WO2021028774A1 - Appareil d'élimination de fluide destiné à être utilisé avec une pompe péristaltique - Google Patents

Appareil d'élimination de fluide destiné à être utilisé avec une pompe péristaltique Download PDF

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Publication number
WO2021028774A1
WO2021028774A1 PCT/IB2020/057329 IB2020057329W WO2021028774A1 WO 2021028774 A1 WO2021028774 A1 WO 2021028774A1 IB 2020057329 W IB2020057329 W IB 2020057329W WO 2021028774 A1 WO2021028774 A1 WO 2021028774A1
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WO
WIPO (PCT)
Prior art keywords
valve
fluid
tube
container
pressure
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Application number
PCT/IB2020/057329
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English (en)
Inventor
Christopher Brian Locke
Original Assignee
Kci Licensing, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by Kci Licensing, Inc. filed Critical Kci Licensing, Inc.
Publication of WO2021028774A1 publication Critical patent/WO2021028774A1/fr

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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
    • A61M1/71—Suction drainage systems
    • A61M1/73—Suction drainage systems comprising sensors or indicators for physical values
    • 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
    • A61M1/71—Suction drainage systems
    • A61M1/74—Suction control
    • 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
    • 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
    • A61M1/98—Containers specifically adapted for negative pressure wound therapy
    • 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
    • A61M1/98—Containers specifically adapted for negative pressure wound therapy
    • A61M1/982—Containers specifically adapted for negative pressure wound therapy with means for detecting level of collected exudate
    • 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
    • A61M1/80—Suction pumps
    • 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
    • A61M2205/3317—Electromagnetic, inductive or dielectric measuring means
    • 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
    • A61M2205/3379—Masses, volumes, levels of fluids in reservoirs, flow rates
    • A61M2205/3382—Upper level detectors
    • 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
    • A61M2205/3379—Masses, volumes, levels of fluids in reservoirs, flow rates
    • A61M2205/3386—Low level detectors

Definitions

  • the invention set forth in the appended claims relates generally to fluid management systems and more particularly, but without limitation, to systems for management of fluid buildup including pleural effusion and ascites.
  • 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.
  • Effusion refers to an abnormal accumulation of fluid in a body cavity.
  • the most common sites of effusion include serous cavities, such as the pleural cavity (pleural effusion) and the peritoneal cavity (ascites).
  • Effusion can produce considerable amounts of liquid, such as transudates and exudates. If not properly addressed, the accumulation of liquid can lead to infection, compression of internal structures, reduction of blood supply to the area, and even tissue death.
  • a therapy system may provide removal and storage of fluid from a tissue site using a disposable fluid pathway coupled with a peristaltic pump.
  • the fluid pathway may include a container for the storage of fluid removed from the tissue site.
  • the system may include sensors configured to detect one or more of a variety of conditions, including, for example, a gross leak in the fluid pathway, complete removal of fluid from the tissue site, a blockage in the fluid pathway, and a full container.
  • the fluid pathway may further include at least one pressure regulator valve with a filter.
  • the fluid pathway may be disposable and, as it is fluidly decoupled from the peristaltic pump, reduces or eliminates risk of contamination of the therapy system and allows reuse of the therapy system on multiple patients without the need for sterilization.
  • the one or more pressure regulator valves can reduce or eliminate the possibility of delivering unsafe levels of negative pressure to the tissue site.
  • an apparatus for removing fluid from a tissue site may include a fluid conductor, a first valve, a second valve, and a third valve.
  • the container may be configured to receive the fluid removed from the tissue site.
  • the fluid conductor may have a first end configured to be fluidly coupled to the tissue site and a second end configured to be fluidly coupled to the container.
  • the fluid conductor may include a first conductor portion, a second conductor portion fluidly coupled to the first conductor portion, and a third conductor portion fluidly coupled to the second conductor portion.
  • the second conductor portion may be configured to be engaged with a peristaltic pump.
  • the first valve and the second valve may be configured to be fluidly coupled to the fluid conductor proximate the first end.
  • the third valve may be configured to be fluidly coupled in-line with the fluid conductor proximate the second end.
  • the third valve may be configured to only permit flow in a direction from the first end to the second end.
  • the first valve may be configured to open to atmosphere if a negative pressure within the fluid conductor is in a range of about 40 mmHg to about 50 mmHg. In some embodiments, the first valve may be configured to open to atmosphere if a negative pressure within the fluid conductor is in a range of about 110 mmHg to about 130 mmHg.
  • the second valve may be configured to open to atmosphere if a negative pressure within the fluid conductor is greater than about 100 mmHg. In some embodiments, the second valve may be configured to open to atmosphere if a negative pressure within the fluid conductor is greater than about 200 mmHg. In some embodiments, the second valve is configured to open and remain open if the first valve fails to regulate pressure within the fluid conductor.
  • an apparatus for removing fluid from a tissue site may include a tube, a first valve, a second valve, and a check valve.
  • the container may be configured to receive the fluid removed from the tissue site.
  • the tube may have a first end configured to be fluidly coupled to the tissue site and a second end configured to be fluidly coupled to the container. A portion of the tube may be configured to be engaged with a peristaltic pump.
  • the first valve and the second valve may be configured to be fluidly coupled to the tube proximate the first end.
  • the first valve and the second valve may be configured to regulate pressure in the tube.
  • the check valve may be configured to be fluidly coupled in-line with the tube proximate the second end. The check valve configured to only permit flow toward the container.
  • Some illustrative embodiments of a system for applying negative pressure to a tissue site may include a negative-pressure source, a fluid removal apparatus, a first sensor, a second sensor, and a third sensor.
  • the negative-pressure source may include a peristaltic pump head.
  • the fluid removal source may include a container, a tube, a first valve, a second valve, and a check valve.
  • the container may be configured to receive fluid removed from the tissue site.
  • the tube may have a first end configured to be fluidly coupled to the tissue site and a second end configured to be fluidly coupled to the container. A portion of the tube may be configured to be engaged with the peristaltic pump head.
  • the first valve and the second valve may be configured to be fluidly coupled to the tube proximate the first end.
  • the check valve may be configured to be fluidly coupled in-line with the tube proximate the second end.
  • the first sensor may be configured to be located upstream of the peristaltic pump head.
  • the second sensor may be configured to be located downstream of the peristaltic pump head.
  • the third sensor may be configured to be located downstream of the peristaltic pump head.
  • the first sensor may be configured to measure the pressure in the tube upstream of the peristaltic pump head.
  • the second sensor may be configured to measure the pressure in the tube downstream of the peristaltic pump head.
  • the third sensor may be configured to detect air in the tube downstream of the peristaltic pump head.
  • the system may further comprise a controller coupled to the negative-pressure source, the first sensor, the second sensor, and the third sensor.
  • the controller may be configured to determine that the container is full based on an expansion of the tube downstream of the peristaltic pump head measured by the second sensor.
  • the controller may be configured to deactivate the negative-pressure source in response to determining that the container is full.
  • the controller may be configured to determine a blockage in the tube downstream of the peristaltic pump head based on an expansion of the tube downstream of the peristaltic pump head measured by the second sensor.
  • the controller may be configured to deactivate the negative- pressure source in response to determining a blockage in the tube downstream of the peristaltic pump head.
  • the controller may be configured to determine a blockage in the tube upstream of the peristaltic pump head based on a collapse of the tube upstream of the peristaltic pump head measured by the first sensor.
  • the controller may be configured to deactivate the negative-pressure source in response to determining a blockage in the tube upstream of the peristaltic pump head.
  • the controller may be configured to determine a leak based on detecting air in the tube by the third sensor after a first period of time that the negative-pressure source has been operating.
  • the controller may be configured to continue to operate the negative-pressure source and to indicate a leak.
  • the controller may be configured to deactivate the negative-pressure source after a second period of time following the determination of a leak.
  • the apparatus may be beneficial for various modes of treatment and for various types of tissue sites, and may be particularly advantageous for management of fluid buildup in serous cavities, such as pleural effusion or ascites.
  • Other objectives, advantages, and a preferred mode of making and using the claimed subject matter may be understood best by reference to the accompanying drawings in conjunction with the following detailed description of illustrative embodiments.
  • Figure 1 is a schematic diagram of an example embodiment of a fluid management system that can provide treatment in accordance with this specification
  • Figure 2 is a schematic diagram of an example of the fluid management system of Figure 1 applied to an example cavity
  • Figure 3 is a flow chart illustrating a method of managing fluid that may be associated with some embodiments of the fluid management system of Figure 1.
  • tissue site in this context broadly refers to a wound, defect, or other treatment target located on or within tissue, including, but not limited to, bone tissue, adipose tissue, muscle tissue, neural tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendons, ligaments, or a body cavity, including, but not limited to, a serous cavity, a pleural cavity, or a peritoneal cavity.
  • a wound may include chronic, acute, traumatic, subacute, and dehisced wounds, partial thickness bums, ulcers (such as diabetic, pressure, or venous insufficiency ulcers), flaps, and grafts, for example.
  • tissue site may also refer to areas of any tissue that are not necessarily wounded or defective, but are instead areas in which it may be desirable to add or promote the growth of additional tissue. For example, negative pressure may be applied to a tissue site to grow additional tissue that may be harvested and transplanted.
  • the tissue site 102 may extend through or otherwise involve an epidermis 104, a dermis 106, and a subcutaneous tissue 108.
  • the tissue site 102 may include a wound 110 that extends below the surface of the epidermis 104.
  • the tissue site 102 may be a surface tissue site that predominantly resides on the surface of the epidermis 104, such as an incision.
  • the fluid management system 100 may provide therapy to, for example, the epidermis 104, the dermis 106, and the subcutaneous tissue 108, regardless of the positioning of the fluid management system 100 or the type of tissue site.
  • the fluid management system 100 may also be utilized without limitation at other tissue sites.
  • the fluid management system 100 may include a fluid removal apparatus 112 having one or more distribution components, a source or supply of negative pressure, such as a negative- pressure source 114, and a regulator or controller, such as a controller 116.
  • a source or supply of negative pressure such as a negative- pressure source 114
  • a regulator or controller such as a controller 116.
  • 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. Alternatively, the pressure may be less than a hydrostatic pressure associated at the tissue site 102. 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 114 may vary according to treatment requirements, the pressure is generally a low vacuum, also commonly referred to as a rough vacuum, between -5 mmHg (-667 Pa) and -500 mmHg (-66.7 kPa). In some examples, the negative-pressure source 114 may be configured to provide a negative pressure in a range of about 50 mmHg to about 75 mmHg for drainage.
  • the fluid mechanics of using a negative-pressure source to reduce pressure in another component or location, such as at a tissue site can be mathematically complex.
  • the basic principles of fluid mechanics applicable to reducing pressure at a tissue site are generally well-known to those skilled in the art, and the process of reducing pressure may be described illustratively herein as “delivering,” “distributing,” or “generating” negative pressure, for example.
  • components of the fluid management system 100 may be coupled directly or indirectly. 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 114 may be electrically coupled to the controller 116 and one or more distribution components one or more of the distribution components of the fluid removal apparatus 112 may be fluidly coupled to provide a fluid path to the tissue site 102.
  • 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 distribution component may be disposable, reusable, or recyclable.
  • the distribution components of the fluid removal apparatus 112 may include a fluid container, such as a container 118, and a fluid conductor 120 configured to be fluidly coupled to the container 118.
  • 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.
  • the fluid conductor 120 may have a first end 122 configured to be fluidly coupled to the tissue site 102 and a second end 124 configured to be fluidly coupled to the container 118. At least a portion of the fluid conductor 120 may be elastically deformable. For example, the fluid conductor 120 may have a lumen extending in a longitudinal direction, and at least a portion the fluid conductor 120 can be deformed in the radial direction. In some embodiments, at least a portion of the fluid conductor 120 may be compressed in the radial direction, after which it may return to its original shape. Additionally, at least a portion of the fluid conductor 120 may be expanded in the radial section, after which it may return to its original shape.
  • the fluid conductor 120 may include a first conductor portion 126, a second conductor portion 128 fluidly coupled to the first conductor portion 126, and a third conductor portion 130 fluidly coupled to the second conductor portion 128, wherein the second conductor portion 128 is deformable.
  • the first conductor portion 126 may have a first durometer and the second conductor portion 128 may have a second durometer, wherein the second durometer is less than the first durometer.
  • the second durometer may be about half of the first durometer.
  • the third conductor portion 130 may have a third durometer, wherein the third durometer is equal to the first durometer.
  • the second conductor portion 128 of the fluid conductor 120 may be more deformable than the first conductor portion 126 and the third conductor portion 130.
  • the second conductor portion 128 may expand more under positive pressure and contract more under negative pressure than the first conductor portion 126 and the third conductor portion 130.
  • the second conductor portion 128 may be configured to be deformed by a peristaltic pump head.
  • the fluid conductor 120 may be similar to the instillation tubing used in the V.A.C VERAFUOWTM Therapy System available from Kinetic Concepts, Inc. of San Antonio, Texas.
  • the fluid removal apparatus 112 may further include a first valve 132 and a second valve 134.
  • the first valve 132 may be configured to be fluidly coupled to the fluid conductor 120 proximate the first end 122.
  • the first valve 132 may be a valve configured to regulate pressure.
  • the first valve 132 may be a normally-closed, spring-based valve.
  • the first valve 132 may be characterized by a cracking pressure, which is the pressure that opens the first valve 132.
  • the cracking pressure can be determined by the spring force if the first valve 132 is a spring -based valve.
  • the spring may be, for example, a coiled spring or may be formed as a part of the structure of the first valve 132.
  • the first valve 132 may be configured to have a cracking pressure in a range of about -40 mmHg to about -50 mmHg. In some embodiments, the first valve 132 may be configured to have a cracking pressure in a range of about -110 mmHg to about -130 mmHg. If the negative pressure inside the fluid conductor 120 is equal to or exceeds the cracking pressure of the first valve 132, the first valve 132 may be configured to open to atmosphere and allow air to enter the fluid conductor 120. For example, the first valve 132 may be configured to open if a negative pressure within the fluid conductor 120 is in a range of about -40 mmHg to about -50 mmHg.
  • the first valve 132 may be configured to open if a negative pressure within the fluid conductor 120 is in a range of about -110 mmHg to about -130 mmHg.
  • the first valve 132 may be a standalone component.
  • the first valve 132 may be integrated with an in-line connecter, such as, for example, a tee fitting configured to couple with the fluid conductor 120.
  • the second valve 134 may be configured to be fluidly coupled to the fluid conductor 120 proximate the first end 122.
  • the second valve 134 may be a valve configured to regulate pressure.
  • the second valve 134 may be a normally-closed, spring -based valve.
  • the second valve 134 may be characterized by a cracking pressure, which is the pressure that opens the second valve 134.
  • the cracking pressure can second valve 134be determined by the spring force if the second valve 134 is a spring -based valve.
  • the spring may be, for example, a coiled spring or may be formed as a part of the structure of the second valve 134.
  • the second valve 134 may be configured to open at a cracking pressure and then remain open even if the pressure subsequently drops, such that the second valve 134 irreversibly opens.
  • the second valve 134 may be configured to have a cracking pressure of about -100 mmHg and then remain open.
  • the second valve 134 may be configured to have a cracking pressure in a range of about -200 mmHg to about -250 mmHg and then remain open. If the negative-pressure inside the fluid conductor 120 is equal to or exceeds the cracking pressure of the second valve 134, the second valve 134 may be configured to open to atmosphere and allow air to enter the fluid conductor 120.
  • the second valve 134 may be configured to open if a negative pressure within the fluid conductor 120 is greater than about -100 mmHg.
  • the second valve 134 may be configured to open if a negative pressure within the fluid conductor 120 is greater than about -200 mmHg.
  • the second valve 134 may be configured to open if a negative pressure within the fluid conductor 120 is in a range of about -200 mmHg to about -250 mmHg.
  • the second valve 134 may be a standalone component.
  • the second valve 134 may be integrated with an in-line connecter, such as, for example, a tee fitting configured to couple with the fluid conductor 120.
  • the first valve 132 and the second valve 134 may be incorporated into a single integrated valve assembly that is configured to be fluidly coupled to the first end 122 of the fluid conductor 120.
  • a first filter 136 may be fluidly coupled to the first valve 132 and a second filter 138 may be fluidly coupled to the second valve 134.
  • the first filter 136 and the second filter 138 may be configured to filter air entering the first valve 132 and the second valve 134, respectively, to prevent damage, contamination, or both of the first valve 132, the second valve 134, and the fluid conductor 120.
  • the first filter 136 and the second filter 138 may each comprise a membrane with sufficient area to not impede the flow of air into and through the first valve 132 and the second valve 134, respectively, but to reduce or eliminate the potential of bacteria and viruses to enter the fluid conductor 120 and potentially reflux to the tissue site 102.
  • the first filter 136 and the second filter 138 may be antimicrobial, hydrophobic, or both.
  • the surface area of each of the first filter 136 and the second filter 138 may be in a range of about 1 cm 2 to about 2 cm 2 .
  • the first filter 136 and the second filter 138 may be microfiltration media filters such as, for example, the MMT 314 filter available from W. L. Gore & Associates, Inc.
  • Each of the first filter 136 and the second filter 138 may be supported by an open rigid structure to prevent deformation and breach of the first filter 136 and the second filter 138.
  • each of the first filter 136 and the second filter 138 may further include a gel-blocking filter material configured to face the first valve 132 and the second valve 134, respectively.
  • the gel blocking filter material may prevent unintentional fluid egress through the first valve 132 or the second valve 134.
  • the first filter 136 and the second filter 138 may be integrated into a single filter.
  • the first filter 136 may provide filtration for both the first valve 132 and the second valve 134.
  • the second filter 138 may provide filtration for both the first valve 132 and the second valve 134.
  • the fluid removal apparatus 112 may further include a third valve 140 configured to be fluidly coupled in-line with the fluid conductor 120 proximate the second end 124.
  • the third valve 140 may be, for example, a check valve or a duckbill valve.
  • the third valve 140 may be configured to only permit flow in the direction from the first end 122 to the second end 124 of the fluid conductor 120.
  • the third valve 140 may be configured to allow fluid flow toward the container 118 and may be configured to prevent fluid flow from the container 118 toward the first end 122 of the fluid conductor 120.
  • the third valve 140 may prevent fluid from the container 118 from flowing back to the tissue site 102.
  • the container 118 is representative of a container, canister, pouch, or other storage component, which can be used to manage exudates and other fluids withdrawn from the tissue site 102.
  • the container 118 may be a flexible bag configured to receive fluid from the tissue site 102.
  • the container 118 may be configured to be disposed of after a single use.
  • the container 118 may include one or more vent filters 142 configured to allow air to be evacuated from the container 118 as the container 118 fills with fluid.
  • the vent filters 142 may be constructed of a vapor-permeable, liquid-impermeable material, which may allow evaporation of liquid from the fluids received in the container 118 even if the fluids are in contact with the vent filters 142.
  • multiple vent filters 142 may be located in different locations of the container 118 to allow for the container 118 to be used in multiple orientations.
  • a stabilizer 144 such as, for example, a superabsorbent polymer may be located in the container 118 configured to at least partially solidify the fluid received in the container 118.
  • the stabilizer 144 may be a mat comprising superabsorbent polymer that is configured to cover at least a portion of the interior of the container 118.
  • the stabilizer 144 may be an absorbent available from Gelok International.
  • the container 118 may further include one or more hydrochromic indicators 146 coupled to the container 118.
  • the hydrochromic indicators 146 may be printed in the container 118.
  • the hydrochromic indicators 146 may be visible through the container 118.
  • the hydrochromic indicators 146 may be internally mounted in the container 118.
  • the hydrochromic indicators 146 may be externally mounted on the container 118.
  • the hydrochromic indicators 146 may be configured to change color if they come into contact with fluid. Accordingly, in some embodiments, if the container 118 is full of fluid, one or more of the hydrochromic indicators 146 may change color.
  • the fluid management system 100 may include a sensor, such as, for example, a pressure sensor to detect if the container 118 is full of fluid.
  • the first valve 132 and the second valve 134 may be downstream of the first end 122 of the fluid conductor 120.
  • the first valve 132 may be downstream of the first end 122 and the second valve 134 may be downstream of the first valve 132.
  • the first valve 132 may be upstream of the second valve 134.
  • the first valve 132 may be between the first end 122 and the second valve 134.
  • the second valve 134 may be upstream of the first valve 132.
  • the second valve 134 may be between the first end 122 and the first valve 132.
  • the second conductor portion 128 may be downstream of the first valve 132 and the second valve 134.
  • the first valve 132 and the second valve 134 may be between the first end 122 and the second conductor portion 128.
  • the third valve 140 may be downstream of the second conductor portion 128. In some embodiments, the third valve 140 may be between the second conductor portion 128 and the container 118. In some embodiments, the third valve 140 may be upstream of the second end 124 of the fluid conductor 120. In some embodiments, the third valve 140 may be downstream of the second end 124.
  • the container 118 may be downstream of the third valve 140. In some embodiments, the second end 124 may be between the third valve 140 and the container 118. In some embodiments, the third valve 140 is between the second end 124 and the container 118.
  • the fluid removal apparatus 112 may have a first terminal end 148 and a second terminal end 150.
  • the components of the fluid removal apparatus 112 may be arranged in order from the first terminal end 148 to the second terminal end 150 as follows: (i) the first end 122 of the fluid conductor 120; (ii) the first valve 132; (iii) the second valve 134; (iv) the second conductor portion 128; (v) the third valve 140; and (vi) the container 118.
  • the components of the fluid removal apparatus 112 may be arranged in order from the first terminal end 148 to the second terminal end 150 as follows: (i) the first end 122 of the fluid conductor 120; (ii) the second valve 134; (iii) the first valve 132; (iv) the second conductor portion 128; (v) the third valve 140; and (vi) the container 118.
  • the components of the fluid removal apparatus 112 may be arranged in order from the first terminal end 148 to the second terminal end 150 as follows: (i) the first end 122 of the fluid conductor 120; (ii) the first valve 132; (iii) the second valve 134; (iv) the second conductor portion 128; (v) the third valve 140; (vi) the second end 124 of the fluid conductor 120; and (vii) the container 118.
  • the components of the fluid removal apparatus 112 may be arranged in order from the first terminal end 148 to the second terminal end 150 as follows: (i) the first end 122 of the fluid conductor 120; (ii) the second valve 134; (iii) the first valve 132; (iv) the second conductor portion 128; (v) the third valve 140; (vi) the second end 124 of the fluid conductor 120; and (vii) the container 118.
  • the components of the fluid removal apparatus 112 may be arranged in order from the first terminal end 148 to the second terminal end 150 as follows: (i) the first end 122 of the fluid conductor 120; (ii) the first valve 132; (iii) the second valve 134; (iv) the second conductor portion 128; (v) the second end 124 of the fluid conductor 120; (vi) the third valve 140; and (vii) the container 118.
  • the components of the fluid removal apparatus 112 may be arranged in order from the first terminal end 148 to the second terminal end 150 as follows: (i) the first end 122 of the fluid conductor 120; (ii) the second valve 134; (iii) the first valve 132; (iv) the second conductor portion 128; (v) the second end 124 of the fluid conductor 120; (vi) the third valve 140; and (vii) the container 118.
  • the fluid conductor 120, the container 118, the first valve 132, the second valve 134, the first filter 136, the second filter 138, and the third valve 140 of the fluid removal apparatus 112 may be integrated into a single unit.
  • the fluid removal apparatus 112 is disposable.
  • the fluid removal apparatus 112 is configured as a single-use device. The fluid removal apparatus 112 forms a fluid pathway that is separate and independent from the negative-pressure source 114 such that no fluid from the tissue site 102 routes through or comes into contact with the negative-pressure source 114.
  • the negative-pressure source 114 may be a peristaltic pump comprising a pump head 152 having one or more rollers 154.
  • the pump head 152 may also be referred to as a rotor, and rollers 154 may also be referred to as shoes, wipers, or lobes, for example.
  • the rollers 154 may be attached around a circumference of the pump head 152 and the second conductor portion 128 of the fluid conductor 120 may be configured to be positioned proximate the rollers 154.
  • a peristaltic pump may further include a motor (not shown) coupled to the pump head 152 and configured to rotate the pump head 152, for example, as shown by arrow A, so that the rollers 154 engage the second conductor portion 128 of the fluid conductor 120. As each roller 154 engages the second conductor portion 128, it may compress a portion of the second conductor portion 128, occluding the compressed portion of the second conductor portion 128. Rotation of the pump head 152 may move the compressed location of the second conductor portion 128, pushing fluid through the fluid conductor 120 ahead of the roller 154 from a suction side of the pump head 152 to a discharge side of the pump head 152.
  • fluid may be drawn into the fluid conductor 120 behind the roller 154.
  • fluid may be drawn into and moved through the fluid conductor 120 from the suction side of the pump head 152 to the discharge side of the pump head 152.
  • the rotation of the rollers 154 against the fluid conductor 120 also creates a negative pressure within the fluid conductor 120.
  • the suction side is upstream of the pump head 152 and the discharge side is downstream of the pump head 152.
  • a controller such as the controller 116, may be a microprocessor or computer programmed to operate one or more components of the fluid management system 100, such as the negative-pressure source 114.
  • the controller 116 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 fluid management system 100. Operating parameters may include the power applied to the negative-pressure source 114 and the pressure generated by the negative-pressure source 114, for example.
  • the controller 116 may also be 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.
  • Sensors such as, for example, a first sensor 156, a second sensor 158, a third sensor 160, and a fourth sensor 162 are generally known in the art as any apparatus operable to detect or measure a physical phenomenon or property, and generally provide a signal indicative of the phenomenon or property that is detected or measured.
  • the first sensor 156, the second sensor 158, the third sensor 160, and the fourth sensor 162 may be configured to measure one or more operating parameters of the fluid management system 100.
  • the first sensor 156, the second sensor 158, the third sensor 160, and the fourth sensor 162 of the fluid management system 100 may be coupled to the controller 116.
  • the first sensor 156 may be located on the suction side of the pump head 152, while the second sensor 158, the third sensor 160, and the fourth sensor 162 may be located on the discharge side of the pump head 152.
  • Some embodiments of the fluid management system 100 may include all of the first sensor 156, the second sensor 158, the third sensor 160, and the fourth sensor 162. Some embodiments of the fluid management system 100 may include less than all of the first sensor 156, the second sensor 158, the third sensor 160, and the fourth sensor 162.
  • the third sensor 160 may be omitted.
  • Some embodiments of the fluid management system 100 may include additional sensors beyond the first sensor 156, the second sensor 158, the third sensor 160, and the fourth sensor 162.
  • the first sensor 156, the second sensor 158, and the third sensor 160 may be transducers configured to measure pressure in a pneumatic pathway and convert the measurement to a signal indicative of the pressure measured.
  • the first sensor 156, the second sensor 158, and the third sensor 160 may be piezo-resistive strain gauges.
  • the first sensor 156, the second sensor 158, and the third sensor 160 may comprise load cells that may be transducers that convert a force into an electrical signal. A force applied through a load cell may deform a strain gauge, changing the electrical resistance of the strain gauge which may be interpreted by the controller 116 or other device as an amount of force applied.
  • the first sensor 156 may be configured to be in contact with the second conductor portion 128 of the fluid conductor 120 to measure a pressure in the portion of the fluid conductor 120 on the suction side of the pump head 152. If the fluid conductor 120 of the fluid removal apparatus 112 is coupled to the pump head 152 of the negative-pressure source 114, one or more of the second sensor 158 and the third sensor 160 may be configured to be in contact with the second conductor portion 128 of the fluid conductor 120 to measure a pressure in the portion of the fluid conductor 120 on the discharge side of the pump head 152.
  • the second conductor portion 128 of the fluid conductor 120 may expand or contract depending upon the pressure inside the fluid conductor 120.
  • the expansion, contraction, or both of the second conductor portion 128 may act upon the one or more of the first sensor 156, the second sensor 158, and the third sensor 160 which may deform the transducer of the first sensor 156, the second sensor 158, and the third sensor 160.
  • the first sensor 156 may be configured to detect collapse of the second conductor portion 128 on the suction side of the pump head 152.
  • the second sensor 158 may be configured to detect expansion of the second conductor portion 128 on the discharge side of the pump head 152.
  • the third sensor 160 may be configured to detect collapse of the second conductor portion 128 on the discharge side of the pump head 152.
  • the second sensor 158 may be configured to detect both expansion and collapse of the second conductor portion 128 and the third sensor 160 may be omitted.
  • the amount of deformation of the transducer of the first sensor 156, the second sensor 158, and the third sensor 160 may be indicative of the pressure in the fluid conductor 120.
  • the fourth sensor 162 may be a sensor configured to detect air in the fluid conductor 120 on the discharge side of the pump head 152.
  • the fourth sensor 162 may be, for example, an ultrasonic bubble sensor.
  • the fourth sensor 162 may be a bubble sensor available from Strain Measurement Devices of Wallingford, CT.
  • the fluid conductor 120 of the fluid removal apparatus 112 is coupled to the pump head 152 of the negative- pressure source 114, the fluid conductor 120 may be configured to be received within at least a portion of the fourth sensor 162.
  • the fourth sensor 162 may be a capacitive sensor.
  • the signals from the first sensor 156, the second sensor 158, the third sensor 160, and the fourth sensor 162 are suitable as input signals to the controller 116, but some signal conditioning may be appropriate in some embodiments.
  • the one or more of the signals may need to be filtered or amplified before they can be processed by the controller 116.
  • the signal is an electrical signal, but may be represented in other forms, such as an optical signal.
  • the controller 116 may receive and process data from one or more sensors, such as the first sensor 156, the second sensor 158, the third sensor 160, and the fourth sensor 162.
  • the controller 116 may also control the operation of one or more components of the fluid management system 100, such as, for example, the negative-pressure source 114 to manage the pressure delivered to the tissue site 102 based on, for example, the data from one or more of the first sensor 156, the second sensor 158, the third sensor 160, and the fourth sensor 162.
  • Some components of the fluid management 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 fluid management.
  • the negative-pressure source 114 may be combined with the controller 116, the first sensor 156, the second sensor 158, the third sensor 160, the fourth sensor 162 and other components, into a fluid management treatment unit.
  • the fluid management system 100 may further include a carrier, such as, for example, a cartridge 164 configured to retain at least a portion of the second conductor portion 128 of the fluid conductor 120.
  • the cartridge 164 may also be referred to as a cassette.
  • the cartridge 164 may be used to couple the fluid conductor 120 to the negative-pressure source 114.
  • the cartridge 164 may engage with the negative- pressure source 114, for example, by clipping, snapping, sliding, or inserting into the negative-pressure source 114, to couple the fluid conductor 120 to the negative-pressure source 114.
  • the cartridge 164 may place the second conductor portion 128 in contact with one or more of the rollers 154 of the pump head 152.
  • the cartridge 164 may be coupled to and/or supplied with the fluid removal apparatus 112.
  • the cartridge 164 may be a part of the negative-pressure source 114.
  • the cartridge 164 may include the pump head 152, wherein the pump head 152 is coupled to the motor if the cartridge 164 is coupled to the negative-pressure source 114.
  • the pump head 152 may be disposable with the cartridge 164.
  • the cartridge 164 may include a raceway into which the second conductor portion 128 of the fluid conductor 120 may be pressed into and/or against by the rollers 154 of the pump head 152.
  • the cartridge 164 may ensure proper placement of the second conductor portion 128 in relation to the pump head 152, the first sensor 156, the second sensor 158, the third sensor 160, and the fourth sensor 162.
  • measurements from one or more of the first sensor 156, the second sensor 158, the third sensor 160, and the fourth sensor 162 may be taken prior to turning on the negative-pressure source 114 to ensure proper placement of the second conductor portion 128.
  • the controller 116 may be programmed with the correct nominal measurements from one or more of the first sensor 156, the second sensor 158, the third sensor 160, and the fourth sensor 162 if the second conductor portion 128 is properly placed.
  • the controller 116 may be able to indicate that the second conductor portion 128 is improperly placed. In some embodiments, the controller 116 may not operate the negative-pressure source 114 until some or all ofthe measurements from the first sensor 156, the second sensor 158, the third sensor 160, and the fourth sensor 162 are at, or within a tolerance of, their nominal measurements.
  • the fluid management system 100 may be coupled to a dressing, such as a dressing 166, to provide negative-pressure wound therapy to the tissue site 102.
  • a dressing such as a dressing 166
  • the dressing 166 may comprise or consist essentially of a tissue interface 168, a cover 170, or both in some embodiments.
  • a dressing interface 172 may facilitate coupling the first end 122 of the fluid conductor 120 to the dressing 166.
  • the dressing interface 172 may be an elbow connector, which can be placed over an aperture in the cover 170 to provide a fluid path between the fluid conductor 120 and the tissue interface 168.
  • a dressing interface may be a SENSAT.R.A.C.TM Pad available from Kinetic Concepts, Inc. of San Antonio, Texas.
  • the tissue interface 168 can be generally adapted to partially or fully contact the tissue site 102.
  • the tissue interface 168 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 the tissue site 102.
  • the size and shape of the tissue interface 168 may be adapted to the contours of deep and irregular shaped tissue sites. Any or all of the surfaces of the tissue interface 168 may have an uneven, coarse, or jagged profile.
  • the tissue interface 168 may comprise or consist essentially of a manifold.
  • a manifold in this context may comprise or consist essentially of a means for collecting or distributing fluid across the tissue interface 168 under pressure.
  • a manifold may be adapted to receive negative pressure from a source and distribute negative pressure through multiple apertures across the tissue interface 168, which may have the effect of collecting fluid from across the tissue site 102 and drawing the fluid toward the source.
  • the fluid path may be reversed or a secondary fluid path may be provided to facilitate delivering fluid across the tissue site 102
  • a manifold may comprise a plurality of pathways, which can be interconnected to improve distribution or collection of fluids.
  • a manifold may comprise or consist essentially of a porous material having interconnected fluid pathways.
  • suitable porous material that can be adapted to form interconnected fluid pathways may include cellular foam, including open-cell foam such as reticulated foam; porous tissue collections; and other porous material such as gauze or felted mat that generally include pores, edges, and/or walls.
  • Liquids, gels, and other foams may also include or be cured to include apertures and fluid pathways.
  • a manifold may additionally or alternatively comprise projections that form interconnected fluid pathways.
  • a manifold may be molded to provide surface projections that define interconnected fluid pathways.
  • the tissue interface 168 may comprise or consist essentially of reticulated foam having pore sizes and free volume that may vary according to needs of a prescribed therapy.
  • reticulated foam having a free volume of at least 90% may be suitable for many therapy applications, and foam having an average pore size in a range of 400-600 microns (40-50 pores per inch) may be particularly suitable for some types of therapy.
  • the tensile strength of the tissue interface 168 may also vary according to needs of a prescribed therapy.
  • the 25% compression load deflection of the tissue interface 168 may be at least 0.35 pounds per square inch, and the 65% compression load deflection may be at least 0.43 pounds per square inch.
  • the tensile strength of the tissue interface 168 may be at least 10 pounds per square inch.
  • the tissue interface 168 may have a tear strength of at least 2.5 pounds per inch.
  • the tissue interface may be foam comprised of polyols such as polyester or polyether, isocyanate such as toluene diisocyanate, and polymerization modifiers such as amines and tin compounds.
  • the tissue interface 168 may be reticulated polyurethane foam such as found in GRANUFOAMTM dressing or V.A.C. VERAFLOTM dressing, both available from Kinetic Concepts, Inc. of San Antonio, Texas.
  • the thickness of the tissue interface 168 may also vary according to needs of a prescribed therapy. For example, the thickness of the tissue interface may be decreased to reduce tension on peripheral tissue. The thickness of the tissue interface 168 can also affect the conformability of the tissue interface 168. In some embodiments, a thickness in a range of about 5 millimeters to 10 millimeters may be suitable.
  • the tissue interface 168 may be either hydrophobic or hydrophilic. In an example in which the tissue interface 168 may be hydrophilic, the tissue interface 168 may also wick fluid away from the tissue site 102, while continuing to distribute negative pressure to the tissue site 102. The wicking properties of the tissue interface 168 may draw fluid away from the tissue site 102 by capillary flow or other wicking mechanisms.
  • a hydrophilic material that may be suitable is a polyvinyl alcohol, open-cell foam such as V.A.C. WHITEFOAMTM dressing available from Kinetic Concepts, Inc. of San Antonio, Texas.
  • Other hydrophilic foams may include those made from polyether.
  • Other foams that may exhibit hydrophilic characteristics include hydrophobic foams that have been treated or coated to provide hydrophilicity.
  • the tissue interface 168 may be constructed from bioresorbable materials. Suitable bioresorbable materials may include, without limitation, a polymeric blend of polylactic acid (PLA) and polygly colic acid (PGA). The polymeric blend may also include, without limitation, polycarbonates, polyfumarates, and capralactones.
  • the tissue interface 168 may further serve as a scaffold for new cell-growth, or a scaffold material may be used in conjunction with the tissue interface 168 to promote cell -growth.
  • a scaffold is generally a substance or structure used to enhance or promote the growth of cells or formation of tissue, such as a three-dimensional porous structure that provides a template for cell growth.
  • Illustrative examples of scaffold materials include calcium phosphate, collagen, PLA/PGA, coral hydroxy apatites, carbonates, or processed allograft materials.
  • the cover 170 may provide a bacterial barrier and protection from physical trauma.
  • the cover 170 may also be constructed from a material that can reduce evaporative losses and provide a fluid seal between two components or two environments, such as between a therapeutic environment and a local external environment.
  • the cover 170 may comprise or consist of, for example, an elastomeric fdm or membrane that can provide a seal adequate to maintain a negative pressure at the tissue site 102 for a given negative-pressure source.
  • the cover 170 may have a high moisture-vapor transmission rate (MVTR) in some applications.
  • MVTR moisture-vapor transmission rate
  • the MVTR may be at least 250 grams per square meter per twenty-four hours in some embodiments, measured using an upright cup technique according to ASTM E96/E96M Upright Cup Method at 38°C and 10% relative humidity (RH). In some embodiments, an MVTR up to 5,000 grams per square meter per twenty-four hours may provide effective breathability and mechanical properties.
  • the cover 170 may be a polymer drape, such as a polyurethane fdm, that is permeable to water vapor but impermeable to liquid.
  • a polymer drape such as a polyurethane fdm
  • Such drapes typically have a thickness in the range of 25-50 microns.
  • the permeability generally should be low enough that a desired negative pressure may be maintained.
  • the cover 170 may comprise, for example, one or more of the following materials: polyurethane (PU), such as hydrophilic polyurethane; cellulosics; hydrophilic polyamides; polyvinyl alcohol; polyvinyl pyrrolidone; hydrophilic acrylics; silicones, such as hydrophilic silicone elastomers; natural rubbers; polyisoprene; styrene butadiene rubber; chloroprene rubber; polybutadiene; nitrile rubber; butyl rubber; ethylene propylene rubber; ethylene propylene diene monomer; chlorosulfonated polyethylene; polysulfide rubber; ethylene vinyl acetate (EVA); co-polyester; and polyether block polymide copolymers.
  • PU polyurethane
  • PU polyurethane
  • hydrophilic polyurethane such as hydrophilic polyurethane
  • cellulosics such as cellulosics; hydrophilic polyamides
  • the cover 170 may comprise INSPIRE 2301 having an MVTR (upright cup technique) of 2600 g/m 2 /24 hours and a thickness of about 30 microns.
  • An attachment device may be used to attach the cover 170 to an attachment surface, such as undamaged epidermis, a gasket, or another cover.
  • the attachment device may take many forms.
  • an attachment device may be a medically-acceptable, pressure -sensitive adhesive configured to bond the cover 170 to epidermis around the tissue site 102.
  • some or all of the cover 170 may be coated with an adhesive, such as an acrylic adhesive, which may have a coating weight of about 25-65 grams per square meter (g.s.m.). Thicker adhesives, or combinations of adhesives, may be applied in some embodiments to improve the seal and reduce leaks.
  • Other example embodiments of an attachment device may include a double-sided tape, paste, hydrocolloid, hydrogel, silicone gel, or organogel.
  • the tissue interface 168 may be placed within, over, on, or otherwise proximate to the tissue site. If the tissue site 102 is a wound 110, for example, the tissue interface 168 may partially or completely fill the wound 110, or it may be placed over the wound 110.
  • the cover 170 may be placed over the tissue interface 168 and sealed to an attachment surface near the tissue site 102. For example, the cover 170 may be sealed to undamaged epidermis 104 peripheral to the tissue site 102.
  • the dressing 166 can provide a sealed therapeutic environment proximate to the tissue site 102, substantially isolated from the external environment, and the negative-pressure source 114 can reduce pressure in the sealed therapeutic environment.
  • Negative pressure applied across the tissue site 102 through the tissue interface 168 in the sealed therapeutic environment can induce macro-strain and micro-strain in the tissue site 102. Negative pressure can also remove exudate and other fluid from the tissue site 102, which can be collected in the container 118.
  • the first valve 132 and the second valve 134 may be downstream of the dressing 166. Additionally, in some embodiments, if the fluid removal apparatus 112 is coupled to the negative-pressure source 114: (i) the first sensor 156 may be downstream of the first valve 132 and the second valve 134; (ii) the pump head 152 may be downstream of the first sensor 156; (iii) and the second sensor 158, the third sensor 160, and the fourth sensor 162 may be downstream of the pump head 152.
  • the first sensor 156, the pump head 152, the second sensor 158, the third sensor 160, and the fourth sensor 162 may be between the first end 122 of the fluid conductor 120 and the container 118. In some embodiments, if the fluid removal apparatus 112 is coupled to the negative-pressure source 114 and the dressing 166, the first sensor 156, the pump head 152, the second sensor 158, the third sensor 160, and the fourth sensor 162 are between the dressing 166 and the container 118.
  • FIG. 2 is a schematic diagram of an example of the fluid management system 100, wherein the fluid management system includes a drain 200, which is inserted into the tissue site 102, such as, for example, a cavity.
  • the first end 122 of the fluid removal apparatus 112 may be fluidly coupled to a drain 200.
  • the first valve 132 and the second valve 134 of the fluid removal apparatus 112 may be downstream of the drain 200.
  • the drain 200 can be generally adapted for insertion into tissue sites, such as body cavities.
  • the drain 200 may take many forms, and have many sizes, shapes, or thicknesses, depending on a variety of factors, such as the type of tissue site 102 or the nature and size of the tissue site 102.
  • the size and shape of the drain 200 may be adapted to the contours of a pleural cavity.
  • the drain 200 may comprise or consist essentially of a fluid conductor.
  • a fluid conductor in this context may comprise a means for transmitting negative pressure or collecting fluid from the tissue site 102 under negative pressure.
  • the drain 200 may be adapted to receive negative pressure from the fluid conductor 120 and distribute negative pressure across the drain 200, which may have the effect of collecting fluid from the cavity and drawing the fluid through the fluid conductor 120towardthe container 118.
  • the drain 200 may comprise a tube 202 having a plurality of apertures 204 through which negative pressure may be distributed to the cavity and fluid may be removed from the cavity. The fluid removed from the cavity may be deposited in the container 118.
  • the fluid removal apparatus 112 may be coupled to the dressing 166 for use in negative-pressure wound therapy or the drain 200 for fluid drainage therapy.
  • the fluid removal apparatus 112 may be coupled to the negative-pressure source 114.
  • the second conductor portion 128 may be routed around at least a portion of the pump head 152 so that the rollers 154 of the negative-pressure source 114 can engage and compress at least a portion of the second conductor portion 128.
  • the fluid removal apparatus 112 may be coupled to the negative -pressure source 114 by the cartridge 164.
  • the second conductor portion 128 of the fluid conductor 120 may be placed in close proximity to or in contact with the first sensor 156, the second sensor 158, the third sensor 160, and the fourth sensor 162.
  • the container 118 may be placed within a chamber or enclosure of the negative-pressure source 114.
  • the container 118 may be coupled to an exterior surface of the negative-pressure source 114, such as, for example, a hook on the negative- pressure source 114.
  • the container 118 may be coupled to an object separate from the negative-pressure source 114, such as an intravenous pole.
  • Therapy may be initiated by rotating the pump head 152.
  • the rollers 154 of the pump head 152 begin to act upon the fluid conductor 120, negative pressure is applied to either the tissue interface 168 or the drain 200 (depending upon the type of therapy being applied).
  • the application of negative-pressure to the tissue site 102 may cause fluid to flow toward the fluid removal apparatus 112.
  • the fluid may be removed from the tissue site 102, where it may be drawn into the first end 122 of the fluid conductor 120.
  • the fluid may then flow past the first valve 132 and the second valve 134.
  • the fluid may flow past the first sensor 156 toward the pump head 152.
  • the pump head 152 pushes the fluid toward the second end 124 of the fluid conductor 120 past the fourth sensor 162, the second sensor 158, the third sensor 160, through the third valve 140, and into the container 118.
  • the negative pressure at the tissue site 102 and within the fluid conductor 120 builds as the pump head 152 continues to operate. If the negative pressure within the fluid conductor 120 exceeds the cracking pressure of the first valve 132, the first valve 132 is configured to open to allow air to be drawn from the atmosphere into the fluid conductor 120 to reduce the negative pressure.
  • the first valve 132 may be configured to have a cracking pressure at or within a range of a desired negative- pressure level for the particular therapy being applied. For example, in some embodiments, in wound drainage applications, the cracking pressure of the first valve 132 may be in a range of about -40 mmHg to about -50 mmHg.
  • the cracking pressure of the first valve 132 may be in a range of about -110 mmHg to about -130 mmHg.
  • the air drawn into the fluid conductor 120 through the first valve 132 may be filtered by the first filter 136.
  • the air drawn into the fluid conductor 120 through the first valve 132 may also enter the container 118 where it may aid in drying out the stabilizer 144, thus reversing absorption of the fluid so that the fluid can evaporate through the vent filters 142. Drying of the stabilizer 144 may increase the storage capacity of the container 118, allowing the fluid removal apparatus 112 to be used for longer periods of time before needing to be switched out or removed.
  • the second valve 134 is configured to open to allow air to be drawn from the atmosphere into the fluid conductor 120 to reduce the negative pressure.
  • the second valve 134 may be configured to have a cracking pressure at or below an unsafe negative-pressure level for the particular therapy being applied.
  • the cracking pressure of the second valve 134 may be about -100 mmHg.
  • the cracking pressure of the second valve 134 may be in a range of about -200 to about -250 mmHg.
  • the air drawn into the fluid conductor 120 through the second valve 134 may be fdtered by the second fdter 138.
  • the cracking pressure of the second valve 134 may be a greater negative pressure than the cracking pressure of the first valve 132.
  • the second valve 134 may act as a safety valve to ensure that the negative pressure within the fluid conductor 120 does not get too high if, for example, the first valve 132 fails to open or the negative-pressure source 114 delivers negative pressure to the fluid conductor 120 beyond a certain safe threshold.
  • the second valve 134 may be configured to permanently open once the cracking pressure of the second valve 134 is met or exceeded.
  • the fluid removal apparatus 112 may then need to be disposed of.
  • the activation of the second valve 134 may render the fluid removal apparatus 112 unusable for providing or continuing therapy and thus, in some embodiments, the second filter 138 may be omitted.
  • Figure 3 is a flow chart illustrating an example of a method 300 of managing fluid with a negative-pressure source.
  • the method 300 may be associated with delivering negative-pressure therapy to the tissue site 102 using the dressing 166 and fluid management system 100 of Figure 1, for example.
  • the method 300 may be associated with removing liquid from the cavity, of Figure 2 with the fluid management system 100, for example.
  • the method may be implemented in a controller, such as the controller 116 in the fluid management system 100.
  • the controller 116 may be configured to receive one or more input signals, such as pressure data from the first sensor 156, pressure data from the second sensor 158, pressure data from the third sensor 160, and fluid data from the fourth sensor 162, and may be programmed to modify one or more operating parameters based on the input signals.
  • input signals such as pressure data from the first sensor 156, pressure data from the second sensor 158, pressure data from the third sensor 160, and fluid data from the fourth sensor 162, and may be programmed to modify one or more operating parameters based on the input signals.
  • the method 300 may begin by rotating the pump head 152 to generate reduced pressure in the fluid conductor 120 at step 302.
  • the reduced pressure may be supplied to the dressing 166 or the drain 200 through the fluid conductor 120. Fluid may then be removed from the tissue site 102, conducted through the fluid conductor 120, and deposited in the container 118. If the container 118 becomes full, the negative-pressure source 114 may continue to operate and push additional fluid into the container 118, creating a backpressure in the fluid conductor 120 on the discharge side of the pump head 152. The backpressure may cause the discharge side of the second conductor portion 128 to expand.
  • backpressure may also build up in the discharge side of the fluid conductor, causing the discharge side of the second conductor portion 128 to expand.
  • the second sensor 158 may be located within a sufficient proximity to or in contact with the second conductor portion 128 to detect the expansion of the discharge side of the second conductor portion 128.
  • the controller 116 may be configured to determine that the container 118 is full or that there is a blockage in the fluid conductor 120 downstream of the pump head 152.
  • the controller 116 can indicate that the container 118 is full or that the discharge side of the fluid conductor 120 is blocked. Then at step 308, the controller 116 can turn the motor of the negative- pressure source 114 off to stop rotating the pump head 152.
  • the method 300 may proceed to step 310. If a blockage in the suction side of the fluid conductor 120 occurs during the application of negative pressure, the negative-pressure source 114 may continue to operate, causing the suction side of the second conductor portion 128 to collapse. If a blockage occurs in the suction side of the fluid conductor 120, negative pressure is no longer being supplied to the tissue site 102.
  • the first sensor 156 may be located within a sufficient proximity to or in contact with the second conductor portion 128 to detect the collapse of the suction side of the second conductor portion 128.
  • the controller 116 may be configured to determine that there is a blockage in the fluid conductor 120 upstream of the pump head 152. Accordingly, if at step 310 the first sensor 156 detects that the suction side of the second conductor portion 128 is collapsed, then at step 312 the controller 116 can indicate that the suction side of the fluid conductor 120 is blocked. Then at step 308, the controller 116 can turn the motor of the negative-pressure source 114 off to stop rotating the pump head 152.
  • the method 300 may proceed to step 314. If during the course of therapy, a higher than required negative pressure develops within the fluid conductor 120, due to, for example, the first valve 132 and the second valve 134 not opening, the negative pressure in the suction side of the fluid conductor 120 may bleed past the pump head 152 into the discharge side of the conductor 120. This negative pressure in the discharge side of the fluid conductor 120 may then act upon the third valve 140, pulling it closed, which may cause the discharge side of the second conductor portion 128 to collapse.
  • the third valve 140 does not close and the negative pressure in the discharge side of the fluid conductor 120 exceeds the flow rate of the vent filters 142, then the discharge side of the second conductor portion 128 may collapse.
  • the third sensor 160 may be located within a sufficient proximity to or in contact with the second conductor portion 128 to detect the collapse of the discharge side of the second conductor portion 128.
  • the controller 116 may be configured to determine that there is an over pressurization in the fluid conductor 120 based on the collapse of the discharge side of the second conductor portion 128. Accordingly, if at step 314 the third sensor 160 detects that the discharge side of the second conductor portion 128 is collapsed, then at step 316 the controller 116 can indicate an over-pressurization condition in the fluid conductor 120. Then at step 308, the controller 116 can turn the motor of the negative-pressure source 114 off to stop rotating the pump head 152.
  • the method 300 may proceed to step 318. If during the course of therapy, there is no more liquid at the tissue site 102 to remove, the first valve 132 has opened, the second valve 134 has opened, or there is another leak in the upstream side of the fluid conductor 120, the fluid drawn into the fluid conductor 120 may be substantially or completely air, with little or no liquid in the fluid conductor 120. If one or more of the first valve 132 and the second valve 134 have opened, there may be no need to continue operating the negative-pressure source 114.
  • the controller 116 may be configured to detect a leak or that there is no more liquid at the tissue site 102. If at step 318 the fourth sensor 162 detects that the fluid conductor 120 is substantially or completely filled with air such that there is little or no liquid in the fluid conductor 120, then at step 320 the controller 116 can indicate that there is a leak in the fluid removal apparatus 112 or that there is no more liquid at the tissue site 102.
  • the controller 116 can then wait a period of time at step 322 before turning off the motor of the negative- pressure source 114 to stop rotating the pump head 152 at step 308. In some embodiments, a desired wait time at step 318 may be specified. If liquid is detected in the fluid conductor at step 318, the method 300 may cycle back to step 302.
  • step 314 and step 316 may be omitted.
  • the controller 116 may be programmed to simultaneously monitor the signals from one or more of the first sensor 156, the second sensor 158, the third sensor 160, and the fourth sensor 162 to control the operation of the fluid management system 100, such as, for example, the negative-pressure source 114.
  • the fluid management system 100 with a flexible container 118 may be more efficient at fluid removal than therapy systems that utilize rigid containers.
  • therapy systems that employ a rigid container if fluid removal is required, air must first be evacuated from the container before liquid removal can begin, leading to inefficiencies.
  • the time and energy required to evacuate the air from a rigid container may be significant if a large container is utilized.
  • the requirement of evacuating air from a rigid container prior to every delivery of negative pressure to a tissue site is a drain on the power system of a negative-pressure source, which may thus require a larger power source (e.g., battery) or constant access to an electrical receptacle, resulting in decreased portability of the therapy system and patient mobility.
  • a larger power source e.g., battery
  • the fluid management system 100 may provide increased therapeutic and power efficiencies (e.g. reduced battery size), as well as improved portability of the fluid management system 100 and patient mobility.
  • a single-use, disposable fluid removal apparatus 112 may be particularly beneficial in the home health context where the fluid removal apparatus 112 can be easily disposed of once the container 118 becomes full or the second valve 134 opens, and the negative-pressure source 114 may be reused with a new fluid removal apparatus 112 without needing to sterilize the negative- pressure source 114.
  • the ability to easily dispose of the container 118, such as a flexible bag, eliminates a need to clean and reuse the container 118.
  • Flexible containers 118 may be particularly advantageous in the home health context where storage space may be limited. Additionally, flexible containers 118 may be environmentally friendly.
  • the fluid removal apparatus 112 having a flexible container 118 may be packaged in a small volume, allowing for easier storage.
  • the container 118 of the fluid removal apparatus 112 does not need to be physically coupled to the negative-pressure source 114 in order to provide therapy, the size of the negative-pressure source 114 may be reduced, potentially allowing for greater portability and reduced barriers to use of the fluid management system 100, for example, in the home health context.
  • the fluid management system 100 provides for a low-cost, safe, efficient, and easily disposed of fluid removal apparatus 112.
  • the fluid removal apparatus 112 may be easily coupled to the negative-pressure source 114 without having to first assemble elements of the fluid removal apparatus 112. Providing a fully assembled fluid removal apparatus 112 reduces or eliminates the potential for improper assembly of the fluid removal apparatus 112. Additionally, including the cartridge 164 with the fluid removal apparatus 112 may further aid in coupling the fluid removal apparatus 112 to the negative-pressure source 114.
  • the cartridge 164 may include features that only allow the cartridge 164 to be coupled to the negative-pressure source 114 in one way. These features may prevent incorrect coupling of the fluid removal apparatus 112 to the negative-pressure source 114, such as reversing the flow direction. The features may also ensure proper placement of the fluid conductor 120 against the pump head 152 and coupling of the fluid conductor 120 with the first sensor 156, the second sensor 158, the third sensor 160, and the fourth sensor 162.
  • the first valve 132 may be set to open at a safe operating pressure for the particular therapy to easily control the negative pressure applied to a tissue site with a peristaltic pump; however, first valve 132Accordingly, configuring the first valve 132 to open at the desired operating negative pressure provides a simple and cost-effective negative-pressure control solution.
  • the included first filter 136 may provide bacterial and viral filtering of the air being drawn into the fluid conductor 120 through the first valve 132, which may ensure that in the event of fluid or gas reflux, contaminants are removed from the intake air before they can contaminate the fluid or the tissue site 102.
  • the ability to determine whether the container 118 is full based upon the fluid conductor 120 expanding using the second sensor 158 allows the fluid management system 100 to be used in multiple orientations.
  • the container 118 of the fluid removal apparatus 112 can be oriented in many different positions, either coupled to or physically separate from the negative- pressure source 114, and a “container full” condition can still be determined based on input from the second sensor 158. Determining whether the container 118 is full does not rely on a sensor in direct contact with the container 118.
  • a container 118 of various sizes or shapes can be used with the fluid management system 100 without the need to change fluid management system 100. For example, no reprogramming of the controller 116 is required if a larger or smaller container 118 is used. For an additional example, the negative-pressure source 114 does not need to be of different sizes to accept a different sized container 118. The ability of the fluid management system 100 to be used with different sized containers 118 provides a modular solution with lower cost and complexity.
  • An additional benefit provided by the first sensor 156 and the second sensor 158 is the ability to detect blockages, entrapments, crushing, or occlusion of the fluid conductor 120 on the suction side and the discharge side of the pump head 152, respectively.
  • the fourth sensor 162 can permit detection of a gross leak in the fluid removal apparatus 112.
  • the fourth sensor 162 can determine a leak based on a period of time that little or no liquid is flowing through the fluid conductor 120.
  • the absence of liquid flowing through the fluid conductor 120 after a period of time that the negative -pressure source 114 has been operating may be the result of a gross leak at some part of the fluid removal apparatus 112 (e.g., the connection between the first end 122 of the fluid conductor 120 and the dressing interface 172 or drain 200) or the tissue site 102 has been fully evacuated of fluid and one or more of the first valve 132 and the second valve 134 have opened.
  • the controller 116 may be able to shut down the negative-pressure source 114 and indicate that either a leak exists or all the fluid has been removed from the tissue site 102.
  • the second valve 134 also provides a safety feature that may ensure that no unsafe negative pressure is delivered to the tissue site 102 in the event of a system failure, such as, for example, failure of the negative-pressure source 114 to shut off, failure of the first valve 132 to open, damage to the first valve 132 rendering it unable to open, contamination occluding the first valve 132, or the first valve 132 is covered such that it cannot regulate pressure.
  • a system failure such as, for example, failure of the negative-pressure source 114 to shut off, failure of the first valve 132 to open, damage to the first valve 132 rendering it unable to open, contamination occluding the first valve 132, or the first valve 132 is covered such that it cannot regulate pressure.
  • the third sensor 160 may be able to detect if the negative pressure in the fluid conductor 120 has exceeded a desired negative pressure and the controller 116 may be configured to turn off the negative-pressure source 114 to reduce or prevent damage to the tissue site.
  • the ability to turn off the negative-pressure source 114 based on the measurements from the third sensor 160 is another safety feature provided by the fluid management system 100.
  • the location of the first valve 132 and second valve 134 downstream of the dressing 166 or drain 200 can provide further benefits.
  • placing the first valve 132 and the second valve 134 downstream of the dressing 166 can reduce or eliminate excessive drying of the tissue site 102 that may occur if the first valve 132 and the second valve 134 were placed upstream of the dressing 166. Excessive drying of the tissue site 102 may result in longer healing time and overall reduced effectiveness of negative-pressure wound therapy. Additionally, if the first valve 132 and the second valve 134 were placed upstream of the drain 200, it could be difficult or impossible for the drain 200 to be placed within the cavity and still function properly.
  • the first valve 132 and the second valve 134 would likely also be inserted into the cavity where they would not be able to draw in ambient air at atmospheric pressure, rendering the first valve 132 and the second valve 134 unable to relieve pressure within the cavity and the fluid conductor 120. This could potentially result in an unsafe over pressurization within the cavity. Placing the placing the first valve 132 and the second valve 134 downstream of the drain 200 allows for the drain 200, the first valve 132, and the second valve 134 to operate properly.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne un appareil servant à éliminer du fluide d'un site tissulaire, celui-ci comprenant un récipient, un tube conçu pour être couplé de manière fluidique au site tissulaire au niveau d'une première extrémité et au récipient au niveau d'une seconde extrémité, une première vanne et une seconde vanne conçues pour être couplées de manière fluidique au tube situé à proximité de la première extrémité, un clapet anti-retour conçu pour être couplé de manière fluidique au tube situé à proximité de la seconde extrémité. Le tube peut être conçu pour venir en prise avec une source de pression négative ayant une tête de pompe péristaltique. L'appareil peut être couplé à un drain et utilisé pour gérer l'accumulation de fluide dans une cavité interne. L'appareil peut être couplé à un pansement et utilisé pour appliquer une pression négative au site tissulaire. L'appareil peut en outre comprendre un système de commande configuré pour faire fonctionner la source de pression négative pour gérer l'élimination de fluide ou l'application d'une pression négative à l'aide de l'appareil.
PCT/IB2020/057329 2019-08-09 2020-08-03 Appareil d'élimination de fluide destiné à être utilisé avec une pompe péristaltique WO2021028774A1 (fr)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024035645A1 (fr) * 2022-08-08 2024-02-15 The Children's Hospital Of Philadelphia Système de détection de débit extensible pour soulager une congestion du système lymphatique

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150246164A1 (en) * 2012-09-21 2015-09-03 12R Medical Limited Portable Medical Device System
US20190001032A1 (en) * 2008-01-08 2019-01-03 Bluesky Medical Group Inc. Sustained variable negative pressure wound treatment and method of controlling same

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190001032A1 (en) * 2008-01-08 2019-01-03 Bluesky Medical Group Inc. Sustained variable negative pressure wound treatment and method of controlling same
US20150246164A1 (en) * 2012-09-21 2015-09-03 12R Medical Limited Portable Medical Device System

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024035645A1 (fr) * 2022-08-08 2024-02-15 The Children's Hospital Of Philadelphia Système de détection de débit extensible pour soulager une congestion du système lymphatique

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