Note: Descriptions are shown in the official language in which they were submitted.
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STEERABLE VASCULAR SHEATH
CROSS-REFERENCE TO RELATED APPLICATION
This application is a continuation-in-part of U.S. Patent Application No.
10/832,867, filed April 26, 2004 and claims benefit of U.S. Provisional
Application
No. 60/579,500, filed June 14, 2004, the entire disclosures of which are
hereby
incorporated by reference as if set forth in full herein. U:S. Patent
Application No.
10/832,867 is a continuation-in-part of U.S. Patent Application No.
10/766,138,
filed January 28, 2004 and 10/298,116, filed November 15, 2002, and claims
benefit of U.S. Provisional Application No. 60/465,310, filed April 25, 2003,
the
entire disclosures of which are hereby incorporated by reference as if set
forth in
full herein.
BACKGROUND
The present invention generally relates to surgical access devices and,
more specifically, to sheaths that are steerable and applicable in vascular
procedures.
Sheaths and catheters have long been used to access body conduits such
as the arterial and venous branches of the vascular system, urinary tract,
body
cavities such as the thorax and abdomen, and hollow viscous organs such as the
stomach, intestines and urinary bladder. More specifically, sheaths and
catheters
have been used for fluid delivery, fluid recovery, implant delivery and for
providing an access pathway for an instrument such as an endoscope. However,
many endoscopes, for example, are flexible enough to bend but are not
steerable
or deflectable in a controlled and/or dynamic manner. As such, there is a
desire
in the art for a steerable access sheath that is able to perform intricate
manipulations through vessels, body cavities and/or tissue.
For some instruments, steering has been achieved, for example, by "pre-
bending" the distal tip of a surgical device before insertion and then
rotating the
device once it has been inserted and has reached a branch artery inside the
body. If the angle of the bend has to be adjusted, then the device may have to
be removed, re-bent and reinserted. This may result in greater time spent in
the
body and thereby increase surgery time. Furthermore, since these sheaths and
catheters navigate many hard-to-reach areas, it may be desirable that these
devices be stiff and yet as flexible as possible. It may also useful that the
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sheaths and catheters are constructed with thin walls to minimize the diameter
of
the device and to maximize the radii of the internal lumen.
If the access sheath is constructed with a thin wall made of a plastic or
rubber material, the sheath may bend or twist during use. This may result in
potential damage as the sharp edge of the kinked sheath may allow an
endoscope or other device to complicate the surgical procedure. Moreover, a
bent or kinked sheath may be useless because it cannot communicate and it may
not allow the passage of an instrument. As such, there is a desire in the art
for a
steerable access sheath that is durable enough to provide sufficient strength
and
stiffness to be guided through a body cavity or tissue and, at the same time,
be
flexible enough to perform intricate manipulations through the body cavity or
tissue.
SUMMARY
A surgical access device or a vascular surgical access device, is provided
having an elongate body with at least one steerable region. The elongate body
also has a proximal end, a distal end and a lumen extending through the body
and sized and configured to be inserted into a blood vessel. The device also
comprises a tensioning device extending through the elongate body and
connected to the at least one steerable region of the elongate body and an
actuator connected to the tensioning device distally from the proximal end of
the
elongated body to control tension of the tensioning device to navigate the
elongate body through a circulatory system. The tensioning device may be made
of a kink resistant material such as Nitinol, a braided cable or any flexible
strand
or wire. The actuator may include a control knob to control the tensioning or
loosening of the tensioning device.
In one aspect, a vascular surgical access device is provided comprising a
tube having a proximal end, a distal end, a steerable region, and an enlarged
entry with the tube having a primary lumen and a first and second secondary
lumen both extending through the tube. The device also has a first tensioning
device connected to the steerable region and extending through the first
secondary lumen and a second tensioning device connected to the steerable
region and extending through the secondary lumen. An enlarged entry extending
from the distal end of the tube forming a transition into the primary lumen of
the
tube from an exterior of the tube and a movable actuator disposed about the
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enlarged entry and connected to the first tensioning device and the second
tensioning device and configured to rotate in one direction causing movement
of
the first tensioning device and rotate in an opposite direction causing
movement
of the second tensioning device are also provided. The steerable region may be
deflected or steered through the action of the tensioning device, such that a
pull
wire imparts a pulling force on the steerable region of the tube, thereby
causing
the steerable region to deflect.
In another aspect, a vascular surgical access device comprises an
elongate tube having a proximal end, a distal end, a steerable region, and an
enlarged entry. The elongate tube has a lumen extending through the elongate
tube and is configured to operate in through femoral arteries, iliac arteries
and
uterine arteries. Tensioning means, e.g., a pull wire, is connected to the
steerable region and extends through the lumen and actuator means, e.g., an
hand-piece, is connected to the tensioning means and is configured to cause
movement of the tensioning means to cause movement of the steerable region.
Many of the attendant features of this invention will be more readily
appreciated as the same becomes better understood by reference to the
following detailed description and considered in connection with the
accompanying drawings in which like reference symbols designate like parts
throughout.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 illustrates a surgical access device or steerable access sheath in
accordance with one aspect of the invention;
FIG. 2 is a cross sectional view of the access device of FIG. 1;
FIG. 3 illustrates a dilator in accordance with one aspect of the present
invention;
FIG. 4 illustrates a surgical access device or steerable access sheath in
accordance with one aspect of the present invention;
FIG. 5 illustrates a surgical access device or steerable access sheath in
accordance with another aspect of the present invention;
FIG. 6 illustrates a surgical access device or steerable kink resistant
access device in accordance with one embodiment of the present invention;
FIG. 7 is a front view of the distal end of the access device of FIG. 6;
FIG. 8 is a rear view of the proximal end of the access device of FIG. 6;
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FIG. 9 is an enlarged side view of the distal portion of the access sheath
of FIG. 6;
FIG. 10 is a side-section view of the distal portion of the access sheath of
FIG. 9;
FIG. 11 illustrates a steerable kink resistant access device of the present
invention with its distal portion deflected;
FIG. 12 is a top view of the distal portion of the access sheath of the
present invention;
FIG. 13 is a bottom view of the distal portion of the access sheath of the
present invention;
FIG. 14 illustrates the atraumatic distal end of the access sheath of the
present invention;
FIG. 15 illustrates an actuator of the access device of the present
invention used to control the steerable region or portion of the access
sheath;
FIG. 16 illustrates the access device of the present invention guiding a
scope into a kidney pole;
FIG. 17 illustrates a perspective view of the distal portion of an access
sheath having a flattened tensioning member;
FIG. 18 illustrates a perspective view of an actuator or actuation hand-
piece in accordance with another embodiment of the present invention;
FIG. 19 is a side view of the actuation hand-piece of FIG. 18;
FIG. 20 illustrates a perspective view of an actuation hand-piece of the
invention including a directional indicator showing the direction of
deflection or
bending of the access sheath;
FIG. 21 illustrates another perspective view of an actuation hand-piece of
the invention including a directional indicator;
FIG. 22 illustrates a side-elevation view illustrating a spring embodiment of
the tube associated with the sheath of the present invention;
FIG. 23A illustrates a side view of an actuation hand-piece in accordance
with one embodiment of the present invention; .
FIG. 23B illustrates a perspective view of an actuation hand-piece in
accordance with one embodiment of the present invention;
FIG. 24 illustrates a cross-sectional view of the actuation hand-piece of
FIGS. 23A-B;
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FIG. 25 illustrates a perspective view of an actuation hand-piece in
accordance with one embodiment of the invention;
FIG. 26A illustrates a top view of a disassembled actuation hand-piece of
FIG. 25;
FIG. 26B illustrates a cross-sectional view of the actuation hand-piece of
FIG. 25;
FIG. 27 illustrates a perspective view of an actuation hand-piece in
accordance with one embodiment of the invention;
FIG. 28A illustrates a cross-sectional view of the actuation hand-piece of
FIG. 27;
FIG. 28B illustrates a perspective view of a disassembled actuation hand-
piece of FIG. 27;
FIG. 29 illustrates a perspective view of an actuator or actuation hand-
piece in accordance with one embodiment of the invention;
FIG. 30 illustrates a cross-sectional view of the actuation hand-piece of
FIG. 29;
FIG. 31 illustrates a perspective view of an actuation hand-piece in
accordance with one embodiment of the present invention;
FIG. 32 illustrates a perspective view of an actuation hand-piece in
accordance with one embodiment of the present invention;
FIG. 33A illustrates a side view of an actuator or actuation hand-piece in
accordance with one embodiment of the invention;
FIG. 33B illustrates another side view of the actuation hand-piece of FIG.
33A;
FIG. 34 illustrates a perspective view of an actuation hand-piece in
accordance with one embodiment of the present invention;
FIG. 35 illustrates a cross-sectional view of a connector in accordance
with one embodiment of the present invention;
FIG. 36 illustrates a cross-sectional view of the actuation hand-piece of
FIG. 34;
FIGS. 37A-B illustrate perspective views of a disassembled actuation
hand-piece in accordance with one embodiment of the present invention;
FIGS. 38A-B illustrate other perspective views of the disassembled
actuation hand-piece of FIGS. 36A-B;
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FIG. 39 illustrates a cross-sectional view of the actuation hand-piece of
FIG. 37;
FIG. 40 illustrates a perspective view of an actuation hand-piece in
accordance with one embodiment of the present invention;
FIGS. 41A-B illustrate cross-sectional views of the actuation hand-piece of
FIG. 40;
FIGS. 42-43 illustrate perspective views of embodiments of components of
the actuation hand-piece of FIG. 40;
FIG. 44 illustrates a view of an actuation hand-piece in accordance with
one embodiment of the present invention;
FIG. 45 illustrates a perspective view of an actuation hand-piece in
accordance with one embodiment of the present invention;
FIG. 46 illustrates a perspective view of an actuation hand-piece in
accordance with one embodiment of the present invention;
FIG. 47A illustrates a perspective view of an actuation hand-piece in
accordance with one embodiment of the present invention;
FIG. 47B illustrates a perspective view of one embodiment of components
of the actuation hand-piece of FIG. 47A; and
FIG. 48-51 illustrate cross-sectional views of embodiments of an access
sheath in various stages of fabrication in accordance with the present
invention.
DETAILED DESCRIPTION
In FIGS. 1-4, the steerable access sheath 80 includes an elongate body
81 and, in one embodiment, a funnel or tapered entry 83. The elongate body 81
is substantially or completely steerable and may have a variable stiffness or
flexibility or is fully pliable. The outside diameter of the elongate body is
also
sufficiently small so that it may be inserted into a reduced or minimally
sized body
cavity or conduit, e.g., a vein or artery.
The access sheath 80 further 'includes a primary lumen 84 and a
secondary lumen 85 both extending through the elongate body 81. The primary
lumen 84 is sized and configured to provide an access pathway to a surgical
site
or a target site for the surgical procedure. For example, primary lumen 84
provides a conduit to advance a surgical instrument, e.g., a dilator, or
diagnostic
and therapeutic elements, e.g., a contrast agent, to the surgical or target
site.
The secondary lumen 85 is sized and configured to contain a tensioning device
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86 such as a control or pull wire that, when acted upon, will deflect the
elongate
body 81 of the access sheath 80. In one embodiment, a secondary lumen is not
utilized and thus the tensioning device 86 is directly included with the
access
sheath 80. For example, the tensioning device 86 may be secured to the access
sheath or primary lumen and extend along the length of the access sheath or
primary lumen to provide sufficient deflection of the elongate body 81 of the
access sheath 80 via the tensioning device 86. In one aspect, tensioning
device
86 may be embedded in the wall of the access sheath 80 and/or the primary
lumen 84.
The tensioning device 86 extends through the secondary lumen 85 and is
attached to an actuator 87 at one end and to a distal portion of the elongate
body
81 at the other end. The actuator 87 may include a thumb-actuated knob, a
ring,
as illustrated, or another type of device to control the tensioning device 86.
As
shown, a ring connected to a pull wire may be drawn proximally to provide
tension to the tensioning device 86. When the ring is released, the pull wire
moves distally to loosen tension or cause the tensioning device 86 to loosen
to
allow the access sheath to straighten or return back to a previous or initial
form.
As such, by manipulating the actuator 87, a user can steer the access
sheath 80 to navigate circuitous or torturous conduits or cavities within the
body
to access the surgical site or point of interest. Additionally, the access
sheath via
the primary lumen provides a conduit or a channel from outside the body to the
point of interest for the insertion and withdrawal of instruments, tissue or
other
items used for or in conjunction with the surgical procedure.
It is appreciated that the actuator 87 may resemble, emulate, embody or
otherwise incorporate the actuation hand-pieces described in previous or the
following embodiments and may be in-line, offset or remote from the access
sheath. Additionally, the access sheath may comprise a plurality of pull wires
attached to a plurality of thumbwheels, axles, knobs or other types of movable
components of an actuator or actuation hand-piece to deflect the access sheath
in one or more different directions.
In one particular embodiment, the funnel-shaped entry 83 is sized and
configured to guide a dilator, an obturator and/or other instrumentation into
a
working channel to form a transition into the primary lumen of the access
sheath
80. The funnel-shaped entry also includes or is connected to a connector to
provide a conduit that connects the secondary lumen and tensioning device 86
to
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the actuator 87. In one embodiment, the entry 83 includes or is connected to a
valve, such as a zero and/or septum valve, which is fixed or floats. The valve
may also include deformable material, construction, gel or any combination
thereof to form a seal around instruments and the like inserted in to the
entry or
to seal the entry after or prior to instruments and the like being removed or
inserted in the entry 83.
The access sheath 80 and various embodiments of access sheaths and
actuators or actuation hand-pieces previously described, here now referred to
as
the access sheath, in accordance with one aspect of the invention is
applicable in
vascular procedures and in other procedures among other fields, such as
cardiology, urology, radiology, electrophysiology and gastroenterology. For
example, in interventional radiology or interventional nephrology in which
guided
imaging is utilized, the access sheath 80 being steerable and appropriately
sized
assists in the placement of instruments, solutions or agents used in these
procedures.
In one embodiment, the access sheath is combined with an instrument or
device used to stretch or enlarge an opening, e.g., a dilator, which allows
for
gradual and atraumatic dilation of the artery or vein while the access sheath
is
being placed. Once the access sheath has been placed at a desired location,
the
dilator is removed and the access sheath is left in place. The access sheath
allows for continued access to the desired area, for example, for the
placement of
surgical and/or therapeutic instruments or agents, while providing protection
of
the vessel. Continuous access provided by the access sheath may also reduces
the need to re-locate a site or vessel. Additionally, with the access sheath
being
deflectable or steerable, the user may effectively and efficiently navigate
the
intricate and sometimes extensive circulatory system. As such, placement of
instruments through the primary lumen of the access sheath at or proximal the
operation site can be achieved by dynamically steering and/or continuously
steering the access sheath.
In another embodiment, the access sheath being steerable provides direct
and proximal vascular access to circulatory vessels or specific organ or
tissue to
ensure that healthy blood flow or the ability to deliver therapeutic agents is
maintained. For example, for hemodialysis, regular vascular access to
circulatory
system can be provided by the access sheath or for cancer, chemotherapy via
vascular access to the circulatory system can be provided by the access
sheath.
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The access sheath may also be useful in diagnostic radiography, which
confirms the presence of an occlusion of vessels, e.g., lesion or thrombus
formations. When performed at or near junction of an artery and a vein, such
as
a fistula, directing the contrast agent utilized such that the agent flows
towards
the downstream vessels of interest may be difficult. By deflecting or changing
the
shape of the access sheath to conform to the shape of the vessel(s), the
access
sheath allows the contrast agent to be directed in the antegrade flow of the
artery
and/or vein.
In one aspect, an access sheath 80 with a long length, e.g., over 100
centimeters, may also be useful for specific surgical, therapeutic or
diagnostic
procedures for various diseases or conditions, e.g., embolization and in
particular, uterine fibroid embolization. The access sheath being able to have
a
long length does not restrict the path taken to reach the tissue, vessel or
area of
interest. The steerable access sheath 80 also eases the navigation of the
circuitous path from the femoral arteries, the iliac arteries to the uterine
arteries.
For example, by deflecting the access sheath 80 making the turn, bend or
course
change from one artery to another, e.g., from the iliac to the femoral artery
or
from the femoral artery to the uterine artery, is made easier. With the access
sheath placed at or near the area of interest, the primary lumen provides the
conduit for the insertion of agents, e.g., biocompatible occlusion particles,
or
other treatment or diagnostic agents, solutions or devices.
The primary lumen of the access sheath 80 can also provide a fixed size
to accommodate or overcome limitations imposed by the length of the surgical
instrument to be inserted, the size of a vessel relative to the instrument
and/or the
blood flow around the instrument. In one embodiment, the distal end of the
access sheath is tapered and thus has a smaller diameter than the proximal end
of the access sheath. The primary lumen and secondary lumen diameters,
however, remain substantially constant throughout the access sheath.
In one embodiment, one or more coated wires are wound around the
inner/outer periphery of the access sheath; the primary lumen and/or any
combination thereof to strengthen the access sheath, such that a flexible, pre-
bendable or otherwise not actively controllable instrument may be controllably
deflected dynamically as the access sheath is controlled. Additionally, an
actively
deflectable surgical instrument may have a complicated construction providing
components, e.g., optics or clamps, to perform its surgical function and
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components to perform the active deflection. Therefore, such instruments may
be fragile or if broken may be expensive to replace or repair or still usable
as a
surgical instrument but not actively deflectable. Also, the vessel or body
conduit
accessed or the surgical procedure performed may impose size limitations to
prevent the inclusive of deflectable components or mechanisms in the surgical
instruments.
As such, the access sheath may replace the components or use of the
components in such surgical instruments or induce a broken instrument to be
controllably deflected thereby reducing replacement, repair and/or
construction
costs, reducing wear and tear of such instruments and increasing the life of
such
instruments. Also, the reinforced access sheath allows the size and shape of
the
primary lumen to remain substantially constant throughout the access sheath,
thereby reducing forces on instruments placed within the access sheath, which
may extend the life of these instruments.
The forces or stress accumulated along the access sheath that may cause
kinks in the access sheath are also distributed along the access sheath due to
the composite construction of the access sheath. Thus, kinks in the access
sheath are reduced. The wire coil(s) may also allow the access sheath walls to
be very thin without reducing durability or strength in the access sheath.
Thus,
the overall or outer diameter of the access sheath may be small, which may
also
reduce the incision or insertion point for the access sheath, without reducing
the
size or diameter of the primary lumen.
As such, the access sheath of various embodiments of the present
invention has thin walled portions, a large lumen, an atraumatic end, a kink
resistant construction and/or any combination thereof. Additionally, the
access
sheath of various embodiments of the present invention has an extensive range
of lengths from about 5.5 centimeters or less all the way up to 100
centimeters or
more and various lengths there between, e.g., about 13 and 45 centimeters. The
access sheath of various embodiments of the present invention is also strong,
stiff and yet flexible enough to be intricately guided through the body
conduits,
cavities or tissue.
Referring now to FIG. 5, an embodiment of an actuator or actuation hand-
piece 90 adapted to be in line with the access sheath 80 is shown. The
proximal
end of the actuator 90 includes a funnel-shaped entry 91 connected within the
actuator to access a working channel, which forms a transition into the
primary
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lumen of the access sheath. The entry 91 is also sized and arranged to receive
surgical instruments such as a dilator 82.
A pull wire extending through a first secondary lumen of the access sheath
80 is attached to a first movable component, e.g., a threaded cylinder or
ratcheted slider. Another pull wire extending through a second secondary lumen
of the access sheath is also attached to a second movable component. The first
secondary lumen extends through the access sheath along a first side of the
access sheath. The second secondary lumen also extends through the access
sheath 80 along a second side of the access sheath. The first side of the
access
sheath opposes the second side of the access sheath.
A knob 92 surrounding the movable components is correspondingly
threaded or otherwise arranged to engage the components, which allows a user
with a twist or turn of the knob 92 in one direction, e.g., clockwise or
proximally,
to move one of the movable components linearly. For example, as the first
movable component is moved proximally when the knob 92 is rotated clockwise
or dragged proximally, the tensioning device connected to the first movable
component also traverses towards the proximal end of the access sheath to
impart a pulling force on the access sheath thereby deflecting the access
sheath
in a first direction.
The knob 92 is also allowed to move in the opposite direction moving the
first movable component distally to straighten the access sheath. As the knob
92
continues to move in the opposite direction and past a zero point 93, the knob
92
disengages from the first movable component and engages the second movable
component. The tensioning device connected to the second movable component
traverses proximally as the knob 92 traverses distally to impart a pulling
force on
the access sheath 80 thereby deflecting the access sheath in a different or
opposing direction. The knob 92 moved in the opposite direction back towards
the. zero point 93 moves the second movable component distally to cause the
tensioning device to loosen and thus allow the access sheath to straighten.
The various access devices and their construction described below may
also be applicable to the steerable access sheath described above. For
example, the remote actuation hand-pieces to be described below can be used
instead of the ring shown in FIG. 1.
FIGS. 6-8 illustrate a surgical access device or steerable kink resistant
access device 100 in accordance with the one embodiment of the present
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invention for use in, among other fields, cardiology, urology, radiology,
electrophysiology and gastroenterology. Access device 100 comprises an
access sheath 102 having a longitudinal axis 103 extending from a proximal end
to a distal end, and a handle portion 104 operatively connected to the
proximal
end of the access sheath 102. The access sheath 102 includes an elongated
body 105 and a steerable region or portion 106. It is appreciated that the
steerable portion 106 may be formed anywhere along the access sheath 102. It
is further appreciated that the steerable portion 106 and the elongated body
105
may have variable stiffness depending on the application of the access sheath
102. The access sheath 102 has an outside diameter sufficiently small so that
it
may be inserted into a body cavity or conduit. The access sheath 102 typically
has two internal lumens, a primary lumen 112 and a secondary lumen 114, as
illustrated in FIG. 7.
The primary lumen 112 is sized and configured as an access to a surgical
site or the target of a surgical procedure. In particular, primary lumen 112
operates to advance diagnostic and therapeutic elements to the surgical site
or
target. The secondary lumen 114 is sized and configured to contain a
tensioning
device 116 such as a control or pull wire that, when acted upon, will deflect
the
steerable portion 106 of the access sheath 102. The tensioning device 116
extends through the secondary lumen 114 and is attached to the actuator or
handle portion 104 at one end and to a distal portion 107 of the steerable
portion
106 at the other end. The handle portion 104 may include a thumb-actuated
knob 118 controlling the tensioning device 116. For example, the knob 118 may
be drawn proximally in a direction 119 to provide tension to the tensioning
device
116 or cause the tensioning device to tense or distally in a direction 120 to
loosen
tension or cause the tensioning device 116 to loosen.
In another embodiment of the present invention, FIGS. 18-21 illustrate an
actuator or actuation hand-piece 500 having a proximally-facing portion 502, a
distally-facing portion 504, hand-engaging extensions 506, and at least one
thumbwheel member 508a,b. The proximally-facing portion 502 has a generally
flat support surface and includes a funnel-shaped entry portion 510. The
funnel-
shaped entry portion 510 is sized and configured to guide an obturator and
other
instrumentation into a working channel within the hand-piece 500. The distally-
facing portion 504 is connected to the access sheath 102. The working channel
of hand-piece 500 is sized and configured to form a transition into the
primary
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lumen 112 of the access sheath 102. The hand-engaging extensions 506 are
sized and shaped to accommodate two extended human fingers in a holding
position. The at least one thumbwheel 508 allows a user to deflect the
steerable
portion 106 of the access sheath 102.
The steerable portion 106 may be deflected through the action of a
tensioning device 116, such as a pull wire or control wire associated with the
secondary lumen 114 within the access sheath 102. The tensioning device 116
may be connected to an axle positioned between two thumbwheels 508a and
508b or at least one thumbwheel and an opposing side of hand-piece 500. As
the thumbwheels 508a and 508b are rotated, the tensioning device116 imparts a
pulling force on the steerable portion 106 of sheath 102, thereby causing
portion
106 to deflect. In one aspect of the present invention, directional indicators
512
may be placed on each of hand-engaging extensions 506 of hand-piece 500 to
indicate the direction of distal deflection or bending of access sheath 102.
It is appreciated that the actuator or actuation hand-piece of the invention
may be remotely attached to the associated access sheath to control the
tensioning and loosening of the tensioning device. In this case, the hand-
piece
may be connected to a flexible tubing or body, which is connected to the
access
sheath. By providing a remote access point or attachment, the thumbwheels of
the hand-piece, for example, may be placed away from the surgical site so that
they do not prevent or interfere with full insertion of the working length of
the
access sheath. It is further appreciated that the access sheath may comprise a
plurality of pull wires attached to a plurality of thumbwheels of an actuation
hand-
piece to deflect the steerable portion of the sheath in different directions.
In one embodiment of the invention, the access sheath 102 comprises an
extruded multi-lumen plastic tube. Alternatively, the access sheath 102 may be
molded from a plastic or rubber-like material. Preferred materials include
polyvinyl chloride, polyester, silicone elastomer, natural or synthetic
rubber,
polyurethane or the like. The materials may range in hardness from around 40
Shore A to 70 Shore D. These materials are generally flexible and durable. In
another embodiment of the invention as illustrated in FIG. 22, a structure
such as
a spring can be molded into the tube of the sheath to facilitate kink
resistance.
More specifically, the access sheath 102 may be formed with an inner plastic
body 610, surrounded by a metal spring coil 612, which is further covered by
an
outer body 614. This particular embodiment of access sheath 102 provides a
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high degree of kink resistance. The inner body 610 provides a smooth surface
within the sheath, which facilitates passage of instrumentation. The spring
coil
612 adds kink resistance to the sheath tube, while the outer body 614 provides
a
suitable covering for the coils of the spring 612.
In one aspect of steerability of the present invention, a tightly wound
spring may be placed in the secondary lumen 114 of the access sheath 102 to
facilitate movement of the tensioning device 116 inserted there through. The
spring may be bonded or otherwise fixed to the secondary lumen 114. Among
other features, the spring operates to isolate forces applied by the
tensioning
device 116, which is inserted through the spring and is attached to the distal
portion 107 of the steerable portion 106. In particular, the spring adds
stability
and rigidity to the elongate body 105 when the tensioning device 116 is acted
upon such that only the steerable portion 106 is bent or steered. Furthermore,
the spring operates to direct the tension force applied on the device 116 to
the
steerable portion 106 so as to allow deflection of only the portion 106 and
not the
elongate body 105. That is, the tension force is isolated to the steerable
portion
106, which may be formed anywhere along the access sheath 102. The spring
may be coated with a lubricious material further facilitating movement of the
tensioning device 116. The spring may line or cover the inner surface area of
the
entire secondary lumen 114 or just portions of the secondary lumen 114 to
facilitate isolation of the tension force.
The spring may be constructed from a 0.005-inch diameter wire that is
tightly wound forming a closed wound spring having a 0.02-inch outer diameter.
The distal 0.5 to 2 inches of the spring may be stretched to an open wound
state
such that the windings have an approximately 0.02-inch gap between them. This
stretched portion of the spring facilitates isolation of the tension force
applied by
the tensioning device 116. The spring may be coated, for example, in a plastic
jacket and bonded to the secondary lumen 114 from the proximal end of the
spring to the proximal end of the stretched portion. The stretched portion is
then
left free to move and/or compress in the plastic jacket. The distal end of the
stretched portion may be anchored to the distal end of the access sheath 102
along with the tensioning device 116. The distal end of the plastic jacket may
also be bonded to the distal end of the access sheath 102 along with the
tensioning device 116 and the spring although these elements do not require a
common bonding point or bonding method.
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As discussed above, the proximal end of the access sheath 102 may be
directly or remotely attached to handle portion 104 or actuator or hand-piece
500,
which allows the operator to place tension on the tensioning device 116, such
as
a control or pull wire, while maintaining the position of the catheter. This
tension
causes the stretched portion of the 0.02-inch diameter spring to collapse and
this,
in turn, forces the sheath to bend in the region where the stretched portion
of the
spring is located. It is appreciated that the stretched portion may be formed
anywhere along the catheter or surgical access device that may require
bending,
and is not limited to the distal end of the device. In addition, more than one
deflection assembly of spring and tensioning device may be added to the access
device to create deflection in different regions or planes. The amount of
bending
or deflection will in some way be proportional to the amount of force or
tension
placed on the tensioning device.
The tensioning device 116 is, in one embodiment, a control or pull wire
made of Nitinol, a braided cable or any flexible strand or wire. In one
embodiment, the control wire is inserted through the spring such that it runs
through the secondary lumen 114 as illustrated in FIG. 10. The proximal end of
the tensioning device 116, e.g., a control or pull wire, is connected to an
actuator
such as the knob 118 of the handle portion 104. The distal end of the control
or
pull wire, as previously described, is attached to the distal portion 107 of
steerable portion 106. In another aspect of the invention as illustrated in
FIG. 17,
the tensioning device 416 may be a flattened or flat member extending through
at
least the steerable portion 106 of the access sheath 102.
In another aspect of the present invention as illustrated in FIGS. 6 and 9-
10, the steerable portion 106 includes a plurality of radially and
longitudinally
spaced notches 108 and slits 110 disposed on opposite sides of each other
facilitating radial deflection of the distal portion 107 in a desired
direction or angle.
The notches 108 and slits 110 are cut into the access sheath 102 across the
longitudinal axis 103. The degree of deflection may vary greatly based on many
factors such as the number, size, direction, shape and spacing of the notches
108 and slits 110. The notches 108 are cut deeper and wider at a distal end
150
than they are at a proximal end 152 of steerable portion 106. The slits 110
comprise of very shallow cuts to provide a reduction in resistance to
stretching as
the steerable portion 106 is bent or deflected toward the notches 108.
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As discussed above, the notches 108 and slits 110 may be of any desired
width, length, depth and shape. The number of notches 108 and slits 110 in the
steerable portion 106 can be varied in accordance with the use and flexure
requirements of the access sheath 102. However, in one embodiment, the slits
110 are narrower and shallower than the notches 108 to provide a "weak-
side/strong-side" arrangement of the steerable portion 106 so as to allow the
access sheath 102 to be predisposed to bending in the desired direction. That
is,
when the control wire of the tensioning device 116 is drawn proximally as
illustrated in FIG. 11, the more flexible side of the steerable portion 106,
i.e., the
side with notches 108, will give first thereby bending in the direction of the
notches. Moreover, the distal end 150 of the steerable portion 106 with the
deeper and wider notches 108 will bend first as the bending progressively
moves
toward the proximal end 152 having shallower and narrower notches. It is
appreciated that the notches 108 may extend through the wall of the access
sheath 102.
Referring now to FIGS. 12 and 13, the opposing series of notches 108 and
slits 110 are further illustrated. The notches 108, as discussed above,
provide a
"weak-side" or preferred bend path as the notches 108 are closed when bent. It
can be seen that the notches 108 are wedge-shaped and have material removed
from them. There is, therefore, sufficient room for the material adjacent to
each
notch to approximate, thereby shortening the length of the steerable portion
106
on the weak-side. In contrast, the slits 110 are shallow radial cuts made
directly
opposite the notches 108 with little or no material removed. The slits 110
provide
the mechanical equivalent of increased plastic elasticity. That is, the slits
110
allow the material of the steerable portion 106 to stretch beyond the
intrinsic
properties of the material itself. As a result of this construction, the
primary
lumen 112 of the steerable portion 106 will not collapse when deformed or bent
into a tight circular profile as can be seen in FIG. 11. In other words, the
slits 110
will only open to provide an elongation of the "strong-side" and will not
collapse to
provide a shortening of the "strong-side". The material on either side of the
notches 108 and slits 110 maintains the general elongate dimension and forms a
continuum of the access sheath 102.
In another embodiment of the invention as illustrated in FIG. 14, the distal
end 200 of the steerable portion 106 has a generally rounded off wall section
205
providing an atraumatic insertion tip. With the current construction of the
access
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sheath having a steerable distal portion, less pushing force is required to
advance the access sheath since it may be deflected around, under or over
anomalies and irregularities in a body cavity or conduit rather than being
forced
through the tortuous paths. Surgical instruments such as an ureteroscope 300
may be directed through a steerable access sheath as illustrated in FIGS. 11
and
16. For instance, the steerable access sheath may be used to pass the
ureteroscope 300 into the upper and lower poles of the renal calices as
generally
illustrated in FIG. 16. It is appreciated that flexible ureteroscopes and
other
flexible endoluminal scopes, including completely passive scopes, may be
accurately positioned with the assistance of the steerable access sheaths of
the
present invention.
In another embodiment of the present invention, FIGS. 23-24 illustrate an
actuation hand-piece or actuator 510 in line with the access sheath 102. The
proximal end of the actuator 510 includes a funnel-shaped entry portion 516
that
is sized and configured to guide an obturator, dilator, ureteroscope and other
instrumentation into a working channel 518 within the actuator 510. The
working
channel 518 of actuator 510 is sized and configured to form a transition into
the
primary lumen 112 of the access sheath 102.
The tensioning device 116 extending through the secondary lumen 114 is
attached to a bracket 512. A proximal end of the tensioning device 116 is
balled,
crimped, or otherwise sized or deformed to secure the tensioning device 116 to
the bracket 512. The bracket 512 is further connected to a slider 514. A lever
511 connected to the slider 514 allows a user to move the slider 514 and
thereby
control tensioning device 116. In FIG. 23B, the hand-piece 510 includes a
pivotable lever 519 connected to lever 511. Pivotable lever 519 provides a
counter actuation point relative to lever 511. In other words, as the lever
519 is
moved distally, lever 511 moves proximally and vice versa.
When the slider 514 is moved proximally, the tensioning device 116
imparts a pulling force on the steerable portion 106 (FIG. 6) of access sheath
102
thereby deflecting the steerable portion 106. The slider 514 also includes a
plurality of teeth 515 that operatively engage corresponding teeth 517 along
the
inside of the hand-piece 510. Therefore, as the slider 514 is moved proximally
and distally, this engagement allows incremental control of the deflection and
straightening of the steerable region or portion 106 of the access sheath 102.
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Referring now to FIGS. 25-26, an embodiment of an actuator or actuation
hand-piece 520 also adapted to be in line with the access sheath 102 is shown.
The proximal end of the hand-piece 520 includes a funnel-shaped entry portion
522 connected within the hand-piece 520 to access a working channel 524 which
forms a transition into the primary lumen 112 of the access sheath 102.
Tensioning device 116 extending through the secondary lumen 114 is
attached to a threaded cylinder 526. A knob 527 surrounding the cylinder 526
is
correspondingly threaded to engage the cylinder 526, which allows a user with
a
twist or turn of the knob 527 in one direction, e.g., clockwise, to move the
cylinder
526 linearly, e.g., proximally. As a result, tensioning device 116 also
traverses
towards the proximal end of the hand-piece 520 to impart a pulling force on
the
steerable portion 106 thereby deflecting the steerable portion 106 of the
access
sheath 102. The knob 527 is also allowed to move in the opposite direction
moving the threaded cylinder 526 distally to straighten the steerable portion
106
of the access sheath 102. Therefore, the hand-piece 520 provides a rotary or
scroll type control of the deflection and/or straightening of the steerable
portion
106 of the access sheath 102.
In another embodiment of the present invention, FIGS. 27-29 illustrate an
actuator or actuation hand-piece 530 in line with the access sheath 102, with
the
hand-piece 530 including a funnel-shaped entry portion 531. An axle 532
disposed within the hand-piece 530 is connected to a tensioning device from
the
access sheath 102 and connected to two thumb-actuated dials or wheels 533
and 534. In one embodiment, the wheels 533 and 534 are partially disposed
within the hand-piece 530. The wheel 533 and/or wheel 534 control the
tensioning device. For example, the wheel 533 turned clockwise causes the
tensioning device to be drawn proximally to provide tension to the tensioning
device, e.g., one or more a pull or control wires. The control wire(s) being
drawn
proximally wraps or winds around the axle 532 in the hand-piece 530.
The wheels 533 and 534 also include ratchet wheels or a number of
radially extending teeth 535 connected to or integrated with the wheels 533
and
534. The teeth 535 operatively engage with a corresponding lever or pawl 536
connected to a trigger 537. The pawl 536 engaged with the teeth 535 permits
rotational movement of the wheels 533 and 534 in one direction, e.g., a
clockwise
direction, while preventing rotational movement in the opposite direction. As
such, as the wheels 533 and 534 are turned clockwise, incremental control of
the
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deflection of the steerable portion 106 of the access sheath 102 is provided
as.
the axle 532 in the hand-piece 530 draws the tensioning device 116 proximally.
The trigger 537, when actuated, pivots pawl 536 causing pawl 536 to disengage
from teeth 535. As a result, the control wire(s) unwind or move distally from
the
axle 532 whereby the steerable portion 106 of the access sheath 102
straightens.
Referring now to FIGS. 29-30, an actuator or actuation hand-piece 610
being connected yet offset from the access sheath 102 is shown. As such, the
offset hand-piece may reduce the working length used in the access sheath or
added to the access sheath with the hand-piece being in line with the access
sheath. Additionally, the user may operate the hand-piece proximate to the
access sheath to provide a tactile or visual feedback or reminder of the
steerable
portion 106 of the access sheath 102. The hand-piece 610, in one embodiment,
includes or is connected to a connector 611 with a funnel-shaped entry portion
612 that is sized and configured to receive and guide instruments into/out of
the
access sheath 102. The secondary lumen 114 is separately connected to the
hand-piece 610. Through connector 611, in one aspect of the present invention,
a conduit connects the secondary lumen 114 and tensioning device 116 to the
hand-piece 610.
The tensioning device 116 extending through the secondary lumen 114 is
attached to slider 614. A lever 613 connected to the slider 614 allows a user
to
move the slider 614 that imparts a pulling force on the steerable portion 106
to
deflect the steerable portion 106 or a reduction in tension on the steerable
portion
106 allowing the steerable portion 106 of the access sheath 102 to straighten.
The slider 614, in one aspect of the present invention, includes a plurality
of teeth
that operatively engage corresponding teeth along the inside of hand-piece 610
to provide incremental control of the deflection and/or straightening of the
steerable portion 106 of the access sheath 102.
FIG. 31 illustrates another embodiment of the present invention of an
actuator or actuation hand-piece 620 offset from the access sheath 102. The
hand-piece 620 includes a funnel-shaped entry portion 621 providing access to
the primary lumen of the access sheath 102. The secondary lumen and the
tensioning device of the access sheath 102 are also connected to the hand-
piece
620. The tensioning device 116, for example, is attached to a movable handle
member 622 that is pivotally connected to a stationary handle member 623. In
one embodiment, the tensioning device is connected to a semi-circular plate or
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disc that rotates or pivots as the movable handle member is actuated.
Manipulation of the movable handle member 622 allows a user to pull or release
the tensioning device 116 to respectively deflect or straighten the steerable
portion 106 of the access sheath 102. In one aspect of the present invention,
a
ratchet mechanism disposed within the hand-piece 620 or between the movable
handle member 622 and the stationary handle member 623 is included to provide
incremental control of the tensioning device 116 and thus the deflection of
the
steerable portion 106 of the access sheath 102.
Referring now to FIGS. 32-33 illustrate an actuator or actuation hand-
piece 630 and 630' situated offset from the access sheath 102. The actuation
hand-piece 630 and 630' includes a funnel-shaped entry portion 631 and is
connected to a tensioning device attached to an axle disposed within the hand-
piece 630 and 630'. The axle is connected to two thumb-actuated knobs or
wheels 632 and 633. As shown in FIGS. 33A-B, the wheels 632 and 633 are
partially disposed within the hand-piece 630'. The wheels 632 and 633 control
the tensioning device 116. For example, the wheel 632 and/or wheel 633 may be
rotated to provide tension to the tensioning device 116, e.g., a control wire,
or to
loosen tension in the control wire. In one embodiment, the wheel 632 and 633
are connected to separate and independent control wires adapted to deflect the
access sheath in an opposing manner and/or to deflect different portions of
the
access sheath.
In one aspect of the present invention, a trigger 634, when actuated, locks
the wheel 632 and/or wheel 633 thus preventing further movement of the
tensioning device 116 and the deflection/straightening of the steerable
portion
106 of the access sheath 102. Alternatively, the trigger 634 releases or
disengages control of the tensioning device 116 from wheels 632 or 633 to
allow
the tensioning device to return to its original position.
In FIGS. 34-36, one embodiment of an actuator or actuation hand-piece
710 of the present invention is remotely attached to an access sheath to
control
the tensioning and loosening of a tensioning device connected to the access
sheath. As such, the actuator may be placed away from the surgical site or
operating path or area so that the hand-piece does not prevent or interfere
with
the insertion of instruments along the working length of the access sheath.
Additionally, the remote actuator does not occupy or add additional working
space or length to the access sheath. Furthermore, another user may operate
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the actuator remotely allowing another user to focus on the surgical
procedure,
e.g., manipulating instruments to be or already inserted in the access sheath.
Extended surgery time and confusion caused by switching between the actuator
and other devices or simultaneously using the many devices may be reduced.
The actuator 710, in one embodiment, is connected to a flexible body or
conduit 711, which is connected to the access sheath 102 via a Y-connector
712.
The Y-connector 712 includes a funnel-shaped entry portion 713 that is sized
and
arranged to guide instruments into the primary lumen 112 of the access sheath
102. The Y-connector 712 also includes a channel 714 for connecting to the
flexible conduit 711. The tensioning device 116 extends through the secondary
lumen 114, channel 714, and flexible conduit 711 and is attached to an axle
715
disposed within the actuator 710. The axle 715 is connected to a dial or knob
716 that partially extends laterally from the hand-piece 710 with finger holds
disposed radially throughout the knob 716. The other end of the axle 715 is
rotatably connected to the hand-piece 710.
The knob 716 allows a user to control the tensioning device 116. For
example, when rotated in one direction, e.g., clockwise, the tensioning device
116 is drawn proximally to wrap or wind around the axle 715. A plurality of
teeth
717 radially disposed on the knob 716 within the hand-piece 710 or disposed on
a separate or embedded ratchet wheel operatively engages with a corresponding
lever or pawl 718. The pawl 718 pivoting about a post connected to the hand-
piece 710 and biased by a leaf spring 719 engages with the teeth to permit
rotational movement of the knob 716 in one direction, e.g., clockwise, while
preventing rotational movement in the opposite direction. As such, as the knob
716 is rotated, incremental control of the deflection of the steerable portion
106 of
the access sheath 102 is provided as the axle in the hand-piece 710 draws the
tensioning device 116 proximally. A trigger 720 when actuated pivots the pawl
718 to disengage the pawl 718 from the teeth 717. As a result, the tensioning
device 116 is allowed to unwind or move distally from the axle 715. Thus, the
steerable portion 106 of the access sheath 102 straightens.
Referring now to FIGS. 37-39, another embodiment of an actuator or
actuation hand-piece 730 of the present invention remotely attached to an
access
sheath 102 is shown. An axle 731 disposed within the hand-piece 730 is
attached to the tensioning device 116. The axle 731 is also connected to a
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rotatable key or winged lever 732 extending laterally from one side of hand-
piece
730.
The lever 732 allows a user to control the tensioning device 116. For
instance, when rotated in one direction, e.g., clockwise, the tensioning
device 116
is drawn proximally to wrap or wind around the axle 731 in the hand-piece 730.
A
plurality of teeth 733 radially disposed around the axle 731 or disposed on a
ratchet wheel surrounding the axle operatively engages with a corresponding
pawl or cantilever arm 734. The arm 734 mounted on the hand-piece 730 and
engaged with the teeth 733 permit rotational movement of the lever 732 and
axle
731 in one direction while preventing rotational movement in the opposite
direction. This engagement provides incremental control of the tensioning
device
116 and thus also of the steerable portion 106 of the access sheath 102.
The hand-piece 730 also includes a trigger lever 735 that is pivotally
connected to a post in the hand-piece 730 and partially extends through a slot
in
the hand-piece 730. The lever 735 when actuated, e.g., pulled proximally,
moves
the cantilever arm 734 to disengage from the teeth 733 to allow the axle 731
to
freely rotate. Therefore, the tensioning device 116 connected to the axle 731
unwinds and/or moves distally from the axle 731 causing the steerable portion
106 of the access sheath 102 to straighten.
In FIGS. 40-43, another embodiment of an actuator or actuation hand-
piece 740 of the present invention that is remotely attached to an access
sheath
102 to control the tensioning and loosening of the tensioning device 116 is
shown. Disposed within the hand-piece 740 is an axle 741, which is attached to
tensioning device 116. The axle 741 is connected to a slotted wheel 742 that
is
partially rotatable within the hand-piece 740. Generally opposing slots 743
and
744 are disposed in the slotted wheel through which respective dowels or pins
745 and 746 extend through and connect to distal ends of respective button
arms
747 and 748. Proximal ends of button arms 747 and 748 extend through
openings in the hand-piece 740.
Operationally, when the button arm 748 is lowered, the button arm 747
rises as the slotted wheel 742 rotates clockwise. As a result, the tensioning
device 116 connected to axle 741 is not drawn to the hand-piece 740, such that
the steerable portion 106 of the access sheath 102 is substantially straight.
When button arm 747 is lowered, the button arm 748 rises and the slotted wheel
742 rotates causing the tensioning device 116 to be pulled by rotating axle
741
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such that the steerable portion 106 of access sheath 102 deflects. In one
aspect
of the present invention, the hand-piece 740 includes guides 749 for aligning
and
guiding traversal of the button arms 747 and 748 and slots (not shown) for
assisting linear movement of the pins 745 and 746 as the button arms move.
The slotted wheel 742 also includes one or more openings along the
circumference of the wheel to permit rotation of the wheel without interfering
with
the guides 749. In another aspect of the present invention, the axle 741 is
connected to a screw knob for adjusting the tension or pre-winding the
tensioning
device 116 around the axle 741.
Referring now to FIG. 44, another embodiment of a remotely attached
actuator or actuation hand-piece 750 is shown. In one aspect of the present
invention, the hand-piece 750 fits within a user's hand in that a fist closing
motion
moves a t-bar 753 proximally deflecting the access sheath 102 and an opening
motion moves the t-bar 753 distally allowing the access sheath 102 to
straighten.
For example, the hand-piece 750 includes finger-extension members 754 to
provide one or more fingers on each member 754 to grasp the t-bar 753. A
distally flared end 756 of a tube 751 is also provided for resting in the palm
of a
hand.
Extending through a distal end of the tube 751 is the tensioning device
116 that attaches to plate 752 within the tube 751. The plate 752 is connected
to
the t-bar 753 that is slidably connected to tube 751. In one embodiment, an
adjustment screw is connected to the t-bar 753 to adjust the location of the
plate
752 relative to the t-bar 753 and within the tube 751. A set of teeth 755
within
tube 751 operatively engages with a tooth or detent on t-bar 753 as the t-bar
753
moves.
With the t-bar 753 moving proximally, plate 751 also moves proximally
thereby pulling tensioning device 116 to cause the steerable portion 106 of
the
access sheath 102 to deflect. Similarly, as the t-bar 753 and plate 751 moves
distally, the tensioning device 116 loosens and thus the steerable portion 106
straightens. As such, this engagement provides incremental control of the
deflection and/or straightening of the steerable portion 106 of the access
sheath
102. A spring-loaded button 757 on one end of the t-bar 753, when actuated,
disengages the tooth on t-bar 753 from the teeth 755 within tube 751 allowing
the
t-bar 753 to move freely.
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FIGS. 45-46 illustrate another embodiment of the present invention of an
actuator or actuation hand-piece 760 and 760' each remotely attachable to the
access sheath 102. The hand-piece 760 and 760' are connected to a flexible
body or tube 761 through which the tensioning device 116 extends. The
tensioning device 116 is attached to a first handle member 762 that is
pivotally
connected to a second handle member 763. Actuation of the first handle
member 762 allows a user to pull or release the tensioning device 116 to
respectively deflect or straighten the steerable portion 106 of the access
sheath
102. In one aspect of the present invention, a ratchet assembly is included to
provide incremental control of the tensioning device 116 and thus the
deflection
of the steerable portion 106 of the access sheath 102.
It is appreciated that the access sheath may comprise a plurality of pull
wires attached to a plurality of thumbwheels, axles, knobs or other types of
movable components of an actuation hand-piece to deflect the steerable portion
of the sheath in different directions. Also, it is appreciated that the
tensioning
device may be hydraulic, pneumatic or electronic in nature and the actuation
hand-piece may instead be foot, finger or otherwise sensor actuated and may
include corresponding foot, finger or otherwise sensor extensions.
In various embodiments, for example, the embodiments previously
described and/or the embodiment of an actuation hand-piece 810 shown in FIGS.
47A-B, the tensioning device 116 is connected to a belt 811. The belt 811 acts
as an intermediary between the tensioning device 116 and a movable component
818 in the hand-piece 810. The movable component may also be, for example,
slider 514 or 614 (FIGS. 23B and 29), cylinder 526 (FIG. 25), movable handle
member 622 (FIG. 31), axle 715 or 731 (FIGS. 36 and 37), and various other
movable components fully or partially disposed within or otherwise part of an
actuator or hand-piece which is connectable to the tensioning device 116.
Through belt 811, stress or forces that may be applied by or result from the
movable component 818 is displaced from the tensioning device 116. Therefore,
stress experienced by the tensioning device 116 caused by the actuation of the
hand-piece may be reduced.
The belt 811 includes a number of apertures 812 for engaging teeth 813
radially disposed on the movable component 818 of the hand-piece 810. In one
embodiment, the belt 811 includes teeth or protrusions for engaging
corresponding apertures, teeth or protrusions of the movable component 818.
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With either engagement, incremental control of the tensioning device 116 is
provided. As such, the belt 811 draws the tensioning device 116 proximally as
the knob is rotated in one direction and rotating the knob in the opposite
direction,
allows the tensioning device to withdraw from the hand-piece 810.
A pin or roller 814 may also be included to assist in the engagement of the
belt 811 with a movable component 818 of the hand-piece 810. In one aspect of
the present invention, the belt 811 is pliable. In another embodiment, a
plate,
bar, or a less flexible component may be connected to the belt 811 for drawing
or
releasing the belt 811 in conjunction with or without the movable component
818.
A u-shaped lever 815 is connected to a knob 816 that is disposed on one
or both sides of the hand-piece 810 and is connected to the movable component
818 in the hand-piece 810. Through actuation of the u-shaped lever 815, a user
can control the movement/tension of the tensioning device 116 and thus the
deflection and straightening of the steerable portion 106 of the access sheath
102. In one embodiment, a plate is connected to the u-shaped lever 815 and the
belt 811 to draw and release the tensioning device 116.
In one aspect of the present invention, a trigger 817, when actuated, locks
the belt 811, the movable component 818 or the u-shaped lever 815, thus
preventing further movement of the tensioning device 116 and the
deflection/straightening of the steerable portion 106 of the access sheath
102.
Alternatively, the trigger 817 releases or disengages control of the
tensioning
device 116 from the belt 811, the movable component 818 or the u-shaped lever
815 to allow the tensioning device 116 to return to its original position or
state.
Referring now to FIGS. 48-51, embodiments of an access sheath in
various stages of fabrication is shown. A wire 801 is wound around a support
member or mandrel 802 in which the size and shape of mandrel generally defines
the size and shape of primary lumen 112 of the access sheath 102. The
mandrel, in one embodiment, is stainless steel and made of or is coated with a
low friction material or surface, e.g., Teflon or various mold releases,
allowing for
the mandrel to be easily removed from the access sheath 102. The wire 801 is
wound in an over counter fashion by using anchors or starting and stopping
points substantially orthogonal of each other and thus winding the wire 801 in
an
oblique line along mandrel 802. As such, the wire 801 is wound such that the
wire's tendency to unwind is counteracted. In one embodiment, prior to the
addition of the wire 801, the mandrel 802 is coated with or inserted into a
plastic
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or PVC material tube to allow instruments and the like to be smoothly inserted
into the primary lumen without interference from the wire 801.
The wire 801, in one embodiment, is a plastic coated wire and particularly,
a stainless steel co-extruded wire with an approximate diameter of .006 inches
fused, coated or otherwise included with a plastic material to make the total
diameter of the wire 801 to be about .012 inches. The mandrel 802 including
wire 801 is placed into or inserted into a control tube. Air, in one
embodiment, is
supplied, e.g., at 100 PSI, on the opposite end of insertion to assist
insertion of
the mandrel 802 by expanding the control tube. The control tube, in one
embodiment, may be made of silicon or a material with a higher melting point
than the plastic coating of wire 801. This assembly is then heated such that
the
plastic coating of wire 801 melts and adheres to itself to form a generally
continuous tubular structure or major tube 803. The control tube is then
removed.
A minor tube 804 is placed on or included with the major tube 803. The
minor tube 804 is longer than the major tube 803 and thus extends
substantially
further along the mandrel 802 than the major tube 803. Extending within a
portion of the minor tube 804 is a generally tubular structure or inner tube
805
that is about as long as the major tube 803. In one embodiment, the inner tube
805 is made of polyimide and the minor tube 804 is made of carbothane that
when heated adheres to the inner tube 805, the major tube 803 and other
portions of the access sheath, which are described below, that surrounds the
outer periphery of the minor tube 804.
The inner tube 805 within the minor tube 804 is adapted to receive the
support wire 806. The size and shape of the support wire 806 along with the
inner tube 805 generally defines the size and shape of the secondary lumen 114
of the access sheath 102. In one embodiment, the support wire is a stainless
steel wire with a diameter of about .12 inches. The support wire 806 is
secured
to a proximal end of the mandrel 802, threaded through the inner tube 805 and
the minor tube 804 and secured to the distal end of the mandrel 802. In one
embodiment, the support wire 806 secures the minor tube 804 to the major tube
803.
The minor tube 804 extends along the mandrel 802 substantially more
than the inner tube 805. In other words, the length of the minor tube 804 is
longer than the inner tube 805. The minor tube 804 is also more flexible than
the
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inner tube 805. As such, the portion from the end point of the inner tube 805
and/or the major tube 803 to near the end point of the minor tube 804
eventually
defines the steerable portion 106 of the access sheath 102. In one embodiment,
the minor tube 804 is shorter and less flexible than the inner tube 805. Thus,
in
this embodiment, the portion from the end point of the minor tube 804 and/or
the
major tube 803 to near the end point of the inner tube 805 eventually defines
the
steerable portion 106 of the access sheath 102.
In one embodiment, the minor tube 804, inner tube 805 and the major
tube 803 are placed into a final tube to enclose the minor tube 804 and inner
tube
805 between the major tube 803 and the final tube. This assembly is placed
into
or inserted into a control tube such that the assembly adheres or bonds
together
and then the control tube is removed.
In one embodiment, the minor tube 804 or the inner tube 805, whichever
extends further, is rigid, e.g., a stainless steel tube, to assist in the
deflection of
the steerable region 106. As such, the rigidity of the minor tube 804 or inner
tube
804 prevents the non-steerable portion of the access sheath 102 from bowing.
As such, the tube shifts the force caused by the tensioning device 116 to
deflect
the steerable region directly towards or at the steerable region 106. Also, a
rigid
secondary lumen formed by the rigid tube may assist in the protection of the
tensioning device and instruments inserted or withdrawn from the primary
lumen.
A wire 807 is wound around the minor tube 804, the inner tube 805 and
the major tube 803. In one embodiment, where the final tube is utilized, the
wire
807 is also wound around the final tube. In one embodiment, the wire 807 is
similar in construction or composition as that of wire 801 and/or extends
slightly
beyond the distal end of the minor tube 804 or inner tube 805.
A support tip, in one embodiment, is placed on a distal end or slightly
beyond the distal end of the wire 807 to assist in securing the wire 807
around
the minor tube 804 or inner tube 805 and/or to provide an atraumatic tip. The
support tip may be a 75 Shore D material. The mandrel 802 with rest of the
assembly is inserted into a control tube. As previously mentioned, air, in one
embodiment, is supplied on the opposite end of insertion to assist insertion
of the
mandrel 802 by expanding the control tube. In one aspect, a support tube is
used to temporarily encompass the control tube when the tube is pressurized in
the event the tube breaks down. The control tube with the assembly is heated
such that the plastic coating of wire 807 melts and adheres to itself to form
a
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generally continuous tubular structure or tube 808. The control tube is then
removed. In one embodiment, the control tube and assembly are heated at
around 165 degrees plus or minus about five to ten degrees for about ten to
fifteen minutes. As such, an access sheath 102 with a variable flexibility is
created.
The support wire 806 is disconnected from the mandrel 802. For
example, the support wire 806 on the distal end of the mandrel 802 is cut and
then the mandrel 802 is withdrawn from the access sheath 803. At or near the
tip
of the access sheath, a tensioning device, e.g., a pull wire, is attached and
threaded to the minor tube 804 and inner tube 805 out the proximal end of the
access sheath 102 for securing to an actuator. As such, the access sheath is
deflectable and controllable.
In one embodiment, the tensioning device is knotted or looped around an
opening or cut in the access sheath, the support tip and/or between loops in
the
wire 807 and back through itself. A catch wire threaded through the inner tube
805 and the minor tube 804 hooks or otherwise attaches to the tensioning
device.
The catch wire is removed out the proximal end of the access sheath thereby
threading the tensioning device through and out the proximal end of the access
sheath 102. As it is appreciated the support wire 806 has a diameter
sufficiently
larger than the diameter of the tensioning device, the catch wire or loops and
hooks of the catch wire to permit easy passage of these devices through the
secondary lumen of the access sheath 102. A secondary support tip, in one
embodiment, is placed on the distal end of the access sheath 102 to assist in
securing the tensioning device to the access sheath and/or to provide an
atraumatic tip.
As shown in FIGS. 51A-C, the distal end 809a of the access sheath 102 is
tapered and thus has a smaller diameter than the proximal end 809b of the
access sheath 803. The primary lumen 112 and secondary lumen 114
diameters, however, remain substantially constant throughout the access sheath
102. Additionally, the tapering or reduced diameter of the access sheath is a
result of the halting or non-extension of the inner tube 805 or minor tube
804, in
one embodiment, and the major tube 803 along the length of the mandrel 802.
As a result, the steerable portion 106 includes a reduced amount of materials
and
more flexible materials, and thus the steerable portion is easily deflected,
bent,
shaped or curved in response to the manipulation of the attached tensioning
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device while the other portion of the access sheath 102, including more
material
and less flexible material, remains substantially fixed, e.g., straight and
substantially in the same plane, preventing any inadvertent or unintended
movement of the access sheath.
Additionally, since the steerable region 106 of the access sheath 102 is
reinforced by wire 807, the steerable region 106 is strengthen such that a
flexible,
pre-bendable or otherwise not actively controllable instrument may be
controllably deflected dynamically as the steerable region 106 is controlled.
Additionally, an actively deflectable surgical instrument may have a
complicated
construction providing components, e.g., optics or clamps, to perform its
surgical
function and components to perform the active deflection. Therefore, such
instruments may be fragile or if broken may be expensive to replace or repair
or
still usable as a surgical instrument but not actively deflectable. As such,
the
strengthen steerable region 106 may replace the components or use of the
components in such surgical instruments or induce an broken instrument to be
controllably deflected thereby reducing replacement, repair and/or
construction
costs, reducing wear and tear of such instruments and increasing the life of
such
instruments. Also, the reinforced access sheath 102 through wire 807 and/or
wire 801 allows the size and shape of the primary lumen to remain
substantially
constant throughout the access sheath 102, thereby reducing forces on
instruments placed within the access sheath which may extend the life of these
instruments.
The forces or stress accumulated along the access sheath that may cause
kinks in the access sheath are also distributed along the access sheath due to
the composite construction of the access sheath described above and are
further
counteracted by the wire coils, e.g., wire 807 and 803. Thus, kinks in the
access
sheath are reduced. The wire coils also allow the access sheath walls to be
very
thin without reducing durability or strength in the access sheath. Thus, the
overall or outer diameter of the access sheath may be small, which may also
reduce the incision or insertion point for the access sheath, without reducing
the
size or diameter of the primary lumen. As such, the access sheath of various
embodiments of the present invention has thin walled portions, a large lumen,
an
atraumatic end, and a kink resistant construction and is strong, stiff and yet
flexible enough to be intricately guided through the body cavity or tissue. In
one
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embodiment, the wire coils are wound in a multifilar fashion with materials
having
alternating durometers.
Various other examples of processes that may be used to manufacture
the access sheath 102 or portions of the access sheath 102 are described in
U.S.
Patent Application Nos. 10/766,138 and 10/298,116, the disclosures of which
are
hereby incorporated by reference. It is appreciated that these processes or
portions of the processes may be varied or combined with the previously
described process and vice versa. For example, various ring-shaped elements,
such as, plastic rings, metallic rings, un-reinforced plastic rings and metal
reinforced plastic rings, and the like may be utilized instead of or in
addition to the
wires 803 and/or 807. Additionally, a separate mandrel may be utilized to
separately form or define the primary and secondary lumens and combined to
make the access sheath.
In one embodiment of the present invention, various embodiments of
access sheaths and actuators previously described, here now referred to as the
access sheath, combined with an instrument or device used to stretch or
enlarge
an opening, e.g., a dilator, allows for gradual and atraumatic dilation of the
ureter
while being placed. Once the access sheath has been placed at a desired
location, the dilator is removed and the access sheath is left in place. The
access sheath allows for continued access to the desired area, for example,
for
the placement of an ureteroscope and other therapeutic instruments, while
providing protection of the ureter. For instance, the access sheath may
protect
the ureter during the placement and removal of devices within the access
sheath,
during the removal of stone fragments or other tissue, and during the removal
of
a potentially cancerous biopsy specimen.
Additionally, with the access sheath being deflectable or steerable, an
urologist may effectively and efficiently locate stones and stone fragments
within
the kidney. When a stone burden is found in one of the calyces of the kidney,
especially in the lower pole portion of the kidney; it may be difficult for
the
urologist to continue to go back to the same calyx or location to remove the
burden.
When there are many fragments within a calyx, many entries and exits
may be performed to remove the burden. Also, when a stone or stone fragment
is removed, the instruments and tissue, e.g., the scope and stone basket (with
the stone or stone fragment) are removed as a single unit. The scope is then
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passed back through the sheath and manipulated to find the same calyx in order
to remove the remaining burden. However, with the access sheath 102, the
access sheath can be left deflected in place looking at the same calyx or
location,
while the scope and stone basket are removed. As a result, the urologist's
procedure time may be reduced, as the urologist may not have to manipulate the
ureteroscope to look for the same calyx each time. The amount of time saved
may be significant, especially if there is a large stone burden within the
kidney.
Additionally, the likelihood of doing damage to the kidney due to the
additional
manipulation that takes place every time the ureteroscope is placed back into
the
kidney may be reduced. Thus, with the access sheath, one can keep the sheath
deflected towards a particular calyx and remove the stone burden without
having
to find the calyx each and every time a fragment is removed.
When the urologist manipulates an ureteroscope, the urologist may
sometimes use the inside walls of the kidney to help deflect the ureteroscope
to
enter into a particular difficult locale. With the access sheath 102, instead
of
using the inside wall to help deflect the ureteroscope the access sheath may
be
used. Also, as previously mentioned, this will also help reduce the "wear and
tear" on surgical instruments, such as ureteroscopes. The deflecting mechanism
with the ureteroscope, if provided, can be damaged often and expensive repair.
The use of the access sheath may reduce the damage to the ureteroscope when
it is used to help manipulate the ureteroscope to desired locations within the
kidney.
The use of the access sheath 102 may also help a lesser-experienced
urologist perform the same difficult procedure as their more experienced
colleagues. In performing this procedure, the urologist may access the lower
pole of the kidney in order to remove a stone burden. By performing this
procedure in a retrograde fashion, one can reduce a patient's recovery time.
If
an urologist were neither skilled nor comfortable with using an ureteroscope
in a
retrograde fashion to remove a stone burden from a kidney's lower pole, the
urologist would typically approach the stone burden in an antegrade fashion.
This places a sheath percutaneously and thus may add additional recovery time
for a patient as well as potentially increasing morbidity. But, with the
access
sheath 102 and an ureteroscope, an urologist may efficiently and effectively
locate and remove a stone burden within the lower pole of a kidney. The access
sheath can also be used in an antegrade fashion and will provide the same or
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similar features described above, however access in this manner may not be the
preferred method.
Accordingly, the present invention provides a vascular steerable access
device. Although this invention has been described in certain specific
embodiments, many additional modifications and variations would be apparent to
those skilled in the art. It is therefore to be understood that this invention
may be
practiced otherwise than specifically described, including various changes in
the
size, shape and materials, without departing from the scope and spirit of the
present invention. Thus, embodiments of the present invention should be
considered in all respects as illustrative and not restrictive.
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