Patent Application
20200323695
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
Clause 1. A negative pressure wound therapy system comprising:
a wound dressing; and
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:
a vacuum connection configured to be coupled to a second conduit;
a vacuum pump configured to supply negative pressure;
an electronic pressure sensor in electrical communication with the vacuum pump; and
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.
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.
Clause 3. The system of any one of the preceding Clauses, wherein the passive valve assembly comprises:
an interior configured to receive negative pressure from the vacuum pump;
an ambient vent outlet;
a vacuum outlet;
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
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.
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.
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.
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.
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.
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.
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.
Clause 10. The system of any one of the preceding Clauses, wherein the first plunger assembly is more compressed than the second plunger assembly.
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.
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.
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.
Clause 14. The system of any one of the preceding Clauses, wherein the vacuum connection comprises:
a male connector secured to the suction device;
a female connector removably coupleable to the male connector; and
a filter disposed between the female connector and the male connector.
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.
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.
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.
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.
Clause 19. The system of any one of the preceding Clauses, wherein the female connector comprises a receptacle configured to receive the filter therein.
Clause 20. The system of any one of the preceding Clauses, wherein the female connector is sterilizable and reusable.
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.
Clause 22. The system of any one of the preceding Clauses, wherein the predefined pressure is −125 mmHg.
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.
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.
Clause 25. The system of any one of the preceding Clauses, wherein the system does not include a microprocessor or microcontroller.
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.
Clause 27. The system of any one of the preceding Clauses, wherein the vacuum pump comprises a microdiaphragm pump.
Clause 28. 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.
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.
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.
Clause 31. The device of any one of the preceding Clauses, wherein the passive valve assembly comprises:
an interior configured to receive negative pressure from the vacuum pump;
an ambient vent outlet;
a vacuum outlet;
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
a second moveable occluder configured to close and open the vacuum outlet.
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.
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.
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.
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.
Clause 36. The device of any one of the preceding Clauses, wherein the vacuum connection comprises:
a male connector secured to the suction device;
a female connector removably coupleable to the male connector; and
a filter disposed between the female connector and the male connector.
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.
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.
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.
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.
Clause 41. The device of any one of the preceding Clauses, wherein the female connector comprises a receptacle configured to receive the filter therein.
Clause 42. The device of any one of the preceding Clauses, wherein the female connector is sterilizable and reusable.
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.
Clause 44. The device of any one of the preceding Clauses, wherein the predefined pressure range includes −125 mmHg.
Clause 45. The device of any one of the preceding Clauses, wherein the device does not include a microprocessor or microcontroller.
Clause 46. The device of any one of the preceding Clauses, wherein the predefined pressure range is not adjustable by a user.
Clause 47. The device of any one of the preceding Clauses, wherein the pump comprises a microdiaphragm pump.
Clause 48. A method of applying negative pressure wound therapy, the method comprising:
(a) disposing a wound dressing over a wound site on a patient;
(b) fluidically coupling the wound dressing to a canister;
(c) fluidically coupling the canister to a suction device, thereby establishing a fluidic pathway;
(d) supplying power to the suction device;
(e) determining pressure in the fluidic pathway using a pressure sensor;
(f) comparing the pressure to an upper threshold and a lower threshold;
(g) powering on a pump of the suction device until the pressure meets the upper threshold;
(h) after (g), powering off the pump until the pressure falls to the lower threshold;
(i) repeating steps (e)-(h) to maintain pressure in the fluidic pathway between the upper threshold and the lower threshold; and
(j) terminating therapy by removing power to the suction device and relieving pressure in the fluidic pathway.
Clause 49. The method of any one of the preceding Clauses, further comprising:
(k) fluidically connecting the pressure sensor to a passive valve assembly, wherein the passive valve assembly comprises:
an interior configured to receive negative pressure from the pump;
an ambient vent outlet;
a vacuum outlet;
a sensor outlet;
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
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;
(l) limiting the maximum vacuum pressure in the fluidic pathway with the passive valve assembly; and
(m) preventing backflow in the fluidic pathway.
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.
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.
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.
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.
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.
Clause 55. The method of any one of the preceding Clauses, wherein the upper and lower thresholds are not configurable by a user.
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.
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.
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.
As described in more detail below with respect to
The housing 109 forms an upper aperture 201 and a lower ring 203 (
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
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.
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
As shown in
Mounted on the PCB 301 may be electronic components including the pressure control circuitry 700, which is shown in
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.
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.
With continued reference to
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.
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:
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:
As shown in
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.
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.
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.
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.
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.
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.
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
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).
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.
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.
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,
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.
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.
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.
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
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.
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 (
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.
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.
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.
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.
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.
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.
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.
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.
In some embodiments, the pressure control circuitry 700 described is coupled to the user interface 207 described in
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.
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
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.
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
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.
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.
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.
| Number | Date | Country | |
|---|---|---|---|
| 62629185 | Feb 2018 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16272980 | Feb 2019 | US |
| Child | 16814715 | US |
