Note: Descriptions are shown in the official language in which they were submitted.
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
INTRODUCER AND METHODS OF USE THEREOF
Technical Field
[001] The present disclosure generally relates to devices and methods for the
introduction of medical instruments or objects into a patient. Specifically,
the present
disclosure relates to devices and methods for controlled introduction of a
medical instrument
into a surgical site on a patient.
Background
[002] Laparoscopic instruments are traditionally introduced via set ports that
pass
through the skin and fascia in order to access the desired operative site. The
placement of
such ports is traditionally achieved by first creating a pneumoperitoneum, and
then inserting a
port with a trocar or similar device.
[003] Insertion of initial trocars and ports, subsequent trocars, needles, and
other
surgical tools can result in complications, such as port scars, hernias at
insertion points, and
trauma to the abdominal wall. The use of set ports during a surgery also
limits the ability of a
surgeon to select the optimal insertion point for an instrument, and requires
larger incisions
which the surgeon must suture or otherwise close after completion of the
surgery.
Additionally, existing methods of inserting medical instruments into a
surgical field may
result in accidental over insertion into the surgical site resulting in damage
to internal
structures.
[004] The present disclosure overcomes one or more of these problems, and/or
other
problems in the art.
Summary
[005] A method of inserting an instrument into a patient includes supplying
pressurized fluid to an introducer to an instrument introduction site, and
advancing an
1
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
instrument located in the introducer through the introduction site after an
initiation of
supplying of pressurized fluid.
[006] According to another aspect, a medical instrument introducer includes a
housing having a proximal end and a distal end, and an instrument support
supporting an
instrument from the proximal end to the distal end. The introducer also
includes an
instrument drive assembly having a drive actuator to incrementally advance the
instrument
through the housing.
[007] A medical instrument introducer includes a housing having a proximal end
and a distal end, and an instrument support supporting an instrument from the
proximal end
to the distal end. The introducer also includes a pressurized fluid supply
assembly, an
instrument drive assembly having a drive actuator to incrementally advance the
instrument
through the housing, and an exit port at the distal end of the housing, the
exit port receiving
both the instrument and pressurized fluid from the pressurized fluid supply
assembly.
[008] It may be understood that both the foregoing general description and the
following detailed description are exemplary and explanatory only and are not
restrictive of
the features claimed.
[009] As used herein, the terms "comprises" "comprising," or any other
variation
thereof, are intended to cover a non-exclusive inclusion, such that a process,
method, article,
or apparatus that "comprises" a list of elements does not necessarily include
only those
elements, but may include other elements not expressly listed or inherent to
such process,
method, article, or apparatus. The term "exemplary" is used in the sense of
"example," rather
than "ideal."
Brief Description of the Drawings
[0010] The accompanying drawings, which are incorporated in and constitute a
part
of this specification, illustrate various exemplary embodiments and together
with the
2
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
description, serve to explain the principles and operation of the disclosed
embodiments. Any
features of an embodiment described herein (e.g., device, method of treatment)
may be
combined with any other embodiment, and are encompassed by the present
disclosure.
[0011] Fig. 1 shows a schematic view of an exemplary introducer device in
accordance with the present disclosure.
[0012] Fig. 2 shows an exemplary drive assembly of the introducer device of
Fig. 1.
[0013] Fig. 3A shows another exemplary drive assembly of the introducer device
of
Fig. 1.
[0014] Fig. 3B shows an exemplary introducer device.
[0015] Fig. 3C shows another exemplary introducer device.
[0016] Fig. 4 shows yet another exemplary drive assembly of the introducer
device of
Fig. 1.
[0017] Fig. 5 shows a partial cross section view of the distal end of the
introducer
device of Fig. 1.
[0018] Fig. 6 is a flow chart of exemplary steps of a method in accordance
with the
present disclosure.
[0019] Figs. 7A-7C illustrate certain exemplary steps of the method of Fig. 6.
[0020] Fig. 8 shows yet another exemplary introducer device.
[0021] Fig. 9 shows yet another exemplary introducer device.
[0022] Fig. 10 shows yet another exemplary introducer device.
Detailed Description
[0023] The present application relates to embodiments of an introducer for the
incremental introduction or retraction of an instrument into or from a desired
location. The
introducer could be used to introduce any appropriate instrument, for any type
of application,
in any environment. For example, the introducer could be used for the
incremental
3
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
introduction or retraction of a medical instrument into or from a surgical
site on a patient
(adult, pediatric, adolescent and/or geriatric). The embodiments provided
herein will be
explained with respect to the introduction of medical instruments, but it is
understood that the
introducer is not limited to such medical uses. The device as described may
also be used in
many existing veterinary procedures. Reference now will be made in detail to
aspects of the
present disclosure, examples of which are illustrated in the accompanying
drawings. Wherever possible, the same reference numbers will be used
throughout the
drawings to refer to the same or similar parts.
[0024] The term "distal" refers to a portion farthest away from the operator
when
introducing an instrument into a subject. By contrast, the term "proximal"
refers to a portion
closest to the operator when placing the instrument into the subject. The
following
description refers to the introduction of medical instruments. As used herein,
a "medical
instrument" may include any type of instrument or device that is used in a
medical procedure,
regardless of the particular use purpose, specialty, or size of the
instrument. For example, the
medical instrument may be a laparoscopic instrument, such as a mini-
laparoscopic
instrument, a needle, sensor/chip, catheter, transfusion device, drain tube,
biopsy needle,
and/or devices containing fluids, etc. The medical instrument may also be an
introduction
port, such as a trocar, to provide an accessway for one or more additional
medical
instruments, or for the simultaneous introduction of instruments with the
introduction port.
Such an introduction port could be a regular port (such as 5, 10, 12mm) or
smaller. While
reference is made in this specification to medical instruments having
generally straight shafts,
it is understood that bent or curved instruments may also be used with the
disclosed
introducers.
[0025] Fig. 1 shows a medical device introducer 10 in schematic form. The
introducer 10 includes a housing 12 having a proximal end 14 and a distal end
16. A distal
4
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
cap 18 may be located at the distal end 16 of the introducer 10. A medical
instrument 20 is
supported within the introducer 10 and is coupled to an instrument drive
assembly 22. The
instrument drive assembly 22 includes a drive actuator 24 and incremental
drive linkages 26.
The introducer may also include a fluid supply assembly 28, including a
pressurized fluid
supply 30, a valve assembly 32, and a fluid conduit 34 that may run to the
distal end 16 of the
housing 12. The distal cap 18 may include a coupling end 36 for coupling with
the tissue of a
patient, and a passage 38 for receiving the medical instrument 20 and a supply
of fluid from
the fluid supply assembly 28, for allowing both the medical instrument 20 and
the pressurized
supply of fluid to exit through a distal opening in the introducer 10. As
shown in Fig. 1, the
drive actuator 24 may extend on both sides of a handle 40. The valve assembly
32 may be
provided at a central location of the proximal end 14 of the housing 12 so as
to be positioned
for use by both left and right handed users.
[0026] The housing 12 may receive a shaft of the medical instrument 20 as well
as a
part or all of the instrument drive assembly 22 and the fluid supply assembly
28. The
housing 12 may be any of a variety of shapes and sizes. Housing 12 may
include, for
example, a cylindrical shape as shown in Fig. 1, or may have a rectangular
open frame
configuration (Figs. 2 and 3) to allow for ease of loading and removal of the
medical
instrument 20 before, during, and/or after introduction. Thus, the housing 12
may fully
enclose a portion of the medical instrument 20, or partially surround the
medical instrument
20 with an open frame (FIGS. 2 and 3) to allow for quick removal of the
medical instrument
20 from the housing 12. The shape of the housing 12 may have contouring, for
example, to
allow for ease of grip by a user, or to fit more ergonomically into a surgical
field. The
housing 12 may be made in a variety of sizes, based on, for example, the size
of the medical
instrument 20 to be inserted by the introducer 10, the size of the drive
assembly 22, and/or
ease of handling or use. In another embodiment using various inserts with the
device, it may
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
also be possible to use the same introducer device for various sizes of
instrument. For
example using an insert kit it may also be possible to use instruments from 2,
3, 4, 5 mm and
including the larger size devices.
[0027] As best shown in Figs. 3-5, the housing 12 may have one or more
instrument
supports to support the medical instrument 20 from the proximal end 14 to the
distal end 16.
The handle 40 of housing 12 may be configured as a stationary pistol grip, as
depicted in Fig.
1. The housing 12 may optionally be constructed in multiple parts, with at
least one openable
seam running from the proximal end 14 to the distal end 16, such that it may
be separated for
accessing the medical instrument 20. Alternatively, the housing 12 could be a
closed
structure with a securable door member (not shown) that would allow for
connection/access/removal of the medical instrument 20.
[0028] The proximal end 14 of the housing 12 may be located proximate to the
user
or operator of the introducer, and the distal end 16 may be located closest to
the tissue of the
subject. The distal cap 18 is located at the distal end 16 of introducer 10.
The distal cap 18
may be constructed as a contiguous part of the distal end 16, or may be a
separately
constructed part. The distal cap 18 may be a single unit or may divide in
order to allow for
its removal after introduction of the medical instrument 20. The distal cap 18
may cover the
entire distal end 16, and may be coupled to the distal end 16 either removably
or
permanently. For example, distal cap 18 may be removably connected to distal
end 16 by a
peg-in-groove rotational coupling 17 (Fig. 1), by a threaded connection, by
adhesive, or
otherwise. With such a removable distal cap 18, the housing 12 could be a
reusable
component while the distal cap 18 could be single-use only. Removal of the
housing 12 from
the medical instrument 20 may include any appropriate connection, for example,
a series of
dovetail connections 115 and 117 (Fig. 5). The proximal end 14 of a frame-type
housing 12
(Figs. 2 and 3) may be removed from the medical instrument 20 (and separated
from housing
6
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
distal end 16) by sliding the frame-type housing 12 along lateral dovetails
connections 117
formed with distal end 16. Thereafter, the remaining distal end 16 of housing
that encircles
the medical instrument 20 can be removed from medical instrument 20 (after
disconnection
from distal cap 18 as described above) by sliding opposite mating portions of
distal end 16
along axial dovetails 115. With such a removal process, seal 114 may remain on
medical
instrument 20 and be removed as desired. Alternatively, the distal cap 18 may
be retained in
position on the patient to provide support for the medical instrument 20, or
for introduction of
a different medical instrument 20.
[0029] The medical instrument 20 may be any medical instrument or device
having
an elongate shaft for introduction into a patient. Examples of suitable
instruments 20 include
laparoscopic instruments, laparoscopic cameras, trocars, cannulas, wires,
interventional
radiology devices, stents, stent introducers, substance introducers, catheters
of all sizes and
rigidities, or fluid tubes.
[0030] In another embodiment when introducing an instrument or device, the
instrument or device could be surrounded by a sheath that would be advanced
together with
the instrument or device. This sheath could serve several functions, such as
to allow for fluid
to be delivered at the tip of the instrument or device being introduced, act
as a port if left in
place. This could potentially allow for the removal of the instrument and the
subsequent re-
introduction of the same or of another instrument or device. The sheath could
also allow for
the placement at its tip or on a tip of a medical instruments 20, one or more
sensors to
monitor, for example, pressure, or pH, etc. The sheath could also allow for
the placement at
its tip of a small blade or cauterization device that would incise/cut tissue
with each
advancement allowing for an easier introduction of the instrument or device. A
sheath could
also serve to protect the medical instrument 20, such as a laparoscopic
grasper, scissors or
camera.
7
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
[0031] An exemplary grasper is schematically illustrated in Fig. 1. A medical
instrument 20 for use in this disclosure may have an elongate shaft suitable
for passing
through the introducer 10 and into a surgical site, or may be inserted into a
carrying shaft (not
shown) for better compatibility with the introducer 10.
[0032] The instrument drive assembly 22 is configured to incrementally advance
the
medical instrument 20 towards and through the distal end 16 of the introducer
10. The
instrument drive assembly 22 may have an instrument drive actuator 24 and
incremental
drive linkages 26. A variety of instrument drive assemblies 22 may be suitable
for use in the
introducer 10. For example, the instrument drive assembly may be manually
powered,
electrically powered, pneumatically powered, hydraulically powered, or
otherwise. Further,
the instrument drive assembly be manually triggered, or may be automatic.
Examples of
different configurations for drive assembly 22 are depicted in Figs. 2-4.
[0033] Fig. 2 depicts a first exemplary embodiment of the drive assembly 22,
in
which the drive assembly 22 is manually powered and manually triggered. A
side, cross-
sectional view of a part of the housing 12 is depicted. In this embodiment,
actuator 24
includes manual trigger 44 pivotably coupled to handle 40 and arranged to abut
a spring-
biased tab 48. Examples of triggers could also be smaller (similar to that
found on firearms),
or could be a button near the grip site (similar to joysticks and computing
gaming), or further
could include a three-finger actuator, such as those used to actuate syringes.
Other possible
triggering mechanisms could be foot activated (such as with a pedal), or
remotely activated
(as in the case of robotic surgery where the activation would take place at a
console).
[0034] As shown in Fig. 2, teeth on a linear rack 50 interlock with teeth on
the tab 48.
Both the tab 48 and the rack 50 are depicted with opposing angled teeth. The
rack 50 is
coupled to the shaft 21 of the medical instrument 20 with, for example, a
releasable clip 54.
A clamp or other type of coupling mechanism may be used in lieu of a clip 54.
In an
8
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
alternative arrangement, a proximal end or rack 50 could include an abutment
that would
contact the proximal end of medical instrument 20 to push the medical
instrument 20 distally.
Upon the trigger 44 being actuated towards the handle 40, as indicated by
arrow 59, the
trigger 44 pushes the tab 48 towards the distal end 16 of the introducer 10.
The tab 48
compresses a spring 58 as it moves toward the distal end, and engages the
angled teeth of the
rack 50. The rack 50 and coupled medical instrument 20 are therefore pushed
towards the
distal end 16 of the introducer 10 with the tab 48. Upon release of the
trigger 44, the trigger
44 and the spring-biased tab 48 return to their original positions due to
pressure from the
compressed spring 58. The angle of the teeth on the tab 48 and the rack 50,
together with the
pressure from the compressed spring 58, allow the tab 48 to disengage from the
rack 50 when
returning to its original position, leaving the rack 50 and the coupled
medical instrument 20
in an incrementally advanced position. In this embodiment, an incremental
advancement
distance for the medical instrument 20 may be determined by, for example, the
"throw"
length and position of the trigger 44, the length and resistance to
compression of the spring
58, and/or the size of the teeth on the tab 48 and the rack 50.
[0035] In addition or alternatively, drive assembly 22 may include a
rotational drive
component 23 (Fig. 2) for rotating the medical instrument 20. According to one
aspect of the
disclosure, the rotational drive component 23 may be actuated with trigger 44,
however, it is
understood the rotational drive component 23 may be separately actuatable. If
associated
with trigger 44, rotational drive component 23 may include any conventional
structure for
converting liner to rotational movement. Thus, according to one aspect of this
disclosure,
actuation of trigger 44 can actuate both incremental linear advancement and
incremental
rotation of medical instrument 20. Alternatively or additionally, the
rotational drive
component 23 may include, a manual knob, or other mechanism coupled to the
medical
instrument 20 to allow for selective rotation of the medical instrument 20 by
the user.
9
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
Rotating the medical instrument 20 during introduction assists in movement of
the medical
instrument 20 through the tissue. For example such rotation would assist the
introduction of
a trocar incorporating laparoscopic devices. The introduction of a trocar or
other similar
device provides a mini port that allows for the re-introduction of other
medical instruments
20, such as flexible and semi-flexible catheters. When introducing a trocar
with the
introducer 10, a camera may be provided in the trocar lumen to provide for
visualization
during port placement.
[0036] Fig. 3A depicts a second embodiment of a manually powered and manually
triggered instrument drive assembly 60. A side, cross-sectional view of an
open frame
housing 62 is depicted. A manual trigger 64 is coupled to a handle 66, and
abuts an
advancement bar 68. Handle 66 may have left and right parts 66 (only one
shown) with the
trigger 64 sandwiched therebetween. The advancement bar 68 includes an opening
70 for
passage of the medical instrument 20, and is coupled to the housing 62 by an
angling spring
74. Upon the trigger 64 being pulled proximally, as indicated by arrow 71, the
advancement
bar 68 has an end 76 that is pushed towards the distal end 78 of the housing
62 while a spring
74 restricts proximal movement of an end 79 of the advancement bar 68 opposite
end 76.
The angling of the advancement bar 68 causes the shaft 21 of the medical
instrument 20 to be
secured with the edges of the opening 70 in the advancement bar 68, thereby
gripping the
shaft 21 of the medical instrument 20 and advancing the instrument 20 toward
the distal end
78. Upon release of the trigger 64, the advancement bar 68 loses securement on
the medical
instrument 20 and returns to its original position, leaving the medical
instrument 20 in an
incrementally advanced position. A brake bar 80, located at the proximal end
81 of the
housing 62, also includes an opening 82 through which the shaft 21 of the
medical instrument
20 passes. A spring 72 angles the brake bar 80 and opening 82 to provide a
grip on the shaft
21 of the medical instrument 20 to prevent unintended movement of the medical
instrument
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
20 away from the distal end 78, when the advancement bar 68 is not coupled to
the shaft 21
of the medical instrument 20. The brake bar 80 may be pressed distally,
compressing the
brake spring 72 and eliminating the gripping action of the brake bar 80 on the
shaft 21 of the
medical instrument 20, allowing for a manual pushing or pulling movement of
the medical
instrument 20 when the advancement bar 68 is not gripping the shaft 21 of the
medical
instrument 20.
[0037] Fig. 3B depicts an introducer device 300 similar to the introducer
device 10 of
Fig. 1, and drive assembly 60 of Fig. 3A, with common reference numbers being
used to
identify the same or similar elements. Introducer device 300 includes a stroke
limiter 310
having, for example, a threaded bolt 312 extending through brake bar 80 and
brake spring 72,
and threadingly engaging housing 62. Stroke limiter 310 has a distal end 314
(shown in
dashed lines) that abuts a top end of trigger 64 to limit forward motion of
the bottom end of
trigger 64 (i.e., counter-clockwise motion of trigger 64 in Fig. 3B).
Turning/rotating threaded
bolt 312 controls the axial position of the distal end 314, which controls the
stroke length of
trigger 64, thus adjusting the movement of shaft 21 of medical instrument 20
for each trigger
actuation. It is understood that stroke limiter 310 need not include the
threaded bolt 312, but
could include any other appropriate element or elements to limit the travel of
trigger 64.
[0038] The introducer device 300 of Fig. 3B may also include a shaft securing
device 318. Shaft securing device 318 may include a rotating plate that blocks
the medical
instrument 20 from being radially removed from housing 62. Housing 62 may
include a
series of aligned radial grooves 322 (located on the introducer device 300
opposite the side
shown in Fig. 3B, and indicated with dashed lines) extending to a centerline
of the device
300. Similarly aligned radial grooves are also included in brake bar 80 and
advancement bar
68. The aligned radial grooves allow the medical instrument 20 to be radially
inserted into
and removed from housing 62. Shaft securing device 318 is rotatable about an
axis parallel
11
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
to medical instrument 20, to block or unblock a portion of radial groove 322
in housing 62.
When unblocked, the medical instrument 20 can be introduced or removed from
housing 62.
When blocked, the shaft securing device 318 assists in ensuring that medical
instrument 20
remains properly positioned within the radial grooves 322. It is understood
that shaft
securing device 318 can be any type of device that closes a portion of the
radial grooves to
help secure the medical device 20 in place.
[0039] The introducer device 300 of Fig. 3B may be configured to include a
distal cap
330 similar to distal cap 18 of the introducer device 10 of Fig. 1, except
that fluid conduit 34
may directly couple to distal cap 330 rather than run through housing 62.
Thus, fluid conduit
34 may couple to the valve assembly 32 and fluid supply outside introducer
device 300. It is
understood that valve assembly 32 may alternatively be formed as part of
distal cap, and can
be controlled in any appropriate manner.
[0040] Distal cap 330 may be secured to housing 62 in any appropriate manner,
such
as the peg-in-groove coupling disclosed with respect to the introducer device
of Fig. 1. Distal
cap 330 may alternatively be coupled to housing 62 with a ball-and-socket type
connection,
such that the distal cap 330 may swivel and rotate with respect to housing 62.
Such a ball-
and-socket connection may include a ball element (not shown) protruding from
housing 62,
and a mating locking cap and end cap (not shown) on the proximal and distal
sides of the
ball, respectively (and/or vice versa). The locking and end caps can be, for
example,
threadingly engaged allow both sliding and locking of the ball between the
locking and end
caps. Alternatively, the locking cap can include a slot to limit movement of
the distal cap
330 relative to the housing 62 only along the slot axis.
[0041] Fig. 3C depicts an introducer device 400 similar to the introducer
device 300
of Fig. 3B, with common reference numbers being used to identify the same or
similar
elements. Introducer device 400 includes a drive rod 410 that is coupled to
the medical
12
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
instrument 20 via a releasable clip 412, similar to the coupling described
with respect the
embodiment of Fig. 2. Drive rod 410 is driven by an advancement bar 68 in a
similar manner
as the drive assembly 60 of Fig. 3A.
[0042] Fig. 4 depicts another alternative embodiment of the instrument drive
assembly 22 of Fig. 1. This embodiment considers that the drive mechanism can
be powered
from a mains supply (at line voltage or stepped down by a transformer),
battery power pack
or other similar power supply to drive the instrument the requisite
incremental distance. The
drive mechanism also incorporates a safety override to prevent accidental over-
introduction,
examples of such sensing may occur from closed loop feedback, pressure sensing
or other
suitable methods. In this embodiment, an introducer 100 includes an automated
drive
assembly 84. The drive assembly 84 is schematically depicted in a cross-
sectional side view
in Fig. 4. The automated drive assembly 84 may be in a housing 86 that may
split in half to
facilitate loading or unloading of the medical instrument 20. A plurality of
holding rollers 90
are configured to hold the medical instrument shaft 21 and allow for smooth
advancement.
At least one driving roller 92 is connected to a driving motor 94 which is
controlled by an
actuator 96. In Fig. 4, the actuator 96 is represented by a button, but may be
in any form that
can activate the driving motor 94. The rollers 90, 92 may be engaged or
disengaged from the
shaft of the medical instrument 20 by means of a roller engagement mechanism,
controlled
by, for example, a roller engagement button 98. Additional idler rollers (not
shown) may be
included to aid in keeping the shaft 21 of the medical instrument 20
appropriately positioned,
and allow for smooth advancement of the medical instrument 20 towards a distal
end 102 of
the housing 86.
[0043] A variety of configurations of driving rollers, holding rollers and
idler rollers
are possible, depending on the medical instrument 20 intended for use in the
housing 86. In
this embodiment, the mechanism to measure or control the incremental
advancement of the
13
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
medical instrument 20 may be determined by, for example, a fixed time of
delivery of power
to the driving motor 94 each time the actuator button 96 is pressed. The fixed
time may be
set, for example, by an increment adjustor button or dial (not shown) on the
device itself
Alternately, the actuator button 96 may directly activate the driving motor
94, such that the
user may control the advancement distance by pressing the actuator button 96
for the desired
amount of time. The driving motor 94 may be powered using a direct connection
to an
electrical outlet, or may be battery-operated to allow for more freedom of
movement during
use of the introducer 100. Further, the actuator button 96 may power both the
driving motor
and the fluid supply assembly 28, such that activating the actuator button 96
may release a
desired amount of fluid and subsequently or substantially simultaneously
advance the
medical instrument 20. Even further, driving motor 94 may be reversible so
that the medical
instrument 20 may be withdrawn if desired.
[0044] The embodiment of Fig. 4 may also include a driving motor 94 with
pressure-
sensing capabilities. As such, the driving motor 94 may be able to sense the
pressure acting
on a medical instrument 20 as it progresses through tissue layers, for
example, in the
abdomen, to the peritoneal layer. This pressure sensing capability may have
several uses.
For example, a medical instrument 20 that is being incrementally inserted by a
medical
introducer 100 according to this disclosure will experience a rise in pressure
while traversing
the peritoneal layer. Once the medical instrument 20 passes through the
peritoneal layer, the
pressure on the medical instrument will reduce. By sensing these changes in
pressure
through the driving motor 94, an introducer 100 according to Fig. 4 may be
able to sense that
the medical instrument 20 is under little or no pressure and is therefore
inserted into the
abdominal cavity. As another example, pressure-sensing capabilities in the
driving motor 94
could be used to sense when the medical instrument 20 has collided with tissue
within the
surgical site. An introducer 100 according to this embodiment may be linked to
or equipped
14
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
with an alert system, such as a display screen, a light, or an audible alert,
to notify the user of
the introducer 100 that the medical instrument 20 is inserted into the
abdominal cavity, or that
medical instrument 20 has collided with tissue within the surgical site. In
another
embodiment other sensors such as pH, oxygen monitoring, temperature monitoring
and other
such sensing could also be introduced using the introducer device.
[0045] Referring back to Fig. 1, and as noted above, introducer 10 according
to the
present disclosure may include a fluid supply assembly 28, comprising a
pressurized fluid
supply 30, an valve assembly 32, and a fluid conduit 34 from the valve
assembly 32 to the
distal end 16 of the introducer housing 12. The fluid supplied by the fluid
supply assembly
28 may be any surgically compatible fluid, such as a non-combustible gas
(e.g., carbon
dioxide) or a sterile liquid (e.g., saline). In another embodiment the
surgically compatible
fluid could include therapeutic fluids/gels/other substances; some examples
include local
anesthetic agents, local pain relief and hemostasis substances.
[0046] Pressurized fluid supply 30 may be connected to the housing 12 through
the
valve assembly 32. The valve assembly 32 may comprise a manual control valve
including a
manual actuator 110, and a two-position valve body 33 biased toward a closed
position
(shown in Fig. 1). Upon actuation of the actuator 110 the valve body 33 moves
to an open
position and pressurized fluid from the fluid supply 30 enters the fluid
conduit 34 and
supplies pressurized fluid to the distal end 16 of the housing 12. The valve
assembly 32 may
be a manually-activated mechanical button as shown in Fig. 1, or may comprise
an electronic
valve assembly. The system may supply pressurized fluid under constant or
variable
pressure.
[0047] As best seen in Figs. 1 and 5, fluid conduit 34 runs from the valve
assembly 32
through the housing 12, to the distal end 16 of the housing 12, where it joins
with a passage
38 in the distal cap 18. Alternatively, fluid conduit 34 could be formed with
a separate tube
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
(e.g., a rubber or plastic tubing) running outside the housing 12 and
extending from valve
assembly 32 to a connection at the distal end 16 of housing 12. In a further
embodiment
where the device is used outside the hospital (for example in battlefield
hospital) there may
also be a requirement for the device to include a self-contained gas (such as
a CO2 cartridge)
or liquid supply. When air is used as a gas to assist with incising, a bulbous
hand pump may
be attached to the trigger 40. With each activation of the trigger 40 the gas
is transmitted to
the required location.
[0048] In one embodiment, towards the distal end 16 of introducer 10, the
conduit 34
widens to become a conduit for both the instrument 20 and the pressurized
fluid, such that the
shaft 21 of the medical instrument 20 and the fluid pass through the same
conduit 34 at the
distal end 16. A seal 114, such as an o-ring seal, may be located at a
proximal portion 35 of
conduit 34, prevents fluid in the conduit from exiting the conduit 34 at the
proximal entry
point of the medical instrument 20 into the conduit 34. In addition or
alternatively, the
medical instrument may include a seal (not shown) about its shaft to assist in
sealing the fluid
passage. The fluid conduit 34 may be coaxial with the conduit for the medical
instrument 20,
as depicted in Fig. 5. Further, portions of fluid conduit 34 may be exterior
to the housing 12
of the introducer 10, until it enters the housing 12 near the distal end 16 of
the housing 12 and
creates a conduit for both the medical instrument 20 and the pressurized fluid
supply. This
conduit may also surround the instrument and extend into the tissues.
[0049] As noted above, the introducer 10 according to the present disclosure
also
includes a distal cap 18 at the distal end 16 of the housing 12. The distal
cap 18 may include
a distal coupling end 36 for coupling with the outer tissue (e.g., skin) at a
surgical site of a
subject. The coupling end 36 may be configured to couple to the tissue of the
surgical site in
a manner that allows the user of the introducer 10 to pull the outer tissues
up and away from
the inner tissues. For example, the coupling end 36 may be coated with a
waterproof
16
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
biocompatible adhesive suitable for attaching to skin. As another example, the
coupling end
36 may be coupled to tissue with one or more manually-operated tissue clamps
positioned
around the flange 37. As a third example, the coupling end 36 may include one
or more
openings 111 fluidly connected to a suction supply 112 to create a suction-
type connection
with the skin. Openings 111 in coupling end 36 may include suction cups to
better isolate the
suction pressure. While coupling end 36 is shown in Fig. 1 as being circular,
it is understood
that other shapes are possible, such as an "X" shape with each branch of the
"X" having a
suction opening 111. Alternatively, the coupling end may include a series of
ring shaped
grooves separated by protruding rings forming a bulls-eye configuration.
Alternating rings
could be connected with suction supply 112. By applying suction to separate
sections of the
coupling end 36, the potential for the leakage of positive or negative
pressure is lessened.
According to one aspect, applying additional vacuum bursts with each actuation
of trigger 40
would allow better contact with the skin and less potential for accidental
detachment.
[0050] The distal cap 18 of the introducer 10 also may include a passage 38
for
receiving the medical instrument 20 as it passes out an exit port at the
distal end 16 of the
introducer 10, as well as the fluid supply from the fluid supply conduit 34.
For example, Fig.
depicts a distal cap 18 with a centered passage 38 that continues from the
fluid conduit 34
in the housing 12, and that ends in a distal opening of the introducer 10
through which both
the medical instrument 20 and fluid from the fluid supply 30 may pass to exit
the introducer
10. A further embodiment of this system is that it could also be developed as
an attachment
for robotic devices where for example the robotic arm approaches the patient.
A suction end
36 that attaches to the skin and instruments are automatically introduced.
[0051] Fig. 6 depicts a method for advancing a medical instrument into a
surgical site
in a controlled manner. According to a first step 120, a predetermined volume
of fluid may
be set, and may be based on parameters relevant to the surgery, surgeon and/or
patient. The
17
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
volume of fluid may be preset, or may be variably set by the operator. As
noted above, the
fluid may be a biocompatible noncombustible gas known in the art (e.g., carbon
dioxide), or
may be a biocompatible liquid. In step 140, a predetermined advancement
distance for the
medical instrument 20 into the surgical site may also be set, and may be based
on parameters
relevant to the surgery, surgeon and/or patient, and/or on the predetermined
volume of fluid.
The advancement distance may also be preset, or may be variably set by the
operator. For
example, in some laparoscopic procedures, a predetermined advancement distance
may be
between 2 and 4 millimeters. The distance advanced may also be regulated by
the pressure
(or other) sensor at the tip of the instrument. The addition of a monitoring
imaging or
sensory device (such as an ultrasound or a chip) able to identify intra-
abdominal viscera (such
as intestine, spleen, liver) and blood vessels, and to distinguish it from the
abdominal wall,
would provide for a more safe device since it would incorporate an automatic
safety
mechanism to avoid further advances of the instrument if such structures are
not displaced by
the bursts of fluid/air.
[0052] In step 160, a preliminary incision may be made in the tissue at the
instrument
introduction site. The preliminary incision may be made by using a small blade
on the
medical instrument introducer 10, or optionally using a separate, suitable
surgical instrument
known in the art. Alternatively small blade or lancet may be incorporated in
the introducer
that activated to make the initial incision (similar to mechanisms used to
obtain a drop of
blood to measure glucose levels in diabetic patients). Another variation would
include
having the blade advance together with the instrument, and cutting the tissues
with each
triggering.
[0053] The introducer 10 may then be applied to the tissue at the instrument
introduction site (step 180). For example, Fig. 7A depicts the introducer 10
being applied to
tissue at a surgical site. Application of the introducer 10 to the tissue at
the site may include
18
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
coupling the introducer to the tissue at the instrument introduction site by
means of an
adhesive such as a biocompatible adhesive, medical tissue clips, or other
means known in the
art, as described above. Once secured to the tissue, the introducer 10 may be
used to lift the
outer tissue at the introduction site away from the inner tissue (step 190),
allowing for more
space to be created underneath the outer tissue.
[0054] A predetermined volume of fluid may then be supplied through the
introducer
into the preliminary incision at the instrument introduction site (step 200).
For example,
Fig. 7B depicts the introduction of fluid through the medical introducer 10
into the surgical
site. The medical instrument 20 may then be advanced by the previously set
predetermined
distance through the introducer 10 and the preliminary incision (step 210).
Step 210 may be
carried out after completion of supplying of the predetermined volume of fluid
(step 200) or
may be carried out merely after initiation of the supply of fluid. For
example, Fig. 7C depicts
the advancement of a medical instrument 20 through the medical instrument
introducer 10
and the preliminary incision. Following insertion of the medical instrument 20
into the
surgical site by the predetermined distance, the predetermined volume of fluid
may be
reapplied through the introducer and the medical instrument may be further
advanced by the
predetermined distance repeatedly, until the medical instrument is inserted to
the desired
depth and/or position. It is understood that the present disclosure is not
limited to a method
requiring all of the steps of Fig. 6, but rather, certain identified steps may
be omitted, and/or
other steps added.
[0055] Figs. 7A-7C further depict a method of introducing a medical instrument
20
into a surgical site using an introducer 10. The distal cap 18 of the
introducer 10 is brought to
a preliminary incision in a patient's outer tissue 212 at a surgical site. The
coupling end of
the distal cap 18 is brought into contact with the outer tissue 212. As
previously described,
the coupling end may be adhered or affixed to the outer tissue 212 by a
variety of means.
19
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
Referring to Fig. 7B, a pre-set amount of fluid is introduced through the
central passage 38
into the preliminary incision. The introduced fluid may create a new space
between the outer
tissue 212 and underlying viscera 214 adhering to the outer tissue 212, as
depicted in Fig. 7B,
or may enlarge a preexisting space between the outer tissue 212 and underlying
viscera 214.
Referring to Fig. 7C, the medical instrument 20 is then advanced by a pre-set
distance into
the space created or maintained by the fluid. Variations on the above-
described introducer
and method will be evident to those of ordinary skill in the art.
[0056] Fig. 8 depicts an introducer device 800 similar to the introducer
device 300 of
Fig. 3B, with common reference numbers being used to identify the same or
similar elements.
Introducer device 800 includes a drive assembly 810 having a rotating cam 820
and a clamp
830 coupled for movement with trigger 64. The rotating claim 820 may be
rotated into
contact with the medical instrument 20 by manual manipulation via a dial or
button located
outside the housing 62.
[0057] Clamp 830 is coupled to trigger 64 through a rod 840 and plate 850
rigidly
coupled to clamp 830. Upon actuation of trigger 64, a top end of trigger 64
contacts and
moves plate 850 distally, which in turn moves rod 840 and clamp 830 distally.
Upon
movement of the clamp 830 distally, a ramp 860 of the clamp 830 slides on a
ramp 870 of
housing 62, and urges the clamp 830 toward medical instrument 20. The clamp
830 engages
and moves medical instrument 20 if the rotating cam 820 has been moved into
contact with
the medical instrument 20. However, if the rotating cam 820 is in the position
shown in Fig.
8, then distal (or proximal) movement of clamp 830 will not move medical
instrument 20.
Thus, the rotational position of the rotating cam 820 dictates whether the
clamp 830 moves
the medical instrument 20. In such an arrangement, the rotating cam 820 can be
positioned to
move medical instrument 20 distally or proximally depending on whether the
trigger is
moving plate 850 distally, or allowing plate 850 to move proximally due to
springs 74.
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
[0058] Fig. 9 depicts an introducer device 900 similar to the introducer
device 800 of
Fig. 8, with common reference numbers being used to identify the same or
similar elements.
Introducer device 900 includes a plurality of forward motion cams 930, and a
plurality of
rearward motion cams 940. The forward and rearward motion cams 930 and 940 are
secured
to housing 62, and movable radially with respect to the housing 62. Springs
950 and 960
urge forward and rearward motion cams 930 and 940 radially outward. A
plurality of clamps
910 and 920 are rigidly coupled to rods 840 and plate 850 to move with the
actuation and
release of trigger 64. Upon proximal or distal movement of plate 850, rods
840, and clamps
910 and 920, forward or rearward motion cams may be actuated manually
(depressed
radially) to secure clamps 910 or 920 on medical instrument 20, and thereby
move medical
instrument 20. Thus, depending on when the cams 930 or 940 are actuated during
the
movement of plate 850, the medical instrument 20 can be moved proximally
and/or distally.
[0059] The introducer device 900 may also include a stroke limiter (not shown)
protruding inwardly from the housing 62 to limit movement of plate 850.
Further, releasable
locking mechanisms (not shown) may be incorporated into forward and rearward
motion
cams 930 and 940 to further control movement of the medical instrument 20.
[0060] Fig. 10 depicts an introducer device 1000 similar to the introducer
device 900
of Fig. 9, with common reference numbers being used to identify the same or
similar
elements. Introducer device 900 includes a plurality of motion cams 940
secured to housing
62, and movable radially with respect to the housing 62. Springs 960 urge
motion cams 940
radially outward. A plurality of clamps 920 are rigidly coupled to rods 840
and plate 850 to
move with the actuation and release of trigger 64. Upon proximal or distal
movement of
plate 850, rods 840, and clamps 920, motion cams 940 may be actuated manually
(depressed
radially) to secure clamps 920 on medical instrument 20, and thereby move
medical
21
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
instrument 20. Thus, depending on when the cams 940 are actuated during the
movement of
plate 850, the medical instrument 20 can be moved proximally and/or distally.
[0061] Further additions to and variations on the medical introducers and
method
disclosed herein are possible. For example, the introducers in any of the
embodiments
described herein may include an imaging device, such as an ultrasound probe,
to allow for
even safer incremental advancement of a medical instrument 20. Additionally,
any of the
above embodiments may further include a safety catch, valve, or switch, to
prevent accidental
injection of fluid, overpressurization, or advancement of the medical
instrument beyond what
is desired. Further, any of the above embodiments may be used or performed in
combination
with added lubrication for easier access to the surgical site, provided by
flushing saline
through the introducer and into the site, or by the separate addition of
sterile lubrication to the
site. The above may also provide thermal changes, such as freezing and
cauterizing.
Introducers according to this disclosure may be single-use devices, or may be
created so as to
be reusable. The embodiments described herein can be used independently of
other
laparoscopic introduction tools, such as trocars or ports, or can optionally
be used in
combination with trocars, ports and/or other surgical instruments.
[0062] While this patent introduces a new version of technology, the
introducer 10
will also complement existing laparoscopic techniques. For example, in cases
where
additional instruments may be required or would make the procedure simpler or
quicker,
introducing such instruments with the introducer 10 would make it more
acceptable to the
surgeon (and of more rapid implementation) since no additional ports will be
required.
[0063] The invention according to this disclosure may exhibit a variety of
features.
For example, a controlled burst of fluid, when introduced in the abdominal
cavity, may
dissect away potential viscera or adhesions from the abdominal wall as well as
from the
instrument 20. This dissection may occur with or without a pneumoperitoneum in
place; in
22
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
the latter case, obviating the need for a pneumoperitoneum and increasing the
safety of the
surgery to the patient. The controlled burst of fluid may also decrease
resistance imposed by
the abdominal wall when attempting to reach difficult-to-access sites.
Furthermore, the
introduction of a pre-set volume of fluid and the advancement of a medical
instrument 20 by
a predetermined distance using the introducers and methods described herein
may avoid
uncontrolled or accidental pushing of a medical instrument into the abdominal
cavity (or
other surgical site), thus avoiding associated injuries to viscera and
structures in the area of
the surgery.
[0064] The devices and methods described herein also may result in the
elimination
of traditional ports and trocars for laparoscopic procedures, allowing for,
for example,
flexibility in surgical approach. Where a surgeon might traditionally have
been limited to a
small set number of immobile ports for a laparoscopic procedure, the devices
and methods
described herein allow for the creation of numerous ports in various
positions, allowing for
easier surgical access to desired sites with minimal added strain and risk on
the patient. The
elimination of port restrictions may also decrease interference, pushing, or
collisions between
various instruments being used simultaneously in the surgical field. The
elimination of port
restrictions may make laparoscopic techniques easier and safer, the approach
could also
facilitate both therapeutic and diagnostic procedures. The present system and
method using
fluid dissection may reduce the number of port scars associated with larger,
set ports. Also,
the present system and method may reduce the occurrence of hernias developing
at the
instrument (or trocar) insertion points, and decrease trauma to the abdominal
wall.
Additionally, the elimination of a need for a large port or trocar enables the
use of smaller
diameter medical tools (i.e., only the medical instrument and no surrounding
port or trocar)
having to be inserted into the surgical site. The insertion of a smaller
instrument, and lower
numbers of instruments, may mean a lower risk of injury to the patient, a less
invasive
23
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
surgical procedure, and/or a lower cost procedure. The insertion of a smaller
instrument may
also mean that once the medical instrument is withdrawn, no closure of a large
port-created
wound is required.
[0065] Another feature of the devices and methods herein is that they may
expand the
potential use scenarios for laparoscopic medical instruments and procedures.
For example, a
decrease in the complexity of laparoscopic surgeries caused by the elimination
of a need for
set ports may allow for more advanced, and greater use of, diagnostic
laparoscopy. It is also
envisaged that future pre-identified laparoscopic procedures could be
completed with local
anesthesia at locations previously not amenable to these techniques, with a
decreased risk of
infection, with portable single use, (sterile, disposable devices) with the
potential to use
imaging devices such as for example ultrasound and cameras used in conjunction
with cell
phones, laptops or portable computer tablet type devices. Laparoscopy using
the devices and
methods disclosed herein could be expanded to the diagnosis of various
pathologies in
intensive (critical) care units, emergency rooms by surgeons and emergency
room physicians,
in battlefield settings, in rural areas, or in telemedicine, for example.
Diagnostic laparoscopy
using these devices could be performed as a bedside procedure, under local
anesthesia,
(especially if spraying the anesthetic agent at the site of the intervention
and over the
peritoneal surfaces), as only a small sterile field may be required, and
closure of the surgical
wound may be accomplished simply by withdrawing the medical instrument or
instruments,
without the need for sutures. The devices and methods disclosed herein could
also be used to
add laparoscopy to interventional radiology procedures, allowing for hybrid
imaging/laparoscopic approaches to radiology, and an expanded spectrum of
diagnostic
and/or therapeutic interventions. Similarly, laparoscopy could be added to
hybrid procedures,
endoscopic procedures such as colonoscopies, gastro-duodenoscopies, and ERCP,
allowing
for a combined endo-exo visceral approach to better outline pathologies and
obtain tissue
24
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
samples. The device could also be considered for use in various interventional
radiology
procedures, fertility treatment procedures, hybrid procedures (such as
endoscopy,
interventional radiology), nerve block and other various pain management
procedures or
could also be considered for cardio-thoracic or orthopedic procedures. The
instruments may
also be compatible to be used in conjunction with Magnetic resonance, CAT (CT)
Scan,
Positron Emission Tomography (P.E.T. Scan), Ultrasound and other imaging
systems.
[0066] The devices and methods disclosed herein can also be used as a
complement
to traditional laparoscopic instruments, as portless instruments introduced
according to this
disclosure could facilitate the action of classic laparoscopic instruments and
techniques.
[0067] A further feature of the devices and methods described herein is that
they may
be adaptable to a wide variety of cases and procedures beyond laparoscopic
procedures, such
as pediatric interventions, ob/gyn procedures, and neurologic procedures (such
as operations
in small fields, procurement of cells, and spinal access procedures). The
devices and
methods herein may also be applicable in veterinary procedures. Introducers
and methods
according to this disclosure may be adapted to introduce a medical instrument
into the
abdominal cavity, or elsewhere in the body, such as into the reproductive
system or the
circulatory system. Further, as explained above, the disclosed introducers are
configured to
be used with a variety of different instruments, and thus is not limited to
only introducing a
particular instrument.
[0068] Other embodiments of the present disclosure will be apparent to those
skilled
in the art from consideration of the specification and practice of the
embodiments disclosed
herein. While various examples provided herein illustrate specific types of
introducers and
methods, one of ordinary skill in the art will recognize that other
configurations of a medical
instrument introducer, and variations upon the methods described, also may be
used. For
example, the introducer 10 could insert the medical instrument 20 without the
positive
CA 03017626 2018-09-12
WO 2017/161311
PCT/US2017/023029
pressure or suction pressure described above. Further, any features of an
embodiment
disclosed herein may be incorporated into any other embodiment.
26
