Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
  • A61M1/91—Suction aspects of the dressing
  • A61M1/912—Connectors between dressing and drainage tube
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
  • A61M1/96—Suction control thereof
  • A61M1/962—Suction control thereof having pumping means on the suction site, e.g. miniature pump on dressing or dressing capable of exerting suction
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
  • A61M1/96—Suction control thereof
  • A61M1/964—Suction control thereof having venting means on or near the dressing
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
  • A61M1/96—Suction control thereof
  • A61M1/966—Suction control thereof having a pressure sensor on or near the dressing
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/33—Controlling, regulating or measuring
  • A61M2205/3331—Pressure; Flow
  • A61M2205/3358—Measuring barometric pressure, e.g. for compensation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
  • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/82—Internal energy supply devices
  • A61M2205/8237—Charging means
  • A61M2205/8243—Charging means by induction

Definitions

• the invention set forth in the appended claims relates generally to tissue treatment systems and more particularly, but without limitation, to encapsulated negative pressure and wound pressure sensing devices.
• Negative-pressure therapy may provide a number of benefits, including migration of epithelial and subcutaneous tissues, improved blood flow, and micro-deformation of tissue at a wound site. Together, these benefits can increase development of granulation tissue and reduce healing times.
• a system for treating a tissue site with negative pressure can include a dressing, an electric circuit, a cover, an encapsulant, a negative pressure source, and a tube.
• the dressing can be configured to be disposed at a tissue site.
• the electric circuit can include a power source and at least one sensor.
• the cover can include at least one cavity and a negative pressure port.
• the at least one cavity can be configured to create a sealed enclosure around the at least one sensor.
• the encapsulant can surround the cover and at least a portion of the electric circuit.
• the tube can be configured to be fluidly coupled to the negative pressure port and to communicate negative pressure between the negative pressure source and the dressing.
• the cover can further include a negative pressure cavity in fluid communication with the negative pressure port.
• the negative pressure cavity can be configured to be positioned in fluid communication with the dressing.
• the cover can further include a sensing cavity configured to be fluidly isolated from the negative pressure cavity. The sensing cavity can be configured to create the sealed enclosure around the at least one sensor.
• the at least one sensor can be a pressure sensor.
• the electric circuit can include a printed circuit board.
• the cover can be configured to create the sealed enclosure relative to the printed circuit board.
• the printed circuit board can include a rigid material and the encapsulant can include a flexible material.
• the printed circuit board can be formed of a material that is more rigid than the encapsulant.
• the at least one cavity can be a negative pressure cavity.
• the negative pressure cavity can be configured to create the sealed enclosure around the at least one sensor.
• the negative pressure cavity can be in fluid communication with the negative pressure port and can be configured to be positioned in fluid communication with the dressing.
• the electric circuit can include the negative pressure source.
• the at least one sensor can include a negative pressure sensor and an ambient pressure sensor.
• the cover can be configured to create the sealed enclosure around the negative pressure source and the negative pressure sensor.
• the sealed enclosure can be a first sealed enclosure.
• the cover can be configured to create a second sealed enclosure configured to enclose the ambient pressure sensor separate from the first sealed enclosure.
• the cover can include a first exhaust aperture and a first ambient pressure sensor aperture.
• the first exhaust aperture can be configured to provide a path for exhaust from the negative pressure source to escape through the cover.
• the first ambient pressure sensor aperture can be configured to provide a path from the ambient pressure sensor to an ambient environment surrounding the system.
• the encapsulant can include a second exhaust aperture and a second ambient pressure sensor aperture.
• the second exhaust aperture can be configured to provide a path for exhaust from the negative pressure source to escape through the first exhaust aperture and the encapsulant.
• the second ambient pressure sensor aperture can be configured to provide a path from the ambient pressure sensor through the first ambient pressure sensor aperture to the ambient environment surrounding the system.
• the system can further include a first filter, a second filter, a membrane, and an ambient environment pathway.
• the first filter can be configured to couple with the second exhaust aperture.
• the second filter can be configured to couple with the second ambient pressure sensor aperture.
• the encapsulant can include an ambient pressure sensor aperture and a first exhaust aperture.
• the ambient pressure sensor aperture can be configured to provide a path from the ambient pressure sensor to an ambient environment surrounding the system.
• the first exhaust aperture can be configured to align with a second exhaust aperture of the cover.
• the first exhaust aperture and the second exhaust aperture can be configured to provide a path for exhaust from the negative pressure source to reach the ambient environment surrounding the system.
• the system can further include a power button configured to actuate the negative pressure source.
• the port button can be embedded within the encapsulant and the encapsulant can be configured to allow a user to depress the power button.
• the encapsulant can include a power source aperture configured to expose the power source to an ambient environment surrounding the system.
• the at least one sensor can include an ambient pressure sensor disposed proximate to the power source. The ambient pressure sensor and the power source can both be exposed to the ambient environment surrounding the system through the power source aperture.
• the power source can be coupled to a wireless charging device configured to charge the power source through the encapsulant.
• the at least one cavity can include a negative pressure cavity and a sensing cavity isolated from the negative pressure cavity.
• the at least one sensor can include a negative pressure sensor and an ambient pressure sensor.
• the negative pressure cavity can be configured to create a first sealed enclosure around the negative pressure sensor and the sensing cavity can be configured to create a second sealed enclosure around the ambient pressure sensor.
• the first sealed enclosure can be fluidly isolated from the second sealed enclosure.
• the negative pressure cavity can be in fluid communication with the negative pressure port and can be configured to be positioned in fluid communication with the dressing.
• the at least one sensor can include a negative pressure sensor and an ambient pressure sensor.
• the at least one cavity of the cover can include a sensing cavity fluidly isolated from a negative pressure cavity.
• the sensing cavity can be configured to create the sealed enclosure around the negative pressure sensor.
• the sensing cavity and the sealed enclosure can be fluidly isolated from the ambient pressure sensor.
• the negative pressure cavity can be in fluid communication with the negative pressure port.
• the cover can further include a sensing aperture and a negative pressure opening.
• the sensing aperture can be configured to expose the sensing cavity and the negative pressure sensor to the dressing.
• the negative pressure opening can be configured to provide a path from the negative pressure cavity to the dressing.
• the encapsulant can include an opening configured to couple the sensing aperture and the negative pressure opening to the dressing.
• the electric circuit further includes at least one indicator.
• the at least one indicator can be configured to indicate a status of the system.
• the encapsulant is substantially transparent.
• the encapsulant is substantially opaque.
• the method can include providing a printed circuit board including electronic components, coupling a cover around at least one electronic component, and encapsulating the printed circuit board and the cover in an encapsulant.
• the cover can be configured to provide a fluid seal around the at least one electronic component.
• the method can further include drilling at least one hole through the encapsulant and the cover to provide a fluid path from the at least one electronic component to an exterior of the device.
• Figure 1 is a block diagram of an example embodiment of a therapy system that can provide negative-pressure treatment in accordance with this specification
• Figure 2A is an exploded view of an example negative pressure device suitable for use with the therapy system of Figure 1 ;
• Figure 2B is a perspective view of the negative pressure device of Figure 2A;
• Figure 2D is a perspective view of a cover of the negative pressure device of Figure 2A;
• Figure 2E is a cross-sectional view of the cover of Figure 2D taken along the line 2E- 2E depicted in Figure 2D;
• Figure 2F is a perspective view of a bottom surface of the cover of Figure 2D;
• Figure 3A is a top view of another embodiment of a negative pressure device including a power button that may be associated with an example embodiment of the therapy system of Figure 1;
• Figure 3B is a perspective view of the negative pressure device of Figure 3 A;
• Figure 3C is a perspective view of a cover of the negative pressure device of Figure 3A;
• Figure 3D is a perspective view of a bottom surface of the cover of Figure 3C;
• Figure 3E is a cross-sectional view of the cover of Figure 3C taken along the line 3E- 3E depicted in Figure 3C;
• Figure 4A is a top view of another embodiment of a negative pressure device with a power button that may be associated with an example embodiment of the therapy system of Figure 1;
• Figure 4B is a side view of the negative pressure device of Figure 4A taken at line 4B-4B depicted in Figure 4A;
• Figure 5A is a top view of another embodiment of a negative pressure device with an exposed ambient pressure sensor that may be associated with an example embodiment of the therapy system of Figure 1;
• Figure 5B is a perspective view of the negative pressure device of Figure 5 A;
• Figure 6 is a perspective view of another embodiment of a negative pressure device with an exposed power source that may be associated with an example embodiment of the therapy system of Figure 1;
• Figure 7 is a perspective view of another embodiment of a negative pressure device with an exposed power source and ambient pressure sensor that may be associated with an example embodiment of the therapy system of Figure 1;
• Figure 8 is a perspective view of another embodiment of a negative pressure device with a charging coil that may be associated with an example embodiment of the therapy system of Figure 1;
• Figure 9A is an exploded view of another example negative pressure device that may be associated with an example embodiment of the therapy system of Figure 1;
• Figure 9B is an exploded view of the negative pressure device of Figure 9A surrounded by an encapsulant
• Figure 9C is a perspective view of the negative pressure device of Figure 9B;
• Figure 10A is an exploded view of a wound pressure sensing device that may be associated with an example embodiment of the therapy system of Figure 1 ;
• Figure 10B is a side, cut-away view of the wound pressure sensing device of Figure 10A;
• Figure 10C is a side, cut-away view of the wound pressure sensing device of Figure 10A surrounded by an encapsulant;
• Figure 10D is a side, cut-away view of the wound pressure sensing device of Figure IOC with at least one hole drilled through the encapsulant and the cover;
• Figure 10E is a perspective view of the wound pressure sensing device of Figure 10D;
• Figure 11A is an exploded view of another example wound pressure sensing device that may be associated with an example embodiment of the therapy system of Figure 1;
• Figure 1 IB is a side, cut-away view of the wound pressure sensing device of Figure 11A;
• Figure 11C is a side, cut-away view of the wound pressure sensing device of Figure 11A surrounded by an encapsulant;
• Figure 1 ID is a perspective view of the wound pressure sensing device of Figure 11C.
• the therapy system 100 may include a source or supply of negative pressure, such as a negative pressure source 105, and one or more distribution components.
• a distribution component is preferably detachable and may be disposable, reusable, or recyclable.
• a dressing, such as a dressing 110, and a fluid container, such as a container 115, are examples of distribution components that may be associated with some examples of the therapy system 100.
• the dressing 110 may comprise or consist essentially of a tissue interface 120, a cover 125, or both in some embodiments.
• a fluid conductor is another illustrative example of a distribution component.
• a tube is an elongated, cylindrical structure with some flexibility, but the geometry and rigidity may vary.
• some fluid conductors may be molded into or otherwise integrally combined with other components.
• Distribution components may also include or comprise interfaces or fluid ports to facilitate coupling and de-coupling other components.
• a dressing interface may facilitate coupling a fluid conductor to the dressing 110.
• such a dressing interface may be a SENSAT.R.A.C.TM Pad available from 3M Company.
• the therapy system 100 may also include a regulator or controller, such as a controller 130. Additionally, the therapy system 100 may include sensors to measure operating parameters and provide feedback signals to the controller 130 indicative of the operating parameters. As illustrated in Figure 1, for example, the therapy system 100 may include a first sensor 135 and a second sensor 140 coupled to the controller 130.
• Some components of the therapy system 100 may be housed within or used in conjunction with other components, such as sensors, processing units, alarm indicators, memory, databases, software, display devices, or user interfaces that further facilitate therapy.
• the negative pressure source 105 may be combined with the controller 130 and other components into a therapy unit 145.
• components of the therapy system 100 may be coupled directly or indirectly.
• the negative pressure source 105 may be directly coupled to the container 115 and may be indirectly coupled to the dressing 110 through the container 115.
• Coupling may include fluid, mechanical, thermal, electrical, or chemical coupling (such as a chemical bond), or some combination of coupling in some contexts.
• the negative pressure source 105 may be electrically coupled to the controller 130 and may be fluidly coupled to one or more distribution components to provide a fluid path to a tissue site.
• components may also be coupled by virtue of physical proximity, being integral to a single structure, or being formed from the same piece of material.
• a negative-pressure supply such as the negative pressure source 105, may be a reservoir of air at a negative pressure or may be a manual or electrically-powered device, such as a vacuum pump, a suction pump, a wall suction port available at many healthcare facilities, or a micropump, for example.
• Negative pressure generally refers to a pressure less than a local ambient pressure, such as the ambient pressure in a local environment external to a sealed therapeutic environment. In many cases, the local ambient pressure may also be the atmospheric pressure at which a tissue site is located. Alternatively, the pressure may be less than a hydrostatic pressure associated with tissue at the tissue site. Unless otherwise indicated, values of pressure stated herein are gauge pressures.
• references to increases in negative pressure typically refer to a decrease in absolute pressure, while decreases in negative pressure typically refer to an increase in absolute pressure. While the amount and nature of negative pressure provided by the negative pressure source 105 may vary according to therapeutic requirements, the pressure is generally a low vacuum, also commonly referred to as a rough vacuum, between -5 mm Hg (-667 Pa) and -500 mm Hg (-66.7 kPa). Common therapeutic ranges are between -50 mm Hg (-6.7 kPa) and -300 mm Hg (-39.9 kPa).
• the container 115 is representative of a container, canister, pouch, or other storage component, which can be used to manage exudates and other fluids withdrawn from a tissue site.
• a rigid container may be preferred or required for collecting, storing, and disposing of fluids.
• fluids may be properly disposed of without rigid container storage, and a re-usable container could reduce waste and costs associated with negative-pressure therapy.
• a controller such as the controller 130, may be a microprocessor or computer programmed to operate one or more components of the therapy system 100, such as the negative pressure source 105.
• the controller 130 may be a microcontroller, which generally comprises an integrated circuit containing a processor core and a memory programmed to directly or indirectly control one or more operating parameters of the therapy system 100. Operating parameters may include the power applied to the negative pressure source 105, the pressure generated by the negative pressure source 105, or the pressure distributed to the tissue interface 120, for example.
• the controller 130 is also preferably configured to receive one or more input signals, such as a feedback signal, and programmed to modify one or more operating parameters based on the input signals.
• the signals from the first sensor 135 and the second sensor 140 are suitable as an input signal to the controller 130, but some signal conditioning may be appropriate in some embodiments.
• the signal may need to be filtered or amplified before it can be processed by the controller 130.
• the signal is an electrical signal, but may be represented in other forms, such as an optical signal.
• the tissue interface 120 can be generally adapted to partially or fully contact a tissue site.
• the tissue interface 120 may take many forms, and may have many sizes, shapes, or thicknesses, depending on a variety of factors, such as the type of treatment being implemented or the nature and size of a tissue site.
• the size and shape of the tissue interface 120 may be adapted to the contours of deep and irregular shaped tissue sites. Any or all of the surfaces of the tissue interface 120 may have an uneven, coarse, or jagged profile.
• the controller 130 may receive and process data from one or more sensors, such as the first sensor 135. The controller 130 may also control the operation of one or more components of the therapy system 100 to manage the pressure delivered to the tissue interface 120.
• the controller 130 may include an input for receiving a desired target pressure and may be programmed for processing data relating to the setting and inputting of the target pressure to be applied to the tissue interface 120.
• the target pressure may be a fixed pressure value set by an operator as the target negative pressure desired for therapy at a tissue site and then provided as input to the controller 130.
• Figures 2A-2F show example embodiments of portions of a system 200 for treating a tissue site with negative pressure that may be associated with the therapy system 100.
• Figure 2A is an exploded view of a negative pressure device 202 of the system 200.
• Figure 2B is a perspective view of the negative pressure device 202.
• Figure 2C is a perspective view of the system 200 including the negative pressure device 202 surrounded by an encapsulant 204.
• Figure 2D is a perspective view of a device cover or a cover 206 of the negative pressure device 202.
• Figure 2E is a cross-sectional view of the cover 206 taken along the line 2E-2E.
• Figure 2F is a perspective view of a bottom surface of the cover 206.
• the system 200 may be configured to deliver negative pressure to a tissue site and may include the negative pressure device 202 and a tube 208 that may be configured to couple the negative pressure device 202 to the dressing 110, shown in Figure 1.
• the negative pressure device 202 may include the cover 206, the negative pressure source 105, the encapsulant 204, and an electric circuit 210 including a power source 212 and at least one sensor, such as a negative pressure sensor 214, and an ambient pressure sensor 216.
• the negative pressure source 105, the power source 212, the negative pressure sensor 214, and the ambient pressure sensor 216 may each couple with the electric circuit 210.
• the cover 206 may have a top surface 224 and a bottom surface 226 opposite the top surface 224.
• the bottom surface 226 may include a coupling edge 228 that may extend past a perimeter 230 of the top surface 224.
• the cover 206 may be configured to couple to the first surface 218 of the electric circuit 210. More specifically, the bottom surface 226 may be configured to couple to the first surface 218 of the electric circuit 210.
• the negative pressure source 105, the negative pressure sensor 214, and the ambient pressure sensor 216 may be disposed between the cover 206 and the first surface 218 of the electric circuit 210 such that the negative pressure source 105, the negative pressure sensor 214, and the ambient pressure sensor 216 are disposed in a cavity 232 of the cover 206.
• the cavity 232 may be configured to create one or more sealed enclosures 233 around the negative pressure source 105, the negative pressure sensor 214, and the ambient pressure sensor 216.
• the cavity 232 may be divided into more than one cavity.
• the cavity 232 may include a negative pressure cavity 234 configured to form a first sealed enclosure 233a and a sensing cavity 236 configured to form a second sealed enclosure 233b.
• the negative pressure cavity 234 may be fluidly isolated from the sensing cavity 236.
• the negative pressure cavity 234 may be configured to house the negative pressure source 105 and the negative pressure sensor 214.
• the negative pressure cavity 234 may have a first section 238 and a second section 240.
• the first section 238 may be configured to house the negative pressure source 105 and the second section 240 may be configured to house the negative pressure sensor 214.
• the first section 238 may be fluidly coupled to the second section 240 through an opening 242 in an interior wall 244 of the cover 206.
• the cover 206 may further include a negative pressure port 246.
• the negative pressure port 246 may be in fluid communication with the negative pressure cavity 234 through a conduit 247 of the negative pressure port 246 such that the negative pressure cavity 234 is configured to be in fluid communication with the dressing 110. More specifically, the negative pressure port 246 may be fluidly coupled to the second section 240 of the negative pressure cavity 234.
• the tube 208 may be configured to couple to the negative pressure port 246 to provide a fluid path between the negative pressure cavity 234 and the dressing 110. The tube 208 may be configured to communicate negative pressure between the negative pressure source 105 and the dressing 110 through the negative pressure cavity 234 and the negative pressure port 246 of the cover 206.
• the cover 206 may further include a first extension 248 with a first exhaust aperture 250 and a second extension 252 with a first ambient pressure sensor aperture 254.
• the first extension 248 and the second extension 252 may extend from the top surface 224 of the cover 206 away from the bottom surface 226 of the cover 206.
• the first exhaust aperture 250 may be configured to provide a path for exhaust from the negative pressure source 105 to escape through the cover 206.
• the first ambient pressure sensor aperture 254 may provide a path from the ambient pressure sensor 216 to an ambient environment surrounding the cover 206.
• the encapsulant 204 may include a second exhaust aperture 256 that may be substantially aligned with the first exhaust aperture 250.
• the first exhaust aperture 250 and the second exhaust aperture 256 may be configured to provide a path for exhaust from the negative pressure source 105 to escape from the cover 206 and the encapsulant 204 to an ambient environment surrounding the system 200.
• the first extension 248 may couple to the encapsulant 204 to provide a sealed path from the negative pressure cavity 234 to the ambient environment surrounding the system 200.
• the encapsulant 204 may further include a second ambient pressure sensor aperture 258 that may be substantially aligned with the first ambient pressure sensor aperture 254.
• the first ambient pressure sensor aperture 254 and the second ambient pressure sensor aperture 258 may be configured to provide a path from the ambient pressure sensor 216 to the ambient environment surrounding the system 200.
• the second extension 252 may couple to the encapsulant 204 so provide a sealed path from the sensing cavity 236 to the ambient environment surrounding the system 200.
• the encapsulant 204 may further include an indicator cover 260.
• the indicator cover 260 may be configured to align with the one or more indicators 222 of the electric circuit 210.
• the indicator cover 260 may be configured to display a signal generated by the one or more indicators 222 such that the signal is easily observed by a user.
• the indicator cover 260 may have a first section 260a configured to align with the first indicator 222a, a second section 260b configured to align with the second indicator 222b, and a third section 260c configured to align with the third indicator 222c.
• the encapsulant 204 may be applied to the negative pressure device 202 without the use of the cover 206.
• the encapsulant 204 may be configured to create a sealed enclosure around at least the negative pressure source 105 and the negative pressure sensor 214 such that the negative pressure source 105 and the negative pressure sensor 214 may be fluidly coupled to the dressing 110 through the tube 208 but may be isolated from the remainder of the negative pressure device 202.
• the electric circuit 210 may be a rigid printed circuit board, a flexible printed circuit board, or another type of circuit that provides connections between the electric components of the negative pressure device 202.
• the cover 206 may be either rigid or flexible such that it is able to couple to the electric circuit 210 to create a sealed enclosure around the necessary electric components of the negative pressure device 202.
• the cover 206 may be formed from plastic.
• the encapsulant 204 may be either rigid or flexible. In some embodiments, the encapsulant 204 may be UV cured to achieve its final shape and rigidity. If the encapsulant 204 is flexible, it may be formed from a silicone encapsulant material that may be UV curable. In some embodiments when the encapsulant 204 is flexible, the encapsulant may be transparent to allow the cover 206, the electric circuit 210, and the other components of the negative pressure device 202 to be visible through the encapsulant. The silicone encapsulant material may be elastomeric and may not generate heat while it is formed around the electric circuit 210 and the cover 206 which may help to reduce any risk of damaging any of the components that are coupled to the electric circuit 210.
• the silicone encapsulant material may be used as the encapsulant 204 when the electric circuit 210 is a flexible printed circuit board.
• the encapsulant 204 may be formed from an epoxy potting compound. When using an epoxy potting compound, heat can be generated during the potting process when a hardener of the epoxy potting compound is mixed with a base resin of the epoxy potting compound. The epoxy potting compound may produce a dark, opaque appearance for the encapsulant 204.
• the encapsulant 204 may be wrapped around the other components of the negative pressure device 202 to add surface finish and to emphasize details of the negative pressure device 202.
• the encapsulant 204 may be formed from urethane and acrylic compounds.
• the use of a rigid printed circuit board and a soft, flexible encapsulant may improve robustness of the system 200.
• Figure 3A shows a top view of the system 200 with the negative pressure device 202 surrounded by the encapsulant 204.
• Figure 3B shows a perspective view of the system 200 of Figure 3A.
• Figure 3C is a perspective view of the cover 206 of the negative pressure device 202 of Figure 3A.
• Figure 3D is a bottom perspective view of the cover 206 of Figure 3C.
• Figure 3E is a cross-sectional view of the cover 206 of Figure 3C taken along line 3E-3E.
• the system 200 may be substantially as described above with reference to Figures 2A-2F.
• the negative pressure device 202 may include the electric circuit 210, the negative pressure source 105, the power source 212, the negative pressure sensor 214, the ambient pressure sensor 216, and the cover 206.
• the negative pressure device 202 of Figures 3A-3E may additionally include a switch 302.
• the switch 302 may be coupled to the first surface 218 of the electric circuit 210 similar to the negative pressure source 105, the negative pressure sensor 214, the ambient pressure sensor 216, and the power source 212.
• the switch 302 may be configured to actuate at least one element of the negative pressure device 202.
• the switch 302 may be configured to actuate the negative pressure source 105.
• the dressing 110 may be drawn down to a desired negative pressure.
• the switch 302 may also be configured to power off the negative pressure source 105 such that negative pressure is no longer being applied to the dressing 110.
• the cavity 232 of the cover 206 may further include a switch cavity 304.
• the switch cavity 304 may be fluidly isolated from the negative pressure cavity 234 and the sensing cavity 236 and may be configured to house the switch 302.
• the cover 206 may further include a button overmount 306.
• the button overmount 306 may be coupled to the top surface 224 of the cover 206 and may be configured to engage an extension 308 of the switch 302.
• the extension 308 of the switch 302 may be configured to engage the switch 302 when a force is applied to the button overmount 306.
• the button overmount 306 may be formed from a material that is more flexible than the material that the cover 206 is formed from. When the button overmount 306 is more flexible than the remainder of the cover 206, the force necessary to actuate the switch 302 may be easily achieved by pressing on the encapsulant 204 adjacent to the button overmount 306.
• Figure 4A shows a top view of the system 200 with the negative pressure device 202 surrounded by the encapsulant 204
• Figure 4B shows a cross-sectional view of the system 200 of Figure 4A taken along line 4B-4B.
• the negative pressure device 202 may include the electric circuit 210, the power source 212, the negative pressure sensor 214, the ambient pressure sensor 216, the negative pressure source 105, and the cover 206.
• the negative pressure source 105 may be a diaphragm pump in some embodiments.
• the cover 206 may be configured to create a sealed enclosure around the negative pressure source 105, the ambient pressure sensor 216, and the negative pressure sensor 214 substantially as described above with reference to Figures 2A-2F.
• the first opening 1046, the second opening 1048, and the ambient pressure sensor opening 1050 may formed through the encapsulant 1004 after the encapsulant 1004 is formed around the wound sensing device 1002. In some embodiments, the first opening 1046, the second opening 1048, and the ambient pressure sensor opening 1050 may formed by drilling through the encapsulant 1004.
• the system 1000 may include the wound sensing device 1002, the encapsulant 1004, and the tube 1006.
• the wound sensing device 1002 may include the electric circuit 1008, the negative pressure sensor 1010, the ambient pressure sensor 1012, the power source 1014, and the cover 1016.
• the electric circuit 1008 may be substantially as described above with reference to Figures 10A-10E but may include a coupling edge 1102.
• the coupling edge 1102 may be configured to couple with a port enclosure 1104 of the cover 1016.
• the cover 1016 may include the ring 1022 and the at least one cavity 1024.
• the at least one cavity may be the sensing cavity 1030.

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• Health & Medical Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
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• 2023
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