction Chamber 611 to the external suction source
through a lumen
616 in the Drive Piston Shaft 602.
102521 The mechanism body 606 may also include a mechanism Body Vent 608,
The
mechanism body vent 608 maintains and allows for the flow of ambient air in
the Vent
Chamber 612.
102531 The biasing component or Return Spring 609 positioned on or around
at least a
portion of the Drive Piston Shaft 602 or against the Drive Piston 601
translates the Drive
Piston 601 to the right when the Suction Chamber 611 is vented to ambient air -
through the
Drive Piston Cross-hole 605.
[02541 The mechanism 600 may also include an End Cap 610. The End Cap 610
may
serve as a bearing surface for the Poppet Valve 603 and the Drive Piston Shaft
602, which
may extend therethrough. The end cap 610 also provides a registration surface
for the
Poppet Valve Spring 604 as it compresses and extends to actuate the Poppet
Valve 603.
10255] Air may be continuously evacuated from the Suction Chamber 611
through the
Drive Shaft Piston Shalt Vent 607. When the Drive Piston Cross-hole 605 is
dosed, air is
evacuated from the suction chamber 611, causing the pressure to decrease
inside the
Suction Chamber 611 while the ambient air pressure On the right side of the
Drive Piston
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601 in the Vent Chamber 612 has greater air pressure than the air pressure in
the Suction
Chamber 611. This causes the Drive Piston 601 and drive piston shaft 602 to
translate to
the left, Le., toward the Suction Chamber 611.
10256] The Vent Chamber 612 may remain vented to ambient air. The Vent
Chamber
612 maintains ambient air pressure against the right Drive Piston 601 to help
translate the
Drive Piston 601 and Drive Piston Shaft 602 to the left when the Drive Piston
Cross-hole
605 is dosed and the suction chamber 611 is evacuated.
[0257] The End Cap Bearing 613 may maintain concentricity between the Drive
Piston 601 and the mechanism body 606 via the Drive Piston Shaft 602, which
extends
through or rides on the End Cap Bearing 13. An airtight seal is not necessary
between the
Drive Piston Shaft 602 and the End Cap Bearing 613 but may be provided.
102581 The mechanism Body Seal 614 maintains an airtight seal between the
Drive
Piston Shaft 602 and the mechanism Body 606 to prevent leakage of ambient air
into the
Suction Chamber 611. The Drive Piston Seal 615 maintains an airtight seal
between the
Drive Piston 601 and the mechanism Body 606 to prevent leakage of ambient air
into the
Suction Chamber 611 from the Vent Chamber 61 2.
[0259] Figures 11A-11F, illustrate the operation of vacuum powered
mechanism 600
described above. The pneumatic method for the mechanism 600 or piston system
includes
the utilization of a Poppet Valve or other valve to reverse the Drive Piston
direction. The
mechanism 600 may use an external vacuum source to provide force to cause
reciprocating motion in one direction and a Return Spring to provide force to
cause or
assist reciprocating motion in the opposite direction. The method of operation
may
include one or more of the tbllowing steps.
[02601 As shown in Figure 11A, at the beginning of the mechanism cycle, the
Poppet
Valve 603 may be opposed to the Drive Piston 601, sealing the Drive Piston
Cross-hole
605. At least a portion of the air (the flow of suction air in the mechanism
is identified by
the arrows A) flows through the Drive Piston shaft lumen 616 as a result of
suction
provided by a vacuum source. As the air is evacuated from the Suction Chamber
611 on
the left side of the Drive Piston 601, the vacuum builds on the left side of
the Drive Piston
601 and the Drive Piston 601 and Drive Piston Shaft 602 translate to the left.
The suction
within the Suction Chamber 611 holds or pulls the Poppet Valve 603 closed,
against the
Drive Piston Cross-hole 605, even as the Drive Piston 601 moves or translates
to the left.
[02611 As shown in Figure 171B, as the Drive Piston 601, Drive Piston Shaft
602 and
the Poppet Valve 603 translate to the left, a.s a result of the evacuation of
air from the
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suction chamber 611 on the left side of the Drive Piston 601, the Poppet Valve
Spring 604
and the Return Spring 609 are compressed.
102621 As shown in Figure 11C, the Poppet Valve 603 translates to the left
until it
reaches the end of its stroke, where the Poppet Valve Spring 604 is fully
compressed and
the Poppet Valve 603 can no longer translate to the left. However, the Drive
Piston 601
and drive piston shaft 602 are capable of continuing translation to the left
after the poppet
valve 603 reaches the end of its stroke, and as a result, the poppet Valve 603
disengages
from the Drive Piston Cross-hole 605 (as shown in Figure 1 I D),
102631 In an alternative variation, the Poppet Valve Spring 604 may not be
fully
compressed; however, the poppet valve spring may be able to apply adequate
force to
overcome the suction force holding the Poppet Valve 603 against the Drive
Piston 601 and
drive piston cross-hole 605, thereby disengaging the Poppet Valve 603 from the
Drive
Piston Cross-hole 605,
[02641 As shown in Figure 11D, after the Poppet Valve 603 loses its seal
against the
Drive Piston cross-hole 605, the Poppet Valve 603 translates to the right,
translating or
springing to the right, bit& to its home position via the Poppet Valve Spring
604. The
suction chamber 6 II on the left side of the Drive Piston 603 is now vented to
atmosphere
air through the mechanism body vent 608 (venting or atmosphere air flow is
indicated by
the arrows B) as the drive piston cross-hole 605 is now open to atmosphere via
the
mechanism body vent 608. The Drive Piston 601 and drive piston shaft 602 then
translate
to the right, pushed by the compressed Return Spring 609 on the left side of
the Drive
Piston 601.
102651 As shown in Figure 11E, the drive piston 601 and drive piston shaft
translate to
the right and return to their home position, and once again the drive piston
601 is sealed
against the Poppet Valve 603 where the cycle may start again.
102661 The above steps may repeat unless the vacuum source is disconnected,
turned
off, or if the vacuum is inadequate to overcome the force required to move the
Drive
Piston 601.
[02671 The vacuum powered mechanism 600 may be utilized to operate a
variety of
medical devices used for performing various types of work on tissue. For
example, in one
variation, the mechanism may be used in the cutting device shown in figures 1A-
IFI, The
vacuum powered mechanism 600 may be substituted for or used as an alternative
to the
mechanism 30, shown in Figures 71 A-I H, to provide power or create
reciprocating motion
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in the device; to create an output motion to cut tissue. In certain
variations, the
mechanism 600 may be used in combination with the mechanism 30
102681 Figures 12A-121) show a variation of a medical device where the
mechanism.
600 is integrated in a variation of a tissue cutting or resecting device as
described herein
102691 Figure 12A shows a cross sectional view of a suction or vacuum
powered
cutting device 620 including' a vacuum or suction powered mechanism 600.
Figures 1.2B-
1.2D show cross sectional views of the mechanism 600 .of cutting device 620.
The vacuum
powered cutting device 620 may include an elongate shaft 621. The elongate
shaft 621
may include a window 622 or cutting window or opening positioned at or near a
distal end
of the elongate shaft 621. An evacuation shaft .may be positioned within the
elongate shaft
621 and a cutter (not shown, but as described supra) may be positioned within
the .elongate
Shaft 621, e.g., coupled or connected to the distal end of the evacuation
shaft. A proximal
portion of the evacuation shaft 623 may be coupled to the drive piston shaft
602 of
mechanism 600, such that the evacuation shaft 623 and the cutter may be
reciprocated as
the drive piston shaft 602 is reciprocated, causing the cutter to reciprocate
past the opening
622. Other types of cutters are .contemplated, e.&.õ the cutter may extend
from a wire or
blade positioned in the elong.ate shaft 621 and coupled to the drive piston
shaft 602.
102701 In any of the .variations of .vacuum powered mechanisms described
herein, 0-
rings or other sealing components may be used to create a seal between
surfaces but are
not necessary if leakage around the seals is tolerable. Also, leakag.e around
the seals may
be reduced by using a lubricant of sufficient viscosity to fill the gap
between the seal and
the bore in which it operates.
[02711 The Shuffle may be configured in several positions including
concentric with.
the Center Shaft, parallel to the Center Shaft, as a rotary valve, and so
forth,
102721 'The vacuum powered .mechanisms described herein .may be utilized
with or
incorporated into a variety of medical devices_ For example, the vacuum
powered
mechanisms may be utilized to reciprocate a cutter on a distal end of a
malleable shaft
which may be manipulated or adjusted manually or automatically or a flexible
shaft
havin;2: a predetermined curvature which is manipulated. through .advancement
or retraction
through a cannula or other sheath as illustrated and described in US Patent
Application
Nos.. 11/848,565, 11/848,564, and 11/848,562, each of which is incomorated
herein by
reference in their entirety for all purposes. US Patent Application No.
61/360,429 is also
incorporated herein by reference in its entirety for all purposes.
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102731 In certain variations of a device having a curved flexible shaft a
rigid orsemi-
rigid straight sheath may be assembled or connected to the device to cause the
curved,
flexible portion of the shaft to straighten as the sheath is advanced over the
curved section
or to cause the curved, flexible portion of the shaft to return to its curved
shape as the
sheath is retracted.
102741 In other variations, a rigid or semi-rigid curved sheath may be
assembled or
connected to a device or end effector having a shaft with a curved, flexible
portion to
direct the shaft as it is advanced through the curved sheath.
102751 In other variations, a rigid or semi-rigid curved sheath may be
assembled or
connected to a device or end effector 'having a shaft with a straight,
flexible portion to
direct the shaft as it is advanced through the curved sheath. The rigid or
semi-rigid curved
or straight sheathes .may be assembled, connected, attached to or otherwise
utilized with
the cutting device. The various sheaths may be detachable from the devices or
end
effectors or affixed or attached to the devices and or end effectors.
1J02761 In certain variations, the vacuum powered mechanisms described
herein may
also be utilized to .reciprocate or actuate a reciprocating cutter of a device
or end effector
or to operate a device having a semi-rigid or rigid, curved end effector or a
rigid or stiff
shaft. A cutter, end effector and/or device may be operated by vacuum powered.
mechanisms or other motorized mechanisms or by hand,
102771 Fig. 6 shows one variation of a rigid, curved end effector 4L0 or
distal end of a
device. The end effector 4.0 may include a scraping edge 4.1, a window 4.6, a
reciprocating cutter 4.2., and/or a blunt distal tip 4.5, The end effector 4.0
may also
include a rigid shaft 4,7. The rigid shaft 4,7 may have a shaft curvature
section 4.3 and/or
a shaft straight section 4.4. In certain variations, a fluid line 4.8, e.g,, a
saline line, may be
attached to the end effector 4,0 or extend along or within the end effector
4Ø In certain
variations, the end effector, distal end of a device, and/or shaft may be
rigid, stiff,
substantially rigid, or semi rigid.
1102781 The end effector 4.0 may be a component of a device. e.g.. a
cutting device or
medical device. The end effector 4.0 may be positioned at a distal end of a
cutting device
or designed for use or attachment to a cutting device, medical device, or
other device. The
end effector 4.0 may be useful for various procedures requiring cutting and/or
scraping of
a .variety of tissues including soft and 'hard tissues,
[0279,1 The Scraping Edge 4.1 is typically made from a rigid material,
e.g., Stainless
Steel, which may withstand cutting forces without substantially bending or
deflecting the,
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scraping edge 4.1. Other materials may be used as warranted by the desired
clinical
application. in certain variations, a semi-rigid material may be used, The
Scraping Edge
4.1 may be used to cut or scrape various soft and hard tissues, such as
intradiscal nucleus
tissue, Vertebral End Mates., cartilage, ligament, bone, and other soft and
hard tissues, The
Scraping Edge 4,1 may be used to cut tissue free and/or to mobilize the tissue
for
evacuation throuah the Window 4.6 and through a lumen of the rigid shaft 4.7.
The tissue
may be evacuated to a Filter or collection receptacle.
[0280] The Scraping edge 4.1 may be affixed or attached to the rigid shaft
4.7 at any
angle relative to the longitudinal axis of the Rigid Shaft 4:7, For example,
the scraping
edge 4,1 may be affixed or attached to the Rigid Shaft 4.7 at a an angle
ranging from or
between 0 to 180 degrees or 0 to 90 degrees relative to an axis of the Rigid
Shaft 4.7. As
Shown in Fig. 6, in certain variations, the Scraping Edge 4.1 may be affixed
or otherwise
attached to the Rigid Shaft 4.7 in a position that is perpendicular or
substantially
perpendicular to the axis of the rigid shaft 4,7.
102811 Where the Scraping Edge 4.1 is rigidly affixed to the Rigid Shaft
4.7 as shown
in Figure 6, the cutting and scraping actions of the scraping edge 4.1 may be
accomplished
by the operator manually moving the Scraping Edge 4.1 through manual movement
of the
rigid shaft 4.7 or the end effector 4.0 or a component thereof Optionally, the
cutting and
scraping actions of the scraping edge 4.1 may be accomplished automatically or
by
motorized movement or operation of the rigid shaft 4,7 or the end effector 4.0
or a
component thereof.
10282] in certain variations, the Scraping Edge 4.1 may be affixed or
attached to the
Reciprocating Cutter 4.2, e.g., external to the Rigid Shaft 4,7, such that the
scraping edge
4.1 can reciprocate in concert with the cutter (not shown), The scraping edge
4.1 may be
affixed or attached to the reciprocating cutter 4.2 at any angle relative to
the longitudinal
axis of the Reciprocating Cutter 4.2. For example, the scraping edge 4.1 may
be affixed or
attached to the Reciprocating Cutter 4.2 at a an angle ranging from or between
0 to 180
degrees or 0 to 90 degrees relative to an axis of the Reciprocating Cutter
4.2, in certain
variations, the Scraping Edge 4.1 may be affixed or otherwise attached to the
Reciprocating Cutter 4.2 in a position that is perpendicular or substantially
perpendicular
to the axis of the Reciprocating Cutter 4.2.
102831 The Scraping Edge 4.1 may be positioned at a location distal to the
Window
4.6 and/or the scraping edge 4,1 may be predominately aligned with the Window
4.6
and/or positioned on the same side of the Rigid Shaft 4.7 as the Window 4,6.
The
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Scraping Edge 4.1 may be positioned distal or proximal to the Window 4.6.
Optionally,
the Scraping edge 4,1 may have exposed scraping surfaces at any location
around the
periphery of the Rigid Shaft 4.7 or reciprocating cutter 4.2.
102841 in certain variations, the end effector 4,0 may be built without a
Scraping Edge
4.1. Indeed, an end effector 4.0 may or may .not include a scraping edge 4.1
depending on
the desired clinical application. in certain variations, one or more scraping
edges may be.
positioned on an end effector, e.g., a plurality .of scraping edges may be
positioned on an
end effector.
102851 Still referring to Fig, 6, the Reciprocating Cutter 4.2 may be
positioned on the
end effector 4.0 such that the reciprocating cutter 4.2 may advance and/or
retract axially
past the Window 4.6 to excise and evacuate tissue or mobilized tissue_ The
Reciprocating
Cutter 4.2 may use a "scissor" action against the window 4.5 or against a
section of the
rigid shaft 4.7 to excise tissue.
102861 The Window 4.6 is an opening in the Rigid Shaft 4.7 that permits the
passage.
of tissue into the window 4.6 and into the path of the Reciprocating Cutter
4:2 such that
the tissue can be cut and/or evacuated. The Window 4.6 or at least a portion
of the
perimeter or an edge of the window 4.6 may serve as a cutting edge to "plane"
tissue and
excise the tissue. Additionally, an edge of the Window 4,6 may provide a
surface with
which the Reciprocating Cutter 4.2 may scissor tissue as the reciprocating
cutter 4.2 passes
by the Window 4.6.
102871 Optionally, the end effector may include a flexible feature that
encourages the
Cutter 4.2 against the Window 4.6 to improve the scissoring action.
102881 The Reciprocating Cutter 4.2 may be powered or actuated by any of
the
vacuum powered mechanisms described herein. Alternatively, the reciprocating
cutter 4.2
or end effector may be actuated through a mechanism that is powered by 'hand
or by other
motorized mechanisms. In certain variations, a rotating cutter may be utilized
and
powered by any of the vacuum powered mechanisms described herein, by hand or
by other
motorized mechanisms.
[02891 The Rigid Shaft 4.7 may serve as the primary structure and/or outer
envelope
of the shaft of a device or cutting device to which the end effector is
attached. The Rigid
Shaft 4,7 may be curved or straight or the rigid shaft 4.7 may include curved
and/or
straight sections or portions. in certain variations, the rigid shaft 4.7 may
be .malleable to
allow an operator or user to adjust or revise the curvature of the shaft 4.7
depending on the
application or use. For example, the rigid shaft 4.7 may be bendable or the
rigid shaft 4.7
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may be annealed or softened in order to alter the Shape or curve of the rigid
shaft 4.7 by
hand or machine. The rigid shaft may be annealed over the bendable portion of
its length
and hard near the .distal extremity to reduce the likelihood of bending or
damaging the
shaft near the cutting window.
102901 As shown in Figure 6, a Shaft Curvature section 4.3 may be provided
in the
rigid shaft 4.7. The rigid shaft may include one or more shaft curvature
sections. The
shaft curvature section 4.3 allows the operator to position the end effector
4.0 or the distal
end of the end effector 4.0 or the distal end of the cutting device or other
device in an area
of anatomy outside of the line-of-sight of the user. For example, the shaft
curvature
section 4,3 may allow the end effector 4.0 to be positioned within an
intradiscal space.
The radius of curvature of the rigid shaft 41 or the shaft curvature section
4.3 may be
determined during manufacturing or it may be operator-adjustable.
102911 The rigid shaft 4.7 may also include a Shaft Straight Section 4.4
which may be
located proximal to the Shaft Curvature section 4.3. The rigid shaft may
include one or
more shaft straight sections.
[02921 A Blunt Distal Tip 4.5 may be provided on the end effector 4Ø The
blunt
distal tip 4.5 may significantly reduce, minimize or eliminate the likelihood
of the end
effector 4.0 or distal end of a device accidentally being advanced through or
into tissue
which is not the intended target. For example, the blunt distal tip 4.5 may
reduce the
likelihood or minimize the risk of the end effector 4.0 or distal end of the
device being
advanced through an annulus when the end effector 4.0 of a device is being
used to cut
intra-discal nucleus or for scraping and/or evacuating vertebral endplate
material. The
blunt distal tip 4.5 may, cover all or a portion of the distal surface of the
Scraping Edge 4.1.
In variations where the entire distal surface or substantially the entire
surface of the
Scraping Edge 4.1 is covered with the Blunt Distal Tip 4.5, the Scraping Edge
4.1 may cut
and/or scrape only when moved in the proximal direction or a lateral direction
and not
when moved in the distal direction In other variations where the entire
distal. surface or
substantially all of the distal surface of the Scraping Edge 4.1 is covered
with the Blunt
Distal Tip 4.5, the Scraping Edge 4,1 may cut and/or scrape in the distal
direction or it
may cut and/or scrape in the distal direction in a limited manner.
102931 in certain variations,, a fluid line 4,8 may be affixed or attached
to the external
or outside surface of the Rigid Shaft 4,7 as shown in Figure 6. Optionally,
the fluid line
4.8 may be contained inside the Rigid Shaft 4.7 by a separate lumen within the
rigid shaft
4.7 or by allowing fluid to flow through the main shaft lumen. The fluid Line
4.8 allows
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fluids, ei.g.õ saline, water, air, etc, to =flow from a source .of fluid
external or internal to a
device to the distal end of the end effector or the distal end of a device or
cutting device,
[0294] A scraping edge 4.1 may be provided or located on an end effector
4.0 having a
rigid shaft 4.7, where the rigid shall 4.7 and scraping edge 4.1 allow side or
axial forces to
be applied to the rigid Shaft, scraping edge, end effector and/or to a device
attached to the
end effector to effect scraping or cutting of tissue in a vertebral disc or
tissue in another
area of the anatomy, while minimizing or preventing deflection or bending of
the end
effector, shaft or scraping edge. A rigid end effector having a rigid shaft
and/or scraping
edge may permit or provide effective scraping and/or cutting of a target
tissue.
Optionally, a scraping edge may be positioned on the distal end of a flexible,
semi-rigid or
less rigid shaft or end effector and side forces may be applied to the
scraping edge and
Shaft to effect scraping. In any of the above variations, axial advancement
and retraction
of the scraping device and/or end effector may result in the scraping or
breaking up of
tissue, such as vertebral disc tissue. Optionally, one or more scraping edges
may be
positioned adjacent to the cutting window to position the scraping edge nearly
perpendicular to the direction of motion when a curved shaft is used.
[0295] In certain variations, an apparatus for scraping tissue in a subject
is provided.
The apparatus includes an end effector. The end effector includes a scraping
edge
positioned on a distal end of the end effector and one or more scraping wings,
edges or
protrusions positioned at an angle relative to the scraping edge such that the
end effector
may be actuated in a back and forth motion approximately perpendicular to the
scraping
edge to scrape or gather tissue, and/or actuated in a back and forth motion
approximately
perpendicular to the scraping wings to scrape or gather tissue. The scraping
wings may
serve to collect tissue at the cutting window opening to improve resection.
[0296] in certain variations, the end effector .may include a scraping edge
positioned
on a distal end of the end effector and one or more scraping wings positioned
at an angle
relative to the scraping edge such that the scraping edge and scraping wings
can provide a
scraping motion in different directions.
[02971 Fig. 7 shows another variation, of an end effector 704 or distal end
of a cutting
or scraping device. The end effector 704 may include a scraping edge 701, a
window 706,
a reciprocating cutter 702, and/or a blunt distal tip 705. The reciprocating
cutter may be
positioned within the end effector. The end effector 704 may include a rigid
or flexible
shaft 707. The end effector may include one or more wings 708 positioned at an
angle to
59.
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the scraping edge 701, cg., such as but not necessarily net to the window 706.
The
wings 708 may be used to scrape, gather and/or cut tissue.
102981 Wings 708 may be positioned on the end effector at an angle relative
to the
scraping edge 701. For example, the wings 708 may be positioned at an angle
ranging
from 0 to 90 degrees, e.g. at about 90 degrees, relative to the scraping edge
701. The
wings 708 are positioned at an angle relative to the scraping edge 701 such
that in use, the
scraping edge 701 and wings 708 may work or scrape tissue in different
directions. The
end effector 704 may be used to cut or scrape a variety of tissues in various
regions of the
body. For example, the end effector may be utilized to cut, scrape and/or
gather tissue in a
spine or spinal disc, e.g., to perform a discectomy.
102991 in the variations described herein, the dimensions of the end
effectors shafts.
-
devices, and/or the various components of the end effectors, shafts or devices
are merely
exemplary in nature and are not intended to be limiting. it is also
contemplated that in
certain variations, one or more of the various components of the end effectors
or the
devices, or one or more of the end effectors or the devices may be provided or
utilized.
[03001 In certain variations, the various sheaths described herein for
guiding a shaft or
end effector may be used with a device or end effector having a curved or
straight flexible
or rigid shaft.
[03011 The cutting devices or scrapers described herein may be utilized to
perform a
discectomy or other spinal procedures. Additionally, the devices described
herein may be
utilized or provide methods for resecting, excising and/or removing tissue or
soft tissue
front various regions in a patient's or subject's body. :For example, the
devices described
herein may be utilized to excise andlor .remove or evacuate various tissues or
cells
including, but not limited to: nasal tissue, for example, nasal polyps; eye
tissue; tissue in
various gynecologic-al procedures; tumors,
cancerous tumors in the lungs, liver, and
in other vital organs; and tissues or cel.ls from other areas in a patient or
subject.
103021 An end effector with a reciprocating or "fixed" Scraper edge 4.1, a
Reciprocating Cutter 4.2, and/or a Rigid Shaft 4.7 (as shown in Figure 6) or
an end
effector of Figure 7 may be useful for excising and/or evacuating various
tissues. Such
tissues include tissues within the full spectrum of consistency ranging from
soft tissues,
such as intradiscal nucleus pulposis, to tough tissues, such as End Plate
cartilage and
ligament, to hard tissues, such as bone. For example, the end effector may be
used to
prepare the intradiscal space for vertebral fusion procedures where, e.g., it
may be
desirable to remove the intradiscal nucleus pulposis and End Plate cartilage
and scrape the
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underlying bone to cause bleeding of the bone to promote healing and fusion
between the
vertebral bodies and implant,
103031 In certain variations, an end effector havin.....! a :Rigid Shaft,.
a Reciprocating
Cutter 4.2, and/or with or without a Scraping Edge, may be useful for excising
and/or
evacuating tissues in procedures such as a foram:en:otomyõ where it is
desirable to
decompress an emanating nerve that passes through a stenose:d foramen. The end
effector
having a curved, rigid shaft with or without a Scraping Edge (4,1) may be
capable of
reaching into the foramen and exposing the Window (4.6) to the inside surface
of the
foramen such that the reciprocating cutter 4.2 and/or the scraping edge 4.1
may excise
tissue. The end effector may be utilized in both "open" and percutaneous
surgical
procedures.
103041 Optionally, an end effector or device having a flexible shaft may be
used in the:
tissue excising, scraping or evacuating procedures described above.
103051 In certain variations, a device may include or a method may utilize
a cutter
positioned at the distal end of a flexible shaft that has a preformed or
predetermined
curvature. The shaft may be adapted for insertion into a cannula or sheath
where the distal
end of the shaft may advance from the cannula (by- advancing or retracting the
cannula
andlor the shaft relative to each other) toward a target site and the shaft
may be configured
to allow its predetermined curvature to position the distal end of the shaft
near the target
site, for example, by reverting or beginning to revert to its predetermined
curvature upon
exiting the cannula or Sheath,
103061 The devices described herein include a mechanism powered by a vacuum
source. The devices may be .used for applications where a source of vacuum is
present.
For example, a source of vacuum is frequently available when, medical
procedures are
performed, Many .medical devices utilize a reciprocating mechanism to perform
their
function. The devices described herein may be useful in procedures where
evacuation or
aspiration is necessary and the device may include evacuation or aspiration
features in
combination with a vacuum powered reciprocating mechanism,
[03071 in certain variations, a device using an external or internal vacuum
source to
power a reciprocating mechanism that is connected to a cutter thereby causing
the cutter to
reciprocate may include a "Y" connection within a handle that connects the
vacuum.
source to both the cutter evacuation tube and the vacuum powered mechanism. As
a
result, the vacuum performs several functions within the device, such as:
powers the
mechanism which causes the cutter to reciprocate, draws tissue into a cutting
window such
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that it may be excised, and/or evacuates the excised tissue to a location
external to the
device, while maintainine. a consistent vacuum pressure even when the vacuum
source is
Shut off to the mechanism during reciprocation.
10308] In certain variations, a cutting device implements a pneumatic logic
or a
method utilizes a pneumatic logic to operate a cutting or other reciprocating
device
whereby a vacuum mechanism valve sequence shuts off the vacuum source from the
mechanism to allow a piston to return to its home position without venting the
vacuum
source to ambient pressure. As a result, the vacuum pressure remains
consistent in the
cutting and evacuation system portion of the device.
103091 In certain variations, a method includes maneuvering a flexible
shaft around.
sensitive tissues or structures in the human body by changing the shape of the
shaft by
extending or retracting an outer sheath on the shaft thereby allowing improved
maneuverability of the shaft around structures or within confined spaces. Such
a shaft and
sheath may be incorporated in any of the devices or vacuum powered devices
describe
herein,
[03101 in certain variations, a semi-rigid or rigid outer sheath positioned
over the
flexible curved shaft that is used to change the radius of curvature of the
curved shaft may
be provided. The radius of curvature of the shaft increases when the straight
and rigid
sheath is extended over the curved portion of the shaft, whereas the radius of
curvature of
the shaft returns to its precurved shape when the sheath is retracted from the
curved
portion of the shaft.
103111 In certain variations, an electrically resistive, or bipolar or
monopolar
electrocautery system is included on the distal tip of the shaft that allows
.the physician to
cauterize tissue to control bleeding at the operative site. The eleetrocautery
system may be
powered by wires that .run the length of the shaft through an internal lumen
within the.
shaft,
103121 In certain variations, a cutting device utilizing any of the
variations of vacuum
powered mechanisms described herein results in automatic actuation of a cutter
positioned
on a flexible or rigid shaft, thereby providing a. vacuum powered cutter. The
vacuum
mechanism for actuating the cutter may enable controls to be utilized for
other functions
or functions other than operating the mechanism, thereby reducing the number
of levers or
control buttons on the device. For, example, other controls positioned on the
device may
be utilized for straightening or curving the shaft or for operating or
controlling bipolar
systems for cauterizing,.
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103131 In one variation., the device may include a handle having a trigger.
Actuation.
of the .trigger may cause a cannula o.r sheath positioned over a .flexible
shaft extending
from the handle to either extend or retract, depending on whether the trigger
is pressed or
released. The extension or retraction of the cannula may cause the flexible
shaft to
straighten or curve. The device may include a roller ball, knob or other
control
mechanism for adjusting. or for turning on/off vacuum flow or ambient flow to
thereby
regulate cutting speed. For example, such a knob of roller ball may be
positioned OD the
cutting device such that the knob or roller ball may be manipulated by a thumb
or other
finger on the hand holding the handle of the device or on a free hand of the
user. Thus, the:
cutting device can by used with one hand, freeing up the other hand of the
user or
physician for other uses. A single vac MI111 line may attach to the device,
which both
evacuates excised tissue and powers the mechanism. For example, a "Y"
connection
within the handle of the device may connect the vacuum source to both the
cutter
evacuation tube and the vacuum powered mechanism, where the device maintains
a.
consistent vacuum pressure or force at the cutting window for evacuating
excised tissue
during operation of the mechanism.
[0314] The mechanism according to the variations described herein may
actuate a
cutter automatically by using a mechanism powered by an external vacuum
source. The
external vacuum source may be connected to the device to provide suction to
facilitate
tissue cutting and evacuation, therefore, the use of the external "vacuum
source to power
the cutter is completed without requiring an additional power source such as
electricity,
compressed air, or mechanical input by the operator.
[03151 Because vacuum power is used to actuate the cutter, operator fatigue
.may be
reduced as compared to a system requiring the operator to manually actuate the
reciprocating mechanism such as via button or trigger methanism. Also, the use
of
vacuum to power the cutter actuation may significantly increase the rate at
which the
cutter actuates, thereby reducing the time required to complete tissue
resection.
103161 The use of vacuum power to actuate the cutter may allow the control
for the
rate of actuation to be moved from a. "primary" position such as a trigger or
button to a
"secondary" position on the device handle. As a result, the primary control
may be
utilized to control the rate at which the cutter mechanism actuates or as a
control for the.
radius of curvature of the shaft, or as a control for an electrocautery
system.
103171 A knob, trigger, roller clamp, or other control interfaces may be
used to control
the rate at which the vacuum mechanism reciprocates. These options allow the
device to
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be designed in a. variety of configurations to suit various surgical
specialties. or personal
.preferenoes.
[0318] 'The various pneumatic logic sequences .titilized by the systems
described
herein may optionally maintain high vacuum throughout the engine cycle by
never venting
the vacuum source to the atmosphere. As a result, the vacuum pressure that
facilitates
cutting and evacuation may not decrease while the mechanism reciprocates.
[03191 A single tube from the vacuum source to the device to serve the
functions of
tissue cutting, evacuation and to power the mechanism which actuates the
reciprocating
cutter may be utilized. The single tube from the vacuum source simplifies
connections
required for device operation and reduces the number of tubes attached to the
device
thereby reducing the "clutter" and unwieldiness caused by multiple tubes and
wire
connections to the device.
10320] In certain variations, a second source of vacuum may be provided
such that
separate vacuum sources power the mechanism and provide suction to the distal
end of the
cutting device or end effector for excising and/or evacuating tissue. In
certain variations,
one or more vacuum sources andlor one or more tubes or conduits connecting a
vacuum
source to a device to supply suction to the device and/or to power the device
may be
utilized or provided.
[03211 A cannula may be used on the flexible shaft to change the radius of
curvature
on the shaft in a range from nearly straight to curved in an arc of 180
degrees This allows
the operator to optimize the curvature of the shaft based on the patient
anatomy. The
operator can increase or decrease the force between the shaft and the target
tissue being
excised by extending or retracting the .eannula to increase or decrease the
natural radius of
curvature of the shaft,
[0322] Optionally, an electrically resistive, or monopolor or bipolar
cautery may be
used on the distal tip of the devices described herein to allow the operator
to cauterize
tissue to control, bleeding at the site where tissue has been excised. This
feature obviates
the need to remove the device from the operative site to replace it with an
electrocaery
device. This improves speed and ease-of-use for the operator while reducing,
blood loss
for the patient.
103231 The devices described herein may be manufactured using low cost
components
and assembly techniques; as a result, the cost of the device is much lower
than a similar
device which utilizes an electric motor.
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103241 The devices described herein may have a =relatively low mass and may
be easily
sterilized using commonly .used sterilization techniques such as, e_g_,
electron beam
radiation. gamma radiation, or Ethylene Oxide gas.
10325] Other variations of vacuum powered devices and methods are provided
below.
For example, a medical device may utilize a mechanism powered by an external
source of
vacuum to perform one or more function(s) through reciprocating motion output
by the
mechanism. The device may excise and evacuate tissueõ The device may have a
single.
attachment to an external vacuum source wherein said vacuum provides power to
the
mechanism and assists in excising tissue. The device may have a single
attachment to an
external vacuum source wherein said vacuum provides power to the mechanism and
assists in evacuating tissue. The device may utilize a mechanism that does not
utilize
inertia of mass to transition past valves to change state. The device may not
vent the.
external vacuum source to ambient air at any time during its cycle thereby
causing a drop
in vacuum within the device. The device may include a flexible shaft that has
a preformed
curvature on the distal portion and a straight rigid or semi-rigid cannula
around the outer
diameter of the shaft; the radius of curvature of the shaft may be changed by
sliding the
cannula over the distal curvature whereby the radius of curvature is increased
when the
cannula is extended over the distal curvature and the distal curvature returns
to its'
preformed curvature when the cannula is retracted from the distal curvature.
The device
may include a monopolar electrode or bipolar electrodes on or near the distal
extremity.
The device may have a single connection to an external vacuum source that
powers a
vacuum powered mechanism and evacuates excised tissue. The single connection
to an
external vacuum source may also use vacuum to draw tissue into a cutting
window to
present tissue for the purpose of excising said tissue.
103261 A medical device may include a mechanism powered by an external
vacuum
source wherein said mechanism is comprised of a piston that is set into motion
by creating
differential pressure on either side of the piston wherein one side of the
piston has ambient
air and the air on the other side of the piston is at least partially
evacuated. The
mechanism may include a valve component that opens the volume next to the
Piston
alternately to ambient air or vacuum. The valve component may be actuated as a
result of
translation of the Piston wherein the Piston acts upon the valve to cause it
to open or close
the fluid connections to ambient air or to the external .vacuum source.
[03271 A method for causing a reciprocating mechanism powered by vacuum to
transition past. valves to change states wherein an adequate volume of air has
been.
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evacuated prior to closing. the valve to the external vacuum source such that
the
mechanism continues to move into the evacuated volume such that the .valve
fully
transitions to open the source of vacuum to a different volume may also be
provided.
10328] The method may include the following logic. sequence: Vacuum open to
the
distal side of the Cylinder, ambient is closed to distal; ambient open to
proximal side of
Cylinder, vacuum is closed to proximal; Piston advances toward distal position
due to the
vacuum inside the distal side of the cylinder and ambient pressure on the
proximal side of
the Piston; Piston contacts Shuttle and advances it toward the distal -
position; Vacuum Seal
on Shuttle moves from proximal side of Vacuum Port to the distal side of the
Vacuum Port
while the Distal Seal on the Shuttle opens the ambient air to vent the distal
side of the
Cylinder to ambient pressure and the Proximal Seal on the Shuttle doses the
ambient air
vent to the proximal side of the Cylinder; Piston reverses direction and moves
in the.
proximal direction due to the vacuum inside the Cylinder proximal to the
Piston and
ambient air on the distal side of the Piston; Piston contacts Shuttle and
advances toward
the proximal position; Vacuum Seal on Shuttle moves from distal side of Vacuum
Port to
the proximal side of the Vacuum Port while the Proximal Seal on the Shuttle
opens the
ambient air to vent the proximal end of the Cylinder to ambient pressure and
the Distal
Seal on the Shuttle closes the ambient air vent to the Distal side of the
Cylinder. The
above steps may repeat unless the vacuum source is disconnected, turned off,
or if the
vacuum is inadequate to overcome the force required to move the Piston,
10329] Optionally; the method may include the following logic. sequence:
Vacuum.
open to the distal side of the Cylinder; ambient is closed to distal; ambient
open to
proximal side of Cylinder; Piston advances toward distal position due to the
vacuum
inside the distal side of the cylinder and ambient pressure on the proximal
side of the
Piston; Piston contacts Shuttle and advances it toward the distal position;
Vacuum Seal on
Shuttle shuts off vacuum to the distal. side of the Piston and continues to
move distally
thereby opening the ambient air supply to the distal side of the Piston;
Return Spring
motivates the Piston in the proximal direction due to the equalization of air
pressure on
both sides of the Piston; Piston Shaft contacts Shuttle and motivates it in
the proximal
direction; Shuttle Seal on the Shuffle shuts off ambient air supply to the
distal side of the
Piston and opens the vacuum to the distal side of the Piston. The above steps
may repeat
unless the vacuum source is disconnected, turned off, or if the vacuum is
inadequate to
overcome the force required to move the Piston,
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103301 in another variation, a medical device includes afeciprocating
cutting blade.
such as is used to excise and evacuate tissue that .uses 'a reciprocating
mechanism powered
by an external vacuum source that may be used for medical procedures where a
source of.
vacuum is present.
[03311 in certain variations, any of the mechanisms described herein may
include a
drive shaft or drive piston located in a chamber. The suction may be applied
to both sides
of a drive shaft or drive piston in an alternating manner to cause the drive
shaft or drive
piston to reciprocate between a drive stroke and a return stroke to create a
reciprocating
motion. The mechanism may include a shuttle body or .valve coupled to the
drive shaft by
a linkage or linkage mechanism. The shuttle body or valve may be .moveable
between a
forward and return position, where movement between the forward and return
positions
alternates a fluid path between the chamber and vacuum source so that during
application
of suction or vacuum from the vacuum source movement, of the shuttle body or
valve
causes the drive Shaft to cycle between the drive stroke and the return
stroke.
1J03321 The linkage may couple the drive shaft to the shuttle body or valve
such that as
the drive shaft approaches the end of the drive or .return stroke the linkage
transfers a force
to the shuttle body or valve to assist in switching between the forward and
return positions
and prevents or minimizes unstable flutter of the shuttle body or valve
between the
forward and return positions.
103331 Deformable Linkage
103341 In certain variations of the mechanisms or devices described herein,
a linkage
or hi-stable switch may be manufactured .using various materials that strain
when ..the hi-
stable switch is exposed. to forces from the switch spring coupled thereto.
For example,
the linkage or switch .may be made from plastic or other materials having
similar
properties. The linkage or hi-stable switch may be configured to deform when
in an
unsupported state. The bi-stable switch may be positioned within the chamber
or handle
of the device for storage and shipment such that features or support elements
within the
chamber or handle engage the switch and assume the stress from the switch
spring or
biasing component, thereby relieving the stress from the hi-stable switch. The
device may
be configured such that after use, the hi-stable switch stops in. a position.
where the hi-
stable switch is not engaged with the support elements and not relieved of
stress from the
switch spring. As a result, the hi-stable switch is exposed to strain or
stress from the
switch spring or biasing component, which causes the linkage or switch to
deform to a
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degree that the hi-stable switch no longer functions at some period of time
after it is used,
The deformed hi-stable switch may prevent re-use of the device, e.g., such
that the device
is suitable for single use.
10335] In certain variations, a medical device having a vacuum powered
mechanism as
described herein may include support elements or features for supporting a
linkage or bi-
stable switch of the mechanism, Figures BA-I3B show an example of a medical
device
including a linkage or bi-stable switch 720 coupled to a drive piston or drive
shaft 721 and
shuttle body or valve 722 of a mechanism and positioned in a chamber or handle
725 of a
cutting device. The chamber or handle 725 of the medical device includes a
posterior
support rib 726. The Posterior support rib 726 may be located inside the
Chamber or
handle 725 of the device and the posterior support rib 726 may support the
posterior arm
727 of the linkage or Switch component 720 while the device is in storage or
during
shipment, prior to use. The posterior support rib 726 prevents the posterior
arm 727 of the
linkage or Switch component 720 from deforming as a result of plastic creep
due to stress
from the Switch Extension Spring 723 on the linkage or switch 720.
[03361 The chamber or handle 725 of the medical device may also include an
Anterior
Support Rib 728. The anterior support rib 728 may support the anterior arm 729
of the
linkage or Switch component 720 while in storage or shipment, prior to use.
The anterior
support rib 728 prevents the anterior arm 729 of the linkage or switch
component 720
from deforming as a result of plastic creep due to stress from the Switch
Extension Spring
723 on the linkage 720.
10337] Figures 13C and 131) are zoomed in cross sectional views showing the
linkage
or bi-stable switch 720 coupled to a drive piston or drive shaft and shuttle
body (not
shown) of a mechanism and positioned in a. chamber or handle of a cutting
device. The,
mechanism includes a Drive Piston Chamber 730 which is a cavity or lumen
within the
mechanism wherein the Drive Piston reciprocates. An End Cap 731 is assembled
to the
ends of the mechanism body (732) to enclose the Drive Piston Chamber (730).
The
mechanism body 732 encloses the Drive Piston Chamber (730) and serves as an
attachment point for the linkage or Switch component 720.
10338] Figure 13C, shows the Posterior Ann 727 of the linkage or Switch 720
as it is
supported by the Posterior Support Rib (726) while in storage or during
shipment. Figure
13C shows the Anterior Arm 729 of the linkage or Switch 720 as it is supported
by the
Anterior Support Rib (728) while in storage or shipment.
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[03391 Figure I3D shows the posterior arm 727 unsupported and subject to
plastic
creep and deformation As a result of stress from the Switch Extension Spring
(not shown),
Figure 13D shows the anterior arm 729 unsupported and subject to plastic creep
and
deformation as a result of stress from the Switch Extension Spring (not
shown). In figure
I 3D, the switch 720 is in a stopped position after use of the device.
103401 The linkage or switch may include a Switch Component Hinge 733. The
switch component hinge 733 is a flexible portion of the Switch Component 720
that
allows the Anterior Arm 729 of the Switch and the Posterior Arm 727 of the
Switch to
change positions between the positions shown in figures 13C and 13D.
[03411 In certain variations, the linkage or switch may include a
protrusion or notch to
engage the ribs or features of the device such that the ribs or features
provide support to
the switch in a stored or pre-use state. After use, the switch may be stopped
in a position
where the switch is disengaged from the ribs or features, such that the force
imparted by
the spring switch on the spring causes deformation of the switch. After use,
the cutter may.
be stopped in an open or proximal position, and the switch may be disengaged
from the
ribs or support features.
10342] in certain variations, the linkage or bi-stable.switch may be made
from a
copolymer or other material, The flex modulus of the copolymer or material of
the switch
or linkage may vary, e_g., in certain variations it may have a flex modulus in
the range of
about 150,000 to about 210,000. Various materials having higher or lower flex
modulus
may be used to create stronger or weaker switches. Depending on the strength
of the
switch, the device may be operable for single use or multiple uses_ For
example, the
device may be operable for 1-.2 days after initial use for a weaker switch or
for 3-5 days to
months after initial use for a stronger switch. The switch may no longer
function after
some time after its initial use. 'The deformable linkage or switch arrangement
described
herein may be utilized with a vacuum powered mechanism (e_g., such as the
mechanisms
described herein) which may be used .to operate various medical devices and to
actuate mi
operable element of a medical device. A method of preventing reuse or for
providing a
certain, number of use of a vacuum powered device described -herein may
include
providing a deformable linkage or switch which deforms in an unsupported or
strained
position to render the mechanism inoperable.
[03431 Malleable Elongate Shaft Variation
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[03441 In certain -variations of the -various cutting devices described
herein, the
evacuation shaft located -proximal to the Cutter and positioned in the
elongate shaft and/or
outer malleable shaft may have a variable diameter to improve tissue
resection. For
exampleõ the diameter may be optimized to increase evacuation and resection
rates. The
diameter .may be optimized to prevent kinking or collapsing when the
evacuation shaft is
curved. The diameter may be optimized to prevent increased friction between
the
evacuation shaft and a lumen of the elongate shaft or outer malleable shaft,
which lumens
may decrease in diameter upon bending. The diameter of the evacuation shaft
may be.
smaller in sections that may be bent or curved or are located in portions of
the elongate
shaft or outer malleable shaft that are bent or curved. The diameter of the
evacuation shaft
may be larger in sections that are located in portions of the elongate shaft
or outer
malleable shaft that are not bent or that remain straight, where a larger
diameter may help
improve the tissue evacuation rate and/or tissue resection rate. Optionally,
the evacuation
shaft or lumen may have a constant diameter having the same size throughout
the shaft to
improve resection and/or evacuation rates.
[03451 Figures 14A-14F show various views of a variation of an elongate
shaft 809 for
use with any of the cutting, devices described herein. The elong.ate shaft 809
includes a
cutting window (810) near the distal extremity of the elongate shaft 809. The
elongate
shaft 809 may also include an outer malleable shaft or Metal Shaft (820),
Outer Sheath
(817), Cutter (818), Evacuation Shaft (821) and irrigant lumen 814..
10346] The Cutting Window 810 includes an opening in the elongate Shaft
(809) that
fluidly communicates with the .external source of suction via the Evacuation
Lumen (815)
of evacuation shaft 821.. Suction applied from an external suction source
draws tissue and
fluids into the Cutting Window (810) where it may 'be excised by the Cutter
(818) and/or
evacuated through the Evacuation Lumen (815).
10347] The elongate shaft may extend from or be coupled to a Device Body
811. The
Device body 81.1 serves as housing for the mechanism, .irrigant conduit, and
Evacuation
Lumen, and may also serve as a handle for the operator of the device. A
Trigger 812 is
provided on the device body 811, The trigger 812 may be actuated by the
operator to
Start/Stop actuation of the device and the Cutter 818 õNn external suction
port 813 may
extend from the device body 811 and serves as a connection port to a source of
.extemal
suction.
[0348,1 The Outer Sheath 817 may he flexible and may provide a covering
around or
on the outer malleable shaft or Metal Shaft ($20) and encloses openings in the
Metal Shaft
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(820) such as the Bending Slits (819). The metal shaft 820 is a malleable
shaft that
provides structure to the elongate Shaft (809), For example, the metal shaft
820 may be a
stainless steel annealed shaft. Bending Slits 819 may be cut into the Metal
Shaft (820) to
enable the elongate Shaft (809) to be bent, twisted, manipulated or shaped
such that the
shaft can be moved into a variety of configuration to access an anatomy of a
patient and to
reach various anatomical locations within the patient. The Outer Sheath 817
may include
one or more lumens (e.g., duel lumens). A lumen may hold the outer malleable
shaft or
metal shaft 820. The Outer sheath 817 may also include an irrigant Lumen
(814). The
figures depict a transparent Outer Sheath, e.g., made from PEBAX, but other
materials,
e.g., flexible materials, may be utilized and/or the outer sheath may not be
transparent.
103491 An irrigant lumen 814 may run through the Outer Sheath (817). The
irrigant
lumen 814 provides fluid communication between a source of irrigant and the
litigant Port
(81). The Irrigam Port 816 serves as an opening in the Metal Shaft (820) that
allows
irrigant to fluidly communicate between the Irrigant Lumen (814) and the
Evacuation
Lumen (815) and/or to the site of cutting. in an alternative variation,
irrigant may be
allowed to flow in the space between the Evacuation Shaft (821) and the Metal
Shaft
(820), to the evacuation lumen and/or the site of cutting.
103501 An Evacuation Shaft 821 may be a flexible component positioned
within the
outer malleable shaft or Metal Shaft (820). The Evacuation shaft 821 may be
connected to
the Cutter (818) at its distal extremity. The evacuation shaft 821
reciprocates from the
motion of the vacuum powered mechanism and causes the Cutter (818) to
reciprocate past
the Cutting Window (810) to excise tissue that enters the Cutting Window
(810). The
Cutter (818) has a sharpened distal edge to cut tissue that is drawn into the
Cutting
Window (810). The lumen within the Evacuation Shaft (821) is the Evacuation
Lumen
(815). The Evacuation Lumen (815) may provide fluid communication between the
Cutting Window (810) and an external source of suction,
103511 The evacuation shaft may optionally have a variable diameter or
bumped
lumen as described above, where the diameter of the evacuation shaft and/or
lumen is
increased or larger in sections where curving of the evacuation shaft is not
performed or is
less necessary and the diameter of the evacuation shaft and/or lumen is
decreased or
smaller in sections where curving or bending is performed or is necessary, to
optimize or
increase the rate of tissue evacuation and/or the resection rate. Optionally,
the evacuation
shaft or lumen may have a constant diameter having the same size throughout
the shaft. In
certain variations, the elongate shaft may be rotatable relative to the handle
or chamber to
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which the elongate shaft is .coupled. The handle or chamber may include
features for
limiting the degree of rotation of the elongate shaft, For example, the degree
ofrotation
may be limited to ninety degrees in either direction or one hundred and eighty
degrees.
103521 Filter mechanism.
103531 In any of the various medical devices described herein, a
filtermechanism may
be utilized for collecting or -filtering resected or cut tissue.
[0354] in certain variations, a filter mechanism may include a filter body
and a filter
lid. The filter body may include one or more tissue collection chambers, a
bypass
chamber and an exit port that serves as a connection point for the external
source of
suction. The filter lid mar have two attachment points or ports for connecting
tubing or a
conduit. One attachment or port is located in a position such that fluid
continuously flows
through the filter lid and the filter body bypass chamber regardless of a
filter lid (switch)
position. This may be useful for connecting a section of tubing or conduit to
perform a
function that does not need the fluid medium to be filtered such as a
connection to a
vacuum powered motor or mechanism.
[0355] The other attachment port may be located in a: position such that it
can be
moved over a bypass chamber or a collection chamber. The filter lid may be
moved
relative to the filter body to position tubing or conduit carrying excised
tissue to any of the
chambers in the filter body. When the tubing port carrying the excised tissue
is positioned.
over the bypass chamber, the tissue and fluid medium flow through the bypass
chamber
and exit the device through the suction connection port.
103561 When the tubing port carrying excised tissue is positioned over one
of the
collection chambers, the fluid. medium passes through the filter and into the
bypass
chamber and then exits the device through the suction connection port. The
tissue remains
in the collection chamber where it may be collected for subsequent analysis.
[03571 Upon completion of the procedure, the filter mechanism, including
the filter lid
and filter body may be removed from the device. The tubing connections can be
separated
from the filter lid and render the device inoperable by making reassembly (and
consequently, re-use) prohibitively difficult.
[0358] Optionally, the filter mechanism may be filled with tissue
preservative, e.g.,
such as formalinõ either by removing the filter lid from the body component,
or by
injecting the preservative through an opening in the filter mechanism. Plugs
may be
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placed in the tubing ports in the filter lid and in the exit port to prevent
the tissue
preservative from leaking out of the filter mechanism.
103591 'The filter lid or other portion of the filter body may have
features to store the
plugs until they are ready for use. The filter lid may be removed from the
filter body to
expose a plurality of chambers to extract tissue from the tissue filter
chamber for analysis_
1J03601 The filter mechanism may have provisions to label the contents of
the tissue
collection chambers with information such as patient name, date of collection,
and the
anatomical location that was sampled or type of tissue.
103611 The tissue filter mechanism may be removed from a tissue resection
device and
used as a container to send tissue samples to a laboratory for analysis.
103621 The filter mechanism may be integrated in or coupled to a vacuum or
suction
powered medical device or tissue resection or cutting device, such as the
devices described
herein. The filter mechanism may also be integrated in or coupled to other
medical
devices, such as cutting or resecting devices, which are powered by
electrical, pneumatic
or other power sources.
[03631 Figures 15A-15F show one variation of a filter mechanism integrated
into a
microdebrider or tissue cutting or resection device 913. The Filter Mechanism
(912) may
include two primary components; Filter Lid (907) and Filter Body (901).
1J03641 The filter mechanism 912 includes a filter body 901. The filter
body 901 may
include at least one tissue collection chamber (902), a bypass chamber (903),
a suction
connection port (904) and a filter or filter slits 906. The filter body 901
may include
markings (905) to help identify the contents of the tissue collection
chambers.
103651 Tissue and/or fluid conduction medium may flow into the tissue
collection
chamber 902 The tissue may be stopped by the filter slits 906 while the fluid
conduction
medium is able to flow into the bypass chamber 903 where it exits the device
through the
suction connection port 904. Tissue collects in the tissue collection chamber
902 where it
may be subsequently removed for analysis.
1103661 Tissue and fluid that flow into the bypass chamber 903 flow
unabated through
the suction connection port (904). Fluid may flow into the bypass chamber 903
directly or
from the tissue collection chamber 902 through the filter slits (906).
103671 The Suction Connection Port (904) serves gs the connection point for
the filter
to the source of suction or vacuum. Tissue and/or fluid passes through the
Suction
Connection Port 904 toward the suction source from the Bypass Chamber (903).
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103681 A filter or Filter Slits (906) separate the tissue collection
chamber (902) fiom
the bypass chamber (903) and serve to prevent the passage of tissue from the
filter
collection chamber (902) into the bypass chamber (903) while allowing fluid to
pass_
10369] The filter mechanism includes a Filter Lid (907) which provides a
fluid-tight
cover for the Filter Body (9(fl) to contain fluid andior tissue within the
Filter Body (901).
The Filter lid includes one or more ports or openings. The Filter Lid 907 may
have a
Motor Supply Opening (908), a Tissue Evacuation Opening (909), one or more,
e.g., two,
Dual Plug Retention Features (910), and a Suction Connection Plug Retention
Feature
(910), The Filter Lid (907) may be rotatable relative to the Filter Body (901)
to position a
tissue evacuation port or opening 909 adjacent to either the bypass chamber
(903) or the
tissue collection chamber (902). .A Filter Lid Control Tab (91.4) may be used
as a control
surface for the operator or other mechanism to rotate the Filter Lid 907
relative to the
Filter Body 901.
103701 The Motor Supply -Opening (908) serves as an opening through the
Filter Lid
(907) between the Bypass Chamber (903) and a conduit that communicates with
the
vacuum or suction powered motor or mechanism of a device. The motor supply
opening
908 is located at or near the center of the Filter Lid (907), therefore, the
position of the
Motor Supply Opening 908 does not change relative to the Bypass Chamber (903),
even
when the lid is rotated. As a result, the air flowing from the vacuum or
suction powered
motor does not flow through a filter, rather, the air always freely flows
through the Bypass
Chamber (903) and exits the device through the Suction Supply Port (904).
10371] The Tissue Evacuation Opening (909) is an opening through the Filter
Lid
(907) which serves as a connection port between a conduit that fluidly
communicates with
the distal cutting mechanism to evacuate tissue and the filter body chambers.
The Tissue
Evacuation Opening (909) moves relative to the Filter Body (901) as the Filter
Lid (907) is
rotated by the operator thereby positioning the Tissue Evacuation Opening 909
over either
a Tissue Collection Chamber (902) or a Bypass Chamber (903).
1103721 The filter lid 907 may include one or more filter Plug Retention
Features (910)
which serve to retain one or more Filter Plugs (911) until ready for use to
plug the
openings in the Filter Mechanism (912) or filter lid 907, once the filter
mechanism is
removed from the device.
103731 Filter Lid Plug (911) may be used to close openings in the Filter
Mechanism
(912) or filter lid 907 to provide a fluid tight seal.
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[03-741 In certain variations, the =microdebrider or:resection device 913
may be
powered by a vacuum source or source of suction as described herein, In
certain
variations, the microdebrider or resection device may be powered solely by a
vacuum
source or source of suction without the need for another power source.
103751 in certain variations, a microdebrider or cutting device may include
an
integrated tissue filter mechanism wherein the removal of the filter mechanism
disables
the device and renders re-assembly of the device to be prohibitively difficult
and thereby
preventing re-use of the device,
103761 In certain variations, a microdebrider or cutting device may include
an
integrated tissue filter mechanism wherein a single source of suction is
connected to the
microdebrider or cutting device and two conduits are connected to the tissue
filter
mechanism, where one conduit communicates with a .motor or mechanism that is
powered
by a source of suction or vacuum and the second conduit communicates with a
cutting
mechanism for the purpose of evacuating excised tissue,
103771 The contents of US patent application having the attorney docket
number
LIZMD-N-Z014,00-US and filed on January 4,2013 and U.S. Patent Application No.
61,597,642 are hereby incorporated by reference in their entirety. In certain
variations,
any of the filter mechanisms and/or other features described herein may be
incorporated in
or utilized with any of the devices or methods described herein or in the
patent
applications referenced. herein,
10378] The above arrangements, materials, and dimensions for the vacuum
powered
mechanisms described herein are exemplary and are not intended to be limiting,
103791 Each of the individual variations described and illustrated herein
has discrete
components and features which may be readily separated from or combined with
the
features of any of the other variations. Modifications may be made to adapt a
particular
situation, material, composition of matter, process, process act(s) or step(s)
to the
objective(s), spirit or scope of the present invention.
1103801 Methods recited herein may be carried out in any order of the
recited events
which is logically possible, as well as the recited order of events.
Furthermore, where a
range of values is provided, every intervening value between the upper and
lower limit of
that range and any other stated or intervening value in that stated range is
encompassed
within the invention. Also, any optional feature of the inventive variations
described may
be set forth and claimed independently, or in combination with any one or more
of the
features described herein.
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103811 Ml existing -subject matter mentioned herein (e.lp, publications,
patents, patent
applications and hardware) is incorporated by reference herein in its entirety
'except
insoar as the subject matter may conflict with that of the present invention
(in which case
what is present herein shall prevail). The referenced items are provided
solely for their
disclosure prior to the filing date of the present application. Nothing herein
is to be
construed as an admission that the present invention is not entitled to
antedate such
material by virtue of prior invention..
[0382] Reference to a singular item, includes the possibility- that there
are plural of the
same items present. More specificallyõ as used herein and in the appended
claims, the
singular forms "a," "an," "said" and "the" include plural referents unless the
context
clearly dictates otherwise. It is further noted that the claims may be drafted
to exclude any.
optional element. As such, this statement is intended to serve as antecedent
basis for use
of such exclusive terminology as "solely," "only" and the like in connection
with the
recitation of claim elements, or use of a "negative" limitation. Unless de-
fined otherwise,
all technical and scientific terms used herein have the same meaning as
commonly
understood by one of ordinary skill in the an to which this invention belongs,
[0383] This disclosure is not intended to be limited to the scope of the
particular forms
set fbrth., but is intended to cover alternatives, modifications, and
equivalents of the
variations described herein. Further, the scope of the disclosure fully
encompasses other
variations that may become obvious to those skilled in the art in view of this
disclosure.
The scope of the present invention is limited only by the appended claims.
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