U.S. patent application number 16/814715 was filed with the patent office on 2020-10-15 for negative pressure wound therapy systems, devices, and methods.
The applicant listed for this patent is Healyx Labs, Inc.. Invention is credited to Lawson Fisher, Robert Hutton, James McCrea, Madeline Sides.
Application Number | 20200323695 16/814715 |
Document ID | / |
Family ID | 1000004916725 |
Filed Date | 2020-10-15 |
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United States Patent
Application |
20200323695 |
Kind Code |
A1 |
Sides; Madeline ; et
al. |
October 15, 2020 |
NEGATIVE PRESSURE WOUND THERAPY SYSTEMS, DEVICES, AND METHODS
Abstract
A negative pressure wound therapy system includes a wound
dressing and a suction device configured to be in fluid
communication with the wound dressing via a conduit to channel a
fluid between at least the wound dressing and the suction device.
The suction device includes a vacuum connection configured to be
coupled to the conduit, a vacuum pump, an analog electronic
pressure sensor in electrical communication with the vacuum pump,
and a passive valve assembly. The passive valve assembly is in
fluid communication with (1) the vacuum pump, (2), the analog
electronic pressure sensor, and (3) the vacuum connection, and is
configured to maintain the vacuum pump in fluid communication with
the vacuum connection within a predefined pressure range, and to
passively inhibit fluid communication between the vacuum pump and
the vacuum connection outside of the predefined pressure range.
Inventors: |
Sides; Madeline; (San
Francisco, CA) ; Hutton; Robert; (Los Altos, CA)
; McCrea; James; (San Carlos, CA) ; Fisher;
Lawson; (Portola Valley, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Healyx Labs, Inc. |
Mountain View |
CA |
US |
|
|
Family ID: |
1000004916725 |
Appl. No.: |
16/814715 |
Filed: |
March 10, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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16272980 |
Feb 11, 2019 |
10624794 |
|
|
16814715 |
|
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62629185 |
Feb 12, 2018 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2205/3334 20130101;
A61M 2205/3331 20130101; A61M 2205/15 20130101; A61M 2205/3344
20130101; A61M 1/0088 20130101; A61M 1/0092 20140204; A61M 1/009
20140204; A61M 1/0031 20130101; A61F 13/0216 20130101 |
International
Class: |
A61F 13/02 20060101
A61F013/02; A61M 1/00 20060101 A61M001/00 |
Claims
1. A suction device for negative pressure wound therapy, the
suction device comprising: a vacuum connection configured to
deliver negative pressure to a treatment site; a pump configured to
supply negative pressure to the vacuum connection; and a passive
valve assembly in fluid communication with the pump and the vacuum
connection, wherein the passive valve assembly is configured to
maintain the pump in fluid communication with the vacuum connection
within a predefined pressure range, and to passively inhibit fluid
communication between the pump and the vacuum connection outside of
the predefined pressure range.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 16/272,980, filed Feb. 11, 2019, which claims
the benefit of priority to U.S. Provisional Application No.
62/629,185, filed Feb. 12, 2018, both of which are hereby
incorporated by reference in their entireties.
TECHNICAL FIELD
[0002] The present technology relates to devices and methods for
using negative pressure to treat wounds. In particular, the present
technology is negative pressure wound therapy (NPWT) devices that
are portable, reusable, easy to use, and economical.
BACKGROUND
[0003] Severe wounds are an urgent, unaddressed health need in
resource-constrained settings. The incidence of these wounds
exceeds 110 million worldwide and is growing due to an increase in
diseases associated with chronic wounds--diabetes, cardiovascular
disease, and obesity--and an aging global population. In the U.S.,
conservative estimates exceed $28 billion spent each year treating
chronic wounds as a primary diagnosis. In developing world
settings, etiological factors that lead to severe wounds are
compounded by parasitic, bacterial, viral exposure, and road
accidents. In both developed and developing world settings, these
open wounds are an enormous cause of morbidity and impose a
significant financial burden on patients and their families,
especially as non-healing wounds may lead to prolonged disability
and prevent a return to employment. The negative socio-economic
impact of a chronic wound places a strain on the individual,
family, and healthcare system. Without access to adequate wound
care treatment in resource-constrained settings, patients suffer
from long and costly healing processes. Quality of life is worsened
by pain, emotional stress, impaired physical mobility, and often
isolation. Direct healthcare costs and opportunity costs in an
absence from work and/or loss of employment can devastate a
patient's entire family. Hospital systems, outpatient facilities,
and home-care settings are burdened with overcrowding and excessive
resource requirements.
[0004] Therapeutic challenges in wound healing amplify this
devastating crisis. Highly orchestrated and specialized procedures
are required to treat these chronic wounds. This dynamic process
involves the removal of debris, control of infection, reduction of
inflammation to clear the area for angiogenesis, deposition of
granulation tissue, wound contraction and maturation--a sequence
leading to repair and closure. A failure in just one step of this
complex process may inhibit healing progression. Neglect present in
wound care can lead to further morbidity and increase mortality
rates. The cascade effect from infection to systemic complications,
extensive hospitalization, amputation and death is inevitable if
there is no effective intervention.
[0005] The current standard in wound care in many
resource-constrained settings is limited to daily gauze dressing
wraps and debridement. As gauze dressings are non-occlusive, or
permeable to exogenous bacteria, treatment with gauze wraps
introduces greater risk of infection, requiring frequent dressing
changes and resulting in a prolonged wound healing period. These
dressings are also associated with high medical costs,
time-consuming care, and patient discomfort.
[0006] Negative Pressure Wound Therapy (NPWT) is a clinically
validated and market proven method of treating severe wounds. This
clinically validated advanced wound management technology addresses
the needs of acute, chronic, and postoperative wound care.
Typically, the therapy includes a vacuum suction device that
applies negative pressure across the surface of a wound through a
sealed dressing covering the wound site. The dressing is typically
a porous foam or gauze-based material that is fitted to the
contours of the wound and covered with an adhesive, airtight film A
canister typically connects the dressing and vacuum suction device.
A canister is a fluid container that collects and stores fluids
pulled out of the wound with negative pressure. The application of
continuous negative pressure (suction) over a wound area leads to
the removal of exudate (excess fluid), improved vascularization,
and creates mechanical forces that stimulate a biological response,
leading to significantly faster wound healing. Moreover, NPWT
creates a moist microenvironment for the wound, conducive to cell
proliferation and migration, angiogenesis, and the elimination of
necrotic tissue.
[0007] NPWT has been validated as a treatment for a variety of
wounds, including pressure ulcers, diabetic foot ulcers, burns and
post-traumatic wounds. The role of NPWT in continuous treatment
includes a multitude of specific healing-related benefits, such as
reduction in wound size and volume as well as decreased healing
time for open wounds by a factor of two or more. Blood flow has
shown up to a fivefold increase during treatment and edema
reduction is significant. Patients treated with a NPWT device,
commonly referred to as a "wound vacuum" display higher rates of
granulation tissue and up to a threefold increase in expression of
enzymes and growth factors at the wound bed. In practice, NPWT is
proven to reduce wound-related complications, including infection
rate and re-amputations, and increase patient survival when
compared to standard treatment. The healing of chronic and acute
wounds can be a multi-week or multi-month process, even when NPWT
is used. For example, Medicare in the US covers up to four months
of treatment with NPWT devices. While NPWT has been shown to be a
useful tool in wound care, currently marketed NPWT products are not
aligned with the needs of users in resource-constrained healthcare
settings, remote/home use settings and/or low-income population
segments. Consequently, currently marketed NPWT devices, including
reusable stand-alone devices and portable/disposable devices, may
be out of reach financially or difficult to use successfully in
these settings. Wound incidence is equivalent if not greater in
these patient segments and settings, which underscores a need for
technology that can be accessed by these patients and their
caregivers.
[0008] Reusable, stand-alone NPWT devices are larger systems
designed for inpatient settings that can be used many times for
repeated treatment and enable healthcare providers to customize the
therapy by adjusting a variety of settings. The primary application
of this product segment has been the treatment of large non-healing
wounds with high volumes of exudate. These reusable stand-alone
devices are limited by elaborate user interfaces, complex internal
structures (making them susceptible to failures and software bugs),
burdensome power requirements and large size. These limitations
additionally contribute to a high per device production cost. User
interface (UI) complexity in stand-alone devices is evidenced by
added features like touch screens and LCD screens, which, while
offering a highly customizable treatment regimen, also require
users to be trained in device operation and have a moderate level
of technological literacy for successful device use and monitoring.
UI complexity is further evident in the physical mechanisms used to
connect and disconnect device accessories, such as canisters and
wound dressings. These mechanisms require adequate physical
dexterity from users to twist, orient or locate specific parts in
order to make an airtight seal in the system, an essential
condition for wound therapy. This can be an obstacle for many wound
patients, who often have limited dexterity due to age or
co-morbidities. Further, these complex mechanisms are subject to
breakage through normal wear and tear or user error, and may be
hard to service onsite due to the specific tools, skills and parts
required for their repair. The internal apparatuses that constitute
current standalone devices feature intricate mechanical and
electronic mechanisms. These devices may use a number of
electromechanical valves, sensors of various types and
microprocessors or microcontrollers for system control in
combination with one or more electric vacuum pumps. These
components enable high-precision control and monitoring of system
pressure and flow rates, but also make the system susceptible to
electrical or software bugs, or breakdown of processors or sensors
that interrupt the delivery of therapy. Due to these abovementioned
factors, often NPWT device manufacturers and suppliers must train
personnel extensively to operate and troubleshoot each NPWT device
to avoid user errors and/or patient risk. This requirement limits
device use to settings with qualified and available trained
personnel. Further, standalone devices can only be used in
locations with a stable AC power source because components used to
create these complex UIs and pressure/flow rate controls draw more
power than can be continuously supplied by a single battery or
battery pack. These components also make devices large and heavy.
Finally, many of these abovementioned limitations have financial
consequences for consumers and healthcare providers in that they
increase the cost of device production and implementation.
[0009] Disposable NPWT devices (single-use) are typically
battery-powered highly portable treatment systems that may or may
not be re-chargeable. Their UIs are more streamlined, often with a
power indicator, power button and no ability to change canisters
(e.g. a single-use canister fully enclosed in a device). These
devices are typically smaller in size and weight than stand-alone
devices. This emerging sector of NPWT devices offers substantial
benefits in simplifying treatment, but it is limited to small,
fast-healing wounds as the devices typically last only 7 days and
can only be used to contain a relatively small amount of exudate
(70-300 mL) before needing to be replaced. While these devices have
a simplified control UI, they may still have complex attachment
mechanisms for accessories that are susceptible to failure, much
like stand-alone devices. Additionally, they may have similar
internal complexity to stand-alone devices in terms of components
used to achieve pressure control, which drives up production cost
while making the devices susceptible to software bugs and component
failures (e.g. microprocessors, microcontrollers, etc.).
Commercially available portable systems address some of the size,
complexity and power requirement limitations of standalone devices,
to encourage ambulatory patients to move around while receiving
treatment. These devices are lower cost and less complex. However,
these devices were tailored to exclusively address specific wound
types such as acute incision wounds or surgical site infections.
This narrower focus limits the indications for use, especially
large wounds with high volumes of exudate. Additionally, a shorter
useful lifespan makes the devices less economical and practical in
chronic wound care.
[0010] Within the Disposable NPWT device (single-use) segment, a
subgroup of non-electrically powered devices (manual) have been
introduced in the marketplace. These non-electric devices provide
similar benefits to the aforementioned powered, single-use
devices--streamlined UI, portability, reduced production cost. They
are also similarly limited in application due to narrower
indications for use (e.g. smaller wounds with lower volumes of
exudate) and shorter useful lifespan. The manually powered suction
apparatus provides an added benefit by reducing reliance on wall
and/or battery power and the internal mechanisms for vacuum
generation and pressure control do not rely on expensive electrical
components (e.g. microprocessors, microcontrollers, etc.). However,
the usefulness of manual systems is limited because they are not
able to accurately control system pressure, which is a critical
NPWT parameter in clinical practice. Though less susceptible to
software bugs or electrical component failures, manual devices
generate vacuum pressure without any feedback and ability to
self-correct if vacuum pressure drops. The manual system requires
significant user attention to maintain a vacuum seal and to
reestablish clinically appropriate vacuum pressure if pressure is
lost for any reason.
[0011] Accordingly, there is a need for improved NPWT systems that
are robust, reusable, portable, economical, clinically effective,
power-efficient and have streamlined interfaces for ease-of-use
even among unskilled populations. Finally, both standalone and
portable units currently on the market are limited by designs that
require a particular brand or type of accessories (waste canister
and wound dressing). These units become completely unusable if a
single piece of a particular accessory is unavailable or out of
supply. This constraint interrupts therapy, drives up prices and
makes NPWT infeasible in regions where medical supply chains are
frequently interrupted. For these reasons, there remains a need to
develop improved solutions that reduce cost, reduce complexity, and
increase robustness and accessibility of the therapy to
patients.
SUMMARY
[0012] The present technology is directed to devices, systems, and
methods for negative pressure wound therapy (NPWT). The present
technology is illustrated, for example, according to various
aspects described herein with reference to FIGS. 1A-8.
[0013] Embodiments of the present technology are directed to NPWT
systems that are simplified for ease-of-use, streamlined for
cost-effectiveness, and designed for portability, robustness and
reusability, through a combination of mechanical, electronic and
electromechanical features. For example, simplified NPWT systems in
accordance with the present technology can be configured to provide
only a single level of negative pressure that is not adjustable by
the user, so as to provide the appropriate and physician-prescribed
level of suction (i.e. the therapeutic vacuum level) for effective
NPWT without requiring user input or expertise. The system can also
be configured such that the only user input to deliver therapy at a
particular vacuum level setting, apart from placing the dressing
over the wound, is pressing a power button to initiate or to
terminate treatment. In some embodiments, the device user interface
can omit any digital output display to reduce cost and complexity.
In some embodiments, the device can contain various types of waste
canisters with volumes sufficient to treat wounds with low to high
rates of exudate production for several days. In some embodiments,
this canister is fluidically coupled to the device with an
easy-to-use external connector piece. The benefits of the present
technology include robustness in care settings without trained
users to initiate and support therapy and/or a reliable source of
wall power, as well as reduced device cost and reduced device
weight, all of which increase device accessibility for
resource-constrained care settings and patients.
[0014] Various examples of aspects of the present technology are
described below as numbered clauses (1, 2, 3, etc.) for
convenience. These are provided as examples and do not limit the
subject technology. The features of any of the following Clauses
can be combined with features of any of the other Clauses. For
example, the features recited in Clause 11 can be combined with the
features of any one of the other Clauses listed.
[0015] Clause 1. A negative pressure wound therapy system
comprising:
[0016] a wound dressing; and
[0017] a suction device configured to be in fluid communication
with the wound dressing via a first conduit to channel a fluid
between the wound dressing and the suction device, the suction
device comprising:
[0018] a vacuum connection configured to be coupled to a second
conduit;
[0019] a vacuum pump configured to supply negative pressure;
[0020] an electronic pressure sensor in electrical communication
with the vacuum pump; and
[0021] a passive valve assembly in fluid communication with (1) the
vacuum pump, (2), the electronic pressure sensor, and (3) the
vacuum connection to the wound, wherein the passive valve assembly
is configured to maintain the vacuum pump in fluid communication
with the vacuum connection within a predefined pressure range, and
to passively inhibit fluid communication between the vacuum pump
and the vacuum connection outside of the predefined pressure
range.
[0022] Clause 2. The system of any one of the preceding Clauses,
further comprising a canister in fluid communication with both the
wound dressing and the vacuum connection of the suction device,
wherein the canister is configured to collect exudate aspirated
from the wound dressing.
[0023] Clause 3. The system of any one of the preceding Clauses,
wherein the passive valve assembly comprises:
[0024] an interior configured to receive negative pressure from the
vacuum pump;
[0025] an ambient vent outlet;
[0026] a vacuum outlet;
[0027] a first moveable occluder configured to close and open the
ambient vent outlet with respect to the interior in response to
pressure conditions within the interior; and
[0028] a second moveable occluder configured to close and open the
vacuum outlet with respect to the interior in response to pressure
conditions within the interior.
[0029] Clause 4. The system of any one of the preceding Clauses,
wherein the first movable occluder comprises a first plunger
assembly, and wherein the second movable occluder comprises a
second plunger assembly.
[0030] Clause 5. The system of any one of the preceding Clauses,
wherein the passive valve assembly further comprises a sensor
outlet in fluid communication with the electronic pressure sensor,
wherein the second moveable occluder is configured to close and
open the sensor outlet with respect to the interior in response to
pressure conditions within the interior, and wherein the electronic
pressure controls actuation of the vacuum pump in response to
sensed pressure from the sensor outlet.
[0031] Clause 6. The system of any one of the preceding Clauses,
wherein in the absence of applied negative pressure from the vacuum
pump, both the first moveable occluder and the second moveable
occluder are closed.
[0032] Clause 7. The system of any one of the preceding Clauses,
wherein in the presence of negative pressure within the predefined
pressure range, the second moveable occluder opens the vacuum
outlet with respect to the interior, and the first moveable
occluder closes the ambient vent outlet with respect to the
interior.
[0033] Clause 8. The system of any one of the preceding Clauses,
wherein the presence of negative pressure having a greater
magnitude than the predefined pressure range, the first moveable
occluder opens the vent outlet with respect to the interior.
[0034] Clause 9. The system of any one of the preceding Clauses,
wherein the first moveable occluder comprises a first spring
coupled to a first plunger, and wherein the second moveable
occluder comprises a second spring coupled to a second plunger.
[0035] Clause 10. The system of any one of the preceding Clauses,
wherein the first plunger assembly is more compressed than the
second plunger assembly.
[0036] Clause 11. The system of any one of the preceding Clauses,
wherein the first plunger assembly exerts a greater outward force
than the second spring.
[0037] Clause 12. The system of any one of the preceding Clauses,
wherein the electronic pressure sensor is in analog electronic
communication with a circuit network of other analog electronic
components and integrated circuits, wherein none of the components
are microcontrollers or microprocessors.
[0038] Clause 13. The system of any one of the preceding Clauses,
wherein the circuit network comprises a logic module that utilizes
one or more comparators with hysteresis with an upper threshold and
lower threshold within the predefined pressure range.
[0039] Clause 14. The system of any one of the preceding Clauses,
wherein the vacuum connection comprises:
[0040] a male connector secured to the suction device;
[0041] a female connector removably coupleable to the male
connector; and
[0042] a filter disposed between the female connector and the male
connector.
[0043] Clause 15. The system of any one of the preceding Clauses,
wherein the male connector is in fluid communication with the
passive valve assembly, and wherein the female connector comprises
a connector configured to engage with the second conduit.
[0044] Clause 16. The system of any one of the preceding Clauses,
wherein the vacuum connection permits the passage of air
therethrough, and wherein substantially all air passing through the
vacuum connection passes through the filter.
[0045] Clause 17. The system of any one of the preceding Clauses,
wherein the female connector comprises an engagement mechanism
including a first wing coupled to a first barb and a second wing
coupled to a second barb, and wherein the male connector comprises
an engagement member, the first and second barbs configured to mate
with the engagement member to secure the female connector and the
male connector together.
[0046] Clause 18. The system of any one of the preceding Clauses,
wherein inwardly deflecting the first and second wings releases the
first and second barbs from the engagement member.
[0047] Clause 19. The system of any one of the preceding Clauses,
wherein the female connector comprises a receptacle configured to
receive the filter therein.
[0048] Clause 20. The system of any one of the preceding Clauses,
wherein the female connector is sterilizable and reusable.
[0049] Clause 21. The system of any one of the preceding Clauses,
wherein the canister is nonspecific and is coupled to the device by
a mechanism that does not have any moving pieces and does not
require a particular waste canister rotational orientation inside
the device.
[0050] Clause 22. The system of any one of the preceding Clauses,
wherein the predefined pressure is -125 mmHg.
[0051] Clause 23. The system of any one of the preceding Clauses,
wherein the predefined pressure range comprises -125 mmHg plus or
minus approximately 10% or less.
[0052] Clause 24. The system of any one of the preceding Clauses,
wherein the predefined pressure range comprises 125 mmHg plus or
minus approximately 20% or less.
[0053] Clause 25. The system of any one of the preceding Clauses,
wherein the system does not include a microprocessor or
microcontroller.
[0054] Clause 26. The system of any one of the preceding Clauses,
wherein the level of negative pressure created by the suction
device is not adjustable by a user.
[0055] Clause 27. The system of any one of the preceding Clauses,
wherein the vacuum pump comprises a microdiaphragm pump.
[0056] Clause 28. A suction device for negative pressure wound
therapy, the suction device comprising:
[0057] a vacuum connection configured to deliver negative pressure
to a treatment site;
[0058] a pump configured to supply negative pressure to the vacuum
connection; and
[0059] a passive valve assembly in fluid communication with the
pump and the vacuum connection,
[0060] wherein the passive valve assembly is configured to maintain
the pump in fluid communication with the vacuum connection within a
predefined pressure range, and to passively inhibit fluid
communication between the pump and the vacuum connection outside of
the predefined pressure range.
[0061] Clause 29. The device of Claim 28, further comprising a
pressure sensor in electrical communication with the pump; and
wherein the pressure sensor is in analog electronic communication
with a circuit network of other analog electronic logic components
and integrated circuits, where none of the integrated circuits are
microcontrollers or microprocessors.
[0062] Clause 30. The device of any one of the preceding Clauses,
wherein the circuit network comprises a logic module that utilizes
one or more comparators with hysteresis with a set point and reset
point within the predefined pressure range.
[0063] Clause 31. The device of any one of the preceding Clauses,
wherein the passive valve assembly comprises:
[0064] an interior configured to receive negative pressure from the
vacuum pump;
[0065] an ambient vent outlet;
[0066] a vacuum outlet;
[0067] a first moveable occluder configured to close and open the
ambient vent outlet with respect to the interior in response to
pressure conditions within the interior; and
[0068] a second moveable occluder configured to close and open the
vacuum outlet.
[0069] Clause 32. The device of any one of the preceding Clauses,
wherein the passive valve assembly further comprises a sensor
outlet; and wherein the second moveable occluder is additionally
configured to close and open the sensor outlet with respect to the
interior in response to pressure conditions within the
interior.
[0070] Clause 33. The device of any one of the preceding Clauses,
wherein in the absence of applied negative pressure from the pump,
both the first moveable occluder and the second moveable occluder
are closed.
[0071] Clause 34. The device of any one of the preceding Clauses,
wherein in the presence of negative pressure within the predefined
pressure range, the second moveable occluder opens the vacuum
outlet with respect to the interior, and the first moveable
occluder closes the ambient vent outlet with respect to the
interior.
[0072] Clause 35. The device of any one of the preceding Clauses,
wherein the presence of negative pressure having a greater
magnitude than the predefined pressure range, the first moveable
occluder opens the vent outlet with respect to the interior.
[0073] Clause 36. The device of any one of the preceding Clauses,
wherein the vacuum connection comprises:
[0074] a male connector secured to the suction device;
[0075] a female connector removably coupleable to the male
connector; and
[0076] a filter disposed between the female connector and the male
connector.
[0077] Clause 37. The device of any one of the preceding Clauses,
wherein the male connector is in fluid communication with the
passive valve assembly, and wherein the female connector comprises
a connector configured to engage with a conduit.
[0078] Clause 38. The device of any one of the preceding Clauses,
wherein the vacuum connection permits the passage of air
therethrough, and wherein substantially all air passing through the
vacuum connection passes through the filter.
[0079] Clause 39. The device of any one of the preceding Clauses,
wherein the female connector comprises an engagement mechanism
including a first wing coupled to a first barb and a second wing
coupled to a second barb, and wherein the male connector comprises
an engagement member, the first and second barbs configured to mate
with the engagement member to secure the female connector and the
male connector together.
[0080] Clause 40. The device of any one of the preceding Clauses,
wherein inwardly deflecting the first and second wings releases the
first and second barbs from the engagement member.
[0081] Clause 41. The device of any one of the preceding Clauses,
wherein the female connector comprises a receptacle configured to
receive the filter therein.
[0082] Clause 42. The device of any one of the preceding Clauses,
wherein the female connector is sterilizable and reusable.
[0083] Clause 43. The device of any one of the preceding Clauses,
further comprising a waste canister configured to be coupled to a
conduit without moving pieces, the device configured to accommodate
non-specific waste canisters in different rotational positions.
[0084] Clause 44. The device of any one of the preceding Clauses,
wherein the predefined pressure range includes -125 mmHg.
[0085] Clause 45. The device of any one of the preceding Clauses,
wherein the device does not include a microprocessor or
microcontroller.
[0086] Clause 46. The device of any one of the preceding Clauses,
wherein the predefined pressure range is not adjustable by a
user.
[0087] Clause 47. The device of any one of the preceding Clauses,
wherein the pump comprises a microdiaphragm pump.
[0088] Clause 48. A method of applying negative pressure wound
therapy, the method comprising:
[0089] (a) disposing a wound dressing over a wound site on a
patient;
[0090] (b) fluidically coupling the wound dressing to a
canister;
[0091] (c) fluidically coupling the canister to a suction device,
thereby establishing a fluidic pathway;
[0092] (d) supplying power to the suction device;
[0093] (e) determining pressure in the fluidic pathway using a
pressure sensor;
[0094] (f) comparing the pressure to an upper threshold and a lower
threshold;
[0095] (g) powering on a pump of the suction device until the
pressure meets the upper threshold;
[0096] (h) after (g), powering off the pump until the pressure
falls to the lower threshold;
[0097] (i) repeating steps (e)-(h) to maintain pressure in the
fluidic pathway between the upper threshold and the lower
threshold; and
[0098] (j) terminating therapy by removing power to the suction
device and relieving pressure in the fluidic pathway.
[0099] Clause 49. The method of any one of the preceding Clauses,
further comprising:
[0100] (k) fluidically connecting the pressure sensor to a passive
valve assembly, wherein the passive valve assembly comprises:
[0101] an interior configured to receive negative pressure from the
pump;
[0102] an ambient vent outlet;
[0103] a vacuum outlet;
[0104] a sensor outlet;
[0105] a first moveable occluder configured to close and open the
ambient vent outlet with respect to the interior in response to
pressure conditions within the interior; and
[0106] a second moveable occluder configured to close and open the
vacuum outlet with respect to the interior in response to pressure
conditions within the interior;
[0107] (l) limiting the maximum vacuum pressure in the fluidic
pathway with the passive valve assembly; and
[0108] (m) preventing backflow in the fluidic pathway.
[0109] Clause 50. The method of any one of the preceding Clauses,
wherein the upper threshold is between 5 and 15% greater than a
therapeutic vacuum level for therapy, and wherein the lower
threshold is between 5 and 15% lower than the therapeutic vacuum
level for therapy.
[0110] Clause 51. The method of any one of the preceding Clauses,
further comprising providing a first indication signifying that the
pressure is lower than specified for therapy while the pressure is
rising until the pressure reaches the upper threshold.
[0111] Clause 52. The method of any one of the preceding Clauses,
further comprising providing a second indication signifying that
the pressure is within a therapeutic range while the pressure is
falling until the pressure reaches the lower threshold.
[0112] Clause 53. The method of any one of the preceding Clauses,
wherein a maximum rate of state change between the first indicator
and another indicator is between 0.5 and 2 Hz.
[0113] Clause 54. The method of any one of the preceding Clauses,
wherein the center of a range bounded by the upper threshold and
the lower threshold is 125 mmHg.
[0114] Clause 55. The method of any one of the preceding Clauses,
wherein the upper and lower thresholds are not configurable by a
user.
BRIEF DESCRIPTION OF THE DRAWINGS
[0115] Many aspects of the present disclosure can be better
understood with reference to the following drawings. The components
in the drawings are not necessarily to scale. Instead, emphasis is
placed on illustrating clearly the principles of the present
disclosure.
[0116] FIG. 1A is a perspective view of a suction assembly of a
negative pressure wound therapy (NPWT) system in accordance with an
embodiment of the present technology.
[0117] FIG. 1B illustrates the NPWT system positioned to treat a
wound on a patient's leg.
[0118] FIG. 1C illustrates a schematic view of the NPWT system of
FIGS. 1A and 1B.
[0119] FIG. 2A illustrates a perspective view of a suction device
in accordance with embodiments of the present technology.
[0120] FIG. 2B illustrates the suction device system of FIG. 2A
with a portion of the housing removed.
[0121] FIG. 2C illustrates a user interface of the suction device
shown in FIGS. 2A and 2B.
[0122] FIG. 3 is an enlarged view of the pump assembly of the
suction device shown in FIGS. 2A and 2B.
[0123] FIG. 4A illustrates a perspective view of the valve assembly
shown in FIG. 3.
[0124] FIG. 4B illustrates a side cross-sectional view of the valve
assembly of FIG. 4A.
[0125] FIG. 4C illustrates a perspective exploded view of the valve
assembly of FIGS. 4A and 3B.
[0126] FIG. 4D illustrates another embodiment of a valve
assembly.
[0127] FIG. 4E is a table of the different operating conditions of
the suction device.
[0128] FIGS. 4F and 4G illustrate how the valve assembly responds
to changes in relative pressure.
[0129] FIG. 5A is an enlarged perspective view of the vacuum
connection assembly shown in FIGS. 2A and 2B.
[0130] FIG. 5B is an exploded perspective view of the vacuum
connection assembly shown in FIG. 5A.
[0131] FIG. 5C is a side cross-sectional view of the vacuum
connection assembly shown in FIGS. 5A and 5B.
[0132] FIG. 6 shows graphs of vacuum pressure and pump voltage over
time.
[0133] FIG. 7 is a schematic diagram of pressure control circuitry
of a suction device.
[0134] FIG. 8 illustrates another embodiment of a suction
device.
DETAILED DESCRIPTION
Selected Embodiments of Negative Pressure Wound Therapy Systems
[0135] FIG. 1A is a perspective view of a suction device 101 of a
negative pressure wound therapy (NPWT) system 100 in accordance
with an embodiment of the present technology, and includes a
housing 109, a conduit 119, and a connection assembly 500. The
housing contains mechanical and electrical components that are
further described in FIGS. 2A-C. FIG. 1A shows the suction device
101 coupled with a canister 111 and lid 113. The lid 113 further
comprises an exudate port 115 and a vacuum port 117.
[0136] FIG. 1B illustrates the NPWT system 100 positioned to treat
a wound on a patient's leg. The NPWT system 100 includes the
suction device 101, a canister 111, a lid 113, a dressing 103, and
a conduit 105 configured to couple the suction device 101 to the
dressing 103. As described herein, the system 100 is preferably
configured to treat a wound by application of reduced pressure to a
wound site 107 (i.e., below atmospheric pressure) to provide
suction to the wound site 107 in a controlled manner for a desired
period of time.
[0137] FIG. 1C illustrates a schematic view of the NPWT system 100
of FIGS. 1A and 1B. The system 100 includes the suction device 101
in communication with the wound dressing 103 and canister 111.
Specifically, the wound dressing is in communication with the
canister 111 (e.g., via a conduit), and the canister 111 in turn is
in fluid communication with a vacuum assembly 300 via a connection
assembly 500. Embodiments of the connection assembly 500 are
described in more detail below with respect to FIGS. 5A-5C. The
vacuum assembly 300, described in more detail below with respect to
FIGS. 2A-4G, can include a pump 317, a power source 303, a pressure
sensor 309, pressure control circuitry 700, and a valve assembly
400. Together, these components of the vacuum assembly 300 can
provide a supply of negative pressure within a desired therapeutic
range to the wound dressing 103 via the connection assembly 500 and
the canister 111. The vacuum assembly may be in electrical
communication with the user interface 207. In some embodiments, the
suction device 101 can be enclosed within a housing or other
body.
[0138] The dressing 103 can be a wound cover or wound dressing
configured to enclose the wound site 107 and to provide a
fluid-tight or gas-tight enclosure over the wound site 107 to
effect treatment of a wound site 107 with reduced or negative
pressure. Any wound cover or dressing presently known in the art or
developed in the future can be configured to be integrated into the
NPWT system 100 described herein.
[0139] To create suction within the dressing 103, the dressing 103
is connected to the suction device 101 via the conduit 105. The
suction device 101 provides a source of suction to deliver reduced
pressure for the sealed wound dressing 103 at the wound site 107.
As described in more detail below, the suction device 101 includes
a housing 109 which encompasses a vacuum assembly that supplies
negative pressure. In some embodiments, all electronic components
and pneumatic system parts are contained within the housing 109.
The housing 109 defines an opening configured to receive a canister
111 therein. The canister 111 can be configured to hold exudate
that is aspirated from the wound site 107. The canister 111 can be
covered with a lid 113 that includes an exudate port 115 and a
vacuum port 117. The exudate port 115 is configured to be coupled
to the conduit 105 that extends between the suction device 101 and
the dressing 103. The vacuum port 117 can be coupled to a conduit
119 that is coupled to a connection assembly 500 which in turn is
coupled to the housing 109 of the suction device 101. In use,
negative pressure is supplied through the connection assembly 500,
through the conduit 119, and to the vacuum port 117 such that
negative pressure is provided within the canister 111. Since the
canister 111 is open to the exudate port 115, the negative pressure
within the canister 111 creates negative pressure within the
conduit 105 and therefore negative pressure at the wound site 107
under the dressing 103. The application of negative pressure causes
exudate to be aspirated from the wound site 107. The exudate passes
through the conduit 105, through the exudate port 115, and into the
canister 111 where it is collected for later disposal.
[0140] As described in more detail below with respect to FIGS.
5A-5C, the female connector 501 of the vacuum connection assembly
500 can be easily connected and disconnected from the male
connector 503 of the vacuum connection assembly 500 for the purpose
of removing the canister 111 temporarily from the suction device
101 in order to dispose of exudate build-up in the canister,
cleaning the housing 109, or to replace disposable components of
the suction unit such as the connection assembly 500 itself and
canister 111. The male connector 503 can be permanently bonded to
the housing 109 (e.g. with adhesive or ultrasonic welding) or
semi-permanently attached to the housing 109 (e.g. with plastic
screw threads). The ease of connecting and disconnecting the female
connector 501 from the housing ensures safety by allowing a
non-skilled user to interrupt the vacuum connection to the patient
if needed. This easily repeatable process to secure an airtight
seal between the male connector 503 and female connector 501 also
reduces the risk of air-leak related performance failures.
[0141] FIG. 2A illustrates the suction device 101 with the conduit
119, omitted, and FIG. 2B illustrates the suction device 101 of
FIG. 2A with a portion of the housing 109 removed to reveal
interior features. Referring to FIGS. 2A and 2B together, the
housing 109 is shaped and configured to encompass interior
components of the suction device 101, including a vacuum assembly
300, a connection assembly 500, and interior conduits connecting
components of the vacuum assembly 300 and connection assembly 500
for operation (conduits not shown for clarity).
[0142] The housing 109 forms an upper aperture 201 and a lower ring
203 (FIG. 2A) that are together configured to receive a canister
111 (FIGS. 1A and 1B) therein. The shape of the suction device 101
allows a large canister 111 to be used with the device. In some
embodiments, the canister 111 can be a container configured to
collect greater than 300 ml wound exudate for the treatment of
chronic wounds with high fluid output (e.g. 300 ml-800 ml). In
contrast, conventional portable/disposable NPWT systems are
typically volume-limited (e.g. 70-300 ml) and cannot treat highly
exuding wounds. The diameters of the upper aperture 201 and lower
ring 203 permits the use of standard, market available containers,
with both appropriate tubing connections and a smooth tapered form,
to be paired with the suction device 101. This could permit users
to employ the most available and/or cost-effective option from a
selection of containers, whereas conventional wound vacuum products
are typically designed to only work with custom or internal
collection containers, so customers have no choice in collection
container and may not be able to replace the container when it
becomes full. Additionally, as shown in FIG. 8, which illustrates
another embodiment of a suction device 800, the upper aperture 801
and lower ring 802 may contain securement pads 803, 805, 806 to
establish a friction fit between the canister 111 and housing 109.
In some embodiments the securement pads 803, 805, 806 are adhesive
foam pads or silicone pads. This enables a standard canister to be
held in place without the use of latches or other moving
mechanisms. This housing 109 shape and simple canister securement
mechanism described above additionally allows for the canister
contents to be easily seen from different positions during use,
which helps patients, doctors or caregivers notice and respond to
changes such as the color of the fluid or the rate of fluid
collection in the canister. The canister 111 may be secured in any
rotational position desired to facilitate treatment.
[0143] The housing 109 also forms a pair of ergonomic handles 205,
120 that allow a user to grip the suction device 101 during
operation with one or two hands. The shape of the housing 109
allows the suction device 101 to be carried comfortably by
caregivers or patient, or to be passed between people.
Additionally, the construction is both highly portable and very
stable when in use. In some embodiments, the housing 109 can have
an overall length along its longest axis of between about 7-14
inches, a height of between about 5-9 inches, and a width that
varies from about 1 inch (at the handle) to 7 inches (at the
canister) and 3 inches (at the electronics compartment 120).
Several aspects of the housing 109 can be configured for
portability, including handle dimensioning, handle tilt, and device
weight. With respect to handle dimensioning, a standardized handle
for typical hand sizes can be used. With respect to handle tilt, by
orienting the handle 205 on the device with an angle such as angle
122 shown in FIG. 1, in a range of 95 to 110 degrees, a user is
able to carry the device easily while ensuring that the suction
device remains upright. In some embodiments, the weight of the
device can be between about 1-10 lbs to ensure that a single person
can transport the device with ease. The weight range is based on
conservative, established limits for the intended user population.
For example, the general recommended limit for lifted weights by
Humanscale 4/5/6 is 22 lbs for women over 50 years of age. The
overall device volume can be small enough for easy transport, and
in some embodiments a carrying case can also be used.
[0144] In some embodiments, aspects of the housing 109 can be
configured specifically for improved stability. For example, a low
center of gravity and ballast at the base (provided by the canister
fluid) ensure bottom-heavy stability. The base surface of the
housing 109 can be provided with rubber feet, suction cups, or
other high-friction elements to increase grip between the lower
surface of the housing 109 and the base surface. In some
embodiments, the surface area of the lower surface of the housing
109 can be greater than the surface area of a top surface of the
housing 109, such that the housing tapers inwardly from the bottom
to the top, thereby providing a relatively wide base to improve
stability of the device when resting on a surface.
[0145] FIG. 2C illustrates a user interface 207 that is provided on
an upper surface of the housing 109 on the side opposite the handle
205. The user interface 207 can include one or more indicators 211
combined with symbols, markings or letters, for example, indicators
of battery level, device operation, error messages, etc. In some
embodiments, the indicators at the user interface 207 can be lights
(e.g., LEDs 214, 215, 216), foregoing the need for more complex and
expensive screen-based displays or touch-screen interfaces. The
user interface 207 can also include a power (on/off) button 217 and
a charging port 121, shown in FIG. 1B, for one or more standard
power inputs.
[0146] FIG. 2B shows the vacuum assembly 300 that provides the
source of negative pressure and is fluidically coupled to the
connection assembly 500 via internal conduits (not shown). FIGS. 1A
and 1B illustrate how the connection assembly 500, is in turn
coupled to the lid 113 via a conduit such as 119 to the vacuum port
117.
Selected Embodiments of Vacuum Assemblies
[0147] FIG. 3 is an enlarged view of the vacuum assembly 300 shown
in FIG. 2B. The vacuum assembly 300 provides the source of negative
pressure and includes a printed circuit board (PCB) 301 or other
substrate onto which various components can be mounted. A power
source 303 (e.g., a battery) is mounted to the PCB 301 and secured
in place via one or more clips 305. In some embodiments, the power
source 303 is a rechargeable lithium-ion or other suitable battery.
A charging adapter 307 is mounted to the PCB 301 and configured to
engage an electrical cable (not shown) that connects to the
charging port 121, shown in FIG. 1B, of the suction device 101 and
to the power source 303.
[0148] In at least some embodiments, the suction device 101 has low
power requirements and low current draw. For example, in some
embodiments the suction device 101 can run on less than 6V, less
than 5V, or less than 4V. This low power requirement can be
achieved by, among other things, eliminating the need for a
microcontroller with the pressure control circuitry 700, shown in
FIG. 7, using a low-power pump (such as a microdiaphragm pump), and
omitting a screen-based display interface in favor of a simplified
user interface 207. One benefit of this lower power need is that
the device can be powered by, for example, a 5V DC power source and
does not require constant AC wall power.
[0149] As shown in FIG. 3, a sensor 309 is mounted to the PCB 301
to detect the pressure. In some embodiments, the sensor includes an
atmospheric input connector 313 that is exposed to the ambient air
and a sensor input connector 315. This allows for the device to be
used at different elevations as the vacuum level prescribed for
therapy is relative to ambient. The connectors 313 and 315 can be
barbed connectors configured to receive tubing thereover. In other
embodiments, any other suitable connectors can be used. The ambient
connector 313 can be unconnected to any tubing, and open to the
ambient air within the housing 109. As described in more detail
below, the sensor input connector 315 can be connected to the valve
assembly 400 via a conduit (not shown) to detect the pressure
within the valve assembly 400. The sensor 309 can be in indirect
electrical communication with a pump 317 through electronic
components configured to cause the pump to be turned on and off in
response to sensor outputs. In use, the sensor input connector 315
is coupled to the valve assembly 400 as described in more detail
below. In at least some embodiments, the pressure sensed via the
sensor input connector 315 is translated into a voltage that scales
(e.g., linearly) with vacuum pressure within a predetermined range
(e.g., 0-250 mmHg, 50-180 mmHg). This voltage becomes an input to
pressure control circuitry 700 to determine whether it falls
outside of a predetermined threshold (e.g. target pressure of 80
mmHg, 125 mmHg or 180 mmHg with a tolerance of 5, 10, 15 or 20%)
and if the pump or other indicators should be activated or
inactivated.
[0150] Mounted on the PCB 301 may be electronic components
including the pressure control circuitry 700, which is shown in
FIG. 7. This circuitry may include comparators 705, 712, RC filters
702, 707, 711, a pump motor drive circuit or chip 706 and may not
include microcontrollers or microprocessors. The circuitry is not
controlled by on-device software of any kind. The first RC filter
702 filters the sensor 309 output. The output of the filter is
analyzed by a first comparator with hysteresis 705. The first RC
filter 702 may have a time constant of 0.05 to 0.5 milliseconds,
which serves to filter out any noise from being delivered to the
comparator and to also limit the pump maximum rate of state change
from on to off or from off to on. The output of the first
comparator with hysteresis is electrically connected to the pump
drive circuit 706 which is connected to the vacuum pump 317. The
output of the first comparator with hysteresis 705 is additionally
connected to a RC filter 707 which may have a time constant of 0.5
to 2 seconds. The output of this filter may be connected to LEDs
214, 215. The function of this RC filter 707 is to limit the
maximum rate of state change of the LEDs 214, 215 such that a
viewer is not confused and the LEDs do not appear to flicker. The
output of the first RC filter 702 is also connected to a third RC
filter 711 with a time constant of 0.5 to 2 milliseconds. The
output of this RC filter 711 is interpreted by a second comparator
with hysteresis 712. The function of the third RC filter 711 is to
additionally remove noise from the input to the second comparator
with hysteresis 712 and control the maximum rate of state change in
the output of the second comparator with hysteresis 712. The output
of this second comparator is electrically connected to a LED 216
and may be connected to other indicators 713 such as an audio
alarm, and/or additional LEDs. The detailed mechanisms of this
pressure control circuitry and how they interact with other
elements of the suction device 101 to control pressure for NPWT are
explained in greater detail along with the description of FIG. 6 in
a later section. The circuitry 700 serves to maintain system vacuum
pressure within a therapeutic range with an upper threshold (e.g. a
value between 130 and 150 mmHg) and lower threshold (e.g. a value
between 100 and 120 mmHg) by selectively actuating the pump 317 in
response to sensed vacuum pressure levels. In some embodiments,
fixed passive components like resistors and capacitors set the
upper and lower thresholds for vacuum pressure control in this
system. In other embodiments, these inputs may be variable, such as
a potentiometer used instead of a resistor, which would allow for
the device's upper and lower thresholds 601, 603 (as shown in FIG.
6) to be adjustable during manufacturing or by service technicians.
The selective actuation of the pump 317 is achieved without using
microcontrollers or microprocessors, which reduces the cost and
complexity of the system as compared to conventional systems that
rely on microprocessor-based pump control schemes.
[0151] The LEDs 214, 215, 216 of the user interface (UI) 207 are
driven by outputs of the pressure control circuitry 700. The
function of the RC filter 707 is to slow the state change rate
between LED 214 and LED 215 when the pressure sensed is near the
upper threshold value or lower threshold value. This avoids
flickering between the two states of LOW pressure and OK pressure
to not confuse an end user who may believe that the two states are
occurring simultaneously if the state change rate is too rapid. 0.5
to 2 Hz has been determined experimentally to be the ideal state
change rate for these UI elements. The LED 216 is driven by the
second comparator with hysteresis 712. Like the first comparator
705, this component can be configured with passive components like
resistors and capacitors to give a selective output when the vacuum
pressure is sensed to be greater than a particular value which may
be higher than the upper threshold. The output may be activating
the LED 216 to signal danger to a user and additionally activating
other indicators 713 which may be audio alarms or other LEDs.
[0152] In some embodiments, the PCB 301 also includes one or more
of the following sensors: a temperature sensor for the monitoring
of temperature of the air; a current sensor to monitor current
drawn by different parts of the system; a flow rate sensor to
monitor flow rate and detect any blockage issues in the pneumatic
system; a gyroscope to monitor orientation of the suction unit to
reduce the risk of tilt and potential fluid spillage; a global
positioning system (GSP) to monitor device location; a biosensor to
detect signs of infection in the fluid; or a humistor to detect
environmental humidity levels that may affect device performance.
Various other sensors can be incorporated onto the PCB 301 or
otherwise coupled to the vacuum assembly 300.
[0153] With continued reference to FIG. 3, the pump 317 is also
mounted to the PCB 301. The pump 317 includes a vacuum output
connector 321 and an exhaust connector 319. The connectors 319 and
321 can be barbed connectors configured to receive tubing
thereover. In other embodiments, any other suitable connectors can
be used. The exhaust connector 319 can be unconnected to any
tubing, and open to the ambient air within the housing 109 to vent
exhaust from the pump 317. As described in more detail below, the
vacuum output connector 321 can be coupled to the connector 437 of
the valve assembly 400 to provide negative pressure.
[0154] The pump 317 can be, for example, a microdiaphragm pump. In
at least some embodiments, a significant cost reduction is achieved
by selecting an inexpensive pump. This also reduces the power
requirement for the system. For example, in at least some
embodiments the pump 317 can run off less than 5V of power, for
example approximately 3.3V. In some embodiments, the pump 317 can
have a lower flow rate than conventional NPWT devices, which
typically operate in the range of 1.5-10 L/minute. In some
embodiments, the flow rate can be less than 1 L/minute, for example
approximately 0.7 L/minute. The low flow rate of the pump 317
allows for delivery of a specific vacuum pressure to the wound site
while using a simple control method with only analog electronic
components (which is also very low cost). Because each stroke of
the pump moves a small volume of air with respect to the total
system air volume, the system is not at risk of overshooting the
target pressure with a simple DC square wave bang-bang control.
This obviates the need for a solenoid valve or microprocessor to
correct the vacuum pressure because of the above-mentioned
resolution from a low flow rate pump and a large air reservoir
(provided via the canister 111). Such low-flow pumps have an
additional benefit over the higher flow pumps used in conventional
NPWT systems in that they are low cost, small, and lightweight. Use
of a lower flow rate pump may extend the user's wait time to
establish a therapeutic vacuum level when the system is being
initially depressurized, but once a therapeutic vacuum level is
established, the low flow rate pump does not affect therapy safety
or effectiveness. Current NPWT disposables are not able to use such
a simple control mechanism because their reservoirs are too small
(70-300 mL), so the system pressure must be monitored and
controlled more actively, e.g. by use of an electromechanical bleed
valve.
[0155] Various aspects of the present technology can allow for the
use of an inexpensive pump, which is a benefit in reducing device
production cost without compromising therapy quality or safety:
[0156] 1) Method of Pressure Control: As described above, the valve
system suggested when used in combination with the control
circuitry described in FIGS. 6 and 7, allows for the pump 317 to be
actuated selectively (i.e. turn on/off) to maintain negative
pressure within a predetermined threshold, rather than requiring
the pump 317 to run continuously. In at least some embodiments, a
pump with less efficiency (e.g., brush motor instead of brushless),
fixed speeds and lower duty cycle ratings or reduced longevity
(e.g. rated life, hours of continuous use) can be utilized in the
suction device 101, as compared to the pumps utilized in most
stand-alone devices. [0157] 2) Single Pressure Setting: Providing
negative pressure at a predefined, single-setting set point enables
the use of a pump 317 that is narrowly specified for most efficient
performance in the therapeutic range. Therefore, the device can
utilize a pump that is rated to a threshold just above the nominal
vacuum pressure level (e.g., in some embodiments for example, the
pump only has to achieve 125 mmHg+/-10% of vacuum, such that a pump
that is rated up to 180 mmHg vacuum is sufficient whereas a pump
rated up to 250 mmHg vacuum would be unnecessary). [0158] 3) Flow
Rate Requirements: Embodiments of the described NPWT technology do
not require high-flow rates to deliver the vacuum pressure required
for therapy. In fact, a low-flow rate allows high resolution in
delivery of a specific vacuum pressure to the wound site while
using a simple control method with only analog electronic
components (which is also very low cost). Therefore, the pump
provided in the system does not require a high-flow rate. [0159] 4)
The Pump Specifications: a) lower duty cycle requirements, b) lower
quality requirements, c) lower pressure rating requirements, d)
lower flow rate requirements each enable the use of an inexpensive
pump to be utilized in the NPWT suction device. In some
embodiments, the pump can be, for example, a microdiaphragm pump, a
pump technology that with specifications that meet the requirements
of the NPWT technology herein described, and a low cost, can
provide significant cost savings when utilized.
[0160] In currently-marketed NPWT devices, in combination with a
microprocessor or microcontroller, a solenoid valve may be actuated
to release vacuum pressure in a controlled manner in the instance
when the device determines the pressure is "too-high" or the
pressure setting is reduced (e.g., negative pressure set-point is
decreased and/or pressure cycle is intermittent or variable such
that the pressure is increases and decreasing on a cycle that needs
to be reliably controlled). Various aspects of the present
technology allow for the device, in some embodiments, to omit any
requirement for a solenoid valve to control pressure: [0161] 1)
Single Setting Pressure: The therapeutic vacuum level can be
predetermined, making user-controlled pressure settings a nonfactor
and eliminating the requirement for a solenoid valve to release
vacuum pressure for the purpose of adjusting the nominal vacuum
pressure to meet user inputs. [0162] 2) No intermittent or variable
pressure: In some embodiments, vacuum pressure is not increased or
decreased on a cycle, and is instead reliably controlled within a
threshold of the predefined therapeutic level, also omitting the
requirement for a solenoid valve to release vacuum pressure
accordingly. [0163] 3) Mechanical Release Valve: In the instance
when the pressure is "too-high," a passive (non-powered) mechanical
release valve can be used that opens in response to high vacuum
pressure in the system, replacing the need for a powered solenoid
valve.
[0164] As shown in FIG. 3, a valve assembly 400 is disposed
adjacent to the PCB 301 and is connected to the sensor 309 and pump
317 as described in more detail below. FIGS. 4A-4C are enlarged
detailed views of the valve assembly 400. In particular, FIGS.
4A-4C illustrate a perspective, cross-sectional, and perspective
exploded views, respectively, of the valve assembly 400 shown in
FIG. 3. Referring to FIGS. 3-4C together, the valve assembly 400 is
a mechanical relief valve that interfaces between the pump 317 and
the connection assembly 500 which supplies negative pressure to the
canister 111 and to the wound site 107 (FIG. 1B). Conventional NPWT
systems often use solenoid valves to regulate delivery of negative
pressure to the wound site. Solenoid valves are expensive and
require precise microcontroller actuation. In contrast, and as
noted above, embodiments of the present technology provide a
passive mechanical valve assembly 400 that is low-cost and may be
used with sensor 309 and electronic circuitry 700 on the PCB 301 to
maintain applied pressure in the therapeutic range. In at least
some embodiments, the valve assembly 400 combines the functions of
a check valve and an over-pressure release valve. The check valve
ensures that flow through the system occurs in only a single
direction, preventing exudate from ever flowing backwards into the
suction device 101. The over-pressure release valve is designed to
release pressure when it exceeds a predetermined value based on the
unique design. In some cases the over-pressure release valve will
release pressure when the pressure exceeds 150 mmHg or any other
pressure value greater than 150 mmHg. This also enables the device
to regulate pressure electrically, such that no initial or periodic
tuning by hand or mechanical monitoring by users is required to
maintain appropriate pressure for effective NPWT. In some
embodiments, no user intervention is required to maintain the
appropriate set-point pressure (e.g., physical adjustments and/or
tuning to the device). In some conventional NPWT devices, periodic
adjustments and manual user intervention, for example tuning a
pressure dial coupled with a bleed valve or alternatively,
software-enabled electromechanical controls to adjust pressure, are
required to ensure pressure is regulated. These design features
significantly reduce the complexity of the system and vastly
improves the ease of use.
[0165] The valve assembly 400 can include a generally cylindrical
body 401 with first and second end caps 403 and 405 disposed on
opposing sides. The end caps 403 and 405 can have cylindrical
portions 407 and 409 configured to receive portions of the body 401
therein. When the end caps 403 and 405 are fitted over the ends of
the cylindrical body 401, they together define an interior space
411. Within the interior space are disposed a first plunger
assembly 413 and a second plunger assembly 415. The first plunger
assembly 413 can include a first spring 417, a first plunger 419,
and a first O-ring 421. The second plunger assembly 415 can include
a second spring 423, a second plunger 425, and a second O-ring 427.
As described in more detail below, the first and second plunger
assemblies 413, 415 serve as moveable occluders, which can each
move between an "open" position in which air is permitted to pass
through a corresponding aperture and a "closed" position in which
air is inhibited from flowing through the aperture. Although some
embodiments disclosed herein use plunger assemblies as moveable
occluders, in other embodiments alternative structural arrangements
can be used, for example bellows, diaphragms, etc.
[0166] The body 401 and end caps 403 and 405 can include one or
more protruding connectors, each of which are configured to receive
a conduit (e.g., plastic tubing) thereon to provide fluidic
connection for air to flow from the interior space 411 through
interior lumens of the connectors. The connectors can be barbed
connectors configured to receive tubing thereover. In other
embodiments, any other suitable connector type can be used. The
first end cap 403 includes first and second ambient vent connectors
429 and 431. When the first plunger assembly 413 does not occlude
flow from the interior 411 through these ambient vent connectors
429 and 431, ambient air is permitted to pass through these
connectors 429 and 431.
[0167] The second end cap 405 includes a sensor output connector
433 and a vacuum output connector 435. The sensor output connector
433 is configured to be coupled via a conduit (e.g., plastic
tubing) to the sensor input connector 315 of the pressure sensor
309. The vacuum output connector 435 is configured to be coupled
via a conduit (e.g., plastic tubing) to the connection assembly 500
to deliver negative pressure to the wound site 107. When the second
plunger assembly 415 does not occlude flow from the interior 411 to
these connectors 433 and 435, negative pressure from the interior
411 is supplied to both to the pressure sensor 309 via the sensor
output connector 433, and to the connection assembly 500 via the
vacuum output connector 435.
[0168] The body 401 includes a vacuum input connector 437
configured to be fluidically coupled via a conduit (e.g., plastic
tubing) to the vacuum output connector 319 of the pump 317. In use,
negative pressure supplied by the pump 317 is delivered to the
interior 411 of the vacuum assembly 400 via the vacuum input
connector 437. The body 401 can further include an interior wall
439 that separates the interior 411 into first and second portions
441 and 443. The first portion 441 retains the first plunger
assembly 413 therein, and the second portion 443 retains the second
plunger assembly 415 therein. The wall 439 can include an opening
or aperture so that the first and second portions 441 and 443 are
in fluid communication with one another. In some embodiments, the
wall 439 provides a surface against which the springs 417 and 423
of the respective plunger assemblies 413 and 415 can press. The
first portion 441 can be smaller than the second portion 443, such
that the wall 439 is positioned off-center with respect to the body
401.
[0169] In at least some embodiments, the first and second plunger
assemblies 413 and 415 can be constructed from similar components.
For example, the first spring 417 and the second spring 423 can
have similar constructions, with similar or identical spring
constants (e.g., having a spring constant suitable to generate
forces needed to open or close the coupling to a conduit at a
clinically-relevant pressure for wound therapy), uncompressed sizes
(e.g., having an uncompressed length of between about 0.5 cm and
about 5 cm), material composition, etc. Similarly, the first and
second plungers 419 and 425 and the first and second O-rings 421
and 427 can be made of similar or identical materials with similar
or identical sizes and configurations. In operation, the first
O-ring 421 can engage with an outer surface of the first plunger
419, and the first spring 417 can be disposed adjacent to the first
plunger 419. The first spring 417 can be configured to exert an
outward force on the first plunger 419. In use, the first spring
417, with one end positioned against the wall 439, exerts an
outward force on the first plunger 419 such that the first plunger
419 and first O-ring 421 together abut against the first end cap
403. In this position, the first plunger 419 and first O-ring 421
occlude the flow of air between the interior 411 and the first and
second ambient vent connectors 429 and 431 of the first end cap
403.
[0170] Similarly, the second spring 423, positioned against the
wall 439, exerts an outward force on the second plunger 425 such
that the second plunger 425 and the second O-ring 427 together abut
against the second end cap 405. In this closed position, the second
plunger 425 and the second O-ring 427 occlude the flow of air
between the interior 411 and both the sensor output connector 433
and the vacuum output connector 435 of the second end cap 405.
[0171] In the absence of any applied negative pressure, the first
and second plunger assemblies 413 and 415 can remain in the closed
configurations (as illustrated in FIG. 4B), in which the interior
411 is not open to either the first or second ambient vent
connectors 429 and 431 of the first end cap 403, or to the sensor
output connector 433 or the vacuum output connector 435 of the
second end cap 405. As negative pressure is applied to the interior
411 via the vacuum input connector 437, the first and second
plungers 421 and 425 can be urged inwardly toward the wall 439, and
if sufficient negative pressure is applied, this inward urging of
the first and second plungers 421 and 425 can overcome the outward
force of the first and second springs 417 and 423. In at least some
embodiments, the first spring 417 exerts a greater outward force on
the first plunger 421 than force exerted by the second spring 423
on the second plunger 427. As a result, as negative pressure
increases above a certain threshold within the interior 411, the
inward urging of the second plunger 427 will overcome the outward
force of the second spring 423, however the inward urging of the
first plunger 421 will not be sufficient to overcome the outward
force of the first spring 417. In this configuration, the first
plunger assembly 413 remains in the closed configuration, while the
second plunger assembly 415 will be pulled into the open
configuration. This permits the interior 411 to be in fluid
communication with the sensor output connector 433 and the vacuum
output connector 435 of the second end cap 405. Negative pressure
is therefore delivered from the pump 317, through the valve
assembly 400, and out to both the connection assembly 500 (via the
vacuum output connector 435) and to the sensor 309 (via the sensor
output connector 433). As noted above, pressure detected at the
sensor 309 can be used to selectively actuate the pump 317, thereby
permitting the pump 317 to be run only when required to achieve the
desired pressure. In the presence of any positive pressure (e.g.,
urging air flow from the direction of the vacuum assembly 400
towards the connection assembly 500, rather than the reverse), both
the first and second plunger assemblies 413 and 415 will be urged
into the closed position. The thresholds of pressure required to
move either or both of the first and second plunger assemblies can
be modified by use of springs with greater or lesser spring
constants, or springs with greater or lesser length.
[0172] As negative pressure within the interior 411 increases, the
first plunger 421 can be urged inward with sufficient force to
overcome the outward force of the first spring 413, thereby causing
the first plunger assembly 413 to assume the open configuration. In
this configuration, the interior 411 is open to the first and
second ambient vent connectors 429 and 431, which will cause
ambient air to enter the interior 411 until the pressure has risen
to a level such that the first plunger assembly 413 returns to the
closed configuration. As a result, the first plunger assembly 413
can serve as an over pressure release valve, in which excess
negative pressure is relieved by opening the valve assembly 400 to
ambient air (via the first and second ambient vent connectors 429
and 431).
[0173] The pump 317, the position of the wall 439, the plunger
assemblies 413, and 415, and the sensor 309 can all be configured
to achieve a desired negative pressure delivered to the patient.
Advantageously, this therapeutic vacuum level range (e.g., in some
embodiments about 125 mmHg+/-10%) can be selected and controlled
during manufacturing and assembly, and does not require user input
or modification of the device to achieve the therapeutically
effective negative pressure. For example, this pressure range can
be controlled during manufacturing with simple changes in
components, component sizing and length, component material, choice
of connection point configuration, number of components used
(multiple springs), or addition of spacers or reducers. In at least
some embodiments, the user cannot modify the amount of negative
pressure supplied via the device 101. In some embodiments, the
vacuum assembly 400 allows the suction device 101 to supply
negative pressure only within a predetermined range. In some
embodiments, the pump 317, valve assembly 400, and sensor 309 are
all configured such that the negative pressure delivered to the
patient can be approximately -125 mmHg, plus or minus 10%. If the
pressure drops below this predetermined threshold (i.e., a higher
magnitude of negative pressure), the first plunger assembly 413
opens to vent ambient air, and if the pressure rises above this
predetermined threshold (i.e., a smaller magnitude of negative
pressure), the second plunger assembly 415 closes, the sensor 309
detects the change, and the pump 317 can be restarted.
[0174] As noted above, the first spring 417 can exert a greater
outward force than the second spring 423. In the illustrated
embodiment, this can be achieved by utilizing substantially
identical springs that have been compressed to different degrees
due to the off-center position of the wall 439. In other
embodiments, the differential outward force of the springs can be
achieved by using springs with different spring constants or other
constructions such that the first spring 417 exerts a greater
outward force than the second spring 423, irrespective of the
position of the wall 429. Additionally, in certain embodiments the
springs 417 and 423 can be replaced with other resilient members
(e.g., balloons, elastomeric members, bellows, etc.) configured to
exert an axially outward force on the plungers 419 and 425. FIG. 4E
illustrates the different conditions that may exist in the use of
the embodiment described above and how this embodiment responds to
the conditions. Conditions 1 and 2 listed in FIG. 4E may occur
simultaneously. Conditions 1 and 4 may also occur simultaneously.
Conditions 3 and 4 may also occur simultaneously. Conditions 2 and
3 may not occur simultaneously in the embodiment described by FIGS.
4B and 4C.
[0175] FIGS. 4F and 4G illustrate how the passive valve assembly
400 and plunger assemblies 413, 415 respond to changes in relative
pressure in the system. FIG. 4B illustrates the "fully closed"
state of the assembly 400, which is a combination of Conditions 3
and 4 (FIG. 4E) in which both plunger assemblies 413, 415 are in
the "closed" position. FIG. 4F illustrates the combination of
Condition 1 and 4 (FIG. 4E) wherein the plunger assembly 415 is in
the "open" position and plunger assembly 413 is in the "closed"
position. Configuration 470 of the shown in FIG. 4F is illustrated
with lines 472 and 471 showing how air can flow through the
assembly 400, from connectors 433 and 435 into connector 437 when
in this state. FIG. 4G illustrates the combination of Condition 1
and 2 (from FIG. 4E) wherein both plunger assemblies 413 and 415
are in the "open" positions. Configuration 473 shown in FIG. 4G is
illustrated with lines 474, 475, 476 and 477 representing how air
can flow through the assembly 400 from connectors 433, 435, 431 and
429 around the plunger assemblies in "open" positions and into
connector 437.
[0176] The valve assembly 400 can take a variety of others forms
while providing the functionality of a combined over-pressure
release valve and a check valve. For example, FIG. 4D illustrates
another embodiment of a valve assembly 450 that can serve as both
an over-pressure release valve and a check valve. The assembly 450
includes a first body 451 mated with a second body 453 to define an
interior chamber 455. The chamber 455 includes first barrel 457 and
second barrel 459 which house first and second moveable occluders
461 and 463, respectively. The moveable occluders can take the form
of plunger assemblies as described above (e.g., plungers coupled to
springs). In other embodiments, the moveable occluders can include
bellows, diaphragms, or other mechanisms to moveably occlude flow
through the respective barrels of the chamber 455. Each of the
moveable occluders 461, 463 is moveable between a "closed"
configuration in which air flow through its respective barrel is
blocked and an "open" configuration in which air flow through its
respective barrel is permitted. For example, with respect to the
first moveable occluder 461, the "closed" position can be achieved
when the occluding surface (e.g., the plunger at the end of the
spring) is in contact with a lower wall of the first barrel 457,
thereby occluding flow between the ambient vent connector 467 and
the first barrel 457. The "open" position can be achieved when the
occluding surface is separated from the lower wall of the first
barrel 457 (e.g., by compression of the spring to move the
occluding surface away from the lower wall of the first barrel
457). In this open configuration, the first barrel 457 is in fluid
communication with the ambient vent connector 467. Similarly, the
second moveable occluder 463 can be moved between a closed
configuration in which the second barrel 459 is not in fluid
communication with the vacuum output connector 469 and an open
configuration in which the second barrel 459 is in fluid
communication between the second barrel 459 and the vacuum output
connector 469. The moveable occluders 461 and 463 can be configured
such that they move from open to closed configurations under
different conditions, such as at different negative pressure
thresholds, as described in more detail below.
[0177] The chamber 455 is in fluid communication with three
connectors: a pump input connector 465, an ambient vent connector
467, and a vacuum output connector 469. In use, the pump input
connector 465 is coupled (e.g., via a conduit) to the pump 317
which supplies negative pressure. The ambient vent connector 467 is
open to the ambient air, and the vacuum output connector 469 is
coupled to the canister (e.g., via the connection assembly 500) and
can also be coupled to a sensor to provide feedback to the
pump.
[0178] During operation, negative pressure provided from the pump
through the pump input connector 465 is supplied to the chamber
455. The negative pressure within the chamber 455 exerts a
compressive force on each of the moveable occluders 461 and 463
which urges them towards their respective open positions. Each of
the first and second moveable occluders 461 and 463 can move from
the closed to open positions once the supplied negative pressure
exceeds a corresponding threshold. In some embodiments, the
threshold negative pressure to move the first moveable occluder 461
from the closed to the open state is higher than the corresponding
threshold negative pressure required to move the second moveable
occluder 463 from the closed state to the open state.
[0179] When the supplied negative pressure is less than the
threshold for either occluder 461 or 463 (or when there is no
negative pressure supplied at all), both moveable occluders 461 and
463 maintain the closed state, and there is no fluid communication
between the pump input connector 465 and either the ambient vent
connector 467 or the vacuum output connector 469. When the negative
pressure supplied is greater than the threshold of the second
moveable occluder 463, but lower than the threshold of the first
moveable occluder 461, the second moveable occluder 463 maintains
the open state while the first moveable occluder 461 maintains the
closed state. In this configuration, negative pressure is supplied
to the chamber 455 and, via the vacuum output connector 469, to the
canister and/or the sensor. If the negative pressure rises to meet
or exceed the threshold of the first moveable occluder 461, then
the first moveable occluder 461 also moves into the open state. In
this state, ambient air is in fluid communication with the chamber
455 via the ambient vent connector 467, and the pressure will in
the chamber 455 will rise (i.e., the magnitude of negative pressure
will decrease). This provides an over-pressure release function, in
which excess negative pressure is "vented" to maintain the negative
pressure supplied to the canister within a desired range.
Selected Embodiments of Vacuum Connection Assemblies
[0180] FIGS. 5A-5C are enlarged perspective, exploded perspective,
and cross-sectional views, respectively, of the connection assembly
500. As noted above, most conventional wound vacuum products are
designed to only work with custom or internal collection
containers, so customers have no choice in collection container and
may not be able to replace the container when it becomes full.
Embodiments of the present technology can allow users to provide
their own collection containers for use with the suction device 101
by virtue of the connection assembly 500. The connection assembly
500 enables connection to a generic canister while protecting the
suction device 101 from contamination, thereby ensuring patient
safety. This also allows for the use of reusable canisters in
therapy which reduces medical waste. Particularly in
resource-constrained settings such as the developing world, there
is great desire to reuse medical equipment wherever possible. The
connection assembly 500 allows this to be achieved while
maintaining patient and equipment safety. In at least some
embodiments, the suction device 101 can be provided with no
container, which allows customers to provide a container that has
been sterilized or cleaned at the treatment site or elsewhere and
possibly used multiple times. In some embodiments, the container
need not be sterile at all if the device is sufficiently protected
by the connection assembly, particularly with use of a filter as
described in more detail below.
[0181] The connection assembly 500 can include a female connector
501 that releasably engages a male connector 503. A filter 505 and
O-ring 507 can be configured to be received at the junction between
the female connector 501 and the male connector 503. In some
embodiments, the male connector 503 is configured to be received
permanently or semi-permanently within an aperture in the housing
(shown as 807 in FIG. 8) such that an upper portion 509 of the male
connector 503 protrudes above an upper surface of the housing 109,
while the lower portion 511 is positioned within an interior of the
housing 109. The upper portion 509 of the male connector 503 can
include an engagement member 513 which protrudes radially outwardly
from the upper portion 509 and provides a surface against which the
female connector 501 can engage, as described in more detail below.
The engagement member 513 can be a ring or other shape that permits
the female connector 501 to removably engage with the male
connector 503.
[0182] The lower portion 511 of the male connector 503 can include
a downwardly projecting connector 515. In some embodiments, the
first lumen 517 extends through the male connector 503 between a
first opening 519 on an upper surface 521 of the male connector
503, and a second opening 523 at the end of the connector 515. The
connector 515 can be configured to removably engage with a conduit
(e.g., plastic tubing), which connects the connection assembly 500
to the vacuum output connector 435 of the valve assembly 400. The
intervening conduit (not shown) can extend within the housing 109
between the two connectors.
[0183] The female connector 501 can include a receptacle 527
configured to receive a filter 505 and O-ring 507 therein, which
allow for the protection of the device from odors or vapors and
sealing of the system from ambient leaks. In some embodiments, the
receptacle 527 can define a substantially cylindrical opening,
though other shapes may be employed in other embodiments. The
female connector 501 can additionally include an upwardly extending
connector 529. A second lumen 531 extends between a third opening
532 on an interior surface of the receptacle 527 and a fourth
opening 533 at the end of the connector 529. The connector 529 is
configured to be removably engaged with a conduit (e.g., plastic
tubing), which connects the connection assembly 500 to the vacuum
port 117 of the lid 113 (FIGS. 1A and 1B).
[0184] The female connector 501 can also include a bridge 535 that
extends laterally away from the connector 529 in opposing
directions, terminating in a first end 537 and a second end 539. At
the first end 537, a first wing 541 extends upwardly and a first
barb 543 extends downwardly. The first wing 541 and the first barb
543 can be continuous such that manually deflecting the wing 541
inwardly (i.e., towards the connector 529) causes the first barb
543 to deflect outwardly. Similarly, at the second end 539 of the
bridge 535, a second wing 545 extends upwardly and a second barb
547 extends downwardly. The barbs 543 and 547 include respective
angled protrusions 549 and 551 that project inwardly from the lower
ends of the respective barbs 543 and 547. These angled surfaces of
these protrusions 549 and 551 are configured such that when the
female connector 501 is lowered onto the male connector 503, the
angled surfaces of the protrusions 549 and 551 contact the
engagement member 513 of the male connector 503. As the female
connector 501 is lowered further with respect to the male connector
503, the protrusions 549 and 551 are deflected outwardly to permit
the protrusions 549 and 551 to be lowered beneath the engagement
member 513, at which point the protrusions 549 and 551 move again
inwardly beneath the engagement member 513 to lock the female
connector 501 in place with respect to the male connector 503. To
release the female connector 501 from the male connector 503, one
or both of the wings 541 and 545 can be deflected inwardly (e.g.,
by manually pinching the wings 541 and 545 together toward the
connector 529), thereby causing the barbs 543 and 547 to be
deflected radially outwardly until the protrusions 549 and 551 are
disengaged from the engagement member 513 of the male connector
503. The female connector 501 can then be lifted and separated from
the male connector 503.
[0185] As noted above, the filter 505 is configured to be received
within the receptacle 527 of the female connector 501. In some
embodiments, the filter 505 can be an anti-bacterial filter made of
foam or other suitable material. The filter 505 can include an
upper portion 553 configured to abut against the third opening 532
on the interior of the receptacle 527, and a lower portion 555
configured to be inserted at least partially into the first opening
519 in the male connector 503. In some embodiments, the upper
portion 553 be a disc-like member having a diameter substantially
corresponding to that of the receptacle 527. The upper portion 553
of the filter 505 can be sized and configured to cover the third
opening 532 on the interior surface of the receptacle 527, such
that fluid and air flowing through the third opening 532 passes
through the filter 505. The lower portion 555 of the filter 505 can
have a smaller outer diameter than the upper portion 553,
corresponding substantially to the diameter of the lumen 517 of the
male connector 503. The O-ring 507 can be positioned to surround
the lower portion 555 of the filter 505. When the O-ring 507 is in
this position and the filter 505 is compressed between the female
connector 501 and male connector 503, the O-ring can ensure a
substantially air-tight seal between the filter 505 and the upper
portion 509 of the male connector 503. The O-ring 507 may
alternatively be held by the male connector 503 in one of the
grooves in portion 509 over which the female connector will slide
to create a substantially air-tight seal.
[0186] In some embodiments, the filter 505 can have a pore size of
approximately 0.22 micron, approximately 0.45 micron, approximately
0.8 micron, or approximately 1.2 micron. Furthermore, in some
embodiments an additional hydrophobic layer or coating made of
polypropylene (e.g., pore size of 0.2 or 0.45 micron) or PTFE
(e.g., with a pore size of 0.2 or 0.45 micron) can be added to
ensure that no fluids enter the suction device 101 through the
connection assembly 500. In some embodiments, the filter 505 can be
a two-part or multi-part construction, with a thinner filter (e.g.,
approximately 0.1 mm) membrane supported mechanically by the use of
a rigid felt filter and/or other structural support.
[0187] When the female connector 501 is engaged with the male
connector 503, a fluidic connection is established across the
connection assembly 500. With negative pressure applied (e.g., from
the valve assembly 400 to the second opening 523 at the bottom of
the connector 515) air can flow from the fourth opening 533, down
through the lumen 531 of the female connector 501, through the
filter 505, through the lumen 517 of the male connector 503, and
through an intervening conduit (not shown) to the valve assembly
400. As all air from the patient and canister passes through the
filter 505, contaminants can be removed, and the device can be
maintained in a clean and sterile manner.
[0188] The female connector 501 can be easily removed for cleaning
and to replace the filter 505 and/or the O-ring 507 as needed. In
some embodiments, the female connector 501 and/or the male
connector 503 can be made from durable materials to enable reuse
after sterilization. For example, in some embodiments the female
connector 501 and/or the male connector 503 can be made of plastic,
metal, ceramics or composites or other materials useful for
mechanical flexures (can deform elastically in the range needed).
The connection assembly 500 disclosed herein provides for a
reusable filter connection that can be used with a variety of
canister options. Since the connection assembly 500 can connect to
a standard tube (via connector 529), the connection assembly 500
(and therefore the suction device 101) can be connected to any
rigid port of a generic suction container. The filter disposed
within the female connector 501 provides a safety barrier to
protect the suction device 101 from contaminants associated with a
user-supplied container such as bacterial, viral or fungal
pathogens transmitted through air or liquid, or residue on the
canister from other use or incomplete cleaning and
sterilization.
Selected Embodiments of NPWT Methods
[0189] The present technology includes a method comprising
selectively actuating a vacuum pump with a square wave in response
to analog electronic signals from a sensor to maintain vacuum
pressure to be within a therapeutic range for NPWT. The method
additionally comprises holding vacuum pressure in the therapeutic
range by use of a passive valve assembly such as 400 and limiting
the maximum vacuum pressure supplied by the device by use of the
same passive valve assembly 400. The method additionally comprises
turning indicators on and off within a user interface 207.
[0190] The method can be used to operate a device that is similar
to the suction device 101 described above. For example, in some
embodiments the suction device can include a vacuum connection
assembly 500 configured to be fluidically coupled to the canister
111, a pump 317 configured to supply negative pressure to the
vacuum connection assembly 500, and a passive valve assembly 400 in
fluid communication with the pump 317 and the vacuum connection
assembly 500. The passive valve assembly 400 can be configured to
maintain the pump 317 in fluid communication with the vacuum
connection assembly 500 within a predefined pressure range, and to
passively inhibit fluid communication between the pump and the
vacuum connection outside of the predefined pressure range.
[0191] FIG. 6 illustrates how in some embodiments, the pressure
control circuitry 700 may produce a square wave 605, for example,
of DC voltage, that turns the pump 317 on and off according to
changing vacuum pressure levels 604 in the system. When the device
is powered on, the pump is turned on to increase the vacuum
pressure inside the device if the device pneumatic system is at
ambient pressure. The pump activation during phase 606 causes the
vacuum pressure in the system indicated as line 604 to increase
from ambient. When the vacuum pressure level reaches the upper
threshold 601, which is slightly greater than the specific
therapeutic vacuum level prescribed for therapy 602, the pump will
turn off 607. The pump will rest until the vacuum pressure level
604 gradually falls (due to leaks in the device or wound dressing)
to the point of the lower threshold 603, at which point the pump
will turn back on 608. This method is presented in graphs 600 and
605 wherein the x axes 611 and 612 represent time and share the
same scale. The y axis 613 represents vacuum pressure and the y
axis 610 represents voltage supplied to a pump. Through this simple
control method with hysteresis, the system pressure is maintained
within a range that averages to the nominal pressure for therapy if
the range is centered on the nominal pressure for therapy 602. A
benefit of this method is that the pump is turned on and off less
often, which reduces the wearing of a brush motor, and disturbs the
patient fewer times per hour or day. The larger the range above 601
and below 603 the nominal pressure 602, the less often the pump is
turned on during therapy, though the pump will run longer each time
it is turned on. The differences between the upper and lower
thresholds and the nominal pressure may be between 2.5% and
10%.
[0192] In some embodiments, the electronic system described is
coupled to the passive valve assembly, in which case the valve can
serve both as a check valve and over pressure relief valve. In this
case, the vacuum pressure required to open the check valve side
should be well below the lower threshold for therapy 603 and the
vacuum pressure required to open the pressure relief valve side
should be above the upper threshold for therapy 601 and may be well
above that threshold, such as 614. The check valve function serves
to slow the rate of decay of vacuum pressure in the system,
allowing the pump to rest longer as in 607. The passive valve
assembly serves an additional safety function when used with the
pressure control circuitry 700, sensor 309 and pump 317. A benefit
of the pressure control circuitry described is that only one sensor
is required for pressure control in the system, which lowers device
cost and weight. However, the single sensor 309 could experience a
component level failure that could cause the pump to run without
control, raising system vacuum pressures to a level that could
cause damage to the patient's coupled wound. If the vacuum pressure
level required to open the ambient vent of the valve is set below
the threshold at which wound damage can occur (for example, 150-200
mmHg), the device will be failsafe to electrical failures in the
sensor or other electronic components of the circuitry 700 or pump
317.
[0193] In some embodiments, the pressure control circuitry 700
described is coupled to the user interface 207 described in FIG.
2C. The circuitry can be configured such that an LED 214 marked
"LOW", or otherwise marked to indicate that vacuum pressure is
lower than specified for therapy (e.g. with symbols, minus sign,
markings, shapes, letters, and/or icons), is illuminated when the
vacuum level is rising and the pump is on as in phase 606, until
the rising threshold is met. Additionally, the circuitry can cause
an LED 215 marked "OK", or otherwise marked to indicate that vacuum
pressure in the device is appropriate for therapy (e.g. with
symbols, markings, shapes, letters, and/or icons), to be
illuminated when the vacuum level is falling, until the falling
threshold 603 is met. Further, the circuitry can be configured such
that only one of these two LEDs is illuminated at one time and the
maximum rate of state change between them can be between 0.5 and 2
Hz. Additionally, the pressure control circuitry 700 can be
configured such that the LED 216 marked HIGH is illuminated if the
vacuum pressure in the system exceeds the upper threshold limit 601
or a limit higher than that threshold, such as 614, for example in
case of a pump malfunction. The benefit of such an indication
method is that an unskilled user can quickly determine the state of
the system without requiring prior knowledge of NPWT. Additionally,
this method does not allow for user configuration, so therapy is
ensured to be provided in the range prescribed for the patient's
wound. Finally, this user interface method does not require screens
or LCD displays, which would increase complexity, weight, and cost
of a device.
[0194] In some embodiments, activating the suction device can
require only simple on/off activation to start the pressure sensing
and square wave generation, without any need for tuning the
supplied pressure or selecting from among a variety of input
options. This simple on/off activation improves ease-of-use and
lowers the barriers to treatment for patients in
resource-constrained environments.
Examples
[0195] As an example of the present technology used in medical
practice, NPWT devices were fabricated that utilize the
above-described pump 317 with PCB 301, pressure control circuitry
700 and pressure control scheme outlined in FIG. 6. The device was
configured to provide -125 mmHg+/-10% via microdiaphragm pump with
flow rate 0.7 liters/min with the pressure control circuitry 700
above described. Fourteen patients with various open wound types
indicated for NPWT were treated with these devices. Patients
treated with the devices benefitted from reduction in wound volume
from median 47.25 cm.sup.3 to median 9.75 cm.sup.3 (p=0.01).
Granulation tissue surface area increased from median 7.63 cm.sup.2
to median 28.73 cm.sup.2 (p=0.003). Granulation tissue formation is
a known benefit of NPWT. Open wound surface area decreased from
median 48.33 cm.sup.2 to median 33.6 cm.sup.2 (p=0.01). Wound
surface area reduction is another benefit of NPWT.
As an additional example of the embodiment in practice, when the
female connector 501 and male connector 503 were used in a NPWT
device prototype as the vacuum connection assembly 500 with a
conduit 119 to a canister 111, usability study data collected
suggest that the design was usable and allowed for unskilled users
to make pneumatic connections as part of NPWT application and
monitoring. After a short product briefing, 14 of 14 representative
lay person users were able to attach and remove the female
connector from the male connector as part of changing a waste
canister without assistance. The users were also 100% successful in
inserting and connecting a new waste canister with the female
connector 501 coupled via conduit such as 119.
CONCLUSION
[0196] Although many of the embodiments are described above with
respect to systems, devices, and methods for negative pressure
wound therapy, the technology is applicable to other applications
and/or other approaches. Moreover, other embodiments in addition to
those described herein are within the scope of the technology.
Additionally, several other embodiments of the technology can have
different configurations, components, or procedures than those
described herein. A person of ordinary skill in the art, therefore,
will accordingly understand that the technology can have other
embodiments with additional elements, or the technology can have
other embodiments without several of the features shown and
described above with reference to FIGS. 1A-8.
[0197] The above detailed descriptions of embodiments of the
technology are not intended to be exhaustive or to limit the
technology to the precise form disclosed above. Where the context
permits, singular or plural terms may also include the plural or
singular term, respectively. Although specific embodiments of, and
examples for, the technology are described above for illustrative
purposes, various equivalent modifications are possible within the
scope of the technology, as those skilled in the relevant art will
recognize. For example, while steps are presented in a given order,
alternative embodiments may perform steps in a different order. The
various embodiments described herein may also be combined to
provide further embodiments.
[0198] Moreover, unless the word "or" is expressly limited to mean
only a single item exclusive from the other items in reference to a
list of two or more items, then the use of "or" in such a list is
to be interpreted as including (a) any single item in the list, (b)
all of the items in the list, or (c) any combination of the items
in the list. Additionally, the term "comprising" is used throughout
to mean including at least the recited feature(s) such that any
greater number of the same feature and/or additional types of other
features are not precluded. It will also be appreciated that
specific embodiments have been described herein for purposes of
illustration, but that various modifications may be made without
deviating from the technology. Further, while advantages associated
with certain embodiments of the technology have been described in
the context of those embodiments, other embodiments may also
exhibit such advantages, and not all embodiments need necessarily
exhibit such advantages to fall within the scope of the technology.
Accordingly, the disclosure and associated technology can encompass
other embodiments not expressly shown or described herein.
* * * * *