U.S. patent application number 16/752994 was filed with the patent office on 2020-05-21 for method of internally potting or sealing a handheld medical device.
The applicant listed for this patent is Covidien LP. Invention is credited to Xingrui Chen, Matthew Chowaniec, Michael Zemlok.
Application Number | 20200155152 16/752994 |
Document ID | / |
Family ID | 46149295 |
Filed Date | 2020-05-21 |
United States Patent
Application |
20200155152 |
Kind Code |
A1 |
Chowaniec; Matthew ; et
al. |
May 21, 2020 |
METHOD OF INTERNALLY POTTING OR SEALING A HANDHELD MEDICAL
DEVICE
Abstract
The present disclosure provides a powered surgical instrument
including a housing defining an inner cavity therein; at least one
internal component disposed within the housing; and potting
material injected into the inner cavity encapsulating at least a
portion of the at least one internal component.
Inventors: |
Chowaniec; Matthew;
(Madison, CT) ; Chen; Xingrui; (Glastonbury,
CT) ; Zemlok; Michael; (Prospect, CT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Covidien LP |
Mansfield |
MA |
US |
|
|
Family ID: |
46149295 |
Appl. No.: |
16/752994 |
Filed: |
January 27, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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13117410 |
May 27, 2011 |
10542978 |
|
|
16752994 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/00017
20130101; A61B 2017/2927 20130101; A61B 2017/00398 20130101; A61B
2017/00128 20130101; A61B 2090/0813 20160201; A61B 2017/00115
20130101; A61B 17/07207 20130101; A61B 2017/00734 20130101 |
International
Class: |
A61B 17/072 20060101
A61B017/072 |
Claims
1. A powered surgical instrument, comprising: a housing defining an
inner cavity therein; at least one internal component disposed
within the housing; and a potting material injected into the inner
cavity encapsulating at least a portion of the at least one
internal component.
2. The powered surgical instrument according to claim 1, wherein
the at least one internal component is selected from the group
consisting of a control circuit and a drive motor.
3. The powered surgical instrument according to claim 1, wherein
the potting material is a polymer selected from the group
consisting of polyesters, silicones, rubbers, epoxies, nylons,
polyphthalamides, liquid crystal polymers, and combinations
thereof.
4. The powered surgical instrument according to claim 1, wherein
the potting material includes at least one additive selected from
the group consisting of a thermally conductive additive, a
dielectric additive, an electro-magnetic shielding additive, and
combinations thereof.
5. The powered surgical instrument according to claim 4, wherein
the thermally conductive additive is selected from the group
consisting of abrasive ceramics, lubricious ceramics, boron
nitride, aluminum oxide, aluminum nitride, and combinations
thereof.
6. The powered surgical instrument according to claim 1, wherein
the potting material is at least one of transparent and
translucent.
7-11. (canceled)
12. A powered surgical instrument, comprising: a housing defining
an inner cavity therein, the housing including a handle portion; a
body portion extending distally from the handle portion; a tool
assembly disposed at a distal end of the body portion; a control
circuit and a drive motor disposed within the inner cavity, wherein
the drive motor is mechanically coupled to the tool assembly and
the control circuit is configured to control the operation of the
drive motor; and a potting material injected into the inner cavity
encapsulating at least a portion of at least one of the control
circuit and the drive motor.
13. The powered surgical instrument according to claim 12, wherein
the potting material is a polymer selected from the group
consisting of polyesters, silicones, rubbers, epoxies, nylons,
polyphthalamides, liquid crystal polymers, and combinations
thereof.
14. The powered surgical instrument according to claim 12, wherein
the potting material includes at least one additive selected from
the group consisting of a thermally conductive additive, a
dielectric additive, an electro-magnetic shielding additive, and
combinations thereof.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. patent application
Ser. No. 13/117,410, filed on May 27, 2011. The entire disclosure
of the foregoing application is incorporated by reference
herein.
BACKGROUND
Technical Field
[0002] The present disclosure relates to a powered surgical
instrument having housing enclosing a plurality of internal
components, including a drive mechanism and a control circuit. More
particularly, the present disclosure relates to a surgical
instrument including internal components that are encapsulated in a
potting material within the housing.
Background of Related Art
[0003] Surgical devices wherein tissue is first grasped or clamped
between opposing jaw structure and then joined by surgical
fasteners are well known in the art. In some instruments a knife is
provided to cut the tissue which has been joined by the fasteners.
The fasteners are typically in the form of surgical staples but two
part polymeric fasteners can also be utilized.
[0004] Instruments for this purpose may include two elongated
members which are respectively used to capture or clamp tissue.
Typically, one of the members carries a staple cartridge which
houses a plurality of staples arranged in at least two lateral rows
while the other member has an anvil that defines a surface for
forming the staple legs as the staples are driven from the staple
cartridge. Generally, the stapling operation is effected by cam
bars that travel longitudinally through the staple cartridge, with
the cam bars acting upon staple pushers to sequentially eject the
staples from the staple cartridge. A knife can travel between the
staple rows to longitudinally cut and/or open the stapled tissue
between the rows of staples.
[0005] In endoscopic or laparoscopic procedures, surgery is
performed through a small incision or through a narrow cannula
inserted through small entrance wounds in the skin. In order to
address the specific needs of endoscopic and/or laparoscopic
surgical procedures, endoscopic surgical stapling devices have been
developed.
[0006] Current known devices can typically require 10-60 pounds of
manual hand force to clamp tissue and deploy and form surgical
fasteners in tissue which, over repeated use, can cause a surgeon's
hand to become fatigued. Gas powered pneumatic staplers which
implant surgical fasteners into tissue are known in the art.
Certain of these instruments utilize a pressurized gas supply which
connects to a trigger mechanism. The trigger mechanism, when
depressed, simply releases pressurized gas to implant a fastener
into tissue.
[0007] Motor-powered surgical staplers are also known in the art.
These include powered surgical staplers having motors which
activate staple firing mechanisms. However, these motor powered
devices also include a variety of internal components (e.g.,
circuits) which require additional protection from moisture,
chemical cleaners, vapors, gases, and biological contaminants.
[0008] There is a continual need for new and improved powered
surgical staplers which provide protection to the internal
components.
SUMMARY
[0009] The present disclosure provides a powered surgical
instrument including a housing defining an inner cavity therein; at
least one internal component disposed within the housing; and
potting material injected into the inner cavity encapsulating at
least a portion of the at least one internal component.
[0010] The present disclosure also provides a method for
manufacturing a powered surgical device. The method includes
injecting a liquid potting material injected into a housing
defining an inner cavity therein, the housing including at least
one internal component disposed within the housing; and solidifying
the potting material to encapsulate at least a portion of the at
least one internal component.
[0011] The present disclosure further provides a powered surgical
instrument. The instrument includes a housing defining an inner
cavity therein, the housing including a handle portion; a body
portion extending distally from the handle portion; a tool assembly
disposed at a distal end of the body portion; a control circuit and
a drive motor disposed within the inner cavity, wherein the drive
motor is mechanically coupled to the tool assembly and the control
circuit is configured to control the operation of the drive motor;
and a potting material injected into the inner cavity encapsulating
at least a portion of at least one of the control circuit and the
drive motor.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] Various embodiments of the subject instrument are described
herein with reference to the drawings wherein:
[0013] FIG. 1 is a perspective view of a powered surgical
instrument according to the present disclosure;
[0014] FIG. 2 is a partial enlarged perspective view of the powered
surgical instrument according to the embodiment of the present
disclosure of FIG. 1 according to the present disclosure;
[0015] FIG. 3 is a partial enlarged plan view of the powered
surgical instrument according to the embodiment of the present
disclosure of FIG. 1 according to the present disclosure; and
[0016] FIG. 4 is a partial perspective sectional view of internal
components of the powered surgical instrument of FIG. 1 according
to the present disclosure.
[0017] FIG. 5 is a flowchart of an embodiment of a method of
injecting potting material according to the present disclosure.
DETAILED DESCRIPTION
[0018] Embodiments of the presently disclosed powered surgical
instrument are now described in detail with reference to the
drawings, in which like reference numerals designate identical or
corresponding elements in each of the several views. As used herein
the term "distal" refers to that portion of the powered surgical
instrument, or component thereof, farther from the user while the
term "proximal" refers to that portion of the powered surgical
instrument or component thereof, closer to the user.
[0019] A powered surgical instrument, e.g., a surgical stapler, in
accordance with the present disclosure is referred to in the
figures as reference numeral 10. Referring initially to FIG. 1,
powered surgical instrument 100 includes a housing 110, an
endoscopic portion 140 defining a first longitudinal axis A-A
extending therethrough, and an articulating tool assembly (e.g.,
end effector 160), defining a second longitudinal axis B-B
extending therethrough. Endoscopic portion 140 extends distally
from housing 110 and the end effector 160 is disposed adjacent a
distal portion of endoscopic portion 140. In an embodiment, the
components of the housing 110 are sealed against infiltration of
particulate and/or fluid contamination and help prevent damage of
the components by sterilization processes. The instrument 100 also
includes a power source 300
[0020] According to an embodiment of the present disclosure, end
effector 160 includes a first jaw member having one or more
surgical fasteners (e.g., cartridge assembly 164) and a second
opposing jaw member including an anvil portion for deploying and
forming the surgical fasteners (e.g., an anvil assembly 162). In
certain embodiments, the staples are housed in cartridge assembly
164 to apply linear rows of staples to body tissue either in
simultaneous or sequential manner. Either one or both of the anvil
assembly 162 and the cartridge assembly 164 are movable in relation
to one another between an open position, in which the anvil
assembly 162 is spaced from cartridge assembly 164, and an
approximated or clamped position, in which the anvil assembly 162
is in juxtaposed alignment with cartridge assembly 164.
[0021] It is further envisioned that end effector 160 is attached
to a mounting portion 166, which is pivotably attached to a body
portion 168. Body portion 168 may be integral with endoscopic
portion 140 of powered surgical instrument 100, or may be removably
attached to the instrument 100 to provide a replaceable, disposable
loading unit (DLU) or single use loading unit (SULU) (e.g., loading
unit 169). In certain embodiments, the reusable portion may be
configured for sterilization and re-use in a subsequent surgical
procedure.
[0022] The loading unit 169 may be connectable to endoscopic
portion 140 through a bayonet connection. It is envisioned that the
loading unit 169 has an articulation link connected to mounting
portion 166 of the loading unit 169 and the articulation link is
connected to a linkage rod so that the end effector 160 is
articulated as the linkage rod is translated in the distal-proximal
direction along first longitudinal axis A-A. Other means of
connecting end effector 160 to endoscopic portion 140 to allow
articulation may be used, such as a flexible tube or a tube
comprising a plurality of pivotable members.
[0023] The loading unit 169 may incorporate or be configured to
incorporate various end effectors, such as vessel sealing devices,
linear stapling devices, circular stapling devices, cutters,
graspers, etc. Such end effectors may be coupled to endoscopic
portion 140 of powered surgical instrument 100. An intermediate
flexible shaft may be included between handle portion 112 and
loading unit. It is envisioned that the incorporation of a flexible
shaft may facilitate access to and/or within certain areas of the
body.
[0024] With reference to FIGS. 1 and 2, an enlarged view of the
housing 110 is illustrated according to an embodiment of the
present disclosure. In the illustrated embodiment, housing 110
includes a handle portion 112 having a main drive switch 114
disposed thereon. The switch 114 may include first and second
switches 114a and 114b formed together as a toggle switch. The
handle portion 112, which defines a handle axis H-H, is configured
to be grasped by fingers of a user. The handle portion 112 has an
ergonomic shape providing ample palm grip leverage which helps
prevent the handle portion 112 from being squeezed out of the
user's hand during operation. Each switch 114a and 114b is shown as
being disposed at a suitable location on handle portion 112 to
facilitate its depression by a user's finger or fingers.
[0025] Additionally, and with continued reference to FIGS. 1 and 2,
switches 114a, 114b may be used for starting and/or stopping
movement of a drive mechanism (e.g., drive motor 200) (FIG. 4). The
drive motor 200 is configured to actuate the end effector 160,
including but not limited to, articulation, closing of the jaw
members, ejection of fasteners, cutting, and the like. In one
embodiment, the switch 114a is configured to activate the drive
motor 200 in a first direction to advance firing rod (not
explicitly shown) in a distal direction thereby approximating the
anvil and the cartridge assemblies 162 and 164. Conversely, the
switch 114b may be configured to retract the firing rod to open the
anvil and cartridge assemblies 162 and 164 by activating the drive
motor 200 in a reverse direction. The retraction mode initiates a
mechanical lock out, preventing further progression of stapling and
cutting by the loading unit 169. The toggle has a first position
for activating switch 114a, a second position for activating switch
114b, and a neutral position between the first and second
positions. Further, the switches 114a and 114b may have high
tactile feedback requiring increased pressure for activation.
[0026] In one embodiment, the switches 114a and 114b are configured
as multi-speed (e.g., two or more), incremental or variable speed
switches which control the speed of the drive motor 200 and the
firing rod in a non-linear manner. For example, switches 114a, 114b
can be pressure-sensitive. This type of control interface allows
for gradual increase in the rate of speed of the drive components
from a slower and more precise mode to a faster operation. To
prevent accidental activation of retraction, the switch 114b may be
disconnected electronically until a fail safe switch 114c is
pressed.
[0027] The switches 114a and 114b are coupled to a non-linear speed
control circuit 400 which may include a non-linear speed control
circuit implemented as a voltage regulation circuit, a variable
resistance circuit, or a microelectronic pulse width modulation
circuit. The switches 114a and 144b may interface with the control
circuit 400 by displacing or actuating variable control devices,
such as rheostatic devices, multiple position switch circuit,
linear and/or rotary variable displacement transducers, linear
and/or rotary potentiometers, optical encoders, ferromagnetic
sensors, and Hall Effect sensors. This allows the switches 114a and
114b to operate the drive motor 200 in multiple speed modes, such
as gradually increasing the speed of the drive motor 200 either
incrementally or gradually depending on the type of the control
circuit being used, based on the depression of the switches 114a
and 114b.
[0028] FIGS. 2-4 illustrate an articulation mechanism 170,
including an articulation housing 172, a powered articulation
switch 174, an articulation motor 132 and a manual articulation
knob 176. Translation of the powered articulation switch 174 or
pivoting of the manual articulation knob 176 activates the
articulation motor 132 which then actuates an articulation gear 233
of the articulation mechanism 170 as shown in FIG. 4. Actuation of
articulation mechanism 170 causes the end effector 160 to move from
its first position, where longitudinal axis B-B is substantially
aligned with longitudinal axis A-A, towards a position in which
longitudinal axis B-B is disposed at an angle to longitudinal axis
A-A. The powered articulation switch 174 may also incorporate
similar non-linear speed controls as the clamping mechanism.
[0029] Additionally, articulation housing 172 and powered
articulation switch 174 are mounted to a rotating housing assembly
180. Rotation of a rotation knob 182 about first longitudinal axis
A-A causes housing assembly 180 as well as articulation housing 172
and powered articulation switch 174 to rotate about first
longitudinal axis A-A, and thus rotating the end effector 160 about
first longitudinal axis A-A. The articulation mechanism 170 is
electro-mechanically coupled to one or more conductive rings that
are disposed on a housing nose assembly 155 (FIG. 4). The
conductive rings may be soldered and/or crimped onto the nose
assembly 155 and are in electrical contact with the power source
300 thereby providing electrical power to the articulation
mechanism 170. The nose assembly 155 may be modular and may be
attached to the housing 110 during assembly to allow for easier
soldering and/or crimping of the rings. The articulation mechanism
170 may include one or more brush and/or spring loaded contacts in
contact with the conductive rings such that as the housing assembly
180 is rotated along with the articulation housing 172 the
articulation mechanism 170 is in continuous contact with the
conductive rings thereby receiving electrical power from the power
source 300.
[0030] Further details of articulation housing 172, powered
articulation switch 174, manual articulation knob 176 and providing
articulation to end effector 160 are described in detail in
commonly-owned U.S. patent application Ser. No. 11/724,733 filed
Mar. 15, 2007, the contents of which are hereby incorporated by
reference in their entirety. It is envisioned that any combinations
of limit switches, proximity sensors (e.g., optical and/or
ferromagnetic), linear variable displacement transducers and shaft
encoders which may be disposed within housing 110, may be utilized
to control and/or record an articulation angle of end effector 160
and/or position of the firing rod 220.
[0031] As shown in FIG. 4, the instrument 100 also includes the
control circuit 400 electrically coupled to the motor 200 and
various sensors disposed in the instrument 100. The sensors detect
various operating parameters of the instrument 100 (e.g., linear
speed, rotation speed, articulation position, temperature, battery
charge, and the like), which are then reported to the control
circuit 400. The control circuit 400 may then respond accordingly
to the measured operating parameters to control the actuation of
the end effector 160 (e.g., adjust the speed of the motor 200,
control articulation angle, shut-off the power supply, report error
conditions, etc.).
[0032] As shown in FIGS. 3 and 4, the control circuit 400 is also
coupled to one or more visual devices which may include one or more
colored visible lights or light emitting diodes 401 ("LED") to
relay feedback to the user. The LEDs 401 may disposed on top of the
housing 110 such that the LEDs 401 are raised and protrude in
relation to the housing 110 providing for better visibility thereof
as shown in FIG. 4. In embodiments, the LEDs 401 may be disposed
within the housing 110 as shown in FIG. 4. The LEDs 401 may be
activated in a various combinations to denote status of the
instrument 100.
[0033] The multiple lights may be activated in a certain
combination to illustrate a specific operational mode to the user.
In one embodiment, the LEDs 401 include a plurality of
multi-colored lights--a first light (e.g., yellow), a second light
(e.g., green) and a third light (e.g., red). The lights are
operated in a particular combination associated with a particular
operational mode as listed in Table 1 below.
TABLE-US-00001 TABLE 1 Light Combination Light Status Operational
Mode First Light Off No loading unit 169 or staple cartridge is
Second Light Off loaded. Third Light Off First Light On The loading
unit 169 and/or staple cartridge Second Light Off are loaded and
power is activated, allowing Third Light Off the end effector 160
to clamp as a grasper and articulate. First Light Flashing A used
loading unit 169 or staple cartridge Second Light Off is loaded.
Third Light Off First Light N/A Instrument 100 is deactivated and
prevented Second Light Off from firing staples or cutting. Third
Light N/A First Light On A new loading unit 169 is loaded, the end
Second Light On effector 160 is fully clamped and the instru- Third
Light Off ment 100 is in firing staple and cutting modes. First
Light On Due to high stapling forces a pulse mode is in Second
Light Flashing effect, providing for a time delay during which
Third Light Off tissue is compressed. First Light N/A No system
errors detected. Second Light N/A Third Light Off First Light On
Tissue thickness and/or firing load is too high, Second Light On
this warning can be overridden. Third Light On First Light N/A
Functional system error is detected, instrument Second Light N/A
100 should be replaced. Third Light Flashing
[0034] In another embodiment, the LEDs 401 may be multi-colored
LEDs which display a particular color associated with the
operational modes as discussed above with respect to the first,
second and third lights in Table 1.
[0035] The housing 110 defines an inner cavity 402 in which the
control circuit 400 and the motor 200 as well as other components
of the instrument 100 are disposed. With reference to FIG. 5,
during step S20, a potting material 404 is injected into the cavity
402 so that the material flows into and through the cavity 402,
thereby coating and encapsulating the internal components (e.g.,
the control circuit 400 and the motor 200) of the instrument 100.
The material 404 may be injected such that the cavity 402 is either
partially or wholly filled with the material 404. Encapsulation of
the internal components eliminates voids within the inner cavity
402, which may collect moisture and condensation. Further, the
material 404 also seals the components, thereby providing
protection from moisture, chemical compounds (e.g., cleaners),
vapors, gases, and biological contaminants. This would also allow
for sterilization of the instrument 100 providing for multiple
uses.
[0036] Prior to injecting the material 404 into the housing 110
during step S20, the housing 110 may be suitably sealed during step
S10 to withstand the pressures of the sealing process as well as to
hermetically seal the housing 110 as described above. The material
404 may be any material that may be any liquid or amorphous
material that solidifies upon injection into the cavity 402. In
embodiments, the material 404 may be any material or combination of
materials (e.g., epoxy) that may change its phase after injection
into the housing 110, such that the material 404 is initially in a
liquid phase and then transitions into a solid phase to encapsulate
the components. Once solidified during step S30, the material 404
may be relatively rigid to protect the components from shock,
maintain compliance and to reduce stress under temperature extremes
and other environmental conditions.
[0037] In embodiments, the material 404 may be a liquid material
that may be solidified by one of the following processes which
include, but are not limited to, room temperature vulcanization, a
thermosetting polymer reaction (e.g., epoxy), curing (e.g.,
anaerobic or ultra-violet), and combinations thereof. The material
404 may be a polymer, which may include, but not limited to,
polyesters, silicones, rubbers, epoxies, nylons, polyphthalamides,
liquid crystal polymers, and combinations thereof.
[0038] The material 404 once solidified may have a hardness as
measured by a durometer from about 5 Shore A to about 100 Shore A,
in embodiments from about 10 Shore A to about 50 Shore A. In
embodiments, the material 404 may be compliant and/or elastic. This
prevents high physical stress that the instrument 100 is subjected
to from being transferred to the internal components and/or in
embodiments where components or materials of the instrument 100
have discrepant thermal expansion properties. In addition,
elasticity of the material 404 absorbs noise and vibration
generated by the drive motor 200 and other drive mechanisms, which
enhances the handling characteristics of the instrument 100.
[0039] The material 404 may include one or more thermally
conductive and/or dielectric additives to draw thermal energy from
the components as well as to electrically isolate electronic and
other sensitive components (e.g., drive mechanisms, batteries,
etc.). In addition, material 404 that is thermally conductive also
reduces thermal shock and temperature extremes associated with
sterilization (e.g., autoclaving) processes. The material 404 may
have a thermal conductance from about 0.024 watts per meter.degree.
C. (W/m.degree. C.) and above. The material 404 may have an
electrical resistance from about 3 millivolts per meter under
standard temperature and pressure (STP) (mV/m) and above. The
material 404 may have a coefficient of thermal expansion from about
1 parts per million/.degree. C. (ppm/.degree. C.) to about 30
ppm/.degree. C., in embodiments from about 5 ppm/.degree. C. to
about 20 ppm/.degree. C. The material may have a surface energy
from about 10 dynes per centimeter2 (dynes/cm2) to about 45
dynes/cm2, in embodiments from about 20 dynes/cm2 to about 35
dynes/cm2. The term "surface energy" as used herein denotes the
disruption of intermolecular bonds that occurs when a surface is
created expressed as pressure.
[0040] Suitable thermally conductive additives include, but are not
limited to, abrasive or lubricious ceramics, boron nitride,
aluminum oxide, aluminum nitride, and combinations thereof. The
material 404 may include the thermally conductive additive in
amount from about 0.5 to about 90% by weight of the material 404,
in embodiments, from about 5 to about 25% by weight of the material
404. The material 404 may also be substantially translucent,
transparent or combination thereof to allow the LEDs 401 to
transmit light therethrough such that the light transmitted by the
LEDs 401 is visible to the user.
[0041] The material 404 may also include an electro-magnetic
shielding additive. Suitable electro-magnetic shielding additives
include, but are not limited to metallic compounds, such as ferrous
or nickel-based compounds, as well as carbon-based conductive
fibers and powders, and combinations thereof. The material 404 may
include the electro-magnetically shielding additive in amount from
about 0.5 to about 90% by weight of the material 404, in
embodiments, from about 5 to about 25% by weight of the material
404.
[0042] It will be understood that various modifications may be made
to the embodiments shown herein. Therefore, the above description
should not be construed as limiting, but merely as exemplifications
of preferred embodiments. Although specific features of the powered
surgical instrument are shown in some of the drawings and not in
others, this is for convenience only as each feature may be
combined with any or all of the other features in accordance with
the aspects of the present disclosure. Other embodiments will occur
to those skilled in the art and are within the following
claims.
* * * * *