Note: Descriptions are shown in the official language in which they were submitted.
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Applicator for robot-assisted surgery
Technical field
The present disclosure relates to an applicator, more specifically a
laparoscopic
applicator for dispensing a medical substance or fluid at a selected site by
means of a
surgical robotic arm. The invention further relates to a laparoscopic
applicator tip for the
laparoscopic applicator, a kit of parts comprising said applicator tip and/or
applicator.
Background
Robotic systems are increasingly used in surgery, particularly minimally
invasive
surgical procedures, to avoid the more invasive traditional open surgery
techniques. A
robotic system includes a number of robotic arms to which medical devices are
attached, and where the robotic arms and the medical devices are controlled
and
manipulated by the surgeon from a console, e.g. via control devices such as a
joystick
and foot pedal. Hence, the robotic arms replace the surgeon's hands at the
surgical
site, and the surgeon is instead located remotely from the patient and views
the
surgical site via a display showing a three-dimensional view of the surgical
site.
Similarly to traditional open surgery techniques, where an assistant provides
the
physically present surgeon with the required medical devices, in robotic
surgery an
assistant is positioned near the robotic arms to provide the arms with the
required
medical devices. For example, the assistant may replace the medical devices of
the
robotic arms, and provide medical fluids, either directly as a medical device
to the
robotic arm, or via an applicator tube introduced into the body via a trocar
port.
Surgical haemostatics, as well as other medical fluids and pastes, are
traditionally
dispensed to a target site by use of a manually operated syringe comprising
the paste
within the syringe barrel. However, for minimally invasive surgical
procedures, the
target site is not directly accessible to syringe cannula. Hence, to dispense
paste to a
target site within a bodily cavity, an elongated applicator tube prefilled
with the paste is
typically introduced into the body via a trocar port. The insertion of the
elongated
applicator tube occurs at the trocar port, and is therefore not visible to the
surgeon
performing the minimally invasive surgical procedure, because the surgeon's
field of
view is limited to the display showing the internal target site in high-
definition. Thus, the
insertion of the applicator tube, as well as the dispensing of the paste from
the
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applicator tube, is typically performed by the surgeon's assistant, via oral
instructions of
the surgeon. Consequently, the dispensing of the paste using the presently
available
systems is not controlled directly by the surgeon.
US 9,636,177 discloses a robotic arm to which a haemostatic applicator,
comprising a
catheter and a syringe filled with a haemostatic agent, is attached, and where
the
haemostatic agent is discharged from the catheter to the surgical site, when
the
surgeon depresses a button actuating the syringe plunger.
US 2012/0289894 discloses a suction/irrigation device for laparoscopic
surgery,
comprising a tip graspable by a robotic tool. The supply of liquid/vacuum to
the device
is delivered from a remotely located valvular unit including valves located
outside and
remotely from the surgical field. Hence, the device is adapted for irrigation
with free-
flowing fluids, such as liquids and gasses, from a remote source.
EP 1 915 950 discloses an adhesive applier, where the distal applicator tip
may be
moved via cables extending to a proximal manual handle. Similarly, US
2009/171332
discloses a distal applicator tip which may be moved by cables.
To further improve robotic-assisted surgery, medical devices that are adapted
to be
controlled by robotic arms, and hence directly by the surgeon, are desired.
Particularly,
there is a need for devices which may be controlled by robotic arms with a
higher
precision, accuracy, and intuitive haptic control, such that the reproduced
remote
operation of the robotic arm simulates the surgeon's interactions to a higher
degree.
Furthermore, there is a desire to have medical devices that give feedback to
the
surgeon, e.g. relating to the amount of paste available in the elongated
applicator tube.
Summary of invention
The present disclosure relates to an applicator, which is particularly
suitable for robotic-
assisted surgery. Particularly, the present disclosure provides an applicator
suitable for
insertion into a trocar port and having an applicator tip, where the
orientation and/or the
activity of the applicator, is actuated via the inserted applicator's distal
end or the
applicator tip. Thus, the applicator may be manipulated and activated via the
applicator
tip, and hence it is particularly suitable for being manipulated and activated
by a robotic
arm interacting with the applicator distal end/tip e.g. intra-abdominally
during the
medical procedure at the surgical site, e.g. wherein the applicator is
configured for
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intra-abdominal delivery of a medical substance. The medical substance may be
a
medical fluid, a medical paste and/or a medical powder.
Replacing the movements of actual human hands by robotic arms controlled by
computer software, facilitates very precise and controlled movements. Hence, a
laparoscopic applicator being spatially manipulated by a robotic arm may be
more
precise and accurately controlled, as well as being more reliable with reduced
risk of
accidental movements, which are critical during surgery. Thus, for example a
laparoscopic applicator for dispensing a medical substance by means of a
robotic arm,
will be able to dispense the substance at a selected site more precisely and
reliably.
Specifically, a robotic manipulated applicator for dispensing a haemostatic
substance
at a selected site, may result in a bleeding being stopped more efficiently.
Since robotic arms and fingers as such have restricted haptic feedback and
design
compared to human hands, the means for manipulating and activating the
applicator's
distal end/tip may advantageously be adapted for robotic arms/fingers to
enhance the
safety, accuracy and reliability of the applicator.
Applicator and applicator tip
Hence, the present disclosure is generally related to an applicator, which
orientation
and/or activity may be accurately and reliably controlled by a robotic arm
with restricted
design and haptic feedback. Particularly, the present disclosure is generally
related to
an applicator having an applicator tip configured for being controllable
operated by the
robotic arm, such that only the tip needs to be accessible and visible to
robotic arm.
A first aspect of the present disclosure relates to a laparoscopic applicator
for
dispensing or withdrawing a substance, such as a substance comprising a
haemostatic
agent, at a selected site by means of a surgical robotic arm, the laparoscopic
applicator
comprising:
- a delivery tube for holding the substance; and
- an applicator tip connected to a distal end of the
delivery tube, the applicator tip
configured for:
- being spatially manipulated by the robotic arm, and/or
- controllably releasing the substance from the delivery tube by the
robotic
arm, or controllably withdrawing the substance from the selected site into the
delivery tube.
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Preferably, the applicator tip is configured for being controllable operated
by the robotic
arm by either the tip being spatially manipulated by the robotic arm, and/or
the tip being
configured for releasing/withdrawing substance by the robotic arm.
The spatial discharge of the substance is mainly determined by the orientation
of the
distal end of the delivery tube and/or the orientation of the applicator tip.
A flexible
orientation of the distal end / applicator tip may be obtained by a partially
deformable
applicator, e.g. wherein at least a part of the delivery tube is stretchable
and/or flexible.
Hence, the delivery tube may comprise a deformable section. The distal end of
the
tube / applicator tip is preferably manipulated by a robotic arm during
laparoscopic
surgery, such that the surgeon may orient and position the distal end / tip by
use of the
robotic arm. In order to reduce the risk of the robotic arm squeezing,
breaking or
kinking the applicator during the manipulation, the applicator may include a
surface
area adapted for safe interaction with the robotic arm. For example, the
applicator may
include a rigid section, which is less deformable and therefore particularly
tangible and
adapted for safe manipulation by the robotic arm. The rigid section may be
provided on
the delivery tube and/or on the applicator tip.
The release of the substance is preferably controlled by the robotic arm in-
situ during
the laparoscopic surgery. Thus, the applicator may include at least one
actuator
adapted for safe interaction with a robotic arm, such as an actuator
configured to be
activated by a specific pressure level and/or a specific pressure orientation
applicable
via a robotic arm. The actuator(s) may alternatively be activated by pulling
or rotation of
the actuator.
Advantageously, the delivery tube of the applicator is configured for holding
the
substance under a pressure or holding a pressurized substance at least
immediately
before the substance is discharged. This may provide a more precise and
reliable
discharge of a substance at a determined site and at a determined time, For
example,
this has the advantage that the substance may be released from the delivery
tube by a
simple interaction with the applicator tip without significant time delay.
Thus, a related aspect of the present disclosure relates to a laparoscopic
applicator for
dispensing or withdrawing a substance, such as a substance comprising a
haemostatic
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agent, at a selected site by means of a surgical robotic arm, the laparoscopic
applicator
comprising:
- a delivery tube configured for holding the substance under a pressure, and
- an applicator tip connected to a distal end of the
delivery tube, the applicator
5 tip configured for controllably releasing the substance from the
delivery tube
by the robotic arm.
Depending on the form of the substance to be pressurized, the distal end of
the
delivery tube may thus include one or more flow controlling elements, such as
valves
adapted such that the substance may be contained and pressurized within the
delivery
tube. Alternatively or in addition, the delivery tube may be dimensioned such
that the
substance may be pressurized due to the capillary forces present. The
capillary forces
may also be defined as the pressure drop occurring across the length of the
delivery
tube. Hence, the delivery tube, and particularly the applicator tip, is
advantageously
dimensionally configured for holding the substance under a pressure or holding
a
pressurized substance, and/or configured to include one or more flow
controlling
elements.
A second aspect of the present disclosure relates to a laparoscopic applicator
tip for
connecting to a laparoscopic delivery tube for holding a substance, such as a
substance comprising a haemostatic agent, the applicator tip comprising:
- at least one valve configured for releasing the substance from the delivery
tube
upon opening of said valve; and
- at least one actuator configured to open/close the at least one valve.
The applicator tip may be detachably attached to the distal end of the
delivery tube,
which allows reusing the tip while discarding the delivery tube (possibly
including the
fluid source or pressure source, as further described below). Accordingly, the
delivery
tube and/or the applicator tip and/or the fluid source may be disposable /
configured for
single-use. Alternatively, the applicator tip may be an integral part of the
delivery tube,
such that the delivery tube and the applicator tip is a single unit. In some
embodiments,
the applicator tip simply refers to the distal end of the delivery tube. The
applicator tip
may comprise a rigid section configured to be gripped by the robotic arm. The
applicator tip may further comprise an adjustable nozzle for adjusting the
dispensing
rate and or dispensing angle of the substance. The applicator tip may further
comprise
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a pressure sensor, such as a resistive film pressure sensor, for sensing a
pressure
applied to the actuator (e.g. by the robotic arm). In this case, the
applicator tip
preferably further comprises a pressure indicator light for indicating the
pressure
applied to the at least one actuator.
Kit of parts
The applicator according to the present disclosure may be provided as a part
in a kit of
parts for laparoscopic procedures, and particularly as a kit of parts suitable
for robotic-
assisted surgery. Optionally, the applicator may be provided as separate parts
of the
kit, e.g. as a delivery tube and an applicator tip, which upon assembly forms
the
applicator according to the first aspect,
The kit may optionally further comprise one or more substance reservoirs for
loading or
charging the delivery tube prior to use. For example, the substance reservoir
may be a
syringe configured to be filled with a substance and configured for forming a
fluid
connection to the delivery tube of the applicator, such as the distal opening
of the
delivery tube.
To reduce the number of parts and to simplify the assembly, the kit of parts
may
comprise the applicator and a pressure source, which is easily assembled and
which
upon assembly is configured for delivering a substance under pressure. For
example,
the pressure source may be a gas cartridge configured for forming a fluid
connection to
the delivery tube of the applicator, such as the proximal opening of the
delivery tube.
To further simplify the assembly, the one or more pressure sources may be
integrated
into the applicator. For example, the pressure source may be integrated into
the
delivery tube in the form of a spring located at a proximal end, where the
spring energy
is pre-stored and/or stored upon loading the delivery tube with a substance.
A third aspect of the disclosure relates to a kit of parts comprising the
applicator
according to the first aspect, or the applicator tip according to the second
aspect, one
or more pressure sources, and optionally one or more substance reservoirs. For
example, the substance reservoirs may be one or more syringes configured to be
filled
with a substance and configured for forming a fluid connection to the delivery
tube,
such as the distal opening of the delivery tube. An embodiment relates to a
kit of parts
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comprising the applicator according to the first aspect, one or more pressure
sources,
and optionally a syringe configured to be filled with a substance
The kit of parts has the advantage that all parts may be manually assembled
and
operated, and that all the parts are disposable after use and adapted for
single-use.
Alternatively, the kit of parts may include parts adapted for multiple uses to
obtain a
more reproducible and sustainable applicator design. For example, the
applicator may
be assembled into a reusable unit or holder, which may include the pressure
source in
the form of a reusable piston or motor.
The kit of parts may further comprise a driver unit for holding the parts,
i.e. the
applicator and the pressure source.
A fourth aspect of the present disclosure relates to a kit of parts
comprising:
- the laparoscopic applicator according to the first aspect, and
- a driver unit for holding:
- at least one fluid source for holding a fluid, said fluid source being in
fluid
connection with the delivery tube; and/or
- at least one pressure source, such as a motor, configured for applying a
pressure to the at least one fluid source and/or configured for applying a
pressure to the inside of the delivery tube.
To further increase the sustainable impact, the driver unit may be refilled
with the fluid
source. Hence, the kit of parts optionally comprises one or more fluid source
reservoirs,
where the fluid source reservoirs are configured to be detachably attached to
the fluid
source within the driver unit.
Pressure source
The release of a substance, e.g. a medical paste, from the applicator implies
that the
substance held within the tube is being pushed through the delivery tube to
the distal
end and tip, where it is expelled and dispensed. The pressure source for
pressurizing
the substance within the applicator may be any sufficient pressure source,
e.g. in the
form of a solid stylus or a fluid being forced to advance into the tube via a
manually or
motor driven piston, spring force, and/or trigger.
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For precise and reliable discharge of a substance at a determined site and at
a
determined time, the delivery tube or applicator tip is advantageously
configured for
holding the substance under a pressure, at least immediately before the
substance is
discharged. Depending on the form of the substance to be pressurized, the
distal end
of the delivery tube or the applicator tip may include one or more flow
controlling
elements, such as valves adapted such that the substance may be contained and
pressurized within the delivery tube. Alternatively, the delivery tube may be
dimensioned such that the substance may be pressurized due to the capillary
forces
present.
A fifth aspect of the disclosure relates to a laparoscopic applicator further
comprising at
least one pressure source configured for applying a pressure to the at least
one fluid
source and/or configured for applying a pressure to the inside of the delivery
tube, such
as the substance within the delivery tube.
Hence, the pressure source advantageously comprise a drive mechanism
configured
for moving the at least one fluid source and/or the substance within the
delivery tube
towards the distal end. The drive mechanism may be mechanically and/or
electrically
operated. For example, the at least one pressure source may comprise a drive
mechanism, selected from the group of: manual piston, motorized piston, spring
force,
and gas pressure.
Mechanical drive mechanism
For easy assembly of the kits according to the third and fourth aspects,
reducing the
numbers of operative steps, and for manual operation of the laparoscopic
applicator,
the pressure source may advantageously comprise a predefined and/or
controllable
pressure force. For example, the pressure source may include a fluid source
comprising a predefined propellant, such as a predefined gaseous pressure
within a
gas cartridge or a syringe with a predefined amount of liquid. Alternatively,
the pressure
source may be a spring with a predefined spring energy stored. Thus, the drive
mechanism of the pressure source is mechanically controlled. For example, by
simple
assembly of the applicator and the pressure source, the applicator is adapted
for
dispensing a (medical) substance, such as a medical paste.
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Electrical drive mechanism
In addition or alternatively, the drive mechanism of the pressure source may
be
controllable via a motor, e.g. as a piston driven by a motor, which
pressurizes the
substance within the delivery tube and provides discharge of the substance.
The
pressure source may also be a fluid flow driven by a motor, e.g. a fluid flow
obtained
from bellows, piston, paddle wheel, or a compressor, which pressurizes and
dispenses
the substance from the delivery tube. Thus, the drive mechanism of the
pressure
source is motor or electrically controlled. For example, an actuator of the
laparoscopic
applicator or applicator tip may be configured to send an electrical signal to
the drive
mechanism or motor, which upon receipt of the electrical signal is configured
to exert a
pressure on the pressure source or the substance within the delivery tube.
Powder
The laparoscopic applicator is configured for dispensing or withdrawing a
substance
comprising a haemostatic agent, and said substance may be in the form of a
liquid, a
paste, or a powder. Due to the flow characteristics of powders, the pressure
source or
drive mechanism for transporting the haemostatic powder through the delivery
tube to
the outside of the delivery tube advantageously comprises a combination of a
variable
rate feeder, such as a screw conveyor, or a vibrating device, in combination
with a gas
pressure source.
A sixth aspect of the present disclosure relates to a laparoscopic applicator
for
dispensing a haemostatic powder at a selected site by means of a surgical
robotic arm,
the laparoscopic applicator comprising:
- a delivery tube holding the haemostatic powder; and
- a variable rate feeder, such as a screw conveyor, configured for
transporting the haemostatic powder through the delivery tube to the
outside of the delivery tube, whereby the haemostatic powder is
dispensed from the applicator.
A seventh aspect of the present disclosure relates to a laparoscopic
applicator for
dispensing a haemostatic powder at a selected site by means of a surgical
robotic arm,
the laparoscopic applicator comprising:
- a delivery tube holding the haemostatic powder;
- a valve located at a distal end of the delivery tube, wherein the valve
is
configured to open at a pre-defined opening pressure; and
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- a vibrating device, such as an ultrasonic vibrating device, configured for
shaking the haemostatic powder out of the delivery tube when the valve
is open.
5 Preferably, the applicator for dispensing a haemostatic powder further
comprises one
or more pressure sources, such as one or more gas pressure sources configured
for
transporting the haemostatic powder through the delivery tube. The gas
pressure
source may for example be a motorized gas pressure source, or a pressurized
container, such as a gas cartridge. A pressurized container may be
characterized as
10 having pressure energy stored, where the pressure energy may be
converted to kinetic
energy by releasing the pressure, e.g. upon manually opening the container.
For
example, a pressurized container may contain a fluid, and the fluid is
discharged from
the container simultaneously as the pressure is released.
A seventh aspect of the present disclosure relates to use of the laparoscopic
applicator
according to the first aspect, to dispense a substance, such as a substance
comprising
a haemostatic agent, from the applicator.
Description of drawings
The invention will in the following be described in greater detail with
reference to the
accompanying drawings.
Figure 1 shows an embodiment of an applicator according to the present
disclosure.
Figure 2 shows perspective views of an embodiment of an applicator according
to the
present disclosure, being manipulated by a robotic arm.
Figure 3 shows an embodiment of an applicator according to the present
disclosure
comprising embodiments of: (A, B) a delivery tube being stretchable and
comprising a
rigid surface area at the tip, (C) a delivery tube comprising a rigid surface
area located
at a distance from the tip, and (D) a delivery tub being semi-rigid.
Figure 4 shows an embodiment of an applicator according to the present
disclosure
comprising embodiments of a deformable section being stretchable,
compressible,
and/or flexible.
Figure 5 shows an embodiment of an applicator according to the present
disclosure
comprising a spring-loaded check valve.
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Figure 6 shows an embodiment of an applicator according to the present
disclosure
comprising a duckbill valve.
Figure 7 shows an embodiment of the applicator according to the present
disclosure
comprising a pressure source.
Figure 8 shows an embodiment of the applicator according to the present
disclosure
comprising a pressure source.
Figure 9 shows an embodiment of the applicator according to the present
disclosure
comprising a pressure source.
Figure 10 shows an embodiment of the applicator according to the present
disclosure
comprising a pressure source.
Figure 11 shows an embodiment of the applicator according to the present
disclosure
comprising a pressure source.
Figure 12 shows an embodiment of the applicator according to the present
disclosure,
wherein the applicator comprises a delivery tube for holding a substance, a
fluid source
for holding a fluid, and a pressure source for exerting a pressure on the
fluid source.
Figure 13 shows an embodiment of the applicator according to the present
disclosure,
wherein the applicator comprises a driver unit for holding the fluid source
and delivery
tube.
Figure 14 shows an embodiment of the applicator according to the present
disclosure,
wherein the applicator comprises a driver unit for holding the fluid source
and delivery
tube.
Figure 15 shows three different activation mechanisms of the actuator: pushing
(A),
pulling (B), and rotating (C).
Figure 16 shows three different embodiments of the actuator: a single button
covering
a part of the applicator tip (A), two buttons placed opposite each other on
the tip (B),
and a single button surrounding the entire circumference of the applicator tip
(C).
Figure 17 shows an embodiment of the applicator according to the present
disclosure,
wherein the applicator comprises a deformable section and an actuator, which
can be
placed on either side of the deformable section.
Figure 18 shows a driver unit holding a fluid source (here a syringe). The
driver unit
may feature various controls such as a flow controller for controlling the
flow rate of the
substance being released from the applicator.
Figure 19 shows an embodiment of an applicator tip according to the present
disclosure, wherein the tip comprises an actuator and a pressure light
indicator for
indicating the applied pressure to the actuator.
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Figure 20 shows an embodiment of an applicator tip according to the present
disclosure, wherein the tip comprises an actuator, a pressure light indicator
for
indicating the applied pressure to the actuator, and a status indicator for
indicating the
remaining volume of substance in the delivery tube.
Figure 21 shows an embodiment of an applicator tip according to the present
disclosure, wherein the tip comprises a status indicator, an actuator, a rigid
section,
and a deformable section. The measurements are provided as an example only.
Figure 22 shows a cross-section of an embodiment of the delivery tube
according to
the present disclosure, wherein the delivery tube comprises a plurality of
lumens (here
four lumens).
Figure 23 shows three different embodiments of a delivery tube with various
deformable and rigid sections.
Figure 24 shows three embodiments of the applicator according to the present
disclosure, wherein the deformable section allows approximately 360
manipulation of
the applicator tip (A), wherein the delivery tube comprises a malleable wire
such that
the position of the applicator tip can be varied but remain in the same
position relative
to the tube (B), and wherein the wire allows bending the deformable section
along one
or more planes at predefined angles (C).
Figure 25 shows an embodiment of the applicator according to the present
disclosure,
wherein the applicator tip comprises an actuator and a status indicator.
Figure 26 shows an embodiment of the applicator according to the present
disclosure,
wherein the applicator comprises a screw conveyor for transporting a powder
through
the delivery tube.
Figure 27 shows an embodiment of the applicator according to the present
disclosure,
wherein the applicator comprises a vibrating device for shaking a powder
through the
delivery tube.
Figure 28 shows the embodiment of figure 27 from another angle, wherein the
end of
the valve is visible.
Figure 29 shows the embodiment of figure 27 from another angle, wherein a
robotic
arm is squeezing the valve, thereby forcing the valve to open such that powder
is
released from the applicator.
Figure 30 shows an embodiment of the applicator according to the present
disclosure,
wherein the applicator comprises two fluid sources (here two syringes) and a
drive
mechanism for pressurizing the two fluid sources.
Figure 31 shows an embodiment of the applicator according to the present
disclosure,
wherein the applicator comprises a gas pressure source for transporting a
powder
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through the delivery tube, where the gas pressure source is bellows, which are
activated by a motorized piston, e.g. a piston vibrating back and forth in the
horizontal
direction. (A) shows a perspective view, and (B) a cross-sectional view of the
applicator.
Figure 32 shows an embodiment of the applicator according to the present
disclosure,
wherein the applicator comprises a gas pressure source for transporting a
powder
through the delivery tube, where the gas pressure source is obtained via a
motorized
propeller, and optionally a gas inlet. (A) shows a perspective view, and (B) a
cross-
sectional view of the applicator.
Figure 33 shows an embodiment of the applicator according to the present
disclosure,
wherein the applicator comprises a pressure source for transporting a powder
through
the delivery tube, where the pressure source is a distally located piston with
apertures,
and where the distally located piston may be motorized to vibrate back and
forth in the
horizontal direction. (A) shows a partly perspective view, where the distal
end is
enlarged in the inserted frame, (B) shows a cross-sectional view, where the
distal end
is enlarged in the inserted frame in perspective view.
Figure 34 shows an embodiment of the applicator according to the present
disclosure,
wherein the applicator comprises a gas pressure source for transporting a
powder
through the delivery tube, where the gas pressure source is obtained form a
rotating
paddle wheel or impeller. The impeller may further be controlled by a gas
cartridge in
combination with a gas flow control valve.
Figure 35 shows an embodiment of the applicator according to the present
disclosure,
wherein the applicator comprises a pressure source for transporting a powder
through
the delivery tube, and further flow confining elements for reducing the gas
flow at the
powder delivery site, where the flow confining elements are (A) grid or slit
elements
within the delivery tube, and (B) a screw conveyor for transporting a powder
through
the delivery tube in combination with a separate gas flow channel.
Figure 36 shows an embodiment of the applicator according to the present
disclosure,
wherein the applicator comprises a first and second substance reservoirs.
Figure 37 shows an embodiment of the applicator according to the present
disclosure,
wherein the applicator comprises a first and second substance reservoir, where
the
second substance reservoir is detachably attached to the first substance
reservoir via
an auxiliary connector element. (A) shows the attached reservoirs, and (B) the
detached reservoirs.
Figure 38 (A) shows an embodiment of the applicator according to the present
disclosure, wherein the applicator is configured for being loaded with
substance from
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the distal end, where the distal end includes (B) a detachably attached
auxiliary
connector element to a substance reservoir, and (C) a flow controlling
element.
Figure 39 shows an embodiment of the applicator according to the present
disclosure,
wherein the applicator is configured for being loaded with substance from the
distal end
as shown in (B), and where the pressure source for pressurizing and dispensing
the
substance as shown in (C-D) is a spring.
Figure 40 shows an embodiment of the applicator according to the present
disclosure,
wherein the applicator is configured for being loaded with substance from the
distal end
as shown in (A), and where the pressure source for pressurizing and dispensing
the
substance as shown in (D) is a gas cartridge.
Figure 41 shows an embodiment of the applicator according to the present
disclosure,
wherein the applicator comprises two first substance reservoirs, and a
detached drive
mechanism for pressurizing the two first substance reservoirs.
Figure 42 shows the applicator of Figure 41 comprising two first substance
reservoirs,
and further comprising two second substance reservoirs (here two syringes),
where (A)
shows loading of the first reservoirs by the syringes, and (B) shows the
loaded
applicator.
Figure 43 shows the applicator of Figures 41-42, wherein the detachable drive
mechanism for pressurizing the two first substance reservoirs is attached in
(A), and in
(B) the drive mechanism has emptied the two first reservoirs.
Detailed description
The invention is described below with the help of the accompanying figures. It
would be
appreciated by the people skilled in the art that the same feature or
component of the
device are referred with the same reference numeral in different figures. A
list of the
reference numbers can be found at the end of the detailed description section.
Applicator for dispensing a substance
For surgical procedures, and particularly endoscopic and/or laparoscopic
procedures, a
substance such as a medical substance such as a surgical haemostatic substance
e.g.
in the form of a powder, a fluid or a paste, is dispensed to a target site
within a body
cavity, via an elongated applicator 1 comprising a delivery tube 2 prefilled
with the
medical fluid/paste/powder 4, or configured to be filled with the medical
fluid/paste/powder during the surgery, as illustrated in Figure 1. The distal
end 2.2 of
the delivery tube may be introduced into the body cavity e.g. via a trocar
port, e.g.
manually by an assistant. To facilitate the handling and insertion of the
delivery tube,
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which may be flexible, the applicator advantageously comprises a rigid sheath
3
configured for inserting the delivery tube into the trocar. The rigid sheath
may for
example be in the form of a rigid tubular sheath, which may be positioned
around a
section of the delivery tube, such as attached to a section of the delivery
tube, or
5 forming a coating layer around a section of the outer delivery tube, as
illustrated in
Figure 1.
The delivery tube can have an inner diameter of approximately 1-8 mm, e.g.
approximately 5 mm, which will ensure a good flow of the substance without the
need
10 for much power from the pressure source or the variable rate feeder for
transporting
the substance through the delivery tube. The delivery tube may have an inner
diameter
of less than 5 mm, or less than 3 mm, or less than 2 mm. In case the delivery
tube
comprises a plurality of lumens, the inner diameter refers to the inner
diameter of the
lumen configured to contain the substance to be dispensed.
In case the delivery tube or a lumen for holding the substance has an inner
diameter of
less than 2 mm, this implies that only a small residue of the substance will
be left in the
delivery tube after the dispense of the substance.
In an embodiment of the disclosure, the applicator further comprises a rigid
sheath
configured for inserting the delivery tube into a trocar, such as a sheath
configured to
be positioned around a section of the delivery tube.
The delivery tube may be prefilled with the substance (e.g. a medical fluid,
paste or
powder), and/or configured to be filled with the substance after insertion
into the trocar
port. Accordingly, the delivery tube may contain a substance, such as a
substance
comprising a bioactive agent, said substance being in the form of a fluid, a
paste, or a
powder. The substance may be a haemostatic substance comprising a haemostatic
agent. Advantageously, the filling of the delivery tube may be performed via
the
proximal end 2.1 of the delivery tube, which is accessible to the surgeon or
an assistant
during surgery, as illustrated in Figure 1. The filling of the delivery tube
is
advantageously done using a separate syringe comprising the substance within a
syringe barrel, where the syringe may be prefilled with the substance, or
configured for
aspirating the substance from a substance source such as a medical fluid
source.
Hence, the container or syringe comprising the substance may be referred to as
a
substance reservoir 24 To facilitate safe and precise filling with a minimum
of
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substance waste, the proximal end 2.1 advantageously comprises one or more
connectors 6 for detachably attaching the fluid source, such as a syringe
prefilled with
the substance. An example of a connector is a Luer lock for attaching a
syringe, or a
compression joint or adhesive joint for attaching a substance reservoir or
fluid
container. Alternatively, the delivery tube and the fluid source, e.g. the
syringe, may be
attached without the use of a connector.
The substance is subsequently dispensed from the filled delivery tube by a
driving
force, such as a pressure source 8. The driving force for expelling the
substance is
advantageously a pressure generated at the proximal end 2.1 of the delivery
tube,
which is directly accessible to the assistant during surgery. For example, the
pressure
may be generated by a second fluid, which is forced to enter the proximal end
from a
separate fluid source 7, and thereby pressurizing the substance present within
the
delivery tube, as seen from Figure 1.
In an embodiment of the disclosure, the applicator further comprises at least
one
pressure source configured for applying a pressure to the at least one fluid
source
and/or configured for applying a pressure to the inside of the delivery tube,
such as the
substance within the delivery tube.
It follows that the pressure source advantageously comprise a drive mechanism
configured for moving the at least one fluid source and/or the substance
within the
delivery tube towards the distal end. The drive mechanism may be mechanically
and/or
electrically operated. For example, the at least one pressure source may
comprise a
drive mechanism, selected from the group of: manual piston, motorized piston,
spring
force, and gas pressure.
Further advantageously, the pressure of the second fluid is predefined and/or
controllable, e.g. by being in the form of a predefined pressurized fluid
source, where
the predefined pressure is released upon fluid connection with the proximal
end of the
delivery tube. To facilitate safe and precise pressure transfer, the proximal
end of the
delivery tube advantageously comprises one or more connectors 6 for detachably
attaching the pressure source 8 or fluid source 7, such as a fluid container,
and more
preferably a fluid container configured to be pressurized.
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Further advantageously, the fluid connectors are configured for forming a
fluid
connection between the fluid source and the proximal end of the delivery tube
upon
connection, e.g. in the same manner as a vial adapter wherein a rubber sealing
of the
fluid source is pierced by a hollow piercing element. Hence, a fluid
connection may be
obtained between a sealed fluid source and the delivery tube via the piercing
element.
Alternatively, the fluid source does not need to be pierced in order to form a
fluid
connection. Instead, it may simply be attached to the delivery tube, either
directly (e.g.
tube and syringe connected) or via a connector.
In an embodiment of the disclosure, the proximal end of the delivery tube
comprises
one or more connectors 6 for detachably attaching the fluid source, such as a
Luer
lock, a compression joint, and/or an adhesive joint for attaching a syringe
and/or a fluid
container. In a further or alternative embodiment, the one or more connectors
comprise
a hollow piercing element for piercing the fluid source, whereby a fluid
connection
between the fluid source and the delivery tube is established.
Hence, the drive mechanism of the pressure source may be mechanically
controlled by
the attachment of the pressure source to the applicator. Thus by the
mechanical
assembly, the applicator is adapted for dispensing a (medical) substance, such
as a
medical paste.
In addition or alternatively, the drive mechanism of the pressure source may
be
controllable via a motor, e.g. as a piston driven by a motor, which
pressurizes the
substance within the delivery tube or the fluid source, and hence provides
discharge of
the substance. For example, the pressure source 8 may be a fluid source 7 flow
driven
by a motor, Thus, the drive mechanism of the pressure source is motor or
electrically
controlled.
Advantageously, the delivery tube of the applicator is configured for holding
the
substance under a pressure or holding a pressurized substance at least
immediately
before the substance is discharged. This provides a more precise and reliable
discharge of a substance at a determined site and at a determined time, For
example,
this has the advantage that the substance may be released from the delivery
tube by a
simple interaction with the applicator tip without significant time delay.
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Depending on the form of the substance to be pressurized, the distal end of
the
delivery tube may thus include one or more flow controlling elements 26, such
as
valves adapted such that the substance may be contained and pressurized within
the
delivery tube. For example, the applicator tip may comprise at least one valve
configured for holding and releasing the substance under a pressure, or a flow
controlling element, such as a three-way valve. In addition, or alternatively,
the valve
may be a constriction valve. A valve is defined as a device that regulates,
directs or
controls the flow of a fluids (i.e. gases, liquids, and fluidized solids, such
as paste and
slurries) by opening, closing, and/or partially obstructing the flow
passageway. Thus,
an example of a valve includes a flow constriction element, such as a
protrusion within
a fluid passageway, where the protrusion blocks fluid passage, when the fluid
pressure
is below a threshold value, and when the fluid pressure is above the threshold
valude,
the fluid flows and circumvents the protrusion. A valve including a flow
constriction
element is also referred to as a "constriction valve".
In an embodiment of the disclosure, the delivery tube is configured for
holding the
substance under a pressure or holding a pressurized substance. In another or
further
embodiment, the laparoscopic applicator tip comprises at least one valve
configured for
holding and releasing the substance under a pressure. For example the valve
may
comprise a flow controller, such as a tree-way valve, which may control the
amount
and direction of a flow.
Alternatively, or in addition, the delivery tube and/or applicator tip may be
dimensioned
such that the substance may be pressurized within the delivery tube due to the
capillary forces present. Hence, advantageously, the delivery tube has a
length above
200 mm, preferably a length between 300-600 mm, such as 440 mm or 500 mm.
Further, the outer diameter of the delivery tube is preferably between 3-10
mm, such as
5 mm. Further, the inner diameter of the delivery tube, or at least the inner
diameter of
the applicator tip, is preferably equal to or less than 2 mm, such as 1.5 or
1.8 mm. In
case the delivery tube comprises a plurality of lumens, the inner diameter
refers to the
inner diameter of the lumen configured to contain the substance to be
dispensed. In
case the delivery tube or a lumen for holding the substance has an inner
diameter of
less than 2 mm, this implies that only a small residue of the substance will
be left in the
delivery tube after the dispense of the substance.
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Hence, the delivery tube, and particularly the applicator tip, is
advantageously
dimensionally configured for holding the substance under a pressure or holding
a
pressurized substance, and/or configured to include one or more flow
controlling
elements.
The delivery tube may comprise a plurality of lumens, such as at least two
lumens, or
at least three lumens, or at least four lumens. Figure 22 illustrates an
embodiment,
wherein the delivery tube comprises four lumens. At least one of the plurality
of lumens
should be configured to contain the substance to be dispensed from the
applicator. In
one embodiment, the delivery tube comprises a first lumen and a second lumen,
wherein the first lumen is configured to contain the substance and the second
lumen is
configured to contain electrical wiring or an optical fibre. The electrical
wiring may be
used to electrically connect an actuator, e.g. located at the distal end of
the tube or at
the tip, to a control unit or a pressure source, e.g. located at the proximal
end of the
tube. The delivery tube may also comprise a plurality of lumens, wherein at
least two
lumens are configured for holding a substance. As an example, the tube may
comprise
a first lumen for holding a first type of substance and a second lumen for
holding a
second type of substance. In some applications, the two types of substances
are mixed
once the substances are dispensed or before they are dispensed. In this case,
one
substance may be in the form of a liquid and the other substance could be a
powder to
be mixed in the liquid. The two substances could also be two liquids or two
pastes, or
other combinations of liquid, paste, and powder. An applicator with a delivery
tube
having two lumens is shown in Figure 30.
In another embodiment, at least one of the plurality of lumens is configured
to contain a
malleable wire or rod, which is placed in a lumen inside the delivery tube
(illustrated in
Figure 24 (B) and (C)). Accordingly, the applicator may further comprise a
malleable
wire or rod, configured such that the deformable section of the delivery tube
may be
bent into a desired shape, said shape being approximately maintained upon
release of
the delivery tube. This has the advantage that the deformable section may be
bent
without the tube returning to the point of origin. This gives the surgeon more
freedom to
put the distal end of the tube and/or the applicator tip in desired
orientations, e.g. such
that hard-to-access areas inside the body are more easily reached. In one
embodiment, the deformable section of the delivery tube may be bent along two
planes
at two pre-determined angles, such as at least 30 or at least 45 . This may
similarly be
achieved by using a malleable wire or rod placed inside the delivery tube.
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Spatial manipulation
Replacing the movements of human hands by robotic arms controlled by computer
software, facilitates very precise and controlled movements. Hence, a
laparoscopic
applicator being spatially manipulated by a robotic arm may be more precise
and
5 accurately controlled, as well as being more reliable with reduced risk
of accidental
movements. Thus, for example a laparoscopic applicator for dispensing a
substance by
means of a robotic arm will be able to dispense the substance at a selected
site more
precisely and reliably. Specifically, a robotic manipulated applicator for
dispensing a
haemostatic substance at a selected site, may result in a bleeding being
stopped more
10 efficiently.
Figure 2 shows perspective views of an embodiment of an applicator configured
for
being spatially manipulated by a robotic arm 5. The robotic arm may include a
medical
device, e.g. a tool for surgery, such as a grasper, tweezer, or a similar
robotic finger
15 element for gripping, pushing, or forming an attachment to the
applicator.
Robotic arms and fingers may not include haptic feedback. Thus, to ensure safe
robotic
use of the applicator with reduced risk of breaking the applicator, the
applicator may
advantageously comprise a rigid surface area 2.4 or rigid section 2.8, the
area or
20 section configured for manipulation by the robotic arm/fingers.
Accordingly, the delivery
tube may comprise at least one rigid section, such as a rigid tubular section
or a rigid
surface area. The rigid section and/or rigid surface area is preferably
dimensioned such
that the robotic arm/fingers may grip, push, or form an attachment to the
rigid surface
area without risking breaking the applicator. For example, for a robotic arm
including a
grasper the rigid surface area is advantageously a rigid tubular section, as
illustrated in
Figure 2. The rigid section is preferably provided with an opening, such that
the robotic
arm may press an actuator placed in said opening, wherein the actuator is
configured
for opening a valve when the pressure exceeds a predefined pressure level,
whereby
the medical substance can be dispensed from the applicator.
In an embodiment of the disclosure, the distal end of the delivery tube
comprises one
or more rigid surface areas configured for manipulation by the robotic arm. In
a further
embodiment, the rigid surface areas are dimensioned such they are tangible by
the
robotic arm, such as tangible by gripping, pushing, or attachment. In a
further
embodiment, the distal end comprises a rigid tubular section.
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To facilitate precise and user friendly discharge of the substance at a
selected site, the
one or more rigid surface areas 2.4 are advantageously located at the distal
end 2.2 of
the applicator and/or on the applicator tip, as illustrated in Figures 1 and
2. It follows
that the substance discharge may be more precisely and easily directed, when
the rigid
surface is in the vicinity of where the substance is dispensed.
However, the rigid surface area 2.4 may also be located at a distance from the
distal
tip, as illustrated in Figure 3C. This may be advantageous when the substance
is to be
dispensed at a location, where there is restricted space within the body
cavity. Hence,
the rigid surface area may be a rigid tubular section of the delivery tube 2,
located at a
distance from the distal tip, as shown in Figure 3C. The orientation of the
distal end is
thus manipulated by use of the rigid tubular section located at a distance
from the tip.
In addition, or alternatively, flexible manipulation of the distal end of the
delivery tube,
may be obtained by use of a delivery tube, where either a section of the
delivery tube,
or optionally the entire delivery tube, comprises a semi-flexible or semi-
rigid material,
as illustrated in Figure 3D. Since the semi-rigid material is sufficiently
tangible by the
robotic arm/fingers, the interaction may occur at any point along the delivery
tube and
at any distance to the distal tip 2.2, which is being spatially manipulated.
The flexible and precise manipulation of the distal end may be further
improved by the
delivery tube comprising a deformable section 2.3. By the term deformable
section is
meant a section, which may be plastically or elastically deformed when
subjected to a
deformation force, such as a tensile, compressive, or bending force.
Advantageously,
the deformable section is plastically deformed, meaning that the deformation
remains
after the deformation force is removed. Alternatively, the deformation is
elastic,
meaning that the deformation is reversible upon removal of the deformation
force.
For example, the deformable section 2.3 may be configured to be stretchable or
extendable, such that when subjected to a tensile force in the longitudinal
direction,
e.g. by a robotic arm pulling at delivery tube tip, the delivery tube is
stretched, as
illustrated in Figures 3A-B and Figures 4A-B as shown by the arrows. In
addition, and
correspondingly, the deformable section may be configured to be compressible,
such
that the delivery tube may be compressed when subjected to a compressive
force, e.g.
by a robotic arm pushing at the delivery tube tip, as indicated in Figure 4B.
In addition,
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and correspondingly, the deformable section is further advantageously
configured to be
flexible or bendable, as indicated by the arrows in Figure 4B.
The deformable section may comprise an elastically or plastically stretchable,
compressible, and/or flexible material. In addition, or alternatively, the
deformable
section may comprise a corrugated surface profile, e.g. in the form of
multiple,
circumferentially extending kinked folds, as illustrated in Figures 4C-D and
Figure 17.
The corrugated surface profile enables extension, compression, and/or bending
in the
same manner as a drinking straw. Accordingly, the delivery tube may comprise a
deformable section that is compressible, e.g. in the form of a corrugated
tube, such that
the length of the tube may be varied.
In an embodiment of the disclosure, the delivery tube comprises a deformable
section.
Advantageously, the deformable section is located at the distal end of the
delivery tube,
such that the applicator tip may be manipulated by a smaller torque/moment.
Alternatively, the deformable section is located at a distance from the distal
end of the
delivery tube, such that the tip may be manipulated by a defined
torque/moment. In a
further embodiment, the deformable section is configured to be stretchable
and/or
flexible, such as comprising a stretchable and/or flexible tube material. In a
further or
alternative embodiment, the deformable section comprises a corrugated surface
profile.
In a further embodiment, the corrugated surface profile comprises a plurality
of
circumferential folds in the manner of the kink of a drinking straw.
Controllable substance release
For precise, reliable and user friendly substance discharge at a selected
site, e.g. for
intra-abdominal substance dispense, the substance release may advantageously
be
controlled by the robotic arm. This may be obtained by one or more actuators
2.6, e.g.
in the form of a valve, configured for releasing the substance from the
delivery tube.
To make the movements of the robotic arm more efficient, the one or more
actuators
are preferably located in the vicinity of the applicator tip used for the
spatial
manipulation of the delivery tube. Hence, the actuators are preferably located
at the
distal end, and/or within the one or more rigid surface areas of the delivery
tube, and/or
on the applicator tip. For example, the actuator 2.6 may advantageously be
located
within an opening 2.5 of the rigid surface area, as illustrated in Figure 2.
Thus, only a
relative small translation of the robotic arm is needed after the robotic arm
has oriented
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the distal end to a selected target site via the rigid surface area, and for
the robotic arm
to activate the actuator for releasing the substance. The actuator may be
configured to
activate by a pressure force, e.g. applied by the robotic arm, or by an
electrical current,
e.g. applied by an energy tool. In one embodiment, the actuator is provided in
the form
of a pressure-sensitive button, e.g. located on the applicator tip, wherein
the button is
configured to open the valve upon being pressed. The actuator/button may be
sensitive
to the amount of pressure (e.g. in a stepwise or continuous manner), such that
the
valve opens to a certain degree based on the applied pressure to the
actuator/button.
In another embodiment, the actuator is configured to be activated by pulling
the
actuator along a longitudinal axis of the tube/applicator tip and/or by
rotating the
actuator around the longitudinal axis. These embodiments are illustrated in
Figure 15.
In an embodiment of the disclosure, the distal end comprises one or more
actuators
configured for releasing the substance from the delivery tube by the robotic
arm. In a
further embodiment, the one or more actuators are located within the one or
more rigid
surface areas, such as within an opening of the rigid surface area.
In an embodiment of the disclosure, the at least one actuator covers a
predefined
circumferential section of the tube and/or applicator tip, such as less than
1800 of the
circumference of the tube and/or applicator tip 9, preferably less than 1400.
This
embodiment is illustrated in Figure 16 (A). The advantage is that the
applicator and
thus also the applicator tip can be rotated so that the risk is reduced that
the robotic
arm accidentally activates the actuator 2.6. In another embodiment, the at
least one
actuator covers at least 180' of the circumference of the tube and/or
applicator tip. The
advantage is that the robotic arm can activate the actuator 2.6 irrespective
of the
rotational orientation of the applicator and the actuator. The substance can
be
delivered from the applicator without having the orient the applicator
correctly in
relation to the robotic arm. In yet another embodiment, two actuators are
provided on
opposite parts of the applicator tip and/or tube, each of said actuators
covering less
than 120 of the circumference of the tube and/or applicator tip, preferably
less than
90 each. The advantage is again that the applicator and thus also the
applicator tip
can be rotated so that the risk is reduced that the robotic arm accidentally
activates the
actuator 2.6. This is illustrated in Figure 16 (B). In yet another embodiment,
the at least
one actuator covers 360 of the circumference of the tube and/or applicator
tip, such
that the at least one actuator surrounds a part of the tube and/or applicator
tip. This is
illustrated in Figure 16 (C). Providing the applicator tip with an actuator,
e.g. a pressure
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sensitive button, surrounding the entire circumference of the tip has the
advantage that
it enables 3600 activation, i.e. the robotic arm may activate the
actuator/button
regardless of how the actuator is gripped.
The one or more actuators 2.6 may be in the form of a valve 2.7, or in
combination with
one or more valves, such as electronically or manually controlled valves.
Accordingly,
the applicator may comprise at least one valve configured for releasing the
substance
from the delivery tube upon opening of said valve. The valve(s) may be
controllable by
an actuator located on the applicator and/or by an external actuator, such as
a foot
pedal. The actuator/button may be located at the distal end of the delivery
tube, such
as on the rigid section, on the applicator tip, or on an external device such
as the driver
unit. Preferably, the actuator/button is placed directly above the valve.
Advantageously,
the at least one valve is activated by a pressure, such as a manual pressure
from a
robotic arm. Hence, by pressing the actuator 2.6, the valve 2.7 is either
electronically or
manually activated to open and release the substance, as e.g. illustrated in
Figure 5.
Accordingly, the applicator may comprise at least one actuator configured to
open
and/or close the at least one valve. To ensure the substance is efficiently
transported to
and through the distal tip, the valve is preferably a one-way valve. The at
least one
valve may be a pressure activated valve, such as a valve having a pre-defined
opening
pressure threshold. Preferably, the substance is dispensed from the applicator
when
the pre-defined opening pressure threshold is exceeded. The at least one valve
may be
located in the delivery tube and/or in the applicator tip. Alternatively, the
applicator
does not comprise a valve, but rather is dimensioned such that the substance
is
retained within the applicator below a certain pressure threshold. This can be
achieved
e.g. by providing a long delivery tube (e.g. more than 30 cm) with a small
diameter (e.g.
2-4 mm or less), whereby the delivery tube itself provides a resistance to
fluid flow
inside the tube.
To improve the simplicity of the applicator and to reduce the number of
electronic
controls and components, the actuator is advantageously a manually controlled
valve.
An examples of manually pressure controlled valve is a spring-loaded check
valve 2.7
as shown in Figure 5, where the spring force may be configured to be overcome
by the
pressure applied by e.g. a robotic arm.
In another example, the actuator 2.6 when activated will not necessarily
activate the
valve 2.7 mechanically, but may send an electric signal to a pressure source
(not
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shown) to be activated and provide a pressure on the substance that will
overcome the
spring of the spring-loaded check valve 2.7 so that the spring-loaded check
valve 2.7
opens and the substance is flowing out of the the delivery tube 2.
5 Another example of a one-way valve, which may be manually pressure
controlled, is
elastomeric one-way valves, such as duckbill valves and cross slit valves.
For example of a manually pressure controlled valve is a duckbill valve 2.7 as
shown in
Figure 6. A duckbill valve is made of an elastically deformable material, and
comprises
10 a deformable linear closure. A perspective view of a duckbill valve in
the non-deformed
and closed state is shown in Figures 6B-C. Figure 6A shows an embodiment of a
duckbill valve within the delivery tube 2, where the duckbill valve in the non-
deformed
state is seen to prevent flow from left to right in the Figure. When the
duckbill valve is
elastically deformed, e.g. by a compressive pressure in parallel with the
linear closure,
15 as illustrated in Figure 6D, the linear closure is deformed, whereby the
valve is opened
and allows flow from left to right in the Figure. Close up perspective views
of an
embodiment of a duckbill valve in the deformed open state is shown in Figures
6E-F.
It follows that an elastomeric valve comprising any number and orientation of
the
20 deformable closures may be used. However, to ensure precise actuation,
elastomeric
valves, where the opening of the valve is obtained by a well defined pressure
orientation, are preferred. For a duckbill valve, opening of the valve is only
obtained
when the compressive pressure is applied in parallel with the linear closure.
25 A cross slit valve is similar to a duckbill valve, but comprises two
deformable linear
closures, which are oriented perpendicular to each other. Thus, opening of the
valve
may be obtained when a compressive pressure is applied in parallel with any of
the
linear closures. This has the advantage that for a robotic grasper arm, the
valve may
be actuated in at least two positions.
In a further embodiment, the one or more actuators are one or more valves. In
a further
embodiment, the one or more valves are pressure activated valves. In a further
embodiment, the one or more valves are selected from the group of: one-way
valve,
elastomeric one-way valve, duckbill valve, cross slit valve, and spring-loaded
check
valve.
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Feedback mechanisms
Advantageously, the applicator is configured to provide feedback e.g. on the
applied
pressure to the actuator / pressure-sensitive button, or feedback relating to
the
remaining volume of substance in the delivery tube. This feedback may be
provided by
integrating various sensors into the applicator. The applicator may comprise a
first
pressure sensor for sensing the pressure in the delivery tube. The pressure
may be
communicated wired or wirelessly to the user, e.g. the surgeon.
In an embodiment, the applicator comprises a second pressure sensor for
sensing the
pressure applied to the actuator / pressure-sensitive button. As an example,
the
second pressure sensor may be a resistive film pressure sensor and/or a force-
sensitive resistor and/or a weight sensor, preferably provided under the
actuator.
Accordingly, the applicator may comprise at least one pressure-sensitive
button
covering a part of the applicator tip, wherein a second pressure sensor for
sensing the
pressure applied to the actuator is integrated in said button or placed under
the button.
The applicator may further comprise a pressure indicator light for indicating
the
pressure applied to the at least one actuator / pressure-sensitive button. The
pressure
indicator light may be located in the applicator tip or on the applicator tip
as illustrated
in Figures 19-20. In one embodiment, the pressure indicator light is provided
as a
circular band positioned along the circumference of the applicator tip as
shown in
Figure 19. Advantageously, the pressure indicator light is configured to:
- display light of a first color, e.g. green, when the applied pressure is
below a
predefined first threshold; and
- display light of a second color, e.g. red, when the applied pressure is
above a
predefined second threshold.
The pressure indicator light may be further configured to display light of a
third color,
e.g. yellow, when the applied pressure is between the predefined first and
second
thresholds. Other alternative arrangements of light or sound for indicating
the pressure
by the pressure indicator light can easily be contemplated.
The applicator may further comprise a status indicator, e.g. in the form of
light diodes,
said status indicator configured to indicate the remaining volume of substance
in the
applicator. As an example, the status indicator may comprise four light diodes
(e.g.
LEDs), wherein e.g. two lit diodes indicates a remaining volume of 50 %
relative to the
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initial volume of the contained substance, whereas three lit diodes would
indicate a
remaining volume of 75 %. This is illustrated in Figure 25. The status
indicator may be
located on any part of the applicator, e.g. on the driver unit, the delivery
tube, and/or
the applicator tip. Hence, the applicator tip may comprise a status indicator,
e.g. in the
form of light diodes, said status indicator configured to indicate the
remaining volume of
substance in the delivery tube. The remaining volume of substance in the
applicator
(i.e. in the delivery tube and/or in the fluid source) may be estimated using
a variety of
methods depending on what type of substance is contained in the applicator.
Some of
these methods are explained in the following. Other alternative arrangements
of light or
sound for indicating the remaining volume of substance in the applicator can
easily be
contemplated. Alternatively, the status indicator may comprise only one light
that is lit
when e.g. only 25% of the substance remains in the applicator.
In some embodiments, the laparoscopic applicator comprises a fluid source in
the form
of a syringe, such as a medical syringe, wherein the syringe comprises a
barrel for
holding a fluid and a plunger for pushing the fluid out of the syringe. The
syringe may
be filled with a fluid, e.g. a saline solution or a gas, for pushing the
substance out of the
delivery tube, or alternatively it may be filled with the substance to be
dispensed. In an
embodiment, the applicator further comprises a second positional sensor
configured for
determining the position of the plunger of the syringe. This may be achieved
by
providing the plunger with a magnet, wherein the second positional sensor is a
magnetic sensor configured to detect the presence of the magnet. The position
of the
plunger can be used to estimate the remaining volume of fluid/substance in the
barrel
of the syringe and/or the position may be used to estimate the remaining
volume of
substance in the delivery tube. Accordingly, the applicator may comprise at
least one
fluid source comprising a plunger in a barrel, wherein the position of the
plunger is
used to estimate the remaining volume of substance in the delivery tube,
wherein the
remaining volume is indicated by the status indicator, preferably positioned
at the distal
end / tip. The second positional sensor may alternatively be an optical
sensor.
In other embodiments, the laparoscopic applicator comprises a haemostatic
powder,
e.g. contained in the delivery tube. In this case, the applicator may comprise
a variable
rate feeder, such as a screw conveyor, configured for transporting the
haemostatic
powder through the delivery tube to the outside of the delivery tube, whereby
the
haemostatic powder is dispensed from the applicator. In order to determine the
remaining volume of powder, the applicator may comprise a first positional
sensor
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configured to determine the position of the variable rate feeder, since the
position may
be correlated with the remaining volume of powder. The variable rate feeder
may be
provided with a magnet, wherein the first positional sensor is a magnetic
sensor
configured to detect the presence of the magnet. Alternatively, the first
positional
sensor may be an optical sensor.
In yet another embodiment, the applicator comprises a vibrating device, such
as an
ultrasonic vibrating device, configured for shaking the haemostatic powder out
of the
delivery tube. In this case, the applicator may further comprise a clock
configured for
measuring the elapsed time when the vibrating device is activated/vibrating.
The
elapsed time may be used to estimate the remaining volume of haemostatic
powder in
the delivery tube.
Accordingly, the remaining volume may be determined by the first positional
sensor,
the second positional sensor, the clock, and/or combinations thereof.
According to another embodiment, the delivery tube comprises one or more light
sensitive sensors configured for sensing light of a pre-defined wavelength
range
passing through the delivery tube, wherein:
- the delivery tube comprises a light source positioned opposite the one or
more
light sensitive sensors; and/or
- the delivery tube is transparent to at least a portion
of the wavelength range.
In one embodiment, the one or more light sensitive sensors are positioned at a
distal
part of the delivery tube. In another embodiment, the delivery tube comprises
at least
two light sensitive sensors, wherein the first sensor is positioned at a
distal part of the
tube and the second sensor is located at a different position than the first
light sensitive
sensor, such as further away from the distal part. The one or more light
sensitive
sensors may be used to provide an indication of whether there is any remaining
substance in the tube, and/or they may be used to estimate the remaining
volume of
substance in the tube.
Pressure source
The release of substance from the applicator implies that the substance held
within the
tube is being pushed through the delivery tube to the distal end and tip,
where it is
expelled and dispensed. In case the substance is a paste, a pressure source 8
is
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preferred to provide the driving force for dispensing the paste. The pressure
source is
preferably configured for pressurizing the delivery tube and/or for
pressurizing the fluid
source. The substance held within the delivery tube will preferably be
pressurized at
least immediately before the paste is discharged. In some embodiments, the
applicator
forms a pressurized system, wherein the substance in the delivery tube is
pressurized.
Upon activation of a valve (e.g. via an actuator or button), said pressure is
released
whereby the substance is dispensed. In other embodiments, the system
(applicator) is
not pressurized beforehand. Rather, the pressure is applied once an actuator
is
activated, e.g. by sending an electrical signal from said actuator to a
pressure source.
An advantage of the first type of embodiments (i.e. the pressurized
applicators), is that
there is less delay between the activation of the valve and the dispense of
the
substance.
In case the medical substance is a powder, such as a haemostatic powder, a
pressure
source is not necessarily needed, since the powder may be discharged from the
applicator by other means. In this case the applicator may, as an alternative,
or in
addition, to the pressure source, comprise a variable rate feeder configured
for
transporting the haemostatic powder through the delivery tube to the outside
of the
delivery tube, whereby the haemostatic powder is dispensed from the
applicator.
Alternatively, the applicator may comprise a vibrating device for shaking the
powder out
of the applicator.
As an example, the pressure source may be a solid stylus advancing through the
delivery tube, e.g. by linear translation by use of a piston, spring force,
and/or trigger,
where the piston or trigger may be activated manually or electronically
controlled. An
example of an intermediate pressure source includes a fluid source 7, which
contains a
liquid (e.g. a saline liquid solution or the medical paste to be dispensed) or
a gas (e.g.
air, nitrous oxide or carbon dioxide), wherein the liquid or gas is forced to
advance
through the delivery tube when the pressure source exerts a force on the fluid
source,
as illustrated in Figure 7. The pressure source may comprise a spring, a gas,
and/or a
piston, wherein the pressure source is configured to exert a pressure on the
at least
one fluid source. In this case, the piston, spring and/or trigger may be
activated
manually or electronically controlled. Advantageously, the fluid source
comprises an
incompressible liquid for a more efficient pressure transfer.
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In an embodiment of the disclosure, the applicator further comprises one or
more
pressure sources. In a further embodiment, the pressure source is selected
from the
group of: a solid stylus configured to be translated through the delivery
tube, a drive
mechanism such as a motor with a piston, a pump, and/or a pressurized fluid
source.
5
In one embodiment, the pressure source is a drive mechanism, such as a motor,
comprising at least one piston configured to exert a pressure on the at least
one fluid
source. The motor may be a mechanical motor or an electric motor. The
applicator may
comprise an actuator configured to, upon activation, send an electrical signal
to the
10 drive mechanism, whereby, upon receipt of said electrical
signal, the drive mechanism
exerts a pressure on the at least one fluid source such that the substance is
dispensed
from the applicator.
In a further embodiment, the drive mechanism comprises two pistons, wherein a
first
15 piston is configured to exert a first pressure on a first
fluid source and a second piston
is configured to exert a second pressure on a second fluid source. This
embodiment is
illustrated in Figure 30. In this case, the drive mechanism may further
comprise a
switching mechanism, such as a gear mechanism, configured to switch between
operating the first piston and/or the second piston. Alternatively, the drive
mechanism
20 may drive the two pistons for dispensing two substances,
simultaneously. That is
advantageous, if e.g. the two substances are both necessary for achieving the
desired
reaction. This may be the case e.g. for thrombin and fibrinogen. Preferably,
the drive
mechanism further comprises a direction control configured to control the
direction
(forward or reverse) of the selected piston. A reverse direction will enable
suction of
25 substance, e.g. blood from the surgery site to allow the
surgeon to better decide what
to do.
To ensure a reproducible and user friendly dispense of substance, the pressure
source
is preferably configured to deliver a predefined pressure and/or controllable
pressure.
30 For example, the pressure source may be a pressurized fluid
source, e.g. a fluid
container comprising a pre-established positive pressure, such that when an
opening is
formed into the fluid container, the fluid source is forced through the
opening as defined
by the established pressure.
The pre-established positive pressure may be obtained by a fluid source 7
being
pressurized by a propellant 8.1, such as a gaseous propellant, as known from
food
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spray dispensers, such as sprayed cream. Figures 8 and 10A show embodiments of
a
fluid source 7 that contained with a gaseous propellant 8.1. Upon forming
fluid
connection between the applicator 2 and the pressure source 8, the propellant
pressure may be released, and the fluid source is forced to advance into the
delivery
tube.
Alternatively, the pressure source may include a spring loaded element
contained in
physical communication with the fluid source. Upon release of the spring
loaded
element, the element acts as a propellant 8.1 forcing the fluid source to
advance into
the delivery tube, as shown in Figure 9A.
Alternatively, the pressure source may include a moveable piston, such as a
manually
driven piston as shown in Figure 9B, or a mechanically or electronically
driven piston
as shown in Figure 10B. In both embodiments, the piston acts as the propellant
8.1,
and a predefined pressure force may be generated based on the movement of the
piston.
Alternatively, the pressure source 8 may be a fluid source 7 contained in an
inflatable
balloon or bladder, as illustrated in Figure 11. Upon forming fluid connection
between
the applicator 2 and the pressure source 8, the inflated balloon will
elastically contract
or collapse, thereby applying a pressure to a substance contained in the
delivery tube,
whereby the substance is pressurized.
In an embodiment of the disclosure, the pressure source is configured to
deliver a
predefined pressure force. In a further embodiment of the disclosure, the
pressure
source comprises a propellant, selected from the group of: spring loaded
element,
gaseous propellant, inflatable balloon or bladder, and/or moveable piston,
such as an
electrically driven piston or a manually driven piston.
Fluid source
Preferably, the applicator comprises at least one fluid source for holding a
fluid, said
fluid source being in fluid connection with the delivery tube (see e.g. Figure
7 or
Figures 12-13). The fluid source may act as an intermediate pressure source,
i.e. a
component that transfers the pressure from the pressure source to the
substance
inside the delivery tube. Therefore, the fluid source need not contain the
substance to
be dispensed, but can instead contain an inert fluid such as a saline solution
or a gas.
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In one embodiment, the fluid source comprises a liquid such as a saline
solution. In
another embodiment, the fluid source comprises a gas selected from the group
of CO2
(carbon dioxide), N (dinitrogen), N20 (nitrous oxide), and air. However, the
fluid source
may alternatively contain the substance to be dispensed, e.g. a medical
substance
such as a medical paste, such that said substance is contained in the fluid
source
and/or in the delivery tube. In an embodiment, the delivery tube and the at
least one
fluid source comprises the same substance provided in the form of a liquid, a
paste, or
a powder. Hence, the fluid source constitutes a substance reservoir 24.
The applicator may also comprise at least two fluid sources as shown in Figure
30.
This has the advantage that each fluid source may contain a specific type of
substance, whereby multiple different substances may be dispensed and/or
withdrawn
by the applicator.
Driver unit
The applicator may further comprise a driver unit for holding:
- at least one fluid source for holding a fluid, said fluid source being in
fluid
connection with the delivery tube; and/or
- at least one pressure source configured for applying a pressure to the at
least
one fluid source and/or configured for applying a pressure to the inside of
the
delivery tube.
In its simplest form, the driver unit may constitute a housing for holding the
fluid source
and/or for holding the pressure source. However, the driver unit may also
comprise
additional, more advanced features, which are explained in further detail in
the present
section. An advantage of providing the driver unit as a separate component
from the
remaining parts of the laparoscopic applicator, is that it provides a modular
design,
wherein the driver unit may be reused multiple times, whereas the delivery
tube and
fluid source may be disposed after each use. Figure 14 shows how the delivery
tube
and the fluid source (here a syringe) may be inserted in the driver unit,
optionally via a
connector. Figure 18 shows another perspective view of the driver unit,
wherein the
fluid source is inserted. The driver unit is preferably configured to exert a
pressure on
the fluid source, e.g. via a driving mechanism such as a motor and a piston,
such that
the driver unit is configured for providing the driving force for driving the
substance out
of the applicator. As an example, the fluid source may be as a medical syringe
or
another container comprising a plunger, where the driver unit comprises a
piston
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configured to exert a force on the plunger. In this case, the driver unit may
similarly be
configured to withdraw the plunger in order to withdraw a substance into the
applicator.
The applicator may be provided with a safety mechanism configured for
switching
between two modes (on/off), wherein the 'off mode' means that no substance can
be
released from the applicator and the 'on mode' means that substance can be
released.
The safety mechanism may be located on the delivery tube, the applicator tip
or the
driver unit. The applicator may further comprise a flow controller configured
for
controlling the flow rate of the substance to be released from the applicator.
The flow
controller may be located in the driver unit, and the exterior of the driver
unit may be
provided with a button or potentiometer configured to adjust the flow rate,
e.g. by
turning the button.
Kit of parts
The applicator according to the present disclosure may be provided as a part
in a kit of
parts for laparoscopic procedures, and particularly as a kit of parts suitable
for robotic-
assisted surgery. Preferably, the kit of parts is a medical substance kit,
such as a
haemostatic matrix kit, for laparoscopic procedures. The kit preferably
includes the
applicator, one or more pressure sources, and optionally a syringe configured
to be
filled with a medical substance, e.g. a haemostatic substance such as a
haemostatic
paste. Preferably, the syringe is prefilled with the substance, such that it
constitutes a
substance reservoir 24. Optionally, the applicator may be provided as separate
parts of
the kit, e.g. as a delivery tube and an applicator tip, which upon assembly
forms the
applicator according to the first aspect,
The kit may optionally further comprise one or more substance reservoirs 24
for
loading or charging the delivery tube prior to use. For example, the substance
reservoir
may be a syringe configured to be filled with a substance and configured for
forming a
fluid connection to the delivery tube of the applicator, such as via a
connector 6 to the
proximal opening of the delivery tube, or via an auxiliary connector element
25 to the
distal opening of the delivery tube.
To reduce the number of parts and to simplify the assembly, the kit of parts
may
comprise the applicator and a pressure source 8, which is easily assembled and
which
upon assembly is configured for delivering a substance under pressure. For
example,
the pressure source may be a gas cartridge 8.2 configured for forming a fluid
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connection to the delivery tube of the applicator, such as the proximal
opening of the
delivery tube, as illustrated in Figures 38 and 40.
To further simplify the assembly, the one or more pressure sources 8 may be
integrated into the applicator. For example, the pressure source may be
integrated into
the delivery tube in the form of a spring 8.3 located at a proximal end, where
the spring
energy is pre-stored and/or stored upon loading the delivery tube with a
substance, as
illustrated in Figure 38.
A third aspect of the disclosure relates to a kit of parts comprising the
applicator
according to the first aspect, or the applicator tip according to the second
aspect, one
or more pressure sources, and optionally one or more substance reservoirs. For
example, the substance reservoirs may be one or more syringes configured to be
filled
with a substance and configured for forming a fluid connection to the delivery
tube,
such as the distal opening of the delivery tube.
The kit of parts has the advantage that all parts may be manually assembled
and
operated, and that all the parts are disposable after use and adapted for
single-use.
Alternatively, the kit of parts may include parts adapted for multiple uses to
obtain a
more reproducible and sustainable applicator design. For example, the
applicator may
be assembled into a reusable unit or holder, which may include the pressure
source 8
in the form of a reusable piston or motor.
To further increase the sustainable impact, the driver unit may be refilled
with the
substance 4 or the fluid source 7. Hence, the kit of parts optionally
comprises one or
more substance reservoirs 24 or fluid source reservoirs, where the fluid
source
reservoirs are configured to be detachably attached to the fluid source within
the driver
unit.
According to one embodiment, the kit of parts comprises the laparoscopic
applicator
according to the first aspect, and a driver unit for holding at least one
fluid source for
holding a fluid, said fluid source being in fluid connection with the delivery
tube; and/or
for holding at least one pressure source, such as a motor, configured for
applying a
pressure to the at least one fluid source and/or configured for applying a
pressure to
the inside of the delivery tube.
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The kit of parts may further comprise at least one fluid source for holding a
fluid, said
fluid source being in fluid connection with the delivery tube. In one
embodiment, the
fluid source is a syringe having a plunger, wherein the driver unit further
comprises a
5 positional sensor configured for determining the position of the plunger.
The kit of parts may further comprise at least one pressure source configured
for
applying a pressure to the at least one fluid source and/or configured for
applying a
pressure to the inside of the delivery tube.
The driver unit in the kit of parts may be configured to hold at least two
fluid sources,
such as at least two syringes. An advantage hereof is that two different
substances
may be dispensed from the applicator. Alternatively, one of the at least two
syringes
may be used to withdraw a substance, such as blood, from a patient.
Substance
The applicator tube of the present disclosure is preferably configured for
dispensing a
substance. The substance may be in the form of a liquid, a paste, or a powder.
As an
example, the substance may be a medical paste. By the term "medical paste" is
meant
a paste comprising a bioactive agent. Examples of bioactive agents include
thrombin or
fibrinogen, which are also referred to as haemostatic agents. As another
example, the
substance may comprise a non-biological adhesive/glue such as a cyanoacrylate
or a
polyethylene glycol hydrogel (PEG). As yet another example, the substance may
comprise a material selected from the group of: Oxidized regenerated cellulose
(OCR),
microporous polysaccharide spheres, and microfibrillar collagen. In case the
substance
is a powder, the powder is preferably a haemostatic powder comprising
particles
having a particle size greater than 180 micron. That the particle size is
greater than 180
micron means that the particles have a good flowability so that the particles
easily can
be spread over an area. That will be extra advantageous if the powder is
haemostatic
powder, since it is important to cover the whole wound as soon as possible to
stop the
bleeding_
A "bioactive agent" is defined as any agent, drug, compound, composition of
matter or
mixture, which provides some pharmacologic, often beneficial, effect that can
be
demonstrated in vivo or in vitro. An agent is thus considered bioactive if it
has
interaction with or effect on a cell tissue in the human or animal body. As
used herein,
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this term further includes any physiologically or pharmacologically active
substance
that produces a localized or systemic effect in an individual. Bioactive
agents may be a
protein, such as an enzyme. Further examples of bioactive agents include, but
are not
limited to, agents comprising or consisting of an oligosaccharide, a
polysaccharide, an
optionally glycosylated peptide, an optionally glycosylated polypeptide, an
oligonucleotide, a polynucleotide, a lipid, a fatty acid, a fatty acid ester
and secondary
metabolites. It may be used either prophylactically, therapeutically, in
connection with
treatment of an individual, such as a human or any other animal. The term
"bioactive
agent" as used herein does not encompass cells, such as eukaryotic or
prokaryotic
cells.
A "paste" according to the present disclosure has a malleable, putty-like
consistency,
such as toothpaste. A paste is a thick fluid mixture of pulverized solid/solid
in powder
form with a liquid. A paste is a substance that behaves as a solid until a
sufficiently
large load or stress is applied, at which point it flows like a fluid, i.e. a
paste is flowable.
Flowables conform efficiently to irregular surfaces upon application. Pastes
typically
consist of a suspension of granular material in a background fluid. The
individual grains
are jammed together like sand on a beach, forming a disordered, glassy or
amorphous
structure, and giving pastes their solid-like character. It is this "jamming
together" that
gives pastes some of their most unusual properties; this causes a paste to
demonstrate
properties of fragile matter. A paste is not a gel/jelly. A "slurry" is a
fluid mixture of a
powdered/pulverized solid with a liquid, such as water. Slurries behave in
some ways
like thick fluids, flowing under gravity and being capable of being pumped if
not too
thick. A slurry may functionally be regarded as a thin, watery paste, but a
slurry
generally contains more water than a paste. Substantially water-insoluble
powder
particles, such as cross-linked gelatine particles, will form a paste upon
mixing with an
aqueous medium.
A "gel" is a solid, jelly-like material that can have properties ranging from
soft and weak
to hard and tough. Gels are defined as a substantially dilute cross-linked
system, which
exhibits no flow when in the steady-state. By weight, gels are mostly liquid,
yet they
behave like solids due to a three-dimensional cross-linked network within the
liquid. It is
the crosslinks within the fluid that give a gel its structure (hardness) and
contribute to
stickiness (tack). In this way gels are a dispersion of molecules of a liquid
within a solid
in which the solid is the continuous phase and the liquid is the discontinuous
phase. A
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gel is not a paste or slurry. For example, non-crosslinked gelatine is soluble
and forms
a gel upon contact with an aqueous medium such as water.
For a medical paste to be discharged from a syringe and an applicator tube, it
should
be flowable, when subjected to a force applicable for a syringe. Thus, by the
term
"flowable paste" is meant a paste having a viscosity facilitating a steady
flow, when
subjected to a force applicable for a syringe. An example of a flowable paste
is a paste
having a viscosity between 500-3500 Pa.s, when measured at 30 C and a
relative
humidity between 65-75%. In an embodiment of the disclosure, the paste is
flowable.
Forming a medical paste, such as a flowable medical paste, requires mixing of
the
bioactive agent with a paste or a paste forming material. Typically, bioactive
agents are
stored in a solid and dried state, such as a powdered form, facilitating
stable storage of
the active agent, and flexible concentrations by mixing the bioactive agent
with a
diluent in an adjustable ratio. Thus, for the bioactive agent to be
administered by a
syringe injection, the solid bioactive agent must first be reconstituted.
Forming a
medical paste therefore typically requires the steps of mixing a solid
bioactive agent
with a liquid or diluent to reconstitute the bioactive agent, and subsequently
mixing the
reconstituted bioactive agent with a paste forming material, which may also be
referred
to as "paste precursor". The bioactive agent may be a haemostatic agent, such
as
thrombin or fibrinogen.
By the term "paste forming material" is meant a material for forming a paste
from a
liquid phase, such as a reconstituted bioactive agent. Thus, a paste forming
material
may also be referred to as a precursor material for forming a paste.
The reconstituted bioactive agent is obtained by mixing the bioactive agent
with a liquid
with low viscosity, such as sterile water or saline water, thereby ensuring
uniform
reconstitution. Thus, the reconstituted bioactive agent is a liquid with low
viscosity. A
paste may be obtained from the reconstituted bioactive agent by adding a paste
forming material, which inherently increases the viscosity.
Substance loading
As described earlier, the delivery tube of the applicator may be prefilled
with the
substance (e.g. a medical fluid, paste or powder) before use, e.g. before
insertion of
the applicator into the trocar port. Alternatively, the delivery tube may be
configured to
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be filled with the substance after insertion into the trocar port, e.g.
immediately before
application or continuously during application of the substance.
Proximal loading
In a first preferred embodiment, the filling of the delivery tube is performed
via the
proximal end 2.1 of the delivery tube, which is accessible to the surgeon or
an assistant
during surgery, as illustrated in Figure 1. The filling of the delivery tube
is
advantageously done using a separate syringe comprising the substance 4 within
a
syringe barrel, where the syringe may be prefilled with the substance, or
configured for
aspirating the substance from a substance source such as a medical fluid
source, as
e.g. illustrated in Figures 12-14. Hence, the container or syringe comprising
the
substance 4 may be referred to as a substance reservoir 24. To facilitate safe
and
precise filling with a minimum of substance waste, the proximal end 2.1
advantageously comprises one or more connectors 6 for detachably attaching the
fluid
source, such as a syringe prefilled with the substance. An example of a
connector is a
Luer lock for attaching a syringe, or a compression joint or adhesive joint
for attaching
a substance reservoir or fluid container. Alternatively, the delivery tube and
the fluid
source, e.g. the syringe, may be attached without the use of a connector.
In an embodiment of the disclosure, the delivery tube and the at least one
fluid source
comprises the same substance, or is configured for comprising the same
substance,
such as a substance comprising a haemostatic agent, the substance provided in
the
form of a liquid, a paste, or a powder, such that the at least one fluid
source constitutes
a first substance reservoir.
Continuous loading
In addition to being prefilled and configured for being filled or loaded with
substance 4
from the proximal end, after being inserted into the trocar port, the
applicator may
advantageously further be configured for being loaded continuously while being
inserted into the trocar. This may be obtained by the applicator being
configured for
being loaded from a multiple amount of substance reservoirs 24.
Figure 36 shows an embodiment of the applicator according to the present
disclosure,
where the applicator 1 comprises a first 24.1 and second substance reservoir
24.2.
Hence, the syringe substance reservoir 24 shown in e.g. Figure 14 is replaced
with an
integrated first substance reservoir 24.1, which is different from a separate
syringe,
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thereby avoiding a separate syringe and plunger. The integrated first
substance
reservoir may comprise a barrel for holding the substance, a stopper defining
the first
substance reservoir, which may also act as a piston for pushing the substance
out of
the barrel. The integrated first substance reservoir is not restricted to
having
conventional syringe dimensions, and may advantageously have a relatively
wider
diameter and shorter length than a conventional syringe.
In an embodiment of the disclosure, the first substance reservoir comprises a
barrel for
holding the substance and a piston for pushing the substance out of the
barrel. In a
further embodiment, the barrel has a diameter between 10-30 mm, more
preferably
between 12-20 mm, and most preferably between 14-18 mm.
A second substance reservoir 24.2 is detachably attachable to the first
substance
reservoir 24.1 via an auxiliary connector element 25, as illustrated in
Figures 36-37.
Figure 37A shows the second reservoir being attached, and 37B shows when the
second reservoir is detached.
For dispensing substance from the applicator before or during operation, the
assistant
may attach a second substance reservoir 24.2, optionally while the applicator
is
inserted into the trocar port. The assembly may be configured for transferring
the
substance, e.g. haemostat, from the second substance reservoir into the first
substance reservoir. For example, the second substance reservoir may be
pressurized
and the auxiliary connector element may include a one way valve Luer lock
facilitating
the transfer.
In an embodiment of the disclosure, the applicator comprises one or more
second
substance reservoir(s). In a further embodiment, the first and/or second
substance
reservoirs are disposable.
In an embodiment of the disclosure, the second substance reservoir(s) are
detachably
attached to the first substance reservoir via at least one auxiliary connector
element. In
a further embodiment, the connector element comprises a Luer lock, a
compression
joint, or an adhesive joint.
The substance may then be dispensed by activating a dispensing button or
actuator
2.6 at the distal end 2.2 of the delivery tube. The actuator may activate the
drive
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mechanism of the pressure source, e.g. a mechanically controlled drive
mechanism or
a motor controlled or electrically controlled drive mechanism. For example,
the
pressure source may correspond to the drive unit 10 shown in Figure 14, where
the
pressure source is motor controlled advancing piston, which may exert a
pressure on
5 the first substance reservoir 24.1. Due to the wider diameter and shorter
length of the
first substance reservoir, a smaller force is required for dispensing the
substance.
Hence, the pressure force may also be a manually driven piston, since a
relatively low
force is needed to prime. Further, the dimensions of the first substance
reservoir
enables that any substances 4 irrespective of the viscosity may be easily
dispensed.
The auxiliary connector element may be configured to avoid back filling of the
second
substance reservoir from the pressure source. This may be obtained by the
auxiliary
connector element being adapted for establishing a sequential fluid connection
between 1) the first and second substance reservoirs, and 2) the first
substance
reservoir and the delivery tube. Thus, the auxiliary connector element may
have two
configurations, which may be obtained by a one-way valve.
In an embodiment of the disclosure, the auxiliary connector element is
configured for
establishing a sequential fluid connection between 1) the first and second
substance
reservoirs, and 2) the first substance reservoir and the delivery tube. In a
further
embodiment, the auxiliary connector element is adapted to have a first
configuration
proving a fluid passageway between the first and second substance reservoirs,
and a
second configuration providing a fluid passageway between the first substance
reservoir and the delivery tube. In an embodiment of the disclosure, the
auxiliary
connector element comprises at least one one-way valve.
It follows that the first substance reservoir may be refilled at any point by
the nurse
detaching and attaching any multiple of further second reservoirs. Further,
the
reservoirs are advantageously disposable, for simple and flexible application.
For
example, all parts excluding the driver unit may be disposable.
It follows from the above that the applicator comprising the first and second
substance
reservoirs may have a particularly compact design and be particularly suitable
for
substances of both high and low viscosity, e.g. liquids, pastes, and powders,
due to the
form factor of the first substance reservoir.
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Continuous loading may be applied to an applicator comprising any number of
substance reservoirs, and to an applicator for substance mixtures. For
example, this
may apply to the embodiment shown in Figure 30, where the delivery tube
comprises a
first lumen for holding a first type of substance and a second lumen for
holding a
second type of substance, and where the two types of substances are mixed once
the
substances are dispensed or before they are dispensed. For example, the
applicator tip
may include a nozzle comprising a mixing chamber. In this case, one substance
may
be in the form of a liquid and the other substance could be a powder to be
mixed in the
liquid. The two substances could also be two liquids or two pastes, or other
combinations of liquid, paste, and powder. The drive mechanism of Figure 30
comprises two pistons, wherein a first piston is configured to exert a first
pressure on
two different reservoirs simultaneously or with a time delay to ensure
sufficient mixing.
In analogy to Figure 30, Figure 41 shows an embodiment of the applicator
according to
the present disclosure, wherein the applicator 1 comprises two first substance
reservoirs 24.1, and a detached drive mechanism 10 for pressurizing the two
first
substance reservoirs. The drive mechanism is exemplified as a motorized driver
unit
with two pistons.
Figure 42 shows the applicator of Figure 41, where the two first substance
reservoirs
24.1 are connected via check valves 25 to two second substance reservoirs 24.2
(shown as two syringes). (A) shows loading of the first reservoirs by the
syringes, and
(B) shows the loaded applicator, where the stopper is defining the first
substance
reservoir, and after the two syringes are detached.
Figure 43 shows the applicator of Figures 41-42, wherein the detachable drive
mechanism for pressurizing the two first substance reservoirs 24.1 is attached
in (A),
and in (B) the pistons of the drive mechanism has translated the stopper, and
thereby
emptied the two first reservoirs.
Distal loading
In addition to, or alternatively to, proximal loading, the applicator may also
be
configured for being loaded from the distal end. This may further improve the
compact
design, reduce the number of parts of the applicator, and provide a fully
disposable
applicator.
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Figure 38A shows an embodiment of the applicator according to the present
disclosure,
where the applicator is configured for being loaded with substance 4 from the
distal end
2.2, opposite to the pressure source 8 located at the proximal end 2.1. This
may be
obtained by the distal end or tip of the delivery tube comprising a detachably
attached
auxiliary connector element 25 for forming a fluid communication with a
substance
reservoir, as shown in Figure 38B, and a flow controlling element 26, as shown
in
Figure 38C. The flow controlling element may for example be a 3-way valve
having
three configurations: a first configuration providing a fluid passageway from
the distally
attached substance reservoir and into the delivery tube, a second
configuration where
no fluid passageway is provided such that the substance within the delivery
tube may
be pressurized, and a third configuration providing a fluid passageway from
the delivery
tube and out of the distal end of the delivery tube. Advantageously, the flow
controlling
element is configured for establishing a sequential fluid connection with
opposite
directions, first between 1) the substance reservoir and the delivery tube,
and then
between 2) the delivery tube and the detached substance reservoir.
In an embodiment of the disclosure, the delivery tube is configured for being
loaded
with substance from the distal end. In an embodiment of the disclosure, the
delivery
tube comprises one or more detachably attached connectors for a substance
reservoir,
and/or a flow controlling element.
Figure 39A shows an embodiment of the applicator according to the present
disclosure,
where the applicator is configured for being loaded with substance from the
distal end
2.2 via a substance reservoir 24 in the form of a syringe comprising the
substance 4.
The applicator 1 comprises a pressure source 8, which advantageously is a
spring 8.3
integrated within the delivery tube, as shown in Figure 39A. The syringe 24 is
attached
to the distal end 2.2 of the delivery tube via the auxiliary connector element
25, which
may be a Luer lock connector, as shown in Figure 39B. The syringe content is
transferred to the delivery tube, whereby the spring 8.3 is compressed, as
shown in
Figure 39C. Hence, the pressure source in the form of spring energy is stored
upon
loading the delivery tube. Alternatively, the spring energy may be pre-stored
by being
pre-compressed, such that a predetermined spring energy amount is provided by
the
applicator. The syringe and the auxiliary connector element may then be
detached, and
the flow controlling element 26 facilitates that the substance within the
delivery tube is
pressured by the spring force. The applicator is ready for use, and the
substance 4
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may be dispensed as shown in Figure 39D,e.g. via an actuator comprised within
the
flow controlling element, as indicated by arrows.
The present embodiment provides an applicator with a particularly compact
design and
small form factor. Further advantageously, the embodiment provides a non-
motorized
and fully disposable applicator for single use.
In an embodiment of the disclosure, the at least one pressure source is a
spring
configured to exert a pressure on the at least one fluid source and/or the
substance
within the delivery tube. In a further embodiment, the spring energy is pre-
stored,
and/or wherein the spring energy is stored upon loading the delivery tube.
As alternative, or in addition, to a spring 8.3, the pressure source may
include a gas
pressure source such as a pressurized container, e.g. a gas cartridge 8.2.
Fiqure 40A
shows an embodiment of the applicator according to the present disclosure,
where the
applicator 1 is configured for being loaded with substance from the distal end
2.2 via a
substance reservoir 24 in the form of a syringe attachable to the distal end
via an
auxiliary connector element 25. The applicator further comprises a pressure
source 8
for pressurizing and dispensing the substance in the form of a gas cartridge
8.2. After
loading, the syringe 24 and the auxiliary connector element 25 is detached, as
shown
in Figure 40B, and the substance 4 is dispensed by the gas pressure exerted,
as
shown in Figure 40C. It follows that a gas pressure may be obtained by other
means
than a gas cartridge, e.g from motorized bellows, -propellers, -compressors,
In an embodiment of the disclosure, the at least one pressure source is a gas
configured to exert a pressure on the at least one fluid source and/or the
substance
within the delivery tube. In an embodiment of the disclosure, the gas pressure
source is
selected from the group of: gas cartridges, motorized bellows, -propellers, -
compressors, and combinations thereof.
Haemostatic powder applications
According to one embodiment, the laparoscopic applicator is configured for
dispensing
a haemostatic powder at a selected site by means of a surgical robotic arm,
wherein
the laparoscopic applicator comprises:
- a delivery tube for holding the haemostatic powder; and
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- a variable rate feeder, such as a screw conveyor, configured for
transporting the haemostatic powder through the delivery tube to the
outside of the delivery tube, whereby the haemostatic powder is
dispensed from the applicator.
The haemostatic powder preferably comprises a haemostatic agent.
Advantageously,
the haemostatic powder comprises particles having a particle size greater than
180
micron. In an embodiment, the haemostatic powder comprises particles having an
average particle size of at least 275 micron, such as approximately 300 micron
in
average. Furthermore, the particles may have a tapped density of at least 0.3
g/cm3,
more preferably at least 0.4 g/cm3, even more preferably at least 0.44 g/cm3.
As an
example, the particles may have a tapped density in the range 0.3-1 g/cm3. In
one
embodiment, the variable rate feeder is a screw conveyor. This is illustrated
in Figure
26. In another embodiment, the variable rate feeder is a paddle wheel. The
applicator
may comprise a first positional sensor, such as a magnetic sensor or an
optical sensor,
said sensor being configured for determining the position of the screw
conveyor and/or
the paddle wheel. The first positional sensor is preferably configured to
register each
turn of the screw conveyor and/or the paddle wheel and each turn is added or
subtracted depending on the rotational direction so that position of the screw
conveyor
and/or the paddle wheel can be determined. If a processor is used to control
the screw
conveyor and/or the paddle wheel processor will know the direction of the
rotation.
Alternatively, the first positional sensor can sense the direction e.g. by
having two
sensors next to each other. The position (e.g. determined by the number of
turns) of
the screw conveyor may be used to determine the remaining amount of powder in
the
delivery tube.
In another embodiment, the laparoscopic applicator for dispensing the
haemostatic
powder at a selected site by means of a surgical robotic arm, comprises:
- a delivery tube holding the haemostatic powder;
- a valve located at a distal end of the delivery tube, wherein the valve is
configured to open at a pre-defined opening pressure; and
- a vibrating device, such as an ultrasonic vibrating device, configured
for
shaking the haemostatic powder out of the delivery tube when the valve
is open.
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A laparoscopic applicator comprising a vibrating device is shown in Figures 27-
29. In
case the applicator comprises a vibrating device, the applicator may further
comprise a
clock configured for measuring the elapsed time when the vibrating device is
activated/vibrating. The elapsed time may be used to estimate the remaining
volume of
5 haemostatic powder in the delivery tube. Alternatively, the applicator
may comprise one
of the sensors described above for determining the amount of substance in the
applicator.
The laparoscopic applicator is configured for dispensing or withdrawing a
substance
10 comprising a haemostatic agent, and said substance may be in the form of
a liquid, a
paste, or a powder. Due to the flow characteristics of powders, the pressure
source or
drive mechanism for transporting the haemostatic powder through the delivery
tube to
the outside of the delivery tube advantageously comprises a combination of a
variable
rate feeder, such as a screw conveyor, or a vibrating device, in combination
with a
15 pressure source, such as a gas pressure source.
In case the medical substance is a powder, such as a haemostatic powder, a
pressure
source is not necessarily needed, since the powder may be discharged from the
applicator by other means. In this case the applicator may, as an alternative,
or an
20 addition, to the pressure source, comprise a variable rate feeder
configured for
transporting the haemostatic powder through the delivery tube to the outside
of the
delivery tube, whereby the haemostatic powder is dispensed from the
applicator.
Alternatively, the applicator may comprise a vibrating device for shaking the
powder out
of the applicator. However, advantageously for efficient and precise discharge
of the
25 powder, e.g. to obtain sufficient flow characteristics and spray angle,
the variable rate
feeder further comprises a pressure source, such as a gas pressure source.
Figure 31 shows an embodiment of the applicator according to the present
disclosure,
wherein the applicator 1 comprises a gas pressure source 8 for transporting a
powder
30 through the delivery tube. For example, the gas pressure source is
bellows, which are
activated by a motorized piston 10.1, e.g. a piston vibrating back and forth
in the
horizontal direction, as indicated by the larger double arrow. (A) shows a
perspective
view, and (B) a cross-sectional view of the applicator. The driving mechanism
of the
pressure source may be activated via an actuator 2.6, such as an electrical
actuator
35 sending an electrical signal to the motor 10.1, as indicated in Figure
31A, whereby the
powder 20 is dispensed from the distal end 2.2 of the delivery tube. The
powder may
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be prefilled into the applicator or supplied from a second substance reservoir
24.2 via
an auxiliary connector element 25, or the bellows may comprise a substance
reservoir,
such as a powder 20 reservoir, such that the powder is transported
simultaneously with
the gas pressure source. as shown in Figure 31B.
Figure 32 shows an embodiment of the applicator according to the present
disclosure,
wherein the applicator comprises a gas pressure source 8 for transporting a
powder 20
through the delivery tube, where the gas pressure source is obtained via a
motorized
propeller, and optionally a gas inlet. (A) shows a perspective view, and (B) a
cross-
sectional view of the applicator. The driving mechanism of the pressure source
may be
activated via an actuator 2.6, such as an electrical actuator sending an
electrical signal
to the motor 10.1, as indicated in Figure 32A, whereby the powder 20 is
dispensed
from the distal end 2.2 of the delivery tube. The powder may be prefilled into
the
applicator or supplied from a second substance reservoir 24.2 via an auxiliary
connector element 25,
Figure 33 shows an embodiment of the applicator according to the present
disclosure,
wherein the applicator comprises a pressure source for transporting a powder
through
the delivery tube, where the pressure source is a distally located piston or
actuator 2.6
with apertures for establishing fluid communication to the distal end 2.2 of
the delivery
tube. The distally located piston may be motorized 10.1 to vibrate back and
forth in the
horizontal direction, as indicated by the large double arrow, whereby the
powder 20 is
dispensed from the distal end 2.2 of the delivery tube. (A) shows a partly
perspective
view, where the distal end is enlarged in the inserted frame, (B) shows a
cross-
sectional view, where the distal end is enlarged in the inserted frame in
perspective
view. The powder may be prefilled into the applicator or supplied from a
second
substance reservoir via an auxiliary connector element.
Figure 34 shows an embodiment of the applicator according to the present
disclosure,
wherein the applicator comprises a gas pressure source for transporting a
powder
through the delivery tube, where the gas pressure source is obtained form a
rotating
paddle wheel or impeller. The impeller may further be controlled by a gas
cartridge 8.2
in combination with a gas flow control valve, e.g. in combination with the
connector 6.
Thus, the powder feed may be controlled by the rotation rate of the impeller
and the
gas cartridge supply. The powder may be prefilled into the applicator or
supplied from a
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first or second substance reservoir 24, such as comprised within the impeller
as
indicated most clearly in Figure 34B.
In an embodiment of the disclosure, the variable rate feeder further comprises
a
pressure source, such as a gas pressure source, optionally selected from the
group of:
gas cartridges, motorized bellows, -propellers, -cornpressors, and
combinations
thereof. In an embodiment of the disclosure, the variable rate feeder
comprises a
powder reservoir, wherein the reservoir optionally comprises a reservoir feed
controller,
such as an adjustable reservoir opening.
For efficient and precise discharge of the powder, e.g. to obtain sufficient
flow
characteristics and spray angle, the gas pressure source advantageously
provides the
possibility of a reduced gas flow, e.g. a reduced air flow or reduced air
volume, such
that the powder discharge is more controlled and powder turbulence at the
discharge is
avoided. This may be obtained by the applicator comprising flow confining
elements for
reducing the gas flow at the powder delivery site.
Figure 35 shows an embodiment of the applicator according to the present
disclosure,
wherein the applicator 1 comprises a gas pressure source 8 for transporting a
powder
through the delivery tube, and further flow confining elements for reducing
the gas flow
at the powder delivery site. For example the flow confining elements 22 may be
a grid
or slit elements within the delivery tube that the powder 20 and gas has to
pass, as
shown in Figure 35A. Alternatively, the flow confining element 22 may be a
separate
gas flow channel as shown in Figure 35B, which is running in parallel with a
screw
conveyor 19 transporting the powder 20.
In an embodiment of the disclosure, the variable rate feeder comprises one or
more
flow confining elements, such as grid elements or separate gas flow channels.
Reference numerals
1 ¨ Laparoscopic applicator
2 ¨ Delivery tube
2.1 ¨ Proximal end
2.2 ¨ Distal end
2.3 ¨Deformable section
2.4 ¨ Rigid surface
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2.5 ¨ Rigid surface opening
2.6 ¨ Actuator
2.7 ¨ Valve
2.8 ¨ Rigid section
3 ¨ Rigid sheath
4 ¨ Substance
5 ¨ Surgical robotic arm
6 ¨ Connector
7 ¨ Fluid source
8 ¨ Pressure source
8.1 ¨ Propellant
8.2 ¨ Gas cartridge
8.3 - Spring
9 ¨ Applicator tip
10 ¨ Driver unit
10.1 ¨ Motor
11 ¨ Flow controller
12 ¨ Pressure indicator light
13¨ Status indicator
14 ¨ First lumen
15¨ Second lumen
16 ¨ Third lumen
17¨ Fourth lumen
18¨ Malleable wire/rod
19 ¨ Screw conveyor
20 ¨ Haemostatic powder
21 ¨ Vibrating device
22 ¨ Flow confining elements
24 ¨ Substance reservoir
24.1 - First substance reservoir
24.2 ¨ Second substance reservoir
25 ¨ Auxiliary connector element
26 ¨ Flow controlling element
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Further details of the invention
1. A laparoscopic applicator for dispensing or withdrawing a substance, e.g. a
substance comprising a haemostatic agent, at a selected site by means of a
surgical robotic arm, the laparoscopic applicator comprising:
- a delivery tube for holding the substance; and
an applicator tip connected to a distal end of the delivery tube, the
applicator tip configured for:
- being spatially manipulated by the robotic arm, and/or
- controllably releasing the substance from the delivery tube by the
robotic arm, and/or
- controllably withdrawing the substance from the selected site into the
delivery tube.
2. The laparoscopic applicator according to item 1, wherein the delivery tube
comprises at least one rigid section, such as a rigid tubular section or a
rigid
surface area.
3. The laparoscopic applicator according to item 2, wherein the at least one
rigid
section is dimensioned such that it is tangible by the robotic arm, such as
tangible by gripping, pushing, or attachment.
4. The laparoscopic applicator according to any of the preceding items,
wherein
the delivery tube comprises a deformable section.
5. The laparoscopic applicator according to item 4, wherein the deformable
section is compressible, e.g. in the form of a corrugated tube, such that the
length of the tube may be varied.
6. The laparoscopic applicator according to any of the items 4-5, wherein the
deformable section comprises a corrugated surface profile, preferably wherein
the corrugated surface profile comprises a plurality of circumferential folds.
7. The laparoscopic applicator according to any of the items 4-6, wherein the
deformable section is located at a distal end of the delivery tube.
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8. The laparoscopic applicator according to any of items 4-6, wherein the
deformable section is located at a distance from the distal end of the
delivery
tube.
5 9. The laparoscopic applicator according to any of the preceding items,
wherein
the delivery tube and/or applicator tip is dimensionally configured for
holding the
substance under a pressure, and/or configured to include one or more flow
controlling elements.
10 10. The laparoscopic applicator according to any of the preceding
items, wherein
the delivery tube and/or applicator tip has an inner diameter of less than 5
mm,
preferably less than 3 mm, even more preferably less than 2 mm.
11. The laparoscopic applicator according to any of the preceding items,
wherein
15 the delivery tube contains a substance, e.g. a substance comprising
a
haemostatic agent, said substance being in the form of a liquid, a paste, or a
powder.
12. The laparoscopic applicator according to item 11, wherein the substance
20 comprises a bioactive agent and/or a haemostatic agent.
13. The laparoscopic applicator according to item 11, wherein the substance
comprises a material selected from the group of: Polyethylene glycol (PEG),
cyanoacrylate, oxidized regenerated cellulose, microporous polysaccharide
25 spheres, and microfibrillar collagen.
14. The laparoscopic applicator according to item 11, wherein the substance is
a
haemostatic paste comprising a haemostatic agent.
30 15. The laparoscopic applicator according to item 14, wherein the
haemostatic
agent is selected from the group of: thrombin and fibrinogen.
16. The laparoscopic applicator according to item 11, wherein the substance is
a
haemostatic powder.
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17. The laparoscopic applicator according to item 16, wherein the haemostatic
powder comprises particles having a particle size greater than 180 micron.
18. The laparoscopic applicator according to any of the items 16-17, wherein
the
haemostatic powder comprises particles having an average particle size of at
least 275 micron.
19. The laparoscopic applicator according to any of the items 16-18, wherein
the
haemostatic powder comprises particles having a tapped density of at least 0.4
g/mL.
20. The laparoscopic applicator according to any of the items 16-19, wherein
the
applicator further comprises a variable rate feeder, such as a screw conveyor,
configured for transporting the haemostatic powder through the delivery tube
to
the outside of the delivery tube, whereby the haemostatic powder is dispensed
from the applicator.
21. The laparoscopic applicator according to item 20, wherein the variable
rate
feeder is configured for being driven/rotated by an external motor.
22. The laparoscopic applicator according to item 20, wherein the applicator
further
comprises a motor for driving/rotating the variable rate feeder.
23. The laparoscopic applicator according to any of the items 20-21, wherein
the
variable rate feeder is a screw conveyor.
24. The laparoscopic applicator according to any of the items 20-21, wherein
the
variable rate feeder is a paddle wheel.
25. The laparoscopic applicator according to any of items 20-24, wherein the
variable rate feeder further comprises a gas pressure source, optionally
selected from the group of: gas cartridges, motorized bellows, -propellers, -
compressors, and combinations thereof.
26. The laparoscopic applicator according to any of items 20-25, wherein the
variable rate feeder comprises a powder reservoir, wherein the reservoir
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optionally comprises a reservoir feed controller, such as an adjustable
reservoir
opening and/or paddle wheel.
27. The laparoscopic applicator according to any of items 20-26, wherein the
variable rate feeder comprises one or more flow confining elements, such as
grid elements or separate gas flow channels.
28. The laparoscopic applicator according to any of the items 20-27, wherein
the
applicator further comprises a first positional sensor configured to determine
the
position of the variable rate feeder.
29. The laparoscopic applicator according to item 28, wherein the first
positional
sensor is an optical sensor.
30. The laparoscopic applicator according to item 28, wherein the variable
rate
feeder is provided with a magnet, and wherein the first positional sensor is a
magnetic sensor configured to detect the presence of the magnet.
31. The laparoscopic applicator according to any of the items 16-30, wherein
the
applicator further comprises a vibrating device, such as an ultrasonic
vibrating
device, configured for shaking the haemostatic powder out of the delivery
tube.
32. The laparoscopic applicator according to item 31, wherein the applicator
further
comprises a clock configured for measuring the elapsed time when the vibrating
device is activated/vibrating.
33. The laparoscopic applicator according to item 32, wherein the elapsed time
is
used to estimate the remaining volume of haemostatic powder in the delivery
tube.
34. The laparoscopic applicator according to any of the preceding items,
wherein
the delivery tube comprises a plurality of lumens, such as at least two
lumens,
or at least three lumens, or at least four lumens.
35. The laparoscopic applicator according to item 34, wherein the plurality of
lumens comprises a first lumen and a second lumen, wherein the first lumen is
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configured to contain a substance, e.g. a substance comprising a haemostatic
agent, and the second lumen is configured to contain electrical wiring or an
optical fibre.
36. The laparoscopic applicator according to item 35, wherein the inner
diameter of
the first lumen is less than 4 mm, preferably less than 3 mm, even more
preferably less than 2 mm.
37. The laparoscopic applicator according to any of the items 34-36, wherein
at
least one of the plurality of lumens is configured to contain a malleable wire
or
rod.
38. The laparoscopic applicator according to any of the items 4-37, wherein
the
applicator further comprises a malleable wire or rod, configured such that the
deformable section of the delivery tube may be bent into a desired shape, said
shape being approximately maintained upon release of the delivery tube.
39. The laparoscopic applicator according to any of the items 4-38, wherein
the
deformable section of the delivery tube may be bent along two planes at two
pre-determined angles, such as at least 30 or at least 45 .
40. The laparoscopic applicator according to any of the preceding items,
wherein
the applicator tip is detachably attached to the distal end of the delivery
tube.
41. The laparoscopic applicator according to any of the preceding items,
wherein
the applicator tip is integrated in the delivery tube, such that the delivery
tube
and the applicator tip is a single unit.
42. The laparoscopic applicator according to any of the preceding items,
wherein
the delivery tube and/or the applicator tip are disposable.
43. The laparoscopic applicator according to any of the preceding items,
wherein
the applicator or applicator tip further comprises at least one valve
configured
for releasing the substance from the delivery tube upon opening of said valve.
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44. The laparoscopic applicator according to item 44, wherein the at least one
valve
is a pressure activated valve having a pre-defined opening pressure threshold.
45. The laparoscopic applicator according to item 44, wherein the substance is
dispensed from the delivery tube when the pre-defined opening pressure
threshold is exceeded.
46. The laparoscopic applicator according to any of the items 43-453, wherein
the
at least one valve is controllable by an actuator located on the applicator.
47. The laparoscopic applicator according to any of the items 43-46, wherein
the at
least one valve is controllable by an external actuator, such as a foot pedal.
48. The laparoscopic applicator according to any of the items 43-47, wherein
the at
least one valve is selected from the group of: one-way valve, elastomeric one-
way valve, duckbill valve, cross slit valve, and spring-loaded check valve.
49. The laparoscopic applicator according to any of the items 43-48, wherein
the at
least one valve is located in the delivery tube.
50. The laparoscopic applicator according to any of the items 43-49, wherein
the at
least one valve is located in the applicator tip.
51. The laparoscopic applicator according to any of the preceding items,
wherein
the applicator or applicator tip further comprises at least one actuator
configured to open and/or close the at least one valve.
52. The laparoscopic applicator according to item 51, wherein the at least one
actuator is configured to activate by a pressure force, e.g. applied by the
robotic
arm, or by an electrical current, e.g. applied by an energy tool.
53. The laparoscopic applicator according to any of the items 51-52, wherein
the at
least one actuator is activated by pulling the actuator along a longitudinal
axis of
the tube/applicator tip and/or by rotating the actuator around the
longitudinal
axis.
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54. The laparoscopic applicator according to any of the items 51-53, wherein
the at
least one actuator is located at a distal end of the delivery tube.
55. The laparoscopic applicator according to any of the items 51-54, wherein
the at
5 least one actuator is located on the rigid section of the delivery
tube.
56. The laparoscopic applicator according to any of the items 51-55, wherein
the at
least one actuator is located on the applicator tip.
10 57. The laparoscopic applicator according to any of the items 51-56,
wherein the at
least one actuator is located on an external device.
58. The laparoscopic applicator according to any of the items 51-57, wherein
the at
least one actuator is a pressure-sensitive button.
59. The laparoscopic applicator according to any of the items 51-58, wherein
the at
least one actuator covers a predefined circumferential section of the tube
and/or
applicator tip.
60. The laparoscopic applicator according to item 59, wherein the at least one
actuator covers less than 180 of the circumference of the tube and/or
applicator tip, preferably less than 140 .
61. The laparoscopic applicator according to any of the items 59-60, wherein
two
actuators are provided on opposite parts of the applicator tip and/or tube,
each
of said actuators covering less than 120' of the circumference of the tube
and/or applicator tip, preferably less than 90 each.
62. The laparoscopic applicator according to any of the items 59-61, wherein
the at
least one actuator covers at least 180 of the circumference of the tube
and/or
applicator tip.
63. The laparoscopic applicator according to any of the items 59-62, wherein
the at
least one actuator covers 360 of the circumference of the tube and/or
applicator tip, such that the at least one actuator surrounds a part of the
tube
and/or applicator tip.
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64. The laparoscopic applicator according to any of the items 51-63, wherein
the at
least one actuator is configured to, upon activation, send an electrical
signal to
a pressure source, such as a drive mechanism, configured to exert a pressure
sufficient to dispense the substance from the laparoscopic applicator.
65. The laparoscopic applicator according to any of the preceding items,
wherein
the applicator further comprises a first pressure sensor for sensing the
pressure
in the delivery tube.
66. The laparoscopic applicator according to any of the items 51-65, wherein
the
applicator further comprises a second pressure sensor for sensing the pressure
applied to the actuator.
67. The laparoscopic applicator according to item 66, wherein the second
pressure
sensor is a resistive film pressure sensor and/or a force-sensitive resistor.
68. The laparoscopic applicator according to any of the items 51-67, wherein
the at
least one actuator is a pressure-sensitive button, wherein a pressure sensor
for
sensing the pressure applied to the actuator is integrated in said button or
placed under the button.
69. The laparoscopic applicator according to any of the items 51-68, wherein
the at
least one actuator is a pressure-sensitive button covering a part of the
applicator tip, said part surrounding the entire circumference of the
applicator
tip, wherein a second pressure sensor for sensing the pressure applied to the
actuator is integrated in said button or placed under the button.
70. The laparoscopic applicator according to any of the items 51-69, wherein
the
applicator further comprises a pressure indicator light for indicating the
pressure
applied to the at least one actuator.
71. The laparoscopic applicator according to item 70, wherein the pressure
indicator light is located in the applicator tip or on the applicator tip.
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72. The laparoscopic applicator according to any of the items 70-71, wherein
the
pressure indicator light is provided as a circular band positioned along the
circumference of the applicator tip.
73. The laparoscopic applicator according to any of the items 70-72, wherein
the
pressure indicator light is configured to:
- display light of a first color, e.g. green, when
the applied pressure is
below a predefined first threshold; and
- display light of a second color, e.g. red, when the applied pressure is
above a predefined second threshold.
74. The laparoscopic applicator according to item 73, wherein the pressure
indicator light is further configured to:
- display light of a third color, e.g. yellow, when the applied pressure is
between the predefined first and second thresholds.
75. The laparoscopic applicator according to any of the preceding items,
wherein
the applicator or applicator tip further comprises a status indicator, e.g. in
the
form of light diodes, said status indicator configured to indicate the
remaining
volume of substance in the applicator.
76. The laparoscopic applicator according to item 75, wherein the remaining
volume is determined by the first positional sensor, the second positional
sensor, the clock, and/or combinations thereof.
77. The laparoscopic applicator according to any of the items 75-76, wherein
the
applicator further comprises at least one fluid source comprising a plunger in
a
barrel, wherein the position of the plunger is used to estimate the remaining
volume of substance in the delivery tube, wherein the remaining volume is
indicated by the status indicator.
78. The laparoscopic applicator according to any of the items 75-77, wherein
the
status indicator is located in the applicator tip or on the applicator tip.
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79. The laparoscopic applicator according to any of the preceding items,
wherein
the delivery tube comprises a first light sensitive sensor configured for
sensing
light of a pre-defined wavelength range passing through the delivery tube, and
wherein:
- the delivery tube comprises a light source positioned opposite the first
light sensitive sensor; and/or
- the delivery tube is transparent to at least a
portion of the wavelength
range.
80. The applicator according to item 79, wherein the first light sensitive
sensor is
positioned at a distal part of the delivery tube.
81. The applicator according to any of the items 79-80, wherein the delivery
tube
comprises a second light sensitive sensor located further away from the distal
end than the first light sensitive sensor.
82. The laparoscopic applicator according to any of the preceding items,
wherein
the applicator tip further comprises a rigid section configured to be gripped
by
the robotic arm.
83. The laparoscopic applicator according to any of the preceding items,
wherein
the applicator tip further comprises an adjustable nozzle for adjusting the
dispensing rate and or dispensing angle of the substance.
84. The laparoscopic applicator according to any of the preceding items,
wherein
the applicator further comprises at least one fluid source for holding a
fluid, said
fluid source being in fluid connection with the delivery tube.
85. The laparoscopic applicator according to item 84, wherein the at least one
fluid
source is a syringe such as a medical syringe, e.g. a single-use medical
syringe.
86. The laparoscopic applicator according to item 85, wherein the syringe
comprises a barrel for holding a fluid and a plunger for pushing the fluid out
of
the syringe.
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87. The laparoscopic applicator according to item 86, wherein the applicator
further
comprises a second positional sensor configured for determining the position
of
the plunger.
88. The laparoscopic applicator according to item 87, wherein the second
positional
sensor is an optical sensor.
89. The laparoscopic applicator according to item 87, wherein the plunger is
provided with a magnet, and wherein the second positional sensor is a
magnetic sensor configured to detect the presence of the magnet.
90. The laparoscopic applicator according to any of the items 87-89, wherein
the
position of the plunger is used to estimate the remaining volume of substance
in
the barrel and/or in the delivery tube.
91. The laparoscopic applicator according to item 84, wherein the at least one
fluid
source is a container such as a container configured to be pressurized.
92. The laparoscopic applicator according to item 84, wherein the at least one
fluid
source is a flexible balloon.
93. The laparoscopic applicator according to any of the items 84-92, wherein
the
applicator comprises at least one connector, such as a Luer lock, a
compression joint, and/or an adhesive joint, for detachably attaching the at
least
one fluid source.
94. The laparoscopic applicator according to item 93, wherein the at least one
connector comprises a hollow piercing element for piercing the at least one
fluid
source, whereby a fluid connection between the fluid source and the delivery
tube is established.
95. The laparoscopic applicator according to any of the items 84-92, wherein
the at
least one fluid source comprises a liquid such as a saline solution.
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96. The laparoscopic applicator according to any of the items 84-95, wherein
the at
least one fluid source comprises a paste such as a haemostatic paste
comprising a haemostatic agent.
5 97. The laparoscopic applicator according to any of the items 84-96,
wherein the at
least one fluid source comprises a gas.
98. The laparoscopic applicator according to item 97, wherein the gas is
selected
from the group of CO2 (carbon dioxide), N2 (dinitrogen), N20 (nitrous oxide),
and
10 air.
99. The laparoscopic applicator according to any of the items 84-97, wherein
the
delivery tube and the at least one fluid source comprises the same substance,
such as a substance comprising a haemostatic agent, the substance provided
15 in the form of a liquid, a paste, or a powder, such that the at
least one fluid
source constitutes a first substance reservoir.
100. The laparoscopic applicator according to item 99, wherein the first
substance reservoir comprises a barrel for holding the substance and a piston
20 for pushing the substance out of the barrel.
101. The laparoscopic applicator according to item 100, wherein the barrel
has
a diameter between 10-30 mm, more preferably between 12-20 mm, and most
preferably between 14-18 mm.
102. The laparoscopic applicator according to any of items 99-101,
comprising
one or more second substance reservoir(s).
103. The laparoscopic applicator according to any of items 99-102, wherein
the second substance reservoir(s) are detachably attached to the first
substance reservoir via at least one auxiliary connector element.
104. The laparoscopic applicator according to item 103, wherein the
auxiliary
connector element comprises a Luer lock, a compression joint, or an adhesive
joint.
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105. The laparoscopic applicator according to any of items 103-104, wherein
the auxiliary connector element is configured for establishing a sequential
fluid
connection between 1) the first and second substance reservoirs, and 2) the
first substance reservoir and the delivery tube.
106. The laparoscopic applicator according to any of items 103-105, wherein
the auxiliary connector element is adapted to have a first configuration
proving
a fluid passageway between the first and second substance reservoirs, and a
second configuration providing a fluid passageway between the first substance
reservoir and the delivery tube.
107. The laparoscopic applicator according to any of items 103-106, wherein
the auxiliary connector element comprises at least one one-way valve.
108. The laparoscopic applicator according to any of items 99-107, wherein
the first and/or second substance reservoirs are disposable.
109. The laparoscopic applicator according to any of the items 84-108,
wherein the at least one fluid source is configured to be pressurized, e.g. by
use
of a pressure source.
110. The laparoscopic applicator according to any of the items 84-109,
wherein the applicator comprises at least two fluid sources.
111. The laparoscopic applicator according to any of the preceding items,
wherein the delivery tube is configured for holding the substance under a
pressure or holding a pressurized substance.
112. The laparoscopic applicator according to any of the preceding items,
wherein the applicator further comprises at least one pressure source
configured for applying a pressure to the at least one fluid source and/or
configured for applying a pressure to the inside of the delivery tube, such as
the
substance within the delivery tube.
113. The laparoscopic applicator according to item 112, wherein the
delivery
tube is configured for being loaded with substance from the distal end.
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114. The laparoscopic applicator according to item 113, wherein the
delivery
tube comprises one or more detachably attached connectors for a substance
reservoir, and/or a flow controlling element.
115. The laparoscopic applicator according to any of items 112-114, wherein
the at least one pressure source is a spring configured to exert a pressure on
the at least one fluid source, and/or the substance within the delivery tube.
116. The laparoscopic applicator according to item 115, wherein the spring
energy is pre-stored, and/or wherein the spring energy is stored upon loading
the delivery tube.
117. The laparoscopic applicator according to any of items 112-114, wherein
the at least one pressure source is a gas configured to exert a pressure on
the
at least one fluid source, and/or the substance within the delivery tube.
118. The laparoscopic applicator according to item 116, wherein the gas
pressure source is selected from the group of: gas cartridges, motorized
bellows, -propellers, -compressors, and combinations thereof.
119. The laparoscopic applicator according to item 112-118, wherein the at
least one pressure source comprises a propellant, selected from the group of:
spring loaded element, gaseous propellant, inflatable balloon or bladder,
and/or
moveable piston, such as an electrically driven piston or a manually driven
piston.
120. The laparoscopic applicator according to item 112-119, wherein the at
least one pressure source is a drive mechanism, selected from the group of:
manual piston, motorized piston, spring force, and gas pressure, such as a
motor, comprising at least one piston configured to exert a pressure on the at
least one fluid source.
121. The laparoscopic applicator according to item 120, wherein the drive
mechanism is an electric motor.
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122. The laparoscopic applicator according to any of the items 120-121,
wherein the at least one actuator is configured to, upon activation, send an
electrical signal to the drive mechanism, whereby, upon receipt of said
electrical
signal, the drive mechanism is configured to exert a pressure on the at least
one fluid source such that the substance is dispensed from the laparoscopic
applicator.
123. The laparoscopic applicator according to any of the items 120-122,
wherein the drive mechanism comprises two pistons, wherein a first piston is
configured to exert a first pressure on a first fluid source and a second
piston is
configured to exert a second pressure on a second fluid source.
124. The laparoscopic applicator according to item 123, wherein the drive
mechanism comprises a switching mechanism, such as a gear mechanism,
configured to switch between operating the first piston and/or the second
piston.
125. The laparoscopic applicator according to any of the items 120-124,
wherein the drive mechanism further comprises a direction control configured
to
control the direction (forward or reverse) of the at least one piston.
126. The laparoscopic applicator according to any of the preceding items,
wherein the applicator further comprises a rigid sheath surrounding at least a
part of the delivery tube, wherein the sheath is configured such that the
delivery
tube may be inserted into a trocar.
127. The laparoscopic applicator according to any of the preceding items,
wherein the applicator further comprises a driver unit for holding:
- at least one fluid source for holding a fluid, said fluid source being in
fluid connection with the delivery tube; and/or
- at least one pressure source configured for applying a pressure to the at
least one fluid source and/or configured for applying a pressure to the
inside of the delivery tube.
128. The laparoscopic applicator according to item 127, wherein the
laparoscopic applicator comprises a syringe having a barrel for holding
substance fluid and a plunger for pushing the fluid out of the syringe and/or
for
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withdrawing a substance into the syringe, wherein the driver unit is
configured
for receiving and holding the syringe.
129. The laparoscopic applicator according to item 128, wherein the driver
unit
is further configured for withdrawing the plunger, such that a substance is
withdrawn into the applicator.
130. The laparoscopic applicator according to any of the preceding items,
wherein the delivery tube and/or the at least one fluid source are disposable.
131. The laparoscopic applicator according to any of the preceding items,
wherein the applicator further comprises a safety mechanism configured for
switching between two modes (on/off), wherein the 'off mode' means that no
substance can be released from the applicator and the 'on mode' means that
substance can be released.
132. The laparoscopic applicator according to item 131, wherein the safety
mechanism is located on the delivery tube or the applicator tip or the driver
unit.
133. The
laparoscopic applicator according to any of the preceding items,
wherein the applicator further comprises a flow controller configured for
controlling the flow rate of the substance to be released from the applicator.
134. The laparoscopic applicator according to item 133, wherein the flow
controller is located in the driver unit.
135. A laparoscopic applicator tip for connecting to a laparoscopic
delivery
tube for holding a substance such as a substance comprising a haemostatic
agent, the applicator tip comprising:
- at least one valve configured for releasing the substance from the
delivery tube upon opening of said valve; and
- at least one actuator configured to open/close the at least one valve.
136. The laparoscopic applicator tip according to item 135, wherein the at
least
one valve is configured for holding and releasing the substance under a
pressure.
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137. The laparoscopic applicator tip according to any of items 135-136,
wherein the applicator tip further comprises a pressure sensor, such as a
resistive film pressure sensor, for sensing the pressure applied to the
actuator.
5
138. The laparoscopic applicator tip according to any of the items 135-137,
wherein the applicator tip further comprises a pressure indicator light for
indicating the pressure applied to the at least one actuator.
10 139. The laparoscopic applicator tip according to any
of the items 135-138,
wherein the applicator tip further comprises a status indicator, e.g. in the
form of
light diodes, said status indicator configured to indicate the remaining
volume of
substance in the delivery tube.
15 140. The laparoscopic applicator tip according to any
of the items 135-139,
wherein the applicator tip further comprises a rigid section configured to be
gripped by the robotic arm.
141. The laparoscopic applicator tip according to any of the items 135-140,
20 wherein the applicator tip further comprises an
adjustable nozzle for adjusting
the dispensing rate and or dispensing angle of the substance.
142. A laparoscopic applicator for dispensing or withdrawing a substance,
such as a substance comprising a haemostatic agent, at a selected site by
25 means of a surgical robotic arm, the applicator
comprising:
- a delivery tube for holding the substance; and
- an applicator tip according to any of the items 135-141, the applicator
tip
being connected to a distal end of the delivery tube, wherein the
applicator tip is configured for:
30 - being spatially manipulated by the robotic arm,
and/or
- controllably releasing the substance from the
delivery tube by the
robotic arm, or controllably withdrawing the substance from the
selected site into the delivery tube.
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143. A kit of parts comprising: a laparoscopic applicator according to any
of
items 1-134, one or more pressure sources, and optionally one or more fluid
sources, such as one or more substance reservoirs.
144. The kit of parts according to item 143, wherein the substance
reservoirs
are one or more syringes configured to be filled with a substance and
configured for forming a fluid connection to the delivery tube, preferably the
distal opening of the delivery tube.
145. The kit of parts according to any of items 143-144, wherein the
pressure
source is one or more gas cartridges configured for forming a fluid connection
to the delivery tube, preferably the proximal opening of the delivery tube.
146. The kit of parts according to any of items 143-145, wherein the
pressure
source is integrated into the applicator, optionally the pressure source is a
spring at a proximal end of the delivery tube.
147. A kit of parts comprising:
-
a laparoscopic applicator according to any of the items 1-134; and
- a driver unit for holding:
- at least one fluid source for holding a fluid, said fluid source being
in fluid connection with the delivery tube; and/or
- at least one pressure source, such as a motor, configured for
applying a pressure to the at least one fluid source and/or
configured for applying a pressure to the inside of the delivery
tube.
148. The kit of parts according to item 147, wherein the kit of parts
further
comprises at least one fluid source for holding a fluid, said fluid source
being in
fluid connection with the delivery tube.
149. The kit of parts according to any of the items 147-148, wherein the
kit of
parts further comprises at least one pressure source configured for applying a
pressure to the at least one fluid source and/or configured for applying a
pressure to the inside of the delivery tube.
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150. The kit of parts according to any of the items 147-149, the kit of
parts
further comprising at least one fluid source, said fluid source being a
syringe
having a plunger, wherein the driver unit further comprises a positional
sensor
configured for determining the position of the plunger.
151. The kit of parts according to any of the items 147-150, wherein the
driver
unit is configured to hold at least two fluid sources, such as at least two
syringes.
152. Use of the laparoscopic applicator according to any of the items 1-134
to
dispense a substance, such as a substance comprising a haemostatic agent,
from the applicator.
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