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WO2021209951A1 - Ensemble de tubes pour la surveillance de la pression - Google Patents

Ensemble de tubes pour la surveillance de la pression Download PDF

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Publication number
WO2021209951A1
WO2021209951A1 PCT/IB2021/053125 IB2021053125W WO2021209951A1 WO 2021209951 A1 WO2021209951 A1 WO 2021209951A1 IB 2021053125 W IB2021053125 W IB 2021053125W WO 2021209951 A1 WO2021209951 A1 WO 2021209951A1
Authority
WO
WIPO (PCT)
Prior art keywords
annular wall
planar surface
lumen
fluid path
lumen tube
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/IB2021/053125
Other languages
English (en)
Inventor
Benjamin Andrew Pratt
James Killingworth Seddon
Thomas Alan EDWARDS
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
KCI Licensing Inc
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.)
Filing date
Publication date
Application filed by KCI Licensing Inc filed Critical KCI Licensing Inc
Publication of WO2021209951A1 publication Critical patent/WO2021209951A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/92—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing with liquid supply 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/84—Drainage tubes; Aspiration tips
    • A61M1/85—Drainage tubes; Aspiration tips with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants
    • 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
    • A61M1/91—Suction aspects of the dressing
    • A61M1/918—Suction aspects of the dressing for multiple suction locations
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/105—Multi-channel connectors or couplings, e.g. for connecting multi-lumen tubes
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/12—Tube connectors; Tube couplings for joining a flexible tube to a rigid attachment
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16L—PIPES; JOINTS OR FITTINGS FOR PIPES; SUPPORTS FOR PIPES, CABLES OR PROTECTIVE TUBING; MEANS FOR THERMAL INSULATION IN GENERAL
    • F16L37/00—Couplings of the quick-acting type
    • F16L37/56—Couplings of the quick-acting type for double-walled or multi-channel pipes or pipe assemblies
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16L—PIPES; JOINTS OR FITTINGS FOR PIPES; SUPPORTS FOR PIPES, CABLES OR PROTECTIVE TUBING; MEANS FOR THERMAL INSULATION IN GENERAL
    • F16L39/00—Joints or fittings for double-walled or multi-channel pipes or pipe assemblies
    • F16L39/02—Joints or fittings for double-walled or multi-channel pipes or pipe assemblies for hoses
    • 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
    • A61M2205/3344—Measuring or controlling pressure at the body treatment site
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A61M5/16854—Monitoring, detecting, signalling or eliminating infusion flow anomalies by monitoring line pressure

Definitions

  • the invention set forth in the appended claims relates generally to tissue treatment systems and more particularly, but without limitation, to apparatuses and methods for providing negative-pressure therapy and instillation therapy.
  • 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.
  • cleansing a tissue site can be highly beneficial for new tissue growth.
  • a wound or a cavity can be washed out with a liquid solution for therapeutic purposes.
  • These practices are commonly referred to as “irrigation” and “lavage” respectively.
  • “Instillation” is another practice that generally refers to a process of slowly introducing fluid to a tissue site and leaving the fluid for a prescribed period of time before removing the fluid.
  • instillation of topical treatment solutions over a wound bed can be combined with negative- pressure therapy to further promote wound healing by loosening soluble contaminants in a wound bed and removing infectious material. As a result, soluble bacterial burden can be decreased, contaminants removed, and the wound cleansed.
  • an apparatus for connecting multi-lumen conduits can comprise a first port having a first fluid path and a second fluid path, a second port having a third fluid path, a third port having a fourth fluid path and a fifth fluid path, and a fourth port having a sixth fluid path.
  • the second fluid path can be independent from the first fluid path and the fifth fluid path can be independent from the fourth fluid path.
  • the connector can have a first housing and a second housing coupled to the first housing.
  • the first housing can have a first receptacle having a first delivery conduit and a first sensing conduit and a second receptacle.
  • the second housing can have a third receptacle having a second delivery conduit and a second sensing conduit and a fourth receptacle.
  • the first sensing conduit can be fluidly coupled to the second sensing conduit between the first housing and the second housing.
  • a system for providing instillation and negative-pressure therapy is also described herein, wherein some example embodiments include an instillation source and a negative-pressure source.
  • the instillation source can deliver instillation fluid.
  • the negative-pressure source can be configured to provide negative-pressure and pressure sensing.
  • the system can also include a first dressing interface and a second dressing interface. The first dressing interface and the second dressing interface can be coupled to the dressing.
  • Embodiments of the system have a first single lumen tube and a first multi -lumen tube. The first single lumen tube can be fluidly coupled to the first dressing interface and the first multi -lumen tube can be fluidly coupled to the second dressing interface.
  • Embodiments of the system also have a second single lumen tube and a second multi -lumen tube.
  • the second single lumen tube can be fluidly coupled to the instillation source and the second multi-lumen tube can be fluidly coupled to the negative pressure source.
  • the first multi-lumen tube can also include a first delivery lumen and a first pressure sensing lumen and the second multi-lumen tube can include a second delivery lumen and a second pressure-sensing lumen.
  • the system can also include an adapter. The adapter can be configured to fluidly couple the first pressure sensing lumen of the first multi -lumen tube to the second pressure sensing lumen of the second multi -lumen tube.
  • the adapter can also be configured to fluidly couple the first delivery lumen of the first multi-lumen tube to the second single lumen tube.
  • the adapter can also be configured to fluidly couple the second delivery lumen of the second multi-lumen tube to the first single lumen tube.
  • a method for providing instillation therapy and negative-pressure therapy is also described herein.
  • An inline connector can be provided.
  • the inline connector can include a first port, a second port, a third port, and a fourth port.
  • the first port can include a first fluid path and a second fluid path.
  • the second fluid path can be independent of the first fluid path.
  • the second port can have a third fluid path.
  • the third port can have a fourth fluid path and a fifth fluid path.
  • the fifth fluid path can be independent of the fourth fluid path.
  • the fourth port can have a sixth fluid path.
  • the first fluid path can be fluidly coupled to the fourth fluid path
  • the second fluid path can be fluidly coupled to the sixth fluid path
  • the third fluid path can be fluidly coupled to the fifth fluid path.
  • the method can also include providing a therapy unit.
  • the therapy unit can have a negative pressure delivery lumen, a pressure sensing lumen, and an instillation therapy lumen.
  • the method can include fluidly coupling the negative-pressure delivery lumen to the fifth fluid path of the inline connector.
  • the method can include fluidly coupling the pressure sensing lumen to the fourth fluid path of the inline connector.
  • the method can also include fluidly coupling the instillation therapy lumen to the sixth fluid path of the inline connector.
  • the method can further include fluidly coupling a first dressing to the third fluid path.
  • the method can also include fluidly coupling a second dressing to the first fluid path and the second fluid path.
  • Figure 1 is a functional block diagram of an example embodiment of a therapy system that can provide negative-pressure treatment and instillation treatment in accordance with this specification;
  • Figure 2 is a schematic diagram of the therapy system of Figure 1;
  • Figure 3 is an exploded, perspective view of an adapter of Figure 2, illustrating additional details that may be associated with some embodiments;
  • Figure 4 is a cross-sectional view of the adapter taken along line 4 — 4 of Figure 2, illustrating additional details that may be associated with some embodiments of the therapy system of Figure 2;
  • Figure 5 is a cross-sectional view of a tube-set with the adapter taken in the plane of Figure 2, illustrating additional details that may be associated with some embodiments;
  • Figure 6A is a right-side view of an exterior of a first housing of the adapter of Figure 2, illustrating additional details that may be associated with some embodiments;
  • Figure 6B is a left-side view of an interior of the first housing of the adapter of Figure
  • Figure 7A is a left-side view of an exterior of a second housing of the adapter of Figure 2, illustrating additional details that may be associated with some embodiments;
  • Figure 7B is a right-side view of an interior of the second housing of the adapter of Figure 2, illustrating additional details that may be associated with some embodiments;
  • Figure 8 is an exploded perspective view of the adapter with the tube set of Figure 2, illustrating additional details that may be associated with some embodiments.
  • Figure 9 is an assembled perspective view of the adapter with the tube set of Figure 2, illustrating additional details that may be associated with some embodiments.
  • FIG. 1 is a simplified functional block diagram of an example embodiment of a therapy system 100 that can provide negative-pressure therapy with instillation of topical treatment solutions to a tissue site in accordance with this specification.
  • 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, or ligaments.
  • 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 therapy system 100 may include a source or supply of negative pressure, such as a negative-pressure source 102, 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 104, and a fluid container, such as a container 106, are examples of distribution components that may be associated with some examples of the therapy system 100.
  • the dressing 104 may comprise or consist essentially of a tissue interface 108 and a cover 112, or both in some embodiments.
  • the dressing 104 may also include a dressing interface 114 to facilitate coupling the negative-pressure source 102 to the dressing 104.
  • 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 such as the dressing interface 114, may facilitate coupling a fluid conductor to the dressing 104.
  • the dressing interface 114 may be a SENSAT.R.A.C.TM Pad available from Kinetic Concepts, Inc. of San Antonio, Texas.
  • the therapy system 100 may also include a regulator or controller, such as a controller 116. Additionally, the therapy system 100 may include sensors to measure operating parameters and provide feedback signals to the controller 116 indicative of the operating parameters. As illustrated in Figure 1, for example, the therapy system 100 may include a first sensor 118 and a second sensor 120 coupled to the controller 116.
  • the therapy system 100 may also include a source of instillation solution.
  • a solution source 122 may be fluidly coupled to the dressing 104, as illustrated in the example embodiment of Figure 1.
  • the solution source 122 may be fluidly coupled to a positive-pressure source such as a positive-pressure source 124, a negative-pressure source such as the negative-pressure source 102, or both in some embodiments.
  • a regulator such as an instillation regulator 126, may also be fluidly coupled to the solution source 122 and the dressing 104 to ensure proper dosage of instillation solution (e.g. saline) to a tissue site.
  • the instillation regulator 126 may comprise a piston that can be pneumatically actuated by the negative-pressure source 102 to draw instillation solution from the solution source during a negative-pressure interval and to instill the solution to a dressing during a venting interval.
  • the controller 116 may be coupled to the negative-pressure source 102, the positive-pressure source 124, or both, to control dosage of instillation solution to a tissue site.
  • the instillation regulator 126 may also be fluidly coupled to the negative -pressure source 102 through the dressing 104, as illustrated in the example of Figure 1.
  • the dressing interface 114 may facilitate coupling the solution source 122 to the dressing 104.
  • the instillation regulator 126 may also be fluidly coupled to the negative-pressure source 102.
  • the instillation regulator 126 may be directly coupled to the negative-pressure source 102, or may be indirectly coupled to the negative-pressure source 102, as illustrated in Figure 1, through other distribution components.
  • the instillation regulator 126 may be fluidly coupled to the negative-pressure source 102 through the dressing 104.
  • 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 102 may be combined with the controller 116, the solution source 122, and other components into a therapy unit 128.
  • the therapy unit 128 may be, for example, a V.A.C.ULTATM Therapy Unit available from Kinetic Concepts, Inc. of San Antonio, Texas.
  • components of the therapy system 100 may be coupled directly or indirectly.
  • the negative-pressure source 102 may be directly coupled to the container 106 and may be indirectly coupled to the dressing 104 through the container 106. 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 102 may be electrically coupled to the controller 116 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 102, 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 micro pump, 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 102 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 106 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 116, may be a microprocessor or computer programmed to operate one or more components of the therapy system 100, such as the negative- pressure source 102.
  • 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 therapy system 100. Operating parameters may include the power applied to the negative-pressure source 102, the pressure generated by the negative-pressure source 102, or the pressure distributed to the tissue interface 108, for example.
  • the controller 116 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.
  • Sensors such as the first sensor 118 and the second sensor 120, 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 118 and the second sensor 120 may be configured to measure one or more operating parameters of the therapy system 100.
  • the first sensor 118 may be a transducer configured to measure pressure in a pneumatic pathway and convert the measurement to a signal indicative of the pressure measured.
  • the first sensor 118 may be a piezo-resistive strain gauge.
  • the second sensor 120 may optionally measure operating parameters of the negative-pressure source 102, such as a voltage or current, in some embodiments.
  • the signals from the first sensor 118 and the second sensor 120 are suitable as an input signal to the controller 116, 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 116.
  • the signal is an electrical signal, but may be represented in other forms, such as an optical signal.
  • the tissue interface 108 can be generally adapted to partially or fully contact a tissue site.
  • the tissue interface 108 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 108 may be adapted to the contours of deep and irregular shaped tissue sites. Any or all of the surfaces of the tissue interface 108 may have an uneven, coarse, or jagged profile.
  • the tissue interface 108 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 108 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 108, which may have the effect of collecting fluid from across a tissue site 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, such as fluid from a source of instillation solution, across a tissue site.
  • 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 108 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 108 may also vary according to needs of a prescribed therapy. For example, the tensile strength of foam may be increased for instillation of topical treatment solutions.
  • the 25% compression load deflection of the tissue interface 108 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 108 may be at least 10 pounds per square inch.
  • the tissue interface 108 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 108 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 108 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 108 can also affect the conformability of the tissue interface 108. In some embodiments, a thickness in a range of about 5 millimeters to 10 millimeters may be suitable.
  • the tissue interface 108 may be either hydrophobic or hydrophilic.
  • the tissue interface 108 may also wick fluid away from a tissue site, while continuing to distribute negative pressure to the tissue site.
  • the wicking properties of the tissue interface 108 may draw fluid away from a tissue site 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.
  • the tissue interface 108 may be constructed from bioresorbable materials. Suitable bioresorbable materials may include, without limitation, a polymeric blend of polylactic acid (PLA) and polyglycolic acid (PGA). The polymeric blend may also include, without limitation, polycarbonates, polyfumarates, and capralactones. The tissue interface 108 may further serve as a scaffold for new cell-growth, or a scaffold material may be used in conjunction with the tissue interface 108 to promote cell -growth.
  • PLA polylactic acid
  • PGA polyglycolic acid
  • the tissue interface 108 may further serve as a scaffold for new cell-growth, or a scaffold material may be used in conjunction with the tissue interface 108 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 112 may provide a bacterial barrier and protection from physical trauma.
  • the cover 112 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 112 may comprise or consist of, for example, an elastomeric film or membrane that can provide a seal adequate to maintain a negative pressure at a tissue site for a given negative-pressure source.
  • the cover 112 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 112 may be a polymer drape, such as a polyurethane film, that is permeable to water vapor but impermeable to liquid.
  • a polymer drape such as a polyurethane film
  • 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 112 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 112 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 112 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 112 to epidermis around a tissue site.
  • some or all of the cover 112 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 solution source 122 may also be representative of a container, canister, pouch, bag, or other storage component, which can provide a solution for instillation therapy.
  • Compositions of solutions may vary according to a prescribed therapy, but examples of solutions that may be suitable for some prescriptions include hypochlorite-based solutions, silver nitrate (0.5%), sulfur-based solutions, biguanides, cationic solutions, and isotonic solutions.
  • the tissue interface 108 may be placed within, over, on, or otherwise proximate to atissue site. If the tissue site is a wound, for example, the tissue interface 108 may partially or completely fill the wound, or it may be placed over the wound.
  • the cover 112 may be placed over the tissue interface 108 and sealed to an attachment surface near a tissue site. For example, the cover 112 may be sealed to undamaged epidermis peripheral to a tissue site.
  • the dressing 104 can provide a sealed therapeutic environment proximate to a tissue site, substantially isolated from the external environment, and the negative-pressure source 102 can reduce pressure in the sealed therapeutic environment. Negative pressure applied across the tissue site through the tissue interface 108 in the sealed therapeutic environment can induce macrostram and microstrain in the tissue site, as well as remove exudates and other fluids from the tissue site, which can be collected in container 106.
  • the fluid mechanics of using a negative-pressure source to reduce pressure in another component or location, such as within a sealed therapeutic environment can be mathematically complex.
  • the basic principles of fluid mechanics applicable to negative-pressure therapy and instillation 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.
  • downstream typically implies some a position in a fluid path relatively closer to a source of negative pressure or further away from a source of positive pressure.
  • upstream implies a position relatively further away from a source of negative pressure or closer to a source of positive pressure.
  • inlet or outlet in such a frame of reference. This orientation is generally presumed for purposes of describing various features and components herein.
  • the fluid path may also be reversed in some applications, such as by substituting a positive-pressure source for a negative-pressure source, and this descriptive convention should not be construed as a limiting convention.
  • Negative pressure applied across the tissue site through the tissue interface 108 in the sealed therapeutic environment can induce macro-strain and micro-strain in the tissue site. Negative pressure can also remove exudate and other fluid from a tissue site, which can be collected in container 106.
  • the controller 116 may receive and process data from one or more sensors, such as the first sensor 118. The controller 116 may also control the operation of one or more components of the therapy system 100 to manage the pressure delivered to the tissue interface 108.
  • controller 116 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 108.
  • 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 116.
  • the target pressure may vary from tissue site to tissue site based on the type of tissue forming a tissue site, the type of injury or wound (if any), the medical condition of the patient, and the preference of the attending physician.
  • the controller 116 can operate the negative-pressure source 102 in one or more control modes based on the target pressure and may receive feedback from one or more sensors to maintain the target pressure at the tissue interface 108.
  • Therapy systems that provide negative-pressure therapy and instillation therapy may provide both negative pressure and instillation to a tissue site through a same dressing interface.
  • the therapy unit may be coupled to a dressing interface by a multi-lumen tube.
  • a primary lumen of the tube may be used to instill fluid to the dressing through the dressing interface, and at the conclusion of the instillation therapy, the therapy unit may draw fluid from the dressing through the primary lumen to provide negative-pressure therapy.
  • the therapy unit may determine the pressure at the tissue site through a pressure sensor disposed at the tissue site or through a plurality of secondary lumens in the multi-lumen tube.
  • Providing instillation and negative -pressure therapy through a single tube may decrease the efficiency of both therapies.
  • instilling fluid or drawing fluid across a pressure sensor or across the secondary lumens may interfere with the determination of a pressure at the tissue site.
  • Some systems separate the provision of instillation therapy and negative-pressure therapy by using separate dressing interfaces for each therapy.
  • a first dressing interface can be positioned at a first location, and a second dressing interface can be positioned at a second location on the same dressing.
  • Instillation fluid may be delivered to the first dressing interface, and negative pressure may be delivered to the second dressing interface.
  • negative pressure may be delivered to the second dressing interface.
  • the instilled fluid may travel across the dressing from the first location to the second location.
  • pressure sensing may still be associated with the negative- pressure therapy. For example, pressure sensing lumens are often located at the second location where negative pressure is being delivered.
  • instilled fluid may be drawn across the pressure -sensing lumens, potentially causing blockages in the pressure-sensing lumens that may inhibit accurate pressure sensing. Furthermore, sensing pressure at the location of delivery of negative-pressure therapy may provide only a partial picture of the pressure at a tissue site.
  • the therapy system 100 which can position the pressure sensing and negative-pressure therapy at different locations of a tissue site. Sensing pressure at a different location than negative-pressure therapy may improve the efficiency of pressure determination at the tissue site and improve delivery of negative-pressure therapy and instillation therapy. For example, if the pressure sensing lumens are located at the first location where instillation fluid is being delivered, fluid and exudate may flow in a direction away from the pressure sensing lumens and towards the source of negative pressure. Thus, fluid and exudate is less likely to contact the pressure sensing lumens, reducing the risks of clogging and blocking of the pressure sensing lumens. Furthermore, during a negative-pressure therapy cycle, the determined pressure may provide a fuller picture of the pressure at the tissue site.
  • FIG. 2 is a schematic diagram of an example embodiment of the therapy system 100 configured to apply negative pressure and instillation fluid to a tissue site 202.
  • the therapy system 100 can generally include the therapy unit 128, a tube-set 200, and the dressing 104.
  • the tube-set 200 may fluidly couple the therapy unit 128 to the dressing 104.
  • the dressing interface 114 may comprise more than one dressing interface.
  • the dressing interface 114 may comprise two dressing interfaces, a first dressing interface 204 and a second dressing interface 206.
  • the first dressing interface 204 and the second dressing interface 206 may be coupled to the cover 112.
  • Each of the first dressing interface 204 and the second dressing interface 206 can be configured to provide a fluid coupling to the tissue interface 108 through the cover 112.
  • the first dressing interface 204 can be positioned at a first location
  • the second dressing interface 206 can be positioned at a second location.
  • the first dressing interface 204 and the second dressing interface 206 may be placed at opposing ends of the tissue site 202.
  • the tissue site 202 may be elongated having a rectangular or elongated ovular shape.
  • the first location may be proximate to a short edge of the tissue site
  • the second location may be proximate to another short edge of the tissue site that is separated from the first location by about a maximum length of the tissue site.
  • the negative-pressure source 102 may be fluidly coupled to the first dressing interface 204
  • the solution source 122 may be fluidly coupled to the second dressing interface 206.
  • the tube-set 200 may include an in-line connector, such as an adapter 224, a first single lumen tube 208, and a first multi-lumen tube 210.
  • the first single lumen tube 208 may be configured to be fluidly coupled to the first dressing interface 204
  • the first multi- lumen tube 10 may be configured to be fluidly coupled to the second dressing interface 206.
  • the tube- set 200 may further include a second single lumen tube 216, and a second multi-lumen tube 218.
  • the second single lumen tube 216 may be configured to be fluidly coupled to the solution source 122
  • the second multi-lumen tube 218 may be configured to be fluidly coupled to the negative-pressure source 102.
  • first single lumen tube 208 and the second single lumen tube 216 may be examples of a fluid conductor and can each be an extruded tube having a single lumen.
  • first single lumen tube 208 may comprise a first lumen 226, and the second single lumen tube 216 may comprise a second lumen 228.
  • the first multi-lumen tube 210 and the second multi lumen tube 218 may be examples of a fluid conductor and can each be an extruded tube having at least two lumens. In some embodiments, the at least two lumens may be side-by-side. In other embodiments, the first multi-lumen tube 210 and the second multi-lumen tube 218 may be an extruded tube having a central lumen and a plurality of peripheral lumens surrounding the central lumen. The plurality of peripheral lumens can be a plurality of pressure sensing lumens. In some embodiments, the plurality of pressure sensing lumens may provide lumen redundancy.
  • first multi-lumen tube 210 and the second multi-lumen tube 2108 may compnse a first film layer welded to a second film layer.
  • a plurality of features may project into a sealed space formed between the first film layer and the second film layer. The plurality of features may maintain an open pathway while also disrupting exudate flow to break up clots and thick exudate.
  • the first multi-lumen tube 210 may comprise a first delivery lumen 212 and a first pressure sensing lumen 214.
  • the second multi -lumen tube 218 may comprise a second delivery lumen 220 and a second pressure sensing lumen 222.
  • the adapter 224 may fluidly couple the first pressure sensing lumen 214 to the second pressure sensing lumen 222 to form a sensing pathway.
  • the sensing pathway may fluidly couple the therapy unit 128 to the second dressing interface 206 for sensing negative pressure at the tissue interface 108.
  • the sensing pathway may be fluidly coupled to one of more of the first sensor 118 and the second sensor 120 for determination of a pressure at the tissue site 202.
  • the adapter 224 may also be configured to fluidly couple the second lumen 228 to the first delivery lumen 212 to form an instillation pathway.
  • the instillation pathway may fluidly couple the solution source 122 to the second dressing interface 206 for delivering instillation solution to the tissue interface 108.
  • the adapter 224 may be further configured to fluidly couple the first lumen 226 to the second delivery lumen 220 to form a negative pressure pathway.
  • the negative pressure pathway may fluidly couple the negative-pressure source 102 to the first dressing interface 204 to deliver negative pressure to the tissue interface 108.
  • the therapy system 100 may be used without the solution source 122.
  • the second single lumen tube 216 that fluidly couples the solution source 122 to the adapter 224 may be removed.
  • An end cap or plug having the same inner diameter and outer diameter as the second single lumen tube 216 may be coupled to the adapter 224 in place of the second single lumen tube 216.
  • the end cap may be bonded to the adapter 224.
  • the first dressing interface 204 may deliver negative-pressure to the tissue site 202, and the second dressing interface 206 may sense pressure at the tissue site 202 separate from the first dressing interface 204.
  • the first dressing interface 204 and the second dressing interface 206 may be placed across a plurality of wounds.
  • the first dressing interface 204 may be positioned on a dressing covering a first tissue site
  • the second dressing interface 206 may be positioned on a dressing covering a second tissue site.
  • the two dressings may be fluidly coupled by a bridge dressing permitting negative-pressure to be distributed to the two dressings from a single negative-pressure source.
  • Negative-pressure can be provided to the first dressing interface 204, and the pressure sensing components can be fluidly coupled to the second dressing interface 206.
  • the pressure for the first tissue site and the second tissue can be determined by measuring the pressure at the tissue site that is not directly receiving negative-pressure therapy. Additional tissue sites can be monitored provided that the second dressing interface 206 be applied to the tissue site that is last in the fluid chain from the first dressing interface 204.
  • FIG 3 is an exploded, perspective view of the adapter 224, illustrating additional details that may be associated with some embodiments.
  • the adapter 224 may comprise a first housing 302 and a second housing 304.
  • the first housing 302 may compnse a base portion, such as a first base 306.
  • the first base 306 may comprise a first planar surface 308 and a second planar surface 310 (not shown) opposite the first planar surface 308.
  • the first base 306 may also include a first end 312 and a second end 314 opposite the first end 312.
  • the first housing 302 may comprise a first annular wall 316 proximate to the first end 312 and a second annular wall 318 proximate to the second end 314.
  • the first annular wall 316 and the second annular wall 318 may each be coupled to and extend from the first planar surface 308 of the first housing 302.
  • the first housing 302 may also include a third annular wall 320 inboard of the first annular wall 316.
  • the first housing 302 may also include a seventh annular wall 338 coupled to and extending from the second planar surface 310. The seventh annular wall 338 may be inboard of an exterior edge of the first base 306.
  • the second housing 304 may comprise a base portion, such as a second base 322.
  • the second base 322 may comprise a third planar surface 324 and a fourth planar surface 326 (not shown) opposite the third planar surface 324.
  • the second base 322 may further comprise a third end 328 and a fourth end 330 opposite the third end 328.
  • the second housing 304 may include a fourth annular wall 332 proximate to the third end 328 and a fifth annular wall 334 proximate to the fourth end 330.
  • the fourth annular wall 332 and the fifth annular wall 334 may be coupled to and extend from the fourth planar surface 326.
  • the second housing 304 may also include a sixth annular wall 336 inboard of the fifth annular wall 334.
  • the second housing 304 may also include an eighth annular wall 340 and a ninth annular wall 342.
  • the eighth annular wall 340 maybe coupled to the third planar surface 324 and extend outward from the third planar surface 324.
  • the eighth annular wall 340 may also be coupled to an exterior edge of the second base 322 and extend outward from the third planar surface 324.
  • the ninth annular wall 342 may be inboard of the exterior edge of the second base 322. In some embodiments, the ninth annular wall 342 is inboard of the eighth annular wall 340.
  • the eighth annular wall 340 and the ninth annular wall 342 may form an annulus 343 adapted to receive a portion of the first housing 302.
  • the annulus 343 may be adapted to receive the seventh annular wall 338 of the first housing 302 to couple the first housing 302 to the second housing 304.
  • the seventh annular wall 338, the eighth annular wall 340, and the ninth annular wall 342 may be coupled to each other, for example, by ultrasonic welding, a friction fit, or by being adhered to each other.
  • Figure 4 is a cross-sectional view of the adapter 224 taken along line 4 — 4 of Figure 2, illustrating additional details that may be associated with some embodiments of the therapy system of Figure 2.
  • the first housing 302 may comprise a first receptacle 400 and a second receptacle 402.
  • the first annular wall 316 may form the first receptacle 400 and the second annular wall 318 may form the second receptacle 402.
  • the first receptacle 400 may have a first fluid path 404 and a second fluid path 406 independent of the first fluid path 404.
  • the second receptacle 402 may have a third fluid path 408.
  • the third annular wall 320 may include a portion extending from the first planar surface 308 into a portion of the first receptacle 400 and another portion extending from the second planar surface 310.
  • the third annular wall 320 may have an outer diameter less than an inner diameter of the first annular wall 316 to form the first fluid path 404 through the first receptacle 400 between the first annular wall 316 and the third annular wall 320.
  • the second fluid path 406 may be formed through the first receptacle 400 and inboard of the third annular wall 320.
  • the second housing 304 may comprise a third receptacle 410 and a fourth receptacle 412.
  • the fifth annular wall 334 may form the third receptacle 410 and the fourth annular wall 332 may form the fourth receptacle 412.
  • the third receptacle 410 may have a fourth fluid path 414 and a fifth fluid path 416 independent of the fourth fluid path 414.
  • the fourth receptacle 412 may have a sixth fluid path 418.
  • the sixth annular wall 336 may include a portion extending from the fourth planar surface 326 into a portion of the third receptacle 410 and another portion extending from the third planar surface 324
  • the sixth annular wall 336 may have an outer diameter less than an inner diameter of the fifth annular wall 334 to form the fourth fluid path 414 through the third receptacle 410 between the fifth annular wall 334 and the sixth annular wall 336.
  • the fifth fluid path 416 may be formed through the third receptacle 410 and inboard of the sixth annular wall 336.
  • Figure 5 is a cross-sectional view of the tube-set 200 with the adapter 224 taken in the plane of Figure 2, illustrating additional details that may be associated with some embodiments.
  • the first receptacle 400 of the adapter 224 may be configured to receive a multi-lumen tube, such as the first multi-lumen tube 210. At least one lumen of the first multi -lumen tube 210 may be fluidly coupled to the first fluid path 404 and at least one other lumen of the first multi-lumen tube 210 may be fluidly coupled to the second fluid path 406.
  • first pressure sensing lumen 214 of the first multi -lumen tube 210 may be fluidly coupled to the first fluid path 404, and the first delivery lumen 212 of the first multi-lumen tube 210 may be fluidly coupled to the second fluid path 406.
  • the second receptacle 402 of the adapter 224 may be configured to receive a single-lumen tube, such as the first single lumen tube 208.
  • the first lumen 226 of the first single lumen tube 208 may be fluidly coupled to the third fluid path 408.
  • the third receptacle 410 of the adapter 224 may be configured to receive another multi lumen tube, such as the second multi-lumen tube 218. At least one lumen of the second multi-lumen tube 218 may be fluidly coupled to the fourth fluid path 414 and at least one other lumen of the second multi -lumen tube 218 may be fluidly coupled to the fifth fluid path 416.
  • the second pressure sensing lumen 222 of the second multi-lumen tube 218 may be fluidly coupled to the fourth fluid path 414, and the second delivery lumen 220 of the second multi-lumen tube 218 may be fluidly coupled to the fifth fluid path 416.
  • the fourth receptacle 412 of the adapter 224 may be configured to receive another single-lumen tube, such as the second single lumen tube 216.
  • the second lumen 228 may be fluidly coupled to the sixth fluid path 418.
  • the first housing 302 may be coupled to the second housing 304.
  • the eighth annular wall 340 and the ninth annular wall 342 of the second housing 304 may receive the seventh annular wall 338 of the first housing 302 to couple the first housing 302 to the second housing 304.
  • a cavity 500 is formed between the first housing 302 and the second housing 304 when the first housing 302 and the second housing 304 are coupled.
  • the cavity 500 may be formed inboard of the ninth annular wall 342 and between the first housing 302 and the second housing 304.
  • the first pressure sensing lumen 214 and the second pressure-sensing lumen 222 may be fluidly coupled via the cavity 00 to form the sensing pathway comprising the first fluid path 404, the cavity 500, and the fourth fluid path 414.
  • the first delivery lumen 212 of the first multi -lumen tube 210 may be fluidly coupled to the second lumen 228 of the second single lumen tube 216 via the second fluid path 406 and the sixth fluid path 418 to form the instillation pathway.
  • the second delivery lumen 220 of the second multi -lumen tube 218 may be fluidly coupled to the first lumen 226 of the first single lumen tube 208 via the third fluid path 408 and the fifth fluid path 416 to form the negative pressure pathway.
  • the first housing 302 may comprise a first hole 600 and a second hole 602, each hole extending through the first base 306 from the first planar surface 308 to the second planar surface 310.
  • the first hole 600 may be proximate to the first end 312 and the second hole 602 may be proximate the second end 314.
  • the first hole 600 of the first housing 302 may be associated with the first receptacle 400 and the second hole 602 of the first housing 302 may be associated with the second receptacle 402.
  • the first annular wall 316 may substantially surround the first hole 600 and have an inner diameter coincident with a diameter of the first hole 600.
  • the inner diameter of the first hole 600 may be about 6 mm to about 8 mm, and the outer diameter of the first annular wall 316 may be about 9 mm to about 12 mm.
  • the second annular wall 318 may substantially surround the second hole 602 and have an inner diameter coincident with a diameter of the second hole 602.
  • the inner diameter of the second hole 602 may be about 5 mm to about 8 mm, and the inner diameter of the second annular wall 318 may be about 8 mm to about 12 mm.
  • the third annular wall 320 may be disposed in the first hole 600 and coupled to the first base 306. In some embodiments, the third annular wall 320 may have an inner diameter of about 2 mm to about 4 mm.
  • the first hole 600 may comprise the first fluid path 404 and the second fluid path 406 independent of the first fluid path 404.
  • the second hole 602 may comprise the third fluid path 408
  • the second housing 304 may comprise a third hole 700 proximate to the third end 328 and a fourth hole 702 proximate to the fourth end 330.
  • the third hole 700 and the fourth hole 702 may each extend through the second base 322 from the third planar surface 324 to the fourth planar surface 326.
  • the third hole 700 may be associated with the fourth receptacle 412 and the fourth hole 702 may be associated with the third receptacle 410.
  • the fourth annular wall 332 may substantially surround the third hole 700 and have an inner diameter coincident with a diameter of the third hole 700.
  • the inner diameter of the third hole 700 may be about 5 mm to about 8 mm, and the inner diameter of the fourth annular wall 332 may be about 8 mm to about 12 mm.
  • the fifth annular wall 334 may substantially surround the fourth hole 702 and have an inner diameter coincident with a diameter of the fourth hole 702.
  • the inner diameter of the fourth hole 702 may be about 6 mm to about 8 mm, and the outer diameter of the fifth annular wall 334 may be about 9 mm to about 12 mm.
  • the sixth annular wall 336 may be disposed in the fourth hole 702 and coupled to the second base 322.
  • the sixth annular wall 336 may have an inner diameter of about 2 mm to about 4 mm.
  • the fourth hole 702 may comprise the fourth fluid path 414 and the fifth fluid path 416 independent of the fourth fluid path 414.
  • the third hole 700 may comprise the sixth fluid path 418.
  • Figure 8 is an exploded perspective view of the adapter 224 with the tube-set 200 of Figure 2, illustrating additional details that may be associated with some embodiments.
  • the portion of the third annular wall 320 extending from the first planar surface 308 may be configured to engage the first multi-lumen tube 210. If the first housing 302 and the second housing 304 are coupled, the portion of the third annular wall 320 extending from the second planar surface 310 may pass through the third hole 700 into a portion of the fourth receptacle 412 of the second housing 304 and be configured to engage the second single lumen tube 216.
  • the third annular wall 320 may fluidly isolate the first delivery lumen 212 from the first pressure sensing lumen 214.
  • the third annular wall 320 may also fluidly couple the first delivery lumen 212 to the second lumen 228 of the second single lumen tube 216.
  • the portion of the sixth annular wall 336 extending from the fourth planar surface 326 may be configured to engage the second multi-lumen tube 218. If the first housing 302 and the second housing 304 are coupled, the portion of the sixth annular wall 336 extending from the third planar surface 324 may pass through the second hole 602 into a portion of the second receptacle 402 of the first housing 302 and be configured to engage the first single lumen tube 208.
  • the sixth annular wall 336 may fluidly isolate the second delivery lumen 220 from the second pressure sensing lumen 222.
  • the sixth annular wall 336 may also fluidly couple the second delivery lumen 220 to the first single lumen tube 208.
  • Figure 9 is an assembled, perspective view of an embodiment of the tube-set 200.
  • the first housing 302 and the second housing 304 are coupled together to form the adapter 224.
  • the first receptacle 400, the second receptacle 402, the third receptacle 410, and the fourth receptacle 412 of the adapter 224 may be configured to receive a lumen or conduit.
  • the first receptacle 400 may receive the first multi -lumen tube 210
  • the second receptacle 402 may receive the first single lumen tube 208
  • the third receptacle 410 may receive the second multi -lumen tube 218, and the fourth receptacle 412 may receive the second single lumen tube 216.
  • a method for providing instillation therapy and negative-pressure therapy includes providing an inline connecter, such as the adapter 224.
  • the adapter 224 may include a plurality of ports, for example, the first receptacle 400, the second receptacle 402, the third receptacle 410, and the fourth receptacle 412.
  • the first receptacle 400 may comprise the first fluid path 404 and the second fluid path 406 independent of the first fluid path 404.
  • the second receptacle 402 may comprise the third fluid path 408.
  • the third receptacle may comprise the fourth fluid path 414 and the fifth fluid path 416 independent from the fourth fluid path 414.
  • the fourth receptacle 412 may comprise the sixth fluid path 418. Additionally, the adapter 224 may fluidly couple the first fluid path 404 to the fourth fluid path 414, the second fluid path 406 to the sixth fluid path 418, and the third fluid path 408 to the fifth fluid path 416.
  • the method may further include providing a therapy unit, such as the therapy unit 128.
  • the therapy unit 128 may comprise a negative pressure delivery lumen, at least one pressure sensing lumen, and an instillation therapy lumen.
  • the method may include fluidly coupling the negative pressure delivery lumen, such as the second delivery lumen 220, to the fifth fluid path 416; the at least one pressure sensing lumen, such as the second pressure sensing lumen 222, to the fourth fluid path 414; and the instillation therapy lumen, such as the second single lumen tube 216, to the sixth fluid path 418.
  • the method may further include fluidly coupling the first dressing interface 204 to the third fluid path 408 and fluidly coupling the second dressing interface 206 to both the first fluid path 404 and the second fluid path 406.
  • the first single lumen tube 208 may fluidly couple the first dressing interface 204 to the third fluid path 408, and the first pressure sensing lumen 214 and the first delivery lumen 212 may fluidly couple the second dressing interface 206 to the first fluid path 404 and the second fluid path 406, respectively.
  • the method may comprise fluidly coupling a multi-lumen tube to the first receptacle 400 of the adapter 224. Additionally, the method may comprise fluidly coupling a single lumen tube to the fourth receptacle of the adapter 224. In such an embodiment, at least one lumen of the multi-lumen tube may be fluidly coupled to the single lumen tube and at least one other lumen of the multi-lumen tube may be uncoupled from the single lumen tube. In some embodiments, the method may also comprise fluidly coupling another single lumen tube to the second receptacle 402 and fluidly coupling another multi-lumen tube to the third receptacle 410.
  • the multi-lumen tube may be a first multi-lumen tube, such as the first multi -lumen tube 210, and the method may further comprise fluidly coupling a second multi lumen tube, such as the second multi -lumen tube 218, to the third receptacle 410 of the adapter 224.
  • a second multi lumen tube such as the second multi -lumen tube 218, to the third receptacle 410 of the adapter 224.
  • at least one lumen of the first multi-lumen tube 210 may be fluidly coupled to a lumen of the second multi -lumen tube 218 and at least one other lumen of the first multi-lumen tube 210 may be uncoupled from at least one other of the lumens of the second multi -lumen tube 218.
  • the method may further comprise fluidly coupling a single lumen tube to the second receptacle 402 of the adapter 224.
  • the single lumen tube may be fluidly coupled to the at least one other lumen of the second multi -lumen tube 218.
  • the single lumen tube may be a first single lumen tube, such as the first single lumen tube 208.
  • the method may further comprise fluidly coupling a second single lumen tube, such as the second single lumen tube 216, to the fourth receptacle 412.
  • the at least one other lumens of the first multi-lumen tube 210 may be fluidly coupled to the lumen of the second single lumen tube 216.
  • the negative-pressure source 102 supplies negative pressure to the tissue interface 108 via the tube-set 200 and the first dressing interface 204.
  • negative pressure supplied from the negative-pressure source 102 travels through the second delivery lumen 220 of the second multi -lumen tube 218, through the fifth fluid path 416 and the third fluid path 408 of the adapter 224, and through the first lumen 226 of the first single lumen tube 208 to the first dressing interface 204.
  • the solution source 122 supplies instillation fluid to the tissue interface 108 via the tube-set 200 and the second dressing interface 206.
  • instillation fluid travels through the second lumen 228 of the second single lumen tube 216, through the sixth fluid path 418 and the second fluid path 406 of the adapter 224, and through the first delivery lumen 212 of the first multi -lumen tube 210 to the second dressing interface 206.
  • the instillation fluid then travels across the tissue site 202 from the second dressing interface 206 to the first dressing interface 204.
  • the instillation fluid and any wound exudate may be removed by the negative-pressure source 102.
  • Pressure at the tissue site 202 may be measured at the second dressing interface 206 where instillation fluid is supplied.
  • the second pressure sensing lumen 222 of the second multi-lumen tube 218 is fluidly coupled to the negative-pressure source 102 and the adapter 224.
  • the first pressure sensing lumens 214 are fluidly coupled to the adapter 224 and the second dressing interface 206.
  • the adapter 224 fluidly isolates the second pressure sensing lumens 222 from the second delivery lumen 220 of the second multi-lumen tube 218.
  • the adapter 224 also fluidly isolates the first delivery lumen 212 from the first pressure sensing lumens 214 of the first multi-lumen tube 210.
  • the adapter 224 fluidly couples the second pressure sensing lumens 222 of the second multi -lumen tube 218 to the first pressure sensing lumens 214 of the first multi-lumen tube 210 via the fourth fluid path 414, the cavity 500, and the first fluid path 404.
  • the embodiments described herein provide a connector or adapter 224 that can fluidly isolate the second delivery lumen 220 from the second pressure sensing lumen 222 of the second multi -lumen tube 218, allowing the second delivery lumen 220 to be fluidly coupled to the first dressing interface 204 and the second pressure sensing lumen 222 to be fluidly coupled to the second dressing interface 206 at opposing sides of the tissue site 202.
  • This arrangement allows pressure sensing to be separate from negative pressure delivery which enables the therapy system to monitor the pressure of the whole wound between the first dressing interface 204 and the second dressing interface 206. Additionally, this arrangement reduces the risk of overpressure and allows the therapy system to ensure that the pressure sensing lumens are subjected to at least -125mmHg.
  • Another advantage is that the therapy system can ensure that the dressing interface components are in pneumatic connection with the wound and each other to reduce errors and blockages. Further, the risk of clogging and blocking is reduced because fluid and exudate flows away from the pressure sensing lumens towards the negative pressure lumens rather than towards and over the pressure sensing lumens.

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  • Oral & Maxillofacial Surgery (AREA)
  • Surgery (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Un appareil destiné à dispenser une thérapie par pression négative et instillation sur un site tissulaire qui peut comprendre un premier orifice comportant un premier trajet de fluide et un deuxième trajet de fluide, un deuxième orifice comportant un troisième trajet de fluide, un troisième orifice comportant un quatrième trajet de fluide et un cinquième trajet de fluide, et un quatrième orifice comportant un sixième trajet de fluide. Le deuxième trajet de fluide peut être indépendant du premier trajet de fluide et le cinquième trajet de fluide peut être indépendant du quatrième trajet de fluide. L'appareil peut accoupler fluidiquement le premier trajet de fluide et le quatrième trajet de fluide, le deuxième trajet de fluide et le sixième trajet de fluide, et le troisième trajet de fluide et le cinquième trajet de fluide. Le premier orifice et le troisième orifice peuvent chacun être conçus pour recevoir un conduit à lumières multiples. Le deuxième orifice et le quatrième orifice peuvent chacun être conçus pour recevoir un conduit à lumière unique.
PCT/IB2021/053125 2020-04-17 2021-04-15 Ensemble de tubes pour la surveillance de la pression Ceased WO2021209951A1 (fr)

Applications Claiming Priority (2)

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US202063012003P 2020-04-17 2020-04-17
US63/012,003 2020-04-17

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3260144A1 (fr) * 2012-09-12 2017-12-27 KCI Licensing, Inc. Systèmes de collecte d'exsudats en thérapie sous pression réduite
EP3536246A1 (fr) * 2013-09-25 2019-09-11 KCI Licensing, Inc. Appareils et procédés de collecte en ligne d'un échantillon de fluide
US20200054804A1 (en) * 2016-11-10 2020-02-20 Mölnlycke Health Care Ab Connector system for a negative pressure wound therapy system
US20200086017A1 (en) * 2018-09-19 2020-03-19 Deroyal Industries, Inc. Tubing connection system for negative pressure wound therapy

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3260144A1 (fr) * 2012-09-12 2017-12-27 KCI Licensing, Inc. Systèmes de collecte d'exsudats en thérapie sous pression réduite
EP3536246A1 (fr) * 2013-09-25 2019-09-11 KCI Licensing, Inc. Appareils et procédés de collecte en ligne d'un échantillon de fluide
US20200054804A1 (en) * 2016-11-10 2020-02-20 Mölnlycke Health Care Ab Connector system for a negative pressure wound therapy system
US20200086017A1 (en) * 2018-09-19 2020-03-19 Deroyal Industries, Inc. Tubing connection system for negative pressure wound therapy

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