U.S. patent application number 17/478632 was filed with the patent office on 2022-03-10 for negative pressure wound therapy device control in presence of fault condition.
The applicant listed for this patent is Smith & Nephew PLC. Invention is credited to Ben Alan Askem, Yeswanth Gadde, William Kelbie, Damyn Musgrave, Felix Clarence Quintanar, Daniel Lee Steward.
Application Number | 20220072212 17/478632 |
Document ID | / |
Family ID | 61617018 |
Filed Date | 2022-03-10 |
United States Patent
Application |
20220072212 |
Kind Code |
A1 |
Askem; Ben Alan ; et
al. |
March 10, 2022 |
NEGATIVE PRESSURE WOUND THERAPY DEVICE CONTROL IN PRESENCE OF FAULT
CONDITION
Abstract
Embodiments of negative pressure wound therapy systems and
methods are disclosed. In one embodiment, an apparatus includes a
wound dressing, negative pressure source, switch, interface
element, and control circuitry. The negative pressure source,
switch, and interface element can be disposed on or within the
wound dressing. The control circuitry can be in a first or second
mode. In the first mode, the control circuitry can cause supply of
negative pressure in response to a first user input via the switch
when the negative pressure source is not supplying negative
pressure and prevent supply of negative pressure in response to the
first user input while the negative pressure source is supplying
negative pressure, and the control circuitry can change from the
first mode to a second mode in response to a second user input via
the interface element. In the second mode, the control circuitry
can disable supply of negative pressure.
Inventors: |
Askem; Ben Alan; (Leeds,
GB) ; Gadde; Yeswanth; (Pocklington, GB) ;
Kelbie; William; (Inverness, GB) ; Musgrave;
Damyn; (Cottenham, GB) ; Quintanar; Felix
Clarence; (Hull, GB) ; Steward; Daniel Lee;
(Hull, GB) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Smith & Nephew PLC |
Watford |
|
GB |
|
|
Family ID: |
61617018 |
Appl. No.: |
17/478632 |
Filed: |
September 17, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16491742 |
Sep 6, 2019 |
11123471 |
|
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PCT/EP2018/055698 |
Mar 8, 2018 |
|
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17478632 |
|
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62468796 |
Mar 8, 2017 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 1/743 20210501;
A61M 2205/13 20130101; A61M 2205/3344 20130101; A61F 13/00068
20130101; A61M 27/00 20130101; A61M 1/962 20210501; A61F 13/0216
20130101; A61M 1/742 20210501; A61M 2205/502 20130101 |
International
Class: |
A61M 1/00 20060101
A61M001/00 |
Claims
1-20. (canceled)
21. An apparatus for applying negative pressure to a wound, the
apparatus comprising: a wound dressing configured to be placed over
a wound of a patient; a negative pressure source disposed on or
within the wound dressing and configured to supply negative
pressure to the wound via a fluid flow path; a switch; a control
circuitry configured to control activation and deactivation of the
negative pressure source responsive to user inputs to the switch; a
first electrical connector configured to selectively, responsive to
a connection state of the first electrical connector, prevent or
permit activation of the negative pressure source; and a second
electrical connector different from the first electrical connector
and configured to selectively, responsive to a connection state of
the second electrical connector, disrupt or not disrupt a power
supply which facilitates delivery of negative pressure by the
negative pressure source.
22. The apparatus of claim 21, wherein the first electrical
connector is configured to prevent activation of the negative
pressure source when the first electrical connector is in a first
disconnected state and is configured to permit activation of the
negative pressure source when the first electrical connector is in
a first connected state, and the second electrical connector is
configured to disrupt the power supply when the second electrical
connector is in a second disconnected state and is configured to
not disrupt the power supply when the second electrical connector
is in a second connected state.
23. The apparatus of claim 21, wherein the second electrical
connector comprises a tab.
24. The apparatus of claim 21, wherein the first electrical
connector comprises an electrical contact.
25. The apparatus of claim 21, wherein while the negative pressure
source is supplying negative pressure, the control circuitry is
configured to control activation and deactivation of the negative
pressure source responsive to no user inputs other than the user
inputs to the switch.
26. The apparatus of claim 21, wherein the control circuitry is
configured to control activation or deactivation of the negative
pressure source responsive to a depression of the switch for a
period of time.
27. The apparatus of claim 26, wherein the period of time is
between 0.5 seconds and 5 seconds.
28. The apparatus of claim 21, wherein the switch is supported by
the wound dressing, and the switch is positioned on an exterior
surface of the wound dressing.
29. The apparatus of claim 21, wherein the switch and the control
circuitry are supported by the wound dressing, and the first
electrical connector and the second electrical connector are
supported by the wound dressing when the first electrical connector
is in a first connected state and the second electrical connector
is in a second connected state.
30. The apparatus of claim 21, further comprising a battery
supported by the wound dressing and configured to provide the power
supply.
31. A method of operating a negative pressure wound therapy
apparatus comprising a wound dressing, a negative pressure source
disposed on or within the wound dressing, a switch, a control
circuitry, a first electrical connector, and a second electrical
connector, the method comprising: activating, by the control
circuitry, supply of negative pressure with the negative pressure
source to a wound responsive to receiving a first user input to the
switch; deactivating, by the control circuitry, supply of negative
pressure from the negative pressure source responsive to receiving
a second user input to the switch; preventing activation of supply
of negative pressure with the negative pressure source responsive
to the first electrical connector being in a first connection
state; permitting activation of supply of negative pressure with
the negative pressure source responsive to the first electrical
connector not being in the first connection state; disrupting a
power supply which facilitates delivery of negative pressure by the
negative pressure source responsive to the second electrical
connector being in a second connection state; and leaving
undisrupted the power supply which facilitates delivery of negative
pressure by the negative pressure source responsive to the second
electrical connector not being in the second connection state.
32. The method of claim 31, wherein the first electrical connector
is detached in the first connection state and attached when not in
the first connection state, and the second electrical connector is
detached in the second connected state and attached when not in the
second connection state.
33. The method of claim 31, wherein the second electrical connector
comprises a tab.
34. The method of claim 31, wherein the first electrical connector
comprises an electrical contact.
35. The method of claim 31, further comprising while the negative
pressure source is supplying negative pressure, controlling, by the
control circuitry, activation and deactivation of the negative
pressure source responsive to no user inputs other than any user
inputs to the switch.
36. The method of claim 31, wherein the first user input is
received responsive to depression of the switch for a period of
time by a user.
37. The method of claim 36, wherein the period of time is between
0.5 seconds and 5 seconds.
38. The method of claim 31, wherein the switch is supported by the
wound dressing, and the switch is positioned on an exterior surface
of the wound dressing.
39. The method of claim 31, wherein the switch and the control
circuitry are supported by the wound dressing, and the first
electrical connector and the second electrical connector are
supported by the wound dressing when the first electrical connector
is not in the first connection state and the second electrical
connector is not in the second connection state.
40. The method of claim 31, further comprising providing the power
supply using a battery supported by the wound dressing.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 16/491,742, filed Sep. 6, 2019, which is a U.S. national stage
application of International Patent Application No.
PCT/EP2018/055698, filed Mar. 8, 2018, which claims the benefit of
U.S. Provisional Application No. 62/468,796, filed Mar. 8, 2017;
the disclosure of which is hereby incorporated by reference in its
entirety.
BACKGROUND
[0002] Embodiments of the present disclosure relate to methods and
apparatuses for dressing and treating a wound with negative or
reduced pressure therapy or topical negative pressure (TNP)
therapy. In particular, but without limitation, embodiments
disclosed herein relate to negative pressure therapy devices,
methods for controlling the operation of TNP systems, and methods
of using TNP systems.
SUMMARY
[0003] In some embodiments, an apparatus for applying negative
pressure to a wound is disclosed. The apparatus can include: a
wound dressing configured to be placed over a wound of a patient; a
negative pressure source disposed on or within the wound dressing,
the negative pressure source configured to provide negative
pressure to the wound dressing via a fluid flow path; a switch
disposed on or within the wound dressing, the switch being
configured to receive a first user input; an interface element
disposed on or within the wound dressing, the interface element
being configured to receive a second user input; and control
circuitry. The control circuitry can be electrically coupled to the
switch and the interface element. When in a first mode, the control
circuitry can: supply of negative pressure with the negative
pressure source in response to receipt of the first user input
while the negative pressure source is not supplying negative
pressure, prevent supply of negative pressure with the negative
pressure source in response to receipt of the first user input
while the negative pressure source is supplying negative pressure,
and change from the first mode to a second mode different from the
first mode in response to receipt of the second user input. When in
a second mode, the control circuitry can disable supply of negative
pressure with the negative pressure source.
[0004] The apparatus of the preceding paragraph can include one or
more of the following features: When the switch experiences a fault
and is no longer able to receive the first user input, the control
circuitry can prevent or disable supply of negative pressure with
the negative pressure source in response to receipt of no user
inputs other than the second user input. The control circuitry can
supply of negative pressure with the negative pressure source in
response to receipt of no user inputs other than the first user
input. While the negative pressure source is supplying negative
pressure, the control circuitry can prevent or disable supply of
negative pressure with the negative pressure source in response to
receipt of no user inputs other than the first user input and the
second user input. When the control circuitry is in the second
mode, the control circuitry can, in response to receipt of the
second user input, change from the second mode to the first mode,
and supply of negative pressure with the negative pressure source.
The control circuitry can disable supply of negative pressure with
the negative pressure source by deactivation of operation of the
negative pressure source or the control circuitry, opening of a
vent positioned in the fluid flow path, or closing of a valve
positioned in the fluid flow path. The control circuitry can
deactivate operation of the negative pressure source or the control
circuitry by (i) disconnection of power to the negative pressure
source or the control circuitry or (ii) withdrawal of an enable
signal provided to the negative pressure source or the control
circuitry. The control circuitry can prevent supply of negative
pressure with the negative pressure source by deactivation of
operation of the negative pressure source, opening of a vent
positioned in the fluid flow path, and closing of a valve
positioned in the fluid flow path. The interface element can be
molded in film coupled to the wound dressing. The interface element
can include an electrical contact configured to receive the second
user input. The switch can receive the first user input in response
to depression of the switch for a period of time. The period of
time can be between 0.5 seconds and 5 seconds.
[0005] A method of operating, using, or manufacturing the apparatus
of the preceding two paragraphs is also disclosed.
[0006] In some embodiments, a method of operating a negative
pressure wound therapy apparatus comprising a wound dressing is
disclosed. A negative pressure source can be disposed on or within
the wound dressing, and a switch can be disposed on or within the
wound dressing. An interface element can be disposed on or within
the wound dressing, and the switch can receive a first user input
and the interface element can receive a second user input. The
method can include: supplying of negative pressure with the
negative pressure source to the wound dressing via a fluid flow
path in response to receipt of the first user input while the
negative pressure source is not supplying negative pressure to the
wound dressing; preventing supply of negative pressure with the
negative pressure source to the wound dressing via the fluid flow
path in response to receipt of the first user input while the
negative pressure source is supplying negative pressure to the
wound dressing; in response to receipt of the second user input,
disabling supply of negative pressure with the negative pressure
source to the wound dressing; and subsequent to said disabling
supply of negative pressure, not supplying of negative pressure
with the negative pressure source to the wound dressing via the
fluid flow path in response to receipt of the first user input.
[0007] The method of the preceding paragraph can include one or
more of the following features: The method can further include,
subsequent to the switch experiencing a fault and no longer being
able to receive the first user input, preventing or disabling
supply of negative pressure with the negative pressure source in
response to receipt of no user inputs other than the second user
input. The method can further include supplying of negative
pressure with the negative pressure source in response to receipt
of no user inputs other than the first user input. The method can
further include, while the negative pressure source is supplying
negative pressure, preventing or disabling supply of negative
pressure with the negative pressure source in response to receipt
of no user inputs other than the first user input and the second
user input. The disabling supply of negative pressure can include
deactivation of operation of the negative pressure source or the
control circuitry, opening of a vent positioned in the fluid flow
path, or closing of a valve positioned in the fluid flow path. The
method can further include receiving the second user input via an
electrical contact of the interface element. The method can further
include receiving the first user input in response to depression of
the switch for a period of time. The period of time can be between
0.5 seconds and 5 seconds.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] Features and advantages of the present disclosure will be
apparent from the following detailed description, taken in
conjunction with the accompanying drawings of which:
[0009] FIG. 1 illustrates a negative pressure therapy system
according to some embodiments.
[0010] FIGS. 2A and 2B respectively illustrate a side view and top
view of a negative pressure therapy system according to some
embodiments, such as the negative pressure therapy system of FIG.
1.
[0011] FIGS. 3, 4, 5A, and 5B illustrate top views of negative
pressure therapy systems according to some embodiments, such as the
negative pressure therapy system of FIGS. 2A and 2B.
[0012] FIG. 6 illustrates a therapy control process performable by
a negative pressure therapy system according to some
embodiments.
[0013] FIGS. 7A, 7B, and 7C illustrate connectors according to some
embodiments.
[0014] FIGS. 8A and 8B illustrate top views of negative pressure
therapy systems according to some embodiments, such as the negative
pressure therapy system of FIGS. 2A and 2B.
[0015] FIGS. 9, 10, 11, and 12 illustrate components of negative
pressure therapy systems according to some embodiments, such as the
negative pressure therapy system of FIGS. 2A and 2B.
DETAILED DESCRIPTION
[0016] The present disclosure relates to methods and apparatuses
for dressing and treating a wound with reduced pressure therapy or
topical negative pressure (TNP) therapy. In particular, but without
limitation, embodiments of this disclosure relate to negative
pressure therapy apparatuses, methods for controlling the operation
of TNP systems, and methods of using TNP systems. The methods and
apparatuses can incorporate or implement any combination of the
features described below.
[0017] Many different types of wound dressings are known for aiding
in the healing process of a human or animal. These different types
of wound dressings include many different types of materials and
layers, for example, gauze, pads, foam pads or multi-layer wound
dressings. TNP therapy, sometimes referred to as vacuum assisted
closure, negative pressure wound therapy, or reduced pressure wound
therapy, can be a beneficial mechanism for improving the healing
rate of a wound. Such therapy is applicable to a broad range of
wounds such as incisional wounds, open wounds and abdominal wounds
or the like.
[0018] TNP therapy can assist in the closure and healing of wounds
by reducing tissue oedema, encouraging blood flow, stimulating the
formation of granulation tissue, removing excess exudates, and
reducing bacterial load and thus, infection to the wound.
Furthermore, TNP therapy can permit less outside disturbance of the
wound and promote more rapid healing.
[0019] As is used herein, reduced or negative pressure levels, such
as -X mmHg, represent pressure levels that are below atmospheric
pressure, which typically corresponds to 760 mmHg (or 1 atm, 29.93
inHg, 101.325 kPa, 14.696 psi, etc.). Accordingly, a negative
pressure value of -X mmHg reflects pressure that is X mmHg below
atmospheric pressure, such as a pressure of (760-X) mmHg. In
addition, negative pressure that is "less" or "smaller" than -X
mmHg corresponds to pressure that is closer to atmospheric pressure
(e.g., -40 mmHg is less than -60 mmHg). Negative pressure that is
"more" or "greater" than -X mmHg corresponds to pressure that is
further from atmospheric pressure (e.g., -80 mmHg is more than -60
mmHg).
Overview
[0020] The user interfaces of some TNP apparatuses may have a
limited elements through which a user can provide user input. In
some instances, particular user interfaces may include just a
single element usable by the user to stop and start delivery of
negative pressure, and the user may not be able to replace or
interchange the single element with another element. These
particular user interfaces can desirably be easier to construct and
operate than more complicated user interfaces having numerous
elements. However, the particular user interfaces may present a
problem if the single element experiences a fault (for example, a
failure) and is no longer able to function to receive user input.
The user of the particular user interfaces may undesirably be
unable to start delivery of negative pressure if negative pressure
is not already being provided and stop delivery of negative
pressure if negative pressure is being provided.
[0021] The situation of a user being unable to stop delivery of
negative pressure can additionally introduce risks to the healing
of a wound of a patient. If the patient experiences discomfort from
the wound dressing during delivery of negative pressure and the
single element experiences is no longer able to function to receive
user input, the patient may be forced to remove the wound dressing
to terminate delivery of negative pressure. The removal of the
wound dressing can damage the wound of the patient and hinder any
healing trajectory that was already progressed, as well as exposing
the wound to external contaminants due to a loss of protection from
the wound dressing.
[0022] To address the situation of the user being unable to stop
delivery of negative pressure, a TNP apparatus with the single
element usable by the user to stop and start delivery of negative
pressure can include another mechanism, such as another redundant
mechanism, to stop delivery of negative pressure. In some
implementations, a header circuit with four circuits could be used,
and each pair of circuits could be used to deactivate operation by
one or more means. One pair of the circuit could be used to connect
to a power supply of the TNP apparatus, and the other pair of
circuits could be used to connect to an enable signal (for example,
a control circuitry enable signal). Additionally or alternatively,
a surface mount technology (SMT) pin header could be used. The
another mechanism can, for instance, be an activating part molded
in a film that may be welded to the wound dressing so that the
activating mechanism may not be easily lost. Additionally or
alternatively, the locking mechanism of a zero insertion force
(ZIF) connector may be used to improve retention. The activating
mechanism can, in another example, be a printed circuit board
(PCB), such as a flexible PCB, built into a film for insertion. The
activating mechanism can, in yet another example, include a
conductive label that completes the circuit when attached and is
removable to stop delivery of negative pressure. In some
implementations, a tab may additionally or alternatively be used,
and the tab may, for instance, be pulled to disrupt a power supply
for the TNP apparatus (such as to remove a battery) or pulled to
rip an aperture in the wound dressing (such as by pulling a tab on
an outside of the wound dressing) to force a gross leak that causes
termination of delivery of negative pressure.
Reduced Pressure Therapy Systems and Methods
[0023] FIG. 1 illustrates a negative pressure therapy system 100
that includes a TNP apparatus 11 and a wound 14. The TNP apparatus
11 can be used to treat the wound 14. The TNP apparatus 11 can
include control circuitry 12A, memory 12B, a negative pressure
source 12C, a user interface 12D, a power source 12E, a first
pressure sensor 12F, a second pressure sensor 12G, and a skin
detector 12H that are configured to electrically communicate with
one another. In addition, the TNP apparatus 11 can include a wound
dressing 13. The power source 12E can provide power to one or more
components of the TNP apparatus 11.
[0024] One or more of the control circuitry 12A, memory device 12B,
negative pressure source 12C, user interface 12D, power source 12E,
first pressure sensor 12F, second pressure sensor 12G, and skin
detector 12H can be integral with, incorporated as part of,
attached to, or disposed in the wound dressing 13. The TNP
apparatus 11 can accordingly be considered to have its control
electronics and pump on-board the wound dressing 13 rather than
separate from the wound dressing 13.
[0025] The control circuitry 12A can include one or more
controllers, activation circuits, boost converters, current
limiters, feedback conditioning circuits, and H-bridge inverters.
The one or more controllers can control the operations of one or
more other components of the TNP apparatus 11 according at least to
instructions stored in the memory device 12B. The one or more
controllers can, for instance, control operations of the negative
pressure source 12C via a signal input (for example, a pulse width
modulation of the signal) to the one or more H-bridge inverters,
which in turn drive power from the power source 12E to the negative
pressure source 12C.
[0026] The negative pressure source 12C can include a pump, such
as, without limitation, a rotary diaphragm pump or other diaphragm
pump, a piezoelectric pump, a peristaltic pump, a piston pump, a
rotary vane pump, a liquid ring pump, a scroll pump, a pump
operated by a piezoelectric transducer, a voice coil pump, or any
other suitable pump or micropump or any combinations of the
foregoing.
[0027] The user interface 12D can include one or more elements that
receive user inputs or provide user outputs to a patient or
caregiver. The one or more elements that receive user inputs can
include buttons, switches, dials, touch screens, or the like, and
the one or more elements that provide user outputs can include
activation of a light emitting diode (LED) or one or more pixels of
the display or activation of a speaker or the like. In one example,
the user interface 12D can include a switch to receive a first user
input (for instance, a negative pressure activation or deactivation
input), an interface element to receive a second user input (for
instance, a negative pressure disable input), and two LEDs to
indicate an operating status (for example, functioning normally,
under fault condition, or awaiting user input) of the TNP apparatus
11.
[0028] The first pressure sensor 12F can be used to monitor
pressure underneath the wound dressing 13, such as pressure in a
fluid flow path connecting the negative pressure source 12C and the
wound 14, pressure at the wound 14, or pressure in the negative
pressure source 12C. The second pressure sensor 12G can be used to
monitor pressure external to the wound dressing 13. The pressure
external to the wound dressing can be atmospheric pressure;
however, the atmospheric pressure can vary depending on, for
instance, an altitude of use or pressurized environment in which
the TNP apparatus 11 may be used.
[0029] The control circuitry 12A can control the supply of negative
pressure by the negative pressure source 12C according at least to
a comparison between the pressure monitored by the first pressure
sensor 12F and the pressure monitored by the second pressure sensor
12G. The control circuitry 12A can include a controller, such as a
microcontroller or microprocessor.
[0030] The skin detector 12H can be used to determine if the wound
dressing 13 has been placed over the wound 14. The skin detector
12H can, for example, detect skin of a patient. The detection by
the skin detector 12H can confirm whether the wound dressing 13 is
coupled to skin of the patient next to the wound 14. When skin is
detected, this may indicate that activation of the TNP apparatus 11
is intentional rather than unintentional and can thus be used to
prevent unintentional activation of the TNP apparatus 11 or an
end-of-life timer of the TNP apparatus 11, such as during
transportation or manufacture of the TNP apparatus 11. In one
example, if the skin detector 12H indicates to the control
circuitry 12A that skin is detected, the control circuitry 12A can
activate the negative pressure source 12C to supply negative
pressure in response to receiving an activation input via the user
interface 12D. If the skin detector 12H, on the other hand,
indicates to the control circuitry 12A that skin is not detected,
the control circuitry 12A may not activate the negative pressure
source 12C to supply negative pressure in response to receiving an
activation input via the user interface 12D. The skin detector 12H
can include one or more of a capacitive sensor, an impedance
sensor, an optical sensor, a piezoresistive sensor, a piezoelectric
sensor, an elastoresistive sensor, and an electrochemical
sensor.
[0031] The wound dressing 13 can include a wound contact layer, a
spacer layer, and an absorbent layer. The wound contact layer can
be in contact with the wound 14. The wound contact layer can
include an adhesive on the patient facing side for securing the
dressing to the skin surrounding the wound 14 or on the top side
for securing the wound contact layer to a cover layer or other
layer of the wound dressing 13. In operation, the wound contact
layer can provide unidirectional flow so as to facilitate removal
of exudate from the wound while blocking or substantially
preventing exudate from returning to the wound 14. The spacer layer
can assist in distributing negative pressure over the wound site
and facilitating transport of wound exudate and fluids into the
wound dressing 13. Further, the absorbent layer can absorb and
retain exudate aspirated from the wound 14.
[0032] The control circuitry 12A can, in some instances, prevent
supply of negative pressure with the negative pressure source 12C.
For example, the control circuitry 12A can prevent supply of
negative pressure by deactivating operation of the negative
pressure source, opening a vent positioned in the fluid flow path,
and closing a valve positioned in the fluid flow path.
[0033] The supply of negative pressure with the negative pressure
source 12C can, in some instances, be disabled. For example, supply
of negative pressure can be disabled by deactivating operation of
the negative pressure source 12C or the control circuitry 12A,
opening a vent positioned in the fluid flow path, and closing a
valve positioned in the fluid flow path. In some implementations,
deactivating operation of the negative pressure source 12C or the
control circuitry 12A can be performed by disconnection of power to
the negative pressure source 12C or the control circuitry 12A or
withdrawal of an enable signal provided to the negative pressure
source 12C or the control circuitry 12A.
[0034] The control circuitry 12A can monitor a duty cycle of the
negative pressure source 12C. As is used herein, the "duty cycle"
can reflect the amount of time the negative pressure source 12C is
active or running over a period of time. In other words, the duty
cycle can reflect time that the negative pressure source 12C is in
an active state as a fraction of total time under consideration.
Duty cycle measurements can reflect a level of activity of the
negative pressure source 12C. For example, the duty cycle can
indicate that the negative pressure source 12C is operating
normally, working hard, working extremely hard, etc. Moreover, the
duty cycle measurements, such as periodic duty cycle measurements,
can reflect various operating conditions, such as presence or
severity of leaks, rate of flow of fluid (for instance, air,
liquid, or solid exudate, etc.) aspirated from a wound, or the
like. Based on the duty cycle measurements, such as by comparing
the measured duty cycle with a set of thresholds (for instance,
determined in calibration), the controller can execute or be
programmed to execute algorithms or logic that control the
operation of the system. For example, duty cycle measurements can
indicate presence of a high leak, and the control circuitry 12A can
be programmed to indicate this condition to a user (for instance,
patient, caregiver, or physician) or temporarily suspend or pause
operation of the source of negative pressure in order to conserve
power.
[0035] When the TNP apparatus 11 may be used to treat the wound 14,
the wound dressing 13 can create a substantially sealed or closed
space around the wound 13 and under the wound dressing 13, and the
first pressure sensor 12F can periodically or continuously measure
or monitor a level of pressure in this space. The control circuitry
12A can control the level of pressure in the space between a first
negative pressure set point limit and at least a second negative
pressure set point limit. In some instances, the first set point
limit can be approximately -70 mmHg, or from approximately -60 mmHg
or less to approximately -80 mmHg or more. In some instances, the
second set point limit can be approximately -90 mmHg, or from
approximately -80 mmHg or less to approximately -100 mmHg or
more.
[0036] FIG. 2A illustrates a side view of a negative pressure
therapy system 200, and FIG. 2B illustrates a top view of the
negative pressure therapy system 200. The negative pressure therapy
system 200 can be an example implementation of the negative
pressure therapy system 100.
[0037] In the negative pressure therapy system 200, the wound
dressing 13 of the TNP apparatus 11 is shown as attached to the
wound 14. Arrows depict the flow of air through the wound dressing
13 and wound exudate from the wound 14. The TNP apparatus 11 can
include an air exhaust 26 and a component area 25, such as a
components housing or storage area for components of the TNP
apparatus 11 like one or more of the control circuitry 12A, memory
device 12B, negative pressure source 12C, user interface 12D, power
source 12E, first pressure sensor 12F, second pressure sensor 12G,
and skin detector 12H.
[0038] The user interface 12D of the negative pressure therapy
system 200 can include a switch 21 (such as a dome switch), an
interface element 22 (such as an electrical contact), a first
indicator 23 (such as a first LED), and a second indicator 24 (such
as a second LED). The switch 21 can receive a negative pressure
activation or deactivation user input (for example, such as
receiving the activation or deactivation user input in response to
depression of the switch 21 for a period of time, like from between
0.5 seconds and 5 seconds). The interface element 22 can receive a
negative pressure disable user input. The first indicator 23 and
the second indicator 24 can indicate an operating status like
functioning normally, under fault condition, or awaiting user
input. In some implementations, the switch 21 or the interface
element 22 can couple to a power supply connection of the negative
pressure source 12C or the control circuitry 12A (such as a
controller of the control circuitry 12A) or an enable signal of the
negative pressure source 12C or the control circuitry 12A to
activate or deactivate supply of negative pressure or disable
supply of negative pressure. Additionally or alternatively, a SMT
pin header may be used to activate or deactivate supply of negative
pressure or disable supply of negative pressure.
[0039] Component parts of the wound dressing 13 of the negative
pressure therapy system 200 are illustrated to include an airlock
layer 27, an absorbing layer 28, and a contact layer 29. The
airlock layer 27 can enable air flow. The absorbing layer 28 can
absorb wound exudate. The contact layer 29 can be soft and include
silicon and be used to couple the TNP apparatus 11 to the
patient.
[0040] FIG. 3 illustrates a top view of a negative pressure therapy
system 300, which can be a more detailed example implementation of
the negative pressure therapy system 200. The interface element 22
as shown can include an activating part 31 that may be molded in
the film welded at position 32 to the wound dressing 13. The
activating part 31 can be used to receive the user input for the
interface element 22.
[0041] FIG. 4 illustrates a top view of a negative pressure therapy
system 400, which can be a more detailed example implementation of
the negative pressure therapy system 200. The interface element 22
as shown can include a printed circuit board (PCB) 41 that may be
flexible and built into a film for insertion and welded at position
42 to the wound dressing 13. The printed circuit board 41 can be
used to receive the user input for the interface element 22.
Moreover, the locking mechanism of a zero insertion force (ZIF)
connector may be used to improve retention.
[0042] FIGS. 5A and 5B illustrate a top view of a negative pressure
therapy system 500, which can be a more detailed example
implementation of the negative pressure therapy system 200. The
interface element 22 as shown can include a conductive label 51
that can be used to complete an electrical contact when attached
(see FIG. 5B) and disconnect the electrical contact upon removal to
receive the user input for the interface element 22. Moreover, the
locking mechanism of a ZIF connector may be used to improve
retention.
[0043] FIG. 6 illustrates a therapy control process 600 usable to
control delivery of negative pressure therapy by an apparatus, such
as the TNP apparatus 11. For convenience, the therapy control
process 600 is described in the context of the TNP apparatus 11,
but may instead be implemented in other systems described herein or
by other systems not shown. The therapy control process 600 can be
performed, in some instances, by the control circuitry 12A of the
TNP apparatus 11.
[0044] At block 602, the therapy control process 600 can determine
whether a disable input was received from a user. The disable input
may, for instance, be received from the user via the interface
element 22. In some implementations, the disable input may not be
provided by any user input to the TNP apparatus 11 other than via
the interface element 22.
[0045] If the disable input was received, at block 604, the therapy
control process 600 can disable supply of negative pressure. The
supply of negative pressure can, for instance, be disabled by
deactivation of operation of the negative pressure source 12C or
the control circuitry 12A, opening of a vent positioned in the
fluid flow path, and closing of a valve positioned in the fluid
flow path. After block 604, the therapy control process 600 can
end. In some implementations, after block 604, the TNP apparatus 11
may no longer be activated by user input to the switch 21, and the
user may thus no longer be able to cause the TNP apparatus 11 to
generate negative pressure.
[0046] If the disable input was not received, at block 606, the
therapy control process 600 can determine whether an activation
input was received from the user. The activation input may, for
instance, be received from the user via the switch 21. In some
implementations, the activation input may not be provided by any
user input to the TNP apparatus 11 other than via the switch
21.
[0047] If the activation input was not received, the therapy
control process 600 can return to block 602 and again determine
whether the disable input was received from the user.
[0048] On the other hand, if the activation input was received, at
block 608, the therapy control process 600 can supply negative
pressure. The supply of negative pressure can be performed by the
negative pressure source 12C, and the negative pressure can be
supplied to the wound dressing 13 via the fluid flow path.
[0049] At block 610, the therapy control process 600 can determine
whether a deactivation input was received from the user. The
deactivation input may, for instance, be received from the user via
the switch 21. In some implementations, the deactivation input may
not be provided by any user input to the TNP apparatus 11 other
than via the switch 21.
[0050] If the deactivation input was received, at block 612, the
therapy control process 600 can prevent the supply of negative
pressure. The supply of negative pressure can, for instance, be
prevented by one or more of deactivation of operation of the
negative pressure source 12C, opening of a vent positioned in the
fluid flow path, and closing of a valve positioned in the fluid
flow path. After block 612, the therapy control process 600 can
return to block 602 and again determine whether the disable input
was received from the user.
[0051] If the deactivation input was received, at block 614, the
therapy control process 600 can determine whether the disable input
was received from the user. The disable input may, for instance, be
received from the user via the interface element 22. In some
implementations, the disable input may not be provided by any user
input to the TNP apparatus 11 other than via the interface element
22. In some embodiments, block 614 is periodically executed while
the TNP apparatus 11 provides negative pressure wound therapy in
order to determine if supply of negative pressure should be
disabled.
[0052] If the disable input was not received, the therapy control
process 600 can return to block 608 and the supply of negative
pressure can continue.
[0053] If the disable input was received, at block 616, the therapy
control process 600 can disable supply of negative pressure. The
supply of negative pressure can, for instance, be disabled by
deactivation of operation of the negative pressure source 12C or
the control circuitry 12A, opening of a vent positioned in the
fluid flow path, and closing of a valve positioned in the fluid
flow path. After block 616, the therapy control process 600 can
end. In some implementations, after block 616, the TNP apparatus 11
may no longer be activated by user input to the switch 21, and the
user may thus no longer be able to cause the TNP apparatus 11 to
generate negative pressure. Additionally or alternatively, the TNP
apparatus 11 may no longer be activated by user input to the switch
21 until an enable input is received, such as from the user via the
interface element 22. In some implementations, the enable input may
not be provided by any user input to the TNP apparatus 11 other
than via the interface element 22.
[0054] In some implementations of the therapy control process 600,
the supply of negative pressure may not stop by any user inputs
other than the deactivation input or the disable input.
[0055] FIGS. 7A, 7B, 7C illustrate connectors, which can be used
with any of the embodiments of the negative pressure system
described herein. FIG. 7A illustrates a header 700A with four
circuits (or connectors) 70A, 70B, 70C, and 70D for connecting, for
example, the switch 21 and the interface element 22 to each pair of
circuits. FIG. 7B illustrates an SMT pin header 700B for
connecting, for example, the switch 21 and the interface element
22. In some implementations, the switch 21 can be connected to the
connector 72A and the interface element 22 can be connected to the
connector 72B or vice versa. FIG. 7C illustrates a ZIF connector
700C having a terminal 74 to which the switch 21 or the interface
element 22 can be connected. In some embodiments, two ZIF
connectors 700C can be used for connecting each of the switch 21
and interface element 22.
[0056] FIG. 8A illustrates a top view of a negative pressure
therapy system 800A, which can be a more detailed example
implementation of the negative pressure therapy system 200. A tab
810A can be pulled to rip an aperture in the wound dressing to
force a gross leak along the dotted line 820A that causes
termination of delivery of negative pressure. FIG. 8B illustrates a
top view of a negative pressure therapy system 800B, which can be a
more detailed example implementation of the negative pressure
therapy system 200. Tabs 810B can be pulled to tear the wound
dressing along the dotted line 820B to disrupt a power supply or
electronics for the TNP apparatus (such as to remove a battery or
electrical components) that causes termination of delivery of
negative pressure.
[0057] FIG. 9 illustrates components 900 of a negative pressure
therapy system, which can be a more detailed example implementation
of the negative pressure therapy system 200. The components 900 can
illustrate that the batteries can be separated from control
electronics, and the connection between the batteries and control
electronics can be used as an activation function. The components
900 can include a surface mount connector 910 on an underside as
illustrated.
[0058] FIG. 10 illustrates components 1000 of a negative pressure
therapy system, which can be a more detailed example implementation
of the negative pressure therapy system 200. The components 1000
can include a surface mount connector 1010 on an upperside as
illustrated. The components 1000 can illustrate that a main
electric area can include a rigid PCB and have a connector on an
uppermost surface to connect to a battery assembly.
[0059] FIG. 11 illustrates components 1100 of a negative pressure
therapy system, which can be a more detailed example implementation
of the negative pressure therapy system 200. The components 1100
can illustrate an arrangement of repartitioned electronics relative
to one or more other embodiments. The pump can be on one side, and
batteries can be added as a pack. The pack could have silicone
underside to adhere to the wound dressing. The components 1100 can
include a surface mount connector on an underside as
illustrated.
[0060] FIG. 12 illustrates components 1200 of a negative pressure
therapy system, which can be a more detailed example implementation
of the negative pressure therapy system 200. The components 1200
can illustrate a top of a pump module with a surface mount
connector 1210 still on an upperside.
Other Variations
[0061] Any value of a threshold, limit, duration, etc. provided
herein is not intended to be absolute and, thereby, can be
approximate. In addition, any threshold, limit, duration, etc.
provided herein can be fixed or varied either automatically or by a
user. Furthermore, as is used herein relative terminology such as
exceeds, greater than, less than, etc. in relation to a reference
value is intended to also encompass being equal to the reference
value. For example, exceeding a reference value that is positive
can encompass being equal to or greater than the reference value.
In addition, as is used herein relative terminology such as
exceeds, greater than, less than, etc. in relation to a reference
value is intended to also encompass an inverse of the disclosed
relationship, such as below, less than, greater than, etc. in
relations to the reference value. Moreover, although blocks of the
various processes may be described in terms of determining whether
a value meets or does not meet a particular threshold, the blocks
can be similarly understood, for example, in terms of a value (i)
being below or above a threshold or (ii) satisfying or not
satisfying a threshold.
[0062] Features, materials, characteristics, or groups described in
conjunction with a particular aspect, embodiment, or example are to
be understood to be applicable to any other aspect, embodiment or
example described herein unless incompatible therewith. All of the
features disclosed in this specification (including any
accompanying claims, abstract, and drawings), or all of the steps
of any method or process so disclosed, may be combined in any
combination, except combinations where at least some of such
features or steps are mutually exclusive. The protection is not
restricted to the details of any foregoing embodiments. The
protection extends to any novel one, or any novel combination, of
the features disclosed in this specification (including any
accompanying claims, abstract and drawings), or to any novel one,
or any novel combination, of the steps of any method or process so
disclosed.
[0063] While certain embodiments have been described, these
embodiments have been presented by way of example only, and are not
intended to limit the scope of protection. Indeed, the novel
methods and systems described herein may be embodied in a variety
of other forms. Furthermore, various omissions, substitutions and
changes in the form of the methods and systems described herein may
be made. Those skilled in the art will appreciate that in some
embodiments, the actual steps taken in the processes illustrated or
disclosed may differ from those shown in the figures. Depending on
the embodiment, certain of the steps described above may be
removed, others may be added. For example, the actual steps or
order of steps taken in the disclosed processes may differ from
those shown in the figure. Depending on the embodiment, certain of
the steps described above may be removed, others may be added. For
instance, the various components illustrated in the figures may be
implemented as software or firmware on a processor, controller,
ASIC, FPGA, or dedicated hardware. Hardware components, such as
processors, ASICs, FPGAs, and the like, can include logic
circuitry. Furthermore, the features and attributes of the specific
embodiments disclosed above may be combined in different ways to
form additional embodiments, all of which fall within the scope of
the present disclosure.
[0064] User interface screens illustrated and described herein can
include additional or alternative components. These components can
include menus, lists, buttons, text boxes, labels, radio buttons,
scroll bars, sliders, checkboxes, combo boxes, status bars, dialog
boxes, windows, and the like. User interface screens can include
additional or alternative information. Components can be arranged,
grouped, displayed in any suitable order.
[0065] Although the present disclosure includes certain
embodiments, examples and applications, it will be understood by
those skilled in the art that the present disclosure extends beyond
the specifically disclosed embodiments to other alternative
embodiments or uses and obvious modifications and equivalents
thereof, including embodiments which do not provide all of the
features and advantages set forth herein. Accordingly, the scope of
the present disclosure is not intended to be limited by the
specific disclosures of preferred embodiments herein, and may be
defined by claims as presented herein or as presented in the
future.
[0066] Conditional language, such as "can," "could," "might," or
"may," unless specifically stated otherwise, or otherwise
understood within the context as used, is generally intended to
convey that certain embodiments include, while other embodiments do
not include, certain features, elements, or steps. Thus, such
conditional language is not generally intended to imply that
features, elements, or steps are in any way required for one or
more embodiments or that one or more embodiments necessarily
include logic for deciding, with or without user input or
prompting, whether these features, elements, or steps are included
or are to be performed in any particular embodiment. The terms
"comprising," "including," "having," and the like are synonymous
and are used inclusively, in an open-ended fashion, and do not
exclude additional elements, features, acts, operations, and so
forth. Also, the term "or" is used in its inclusive sense (and not
in its exclusive sense) so that when used, for example, to connect
a list of elements, the term "or" means one, some, or all of the
elements in the list. Further, the term "each," as used herein, in
addition to having its ordinary meaning, can mean any subset of a
set of elements to which the term "each" is applied.
[0067] Conjunctive language such as the phrase "at least one of X,
Y, and Z," unless specifically stated otherwise, is otherwise
understood with the context as used in general to convey that an
item, term, etc. may be either X, Y, or Z. Thus, such conjunctive
language is not generally intended to imply that certain
embodiments require the presence of at least one of X, at least one
of Y, and at least one of Z.
[0068] Language of degree used herein, such as the terms
"approximately," "about," "generally," and "substantially" as used
herein represent a value, amount, or characteristic close to the
stated value, amount, or characteristic that still performs a
desired function or achieves a desired result. For example, the
terms "approximately", "about", "generally," and "substantially"
may refer to an amount that is within less than 10% of, within less
than 5% of, within less than 1% of, within less than 0.1% of, and
within less than 0.01% of the stated amount. As another example, in
certain embodiments, the terms "generally parallel" and
"substantially parallel" refer to a value, amount, or
characteristic that departs from exactly parallel by less than or
equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or
0.1 degree.
[0069] The scope of the present disclosure is not intended to be
limited by the specific disclosures of preferred embodiments in
this section or elsewhere in this specification, and may be defined
by claims as presented in this section or elsewhere in this
specification or as presented in the future. The language of the
claims is to be interpreted broadly based on the language employed
in the claims and not limited to the examples described in the
present specification or during the prosecution of the application,
which examples are to be construed as non-exclusive.
* * * * *